20 February 2015 EMA/52196/2015 – rev. 1 Procedure Management and Business Support
Products for which the marketing authorisations are recommended for suspension by the CHMP on 22 January 2015
Some of these medicinal products may be considered critical by the individual EU Member States. The suspension of the concerned marketing authorisation(s) may be deferred by the period for which the medicinal product is considered critical.
Article 31 of Directive 2001/83/EC
Procedure number: EMEA/H/A-31/1408
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.
Member State
Marketing Authorisation
(in EEA)
Holder
Austria
Arcana Arzneimittel GmbH
Esomeprazole
Esomeprazol Arcana 20 mg
Huetteldorfer Straße 299
magnesium
magensaftresistente
INN
1140 Wien
Invented name
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule, hard
Hartkapseln
Austria Austria
Arcana Arzneimittel GmbH
Esomeprazole
Esomeprazol Arcana 40 mg
Huetteldorfer Straße 299
magnesium
magensaftresistente
1140 Wien
40 mg
Gastro - resistant
Oral use
capsule, hard
Hartkapseln
Austria Austria
Arcana Arzneimittel GmbH
Esomeprazole
Neximyl 20 mg
Huetteldorfer Straße 299
magnesium
magensaftresistente
1140 Wien
20 mg
Gastro - resistant
Oral use
capsule, hard
Hartkapseln
Austria Austria
Arcana Arzneimittel GmbH
Esomeprazole
Neximyl 40 mg
Huetteldorfer Straße 299
magnesium
magensaftresistente
1140 Wien
40 mg
Gastro - resistant
Oral use
capsule, hard
Hartkapseln
Austria Austria
Arcana Arzneimittel GmbH
Candesartan
Candesartan Arcana 4mg
Huetteldorfer Straße 299
cilexetil
Tabletten
Arcana Arzneimittel GmbH
Candesartan
Candesartan Arcana 8mg
Huetteldorfer Straße 299
cilexetil
Tabletten
4 mg
Tablet
Oral use
8mg
Tablet
Oral use
1140 Wien Austria Austria
1140 Wien Austria
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Member State
Marketing Authorisation
(in EEA)
Holder
Austria
Arcana Arzneimittel GmbH
Candesartan
Candesartan Arcana 16mg
Huetteldorfer Straße 299
cilexetil
Tabletten
Arcana Arzneimittel GmbH
Candesartan
Candesartan Arcana 32mg
Huetteldorfer Straße 299
cilexetil
Tabletten
Nebivolol
Nebivolol Genericon 5 mg
INN
Invented name
Pharmaceutical
Route of
Form
administration
16 mg
Tablet
Oral use
32 mg
Tablet
Oral use
5 mg
Tablet
Oral use
2,5 mg
Orodispersible
Oral use
Strength
1140 Wien Austria Austria
1140 Wien Austria Austria
Genericon Pharma GmbH Hafnerstr. 211
Tabletten
8054 Graz Austria Austria
ratiopharm Arzneimittei-
Desloratadine
Vertriebs-GmbH
Desloratadin ratiopharm 2,5 mg Schmelztabletten
tablet
Albert-Schweitzer-Gasse 3 1140 Wien Austria Austria
ratiopharm Arzneimittei-
Desloratadine
Vertriebs-GmbH
Desloratadin ratiopharm 5
5 mg
mg Schmelztabletten
Orodispersible
Oral use
tablet
Albert-Schweitzer-Gasse 3 1140 Wien Austria Belgium
Apotex Europe B.V.
Desloratadine
Desloratadine Apotex
Darwinweg 20
5 mg
Film - coated
Oral use
tablet
NL 2333 CR Leiden Netherlands
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Member State
Marketing Authorisation
(in EEA)
Holder
Belgium
Mylan bvba/sprl
INN
Donepezil
Invented name
Donepezil Odis Mylan
Strength
5 mg
Terhulpsesteenweg 6A
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
1560 Hoeilaart Belgium Belgium
Mylan bvba/sprl
Donepezil
Donepezil Odis Mylan
10 mg
Terhulpsesteenweg 6A
Orodispersible
Oral use
tablet
1560 Hoeilaart Belgium Belgium
Mylan bvba/sprl
Repaglinide
Terhulpsesteenweg 6A
Repaglinide Mylan 0,5 mg
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
8 mg
Tablet
Oral use
Pharma
1560 Hoeilaart Belgium Belgium
Mylan bvba/sprl
Repaglinide
Terhulpsesteenweg 6A
Repaglinide Mylan 1 mg Pharma
1560 Hoeilaart Belgium Belgium
Mylan bvba/sprl
Repaglinide
Terhulpsesteenweg 6A
Repaglinide Mylan 2mg Pharma
1560 Hoeilaart Belgium Belgium
Mylan bvba/sprl
Candesartan
Candesartan Mylan
Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
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Member State
Marketing Authorisation
(in EEA)
Holder
Belgium
Mylan bvba/sprl
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Candesartan
Candesartan Mylan
16 mg
Tablet
Oral use
Candesartan
Candesartan Mylan
32 mg
Tablet
Oral use
Esomeprazole
Esomeprazole Mylan
20 mg
Gastro - resistant
Oral use
Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Belgium
Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
Belgium
Mylan bvba/sprl Terhulpsesteenweg 6A
capsule, hard
1560 Hoeilaart Belgium Belgium
Mylan bvba/sprl
Esomeprazole
Esomeprazole Mylan
40 mg
Terhulpsesteenweg 6A
Gastro - resistant
Oral use
capsule, hard
1560 Hoeilaart Belgium Belgium
Takeda Belgium
Alendronic acid
Alendromono
70 mg
Tablet
Oral use
Desloratadine
Desloratadine Teva
2,5 mg
Orodispersible
Oral use
Gentsesteenweg 615 1080 Brussels Belgium Belgium
Teva Pharma Belgium NV Laarstraat 16
tablet
2610 Wilrijk Belgium
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Member State
Marketing Authorisation
(in EEA)
Holder
Belgium
Teva Pharma Belgium NV
INN
Desloratadine
Invented name
Desloratadine Teva
Strength
5 mg
Laarstraat 16
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
2610 Wilrijk Belgium Bulgaria
Accord Healthcare Limited
Ropinirole
Ropinirole Accord
0,5 mg
Sage House, 319 Pinner Road
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom Bulgaria
Accord Healthcare Limited
Ropinirole
Ropinirole Accord
1 mg
Sage House, 319 Pinner Road
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom Bulgaria
Accord Healthcare Limited
Ropinirole
Ropinirole Accord
2 mg
Sage House, 319 Pinner Road
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom Bulgaria
Accord Healthcare Limited
Ropinirole
Ropinirole Accord
Sage House, 319 Pinner Road
5 mg
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom
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Member State
Marketing Authorisation
(in EEA)
Holder
Bulgaria
Alkaloid - INT d.o.o.
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Cefpodoxime
FOXERO
200 mg
Tablet
Oral use
Quetiapine
Aquatiapine
25 mg
Film - coated
Oral use
Šlandrova 4 1231 Ljubljana - Črnuče Slovenia Bulgaria
Aquachim AD blvd. Prof. Tsvetan Lazarov
tablet
83 Sofia 1582 Bulgaria Bulgaria
Aquachim AD
Quetiapine
Aquatiapine
100 mg
blvd. Prof. Tsvetan Lazarov
Film - coated
Oral use
tablet
83 Sofia 1582 Bulgaria Bulgaria
Aquachim AD
Quetiapine
Aquatiapine
200 mg
blvd. Prof. Tsvetan Lazarov
Film - coated
Oral use
tablet
83 Sofia 1582 Bulgaria Bulgaria
Generics (UK) Ltd
Esomeprazole
Station Close, Potters Bar
magnesium
Esopragen
20 mg
Gastro - resistant
Oral use
capsule, hard
Hertfordshire, EN6 1TL United Kingdom
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Member State
Marketing Authorisation
(in EEA)
Holder
Bulgaria
Generics (UK) Ltd
Esomeprazole
Station Close, Potters Bar
magnesium
INN
Invented name
Esopragen
Strength
40 mg
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule, hard
Hertfordshire, EN6 1TL United Kingdom Bulgaria
Glenmark Pharmaceuticals
Trimetazidine
s.r.o.
Apstar 35 mg
35 mg
prolonged-release tablets
Prolonged -
Oral use
release tablet
Hvězdova 1716/2b 14078 Praha 4 Czech Republic Bulgaria
Mylan SAS
Trimetazidine
Trimetazigen MR
35 mg
117 allée des Parcs
Prolonged -
Oral use
release tablet
69792 Saint-Priest Cedex France Bulgaria
Neo Balkanika EOOD
Nebivolol
Bivolet
5 mg
Tablet
Oral use
Trimetazidine
Energotrim
35 mg
Prolonged -
Oral use
35 Zemliane Str. Sofia 1618 Bulgaria Bulgaria
Sandoz Pharmaceuticals d.d. Verovskova 57
release tablet
Ljubljana SI-1000 Slovenia Bulgaria
Tchaikapharma Highquality
Bosentan
Pulmohyperta
Medicines
62,5 mg
Film - coated
Oral use
tablet
1 G. M. Dimitrov Blvd. Sofia 1172 Bulgaria
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Member State
Marketing Authorisation
(in EEA)
Holder
Bulgaria
Tchaikapharma Highquality
INN
Bosentan
Invented name
Pulmohyperta
Strength
125 mg
Medicines
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
1 G. M. Dimitrov Blvd. Sofia 1172 Bulgaria Croatia
Alkaloid d.o.o.
Cefpodoxime
Ulica grada Vukovara 226 F
Rexocef 200 mg filmom
200 mg
obložene tablete
Film - coated
Oral use
tablet
Zagreb 10000 Croatia Croatia
Belupo, lijekovi i kozmetika
Desloratadine
d.d.
Alerdin 2,5 mg raspadljive
2,5 mg
tablete za usta
Orodispersible
Oral use
tablet
Ulica Danica 5 Koprivnica 48000 Croatia Croatia
Belupo, lijekovi i kozmetika
Desloratadine
d.d.
Alerdin 5 mg raspadljive
5 mg
tablete za usta
Orodispersible
Oral use
tablet
Ulica Danica 5 Koprivnica 48000 Croatia Croatia
Fidifarm d.o.o. Obrtnička 37, Bestovje
Desloratadine
Sinalerg 5 mg filmom obložene tablete
5 mg
Film - coated
Oral use
tablet
Rakitje 10437 Croatia
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Member State
Marketing Authorisation
(in EEA)
Holder
Croatia
Jadran Galenski Laboratorij
INN
Desloratadine
d.d.
Invented name
Escontral direkt 2,5 mg
Strength
2,5 mg
raspadljiva tableta za usta
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
Svilno 20, Rijeka 51000 Croatia Croatia
Jadran Galenski Laboratorij
Desloratadine
d.d.
Escontral direkt 5 mg
5 mg
raspadljiva tableta za usta
Orodispersible
Oral use
tablet
Svilno 20, Rijeka 51000 Croatia Croatia
Croatia
PharmaS d.o.o.
Tramadol/paraceta
Tramadol/Paracetamol
37,5
Film - coated
Radnička cesta 47
mol
PharmaS 37,5 mg/
mg/325 mg
tablet
10 mg
Film - coated
Zagreb 10000
325 mg filmom obložene
Croatia
tablete
PharmaS d.o.o.
Escitalopram
Escitalopram PharmaS 10
Radnička cesta 47
mg filmom
Zagreb 10000
obložene tablete
Oral use
Oral use
tablet
Croatia Croatia
Sandoz d.o.o.
Trimetazidine
Vazidin 35 mg tablete s
Maksimirska 120
hydrochloride
produljenim oslobađanjem
35 mg
Prolonged -
Oral use
release tablet
Zagreb 10000 Croatia
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Member State
Marketing Authorisation
(in EEA)
Holder
Cyprus
Accord Healthcare Limited
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Alendronic acid
Alendronic Acid Accord
70 mg
Tablet
Oral use
Entacapone
Nobat
200 mg
Film - coated
Oral use
Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex United Kingdom Cyprus
Delorbis Pharmaceuticals Ltd 17 Athinon Street
tablet
Ergates Industrial Area 2643 Ergates P.O. Box 28629 2081 Lefkosia Cyprus Cyprus
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
Valsartan/Hctz Fair-med
DE-22765 Hamburg
160
Film - coated
mg/12,5
tablet
Oral use
mg
Germany Cyprus
Generics Pharma Hellas Ltd
Donepezil
577a Vouliagmenis Avenue
hydrochloride
Donepezil/Generics
5 mg
Orodispersible
Oral use
tablet
Argyroupoli 164-51 Athens Greece Cyprus
Generics Pharma Hellas Ltd
Donepezil
577a Vouliagmenis Avenue
hydrochloride
Donepezil/Generics
10 mg
Orodispersible
Oral use
tablet
Argyroupoli 164-51 Athens Greece
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Member State
Marketing Authorisation
(in EEA)
Holder
Cyprus
Lambda Therapeutic Limited
Ropinirole
Sage House
hydrochloride
INN
Invented name
Ropinirole Lambda
Strength
0,25 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom Cyprus
Lambda Therapeutic Limited
Ropinirole
Sage House
hydrochloride
Ropinirole Lambda
0,5 mg
Film - coated
Oral use
tablet
319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom Cyprus
Lambda Therapeutic Limited
Ropinirole
Sage House
hydrochloride
Ropinirole Lambda
1 mg
Film - coated
Oral use
tablet
319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom Cyprus
Lambda Therapeutic Limited
Ropinirole
Sage House
hydrochloride
Ropinirole Lambda
2 mg
Film - coated
Oral use
tablet
319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom
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Member State
Marketing Authorisation
(in EEA)
Holder
Cyprus
Lambda Therapeutic Limited
Ropinirole
Sage House
hydrochloride
INN
Invented name
Ropinirole Lambda
Strength
5 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom Cyprus
Wockhardt UK Limited
Clopidogrel
Ash Road North
hydrochloride
Clopidogrel/Wockhardt
75 mg
Film - coated
Oral use
tablet
Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom Czech Republic
Abbott Laboratories, s.r.o.
Escitalopram
Evropská 2591/33d
oxalate
Purcema 5 mg
5 mg
Film - coated
Oral use
tablet
160 00 Praha 6 - Hadovka Office Park Czech Republic Czech Republic
Abbott Laboratories, s.r.o.
Escitalopram
Evropská 2591/33d
oxalate
Purcema 10 mg
10 mg
Film - coated
Oral use
tablet
160 00 Praha 6 - Hadovka Office Park Czech Republic Czech Republic
Abbott Laboratories, s.r.o.
Escitalopram
Evropská 2591/33d
oxalate
Purcema 15 mg
15 mg
Film - coated
Oral use
tablet
160 00 Praha 6 - Hadovka Office Park Czech Republic
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Member State
Marketing Authorisation
(in EEA)
Holder
Czech Republic
Abbott Laboratories, s.r.o.
Escitalopram
Evropská 2591/33d
oxalate
INN
Invented name
Purcema 20 mg
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
160 00 Praha 6 - Hadovka Office Park Czech Republic Czech Republic
Actavis Group PTC ehf.
Metformin
Metformin Actavis Retard
Reykjavikurvegi 76-78
hydrochloride
500 mg
Actavis Group PTC ehf.
Metformin
Metformin Actavis Retard
Reykjavikurvegi 76-78
hydrochloride
750 mg
Cefpodoxime
Forexo 200 mg potahované
500 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjördur Iceland Czech Republic
750 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjördur Iceland Czech Republic
Alkaloid - INT d.o.o. Šlandrova 4
200 mg
tablety
Film - coated
Oral use
tablet
1231 Ljubljana - Črnuče Slovenia Czech Republic
Alvogen IPCo S.ar.l.
Desloratadine
Rue Heienhaff 5
Desloratadin Alvogen 5 mg
5 mg
potahované tablety
Film - coated
Oral use
tablet
L-1736 Senningerberg Luxembourg Czech Republic
Apotex Europe B.V.
Trimetazidine
Darwinweg 20
dihydrochloride
Apo-trimetazidin 35 mg
35 mg
Prolonged -
Oral use
release tablet
NL 2333 CR Leiden Netherlands
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Member State
Marketing Authorisation
(in EEA)
Holder
Czech Republic
Generics (UK) Ltd
Esomeprazole
Station Close, Potters Bar
magnesium
INN
Invented name
Esomylan 40 mg
Strength
40 mg
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule, hard
Hertfordshire, EN6 1TL United Kingdom Czech Republic
Generics (UK) Ltd
Rizatriptan
Station Close, Potters Bar
benzoate
Rizatriptan Mylan 5 mg
5 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL United Kingdom Czech Republic
Generics (UK) Ltd
Rizatriptan
Station Close, Potters Bar
benzoate
Rizatriptan Mylan 10 mg
10 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL United Kingdom Czech Republic
Generics (UK) Ltd
Donepezil
Station Close, Potters Bar
hydrochloride
Donepezil Mylan 10 mg
10 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL United Kingdom Czech Republic
Glenmark Pharmaceuticals
Trimetazidine
Portora 35 mg tablety s
s.r.o.
dihydrochloride
prodlouženým uvolňováním
Desloratadine
Geslora 5 mg
35 mg
Prolonged -
Oral use
release tablet
Hvězdova 1716/2b 14078 Praha 4 Czech Republic Czech Republic
GNR Czech s.r.o. Slavojova 579/9
5 mg
Film - coated
Oral use
tablet
128 00 Praha 2 Czech Republic
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Member State
Marketing Authorisation
(in EEA)
Holder
Czech Republic
Labormed-Pharma, SA
INN
Desloratadine
Invented name
Desloratadin Labormed 2,5
Theodor Pallady, 44B
mg tablety dispergovatelné
032266 Bucharest
v ústech
Strength
2,5 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
Romania Czech Republic
Labormed-Pharma, SA
Desloratadine
Desloratadin Labormed 5
Theodor Pallady, 44B
mg tablety dispergovatelné
032266 Bucharest
v ústech
5 mg
Orodispersible
Oral use
tablet
Romania Czech Republic
Mylan SAS
Trimetazidine
Trimetazidin Mylan 35 mg
35 mg
117 allée des Parcs
Prolonged -
Oral use
release tablet
69792 Saint-Priest Cedex France Czech Republic
SVUS Pharma a.s.
Desloratadine
Smetanovo nábřeží 1238/20a
Lotera 5 mg potahované
5 mg
tablety
Film - coated
Oral use
tablet
500 02 Hradec Králové Czech Republic Denmark
Actavis Group PTC ehf.
Metformin
Metformin "Actavis PTC"
500 mg
Reykjavikurvegi 76-78
Prolonged -
Oral use
release tablet
220 Hafnarfjördur Iceland Denmark
Actavis Group PTC ehf.
Metformin
Metformin "Actavis PTC"
Reykjavikurvegi 76-78
750 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjördur Iceland
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Member State
Marketing Authorisation
(in EEA)
Holder
Denmark
Bluefish Pharmaceuticals AB
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Fluconazole
Fluconazol "Bluefish"
50 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol "Bluefish"
150 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol "Bluefish"
200 mg
Capsule, hard
Oral use
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/hydrochlorthiazid
160
Film - coated
Oral use
Planckstrasse 13
orothiazide
"Fair-Med"
mg/12,5
tablet
Torsgatan 11 SE-11123 Stockholm Sweden Denmark
Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden
Denmark
Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden
Denmark
DE-22765 Hamburg
mg
Germany Denmark
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/hydrochlorthiazid
320
Film - coated
Planckstrasse 13
orothiazide
"Fair-Med"
mg/12,5
tablet
DE-22765 Hamburg
Oral use
mg
Germany Denmark
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/hydrochlorthiazid
320 mg/25
Film - coated
Planckstrasse 13
orothiazide
"Fair-Med"
mg
tablet
Oral use
DE-22765 Hamburg Germany
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Member State
Marketing Authorisation
(in EEA)
Holder
Denmark
Mylan AB
INN
Eletriptan
Invented name
Eletriptan Mylan
Strength
40 mg
PO Box 230 33
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
SE-104 35 Stockholm Sweden Denmark
Mylan AB
Esomeprazole
Esomeprazol Mylan
20 mg
PO Box 230 33
Gastro - resistant
Oral use
capsule, hard
SE-104 35 Stockholm Sweden Denmark
Mylan AB
Esomeprazole
Esomeprazol Mylan
40 mg
PO Box 230 33
Gastro - resistant
Oral use
capsule, hard
SE-104 35 Stockholm Sweden Denmark
Mylan AB
Rizatriptan
Rizatriptan Mylan
10 mg
PO Box 230 33
Orodispersible
Oral use
tablet
SE-104 35 Stockholm Sweden Denmark
Stadapharm GmbH
Entacapone
Entacapon STADA
200 mg
Stadastr. 2-18
Film - coated
Oral use
tablet
D-61118 Bad Vilbel Germany Estonia
Accord Healthcare Limited Sage House, 319 Pinner Road
Alendronic acid
ALENDRONIC ACID
70 mg
Tablet
Oral use
ACCORD 70mg
North Harrow HA1 4HF Middlesex United Kingdom
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Member State
Marketing Authorisation
(in EEA)
Holder
Estonia
Sandoz Pharmaceuticals d.d.
INN
Trimetazidine
Invented name
ZIDMETIN
Strength
35 mg
Verovskova 57
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
tablet
Ljubljana SI-1000 Slovenia Finland
Actavis Group PTC ehf.
Metformin
Metformin Actavis
500 mg
Reykjavikurvegi 76-78
Prolonged -
Oral use
release tablet
220 Hafnarfjördur Iceland Finland
Actavis Group PTC ehf.
Metformin
Metformin Actavis
750 mg
Reykjavikurvegi 76-78
Prolonged -
Oral use
release tablet
220 Hafnarfjördur Iceland Finland
Bluefish Pharmaceuticals AB
Fluconazole
Fluconazol Bluefish
50 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
150 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
200 mg
Capsule, hard
Oral use
Torsgatan 11 SE-11123 Stockholm Sweden Finland
Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden
Finland
Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden
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Page 19/131
Member State
Marketing Authorisation
(in EEA)
Holder
Finland
Mylan AB
INN
Eletriptan
Invented name
Eletriptan Mylan
Strength
40 mg
PO Box 230 33
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
SE-104 35 Stockholm Sweden Finland
Mylan AB
Repaglinide
Repaglinid Mylan
0,5 mg
Tablet
Oral use
Repaglinide
Repaglinid Mylan
1 mg
Tablet
Oral use
Repaglinide
Repaglinid Mylan
2 mg
Tablet
Oral use
Valsartan
VALSARTAN ORION
40 mg
Film - coated
Oral use
PO Box 230 33 SE-104 35 Stockholm Sweden Finland
Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden
Finland
Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden
Finland
Orion Corporation Orion Pharma
tablet
PO BOX 65 02101 Espoo Finland Finland
Orion Corporation
Valsartan
VALSARTAN ORION
Orion Pharma
80 mg
Film - coated
Oral use
tablet
PO BOX 65 02101 Espoo Finland
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Member State
Marketing Authorisation
(in EEA)
Holder
Finland
Orion Corporation
INN
Valsartan
Invented name
VALSARTAN ORION
Strength
160 mg
Orion Pharma
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
PO BOX 65 02101 Espoo Finland Finland
Orion Corporation
Valsartan
VALSARTAN ORION
320 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65 02101 Espoo Finland Finland
ratiopharm GmbH
Desloratadine
Desloratadine Ratiopharm
2,5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm Germany Finland
ratiopharm GmbH
Desloratadine
Desloratadine Ratiopharm
5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm Germany France
Abbott Products SAS
Escitalopram
42 rue Rouget de Lisle
ESCITALOPRAM ABBOTT
5 mg
5mg, comprimé pelliculé
Film - coated
Oral use
tablet
92150 Suresnes France France
Abbott Products SAS 42 rue Rouget de Lisle
Escitalopram
ESCITALOPRAM ABBOTT 10mg, comprimé pelliculé
10 mg
Film - coated
Oral use
tablet
92150 Suresnes France
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
France
Abbott Products SAS
INN
Escitalopram
42 rue Rouget de Lisle
Invented name
ESCITALOPRAM ABBOTT
Strength
15 mg
15mg, comprimé pelliculé
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
92150 Suresnes France France
Abbott Products SAS
Escitalopram
42 rue Rouget de Lisle
ESCITALOPRAM ABBOTT
20 mg
20mg, comprimé pelliculé
Film - coated
Oral use
tablet
92150 Suresnes France France
ACCORD HEALTHCARE France
Ropinirole
SAS
Ropinirole Accord 0,25mg,
0,25 mg
comprimé pelliculé
Film - coated
Oral use
tablet
45 Rue de Fbg de Roubaix 59000 Lille France France
ACCORD HEALTHCARE France
Ropinirole
SAS
Ropinirole Accord 0,5mg,
0,5 mg
comprimé pelliculé
Film - coated
Oral use
tablet
45 Rue de Fbg de Roubaix 59000 Lille France France
ACCORD HEALTHCARE France SAS
Ropinirole
Ropinirole Accord 1mg, comprimé pelliculé
1 mg
Film - coated
Oral use
tablet
45 Rue de Fbg de Roubaix 59000 Lille France
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
France
ACCORD HEALTHCARE France
INN
Ropinirole
SAS
Invented name
Ropinirole Accord 2mg,
Strength
2 mg
comprimé pelliculé
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
45 Rue de Fbg de Roubaix 59000 Lille France France
ACCORD HEALTHCARE France
Ropinirole
SAS
Ropinirole Accord 5mg,
5 mg
comprimé pelliculé
Film - coated
Oral use
tablet
45 Rue de Fbg de Roubaix 59000 Lille France France
Brown & Burk UK, Ltd.
Escitalopram
ESCITALOPRAM BROWN 5
5, Marryat Close
mg, comprimé pelliculé
Hounslow
sécable
5 mg
Film - coated
Oral use
tablet
TW4 5DQ Middlesex United Kingdom France
Brown & Burk UK, Ltd.
Escitalopram
ESCITALOPRAM BROWN 10
5, Marryat Close
mg, comprimé pelliculé
Hounslow
sécable
10 mg
Film - coated
Oral use
tablet
TW4 5DQ Middlesex United Kingdom France
Brown & Burk UK, Ltd.
Escitalopram
ESCITALOPRAM BROWN 15
5, Marryat Close
mg, comprimé pelliculé
Hounslow
sécable
15 mg
Film - coated
Oral use
tablet
TW4 5DQ Middlesex United Kingdom
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Page 23/131
Member State
Marketing Authorisation
(in EEA)
Holder
France
Brown & Burk UK, Ltd.
INN
Escitalopram
Invented name
ESCITALOPRAM BROWN 20
5, Marryat Close
mg, comprimé pelliculé
Hounslow
sécable
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
TW4 5DQ Middlesex United Kingdom France
Brown & Burk UK, Ltd.
Ebastine
EBASTINE BROWN & BURK
5, Marryat Close
10 mg, comprimé
Hounslow
orodispersible
10 mg
Orodispersible
Oral use
tablet
TW4 5DQ Middlesex United Kingdom France
France
Cristers
Desloratadine
DESLORATADINE
22, quai Galliéni
CRISTERS
92150 Suresnes
5 mg
France
comprimé pelliculé
Cristers
Ibuprofen
IBUPROFENE CRISTERS
22, quai Galliéni
400 mg
92150 Suresnes
comprimé pelliculé
5 mg
Film - coated
Oral use
tablet
400 mg
Film - coated
Oral use
tablet
France France
Laboratoires Biogaran 15, boulevard Charles de
Ebastine
EBASTINE BIOGARAN 10 mg comprimé pelliculé
10 mg
Film - coated
Oral use
tablet
Gaulle 92707 Colombes Cedex France
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Member State
Marketing Authorisation
(in EEA)
Holder
France
Laboratoires Biogaran
INN
Ebastine
Invented name
EBASTINE BIOGARAN 10
15, boulevard Charles de
mg comprimé
Gaulle
orodispersible
Strength
10 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
92707 Colombes Cedex France France
Laboratoires GERDA
Desloratadine
DESLORATADINE ARROW
24 rue Erlanger
5 mg
75016 PARIS
comprimé pelliculé
5 mg
Film - coated
Oral use
tablet
France France
Medipha Sante
Tramadol/paraceta
TRAMADOL PARACETAMOL
37,5
Film - coated
Les Fjords - Immeuble Oslo
mol
NIALEX 37,5 mg/325 mg
mg/325 mg
tablet
5 mg
Film - coated
19 avenue de Norvège
Oral use
comprimé pelliculé
91953 Courtaboeuf Cedex France France
Medipha Sante
Desloratadine
DESLORATADINE GNR
Les Fjords - Immeuble Oslo
5 mg
19 avenue de Norvège
comprimé pelliculé
Oral use
tablet
91953 Courtaboeuf Cedex France France
Mylan SAS 117 allée des Parcs
Rizatriptan
RIZATRIPTAN MYLAN 5mg, orodispersible tablet
5 mg
Orodispersible
Oral use
tablet
69792 Saint-Priest Cedex France
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Page 25/131
Member State
Marketing Authorisation
(in EEA)
Holder
France
Mylan SAS
INN
Rizatriptan
117 allée des Parcs
Invented name
RIZATRIPTAN MYLAN 10
Strength
10 mg
mg, orodispersible tablet
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
69792 Saint-Priest Cedex France France
Mylan SAS
Ebastine
117 allée des Parcs
EBASTINE MYLAN 10mg,
10 mg
film-coated tablet
Film - coated
Oral use
tablet
69792 Saint-Priest Cedex France France
Mylan SAS
Ebastine
117 allée des Parcs
EBASTINE MYLAN 10mg,
10 mg
orodispersible tablet
Orodispersible
Oral use
tablet
69792 Saint-Priest Cedex France France
Mylan SAS
Trimetazidine
TRIMETAZIDINE MYLAN 35
117 allée des Parcs
mg Modified Release
69792 Saint-Priest Cedex
Tablets
35 mg
Modified - release
Oral use
tablet
France France
Mylan SAS
Candesartan
117 allée des Parcs
CANDESARTAN MYLAN 32
32 mg
Tablet
Oral use
5 mg
Orodispersible
Oral use
mg, comprimé secable
69792 Saint-Priest Cedex France France
Mylan SAS 117 allée des Parcs
Donepezil
DONEPEZIL MYLAN 5 mg, orodispersible tablet
tablet
69792 Saint-Priest Cedex France
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Member State
Marketing Authorisation
(in EEA)
Holder
France
Mylan SAS
INN
Donepezil
117 allée des Parcs
Invented name
DONEPEZIL MYLAN 10
Strength
10 mg
mg, orodispersible tablet
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
69792 Saint-Priest Cedex France France
Mylan SAS
Esomeprazole
117 allée des Parcs
ESOMEPRAZOLE MYLAN
20 mg
PHARMA 20mg, DR capsule
Gastro - resistant
Oral use
capsule, hard
69792 Saint-Priest Cedex France France
Mylan SAS
Esomeprazole
117 allée des Parcs
ESOMEPRAZOLE MYLAN
40 mg
PHARMA 40mg, DR capsule
Gastro - resistant
Oral use
capsule, hard
69792 Saint-Priest Cedex France France
Mylan SAS
Desmopressin
117 allée des Parcs
DESMOPRESSINE MYLAN
0,06 mg
60 µg, orodispersible tablet
Orodispersible
Oral use
tablet
69792 Saint-Priest Cedex France France
Mylan SAS
Desmopressin
DESMOPRESSINE MYLAN
117 allée des Parcs
120 µg, orodispersible
69792 Saint-Priest Cedex
tablet
0,12 mg
Orodispersible
Oral use
tablet
France France
Mylan SAS
Desmopressin
DESMOPRESSINE MYLAN
117 allée des Parcs
240 µg, orodispersible
69792 Saint-Priest Cedex
tablet
0,24 mg
Orodispersible
Oral use
tablet
France
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 27/131
Member State
Marketing Authorisation
(in EEA)
Holder
France
Ranbaxy Pharmacie
INN
Aciclovir
Generiques
Invented name
Aciclovir Ranbaxy 800 mg,
Pharmaceutical
Route of
Form
administration
800 mg
Tablet
Oral use
200 mg
Tablet
Oral use
200 mg
Tablet
Oral use
70 mg
Tablet
Oral use
10 mg
Film - coated
Oral use
Strength
comprimé
11-15 Quai Dion Bouton 92800 Puteaux France France
Ranbaxy Pharmacie
Aciclovir
Generiques
Aciclovir Ranbaxy 200 mg, comprimé
11-15 Quai Dion Bouton 92800 Puteaux France France
Ranbaxy Pharmacie
Aciclovir
Generiques
Aciclovir Almus 200 mg, comprimé
11-15 Quai Dion Bouton 92800 Puteaux France France
Ranbaxy Pharmacie
Alendronic acid
Generiques
Acide Alendronique Ranbaxy 70 mg, comprimé
11-15 Quai Dion Bouton 92800 Puteaux France France
Sanofi Aventis France 1-13 bd Romain Rolland
Ebastine
EBASTINE ZENTIVA 10 mg comprimé pelliculé
tablet
75159 Paris Cedex 14 France
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Member State
Marketing Authorisation
(in EEA)
Holder
France
Sanofi Aventis France
INN
Ebastine
1-13 bd Romain Rolland
Invented name
EBASTINE ZENTIVA 10 mg
Strength
10 mg
comprimé orodispersible
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
75159 Paris Cedex 14 France France
Teva Sante
Desloratadine
DESLORATADINE TEVA
Cœur Défense - 100-110
SANTE
Esplanade du Général de
5 mg
Gaulle
comprimé pelliculé
5 mg
Film - coated
Oral use
tablet
92931 La Défense Cedex France France
Venipharm SAS
Ebastine
4 Bureaux de la Colline
EBOUDA 10 mg comprimé
10 mg
pelliculé
Film - coated
Oral use
tablet
92213 Saint-Cloud France France
Venipharm SAS
Ebastine
4 Bureaux de la Colline
EBARREN 10 mg comprimé
10 mg
pelliculé
Film - coated
Oral use
tablet
92213 Saint-Cloud France France
Venipharm SAS
Ebastine
4 Bureaux de la Colline
EBONDE 10 mg comprimé
10 mg
pelliculé
Film - coated
Oral use
tablet
92213 Saint-Cloud France France
Venipharm SAS 4 Bureaux de la Colline
Ebastine
EBONTAN 10 mg comprimé orodispersible
10 mg
Orodispersible
Oral use
tablet
92213 Saint-Cloud France
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
France
Venipharm SAS
INN
Ebastine
4 Bureaux de la Colline
Invented name
Strength
EBACHOI 10 mg comprimé
10 mg
orodispersible
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
92213 Saint-Cloud France France
Venipharm SAS
Ibuprofen
IBUPROFENE ZYDUS
4 Bureaux de la Colline
FRANCE 200 mg comprimé
92213 Saint-Cloud
pelliculé
200 mg
Film - coated
Oral use
tablet
France France
Zydus France
Ibuprofen
IBUPROFENE ZYDUS
Zacles Hautes Patures
FRANCE 400 mg comprimé
25 Rue des Peupliers
pelliculé
400 mg
Film - coated
Oral use
tablet
92752 Nanterre Cedes France France
Zydus France
Tramadol/paraceta
TRAMADOL PARACETAMOL
37,5
Film - coated
Zacles Hautes Patures
mol
ZYDUS FRANCE
mg/325 mg
tablet
400 mg
Film - coated
37,5
25 Rue des Peupliers
mg/325 mg comprimé
92752 Nanterre Cedes
pelliculé
Oral use
France France
Zydus France Zacles Hautes Patures
Ibuprofen
IBUPROFENE ZF 400 mg comprimé pelliculé
Oral use
tablet
25 Rue des Peupliers 92752 Nanterre Cedes France
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Member State
Marketing Authorisation
(in EEA)
Holder
France
Zydus France
INN
Desloratadine
Zacles Hautes Patures
Invented name
DESLORATADINE ZYDUS 5
Strength
5 mg
mg comprimé pelliculé
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
25 Rue des Peupliers 92752 Nanterre Cedes France France
Zydus France
Escitalopram
Zacles Hautes Patures
ESCITALOPRAM ZYDUS 5
5 mg
mg, comprimé pelliculé
Film - coated
Oral use
tablet
25 Rue des Peupliers 92752 Nanterre Cedes France France
Zydus France
Escitalopram
ESCITALOPRAM ZYDUS 10
Zacles Hautes Patures
mg, comprimé pelliculé
25 Rue des Peupliers
sécable
10 mg
Film - coated
Oral use
tablet
92752 Nanterre Cedes France France
Zydus France
Escitalopram
ESCITALOPRAM ZYDUS 15
Zacles Hautes Patures
mg, comprimé pelliculé
25 Rue des Peupliers
sécable
15 mg
Film - coated
Oral use
tablet
92752 Nanterre Cedes France
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
France
Zydus France
INN
Escitalopram
Invented name
ESCITALOPRAM ZYDUS 20
Zacles Hautes Patures
mg, comprimé pelliculé
25 Rue des Peupliers
sécable
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
92752 Nanterre Cedes France Germany
Accord Healthcare Limited
Alendronic acid
Sage House, 319 Pinner Road
ALENDRONIC ACID
70 mg
Tablet
Oral use
250 mg
Film - coated
Oral use
ACCORD 70MG
North Harrow HA1 4HF Middlesex United Kingdom Germany
betapharm Arzneimittel GmbH
Levetiracetam
Kobelweg 95
Levetiracetam beta 250 mg, Filmtabletten
tablet
D-86156 Augsburg Germany Germany
betapharm Arzneimittel GmbH
Levetiracetam
Kobelweg 95
Levetiracetam beta 500
500 mg
mg, Filmtabletten
Film - coated
Oral use
tablet
D-86156 Augsburg Germany Germany
betapharm Arzneimittel GmbH
Levetiracetam
Kobelweg 95
Levetiracetam beta 750
750 mg
mg, Filmtabletten
Film - coated
Oral use
tablet
D-86156 Augsburg Germany Germany
betapharm Arzneimittel GmbH Kobelweg 95
Levetiracetam
Levetiracetam beta 1000 mg, Filmtabeltten
1000 mg
Film - coated
Oral use
tablet
D-86156 Augsburg Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Germany
Fair-Med Healthcare GmbH
INN
Irbesartan
Planckstrasse 13
Invented name
Irbesartan Tablets
Strength
75 mg
75mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
DE-22765 Hamburg Germany Germany
Fair-Med Healthcare GmbH
Irbesartan
Planckstrasse 13
Irbesartan Tablets
150 mg
150mg
Film - coated
Oral use
tablet
DE-22765 Hamburg Germany Germany
Fair-Med Healthcare GmbH
Irbesartan
Planckstrasse 13
Irbesartan Tablets
300 mg
300 mg
Film - coated
Oral use
tablet
DE-22765 Hamburg Germany Germany
Fair-Med Healthcare GmbH
Irbesartan/hydroch
Irbesartan HCTZ Fair-Med
150
Film - coated
Planckstrasse 13
lorothiazide
150+12,5 mg Filmtabletten
mg/12,5
tablet
DE-22765 Hamburg
Oral use
mg
Germany Germany
Fair-Med Healthcare GmbH
Irbesartan/hydroch
Irbesartan HCTZ Fair-Med
300
Film - coated
Planckstrasse 13
lorothiazide
300+12,5 mg Filmtabletten
mg/12,5
tablet
DE-22765 Hamburg
Oral use
mg
Germany Germany
Fair-Med Healthcare GmbH
Irbesartan/hydroch
Planckstrasse 13
lorothiazide
Irbesartan HCTZ Fair-Med 300+25 mg Filmtabletten
300 mg/25
Film - coated
mg
tablet
Oral use
DE-22765 Hamburg Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 33/131
Member State
Marketing Authorisation
(in EEA)
Holder
Germany
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/HCTZ Fair-Med
Planckstrasse 13
orothiazide
INN
DE-22765 Hamburg
Pharmaceutical
Route of
Form
administration
160
Film - coated
Oral use
Healthcare 160 mg/12.5
mg/12,5
tablet
mg Filmtabletten
mg
Invented name
Strength
Germany Germany
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/HCTZ Fair-Med
320
Film - coated
Planckstrasse 13
orothiazide
Healthcare 320 mg/12,5
mg/12,5
tablet
mg Filmtabletten
mg
DE-22765 Hamburg
Oral use
Germany Germany
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/HCTZ Fair-Med
320 mg/25
Film - coated
Planckstrasse 13
orothiazide
Healthcare 320 mg/25 mg
mg
tablet
37,5 mg
Prolonged -
DE-22765 Hamburg
Oral use
Filmtabletten
Germany Germany
Fair-Med Healthcare GmbH
Venlafaxine
Planckstrasse 13
Venlafaxin Fair-Med 37,5 mg Hartkapseln, retardiert
Oral use
release capsule,
DE-22765 Hamburg
hard
Germany Germany
Fair-Med Healthcare GmbH
Venlafaxine
Planckstrasse 13
Venlafaxin Fair-Med 75 mg
75 mg
Hartkapseln, retardiert
Prolonged -
Oral use
release capsule,
DE-22765 Hamburg
hard
Germany Germany
Fair-Med Healthcare GmbH Planckstrasse 13
Venlafaxine
Venlafaxin Fair-Med 150 mg Hartkapseln, retardiert
DE-22765 Hamburg
150 mg
Prolonged -
Oral use
release capsule, hard
Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Germany
Fair-Med Healthcare GmbH
INN
Ciprofloxacin
Invented name
Ciprofloxacin Fair-Med
Planckstrasse 13
Healthcare 500 mg
DE-22765 Hamburg
Filmtabletten
Strength
500 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Germany Germany
Fair-Med Healthcare GmbH
Ciprofloxacin
Ciprofloxacin Fair-Med
Planckstrasse 13
Healthcare 750 mg
DE-22765 Hamburg
Filmtabletten
750 mg
Film - coated
Oral use
tablet
Germany Germany
Fair-Med Healthcare GmbH
Ciprofloxacin
Ciprofloxacin Fair-Med
Planckstrasse 13
Healthcare 250 mg
DE-22765 Hamburg
Filmtabletten
250 mg
Film - coated
Oral use
tablet
Germany Germany
Heumann Pharma GmbH &
Irbesartan
Co. Generica KG
Irbesartan Heumann 75
75 mg
mg Filmtabletten
Film - coated
Oral use
tablet
Südwestpark 50 90449 Nürnberg Germany Germany
Heumann Pharma GmbH & Co. Generica KG
Irbesartan
Irbesartan Heumann 150 mg Filmtabletten
150 mg
Film - coated
Oral use
tablet
Südwestpark 50 90449 Nürnberg Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 35/131
Member State
Marketing Authorisation
(in EEA)
Holder
Germany
Heumann Pharma GmbH &
INN
Irbesartan
Co. Generica KG
Invented name
Irbesartan Heumann 300
Strength
300 mg
mg Filmtabletten
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Südwestpark 50 90449 Nürnberg Germany Germany
Heumann Pharma GmbH &
Irbesartan/hydroch
Irbesartan/Hydrochlorothia
150
Film - coated
Co. Generica KG
lorothiazide
zid Heumann 150 mg/12.5
mg/12,5
tablet
mg Filmtabletten
mg
Südwestpark 50
Oral use
90449 Nürnberg Germany Germany
Heumann Pharma GmbH &
Irbesartan/hydroch
Irbesartan/Hydrochlorothia
300
Film - coated
Co. Generica KG
lorothiazide
zid Heumann 300 mg/12.5
mg/12,5
tablet
mg Filmtabletten
mg
Südwestpark 50
Oral use
90449 Nürnberg Germany Germany
Heumann Pharma GmbH &
Irbesartan/hydroch
Irbesartan/Hydrochlorothia
300 mg/25
Film - coated
Co. Generica KG
lorothiazide
zid Heumann 300 mg/25
mg
tablet
200 mg
Film - coated
Südwestpark 50
Oral use
mg Filmtabletten
90449 Nürnberg Germany Germany
Hormosan Pharma GmbH
Cefpodoxime
Cefpodoxim-
Wilhelmshoeher Str. 106
proxetil
Hormosan
D-60389 Frankfurt
200mg
06 Hessen
Filmtabletten
Oral use
tablet
Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 36/131
Member State
Marketing Authorisation
(in EEA)
Holder
Germany
Lupin (Europe) Limited
Trimetazidine
Lupamadazine 35 mg
Victoria Court, Bexton Road
hydrochloride
Retardtabletten
Escitalopram
Escitalopram-Micro Labs 5
INN
Invented name
Strength
35 mg
Pharmaceutical
Route of
Form
administration
Controlled -
Oral use
release tablet
Knutsford, Cheshire WA16 0PF United Kingdom Germany
Micro Labs GmbH Lyoner Str. 14
5 mg
mg Filmtabletten
Film - coated
Oral use
tablet
D-60528 Frankfurt/Main Germany Germany
Micro Labs GmbH
Escitalopram
Lyoner Str. 14
Escitalopram-Micro Labs 10
10 mg
mg Filmtabletten
Film - coated
Oral use
tablet
D-60528 Frankfurt/Main Germany Germany
Micro Labs GmbH
Escitalopram
Lyoner Str. 14
Escitalopram-Micro Labs 15
15 mg
mg Filmtabletten
Film - coated
Oral use
tablet
D-60528 Frankfurt/Main Germany Germany
Micro Labs GmbH
Escitalopram
Lyoner Str. 14
Escitalopram-Micro Labs 20
20 mg
mg Filmtabletten
Film - coated
Oral use
tablet
D-60528 Frankfurt/Main Germany Germany
Mylan dura GmBh Wittichstrasse 6
Repaglinide
Repaglinid Mylan 0,5 mg
0,5 mg
Tablet
Oral use
Tabletten
64295 Darmstadt Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 37/131
Member State
Marketing Authorisation
(in EEA)
Holder
Germany
Mylan dura GmBh
INN
Repaglinide
Wittichstrasse 6
Invented name
Repaglinid Mylan 1 mg
Pharmaceutical
Route of
Form
administration
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
5 mg
Orodispersible
Oral use
Strength
Tabletten
64295 Darmstadt Germany Germany
Mylan dura GmBh
Repaglinide
Wittichstrasse 6
Repaglinid Mylan 2 mg Tabletten
64295 Darmstadt Germany Germany
Mylan dura GmBh
Rizatriptan
Wittichstrasse 6
Rizatriptan Mylan dura 5 mg Schmelztabletten
tablet
64295 Darmstadt Germany Germany
Mylan dura GmBh
Rizatriptan
Wittichstrasse 6
Rizatriptan Mylan dura 10
10 mg
mg Schmelztabletten
Orodispersible
Oral use
tablet
64295 Darmstadt Germany Germany
Panacea Biotec Germany
Tacrolimus
Tacpan 0.5 mg Hartkapseln
0,5 mg
Capsule, hard
Oral use
Tacrolimus
Tacpan 1 mg Hartkapseln
1 mg
Capsule, hard
Oral use
GmbH Landshuter Allee 8-10 D-80637 München Germany Germany
Panacea Biotec Germany GmbH Landshuter Allee 8-10 D-80637 München Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 38/131
Member State
Marketing Authorisation
(in EEA)
Holder
Germany
Panacea Biotec Germany
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Tacrolimus
Tacpan 5 mg Hartkapseln
5 mg
Capsule, hard
Oral use
Entacapone
Entacapon STADA 200 mg
200 mg
Film - coated
Oral use
GmbH Landshuter Allee 8-10 D-80637 München Germany Germany
Stadapharm GmbH Stadastr. 2-18
Filmtabletten
tablet
D-61118 Bad Vilbel Germany Germany
Unichem Laboratories Ltd.
Irbesartan
Studio 8B Ard Gaoithe
Irbesartan Unichem 150
150 mg
mg Filmtabletten
Film - coated
Oral use
tablet
Commercial Centre, Business Park Cashel Road Clonmel, Co Tipperary Ireland Germany
Unichem Laboratories Ltd. Studio 8B Ard Gaoithe
Irbesartan
Irbesartan Unichem 300 mg Filmtabletten
300 mg
Film - coated
Oral use
tablet
Commercial Centre, Business Park Cashel Road Clonmel, Co Tipperary Ireland
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 39/131
Member State
Marketing Authorisation
(in EEA)
Holder
Germany
Welding GmbH & Co. KG
Irbesartan/hydroch
Irbesartan +
Esplanade 39
lorothiazide
Hidroclorotiazida Welding
INN
Invented name
D-20354 Hamburg
Pharmaceutical
Route of
Form
administration
300
Film - coated
Oral use
mg/12,5
tablet
Strength
mg
Germany Germany
Welding GmbH & Co. KG
Irbesartan/hydroch
Irbesartan +
150
Film - coated
Esplanade 39
lorothiazide
Hidroclorotiazida Welding
mg/12,5
tablet
D-20354 Hamburg
Oral use
mg
Germany Germany
Welding GmbH & Co. KG
Irbesartan/hydroch
Irbesartan +
300 mg/25
Film - coated
Esplanade 39
lorothiazide
Hidroclorotiazida Welding
mg
tablet
Irbesartan
Irbesartan Welding
75 mg
Film - coated
Oral use
D-20354 Hamburg Germany Germany
Welding GmbH & Co. KG Esplanade 39
Oral use
tablet
D-20354 Hamburg Germany Germany
Welding GmbH & Co. KG
Irbesartan
Irbesartan Welding
150 mg
Esplanade 39
Film - coated
Oral use
tablet
D-20354 Hamburg Germany Germany
Welding GmbH & Co. KG
Irbesartan
Irbesartan Welding
Esplanade 39
300 mg
Film - coated
Oral use
tablet
D-20354 Hamburg Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 40/131
Member State
Marketing Authorisation
(in EEA)
Holder
Greece
Abbott Laboratories
Escitalopram
Hellas ΑΒΕΕ
oxalate
INN
Invented name
Savandra
Strength
5 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Agiou Dimitriou 63 Alimos 17456 Greece Greece
Abbott Laboratories
Escitalopram
Hellas ΑΒΕΕ
oxalate
Savandra
10 mg
Film - coated
Oral use
tablet
Agiou Dimitriou 63 Alimos 17456 Greece Greece
Abbott Laboratories
Escitalopram
Hellas ΑΒΕΕ
oxalate
Savandra
15 mg
Film - coated
Oral use
tablet
Agiou Dimitriou 63 Alimos 17456 Greece Greece
Abbott Laboratories
Escitalopram
Hellas ΑΒΕΕ
oxalate
Savandra
20 mg
Film - coated
Oral use
tablet
Agiou Dimitriou 63 Alimos 17456 Greece Greece
Genepharm S.A.
Desloratadine
Desloratadine/Genepharm
18 Km Marathon Avenue,
5 mg δισκία επικαλυμμένα
15351 Pallini
με υμένιο,
5 mg
Film - coated
Oral use
tablet
Greece
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 41/131
Member State
Marketing Authorisation
(in EEA)
Holder
Greece
Genepharm S.A.
INN
Desloratadine
Invented name
Desloratadine/Genepharm
18 Km Marathon Avenue,
2,5 mg δισκία
15351 Pallini
διασπειρόμενα στο στόμα
Strength
2,5 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
Greece Greece
Genepharm S.A.
Desloratadine
Desloratadine/Genepharm
18 Km Marathon Avenue,
5 mg δισκία διασπειρόμενα
15351 Pallini
στο στόμα
5 mg
Orodispersible
Oral use
tablet
Greece Greece
Generics Pharma Hellas Ltd
Donepezil
577a Vouliagmenis Avenue
hydrochloride
Donepezil/ Generics
5 mg
Orodispersible
Oral use
tablet
Argyroupoli 164-51 Athens Greece Greece
Generics Pharma Hellas Ltd
Donepezil
577a Vouliagmenis Avenue
hydrochloride
Donepezil/ Generics
10 mg
Orodispersible
Oral use
tablet
Argyroupoli 164-51 Athens Greece Greece
Generics Pharma Hellas Ltd
Esomeprazole
577a Vouliagmenis Avenue
magnesium
Esomeprazole/ Generics
40 mg
Prolonged -
Oral use
release capsule
Argyroupoli 164-51 Athens Greece
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 42/131
Member State
Marketing Authorisation
(in EEA)
Holder
Greece
Sieger Pharma A.E.
INN
Desloratadine
Invented name
Desloratadine/Sieger
Strength
5 mg
Marathonos Avenue 106
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Pikermi 19009 Greece Greece
Sieger Pharma A.E.
Desloratadine
Desloratadine/Sieger
2,5 mg
Marathonos Avenue 106
Orodispersible
Oral use
tablet
Pikermi 19009 Greece Greece
Sieger Pharma A.E.
Desloratadine
Desloratadine/Sieger
5 mg
Marathonos Avenue 106
Orodispersible
Oral use
tablet
Pikermi 19009 Greece Hungary
Actavis Group PTC ehf.
Metformin
Gluforlyn XR 500 mg
Reykjavikurvegi 76-78
hydrochloride
retard tabletta
Desloratadine
Alvotadin 5 mg filmtabletta
500 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjördur Iceland Hungary
Alvogen IPCo S.ar.l.
5 mg
Rue Heienhaff 5
Film - coated
Oral use
tablet
L-1736 Senningerberg Luxembourg Hungary
Alvogen IPCo S.ar.l. Rue Heienhaff 5
Desloratadine
Alvotadin 2.5 mg szájban diszpergálódó tabletta
2,5 mg
Orodispersible
Oral use
tablet
L-1736 Senningerberg Luxembourg
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 43/131
Member State
Marketing Authorisation
(in EEA)
Holder
Hungary
Alvogen IPCo S.ar.l.
INN
Desloratadine
Rue Heienhaff 5
Invented name
Alvotadin 5 mg szájban
Strength
5 mg
diszpergálódó tabletta
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
L-1736 Senningerberg Luxembourg Hungary
Generics (UK) Ltd
Esomeprazole
Station Close, Potters Bar
magnesium
Hertfordshire, EN6 1TL
Esomeprazol Mylan 20 mg
20 mg
gyomornedv-ellenálló
Gastro - resistant
Oral use
capsule, hard
kemény kapszula
United Kingdom Hungary
Generics (UK) Ltd
Esomeprazole
Station Close, Potters Bar
magnesium
Hertfordshire, EN6 1TL
Esomeprazol Mylan 40 mg
40 mg
gyomornedv-ellenálló
Gastro - resistant
Oral use
capsule, hard
kemény kapszula
United Kingdom Hungary
Glenmark Pharmaceuticals
Trimetazidine
Apstar 35 mg retard
s.r.o.
dihydrochloride
tabletta
Desloratadine
Inaller 5 mg filmtabletta
35 mg
Prolonged -
Oral use
release tablet
Hvězdova 1716/2b 14078 Praha 4 Czech Republic Hungary
Goodwill Pharma Kft.
5 mg
H-6724 Szeged
Film - coated
Oral use
tablet
Cserzy Mihály u. 32. Hungary Hungary
Mylan SAS 117 allée des Parcs
Trimetazidine
Trimetazidine Mylan 35 mg retard tabletta
35 mg
Prolonged -
Oral use
release tablet
69792 Saint-Priest Cedex France
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 44/131
Member State
Marketing Authorisation
(in EEA)
Holder
Hungary
Sandoz Hungária Kft.
Trimetazidine
Trimetazidine Sandoz 35
H-1114 Budapest
dihydrochloride
mg retard tabletta
Desloratadine
Desloratadin Teva 2.5 mg
INN
Invented name
Strength
35 mg
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
release tablet
Bartók Béla út 43-47. Hungary Hungary
Teva Gyógyszergyár Zrt. H-4042 Debrecen
szájban diszpergálódó
Pallagi út 13.
tabletta
2,5 mg
Orodispersible
Oral use
tablet
Hungary Hungary
Teva Gyógyszergyár Zrt.
Desloratadine
Desloratadin Teva 5 mg
H-4042 Debrecen
szájban diszpergálódó
Pallagi út 13.
tabletta
5 mg
Orodispersible
Oral use
tablet
Hungary Iceland
ratiopharm GmbH
Desloratadine
Desloratadine ratiopharm
5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm Germany Ireland
Accord Healthcare Limited
Ropinirole
Ropinirole 0.25 mg Film-
Sage House, 319 Pinner Road
hydrochloride
coated Tablets
Accord Healthcare Limited
Ropinirole
Ropinirole 0.5 mg Film-
Sage House, 319 Pinner Road
hydrochloride
coated Tablets
0,25 mg
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom Ireland
0,5 mg
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 45/131
Member State
Marketing Authorisation
(in EEA)
Holder
Ireland
Accord Healthcare Limited
Ropinirole
Ropinirole 1 mg Film-
Sage House, 319 Pinner Road
hydrochloride
coated Tablets
Accord Healthcare Limited
Ropinirole
Ropinirole 2 mg Film-
Sage House, 319 Pinner Road
hydrochloride
coated Tablets
Accord Healthcare Limited
Ropinirole
Ropinirole 5 mg Film-
Sage House, 319 Pinner Road
hydrochloride
coated Tablets
Alendronic acid
Alendronic Acid Once
INN
Invented name
Strength
1 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom Ireland
2 mg
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom Ireland
5 mg
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom Ireland
Accord Healthcare Limited Sage House, 319 Pinner Road
70 mg
Tablet
Oral use
Oral use
Weekly 70 mg Tablets
North Harrow HA1 4HF Middlesex United Kingdom Ireland
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/Hydrochlorothiaz
160
Film - coated
Planckstrasse 13
orothiazide
ide Fair-Med 160 mg/12.5
mg/12,5
tablet
mg film-coated tablets.
mg
DE-22765 Hamburg Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 46/131
Member State
Marketing Authorisation
(in EEA)
Holder
Ireland
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
INN
DE-22765 Hamburg
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Oral use
Valsartan/Hydrochlorothiaz
320
Film - coated tablet
ide Fair-Med 320 mg/12.5
mg/12,5
mg film-coated tablets
mg
Valsartan/Hydrochlorothiaz
320 mg/25
Film - coated
ide Fair-Med 320 mg/25
mg
tablet
120 mg
Film - coated
Germany Ireland
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
DE-22765 Hamburg
Oral use
mg film-coated tablets
Germany Ireland
Fannin (UK) Ltd
Fexofenadine
Fexofenadine 120 mg film-
42-46 Booth Drive
hydrochloride
coated tablets
Fannin (UK) Ltd
Fexofenadine
Fexofenadine 180 mg film-
42-46 Booth Drive
hydrochloride
coated tablets
Donepezil
Aripil Orotab 5mg
Oral use
tablet
Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom Ireland
180 mg
Film - coated
Oral use
tablet
Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom Ireland
McDermott Laboratories Ltd t/a Gerard Laboratories
Orodispersible Tablet
5 mg
Orodispersible
Oral use
tablet
35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 47/131
Member State
Marketing Authorisation
(in EEA)
Holder
Ireland
McDermott Laboratories Ltd
INN
Donepezil
t/a Gerard Laboratories
Invented name
Aripil Orotab 10mg
Strength
10 mg
Orodispersible Tablet
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Ireland
McDermott Laboratories Ltd
Esomeprazole
Esomeprazole Mylan 20 mg
t/a Gerard Laboratories
Gastro-resistant Capsules,
35/36 Baldoyle Industrial
hard
20 mg
Gastro - resistant
Oral use
capsule
Estate Grange Road Dublin 13 Ireland Ireland
McDermott Laboratories Ltd
Esomeprazole
Esomeprazole Mylan 40 mg
t/a Gerard Laboratories
Gastro-resistant Capsules,
35/36 Baldoyle Industrial
hard
40 mg
Gastro - resistant
Oral use
capsule
Estate Grange Road Dublin 13 Ireland
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 48/131
Member State
Marketing Authorisation
(in EEA)
Holder
Ireland
McDermott Laboratories Ltd
INN
Candesartan
t/a Gerard Laboratories
Invented name
Candesartan Mylan 4mg
Pharmaceutical
Route of
Form
administration
4 mg
Tablet
Oral use
8 mg
Tablet
Oral use
16 mg
Tablet
Oral use
Strength
Tablets
35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Ireland
McDermott Laboratories Ltd
Candesartan
t/a Gerard Laboratories
Candesartan Mylan 8 mg Tablets
35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Ireland
McDermott Laboratories Ltd t/a Gerard Laboratories
Candesartan
Candesartan Mylan 16 mg Tablets
35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 49/131
Member State
Marketing Authorisation
(in EEA)
Holder
Ireland
McDermott Laboratories Ltd
INN
Candesartan
t/a Gerard Laboratories
Invented name
Candesartan Mylan 32 mg
Pharmaceutical
Route of
Form
administration
32 mg
Tablet
Oral use
250 mg
Film - coated
Oral use
Strength
Tablets
35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Ireland
Morningside Healthcare
Phenoxymethyl
Phenoxymethylpenicillin
Limited
penicillin
250mg Film-coated Tablets
Amlodipine besilate
Amlodipine Niche 5mg
tablet
115 Narborough Road Leicester, LE3 0PA United Kingdom Ireland
Niche Generics Limited 1 The Cam Centre
5 mg
Tablet
Oral use
10 mg
Tablet
Oral use
150 mg
Film - coated
Oral use
tablets
Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom Ireland
Niche Generics Limited
Amlodipine besilate
1 The Cam Centre
Amlodipine Niche 10mg Tablets
Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom Ireland
Niche Generics Limited 1 The Cam Centre
Irbesartan
Irbesartan Niche 150mg film coated tablets
tablet
Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 50/131
Member State
Marketing Authorisation
(in EEA)
Holder
Ireland
Niche Generics Limited
INN
Irbesartan
1 The Cam Centre
Invented name
Irbesartan Niche 300mg
Strength
300 mg
film coated tablets
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom Ireland
Wockhardt UK Limited
Clopidogrel
Clopidogrel 75mg film-
Ash Road North
hydrochloride
coated tablets
Metoclopramide
METOCLOPRAMIDE
75 mg
Film - coated
Oral use
tablet
Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom Italy
Accord Healthcare Italia S.r.l. Largo Esterle, 4
10 mg
Tablet
Oral use
ACCORD
20052 Monza Italy Italy
Accord Healthcare Limited
Alendronic acid
ALENDRONATO AHCL
10 mg
Tablet
Oral use
Alendronic acid
ALENDRONATO AHCL
70 mg
Tablet
Oral use
Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex United Kingdom Italy
Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 51/131
Member State
Marketing Authorisation
(in EEA)
Holder
Italy
Doc Generici SRL
INN
Desloratadine
Via Turati, 40
Invented name
DESLORATADINA DOC
Strength
5 mg
GENERICI
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
20121 Milano Italy Italy
Doc Generici SRL
Desloratadine
Via Turati, 40
DESLORATADINA DOC
2,5 mg
GENERICI
Orodispersible
Oral use
tablet
20121 Milano Italy Italy
Doc Generici SRL
Desloratadine
Via Turati, 40
DESLORATADINA DOC
5 mg
GENERICI
Orodispersible
Oral use
tablet
20121 Milano Italy Italy
Farmaceutici Caber S.P.A.
Valsartan
VALSOTEN
40 mg
Viale Citta' D'Europa, 681
Film - coated
Oral use
tablet
00144 Rome Italy Italy
Farmaceutici Caber S.P.A.
Valsartan
VALSOTEN
80 mg
Viale Citta' D'Europa, 681
Film - coated
Oral use
tablet
00144 Rome Italy Italy
Farmaceutici Caber S.P.A.
Valsartan
VALSOTEN
Viale Citta' D'Europa, 681
160 mg
Film - coated
Oral use
tablet
00144 Rome Italy
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 52/131
Member State
Marketing Authorisation
(in EEA)
Holder
Italy
Farmaceutici Caber S.P.A.
INN
Valsartan
Invented name
VALSOTEN
Strength
320 mg
Viale Citta' D'Europa, 681
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
00144 Rome Italy Italy
Mylan S.P.A.
Esomeprazole
Via Vittor Pisani, 20
magnesium
ESOMEPRAZOLO MYLAN
20 mg
Gastro - resistant
Oral use
capsule, hard
20124 Milan Italy Italy
Mylan S.P.A.
Esomeprazole
Via Vittor Pisani, 20
magnesium
ESOMEPRAZOLO MYLAN
40 mg
Gastro - resistant
Oral use
capsule, hard
20124 Milan Italy Italy
Mylan S.P.A.
Rizatriptan
RIAZATRIPTAN MYLAN
Via Vittor Pisani, 20
benzoate
GENERICS
Mylan S.P.A.
Rizatriptan
RIAZATRIPTAN MYLAN
Via Vittor Pisani, 20
benzoate
GENERICS
Mylan S.P.A.
Donepezil
DONEPEZIL MYLAN
Via Vittor Pisani, 20
hydrochloride
GENERICS ITALIA
5 mg
Orodispersible
Oral use
tablet
20124 Milan Italy Italy
10 mg
Orodispersible
Oral use
tablet
20124 Milan Italy Italy
5 mg
Orodispersible
Oral use
tablet
20124 Milan Italy
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Italy
Mylan S.P.A.
Donepezil
DONEPEZIL MYLAN
Via Vittor Pisani, 20
hydrochloride
GENERICS ITALIA
Repaglinide
REPAGLINIDE MYLAN
0,5 mg
Tablet
Oral use
Repaglinide
REPAGLINIDE MYLAN
1 mg
Tablet
Oral use
Repaglinide
REPAGLINIDE MYLAN
2 mg
Tablet
Oral use
Alendronic acid
Alendronato Pensa
70 mg
Tablet
Oral use
70 mg
Tablet
Oral use
INN
Invented name
Strength
10 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
20124 Milan Italy Italy
Mylan S.P.A. Via Vittor Pisani, 20 20124 Milan Italy
Italy
Mylan S.P.A. Via Vittor Pisani, 20 20124 Milan Italy
Italy
Mylan S.P.A. Via Vittor Pisani, 20 20124 Milan Italy
Italy
Pensa Pharma S.P.A. Via Rossellini Ippolito, 12
70 mg compresse
20124 Milan Italy Italy
Ranbaxy Italia S.P.A. Piazza Filippo Meda, 4, 3
Alendronic acid
ALENDRONATO RANBAXY ITALIA
20121 - Milano Italy
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Latvia
Sandoz Pharmaceuticals d.d.
Trimetazidine
Verovskova 57
dihydrochloride
INN
Invented name
Zidmetin
Strength
35 mg
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
tablet
Ljubljana SI-1000 Slovenia Lithuania
Accord Healthcare Limited
Alendronic acid
Alendronic acid Accord
70 mg
Tablet
Oral use
Ropinirole
Ropinirole Lambada
0,5 mg
Film - coated
Oral use
Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex United Kingdom Lithuania
Lambda Therapeutic Limited Sage House
tablet
319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom Lithuania
Lambda Therapeutic Limited
Ropinirole
Ropinirole Lambada
1 mg
Sage House
Film - coated
Oral use
tablet
319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom Lithuania
Lambda Therapeutic Limited
Ropinirole
Ropinirole Lambada
Sage House
2 mg
Film - coated
Oral use
tablet
319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Lithuania
Lambda Therapeutic Limited
INN
Ropinirole
Invented name
Ropinirole Lambada
Strength
5 mg
Sage House
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom Lithuania
Torrent Pharma GmbH
Irbesartan
Irbesartanas Torrent
75 mg
Südwestpark 50
Film - coated
Oral use
tablet
90449 Nürnberg Germany Lithuania
Torrent Pharma GmbH
Irbesartan
Irbesartanas Torrent
150 mg
Südwestpark 50
Film - coated
Oral use
tablet
90449 Nürnberg Germany Lithuania
Torrent Pharma GmbH
Irbesartan
Irbesartanas Torrent
300 mg
Südwestpark 50
Film - coated
Oral use
tablet
90449 Nürnberg Germany Lithuania
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartanas/Hidrochlorotia
150
Film - coated
Südwestpark 50
lorothiazide
zidas Torrent
mg/12,5
tablet
90449 Nürnberg
Oral use
mg
Germany Lithuania
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartanas/Hidrochlorotia
300
Film - coated
Südwestpark 50
lorothiazide
zidas Torrent
mg/12,5
tablet
90449 Nürnberg
Oral use
mg
Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Lithuania
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartanas/Hidrochlorotia
Südwestpark 50
lorothiazide
Repaglinide
INN
Pharmaceutical
Route of
Form
administration
300 mg/25
Film - coated
Oral use
zidas Torrent
mg
tablet
Repaglinide Mylan Pharma
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
20 mg
Gastro - resistant
Oral use
Invented name
Strength
90449 Nürnberg Germany Luxembourg
Mylan bvba/sprl Terhulpsesteenweg 6A
0,5 mg tabletten
1560 Hoeilaart Belgium Luxembourg
Mylan bvba/sprl
Repaglinide
Terhulpsesteenweg 6A
Repaglinide Mylan Pharma 1 mg tabletten
1560 Hoeilaart Belgium Luxembourg
Mylan bvba/sprl
Repaglinide
Terhulpsesteenweg 6A
Repaglinide Mylan Pharma 2 mg tabletten
1560 Hoeilaart Belgium Luxembourg
Mylan bvba/sprl
Esomeprazole
Esomeprazole Mylan
Terhulpsesteenweg 6A
capsule, hard
1560 Hoeilaart Belgium Luxembourg
Mylan bvba/sprl
Esomeprazole
Esomeprazole Mylan
Terhulpsesteenweg 6A
40 mg
Gastro - resistant
Oral use
capsule, hard
1560 Hoeilaart Belgium
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Malta
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/hydrochlorthiazid
Planckstrasse 13
orothiazide
"Fair-Med" Coated tablets
INN
Invented name
DE-22765 Hamburg
Pharmaceutical
Route of
Form
administration
160
Film - coated
Oral use
mg/12,5
tablet
Strength
mg
Germany Malta
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/hydrochlorthiazid
320
Film - coated
Planckstrasse 13
orothiazide
"Fair-Med" Coated tablets
mg/12,5
tablet
DE-22765 Hamburg
Oral use
mg
Germany Malta
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/hydrochlorthiazid
320 mg/25
Film - coated
Planckstrasse 13
orothiazide
"Fair-Med" Coated tablets
mg
tablet
Ciprofloxacin
Ciprofloxacin Fair-Med
250 mg
Film - coated
Oral use
DE-22765 Hamburg Germany Malta
Fair-Med Healthcare GmbH Planckstrasse 13
Coated Tablets
Oral use
tablet
DE-22765 Hamburg Germany Malta
Fair-Med Healthcare GmbH
Ciprofloxacin
Planckstrasse 13
Ciprofloxacin Fair-Med
500 mg
Coated Tablets
Film - coated
Oral use
tablet
DE-22765 Hamburg Germany Malta
Fair-Med Healthcare GmbH Planckstrasse 13
irbesartan
Irbesartan Fairmed 75mg Film-coated Tablets
75 mg
Film - coated
Oral use
tablet
DE-22765 Hamburg Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Malta
Fair-Med Healthcare GmbH
INN
irbesartan
Planckstrasse 13
Invented name
Irbesartan Fairmed 150mg
Strength
150 mg
Film-coated Tablets
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
DE-22765 Hamburg Germany Malta
Fair-Med Healthcare GmbH
irbesartan
Planckstrasse 13
Irbesartan Fairmed 300mg
300 mg
Film-coated Tablets
Film - coated
Oral use
tablet
DE-22765 Hamburg Germany Malta
Malta
Malta
Fair-Med Healthcare GmbH
Irbesartan/hydroch
Irbesartan/Hydrochlorothia
150
Film - coated
Planckstrasse 13
lorothiazide
tablet
zide Fairmed
mg/12,5
DE-22765 Hamburg
150mg/12.5mg film-coated
mg
Germany
tablets
Fair-Med Healthcare GmbH
Irbesartan/hydroch
Irbesartan/Hydrochlorothia
300
Film - coated
Planckstrasse 13
lorothiazide
zide Fairmed
mg/12,5
tablet
DE-22765 Hamburg
300mg/12.5mg film-coated
mg
Germany
tablets
Fair-Med Healthcare GmbH
Irbesartan/hydroch
Irbesartan/Hydrochlorothia
300 mg/25
Film - coated
Planckstrasse 13
lorothiazide
zide Fairmed 300mg/25mg
mg
tablet
37,5 mg
Prolonged -
DE-22765 Hamburg
Oral use
Oral use
Oral use
film-coated tablets
Germany Malta
Fair-Med Healthcare GmbH
Venlafaxine
Venlafaxine Fair-Med
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Malta
Fair-Med Healthcare GmbH
INN
Venlafaxine
Invented name
Venlafaxine Fair-Med
Strength
75 mg
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Germany Malta
Fair-Med Healthcare GmbH
Venlafaxine
Venlafaxine Fair-Med
150 mg
Prolonged -
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany Malta
Wockhardt UK Limited
Clopidogrel
Ash Road North
Clopidogrel 75mg Film-
75 mg
coated Tablets
Film - coated
Oral use
tablet
Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom Malta
Wockhardt UK Limited
Clopidogrel
Ash Road North
Clopidogrel 75mg Coated
75 mg
Tablets
Film - coated
Oral use
tablet
Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom Norway
Bluefish Pharmaceuticals AB
Fluconazole
Fluconazol Bluefish
50 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
150 mg
Capsule, hard
Oral use
Torsgatan 11 SE-11123 Stockholm Sweden Norway
Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Norway
Bluefish Pharmaceuticals AB
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Fluconazole
Fluconazol Bluefish
200 mg
Capsule, hard
Oral use
Esomeprazole
Esomeprazol Mylan
20 mg
Gastro - resistant
Oral use
Torsgatan 11 SE-11123 Stockholm Sweden Norway
Mylan AB PO Box 230 33
capsule, hard
SE-104 35 Stockholm Sweden Norway
Mylan AB
Esomeprazole
Esomeprazol Mylan
40 mg
PO Box 230 33
Gastro - resistant
Oral use
capsule, hard
SE-104 35 Stockholm Sweden Norway
Mylan AB
Eletriptan
Eletriptan Mylan
20 mg
PO Box 230 33
Film - coated
Oral use
tablet
SE-104 35 Stockholm Sweden Norway
Mylan AB
Eletriptan
Eletriptan Mylan
40 mg
PO Box 230 33
Film - coated
Oral use
tablet
SE-104 35 Stockholm Sweden Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
Kandrozid
4 mg
tablet
Oral use
SE-104 35 Stockholm Sweden
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Kandrozid
8 mg
tablet
Oral use
Kandrozid
16 mg
tablet
Oral use
Kandrozid
32 mg
tablet
Oral use
Mylcande
8 mg
tablet
Oral use
Mylcande
16 mg
tablet
Oral use
Mylcande
32 mg
tablet
Oral use
SE-104 35 Stockholm Sweden Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm Sweden Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm Sweden Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm Sweden Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm Sweden Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm Sweden
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Norway
Mylan AB
INN
Rizatriptan
PO Box 230 33
Invented name
RIZATRIPTAN MYLAN 10
Strength
10 mg
mg, orodispersible tablet
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
SE-104 35 Stockholm Sweden Norway
ratiopharm GmbH
Desloratadine
Desloratadin Ratiopharm
2,5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm Germany Norway
ratiopharm GmbH
Desloratadine
Desloratadin Ratiopharm
5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm Germany Poland
Abbott Laboratories Poland
Escitalopram
Savandra
5 mg
Sp. z o.o.
Film - coated
Oral use
tablet
ul. Postępu 21B 02-676 Warszawa Poland Poland
Abbott Laboratories Poland
Escitalopram
Savandra
Sp. z o.o.
10 mg
Film - coated
Oral use
tablet
ul. Postępu 21B 02-676 Warszawa Poland
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Poland
Abbott Laboratories Poland
INN
Escitalopram
Invented name
Savandra
Strength
15 mg
Sp. z o.o.
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
ul. Postępu 21B 02-676 Warszawa Poland Poland
Abbott Laboratories Poland
Escitalopram
Savandra
20 mg
Sp. z o.o.
Film - coated
Oral use
tablet
ul. Postępu 21B 02-676 Warszawa Poland Poland
Actavis Group PTC ehf.
Metformin
Metformin SR Actavis
500 mg
Reykjavikurvegi 76-78
Film - coated
Oral use
tablet
220 Hafnarfjördur Iceland Poland
Actavis Group PTC ehf.
Metformin
Metformin SR Actavis
750 mg
Reykjavikurvegi 76-78
Film - coated
Oral use
tablet
220 Hafnarfjördur Iceland Poland
Adamed Sp. z o.o.
Desloratadine
Desada
5 mg
Pieńków 149
Orodispersible
Oral use
tablet
05-152 Czosnów k. Warszawy Poland Poland
Adamed Sp. z o.o.
Desloratadine
Hitaxa Fast
Pieńków 149
2,5 mg
Orodispersible
Oral use
tablet
05-152 Czosnów k. Warszawy Poland
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Poland
Adamed Sp. z o.o.
INN
Desloratadine
Invented name
Hitaxa
Strength
2,5 mg
Pieńków 149
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
05-152 Czosnów k. Warszawy Poland Poland
Adamed Sp. z o.o.
Desloratadine
Hitaxa
5 mg
Pieńków 149
Orodispersible
Oral use
tablet
05-152 Czosnów k. Warszawy Poland Poland
Aflofarm Farmacja Polska Sp.
Desloratadine
Teslor
5 mg
z o.o.
Film - coated
Oral use
tablet
ul. Partyzancka 133/151 95-200 Pabianice Poland Poland
Aflofarm Farmacja Polska Sp.
Desloratadine
Teslor fast
5 mg
z o.o.
Orodispersible
Oral use
tablet
ul. Partyzancka 133/151 95-200 Pabianice Poland Poland
Aflofarm Farmacja Polska Sp.
Desloratadine
Teslor fast junior
z o.o.
2,5 mg
Orodispersible
Oral use
tablet
ul. Partyzancka 133/151 95-200 Pabianice Poland
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Poland
Apotex Europe B.V.
INN
Trimetazidine
Invented name
ApoTrimet PR
Strength
35 mg
Darwinweg 20
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
release tablet
NL 2333 CR Leiden Netherlands Poland
Bio-Profil Polska Sp. z o.o.
Desloratadine
Desloratadine Peseri
5 mg
Trakt Lubelski 135
Film - coated
Oral use
tablet
04-790 Warszawa Poland Poland
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
Valsartan HCT Fair-Med
DE-22765 Hamburg
320
Film - coated
mg/12,5
tablet
Oral use
mg
Germany Poland
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
Valsartan HCT Fair-Med
320 mg/25
Film - coated
mg
tablet
250 mg
Film - coated
Oral use
DE-22765 Hamburg Germany Poland
Fair-Med Healthcare GmbH
Ciprofloxacin
Ciprofloxacin Fair-Med
Planckstrasse 13
Oral use
tablet
DE-22765 Hamburg Germany Poland
Fair-Med Healthcare GmbH
Ciprofloxacin
Ciprofloxacin Fair-Med
Planckstrasse 13
500 mg
Film - coated
Oral use
tablet
DE-22765 Hamburg Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Poland
Fair-Med Healthcare GmbH
INN
Irbesartan
Invented name
Irbesartan Fair-Med
Strength
75 mg
Planckstrasse 13
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
DE-22765 Hamburg Germany Poland
Fair-Med Healthcare GmbH
Irbesartan
Irbesartan Fair-Med
150 mg
Planckstrasse 13
Film - coated
Oral use
tablet
DE-22765 Hamburg Germany Poland
Fair-Med Healthcare GmbH
Irbesartan
Irbesartan Fair-Med
300 mg
Planckstrasse 13
Film - coated
Oral use
tablet
DE-22765 Hamburg Germany Poland
Fair-Med Healthcare GmbH
Irbesartan/hydroch
Planckstrasse 13
lorothiazide
Irbesartan HCT Fair-Med
DE-22765 Hamburg
150
Film - coated
mg/12,5
tablet
Oral use
mg
Germany Poland
Fair-Med Healthcare GmbH
Irbesartan/hydroch
Planckstrasse 13
lorothiazide
Irbesartan HCT Fair-Med
DE-22765 Hamburg
300
Film - coated
mg/12,5
tablet
Oral use
mg
Germany Poland
Fair-Med Healthcare GmbH
Irbesartan/hydroch
Planckstrasse 13
lorothiazide
Irbesartan HCT Fair-Med
300 mg/25
Film - coated
mg
tablet
Oral use
DE-22765 Hamburg Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Poland
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
INN
Invented name
Valsartan HCT Fair-Med
DE-22765 Hamburg
Pharmaceutical
Route of
Form
administration
160
Film - coated
Oral use
mg/12,5
tablet
Strength
mg
Germany Poland
Fair-Med Healthcare GmbH
Venlafaxine
VENLAFAXINE FAIR-MED
37,5 mg
Prolonged -
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany Poland
Fair-Med Healthcare GmbH
Venlafaxine
VENLAFAXINE FAIR-MED
75 mg
Prolonged -
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany Poland
Fair-Med Healthcare GmbH
Venlafaxine
VENLAFAXINE FAIR-MED
150 mg
Prolonged -
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany Poland
Generics (UK) Ltd
Candesartan
Station Close, Potters Bar
cilexetil
Kangen
8 mg
Tablet
Oral use
Kangen
16 mg
Tablet
Oral use
Hertfordshire, EN6 1TL United Kingdom Poland
Generics (UK) Ltd
Candesartan
Station Close, Potters Bar
cilexetil
Hertfordshire, EN6 1TL United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Poland
Labormed-Pharma, SA
INN
Desloratadine
Invented name
Desloratadine Labormed
Strength
2,5 mg
Theodor Pallady, 44B
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
032266 Bucharest Romania Poland
Labormed-Pharma, SA
Desloratadine
Desloratadine Labormed
5 mg
Theodor Pallady, 44B
Orodispersible
Oral use
tablet
032266 Bucharest Romania Poland
Medicplast Polska Sp. z o.o
Desloratadine
Desalergo
5 mg
ul. Wólczyńska 232
Film - coated
Oral use
tablet
01-919 Warszawa Poland Poland
Medicplast Polska Sp. z o.o
Desloratadine
Desalergo
2,5 mg
ul. Wólczyńska 232
Orodispersible
Oral use
tablet
01-919 Warszawa Poland Poland
Medicplast Polska Sp. z o.o
Desloratadine
Desalergo
5 mg
ul. Wólczyńska 232
Orodispersible
Oral use
tablet
01-919 Warszawa Poland Poland
Orion Corporation
Valsartan
Valsartan Orion
Orion Pharma
40 mg
Film - coated
Oral use
tablet
PO BOX 65 02101 Espoo Finland
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Poland
Orion Corporation
INN
Valsartan
Invented name
Valsartan Orion
Strength
80 mg
Orion Pharma
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
PO BOX 65 02101 Espoo Finland Poland
Orion Corporation
Valsartan
Valsartan Orion
160 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65 02101 Espoo Finland Poland
Orion Corporation
Valsartan
Valsartan Orion
320 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65 02101 Espoo Finland Poland
Peseri Trading Limited
Desloratadine
Desloratadine Peseri
2,5 mg
20 Queen Frederica Street
Orodispersible
Oral use
tablet
El-Greco House, office 301 1066 Nicosia Cyprus Poland
Peseri Trading Limited
Desloratadine
Desloratadine Peseri
20 Queen Frederica Street
5 mg
Orodispersible
Oral use
tablet
El-Greco House, office 301 1066 Nicosia Cyprus
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Poland
Ranbaxy (Poland) Sp. z o.o.
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Alendronic acid
Alendran 70
70 mg
Tablet
Oral use
Trimetazidine
Dimesar
35 mg
Prolonged -
Oral use
Kubickiego 11 02-954 Warszawa Poland Poland
Sandoz GmbH Biochemiestrasse 10
release tablet
A-6250 Kundl Austria Poland
S-Lab Sp. z o.o.
Desloratadine
Suprodeslon
5 mg
ul. Kiełczowska 2
Film - coated
Oral use
tablet
55-095 Mirków Poland Poland
S-Lab Sp. z o.o.
Desloratadine
Suprodeslon
2,5 mg
ul. Kiełczowska 2
Orodispersible
Oral use
tablet
55-095 Mirków Poland Poland
S-Lab Sp. z o.o.
Desloratadine
Suprodeslon
5 mg
ul. Kiełczowska 2
Orodispersible
Oral use
tablet
55-095 Mirków Poland Poland
SymPhar Sp. z o.o.
Desloratadine
Symdes
ul. Włoska 1
5 mg
Film - coated
Oral use
tablet
00-777 Warszawa Poland
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Member State
Marketing Authorisation
(in EEA)
Holder
Poland
Tactica Pharmaceuticals sp. z
INN
Desloratadine
Invented name
Goldesin
Strength
5 mg
o.o.
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
ul. Bankowa 4 44-100 Gliwice Poland Poland
US Pharmacia Sp. z o.o.
Desloratadine
Aleric Deslo
5 mg
ul.Ziębicka 40
Film - coated
Oral use
tablet
50-507 Wrocław Poland Poland
US Pharmacia Sp. z o.o.
Desloratadine
Aleric Deslo
2,5 mg
ul.Ziębicka 40
Orodispersible
Oral use
tablet
50-507 Wrocław Poland Poland
US Pharmacia Sp. z o.o.
Desloratadine
Aleric Deslo Active
5 mg
ul.Ziębicka 40
Orodispersible
Oral use
tablet
50-507 Wrocław Poland Poland
Wockhardt UK Limited
Clopidogrel
Clopidogrel Wockhardt
Ash Road North
75 mg
Film - coated
Oral use
tablet
Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Accord Healthcare Limited
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Alendronic acid
Ácido alendrónico Accord
70 mg
tablet
Oral use
Cefpodoxime
Cefpodoxima Alkaloid
200 mg
Tablet
Oral use
Brown & Burk UK, Ltd.
Tramadol/paraceta
Tramadol + Paracetamol
37,5
Film - coated
Oral use
5, Marryat Close
mol
Brown
mg/325 mg
tablet
Trimetazidine
Trimetazidina Brown
35 mg
Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex United Kingdom Portugal
Alkaloid - INT d.o.o. Šlandrova 4 1231 Ljubljana - Črnuče Slovenia
Portugal
Hounslow TW4 5DQ Middlesex United Kingdom Portugal
Brown & Burk UK, Ltd. 5, Marryat Close
Modified - release
Oral use
tablet
Hounslow TW4 5DQ Middlesex United Kingdom Portugal
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram Brown
5, Marryat Close
10 mg
Film - coated
Oral use
tablet
Hounslow TW4 5DQ Middlesex United Kingdom
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Brown & Burk UK, Ltd.
INN
Escitalopram
Invented name
Escitalopram Brown
Strength
15 mg
5, Marryat Close
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Hounslow TW4 5DQ Middlesex United Kingdom Portugal
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram Brown
5 mg
5, Marryat Close
Film - coated
Oral use
tablet
Hounslow TW4 5DQ Middlesex United Kingdom Portugal
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram Brown
20 mg
5, Marryat Close
Film - coated
Oral use
tablet
Hounslow TW4 5DQ Middlesex United Kingdom Portugal
Brown & Burk UK, Ltd.
Ebastine
Ebastina Brown
10 mg
5, Marryat Close
Film - coated
Oral use
tablet
Hounslow TW4 5DQ Middlesex United Kingdom Portugal
Brown & Burk UK, Ltd.
Ebastine
Ebastina Brown
5, Marryat Close
20 mg
Film - coated
Oral use
tablet
Hounslow TW4 5DQ Middlesex United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Daquimed - Comércio de
INN
Quetiapine
Invented name
Quetiapina Daquimed
Strength
25 mg
Produtos Farmacêuticos, S.A.
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha 4510-688 Fânzeres Portugal Portugal
Daquimed - Comércio de
Quetiapine
Quetiapina Daquimed
100 mg
Produtos Farmacêuticos, S.A.
Film - coated
Oral use
tablet
Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha 4510-688 Fânzeres Portugal Portugal
Daquimed - Comércio de
Quetiapine
Quetiapina Daquimed
Produtos Farmacêuticos, S.A.
150 mg
Film - coated
Oral use
tablet
Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha 4510-688 Fânzeres Portugal
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Daquimed - Comércio de
INN
Quetiapine
Invented name
Quetiapina Daquimed
Strength
200 mg
Produtos Farmacêuticos, S.A.
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha 4510-688 Fânzeres Portugal Portugal
Daquimed - Comércio de
Quetiapine
Quetiapina Daquimed
300 mg
Produtos Farmacêuticos, S.A.
Film - coated
Oral use
tablet
Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha 4510-688 Fânzeres Portugal Portugal
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
50 mg/12,5
Film - coated
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/200 mg
tablet
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
75
Film - coated
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/18,75
tablet
Oral use
2700-487 Amadora Portugal Portugal
2700-487 Amadora
Oral use
mg/200 mg
Portugal
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
Pharmaceutical
Route of
(in EEA)
Holder
Form
administration
Portugal
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
100 mg/25
Film - coated
Oral use
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/200 mg
tablet
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
125
Film - coated
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/31,250
tablet
INN
Invented name
Strength
2700-487 Amadora Portugal Portugal
2700-487 Amadora
Oral use
mg/200 mg
Portugal Portugal
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
150
Film - coated
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/37,5
tablet
2700-487 Amadora
Oral use
mg/200 mg
Portugal Portugal
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
175
Film - coated
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/43,75
tablet
2700-487 Amadora
Oral use
mg/200 mg
Portugal Portugal
Generis Farmacêutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
Rua João de Deus, 19
a/entacapone
Entacapona Generis
mg/200 mg
200 mg/50
Film - coated tablet
Entacapone
Entacapona Generis
200 mg
Film - coated
Oral use
2700-487 Amadora Portugal Portugal
Generis Farmacêutica, S. A. Rua João de Deus, 19
Oral use
tablet
2700-487 Amadora Portugal
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Labesfal, Genéricos, S.A.
INN
Desloratadine
Invented name
Desloratadina Labesfal OD
Strength
2,5 mg
Av. Dr. Afonso Costa, nº 1370
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
3465-051 Campo de Besteiros Portugal Portugal
Labesfal, Genéricos, S.A.
Desloratadine
Desloratadina Labesfal OD
5 mg
Av. Dr. Afonso Costa, nº 1370
Orodispersible
Oral use
tablet
3465-051 Campo de Besteiros Portugal Portugal
Labesfal, Genéricos, S.A.
Alendronic acid
Ácido alendrónico Labesfal
70 mg
tablet
Oral use
Donepezil
Donepezilo Anova
5 mg
Orodispersible
Oral use
Av. Dr. Afonso Costa, nº 1370 3465-051 Campo de Besteiros Portugal Portugal
Laboratórios Anova - Produtos Farmacêuticos, Lda.
tablet
Rua Doutor António Loureiro Borges Edíficio Arquiparque 1, R/C Esqº 1499-016 Algés Portugal
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Laboratórios Anova - Produtos
INN
Donepezil
Invented name
Donepezilo Anova
Strength
10 mg
Farmacêuticos, Lda.
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
Rua Doutor António Loureiro Borges Edíficio Arquiparque 1, R/C Esqº 1499-016 Algés Portugal Portugal
Laboratórios Anova - Produtos
Esomeprazole
Esomeprazol Anova
20 mg
Farmacêuticos, Lda.
Gastro - resistant
Oral use
capsule, hard
Rua Doutor António Loureiro Borges Edíficio Arquiparque 1, R/C Esqº 1499-016 Algés Portugal Portugal
Laboratórios Anova - Produtos
Esomeprazole
Esomeprazol Anova
Farmacêuticos, Lda.
40 mg
Gastro - resistant
Oral use
capsule, hard
Rua Doutor António Loureiro Borges Edíficio Arquiparque 1, R/C Esqº 1499-016 Algés Portugal
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Laboratórios Azevedos -
INN
Venlafaxine
Invented name
Venlafaxina Azevedos
Strength
37,5 mg
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
Indústria Farmacêutica, S.A.
release capsule,
Edifícios Azevedos - Estrada
hard
Nacional 117-2, Alfragide 2614-504 Amadora Portugal Portugal
Laboratórios Azevedos -
Venlafaxine
Venlafaxina Azevedos
75 mg
Prolonged -
Indústria Farmacêutica, S.A.
release capsule,
Edifícios Azevedos - Estrada
hard
Oral use
Nacional 117-2, Alfragide 2614-504 Amadora Portugal Portugal
Laboratórios Azevedos -
Venlafaxine
Venlafaxina Azevedos
150 mg
Prolonged -
Indústria Farmacêutica, S.A.
release capsule,
Edifícios Azevedos - Estrada
hard
Oral use
Nacional 117-2, Alfragide 2614-504 Amadora Portugal Portugal
Laboratórios Basi - Indústria
Fluconazole
Fluconazol Basi
50 mg
Capsule
Oral use
Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Laboratórios Basi - Indústria
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Fluconazole
Fluconazol Basi
150 mg
Capsule
Oral use
Fluconazole
Fluconazol Basi
200 mg
Capsule
Oral use
Desloratadine
Desloratadina Labormed
5 mg
Orodispersible
Oral use
Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal Portugal
Laboratórios Basi - Indústria Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal
Portugal
Labormed-Pharma, SA Theodor Pallady, 44B
tablet
032266 Bucharest Romania Portugal
Labormed-Pharma, SA
Desloratadine
Desloratadina Labormed
2,5 mg
Theodor Pallady, 44B
Orodispersible
Oral use
tablet
032266 Bucharest Romania Portugal
Lupin (Europe) Limited
Cefpodoxime
Cefpodoxima Lupin
Victoria Court, Bexton Road
200 mg
Film - coated
Oral use
tablet
Knutsford, Cheshire WA16 0PF United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Mylan, Lda.
INN
Esomeprazole
Invented name
Esomeprazol Mylan
Strength
20 mg
Parque Expo, Edifício Atlantis,
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule, hard
Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal
Mylan, Lda.
Esomeprazole
Esomeprazol Mylan
40 mg
Parque Expo, Edifício Atlantis,
Gastro - resistant
Oral use
capsule, hard
Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal
Mylan, Lda.
Atorvastatin
Atorvastatina Anova
10 mg
Parque Expo, Edifício Atlantis,
Film - coated
Oral use
tablet
Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal
Mylan, Lda.
Atorvastatin
Atorvastatina Anova
Parque Expo, Edifício Atlantis,
20 mg
Film - coated
Oral use
tablet
Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Mylan, Lda.
INN
Atorvastatin
Invented name
Atorvastatina Anova
Strength
40 mg
Parque Expo, Edifício Atlantis,
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal
Mylan, Lda.
Atorvastatin
Atorvastatina Anova
80 mg
Parque Expo, Edifício Atlantis,
Film - coated
Oral use
tablet
Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal
Mylan, Lda.
Donepezil
Donepezilo Mylan
5 mg
Parque Expo, Edifício Atlantis,
Orodispersible
Oral use
tablet
Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal
Mylan, Lda.
Donepezil
Donepezilo Mylan
Parque Expo, Edifício Atlantis,
10 mg
Orodispersible
Oral use
tablet
Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Mylan, Lda.
INN
Trimetazidine
Invented name
Trimetazidina Mylan
Strength
35 mg
Parque Expo, Edifício Atlantis,
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
tablet
Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal
Mylan, Lda.
Candesartan
Candesartan Mylan
4 mg
Tablet
Oral use
Candesartan
Candesartan Mylan
8 mg
Tablet
Oral use
Candesartan
Candesartan Mylan
16 mg
Tablet
Oral use
Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal
Mylan, Lda. Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal
Portugal
Mylan, Lda. Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Mylan, Lda.
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Candesartan
Candesartan Mylan
32 mg
Tablet
Oral use
Desloratadine
Desloratadina Peseri
5 mg
Film - coated
Oral use
Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal
Peseri Trading Limited 20 Queen Frederica Street
tablet
El-Greco House, office 301 1066 Nicosia Cyprus Portugal
Peseri Trading Limited
Desloratadine
Desloratadina Peseri
5 mg
20 Queen Frederica Street
Orodispersible
Oral use
tablet
El-Greco House, office 301 1066 Nicosia Cyprus Portugal
Peseri Trading Limited
Desloratadine
Desloratadina Peseri
20 Queen Frederica Street
2,5 mg
Orodispersible
Oral use
tablet
El-Greco House, office 301 1066 Nicosia Cyprus
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Pharmakern Portugal -
INN
Trimetazidine
Invented name
Trimetazidina Pharmakern
Strength
35 mg
Produtos Farmacêuticos,
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
tablet
Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal Portugal
Ratiopharm - Comércio e
Desloratadine
Desloratadina Ratiopharm
2,5 mg
Indústria de Produtos
Orodispersible
Oral use
tablet
Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal Portugal
Ratiopharm - Comércio e
Desloratadine
Desloratadina Ratiopharm
Indústria de Produtos
5 mg
Orodispersible
Oral use
tablet
Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal
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Member State
Marketing Authorisation
(in EEA)
Holder
Portugal
Sandoz Farmaceutica Lda.
INN
Trimetazidine
Invented name
Trimetazidina Itraxel
Strength
35 mg
Avenida Professor Doutor
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
release tablet
Cavaco Silva, n. 10E Taguspark 2740-255 Porto Salvo Portugal Portugal
Teva Pharma - Produtos
Desloratadine
Desloratadina Teva
2,5 mg
Farmacêuticos,Lda.
Orodispersible
Oral use
tablet
Edificio Tejo, Rua Quinta do Pinheiro, 16 - 6º 2790-143 Carnaxide Portugal Portugal
Teva Pharma - Produtos
Desloratadine
Desloratadina Teva
5 mg
Farmacêuticos,Lda.
Orodispersible
Oral use
tablet
Edificio Tejo, Rua Quinta do Pinheiro, 16 - 6º 2790-143 Carnaxide Portugal Romania
Abbott Products SAS
Escitalopram
42 rue Rouget de Lisle
SAVANDRA 5 mg
5 mg
comprimate filmate
Film - coated
Oral use
tablet
92150 Suresnes France Romania
Abbott Products SAS 42 rue Rouget de Lisle
Escitalopram
SAVANDRA 10 mg comprimate filmate
10 mg
Film - coated
Oral use
tablet
92150 Suresnes France
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Romania
Abbott Products SAS
INN
Escitalopram
42 rue Rouget de Lisle
Invented name
SAVANDRA 15 mg
Strength
15 mg
comprimate filmate
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
92150 Suresnes France Romania
Abbott Products SAS
Escitalopram
42 rue Rouget de Lisle
SAVANDRA 20 mg
20 mg
comprimate filmate
Film - coated
Oral use
tablet
92150 Suresnes France Romania
Alkaloid - INT d.o.o.
Cefpodoxime
Šlandrova 4
Forexo 200 mg
200 mg
Tablet
Oral use
5 mg
Film - coated
Oral use
comprimate filmate
1231 Ljubljana - Črnuče Slovenia Romania
Alvogen IPCo S.ar.l.
Desloratadine
Rue Heienhaff 5
Desloratadina Alvogen 5 mg comprimate filmate
tablet
L-1736 Senningerberg Luxembourg Romania
Dr. Reddy’s Laboratories
Levetiracetam
Levetiracetam Dr. Reddy’s,
Romania SRL
250 mg, comprimate
71st-73rd Nicolae Caramfil,
filmate
250 mg
Tablet
Oral use
500 mg
Tablet
Oral use
Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania
Dr. Reddy’s Laboratories
Levetiracetam
Levetiracetam Dr. Reddy’s,
Romania SRL
500mg, comprimate
71st-73rd Nicolae Caramfil,
filmate
Floor 5, Space 10, Sector 1, Bucuresti, Romania
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Romania
Dr. Reddy’s Laboratories
INN
Levetiracetam
Invented name
Levetiracetam Dr. Reddy’s,
Romania SRL
750 mg, comprimate
71st-73rd Nicolae Caramfil,
filmate
Pharmaceutical
Route of
Form
administration
750 mg
Tablet
Oral use
1000 mg
Tablet
Oral use
40 mg
Tablet
Oral use
80 mg
Tablet
Oral use
Tablet
Oral use
Strength
Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania
Dr. Reddy’s Laboratories
Levetiracetam
Levetiracetam Dr. Reddy’s,
Romania SRL
1000 mg, comprimate
71st-73rd Nicolae Caramfil,
filmate
Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania
Dr. Reddy’s Laboratories
Telmisartan
Romania SRL
Telmisartan Dr. Reddy's 40 mg comprimate
71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania
Dr. Reddy’s Laboratories
Telmisartan
Romania SRL
Telmisartan Dr. Reddy's 80 mg comprimate
71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania
Dr. Reddy’s Laboratories
Telmisartan/
Telmisartan HCT Dr.
40 mg/12,5
Romania SRL
hydrochlorothiazide
Reddy’s 40 mg/12,5 mg
mg
71st-73rd Nicolae Caramfil,
comprimate
Floor 5, Space 10, Sector 1, Bucuresti, Romania
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 89/131
Member State
Marketing Authorisation
(in EEA)
Holder
Romania
Dr. Reddy’s Laboratories
Telmisartan/
Telmisartan HCT Dr.
80 mg/12,5
Romania SRL
hydrochlorothiazide
Reddy’s 80 mg/12,5 mg
mg
INN
71st-73rd Nicolae Caramfil,
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Tablet
Oral use
Tablet
Oral use
Gastro - resistant
Oral use
comprimate
Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania
Dr. Reddy’s Laboratories
Telmisartan/
Telmisartan HCT Dr.
80 mg/25
Romania SRL
hydrochlorothiazide
Reddy’s 80 mg/25 mg
mg
71st-73rd Nicolae Caramfil,
comprimate
Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania
Generics (UK) Ltd
Esomeprazole
Esomeprazol Mylan 20 mg
Station Close, Potters Bar
magnesium
capsule gastrorezistente
Generics (UK) Ltd
Esomeprazole
Esomeprazol Mylan 40 mg
Station Close, Potters Bar
magnesium
capsule gastrorezistente
Generics (UK) Ltd
Donepezil
Donepezil Mylan 5 mg
Station Close, Potters Bar
hydrochloride
comprimate
20 mg
capsule, hard
Hertfordshire, EN6 1TL United Kingdom Romania
40 mg
Gastro - resistant
Oral use
capsule, hard
Hertfordshire, EN6 1TL United Kingdom Romania
Hertfordshire, EN6 1TL
5 mg
Orodispersible
Oral use
tablet
orodispersabile
United Kingdom Romania
Generics (UK) Ltd
Donepezil
Donepezil Mylan 10 mg
Station Close, Potters Bar
hydrochloride
comprimate
Hertfordshire, EN6 1TL
10 mg
Orodispersible
Oral use
tablet
orodispersabile
United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Romania
Generics (UK) Ltd
INN
Repaglinide
Station Close, Potters Bar
Invented name
Repaglinida Generics 0.5
Pharmaceutical
Route of
Form
administration
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
4 mg
Tablet
Oral use
8 mg
Tablet
Oral use
16 mg
Tablet
Oral use
Strength
mg comprimate
Hertfordshire, EN6 1TL United Kingdom Romania
Generics (UK) Ltd
Repaglinide
Station Close, Potters Bar
Repaglinida Genericsl 1 mg comprimate
Hertfordshire, EN6 1TL United Kingdom Romania
Generics (UK) Ltd
Repaglinide
Station Close, Potters Bar
Repaglinida Generics 2 mg comprimate
Hertfordshire, EN6 1TL United Kingdom Romania
Generics (UK) Ltd
Candesartan
Candesartan Mylan 4 mg
Station Close, Potters Bar
cilexetil
comprimate
Generics (UK) Ltd
Candesartan
Candesartan Mylan 8 mg
Station Close, Potters Bar
cilexetil
comprimate
Generics (UK) Ltd
Candesartan
Candesartan Mylan 16 mg
Station Close, Potters Bar
cilexetil
comprimate
Hertfordshire, EN6 1TL United Kingdom Romania
Hertfordshire, EN6 1TL United Kingdom Romania
Hertfordshire, EN6 1TL United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Romania
Generics (UK) Ltd
Rizatriptan
Rizatriptan Mylan 5 mg
Station Close, Potters Bar
benzoate
comprimate
INN
Hertfordshire, EN6 1TL
Invented name
Strength
5 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
orrodispersabile
United Kingdom Romania
Generics (UK) Ltd
Rizatriptan
Rizatriptan Mylan 10 mg
Station Close, Potters Bar
benzoate
comprimate
Hertfordshire, EN6 1TL
10 mg
Orodispersible
Oral use
tablet
orrodispersabile
United Kingdom Romania
Glenmark Pharmaceuticals
Trimetazidine
Apstar 35mg
s.r.o.
Comprimate cu
Hvězdova 1716/2b
eliberare
14078 Praha 4
prelungită
35 mg
Modified - release
Oral use
tablet
Czech Republic Romania
Labormed Pharma SA
Desloratadine
Desloratadine Labormed
Bd. Theodor Pallady nr. 44 B
2.5 mg comprimate
032266, sector 3, Bucureşti
orodispersabile
2,5 mg
Orodispersible
Oral use
tablet
România Romania
Labormed Pharma SA
Desloratadine
Desloratadine Labormed 5
Bd. Theodor Pallady nr. 44 B
mg comprimate
032266, sector 3, Bucureşti
orodispersabile
5 mg
Orodispersible
Oral use
tablet
România Romania
Mylan SAS
Trimetazidine
Trimetazidina Mylan 35 mg
117 allée des Parcs
comprimate filmate cu
69792 Saint-Priest Cedex
eliberare prelungita
35 mg
Prolonged -
Oral use
release tablet
France
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 92/131
Member State
Marketing Authorisation
(in EEA)
Holder
Romania
Sandoz Pharma Services SRL
INN
Trimetazidine
Invented name
Trimeluzine Limited 35 mg
Calea Floreasca Street
comprimate filmate cu
No 169A, district 2
eliberare modificata
Strength
35 mg
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
tablet
Bucharest Romania Romania
STADA Hemofarm S.R.L.
Entacapone
Calea Torontalului km 6 -
ENTTANIDA 200
200 mg
comprimate filmate
Film - coated
Oral use
tablet
PITT 300633 Timişoara Romania Romania
Teva Pharmaceuticals S.R.L.
Desloratadine
Desloratadina Teva 5 mg
Str. Domniţa Ruxandra nr.
comprimate
12, parter, sector 2,
orodispersabile
5 mg
Orodispersible
Oral use
tablet
Bucureşti, România Romania
Torrent Pharma SRL
Irbesartan
Irbesartan Torrent 75 mg
Str. Stirbei Voda nr. 36
comprimate
et. 2, biroul A, sector 1
filmate
75 mg
Film - coated
Oral use
tablet
Bucharest Romania Romania
Torrent Pharma SRL
Irbesartan
Irbesartan Torrent 150 mg
Str. Stirbei Voda nr. 36
comprimate
et. 2, biroul A, sector 1
filmate
150 mg
Film - coated
Oral use
tablet
Bucharest Romania
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 93/131
Member State
Marketing Authorisation
(in EEA)
Holder
Romania
Torrent Pharma SRL
INN
Irbesartan
Invented name
Irbesartan Torrent 300 mg
Str. Stirbei Voda nr. 36
comprimate
et. 2, biroul A, sector 1
filmate
Strength
300 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Bucharest Romania Romania
Torrent Pharma SRL
Irbesartan/hydroch
Irbesartan Torrent
150
Film - coated
Str. Stirbei Voda nr. 36
lorothiazide
Hidrochlorotiazida
mg/12,5
tablet
et. 2, biroul A, sector 1
150/12,5mg comprimate
mg
Bucharest
filmate
Oral use
Romania Romania
Torrent Pharma SRL
Irbesartan/hydroch
Irbesartan Torrent
300
Film - coated
Str. Stirbei Voda nr. 36
lorothiazide
tablet
Hidrochlorotiazida
mg/12,5
et. 2, biroul A, sector 1
300/12,5mg comprimate
mg
Bucharest
filmate
Oral use
Romania Romania
Torrent Pharma SRL
Irbesartan/hydroch
Irbesartan Torrent
300 mg/25
Film - coated
Str. Stirbei Voda nr. 36
lorothiazide
Hidrochlorotiazida
mg
tablet
200 mg
Film - coated
et. 2, biroul A, sector 1
300/25 mg comprimate
Bucharest
filmate
Oral use
Romania Slovak Republic
Alkaloid - INT d.o.o. Šlandrova 4
Cefpodoxime
FOREXO 200 mg filmom obalené tablety
Oral use
tablet
1231 Ljubljana - Črnuče Slovenia
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 94/131
Member State
Marketing Authorisation
(in EEA)
Holder
Slovak Republic
Alvogen IPCo S.àr.l.
INN
Desloratadine
412F Route d'Esch
Invented name
Dezloratadin Alvogen 5 mg
Strength
5 mg
filmom obalené tablety
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
L - 2086 Luxembourg Slovak Republic
Genericon s.r.o.,
Desloratadine
GESLORA 5 mg
5 mg
Anny Letenské 1108/15,
Film - coated
Oral use
tablet
120 00 Praha 2 - Vinohrady Czech Republic Slovak Republic
Generics (UK) Ltd
Donepezil
Donepezil Mylan 5 mg
Station Close, Potters Bar
hydrochloride
orodispergovateľné tablety
Generics (UK) Ltd
Donepezil
Donepezil Mylan 10 mg
Station Close, Potters Bar
hydrochloride
orodispergovateľné tablety
Generics (UK) Ltd
Rizatriptan
Rizatriptan Mylan 10 mg
Station Close, Potters Bar
benzoate
5 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL United Kingdom Slovak Republic
10 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL United Kingdom Slovak Republic
10 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL United Kingdom Slovak Republic
Glenmark Pharmaceuticals s.r.o.
Trimetazidine
Apstar 35 mg tablety s predĺženým uvoľňovaním
35 mg
Modified - release
Oral use
tablet
Hvězdova 1716/2b 14078 Praha 4 Czech Republic
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 95/131
Member State
Marketing Authorisation
(in EEA)
Holder
Slovak Republic
Mylan SAS
INN
Trimetazidine
Invented name
Trimetazidin Mylan 35 mg
Strength
35 mg
117 allée des Parcs
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
tablet
69792 Saint-Priest Cedex France Slovak Republic
SVUS Pharma a.s.
Desloratadine
Smetanovo nábřeží 1238/20a
LOTERA 5 mg filmom
5 mg
obalené tablety
Film - coated
Oral use
tablet
500 02 Hradec Králové Czech Republic Slovak Republic
Teva Pharmaceuticals
Desloratadine
Slovakia s.r.o.
Dezloratadin Teva OROTAB
2,5 mg
2,5 mg
Orodispersible
Oral use
tablet
Teslova 26 821 02 Bratislava Slovak Republic Slovak Republic
Teva Pharmaceuticals
Desloratadine
Slovakia s.r.o.
Dezloratadin Teva OROTAB
5 mg
5 mg
Orodispersible
Oral use
tablet
Teslova 26 821 02 Bratislava Slovak Republic Slovenia
Alkaloid - INT d.o.o.
Cefpodoxime
Šlandrova 4
Trexodo 200 mg filmsko
200 mg
obložene tablete
Film - coated
Oral use
tablet
1231 Ljubljana - Črnuče Slovenia Slovenia
Generics (UK) Ltd
Esomeprazole
Esomeprazol Mylan 20 mg
Station Close, Potters Bar
magnesium
trde gastrorezistentne
Hertfordshire, EN6 1TL
20 mg
Gastro - resistant
Oral use
capsule, hard
kapsule
United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 96/131
Member State
Marketing Authorisation
(in EEA)
Holder
Slovenia
Generics (UK) Ltd
Esomeprazole
Esomeprazol Mylan 40 mg
Station Close, Potters Bar
magnesium
trde gastrorezistentne
INN
Hertfordshire, EN6 1TL
Invented name
Strength
40 mg
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule, hard
kapsule
United Kingdom Slovenia
Generics (UK) Ltd
Donepezil
Donepezil Mylan 5 mg
Station Close, Potters Bar
hydrochloride
orodisperzibilne tablete
Generics (UK) Ltd
Donepezil
Donepezil Mylan 10 mg
Station Close, Potters Bar
hydrochloride
orodisperzibilne tablete
Lek farmacevtska družba d.d.
Trimetazidine
Trimeluzine 35 mg tablete
Verovškova 57
hydrochloride
s podaljšanim sproščanjem
Metoclopramide
METOCLOPRAMIDA
5 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL United Kingdom Slovenia
10 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL United Kingdom Slovenia
35 mg
Prolonged -
Oral use
release tablet
1526 Ljubljana Slovenia Spain
Accord Healthcare, S.L.U. Moll de Barcelona s/n. World
ACCORD 10 mg
Trade Center. Edifici Est 6ª
COMPRIMIDOS EFG
10 mg
Tablet
Oral use
Film - coated
Oral use
planta, 8039 Barcelona Spain Spain
Apotex Europe B.V.
Desloratadine
DESLORATADINA APOTEX
Darwinweg 20
5 mg COMPRIMIDOS
NL 2333 CR Leiden
RECUBIERTOS CON
Netherlands
PELICULA EFG
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
5 mg
tablet
Page 97/131
Member State
Marketing Authorisation
(in EEA)
Holder
Spain
Brown & Burk UK, Ltd.
INN
Ebastine
Invented name
EBASTINA BROWN 10 mg
5, Marryat Close
COMPRIMIDOS
Hounslow
BUCODISPERSABLES EFG
Strength
10 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
TW4 5DQ Middlesex United Kingdom Spain
Farmalider, S.A.
Valsartan/hydrochl
VALSARTAN/HIDROCLORO
160
Film - coated
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL 160
mg/12,5
tablet
28108 Madrid
MG/12,5 mg
mg
Spain
COMPRIMIDOS
Oral use
RECUBIERTOS CON PELICULA EFG Spain
Farmalider, S.A.
Valsartan/hydrochl
VALSARTAN/HIDROCLORO
160 mg/25
Film - coated
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL
mg
tablet
28108 Madrid
160/25 mg COMPRIMIDOS
Spain
RECUBIERTOS CON
Oral use
PELICULA EFG Spain
Farmalider, S.A.
Valsartan/hydrochl
VALSARTAN/HIDROCLORO
320
Film - coated
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL
mg/12,5
tablet
28108 Madrid
320/12.5 mg
mg
Spain
COMPRIMIDOS
Oral use
RECUBIERTOS CON PELICULA EFG Spain
Farmalider, S.A.
Valsartan/hydrochl
VALSARTAN/HIDROCLORO
320 mg/25
Film - coated
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL
mg
tablet
28108 Madrid
320/25 mg COMPRIMIDOS
Spain
RECUBIERTOS CON
Oral use
PELICULA EFG GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 98/131
Member State
Marketing Authorisation
(in EEA)
Holder
Spain
Farmalider, S.A.
Valsartan/hydrochl
VALSARTAN/HIDROCLORO
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL
INN
Invented name
28108 Madrid
80/12.5 mg COMPRIMIDOS
Spain
RECUBIERTOS CON
Pharmaceutical
Route of
Form
administration
80 mg/12,5
Film - coated
Oral use
mg
tablet
5 mg
Film - coated
Strength
PELICULA EFG Spain
Laboratorios Combix, S.L.U.
Desloratadine
DESLORATADINA COMBIX
C/ Badajoz 2, Edificio 2
5 mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELÍCULA EFG
Oral use
tablet
Spain Spain
Laboratorios Combix, S.L.U.
Desloratadine
DESLORATADINA FLAS
C/ Badajoz 2, Edificio 2
COMBIX 5 mg
Pozuelo de Alarcon
COMPRIMIDOS
Madrid 28223
BUCODISPERSABLES EFG
5 mg
Film - coated
Oral use
tablet
Spain Spain
Laboratorios Combix, S.L.U.
Escitalopram
ESCITALOPRAM COMBIX
C/ Badajoz 2, Edificio 2
10 mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELICULA EFG
10 mg
Film - coated
Oral use
tablet
Spain Spain
Laboratorios Combix, S.L.U.
Escitalopram
ESCITALOPRAM COMBIX
C/ Badajoz 2, Edificio 2
15 mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELICULA EFG
15 mg
Film - coated
Oral use
tablet
Spain
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Spain
Laboratorios Combix, S.L.U.
INN
Escitalopram
Invented name
ESCITALOPRAM COMBIX
C/ Badajoz 2, Edificio 2
20 mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELICULA EFG
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Spain Spain
Laboratorios Combix, S.L.U.
Escitalopram
ESCITALOPRAM COMBIX 5
C/ Badajoz 2, Edificio 2
mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELICULA EFG
5 mg
Film - coated
Oral use
tablet
Spain Spain
Laboratorios Ranbaxy, S. L U.
Alendronic acid
ACIDO ALENDRONICO
Paseig de Gracia 9
SEMANAL RANBAXY 70 mg
7a Pl
COMPRIMIDOS EFG
70 mg
Tablet
Oral use
10 mg
Orodispersible
Oral use
Barcelona 08007 Spain Spain
Mylan Pharmaceuticals, S.L.
Donepezil
Plom 2-4, 5º Planta
PHARMACEUTICALS 10 mg
8038 Barcelona
COMPRIMIDOS
Spain Spain
DONEPEZILO FLAS MYLAN
Mylan Pharmaceuticals, S.L.
tablet
BUCODISPERSABLES EFG Donepezil
DONEPEZILO FLAS MYLAN
Plom 2-4, 5º Planta
PHARMACEUTICALS 5 mg
8038 Barcelona
COMPRIMIDOS
Spain
BUCODISPERSABLES EFG
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
5 mg
Orodispersible
Oral use
tablet
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Member State
Marketing Authorisation
(in EEA)
Holder
Spain
Mylan Pharmaceuticals, S.L.
INN
Esomeprazole
mg CAPSULAS
8038 Barcelona
GASTRORRESISTENTES
Mylan Pharmaceuticals, S.L.
ESOMEPRAZOL MYLAN 40
Plom 2-4, 5º Planta
mg CAPSULAS
8038 Barcelona
GASTRORRESISTENTES
Mylan Pharmaceuticals, S.L.
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule
EFG Esomeprazole
Spain Spain
ESOMEPRAZOL MYLAN 20
Plom 2-4, 5º Planta Spain Spain
Invented name
40 mg
Gastro - resistant
Oral use
capsule
EFG Repaglinide
Plom 2-4, 5º Planta
REPAGLINIDA MYLAN 0,5
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
10 mg
Orodispersible
Oral use
mg COMPRIMIDOS EFG
8038 Barcelona Spain Spain
Mylan Pharmaceuticals, S.L.
Repaglinide
Plom 2-4, 5º Planta
REPAGLINIDA MYLAN 1 mg COMPRIMIDOS EFG
8038 Barcelona Spain Spain
Mylan Pharmaceuticals, S.L.
Repaglinide
Plom 2-4, 5º Planta
REPAGLINIDA MYLAN 2 mg COMPRIMIDOS EFG
8038 Barcelona Spain Spain
Mylan Pharmaceuticals, S.L.
Rizatriptan
RIZATRIPTAN MAX MYLAN
Plom 2-4, 5º Planta
10 mg COMPRIMIDOS
8038 Barcelona
BUCODISPERSABLES EFG
tablet
Spain
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
Spain
PENSA PHARMA, S.A.U
INN
Alendronic acid
Invented name
ACIDO ALENDRONICO
Jorge Comín (médico
SEMANAL PENSA 70 mg
pediatra)
COMPRIMIDOS EFG
Pharmaceutical
Route of
Form
administration
70 mg
Tablet
Oral use
2,5 mg
Orodispersible
Oral use
Strength
3 - bajos 46015– Valencia (Valencia) Spain Spain
Pharmagenus, S.A.,
Desloratadine
DESLORATADINA
Avda. Camí Real, 51-57,
PHARMAGENUS 2,5 mg
08184 Palau-solita i
COMPRIMIDOS
Plegamans (Barcelona)
BUCODISPERSABLES EFG
tablet
Spain Spain
Pharmagenus, S.A.,
Desloratadine
DESLORATADINA
Avda. Camí Real, 51-57,
PHARMAGENUS 5 mg
08184 Palau-solita i
COMPRIMIDOS
Plegamans (Barcelona)
BUCODISPERSABLES EFG
5 mg
Orodispersible
Oral use
tablet
Spain Spain
Teva Pharma S.L.U.
Desloratadine
DESLORATADINA TEVA 5
C/ Anabel Segura, 11
mg COMPRIMIDOS
Edificio Albatros B, 1ª planta
BUCODISPERSABLES EFG
5 mg
Orodispersible
Oral use
tablet
Madrid 28108 Spain Spain
Welding GmbH & Co. KG
Irbesartan
IRBESARTAN/HIDROCLOR
150
Film - coated
Esplanade 39
OTIAZIDA WELDING 150
mg/12,5
tablet
D-20354 Hamburg
mg/12.5 mg
mg
Germany
COMPRIMIDOS
Oral use
RECUBIERTOS CON PELICULA EFG GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 102/131
Member State
Marketing Authorisation
(in EEA)
Holder
Spain
Welding GmbH & Co. KG
INN
Irbesartan
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Oral use
IRBESARTAN/HIDROCLOR
300
Film - coated
Esplanade 39
OTIAZIDA WELDING 300
mg/12,5
tablet
D-20354 Hamburg
mg/12.5 mg
mg
Germany
COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Spain
Welding GmbH & Co. KG
Irbesartan
IRBESARTAN/HIDROCLOR
300 mg/25
Film - coated
Oral use
Esplanade 39
OTIAZIDA WELDING 300
mg
tablet
D-20354 Hamburg
mg/25 mg COMPRIMIDOS
Germany
RECUBIERTOS CON 70 mg
Tablet
Oral use
Clindamycin Alternova
150 mg
Capsule, hard
Oral use
Fluconazol Bluefish
50 mg
Capsule, hard
Oral use
PELICULA EFG Sweden
Accord Healthcare Limited
Alendronic acid
Sage House, 319 Pinner Road
Alendronat Accord Veckotablett
North Harrow HA1 4HF Middlesex United Kingdom Sweden
Alternova A/S
Clindamycin
Lodshusvej 11
hydrochloride
DK-4230 Skælskør Denmark Sweden
Bluefish Pharmaceuticals AB
Fluconazole
Torsgatan 11 SE-11123 Stockholm Sweden
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Page 103/131
Member State
Marketing Authorisation
(in EEA)
Holder
Sweden
Bluefish Pharmaceuticals AB
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Fluconazole
Fluconazol Bluefish
150 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
200 mg
Capsule, hard
Oral use
Generics (UK) Ltd
Donepezil
Donezil
5 mg
Orodispersible
Oral use
Station Close, Potters Bar
hydrochloride
Torsgatan 11 SE-11123 Stockholm Sweden Sweden
Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden
Sweden
tablet
Hertfordshire, EN6 1TL United Kingdom Sweden
Generics (UK) Ltd
Donepezil
Station Close, Potters Bar
hydrochloride
Donezil
10 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL United Kingdom Sweden
Mylan AB
Donepezil
Donepezil Mylan
5 mg
PO Box 230 33
Orodispersible
Oral use
tablet
SE-104 35 Stockholm Sweden Sweden
Mylan AB
Donepezil
Donepezil Mylan
PO Box 230 33
10 mg
Orodispersible
Oral use
tablet
SE-104 35 Stockholm Sweden
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Page 104/131
Member State
Marketing Authorisation
(in EEA)
Holder
Sweden
Mylan AB
INN
Rizatriptan
Invented name
Rizatriptan Mylan
Strength
10 mg
PO Box 230 33
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
SE-104 35 Stockholm Sweden Sweden
Mylan AB
Repaglinide
Repaglinid Mylan
0,5 mg
Tablet
Oral use
Repaglinide
Repaglinid Mylan
1 mg
Tablet
Oral use
Repaglinide
Repaglinid Mylan
2 mg
Tablet
Oral use
Esomeprazole
Esomeprazol Mylan
20 mg
Gastro - resistant
Oral use
PO Box 230 33 SE-104 35 Stockholm Sweden Sweden
Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden
Sweden
Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden
Sweden
Mylan AB PO Box 230 33
capsule, hard
SE-104 35 Stockholm Sweden Sweden
Mylan AB
Esomeprazole
Esomeprazol Mylan
PO Box 230 33
40 mg
Gastro - resistant
Oral use
capsule, hard
SE-104 35 Stockholm Sweden
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Page 105/131
Member State
Marketing Authorisation
(in EEA)
Holder
Sweden
Mylan AB
INN
Eletriptan
Invented name
Eletriptan Mylan
Strength
20 mg
PO Box 230 33
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
SE-104 35 Stockholm Sweden Sweden
Mylan AB
Eletriptan
Eletriptan Mylan
40 mg
PO Box 230 33
Film - coated
Oral use
tablet
SE-104 35 Stockholm Sweden Sweden
Orion Corporation
Valsartan
Valsartan Orion
40 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65 02101 Espoo Finland Sweden
Orion Corporation
Valsartan
Valsartan Orion
80 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65 02101 Espoo Finland Sweden
Orion Corporation
Valsartan
Valsartan Orion
Orion Pharma
160 mg
Film - coated
Oral use
tablet
PO BOX 65 02101 Espoo Finland
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Page 106/131
Member State
Marketing Authorisation
(in EEA)
Holder
Sweden
Orion Corporation
INN
Valsartan
Invented name
Valsartan Orion
Strength
320 mg
Orion Pharma
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
PO BOX 65 02101 Espoo Finland Sweden
Ranbaxy UK Ltd.
Alendronic acid
Alendronat Ranbaxy
Building 4, Chiswick Park
Veckotablett 70 mg
566 Chiswick High Road
tabletter
70 mg
Tablet
Oral use
200 mg
Film - coated
Oral use
London, W4 5YE Untied Kingdom Sweden
Stada Arzneimittel AG
Entacapone
Entakapon STADA
Stadastrasse 2-18
tablet
DE-61118 Bad Vilbel Germany The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner Road
Ropinirole
Ropinirol Accord 5 mg,
5 mg
filmomhulde tabletten
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner Road
Ropinirole
Ropinirol Accord 0,25 mg filmomhulde tabletten
0,25 mg
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom
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Page 107/131
Member State
Marketing Authorisation
(in EEA)
Holder
The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner Road
INN
Ropinirole
Invented name
Ropinirol Accord 0,5 mg
Strength
0,5 mg
filmomhulde tabletten
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner Road
Ropinirole
Ropinirol Accord 1 mg
1 mg
filmomhulde tabletten
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner Road
Ropinirole
Ropinirol Accord 2 mg
2 mg
filmomhulde tabletten
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner Road
Alendronic acid
Alendroninezuur Accord
10 mg
Tablet
Oral use
70 mg
Tablet
Oral use
10mg Tabletten
North Harrow HA1 4HF Middlesex United Kingdom The
Accord Healthcare Limited
Netherlands
Sage House, 319 Pinner Road
Alendronic acid
Alendroninezuur Accord 70mg Tabletten
North Harrow HA1 4HF Middlesex United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 108/131
Member State
Marketing Authorisation
(in EEA)
Holder
The
Accord Healthcare Limited
Metoclopramide
Metoclopramidemonohydro
Netherlands
Sage House, 319 Pinner Road
hydrochloride
chloride Accord 10 mg,
INN
North Harrow HA1 4HF
Invented name
Pharmaceutical
Route of
Form
administration
10 mg
Tablet
Oral use
37,5 mg
Prolonged -
Oral use
Strength
Tabletten
Middlesex United Kingdom The
Alembic Pharmaceuticals
Netherlands
Europe Limited
Alembic 37,5 mg, capsule
release capsule,
Palazzo Pietro Stiges, 103,
met verlengde afgifte, hard
hard
Venlafaxine
Venlafaxine HCl Retard
Strait Street VLT 1436 Valletta Malta The
Alembic Pharmaceuticals
Netherlands
Europe Limited
Alembic 75 mg, capsule
release capsule,
Palazzo Pietro Stiges, 103,
met verlengde afgifte, hard
hard
Venlafaxine
Venlafaxine HCl Retard
75 mg
Prolonged -
Oral use
Strait Street VLT 1436 Valletta Malta The
Alembic Pharmaceuticals
Netherlands
Europe Limited
Alembic 150 mg, capsule
release capsule,
Palazzo Pietro Stiges, 103,
met verlengde afgifte, hard
hard
Venlafaxine
Venlafaxine HCl Retard
150 mg
Prolonged -
Oral use
Strait Street VLT 1436 Valletta Malta
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Page 109/131
Member State
Marketing Authorisation
(in EEA)
Holder
The
Brown & Burk UK, Ltd.
Netherlands
5, Marryat Close
orodispergeerbare
Hounslow
tabletten
INN
Ebastine
Invented name
Ebastine BB 10 mg
Strength
10 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
TW4 5DQ Middlesex United Kingdom The
Centrafarm B.V.
Netherlands
Nieuwe Donk 3
Entacapone
Entacapone CF 200 mg,
200 mg
filmomhulde tablet
Film - coated
Oral use
tablet
4879 AC Etten Leur The Netherlands The
Fair-Med Healthcare GmbH
Netherlands
Planckstrasse 13
Ciprofloxacin
Ciprofloxacine Fair-Med 250 mg, filmomhulde
DE-22765 Hamburg
tabletten
250 mg
Film - coated
Oral use
tablet
Germany The
Fair-Med Healthcare GmbH
Ciprofloxacin
Ciprofloxacine Fair-Med
Netherlands
Planckstrasse 13
500 mg, filmomhulde
DE-22765 Hamburg
tabletten
500 mg
Film - coated
Oral use
tablet
Germany The
Fair-Med Healthcare GmbH
Ciprofloxacin
Ciprofloxacine Fair-Med
Netherlands
Planckstrasse 13
750 mg, filmomhulde
DE-22765 Hamburg
tabletten
750 mg
Film - coated
Oral use
tablet
Germany The
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/HCTZ Fair-Med
160
Film - coated
Netherlands
Planckstrasse 13
orothiazide
160 mg/12,5 mg,
mg/12,5
tablet
filmomhulde tabletten
mg
DE-22765 Hamburg
Oral use
Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 110/131
Member State
Marketing Authorisation
(in EEA)
Holder
The
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/HCTZ Fair-Med
Netherlands
Planckstrasse 13
orothiazide
INN
DE-22765 Hamburg
Pharmaceutical
Route of
Form
administration
320
Film - coated
Oral use
320 mg/12,5 mg,
mg/12,5
tablet
filmomhulde tabletten
mg
Invented name
Strength
Germany The
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Valsartan/HCTZ Fair-Med
320 mg/25
Film - coated
Netherlands
Planckstrasse 13
orothiazide
320 mg/25 mg,
mg
tablet
37,5 mg
Prolonged -
DE-22765 Hamburg
Oral use
filmomhulde tabletten
Germany The
Fair-Med Healthcare GmbH
Venlafaxine
Venlafaxine Fair-Med 37,5
Netherlands
Planckstrasse 13
mg capsules met verlengde
release capsule,
DE-22765 Hamburg
afgifte, hard
hard
Oral use
Germany The
Fair-Med Healthcare GmbH
Netherlands
Planckstrasse 13
Venlafaxine
mg capsules met verlengde
Venlafaxine Fair-Med 75
75 mg
Prolonged release capsule,
DE-22765 Hamburg
afgifte, hard
hard
Oral use
Germany The
Fair-Med Healthcare GmbH
Netherlands
Planckstrasse 13
Venlafaxine
mg capsules met verlengde
Venlafaxine Fair-Med 150
150 mg
Prolonged release capsule,
DE-22765 Hamburg
afgifte, hard
hard
Oral use
Germany The
Mylan B.V.
Esomeprazole
Esomeprazol Mylan 20 mg,
Netherlands
Dieselweg 25
maagsapresistente
3752 LB Bunschoten
capsules, hard
20 mg
Gastro - resistant
Oral use
capsule, hard
The Netherlands
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 111/131
Member State
Marketing Authorisation
(in EEA)
Holder
The
Mylan B.V.
Netherlands
Dieselweg 25
maagsapresistente
3752 LB Bunschoten
capsules, hard
INN
Esomeprazole
Invented name
Esomeprazol Mylan 40 mg,
Strength
40 mg
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule, hard
The Netherlands The
Mylan B.V.
Rizatriptan
Rizatriptan SmeltTab Mylan
Netherlands
Dieselweg 25
5 mg, orodispergeerbare
3752 LB Bunschoten
tabletten
5 mg
Orodispersible
Oral use
tablet
The Netherlands The
Mylan B.V.
Rizatriptan
Rizatriptan SmeltTab Mylan
Netherlands
Dieselweg 25
10 mg, orodispergeerbare
3752 LB Bunschoten
tabletten
10 mg
Orodispersible
Oral use
tablet
The Netherlands The
Ranbaxy UK Ltd.
Netherlands
Building 4, Chiswick Park
Alendronic acid
Alendroninezuur 70
70 mg
Tablet
Oral use
0,5 mg
Tablet
Oral use
2 mg
Tablet
Oral use
Ranbaxy, tabletten 70 mg
566 Chiswick High Road London, W4 5YE Untied Kingdom The
Sandoz B.V.
Netherlands
Veluwezoom 22
Clonazepam
Clonazepam Sandoz 0,5 mg, tabletten
1327 AH Almere The Netherlands The
Sandoz B.V.
Netherlands
Veluwezoom 22
Clonazepam
Clonazepam Sandoz 2 mg, tabletten
1327 AH Almere The Netherlands
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 112/131
Member State
Marketing Authorisation
(in EEA)
Holder
The
Sandoz B.V.
Netherlands
Veluwezoom 22
INN
Clobazam
Invented name
Clobazam Sandoz 10 mg,
Pharmaceutical
Route of
Form
administration
10 mg
Tablet
Oral use
2,5 mg
Orodispersible
Oral use
Strength
tabletten
1327 AH Almere The Netherlands The
Teva Nederland B.V.
Desloratadine
Netherlands
Swensweg 5
2,5 mg Teva,
2031 GA Haarlem
orodispergeerbare
The Netherlands
Desloratadine Smelttablet
tabletten
The
Teva Nederland B.V.
Netherlands
Swensweg 5
5 mg Teva,
2031 GA Haarlem
orodispergeerbare
The Netherlands
tabletten
The
TioFarma b.v.
Netherlands
Benjamin Franklinstraat 5-10
tablet
Desloratadine
Clonazepam
Desloratadine Smelttablet
Clonazepam TioFarma 0,5
5 mg
Orodispersible
Oral use
tablet
0,5 mg
Tablet
Oral use
2 mg
Tablet
Oral use
10 mg
Tablet
Oral use
mg tabletten, tabletten
3261 LW Oud-Beyerland The Netherlands The
TioFarma b.v.
Netherlands
Benjamin Franklinstraat 5-10
Clonazepam
Clonazepam TioFarma 2 mg tabletten, tabletten
3261 LW Oud-Beyerland The Netherlands The
TioFarma b.v.
Netherlands
Benjamin Franklinstraat 5-10
Clobazam
Clobazam TioFarma 10 mg, tabletten
3261 LW Oud-Beyerland The Netherlands
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 113/131
Member State
Marketing Authorisation
(in EEA)
Holder
The
TioFarma b.v.
Netherlands
Benjamin Franklinstraat 5-10
INN
Clobazam
Invented name
Clobazam TioFarma 20 mg,
Pharmaceutical
Route of
Form
administration
20 mg
Tablet
Oral use
75 mg
Film - coated
Oral use
Strength
tabletten
3261 LW Oud-Beyerland The Netherlands The
Torrent Pharma GmbH
Netherlands
Südwestpark 50
irbesartan
Irbesartan Torrent 75 mg filmomhulde tabletten
tablet
90449 Nürnberg Germany The
Torrent Pharma GmbH
Netherlands
Südwestpark 50
irbesartan
Irbesartan Torrent 150 mg
150 mg
filmomhulde tabletten
Film - coated
Oral use
tablet
90449 Nürnberg Germany The
Torrent Pharma GmbH
Netherlands
Südwestpark 50
irbesartan
Irbesartan Torrent 300 mg
300 mg
filmomhulde tabletten
Film - coated
Oral use
tablet
90449 Nürnberg Germany The
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartan
150
Film - coated
Netherlands
Südwestpark 50
lorothiazide
Hydrochloorthiazide
mg/12,5
tablet
90449 Nürnberg
Torrent 150 mg/12,5 mg
mg
Germany
filmomhulde tabletten
The
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartan
300
Film - coated
Netherlands
Südwestpark 50
lorothiazide
Hydrochloorthiazide
mg/12,5
tablet
90449 Nürnberg
Torrent 300 mg/12,5 mg
mg
Germany
filmomhulde tabletten
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Oral use
Oral use
Page 114/131
Member State
Marketing Authorisation
(in EEA)
Holder
The
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartan
Netherlands
Südwestpark 50
lorothiazide
Hydrochloorthiazide
INN
90449 Nürnberg Unichem Laboratories Ltd.
Netherlands
Studio 8B Ard Gaoithe
Pharmaceutical
Route of
Form
administration
300 mg/25
Film - coated
Oral use
mg
tablet
150 mg
Film - coated
Strength
Torrent 300 mg/25 mg
Germany The
Invented name
filmomhulde tabletten irbesartan
Irbesartan Unichem 150 mg filmomhulde tabletten
Oral use
tablet
Commercial Centre, Business Park Cashel Road Clonmel, Co Tipperary Ireland The
Unichem Laboratories Ltd.
Netherlands
Studio 8B Ard Gaoithe
irbesartan
Irbesartan Unichem 300
300 mg
mg filmomhulde tabletten
Film - coated
Oral use
tablet
Commercial Centre, Business Park Cashel Road Clonmel, Co Tipperary Ireland United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner Road
Ropinirole
Ropinirole 0.25mg filmcoated tablets
0,25 mg
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 115/131
Member State
Marketing Authorisation
(in EEA)
Holder
United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner Road
INN
Ropinirole
Invented name
Ropinirole 0.5mg film-
Strength
0,5 mg
coated tablets
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner Road
Ropinirole
Ropinirole 1mg film-coated
1 mg
tablets
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner Road
Ropinirole
Ropinirole 2mg film-coated
2 mg
tablets
Film - coated
Oral use
tablet
North Harrow HA1 4HF Middlesex United Kingdom United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner Road
Alendronic acid
alendronic acid 10mg
10 mg
Tablet
Oral use
70 mg
Tablet
Oral use
Tablets
North Harrow HA1 4HF Middlesex United Kingdom United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner Road
Alendronic acid
alendronic acid 70mg Once Daily Tablets
North Harrow HA1 4HF Middlesex United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 116/131
Member State
Marketing Authorisation
(in EEA)
Holder
United
Accord Healthcare Limited
Metoclopramide
metoclopramide
Kingdom
Sage House, 319 Pinner Road
hydrochloride
hydrochloride 10mg tablets
Ropinirole
Ropinirole 5mg film-coated
INN
Invented name
Pharmaceutical
Route of
Form
administration
10 mg
Tablet
Oral use
5 mg
Film - coated
Oral use
Strength
North Harrow HA1 4HF Middlesex United Kingdom United
Accord Healthcare Limited
Kingdom
Sage House, 319 Pinner Road
tablets
tablet
North Harrow HA1 4HF Middlesex United Kingdom United
Aptil Pharma Limited
Kingdom
9th Floor, CP House
Fluconazole
Fluconazole 50mg capsules
50 mg
Capsule, hard
Oral use
Fluconazole
Fluconazole 150mg
150 mg
Capsule, hard
Oral use
200 mg
Capsule, hard
Oral use
97-107 Uxbridge Road London W5 5TL United Kingdom United
Aptil Pharma Limited
Kingdom
9th Floor, CP House
capsules
97-107 Uxbridge Road London W5 5TL United Kingdom United
Aptil Pharma Limited
Kingdom
9th Floor, CP House
Fluconazole
Fluconazole 200mg capsules
97-107 Uxbridge Road London W5 5TL United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 117/131
Member State
Marketing Authorisation
(in EEA)
Holder
United
Auden McKenzie Limited
Kingdom
McKenzie House
INN
Dexamethasone
Pharmaceutical
Route of
Form
administration
2 mg
Tablet
Oral use
Tyvera 50mg Tablets
50 mg
Tablet
Oral use
Tyvera 100mg Tablets
100 mg
Tablet
Oral use
Clonazepam 500mcg
0,5 mg
Tablet
Oral use
2 mg
Tablet
Oral use
Invented name
Dexamethasone 2mg
Strength
Tablets
Bury Street, Ruislip Middlesex HA4 7TL United Kingdom United
Auden McKenzie Limited
Thiamine
Kingdom
McKenzie House
hydrochloride
Bury Street, Ruislip Middlesex HA4 7TL United Kingdom United
Auden McKenzie Limited
Thiamine
Kingdom
McKenzie House
hydrochloride
Bury Street, Ruislip Middlesex HA4 7TL United Kingdom United
Auden McKenzie Limited
Kingdom
McKenzie House
Clonazepam
Tablet
Bury Street, Ruislip Middlesex HA4 7TL United Kingdom United
Auden McKenzie Limited
Kingdom
McKenzie House
Clonazepam
Clonazepam 2mg Tablet
Bury Street, Ruislip Middlesex HA4 7TL United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 118/131
Member State
Marketing Authorisation
(in EEA)
Holder
United
Auden McKenzie Limited
Kingdom
McKenzie House
INN
Clobazam
Invented name
CLOBAZAM AUDEN 10mg
Pharmaceutical
Route of
Form
administration
10 mg
Tablet
Oral use
250 mg
Film - coated
Oral use
Strength
TABLETS
Bury Street, Ruislip Middlesex HA4 7TL United Kingdom United
Brown & Burk UK, Ltd.
Phenoxymethyl
Phenoxymethylpenicillin
Kingdom
5, Marryat Close
penicillin
250mg Film-coated Tablets
tablet
Hounslow TW4 5DQ Middlesex United Kingdom United
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram 5mg Film-
Kingdom
5, Marryat Close
oxalate
coated tablets
5 mg
Film - coated
Oral use
tablet
Hounslow TW4 5DQ Middlesex United Kingdom United
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram 10mg Film-
Kingdom
5, Marryat Close
oxalate
coated tablets
10 mg
Film - coated
Oral use
tablet
Hounslow TW4 5DQ Middlesex United Kingdom United
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram 15mg Film-
Kingdom
5, Marryat Close
oxalate
coated tablets
15 mg
Film - coated
Oral use
tablet
Hounslow TW4 5DQ Middlesex United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 119/131
Member State
Marketing Authorisation
(in EEA)
Holder
United
Brown & Burk UK, Ltd.
Escitalopram
Escitalopram 20mg Film-
Kingdom
5, Marryat Close
oxalate
coated tablets
INN
Invented name
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Hounslow TW4 5DQ Middlesex United Kingdom United
Brown & Burk UK, Ltd.
Tramadol
Aceon 100mg Prolonged-
Kingdom
5, Marryat Close
hydrochloride
release tablets
100 mg
Prolonged -
Oral use
release tablet
Hounslow TW4 5DQ Middlesex United Kingdom United
Brown & Burk UK, Ltd.
Tramadol
Aceon 150mg Prolonged-
Kingdom
5, Marryat Close
hydrochloride
release tablets
150 mg
Prolonged -
Oral use
release tablet
Hounslow TW4 5DQ Middlesex United Kingdom United
Brown & Burk UK, Ltd.
Tramadol
Aceon 200mg Prolonged-
Kingdom
5, Marryat Close
hydrochloride
release tablets
Valsartan
Valsartan 40mg Capsules
200 mg
Prolonged -
Oral use
release tablet
Hounslow TW4 5DQ Middlesex United Kingdom United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
40 mg
Capsule
Oral use
6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom
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Member State
Marketing Authorisation
(in EEA)
Holder
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Valsartan
Valsartan 80mg Capsules
80 mg
Capsule
Oral use
Valsartan
Valsartan 160mg Capsules
160 mg
Capsule
Oral use
Valsartan
Valsartan 320mg Capsules
320 mg
Capsule
Oral use
Levetiracetam
Levetiracetam 250mg film-
250 mg
Film - coated
Oral use
6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United
Dr Reddy's Laboratories (UK)
Kingdom
Limited 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
coated tablets
tablet
6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
Levetiracetam
Levetiracetam 500mg filmcoated tablets
500 mg
Film - coated
Oral use
tablet
6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
INN
Levetiracetam
Invented name
Levetiracetam 750mg film-
Strength
750 mg
coated tablets
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
Levetiracetam
Levetiracetam 1000mg
1000 mg
film-coated tablets
Film - coated
Oral use
tablet
6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
Pioglitazone
Pioglitazone 15mg Tablets
15 mg
Tablet
Oral use
Pioglitazone
Pioglitazone 30mg Tablets
30 mg
Tablet
Oral use
Pioglitazone
Pioglitazone 45mg Tablets
45 mg
Tablet
Oral use
6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United
Dr Reddy's Laboratories (UK)
Kingdom
Limited 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom
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Member State
Marketing Authorisation
(in EEA)
Holder
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
INN
Dipyridamole
Invented name
Attia 200mg Modified
Strength
200 mg
Release Capsules
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
capsule, hard
6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
Telmisartan
Telmisartan 20mg Tablets
20 mg
Tablet
Oral use
Telmisartan
Telmisartan 40mg Tablets
40 mg
Tablet
Oral use
Telmisartan
Telmisartan 80mg Tablets
80 mg
Tablet
Oral use
Tablet
Oral use
6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United
Dr Reddy's Laboratories (UK)
Kingdom
Limited 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom
United
Dr Reddy's Laboratories (UK)
Telmisartan/
Telmisartan/Hydrochlorothi
40 mg/12,5
Kingdom
Limited
hydrochlorothiazide
azide 40mg/12.5mg
mg
6 Riverview Road, Beverley
Tablets
East Yorkshire HU17 0LD United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
Page 123/131
Member State
Marketing Authorisation
(in EEA)
Holder
United
Dr Reddy's Laboratories (UK)
Telmisartan/
Telmisartan/Hydrochlorothi
80 mg/12,5
Kingdom
Limited
hydrochlorothiazide
azide 80mg/12.5mg
mg
INN
6 Riverview Road, Beverley
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Tablet
Oral use
Tablet
Oral use
Film - coated
Oral use
Tablets
East Yorkshire HU17 0LD United Kingdom United
Dr Reddy's Laboratories (UK)
Telmisartan/
Telmisartan/Hydrochlorothi
80 mg/25
Kingdom
Limited
hydrochlorothiazide
azide 80mg/25mg Tablets
mg
irbesartan
Irbesartan 75mg Film-
75 mg
6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United
Fair-Med Healthcare GmbH
Kingdom
Planckstrasse 13
coated Tablets
tablet
DE-22765 Hamburg Germany United
Fair-Med Healthcare GmbH
Kingdom
Planckstrasse 13
irbesartan
Irbesartan 150mg Film-
150 mg
coated Tablets
Film - coated
Oral use
tablet
DE-22765 Hamburg Germany United
Fair-Med Healthcare GmbH
Kingdom
Planckstrasse 13
irbesartan
Irbesartan 300mg Film-
300 mg
coated Tablets
Film - coated
Oral use
tablet
DE-22765 Hamburg Germany United
Fair-Med Healthcare GmbH
Irbesartan/hydroch
Irbesartan/Hydrochlorothia
150
Film - coated
Kingdom
Planckstrasse 13
lorothiazide
zide 150mg/12.5mg film-
mg/12,5
tablet
coated tablets
mg
DE-22765 Hamburg
Oral use
Germany
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Member State
Marketing Authorisation
(in EEA)
Holder
United
Fair-Med Healthcare GmbH
Irbesartan/hydroch
Irbesartan/Hydrochlorothia
Kingdom
Planckstrasse 13
lorothiazide
INN
DE-22765 Hamburg
Pharmaceutical
Route of
Form
administration
300
Film - coated
Oral use
zide 300mg/12.5mg film-
mg/12,5
tablet
coated tablets
mg
Invented name
Strength
Germany United
Fair-Med Healthcare GmbH
Irbesartan/hydroch
Irbesartan/Hydrochlorothia
300 mg/25
Film - coated
Kingdom
Planckstrasse 13
lorothiazide
zide 300mg/25mg film-
mg
tablet
DE-22765 Hamburg
Oral use
coated tablets
Germany United
Fannin (UK) Ltd
Kingdom
42-46 Booth Drive
Fluconazole
Fluconazole 150mg capsule
150 mg
Capsule, hard
Oral use
Fexofenadine
Fexofenadine 120mg film-
120 mg
Film - coated
Oral use
Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom United
Fannin (UK) Ltd
Kingdom
42-46 Booth Drive
coated tablets
tablet
Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom United
Fannin (UK) Ltd
Kingdom
42-46 Booth Drive
Fexofenadine
Fexofenadine 180mg filmcoated tablets
180 mg
Film - coated
Oral use
tablet
Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom
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Member State
Marketing Authorisation
(in EEA)
Holder
United
FDC Pharma
Kingdom
Unit 6, Fulcrum 1, Solent Way
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Amlodipine
Amlodipine 5mg Tablets
5 mg
Tablet
Oral use
Amlodipine
Amlodipine 10mg Tablets
10 mg
Tablet
Oral use
Repaglinide
Repaglinide Mylan 0.5mg
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
5 mg
Orodispersible
Oral use
Whiteley, Fareham Hampshire PO15 7FE United Kingdom United
FDC Pharma
Kingdom
Unit 6, Fulcrum 1, Solent Way Whiteley, Fareham Hampshire PO15 7FE United Kingdom
United
Generics (UK) Ltd
Kingdom
Station Close, Potters Bar
Tablets
Hertfordshire, EN6 1TL United Kingdom United
Generics (UK) Ltd
Kingdom
Station Close, Potters Bar
Repaglinide
Repaglinide Mylan 1mg Tablets
Hertfordshire, EN6 1TL United Kingdom United
Generics (UK) Ltd
Kingdom
Station Close, Potters Bar
Repaglinide
Repaglinide Mylan 2mg Tablets
Hertfordshire, EN6 1TL United Kingdom United
Generics (UK) Ltd
Donepezil
Donepezil Hydrochloride
Kingdom
Station Close, Potters Bar
hydrochloride
5mg Orodispersible Tables
tablet
Hertfordshire, EN6 1TL United Kingdom
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Member State
Marketing Authorisation
(in EEA)
Holder
United
Generics (UK) Ltd
Donepezil
Donepezil Hydrochloride
Kingdom
Station Close, Potters Bar
hydrochloride
10mg Orodispersible
INN
Hertfordshire, EN6 1TL
Invented name
Strength
10 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
Tables
United Kingdom United
Generics (UK) Ltd
Rizatriptan
Rizatriptan 10mg
Kingdom
Station Close, Potters Bar
benzoate
Orodispersible Tablet
Esomeprazole 20mg
10 mg
Orodispersible
Oral use
tablet
Hertfordshire, EN6 1TL United Kingdom United
Generics (UK) Ltd
Esomeprazole
Kingdom
Station Close, Potters Bar
magnesium
Hertfordshire, EN6 1TL
20 mg
Gastro-resistant Capsules,
Gastro - resistant
Oral use
capsule
hard
United Kingdom United
Generics (UK) Ltd
Esomeprazole
Esomeprazole 40mg
Kingdom
Station Close, Potters Bar
magnesium
Gastro-resistant Capsules,
Hertfordshire, EN6 1TL
40 mg
Gastro - resistant
Oral use
capsule
hard
United Kingdom United
Generics (UK) Ltd
Levodopa/carbidop
Levodopa/Carbidopa/Entac
150
Film - coated
Kingdom
Station Close, Potters Bar
a/entacapone
apone film-coated tablets
mg/37,5
tablet
150/37.5/200mg
mg/200 mg
Pantoprazole 20mg Gastro-
20 mg
Hertfordshire, EN6 1TL
Oral use
United Kingdom United
Lupin (Europe) Limited
Kingdom
Victoria Court, Bexton Road
Pantoprazole
Resistant tablets
Gastro - resistant
Oral use
tablet
Knutsford, Cheshire WA16 0PF United Kingdom
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Member State
Marketing Authorisation
(in EEA)
Holder
United
Lupin (Europe) Limited
Kingdom
Victoria Court, Bexton Road
INN
Pantoprazole
Invented name
Pantoprazole 40mg Gastro-
Strength
40 mg
Resistant tablets
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
tablet
Knutsford, Cheshire WA16 0PF United Kingdom United
Morningside Healthcare
Phenoxymethyl
Phenoxymethylpenicillin
Kingdom
Limited
penicillin
250mg Film-coated Tablets
250 mg
Film - coated
Oral use
tablet
115 Narborough Road Leicester, LE3 0PA United Kingdom United
Morningside Healthcare
Metformin
Bolamyn/Metabet SR
Kingdom
Limited
hydrochloride
1000mg Prolonged Release
115 Narborough Road
1000 mg
Prolonged -
Oral use
release tablet
Tablets
Leicester, LE3 0PA United Kingdom United
Niche Generics Limited
Kingdom
1 The Cam Centre
irbesartan
Irbesartan Niche 150mg
150 mg
film-coated tablets
Film - coated
Oral use
tablet
Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom United
Niche Generics Limited
Kingdom
1 The Cam Centre
irbesartan
Irbesartan Niche 150mg film-coated tablets
150 mg
Film - coated
Oral use
tablet
Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom
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Member State
Marketing Authorisation
(in EEA)
Holder
United
Ranbaxy UK Ltd.
Kingdom
Building 4, Chiswick Park
INN
Alendronic acid
Invented name
Alendronic Acid 70mg
Strength
70 mg
Pharmaceutical
Route of
Form
administration
Tablet
Oral use
Oral use
Tablets
566 Chiswick High Road London, W4 5YE Untied Kingdom United
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartan
150
Film - coated
Kingdom
Südwestpark 50
lorothiazide
Hydrochlorothiazide
mg/12,5
tablet
90449 Nürnberg
150mg/12.5mg Film-
mg
Germany
coated tablets
United
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartan
300
Film - coated
Kingdom
Südwestpark 50
lorothiazide
Hydrochlorothiazide
mg/12,5
tablet
90449 Nürnberg
300mg/12.5mg Film-
mg
Germany
coated tablets
United
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartan
300 mg/25
Film - coated
Kingdom
Südwestpark 50
lorothiazide
Hydrochlorothiazide
mg
tablet
75 mg
Film - coated
90449 Nürnberg Torrent Pharma GmbH
Kingdom
Südwestpark 50
Oral use
300mg/25mg Film-coated
Germany United
Oral use
tablets irbesartan
Irbesartan 75mg Filmcoated tablets
Oral use
tablet
90449 Nürnberg Germany United
Torrent Pharma GmbH
Kingdom
Südwestpark 50
irbesartan
Irbesartan 150mg Filmcoated tablets
150 mg
Film - coated
Oral use
tablet
90449 Nürnberg Germany
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Member State
Marketing Authorisation
(in EEA)
Holder
United
Torrent Pharma GmbH
Kingdom
Südwestpark 50
INN
irbesartan
Invented name
Irbesartan 300mg Film-
Strength
300 mg
coated tablets
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
90449 Nürnberg Germany United
Waymade PLC
Venlafaxine
Venlasov XL 75mg Modified
Kingdom
Sovereign House
hydrochloride
Release Capsules
75 mg
Prolonged -
Oral use
release capsule,
Miles Grat Road, Basildon
hard
Essex SS14 3FR United Kingdom United
Waymade PLC
Venlafaxine
Venlasov XL 150mg
Kingdom
Sovereign House
hydrochloride
Modified Release Capsules
150 mg
Prolonged -
Oral use
release capsule,
Miles Grat Road, Basildon
hard
Essex SS14 3FR United Kingdom United
Wockhardt UK Limited
Kingdom
Ash Road North
Clopidogrel
Clopidogrel 75mg Film-
75 mg
coated Tablets
Film - coated
Oral use
tablet
Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom United
YJBPort Limited
Kingdom
74 Briarwood Drive
Hydrocortisone
Hydrocortisone 10mg
10 mg
Tablet
Oral use
Tablets
Northwood Hills Middlesex HA6 1PL United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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Member State
Marketing Authorisation
(in EEA)
Holder
United
YJBPort Limited
Kingdom
74 Briarwood Drive
INN
Hydrocortisone
Invented name
Hydrocortisone 20mg
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Tablet
Oral use
Tablets
Northwood Hills Middlesex HA6 1PL United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015
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