Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2015 to 31 July 2015 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2015-08-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015285EN.01001101.xml










28.8.2015   


EN


Official Journal of the European Union


C 285/11





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2015 to 31 July 2015
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2015/C 285/02)
—   Issuing, maintenance or modification of a national marketing authorization











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




16.7.2015


Medicinal products for human use which clinical part of bioequivalence studies were performed at GVK Biosciences Hyderabad site


See Annex I


See Annex I


See Annex I


20.7.2015




17.7.2015


Fentanyl


Fentanyl


Not applicable


Not applicable


20.7.2015




3.7.2015


Zoledronic acid


Zoledronic acid


Not applicable


Not applicable


7.7.2015




—   Suspension of a national marketing authorization











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




16.7.2015


Medicinal products for human use which clinical part of bioequivalence studies were performed at GVK Biosciences Hyderabad site


See Annex I


See Annex I


See Annex I


20.7.2015






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States

Annex IA: Products for which the marketing authorisations are recommended for maintenance












Member State (in EEA)


Marketing Authorisation Holder


INN


Invented name


Strength


Pharmaceutical Form


Route of administration




Austria


Basics GmbH
Hemmelrather Weg 201
51377 Leverkusen
Germany


Venlafaxine


Venlafaxin Ranbaxy
150 mg
Retardkapseln


150 mg


Prolonged — released capsule, hard


Oral use




Austria


Basics GmbH
Hemmelrather Weg 201
51377 Leverkusen
Germany


Venlafaxine


Venlafaxin Ranbaxy
75 mg Retardkapseln


75 mg


Prolonged — released capsule, hard


Oral use




Austria


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxin Bluefish 75 mg Hartkapseln retardiert


75 mg


Prolonged — released capsule, hard


Oral use




Austria


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxin Bluefish 150 mg Hartkapseln retardiert


150 mg


Prolonged — released capsule, hard


Oral use




Austria


G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria


Nebivolol


Nebilan 5 mg Tabletten


5 mg


Tablet


Oral use




Austria


G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria


Nebivolol


Nebivolol G.L. 5 mg — Tabletten


5 mg


Tablet


Oral use




Austria


Ratiopharm Arzneimittei-Vertriebs-GmbH
Albert-Schweitzer-Gasse 3
1140 Wien
Austria


Nebivolol


NEBIVOLOL-RATIOPHARM 5 MG Tabletten


5 mg


Tablet


Oral use




Bulgaria


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Levetiracetam


Lyvam


250 mg


Film-coated tablet


Oral use




Bulgaria


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Levetiracetam


Lyvam


500 mg


Film-coated tablet


Oral use




Bulgaria


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Levetiracetam


Lyvam


750 mg


Film-coated tablet


Oral use




Bulgaria


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Levetiracetam


Lyvam


1  000 mg


Film-coated tablet


Oral use




Bulgaria


Ecopharm Group AD
bul. Cherni vrah 14, bl.3
Sofia 1421
Bulgaria


Nebivolol


Nevolen


5 mg


Tablet


Oral use




Bulgaria


Ewopharma International s.r.o.,
Hlavna 13
Bratislava 83101
Slovakia


Fexofenadine


Ewofex


120 mg


Film-coated tablet


Oral use




Bulgaria


Ewopharma International s.r.o.,
Hlavna 13
Bratislava 83101
Slovakia


Fexofenadine


Ewofex


180 mg


Film-coated tablet


Oral use




Bulgaria


G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria


Nebivolol


Nebilan


5 mg


Tablet


Oral use




Bulgaria


Neo Balkanika EOOD
35 Zemliane Str.
Sofia 1618
Bulgaria


Nebivolol


Bivolet


5 mg


Tablet


Oral use




Bulgaria


Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia


Bosentan


Bosentan Sandoz


62,5 mg


Film-coated tablet


Oral use




Bulgaria


Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia


Bosentan


Bosentan Sandoz


125 mg


Film-coated tablet


Oral use




Croatia


Alkaloid d.o.o.
Ulica grada Vukovara 226 F
Zagreb 10000
Croatia


Levetiracetam


Lyvam 250 mg filmom obložene tablete


250 mg


Film-coated tablet


Oral use




Croatia


Alkaloid d.o.o.
Ulica grada Vukovara 226 F
Zagreb 10000
Croatia


Levetiracetam


Lyvam 500 mg filmom obložene tablete


500 mg


Film-coated tablet


Oral use




Croatia


Alkaloid d.o.o.
Ulica grada Vukovara 226 F
Zagreb 10000
Croatia


Levetiracetam


Lyvam 750 mg filmom obložene tablete


750 mg


Film-coated tablet


Oral use




Croatia


Alkaloid d.o.o.
Ulica grada Vukovara 226 F
Zagreb 10000
Croatia


Levetiracetam


Lyvam 1  000 mg filmom obložene tablete


1  000 mg


Film-coated tablet


Oral use




Cyprus


Delorbis Pharmaceuticals Ltd
17 Athinon Street
Ergates Industrial Area
2643 Ergates
P.O. Box 28629
2081 Lefkosia
Cyprus


Levocetirizine hydrochloride


Zobral


5 mg


Film-coated tablet


Oral use




Czech Republic


Abdi Farma, Unipessoal Lda.
Quinta da Fonte, Rua dos Malhoes
2770-071 Edificio D. Pedro I
Paco de Arcos
Portugal


Bosentan monohydrate


Bosentan Abdi 62,5 mg potahované tablety


62,5 mg


Film-coated tablet


Oral use




Czech Republic


Abdi Farma, Unipessoal Lda.
Quinta da Fonte, Rua dos Malhoes
2770-071 Edificio D. Pedro I
Paco de Arcos
Portugal


Bosentan monohydrate


Bosentan Abdi 125 mg potahované tablety


125 mg


Film-coated tablet


Oral use




Czech Republic


Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznaň
Poland


Levocetirizine hydrochloride


Levocetirizin Biofarm 5 mg potahované tablety


5 mg


Film-coated tablet


Oral use




Czech Republic


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxine Bluefish 75 mg


75 mg


Prolonged — released capsule, hard


Oral use




Czech Republic


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxine Bluefish 150 mg


150 mg


Prolonged — released capsule, hard


Oral use




Czech Republic


Ewopharma International s.r.o.,
Hlavna 13
Bratislava 83101
Slovakia


Fexofenadine hydrochloride


Ewofex 120 mg potahované tablety


120 mg


Film-coated tablet


Oral use




Czech Republic


Ewopharma International s.r.o.,
Hlavna 13
Bratislava 83101
Slovakia


Fexofenadine hydrochloride


Ewofex 180 mg potahované tablety


180 mg


Film-coated tablet


Oral use




Czech Republic


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Levetiracetam


Letiramyl 250 mg potahované tablety


250 mg


Film-coated tablet


Oral use




Czech Republic


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Levetiracetam


Letiramyl 500 mg potahované tablety


500 mg


Film-coated tablet


Oral use




Czech Republic


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Levetiracetam


Letiramyl 750 mg potahované tablety


750 mg


Film-coated tablet


Oral use




Czech Republic


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Levetiracetam


Letiramyl 1  000 mg potahované tablety


1  000 mg


Film-coated tablet


Oral use




Czech Republic


Sandoz s.r.o.
U Nákladového nádrazí 10
130 00 Prague 3
Czech Republic


Bosentan monohydrate


Bosentan Sandoz 62,5 mg


62,5 mg


Film-coated tablet


Oral use




Czech Republic


Sandoz s.r.o.
U Nákladového nádrazí 10
130 00 Prague 3
Czech Republic


Bosentan monohydrate


Bosentan Sandoz 125 mg


125 mg


Film-coated tablet


Oral use




Czech Republic


Teva Pharmaceuticals CR, s.r.o.
Radlická 3185/1c
150 00 Prague 5
Czech Republic


Bosentan monohydrate


Bosentan Teva 125 mg potahované tablety


125 mg


Film-coated tablet


Oral use




Denmark


Alfred E. Tiefenbacher GmbH
Van-der-Smissen-Strasse 1
D-22767 Hamburg
Germany


Levocetirizine


Levocetira


5 mg


Film-coated tablet


Oral use




Denmark


Alfred E. Tiefenbacher GmbH
Van-der-Smissen-Strasse 1
D-22767 Hamburg
Germany


Levocetirizine


Levcetin


5 mg


Film-coated tablet


Oral use




Denmark


Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznaň
Poland


Levocetirizine


Levrin


5 mg


Film-coated tablet


Oral use




Denmark


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxine Bluefish


75 mg


Prolonged-release capsule


Oral use




Denmark


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxine Bluefish


150 mg


Prolonged-release capsule


Oral use




Denmark


Cipla Chanelle Generics Limited
Athenry Road,
Loughrea, Co Galway
Ireland


Fexofenadine


Alterfast


120 mg


Film-coated tablet


Oral use




Denmark


Cipla Chanelle Generics Limited
Athenry Road,
Loughrea, Co Galway
Ireland


Fexofenadine


Alterfast


180 mg


Film-coated tablet


Oral use




Denmark


Cipla Chanelle Generics Limited
Athenry Road,
Loughrea, Co Galway
Ireland


Fexofenadine


Clarifast


120 mg


Film-coated tablet


Oral use




Denmark


Cipla Chanelle Generics Limited
Athenry Road,
Loughrea, Co Galway
Ireland


Fexofenadine


Clarifast


180 mg


Film-coated tablet


Oral use




Denmark


Cipla Chanelle Generics Limited
Athenry Road,
Loughrea, Co Galway
Ireland


Fexofenadine


Histafast


120 mg


Film-coated tablet


Oral use




Denmark


Cipla Chanelle Generics Limited
Athenry Road,
Loughrea, Co Galway
Ireland


Fexofenadine


Histafast


180 mg


Film-coated tablet


Oral use




Denmark


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Fexofenadine


Nefoxef


120 mg


Film-coated tablet


Oral use




Denmark


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Fexofenadine


Nefoxef


180 mg


Film-coated tablet


Oral use




Denmark


Norton Healthcare Ltd T/A Ivax Pharmaceuticals UK
Ridings Point, Whistler Drive
Castleford
West Yorkshire WF10 5HX
United Kingdom


Fexofenadine


Fexofenadinhydrochlorid ‘Ivax’


120 mg


Film-coated tablet


Oral use




Denmark


Norton Healthcare Ltd T/A Ivax Pharmaceuticals UK
Ridings Point, Whistler Drive
Castleford
West Yorkshire WF10 5HX
United Kingdom


Fexofenadine


Fexofenadinhydrochlorid ‘Ivax’


180 mg


Film-coated tablet


Oral use




Denmark


Orifarm Generics A/S
PO BOX 69
DK-5260 Odense S
Denmark


Metoclopramide hydrochloride


Metoclopramide Orifarm


10 mg


Tablet


Oral use




Denmark


Orifarm Generics A/S
PO BOX 69
DK-5260 Odense S
Denmark


Fexofenadine


Altifex


120 mg


Film-coated tablet


Oral use




Denmark


Orifarm Generics A/S
PO BOX 69
DK-5260 Odense S
Denmark


Fexofenadine


Altifex


180 mg


Film-coated tablet


Oral use




Estonia


G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria


Nebivolol


NEBITEN 5 MG


5 mg


Tablet


Oral use




Estonia


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine


VENLAFAXINE ORION


37,5 mg


Prolonged — released capsule, hard


Oral use




Estonia


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine


VENLAFAXINE ORION


75 mg


Prolonged — released capsule, hard


Oral use




Estonia


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine


VENLAFAXINE ORION


150 mg


Prolonged — released capsule, hard


Oral use




Estonia


Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia


Bosentan


BOSENTAN SANDOZ


62,5 mg


Film-coated tablet


Oral use




Estonia


Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia


Bosentan


BOSENTAN SANDOZ


125 mg


Film-coated tablet


Oral use




Estonia


UAB Norameda
Meistru 8a
Vilnius LT-02189
Lithuania


Bosentan


BOSENTAN NORAMEDA 62,5 MG


62,5 mg


Film-coated tablet


Oral use




Estonia


UAB Norameda
Meistru 8a
Vilnius LT-02189
Lithuania


Bosentan


BOSENTAN NORAMEDA 125 MG


125 mg


Film-coated tablet


Oral use




Estonia


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


VENLAGAMMA 75 MG


75 mg


Prolonged — released capsule, hard


Oral use




Estonia


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


VENLAGAMMA 150 MG


150 mg


Prolonged — released capsule, hard


Oral use




Finland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxine Bluefish


75 mg


Prolonged — released capsule, hard


Oral use




Finland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxine Bluefish


150 mg


Prolonged — released capsule, hard


Oral use




Finland


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Fexofenadine


Nefoxef


120 mg


Film-coated tablet


Oral use




Finland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine hydrochloride


VENLAFAXIN ORION


37,5 mg


Prolonged — released capsule, hard


Oral use




Finland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine hydrochloride


VENLAFAXIN ORION


75 mg


Prolonged — released capsule, hard


Oral use




Finland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine hydrochloride


VENLAFAXIN ORION


150 mg


Prolonged — released capsule, hard


Oral use




France


Alfred E. Tiefenbacher GmbH
Van-der-Smissen-Strasse 1
D-22767 Hamburg
Germany


Levocetirizine


Levocetira 5 mg comprimé pelliculé


5 mg


Film-coated tablet


Oral use




France


BIOGARAN
15, boulevard Charles de Gaulle
92707 Colombes Cedex


Fexofenadine


FEXOFENADINE BIOGARAN 120 mg, comprimé pelliculé


120 mg


Film-coated tablet


Oral use




France


BIOGARAN
15, boulevard Charles de Gaulle
92707 Colombes Cedex


Fexofenadine


FEXOFENADINE BIOGARAN 180 mg, comprimé pelliculé


180 mg


Film-coated tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Fexofenadine


FEXOFENADINE MYLAN 120 Film-coated Tablet


120 mg


Film-coated tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Fexofenadine


FEXOFENADINE MYLAN 180 Film-coated Tablet


180 mg


Film-coated tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Levetiracetam


LEVETIRACETAM MYLAN PHARMA 250 mg, comprimé pelliculé


250 mg


Tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Levetiracetam


LEVETIRACETAM MYLAN PHARMA 500 mg, comprimé pelliculé


500 mg


Tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Levetiracetam


LEVETIRACETAM MYLAN PHARMA 1  000 mg, comprimé pelliculé


1  000 mg


Tablet


Oral use




France


Plus Pharmacie SA
26 Boulevard Paul Vaillant-Couturier
F-94200 Ivry-sur-Seine
France


NEBIVOLOL


NEBIVOLOL ISOMED 5 mg, comprimé quadrisécable


5 mg


Tablet


Oral use




France


Ranbaxy Pharmacie Generiques
11-15 Quai Dion Bouton
92800 Puteaux
France


Venlafaxine


Venlafaxine Ranbaxy LP 37,5 mg, gélule à libération prolongée


37,5 mg


Prolonged — release capsule


Oral use




France


Ranbaxy Pharmacie Generiques
11-15 Quai Dion Bouton
92800 Puteaux
France


Venlafaxine


Venlafaxine Ranbaxy LP 75 mg, gélule à libération prolongée


75 mg


Prolonged — release capsule


Oral use




France


Ranbaxy Pharmacie Generiques
11-15 Quai Dion Bouton
92800 Puteaux
France


Venlafaxine


Venlafaxine Ranbaxy LP 150 mg, gélule à libération prolongée


150 mg


Prolonged — release capsule


Oral use




France


Ratiopharm GmbH
Graf-Arco-Strasse 3
D-89079 Ulm
Germany


NEBIVOLOL


NEBIVOLOL RATIOPHARM 5 mg, comprimé quadrisécable


5 mg


Tablet


Oral use




France


Teva Sante
Cœur Défense — 100-110
Esplanade du Général de Gaulle
92931 La Défense Cedex
France


Fexofenadine


FEXOFENADINE TEVA 120 Film-coated Tablet


120 mg


Film-coated tablet


Oral use




France


Teva Sante
Cœur Défense — 100-110
Esplanade du Général de Gaulle
92931 La Défense Cedex
France


Fexofenadine


FEXOFENADINE TEVA 180 Film-coated Tablet


180 mg


Film-coated tablet


Oral use




Germany


AAA-Pharma GmbH
Liebknechstrasse 33
70565 Stuttgart
Germany


Venlafaxine


Venlafaxin AAA 75 mg Hartkapseln, retardiert


75 mg


Prolonged — released capsule, hard


Oral use




Germany


AAA-Pharma GmbH
Liebknechstrasse 33
70565 Stuttgart
Germany


Venlafaxine


Venlafaxin AAA 150 mg Hartkapseln, retardiert


150 mg


Prolonged — released capsule, hard


Oral use




Germany


AAA-Pharma GmbH
Liebknechstrasse 33
70565 Stuttgart
Germany


Venlafaxine


Venlafaxin AAA 37,5 mg Hartkapseln, retardiert


37,5 mg


Prolonged — released capsule, hard


Oral use




Germany


Alfred E. Tiefenbacher GmbH
Van-der-Smissen-Strasse 1
D-22767 Hamburg
Germany


Levocetirizine


Levocetira 5 mg Filmtabletten


5 mg


Film-coated tablet


Oral use




Germany


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxin Bluefish 75 mg Hartkapsel, retardiert


75 mg


Prolonged — released capsule, hard


Oral use




Germany


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxin Bluefish 150 mg Hartkapsel, retardiert


15 mg


Prolonged — released capsule, hard


Oral use




Germany


Dermapharm Aktiengesellschaft
Lil-Dagover-Ring 7
82031 Grünwald
Germany


Fexofenadine


Fexofenaderm 120 mg Filmtabletten


120 mg


Film-coated tablet


Oral use




Germany


Dermapharm Aktiengesellschaft
Lil-Dagover-Ring 7
82031 Grünwald
Germany


Fexofenadine


Fexofenaderm 180 mg Filmtabletten


180 mg


Film-coated tablet


Oral use




Germany


Farmaprojects, S.A.U.
Santa Eulalia, 240-242 L’Hospitalet de Llobregat
08902 Barcelona
Spain


Venlafaxine


Venlafaxin Farmaprojects 37,5 mg Hartkapseln, retardiert


37,5 mg


Prolonged — released capsule, hard


Oral use




Germany


Farmaprojects, S.A.U.
Santa Eulalia, 240-242 L’Hospitalet de Llobregat
08902 Barcelona
Spain


Venlafaxine


Venlafaxin Farmaprojects 75 mg Hartkapseln, retardiert


75 mg


Prolonged — released capsule, hard


Oral use




Germany


Farmaprojects, S.A.U.
Santa Eulalia, 240-242 L’Hospitalet de Llobregat
08902 Barcelona
Spain


Venlafaxine


Venlafaxin Farmaprojects 150 mg Hartkapseln, retardiert


150 mg


Prolonged — released capsule, hard


Oral use




Germany


G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria


Nebivolol


NEBITEN 5 MG


5 mg


Tablet


Oral use




Germany


Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany


Venlafaxine


Venlafaxin Heumann 37,5 mg Hartkapseln, retardiert


37,5 mg


Prolonged — released capsule, hard


Oral use




Germany


Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany


Venlafaxine


Venlafaxin Heumann 75 mg Hartkapseln, retardiert


75 mg


Prolonged — released capsule, hard


Oral use




Germany


Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany


Venlafaxine


Venlafaxin Heumann 150 mg Hartkapseln, retardiert


150 mg


Prolonged — released capsule, hard


Oral use




Germany


Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany


Nebivolol


Nebivolol Heumann 5 mg Tabletten


5 mg


Tablet


Oral use




Germany


Hormosan Pharma GmbH
Wilhelmshoeher Str. 106
D-60389 Frankfurt
06 Hessen
Germany


Levetiracetam


Levetiracetam-Hormosan 500 mg Filmtabletten


500 mg


Film-coated tablet


Oral use




Germany


Hormosan Pharma GmbH
Wilhelmshoeher Str. 106
D-60389 Frankfurt
06 Hessen
Germany


Levetiracetam


Levetiracetam-Hormosan 750 mg Filmtabletten


750 mg


Film-coated tablet


Oral use




Germany


Hormosan Pharma GmbH
Wilhelmshoeher Str. 106
D-60389 Frankfurt
06 Hessen
Germany


Levetiracetam


Levetiracetam-Hormosan 1  000 mg Filmtabletten


1  000 mg


Film-coated tablet


Oral use




Germany


Hormosan Pharma GmbH
Wilhelmshoeher Str. 106
D-60389 Frankfurt
06 Hessen
Germany


Levetiracetam


Levetiracetam-Hormosan 250 mg Filmtabletten


250 mg


Film-coated tablet


Oral use




Germany


Lannacher Heilmittel Ges.m.b.H.
Schlossplatz 1
8502 Lannach
Austria


Nebivolol


Nebivolol Lannacher 5 mg Tabletten


5 mg


Tablet


Oral use




Germany


Ratiopharm GmbH
Graf-Arco-Strasse 3
D-89079 Ulm
Germany


Nebivolol


NEBIVOLOL-RATIOPHARM 5 mg


5 mg


Tablet


Oral use




Germany


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Nebivolol


Nebivolol Torrent 5 mg Tabletten


5 mg


Tablet


Oral use




Germany


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma retard 37,5 mg Hartkapseln, retardiert


37,5 mg


Prolonged — released capsule, hard


Oral use




Germany


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma retard 75 mg Hartkapseln, retardiert


75 mg


Prolonged — released capsule, hard


Oral use




Germany


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma retard 150 mg hartkapseln, retardiert


150 mg


Prolonged — released capsule, hard


Oral use




Greece


Pharmazac SA
31 Naoussis street
Athens 1447
Greece


Venlafaxine


Zacalen pr cap
75 mg/cap


75 mg


Prolonged — released capsule, hard


Oral use




Greece


Pharmazac SA
31 Naoussis street
Athens 1447
Greece


Venlafaxine


Zacalen pr cap
150 mg/cap


150 mg


Prolonged — released capsule, hard


Oral use




Greece


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Nebivolol


Nebivolol Torrent 5 mg


5 mg


Tablet


Oral use




Hungary


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxin Bluefish 150 mg nyújtott hatóanyagleadású kemény kapszula


150 mg


Prolonged — released capsule, hard


Oral use




Hungary


Ewopharma International s.r.o.,
Hlavna 13
Bratislava 83101
Slovakia


Fexofenadine


Ewofex 180 mg filmtabletta


180 mg


Film-coated tablet


Oral use




Hungary


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Fexofenadine


Fexgen 120 mg filmtabletta


120 mg


Film-coated tablet


Oral use




Hungary


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Fexofenadine


Fexgen 180 mg filmtabletta


180 mg


Film-coated tablet


Oral use




Hungary


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Nebivolol


Nebivolol Torrent 5 mg


5 mg


Tablet


Oral use




Hungary


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma 37,5 mg retard kemény kapszula


37,5 mg


Prolonged — released capsule, hard


Oral use




Hungary


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma 75 mg retard kemény kapszula


75 mg


Prolonged — released capsule, hard


Oral use




Hungary


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma 150 mg retard kemény kapszula


150 mg


Prolonged — released capsule, hard


Oral use




Iceland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxine Bluefish


150 mg


Prolonged — released capsule, hard


Oral use




Iceland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxine Bluefish


37,5 mg


Prolonged — released capsule, hard


Oral use




Iceland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxine Bluefish


75 mg


Prolonged — released capsule, hard


Oral use




Iceland


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Fexofenadine


Nefoxef


120 mg


Film-coated tablet


Oral use




Iceland


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Fexofenadine


Nefoxef


180 mg


Film-coated tablet


Oral use




Ireland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlablue XL 75 mg, prolonged release capsules, hard


75 mg


Prolonged — release capsule


Oral use




Ireland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlablue XL 150 mg, prolonged release capsules, hard


150 mg


Prolonged — release capsule


Oral use




Ireland


Chanelle Medical
Dublin road
Loughrea, Co. Galway
Ireland


Fexofenadine hydrochloride


Fexofenadine hydrochloride 120 mg Film-coated tablets


120 mg


Film-coated tablet


Oral use




Ireland


Chanelle Medical
Dublin road
Loughrea, Co. Galway
Ireland


Fexofenadine hydrochloride


Fexofenadine hydrochloride 180 mg Film-coated tablets


180 mg


Film-coated tablet


Oral use




Ireland


Morningside Healthcare Limited
115 Narborough Road
Leicester, LE3 0PA
United Kingdom


Venlafaxine hydrochloride


Vensir XL 75 mg prolonged-release hard capsules


75 mg


Prolonged — release capsule


Oral use




Ireland


Morningside Healthcare Limited
115 Narborough Road
Leicester, LE3 0PA
United Kingdom


Venlafaxine hydrochloride


Vensir XL 150 mg prolonged-release hard capsules


150 mg


Prolonged — release capsule


Oral use




Italy


Alfred E. Tiefenbacher GmbH
Van-der-Smissen-Strasse 1
D-22767 Hamburg
Germany


Levocetirizine


Levcetin 5 mg compresse rivestite con film


5 mg


Film-coated tablet


Oral use




Italy


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


VENLAFAXINA ABC


75 mg


Prolonged — released capsule, hard


Oral use




Italy


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


VENLAFAXINA ABC


150 mg


Prolonged — released capsule, hard


Oral use




Italy


Costanzafarma S.R.L.
Via Taranto, 4
20142 Milan
Italy


Fexofenadine


FIXODIN


120 mg


Film-coated tablet


Oral use




Italy


Costanzafarma S.R.L.
Via Taranto, 4
20142 Milan
Italy


Fexofenadine


FIXODIN


180 mg


Film-coated tablet


Oral use




Italy


FB Health S.p.A.
Via dei Sabini, 28
63100 — Ascoli Piceno
Italy


Venlafaxine


IXILANIA


75 mg


Prolonged — released capsule, hard


Oral use




Italy


FB Health S.p.A.
Via dei Sabini, 28
63100 — Ascoli Piceno
Italy


Venlafaxine


IXILANIA


150 mg


Prolonged — released capsule, hard


Oral use




Italy


Germed Pharma S.P.A.
Via Cantu’, 11
Cinisello Balsamo
Milan 20092
Italy


Nebivolol


NEBIVOLOLO GERMED


5 mg


Scored tablet


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Levetiracetam


LEVETIRACETAM MYLAN GENERICS


250 mg


Film-coated tablet


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Levetiracetam


LEVETIRACETAM MYLAN GENERICS


750 mg


Film-coated tablet


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Levetiracetam


LEVETIRACETAM MYLAN GENERICS


500 mg


Film-coated tablet


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Levetiracetam


LEVETIRACETAM MYLAN GENERICS


1  000 mg


Film-coated tablet


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Fexofenadine


FEXOFENADINA MYLAN GENERICS


120 mg


Film-coated tablet


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Fexofenadine


FEXOFENADINA MYLAN GENERICS


180 mg


Film-coated tablet


Oral use




Italy


Pensa Pharma S.P.A.
Via Rossellini Ippolito, 12
20124 Milan
Italy


Venlafaxine


VENLAFAXINA PENSA


75 mg


Prolonged — released capsule, hard


Oral use




Italy


Pensa Pharma S.P.A.
Via Rossellini Ippolito, 12
20124 Milan
Italy


Venlafaxine


VENLAFAXINA PENSA


150 mg


Prolonged — released capsule, hard


Oral use




Italy


Progefarm S.r.l.
Largo Donegani 4/A
28100 — Novara
Italy


Venlafaxine


VENLAFAXINA PROGE FARM


75 mg


Prolonged — released capsule, hard


Oral use




Italy


Progefarm S.r.l.
Largo Donegani 4/A
28100 — Novara
Italy


Venlafaxine


VENLAFAXINA PROGE FARM


150 mg


Prolonged — released capsule, hard


Oral use




Italy


Ranbaxy Italia S.P.A.
Piazza Filippo Meda, 4, 3
20121 — Milano
Italy


Venlafaxine


VENLAFAXINA RANBAXY GENERICI


75 mg


Prolonged — released capsule, hard


Oral use




Italy


Ranbaxy Italia S.P.A.
Piazza Filippo Meda, 4, 3
20121 — Milano
Italy


Venlafaxine


VENLAFAXINA RANBAXY GENERICI


150 mg


Prolonged — released capsule, hard


Oral use




Italy


Ranbaxy Italia S.P.A.
Piazza Filippo Meda, 4, 3
20121 — Milano
Italy


Lansoprazole


Lansoprazolo
Ranbaxy 15 mg
capsule rigide
gastroresistenti


15 mg


Gastro-resistant tablet


Oral use




Italy


Ranbaxy Italia S.P.A.
Piazza Filippo Meda, 4, 3
20121 — Milano
Italy


Lansoprazole


Lansoprazolo
Ranbaxy 30 mg
capsule rigide
gastroresistenti


30 mg


Gastro-resistant tablet


Oral use




Latvia


G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria


Nebivolol


Nebiten


5 mg


Tablet


Oral use




Latvia


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine


Venlafaxine Orion


37,5 mg


Prolonged — released capsule, hard


Oral use




Latvia


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine


Venlafaxine Orion


75 mg


Prolonged — released capsule, hard


Oral use




Latvia


Ranbaxy UK Ltd
20 Balderton Street
London W1K 6TL
United Kingdom


Lansoprazole


Lanobax 30 mg gastro-resistant capsules, hard


30 mg


Gastro-resistant tablet


Oral use




Latvia


Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia


Bosentan


Bosentan Sandoz


62,5 mg


Film-coated tablet


Oral use




Latvia


Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia


Bosentan


Bosentan Sandoz


125 mg


Film-coated tablet


Oral use




Latvia


UAB Norameda
Meistru 8a
Vilnius LT-02189
Lithuania


Bosentan


Bosentan Norameda


62,5 mg


Film-coated tablet


Oral use




Latvia


UAB Norameda
Meistru 8a
Vilnius LT-02189
Lithuania


Bosentan


Bosentan Norameda


125 mg


Film-coated tablet


Oral use




Lithuania


G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria


Nebivolol


Nebiten


5 mg


Tablet


Oral use




Lithuania


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine


Venlafaxine Orion


37,5 mg


Prolonged — released capsule, hard


Oral use




Lithuania


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine


Venlafaxine Orion


75 mg


Prolonged — released capsule, hard


Oral use




Lithuania


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine


Venlafaxine Orion


150 mg


Prolonged — released capsule, hard


Oral use




Lithuania


Ranbaxy UK Ltd
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom


Lansoprazole


LANOBAX


30 mg


Gastro-resistant tablet


Oral use




Lithuania


Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia


Bosentan


Bosentan Sandoz


62,5 mg


Film-coated tablet


Oral use




Lithuania


Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia


Bosentan


Bosentan Sandoz


125 mg


Film-coated tablet


Oral use




Lithuania


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Nebivolol


Nebivolol Torrent 5 mg


5 mg


Tablet


Oral use




Lithuania


UAB Norameda
Meistru 8a
Vilnius LT-02189
Lithuania


Bosentan


Bosentan Norameda


62,5 mg


Film-coated tablet


Oral use




Lithuania


UAB Norameda
Meistru 8a
Vilnius LT-02189
Lithuania


Bosentan


Bosentan Norameda


125 mg


Film-coated tablet


Oral use




Norway


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxin Bluefish


75 mg


Prolonged — released capsule, hard


Oral use




Norway


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxin Bluefish


150 mg


Prolonged — released capsule, hard


Oral use




Norway


Orifarm Generics A/S
PO BOX 69
DK-5260 Odense S
Denmark


Metoclopramide hydrochloride


Metoclopramide Orifarm


10 mg


Tablet


Oral use




Norway


Orifarm Generics A/S
PO BOX 69
DK-5260 Odense S
Denmark


Fexofenadine hydrochloride


Altifex


120 mg


Film-coated tablet


Oral use




Norway


Orifarm Generics A/S
PO BOX 69
DK-5260 Odense S
Denmark


Fexofenadine hydrochloride


Altifex


180 mg


Film-coated tablet


Oral use




Poland


Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznaň
Poland


Levocetirizine


Zyx


5 mg


Film-coated tablet


Oral use




Poland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxine Bluefish XL


75 mg


Prolonged — released capsule, hard


Oral use




Poland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxine Bluefish XL


150 mg


Prolonged — released capsule, hard


Oral use




Poland


Celon Pharma S.A.
Ogrodowa 2A, Kiełpin
05-092 Łomianki,
Poland


Bosentan


Bosentan Celon


125 mg


Film-coated tablet


Oral use




Poland


Farmaceutyczna Spółdzielnia Pracy Galena
Krucza 62
50-984 Wrocław
Poland


Fexofenadine hydrochloride


Fexofast 120 mg


120 mg


Film-coated tablet


Oral use




Poland


Farmaceutyczna Spółdzielnia Pracy Galena
Krucza 62
50-984 Wrocław
Poland


Fexofenadine hydrochloride


Fexofast 180 mg


180 mg


Film-coated tablet


Oral use




Poland


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Levetiracetam


Levetiracetam-Generics


250 mg


Film-coated tablet


Oral use




Poland


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Levetiracetam


Levetiracetam-Generics


500 mg


Film-coated tablet


Oral use




Poland


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Levetiracetam


Levetiracetam-Generics


750 mg


Film-coated tablet


Oral use




Poland


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Levetiracetam


Levetiracetam-Generics


1  000 mg


Film-coated tablet


Oral use




Poland


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Fexofenadine


FexoGen


120 mg


Film-coated tablet


Oral use




Poland


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Fexofenadine


FexoGen


180 mg


Film-coated tablet


Oral use




Poland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine


Oriven


37,5 mg


Prolonged — released capsule, hard


Oral use




Poland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine


Oriven


75 mg


Prolonged — released capsule, hard


Oral use




Poland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Venlafaxine


Oriven


150 mg


Prolonged — released capsule, hard


Oral use




Poland


Ranbaxy (Poland) Sp. z o.o.
Kubickiego 11
02-954 Warszawa
Poland


Lansoprazole


LANBAX


15 mg


Gastro-resistant tablet


Oral use




Poland


Ranbaxy (Poland) Sp. z o.o.
Kubickiego 11
02-954 Warszawa
Poland


Lansoprazole


LANBAX


30 mg


Gastro-resistant tablet


Oral use




Poland


Ranbaxy (Poland) Sp. z o.o.
Kubickiego 11
02-954 Warszawa
Poland


Venlafaxine


Venlabax MR


37,5 mg


Prolonged — release capsule


Oral use




Poland


Ranbaxy (Poland) Sp. z o.o.
Kubickiego 11
02-954 Warszawa
Poland


Venlafaxine


Venlabax MR


75 mg


Prolonged — release capsule


Oral use




Poland


Ranbaxy (Poland) Sp. z o.o.
Kubickiego 11
02-954 Warszawa
Poland


Venlafaxine


Venlabax MR


150 mg


Prolonged — release capsule


Oral use




Poland


Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl
Austria


Bosentan


Bosentan Sandoz


62,5 mg


Film-coated tablet


Oral use




Poland


Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl
Austria


Bosentan


Bosentan Sandoz


125 mg


Film-coated tablet


Oral use




Poland


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma


75 mg


Prolonged — released capsule, hard


Oral use




Poland


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma


37,5 mg


Prolonged — released capsule, hard


Oral use




Poland


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma


150 mg


Prolonged — released capsule, hard


Oral use




Poland


Zakłady Farmaceutyczne POLPHARMA S.A. Pelplińska 19
83-200 Starogard Gdański
Poland


Fexofenadine hydrochloride


Telfexo 120 mg


120 mg


Film-coated tablet


Oral use




Poland


Zakłady Farmaceutyczne POLPHARMA S.A. Pelplińska 19
83-200 Starogard Gdański
Poland


Fexofenadine hydrochloride


Telfexo 180 mg


180 mg


Film-coated tablet


Oral use




Portugal


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxina Bluefish XR


75 mg


Prolonged — released capsule, hard


Oral use




Portugal


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxina Bluefish XR


150 mg


Prolonged — released capsule, hard


Oral use




Portugal


Bluepharma Genéricos — Comércio de Medicamentos, S.A.
São Martinho do Bispo
3045-016 Coimbra
Portugal


Venlafaxine


Venlafaxina Bluepharma


150 mg


Prolonged — released capsule, hard


Oral use




Portugal


Bluepharma Genéricos — Comércio de Medicamentos, S.A.
São Martinho do Bispo
3045-016 Coimbra
Portugal


Venlafaxine


Venlafaxina Bluepharma


75 mg


Prolonged — released capsule, hard


Oral use




Portugal


Bluepharma Genéricos — Comércio de Medicamentos, S.A.
São Martinho do Bispo
3045-016 Coimbra
Portugal


Venlafaxine


Venlafaxina Bluepharma


37,5 mg


Prolonged — released capsule, hard


Oral use




Portugal


Eurogenus Farmacêutica, Sociedade Unipessoal, Lda.
Rua Alto do Montijo, 13 — 2o Dto., Edifício Monsanto
2790-012 Carnaxide
Portugal


Venlafaxine


Venlafaxina Eurogenus


37,5 mg


Prolonged — released capsule, hard


Oral use




Portugal


Eurogenus Farmacêutica, Sociedade Unipessoal, Lda.
Rua Alto do Montijo, 13 — 2o Dto., Edifício Monsanto
2790-012 Carnaxide
Portugal


Venlafaxine


Venlafaxina Eurogenus


75 mg


Prolonged — released capsule, hard


Oral use




Portugal


Eurogenus Farmacêutica, Sociedade Unipessoal, Lda.
Rua Alto do Montijo, 13 — 2o Dto., Edifício Monsanto
2790-012 Carnaxide
Portugal


Venlafaxine


Venlafaxina Eurogenus


150 mg


Prolonged — released capsule, hard


Oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Nebivolol


Nebivolol Generis


5 mg


tablet


Oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Nebivolol


Nebivolol Inventis


5 mg


tablet


Oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Fexofenadine


Fexofenadina Generis


180 mg


Film-coated tablet


Oral use




Portugal


Germed Farmacêutica, Lda.
Rua Alto do Montijo, 13 — 1o Dto — Edifício Monsanto Portela de Carnaxide
2790-012 Portela de Carnaxide
Portugal’


Nebivolol


Nebivolol Germed


5 mg


Tablet


Oral use




Portugal


GP — Genéricos Portugueses, Lda.
Rua Henrique Paiva Couceiro, 29 — Venda Nova
2700-451 Amadora
Portugal


Nebivolol


Nebivolol GP


5 mg


tablet


Oral use




Portugal


Labesfal, Genéricos, S.A.
Av. Dr Afonso Costa, no 1370
3465-051 Campo de Besteiros
Portugal


Venlafaxine hydrochloride


Venlafaxina Labesfal


37,5 mg


Prolonged — release tablet


oral use




Portugal


Labesfal, Genéricos, S.A.
Av. Dr Afonso Costa, no 1370
3465-051 Campo de Besteiros
Portugal


Venlafaxine hydrochloride


Venlafaxina Labesfal


75 mg


Prolonged — release tablet


oral use




Portugal


Labesfal, Genéricos, S.A.
Av. Dr Afonso Costa, no 1370
3465-051 Campo de Besteiros
Portugal


Venlafaxine hydrochloride


Venlafaxina Labesfal


150 mg


Prolonged — release tablet


oral use




Portugal


Labesfal, Genéricos, S.A.
Av. Dr Afonso Costa, no 1370
3465-051 Campo de Besteiros
Portugal


Nebivolol


Nebivolol Labesfal


5 mg


tablet


Oral use




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


Fexofenadine


Fexofenadina Mylan


120 mg


Film-coated tablet


Oral use




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


Fexofenadine


Fexofenadina Mylan


180 mg


Film-coated tablet


Oral use




Portugal


Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.
Lagoas Park, Edifício 5 A, Piso 2
2740-245 Porto Salvo
Portugal


Nebivolol


Nebivolol Ratiopharm


5 mg


Tablet


Oral use




Romania


Ewopharma International s.r.o.,
Hlavna 13
Bratislava 83101
Slovakia


Fexofenadine hydrochloride


Ewofex 120 mg comprimate filmate


120 mg


Film-coated tablet


Oral use




Romania


Ewopharma International s.r.o.,
Hlavna 13
Bratislava 83101
Slovakia


Fexofenadine hydrochloride


Ewofex 180 mg comprimate filmate


180 mg


Film-coated tablet


Oral use




Romania


Ranbaxy UK Ltd
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom


Lansoprazole


LEVANT


15 mg


Gastro-resistant tablet


Oral use




Romania


Ranbaxy UK Ltd
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom


Lansoprazole


LEVANT


30 mg


Gastro-resistant tablet


Oral use




Romania


Terapia SA
Str. Fabricii nr. 124
Cluj Napoca
România


Venlafaxine


Venlafaxina Terapia 37,5 mg capsule cu eliberare prelungită


37,5 mg


Prolonged — released capsule, hard


Oral use




Romania


Terapia SA
Str. Fabricii nr. 124
Cluj Napoca
România


Venlafaxine


Venlafaxina Terapia 75 mg capsule cu eliberare prelungită


75 mg


Prolonged — released capsule, hard


Oral use




Romania


Terapia SA
Str. Fabricii nr. 124
Cluj Napoca
România


Venlafaxine


Venlafaxina Terapia 150 mg capsule cu eliberare prelungită


150 mg


Prolonged — released capsule, hard


Oral use




Romania


Torrent Pharma SRL
Str. Stirbei Voda nr. 36
et. 2, biroul A, sector 1
Bucharest
Romania


Nebivolol


Nebivolol Torrent com primate


5 mg


Tablet


Oral use




Romania


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma 37,5 mg capsule cu eliberare prelungita


37,5 mg


Prolonged — released capsule, hard


Oral use




Romania


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma 75 mg capsule cu eliberare prelungita


75 mg


Prolonged — released capsule, hard


Oral use




Romania


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma 150 mg capsule cu eliberare prelungita


150 mg


Prolonged — released capsule, hard


Oral use




Slovak Republic


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxine Bluefish XR 75 mg tvrdé kapsuly s predĺženým uvoľňovaním


75 mg


Prolonged — released capsule, hard


Oral use




Slovak Republic


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxine Bluefish XR 150 mg tvrdé kapsuly s predĺženým uvoľňovaním


150 mg


Prolonged — released capsule, hard


Oral use




Slovak Republic


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Fexofenadine


Fexofenadin Generics 120 mg


120 mg


Film-coated tablet


Oral use




Slovak Republic


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Fexofenadine


Fexofenadin Generics 180 mg


160 mg


Film-coated tablet


Oral use




Slovak Republic


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma 37,50 mg


37,5 mg


Prolonged — released capsule, hard


Oral use




Slovak Republic


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma 75 mg


75 mg


Prolonged — released capsule, hard


Oral use




Slovak Republic


Wörwag Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany


Venlafaxine


Venlagamma 150 mg


150 mg


Prolonged — released capsule, hard


Oral use




Slovenia


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Levetiracetam


Lyvam 250 mg filmsko obložene tablete


250 mg


Film-coated tablet


Oral use




Slovenia


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Levetiracetam


Lyvam 500 mg filmsko obložene tablete


500 mg


Film-coated tablet


Oral use




Slovenia


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Levetiracetam


Lyvam 750 mg filmsko obložene tablete


750 mg


Film-coated tablet


Oral use




Slovenia


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Levetiracetam


Lyvam 1  000 mg filmsko obložene tablete


1  000 mg


Film-coated tablet


Oral use




Slovenia


Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia


Bosentan


Bosentan Sandoz 62,5 mg filmsko obložene tablete


62,5 mg


Film-coated tablet


Oral use




Slovenia


Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia


Bosentan


Bosentan Sandoz 125 mg filmsko obložene tablete


125 mg


Film-coated tablet


Oral use




Slovenia


UAB Norameda
Meistru 8a
Vilnius LT-02189
Lithuania


Bosentan


Bosentan Norameda 125 mg filmsko obložene tablete


125 mg


Film-coated tablet


Oral use




Slovenia


UAB Norameda
Meistru 8a
Vilnius LT-02189
Lithuania


Bosentan


Bosentan Norameda 62,5 mg filmsko obložene tablete


62,5 mg


Film-coated tablet


Oral use




Spain


Aristo Pharma Iberia, S.L,
c/Solana, 26, Torrejon de Ardoz,
Madrid, 28850
Spain


Nebivolol


Nebivolol Edigen 5 mg comprimidos efg


5 mg


Tablet


Oral use




Spain


Aristo Pharma Iberia, S.L,
c/Solana, 26, Torrejon de Ardoz,
Madrid, 28850
Spain


Venlafaxine


Venlafaxina Retard Urlabs 150 mg capsulas duras de liberacion prolongada efg


150 mg


Prolonged — released capsule, hard


Oral use




Spain


Aristo Pharma Iberia, S.L,
c/Solana, 26, Torrejon de Ardoz,
Madrid, 28850
Spain


Venlafaxine


Venlafaxina Retard Urlabs 75 mg capsulas duras de liberacion prolongada efg


75 mg


Prolonged — released capsule, hard


Oral use




Spain


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxina Bluefish 150 mg capsulas de liberacion prolongada efg


150 mg


Prolonged — release capsule


Oral use




Spain


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxina Bluefish 75 mg capsulas de liberacion prolongada efg


75 mg


Prolonged — release capsule


Oral use




Spain


Laboratorios Ranbaxy, S. L U.
Paseig de Gracia 9
7a Pl
Barcelona 08007
Spain


Venlafaxine


Venlafaxina Retard Ranbaxygen 75 mg capsulas duras de liberacion prolongada efg


75 mg


Prolonged — released capsule, hard


Oral use




Spain


Lupin (Europe) Limited
Victoria Court, Bexton Road
Knutsford, Cheshire WA16 0PF
United Kingdom


Levetiracetam


Levetiracetam Lupin 750 mg comprimidos recubiertos con pelicula efg


750 mg


Film-coated tablet


Oral use




Spain


Pharmagenus, S.A.,
Avda. Camí Real, 51-57,
08184 Palau-solita i Plegamans (Barcelona)
Spain


Venlafaxine


Venlafaxina Retard Pharmagenus 150 mg capsulas duras de liberacion prolongada efg


150 mg


Prolonged — released capsule, hard


Oral use




Spain


Pharmagenus, S.A.,
Avda. Camí Real, 51-57,
08184 Palau-solita i Plegamans (Barcelona)
Spain


Venlafaxine


Venlafaxina Retard Pharmagenus 75 mg capsulas duras de liberacion prolongada efg


75 mg


Prolonged — released capsule, hard


Oral use




Spain


RATIOPHARM ESPAÑA, S.A.
C/Anabel Segura, 11
Edificio Albatros B, 1a planta
28108 Alcobendas (Madrid)
Spain


Nebivolol


Nebivolol Ratio 5 mg comprimidos efg


5 mg


Tablet


Oral use




Spain


Teva Pharma S.L.U.
C/Anabel Segura, 11
Edificio Albatros B, 1a planta
Madrid 28108
Spain


Fexofenadine


Fexofenadina Tevagen 120 mg comprimidos recubiertos con pelicula efg


120 mg


Film-coated tablet


Oral use




Spain


Teva Pharma S.L.U.
C/Anabel Segura, 11
Edificio Albatros B, 1a planta
Madrid 28108
Spain


Fexofenadine


Fexofenadina Tevagen 180 mg comprimidos recubiertos con pelicula efg


180 mg


Film-coated tablet


Oral use




Spain


Welding GmbH & Co. KG
Esplanade 39
D-20354 Hamburg
Germany


Levetiracetam


Levetiracetam Lupin 1  000 mg comprimidos recubiertos con pelicula efg


1  000 mg


Film-coated tablet


Oral use




Spain


Welding GmbH & Co. KG
Esplanade 39
D-20354 Hamburg
Germany


Levetiracetam


Levetiracetam Lupin 250 mg comprimidos recubiertos con pelicula efg


250 mg


Film-coated tablet


Oral use




Spain


Welding GmbH & Co. KG
Esplanade 39
D-20354 Hamburg
Germany


Levetiracetam


Levetiracetam Lupin 500 mg comprimidos recubiertos con pelicula efg


500 mg


Film-coated tablet


Oral use




Sweden


Alternova A/S
Lodshusvej 11
DK-4230 Skælskør
Denmark


Bendroflumethiazide


Bendroflumetiazid Alternova


2,5 mg


Tablet


Oral use




Sweden


Alternova A/S
Lodshusvej 11
DK-4230 Skælskør
Denmark


Bendroflumethiazide


Bendroflumetiazid Alternova


5 mg


Tablet


Oral use




Sweden


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxin Bluefish


37,5 mg


Prolonged — released capsule, hard


Oral use




Sweden


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxin Bluefish


75 mg


Prolonged — released capsule, hard


Oral use




Sweden


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlafaxin Bluefish


150 mg


Prolonged — released capsule, hard


Oral use




Sweden


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Fexofenadine


Nefoxef


120 mg


Film-coated tablet


Oral use




Sweden


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Fexofenadine


Nefoxef


160 mg


Film-coated tablet


Oral use




Sweden


Orifarm Generics A/S
PO BOX 69
DK-5260 Odense S
Denmark


Metoclopramide hydrochloride


Metoclopramide Orifarm


10 mg


Tablet


Oral use




Sweden


Orifarm Generics A/S
PO BOX 69
DK-5260 Odense S
Denmark


Fexofenadine hydrochloride


Altifex


120 mg


Film-coated tablet


Oral use




Sweden


Orifarm Generics A/S
PO BOX 69
DK-5260 Odense S
Denmark


Fexofenadine hydrochloride


Altifex


180 mg


Film-coated tablet


Oral use




Sweden


Ranbaxy UK Ltd
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom


Venlafaxine


Venlafaxin Ranbaxy
150 mg depotkapsel,
hård


150 mg


Prolonged — released capsule, hard


Oral use




Sweden


Ranbaxy UK Ltd
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom


Venlafaxine


Venlafaxin Ranbaxy
75 mg depotkapsel,
hård


75 mg


Prolonged — released capsule, hard


Oral use




The Netherlands


Alfred E. Tiefenbacher GmbH
Van-der-Smissen-Strasse 1
D-22767 Hamburg
Germany


Levocetirizine


Levocetira 5 mg filmomhulde tablet


5 mg


Film-coated tablet


Oral use




The Netherlands


Apothecon B.V.
Nijverheidsweg 3
3771 ME Barneveld
The Netherlands


Fexofenadine


Fexofenadine HCL 120 A, filmomhulde tabletten 120 mg


120 mg


Film-coated tablet


Oral use




The Netherlands


Apothecon B.V.
Nijverheidsweg 3
3771 ME Barneveld
The Netherlands


Fexofenadine


Fexofenadine HCL 180 A, filmomhulde tabletten 120 mg


180 mg


Film-coated tablet


Oral use




The Netherlands


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxine Bluefish 37,5 mg, capsules met verlengde afgifte, hard


37,5 mg


Prolonged — released capsule, hard


Oral use




The Netherlands


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxine Bluefish 37,5 mg, capsules met verlengde afgifte, hard


75 mg


Prolonged — released capsule, hard


Oral use




The Netherlands


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine


Venlafaxine Bluefish 37,5 mg, capsules met verlengde afgifte, hard


150 mg


Prolonged — released capsule, hard


Oral use




The Netherlands


Farmaprojects, S.A.U.
Santa Eulalia, 240-242 L’Hospitalet de Llobregat
08902 Barcelona
Spain


Venlafaxine


Venlafaxine Farmaprojects 37,5 mg, capsules met verlengde afgifte, hard


37,5 mg


Prolonged — released capsule, hard


Oral use




The Netherlands


Farmaprojects, S.A.U.
Santa Eulalia, 240-242 L’Hospitalet de Llobregat
08902 Barcelona
Spain


Venlafaxine


Venlafaxine Farmaprojects 75 mg, capsules met verlengde afgifte, hard


75 mg


Prolonged — released capsule, hard


Oral use




The Netherlands


Farmaprojects, S.A.U.
Santa Eulalia, 240-242 L’Hospitalet de Llobregat
08902 Barcelona
Spain


Venlafaxine


Venlafaxine Farmaprojects 150 mg, capsules met verlengde afgifte, hard


150 mg


Prolonged — released capsule, hard


Oral use




The Netherlands


Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
The Netherlands


Fexofenadine


Fexofenadine HCL Mylan 120 mg, filmomhulde tabletten


120 mg


Film-coated tablet


Oral use




The Netherlands


Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
The Netherlands


Fexofenadine


Fexofenadine HCL Mylan 180 mg, filmomhulde tabletten


180 mg


Film-coated tablet


Oral use




The Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands


Fexofenadine


Fexofenadine HCl 120 PCH, filmomhulde tabletten 120 mg


120 mg


Film-coated tablet


Oral use




The Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands


Fexofenadine


Fexofenadine HCl 180 PCH, filmomhulde tabletten 120 mg


180 mg


Film-coated tablet


Oral use




The Netherlands


Ranbaxy UK Ltd
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom


Lansoprazole


Lansoprazol Ranbaxy
15 mg,
maagsapresistente
capsules


15 mg


Gastro-resistant tablet


Oral use




The Netherlands


Ranbaxy UK Ltd
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom


Lansoprazole


Lansoprazol Ranbaxy
30 mg,
maagsapresistente
capsules


30 mg


Gastro-resistant tablet


Oral use




The Netherlands


Ranbaxy UK Ltd
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom


Venlafaxine


Venlafaxine Ranbaxy 75 mg, capsules met verlengde afgifte


75 mg


Prolonged — released capsule, hard


Oral use




The Netherlands


Ranbaxy UK Ltd
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom


Venlafaxine


Venlafaxine Ranbaxy 150 mg, capsules met verlengde afgifte


150 mg


Prolonged — released capsule, hard


Oral use




The Netherlands


Ratiopharm Nederland B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands


Fexofenadine


Fexofenadine HCl ratiopharm 120 mg, filmomhulde tabletten


120 mg


Film-coated tablet


Oral use




United Kingdom


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlablue XL 37,5 mg Prolonged Release Capsules Hard


37,5 mg


Prolonged — released capsule, hard


Oral use




United Kingdom


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlablue XL 75 mg Prolonged Release Capsules Hard


75 mg


Prolonged — released capsule, hard


Oral use




United Kingdom


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Venlafaxine hydrochloride


Venlablue XL 150 mg Prolonged Release Capsules Hard


150 mg


Prolonged — released capsule, hard


Oral use




United Kingdom


Chanelle Medical
Dublin road
Loughrea, Co. Galway
Ireland


Fexofenadine


Fexofenadine 120 mg film-coated tablets


120 mg


Film-coated tablet


Oral use




United Kingdom


Chanelle Medical
Dublin road
Loughrea, Co. Galway
Ireland


Fexofenadine


Fexofenadine 180 mg film-coated tablets


180 mg


Film-coated tablet


Oral use




United Kingdom


Forum Products Limted
Crown House
2-8 Gloucester Road
Redhill Surrey RH1 1FH
United Kingdom


Venlafaxine hydrochloride


Foraven XL 75 mg Modified Release Capsules


75 mg


Modified-release capsule, hard


Oral use




United Kingdom


Forum Products Limted
Crown House
2-8 Gloucester Road
Redhill Surrey RH1 1FH
United Kingdom


Venlafaxine hydrochloride


Foraven XL 150 mg Modified Release Capsules


150 mg


Modified-release capsule, hard


Oral use




United Kingdom


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Fexofenadine


Fexofenadine hydrochloride 120 mg Film-coated tablets


120 mg


Film-coated tablet


Oral use




United Kingdom


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Fexofenadine


Fexofenadine hydrochloride 180 mg Film-coated tablets


180 mg


Film-coated tablet


Oral use




United Kingdom


Lupin (Europe) Limited
Victoria Court, Bexton Road
Knutsford, Cheshire WA16 0PF
United Kingdom


Levetiracetam


Levetiracetam Lupin 250 mg Film-coated tablets


250 mg


Film-coated tablet


Oral use




United Kingdom


Lupin (Europe) Limited
Victoria Court, Bexton Road
Knutsford, Cheshire WA16 0PF
United Kingdom


Levetiracetam


Levetiracetam Lupin 500 mg Film-coated tablets


500 mg


Film-coated tablet


Oral use




United Kingdom


Lupin (Europe) Limited
Victoria Court, Bexton Road
Knutsford, Cheshire WA16 0PF
United Kingdom


Levetiracetam


Levetiracetam Lupin 750 mg Film-coated tablets


750 mg


Film-coated tablet


Oral use




United Kingdom


Lupin (Europe) Limited
Victoria Court, Bexton Road
Knutsford, Cheshire WA16 0PF
United Kingdom


Levetiracetam


Levetiracetam Lupin 1  000 mg Film-coated tablets


1  000 mg


Film-coated tablet


Oral use




United Kingdom


Morningside Healthcare Limited
115 Narborough Road
Leicester, LE3 0PA
United Kingdom


Venlafaxine hydrochloride


Vensir XL 75 mg Prolonged Release Hard Capsules


75 mg


Prolonged — released capsule, hard


Oral use




United Kingdom


Morningside Healthcare Limited
115 Narborough Road
Leicester, LE3 0PA
United Kingdom


Venlafaxine hydrochloride


Vensir XL 150 mg Prolonged Release Hard Capsules


150 mg


Prolonged — released capsule, hard


Oral use




United Kingdom


Teva UK Limited
Brampton Road
Hampden Park
Sussex BN22 9AG
United Kingdom


Fexofenadine


Fexofenadine 120 mg film-coated tablets


120 mg


Film-coated tablet


Oral use




United Kingdom


Teva UK Limited
Brampton Road
Hampden Park
Sussex BN22 9AG
United Kingdom


Fexofenadine


Fexofenadine 180 mg film-coated tablets


180 mg


Film-coated tablet


Oral use





Annex IB: Products for which the marketing authorisations are recommended for suspension












Member State (in EEA)


Marketing Authorisation Holder


INN


Invented name


Strength


Pharmaceutical Form


Route of administration




Austria


Arcana Arzneimittel GmbH
Huetteldorfer Straße 299
1140 Wien
Austria


Esomeprazole magnesium


Esomeprazol Arcana 20 mg magensaftresistente Hartkapseln


20 mg


Gastro-resistant capsule, hard


Oral use




Austria


Arcana Arzneimittel GmbH
Huetteldorfer Straße 299
1140 Wien
Austria


Esomeprazole magnesium


Esomeprazol Arcana 40 mg magensaftresistente Hartkapseln


40 mg


Gastro-resistant capsule, hard


Oral use




Austria


Arcana Arzneimittel GmbH
Huetteldorfer Straße 299
1140 Wien
Austria


Esomeprazole magnesium


Neximyl 20 mg magensaftresistente Hartkapseln


20 mg


Gastro-resistant capsule, hard


Oral use




Austria


Arcana Arzneimittel GmbH
Huetteldorfer Straße 299
1140 Wien
Austria


Esomeprazole magnesium


Neximyl 40 mg magensaftresistente Hartkapseln


40 mg


Gastro-resistant capsule, hard


Oral use




Austria


Arcana Arzneimittel GmbH
Huetteldorfer Straße 299
1140 Wien
Austria


Candesartan cilexetil


Candesartan Arcana 4 mg Tabletten


4 mg


Tablet


Oral use




Austria


Arcana Arzneimittel GmbH
Huetteldorfer Straße 299
1140 Wien
Austria


Candesartan cilexetil


Candesartan Arcana 8 mg Tabletten


8 mg


Tablet


Oral use




Austria


Arcana Arzneimittel GmbH
Huetteldorfer Straße 299
1140 Wien
Austria


Candesartan cilexetil


Candesartan Arcana 16 mg Tabletten


16 mg


Tablet


Oral use




Austria


Arcana Arzneimittel GmbH
Huetteldorfer Straße 299
1140 Wien
Austria


Candesartan cilexetil


Candesartan Arcana 32 mg Tabletten


32 mg


Tablet


Oral use




Austria


Genericon Pharma GmbH
Hafnerstr. 211
8054 Graz
Austria


Nebivolol


Nebivolol Genericon 5 mg Tabletten


5 mg


Tablet


Oral use




Austria


Ratiopharm Arzneimittei-Vertriebs-GmbH
Albert-Schweitzer-Gasse 3
1140 Wien
Austria


Desloratadine


Desloratadin ratiopharm 2,5 mg Schmelztabletten


2,5 mg


Orodispersible tablet


Oral use




Austria


Ratiopharm Arzneimittei-Vertriebs-GmbH
Albert-Schweitzer-Gasse 3
1140 Wien
Austria


Desloratadine


Desloratadin ratiopharm 5 mg Schmelztabletten


5 mg


Orodispersible tablet


Oral use




Belgium


Apotex Europe B.V.
Darwinweg 20
NL 2333 CR Leiden
Netherlands


Desloratadine


Desloratadine Apotex


5 mg


Film-coated tablet


Oral use




Belgium


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Donepezil


Donepezil Odis Mylan


5 mg


Orodispersible tablet


Oral use




Belgium


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Donepezil


Donepezil Odis Mylan


10 mg


Orodispersible tablet


Oral use




Belgium


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Repaglinide


Repaglinide Mylan 0,5 mg Pharma


0,5 mg


Tablet


Oral use




Belgium


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Repaglinide


Repaglinide Mylan 1 mg Pharma


1 mg


Tablet


Oral use




Belgium


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Repaglinide


Repaglinide Mylan 2 mg Pharma


2 mg


Tablet


Oral use




Belgium


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Candesartan


Candesartan Mylan


8 mg


Tablet


Oral use




Belgium


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Candesartan


Candesartan Mylan


16 mg


Tablet


Oral use




Belgium


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Candesartan


Candesartan Mylan


32 mg


Tablet


Oral use




Belgium


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Esomeprazole


Esomeprazole Mylan


20 mg


Gastro-resistant capsule, hard


Oral use




Belgium


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Esomeprazole


Esomeprazole Mylan


40 mg


Gastro-resistant capsule, hard


Oral use




Belgium


Takeda Belgium
Gentsesteenweg 615
1080 Brussels
Belgium


Alendronic acid


Alendromono


70 mg


Tablet


Oral use




Belgium


Teva Pharma Belgium NV
Laarstraat 16
2610 Wilrijk
Belgium


Desloratadine


Desloratadine Teva


2,5 mg


Orodispersible tablet


Oral use




Belgium


Teva Pharma Belgium NV
Laarstraat 16
2610 Wilrijk
Belgium


Desloratadine


Desloratadine Teva


5 mg


Orodispersible tablet


Oral use




Bulgaria


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirole Accord


0,5 mg


Film-coated tablet


Oral use




Bulgaria


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirole Accord


1 mg


Film-coated tablet


Oral use




Bulgaria


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirole Accord


2 mg


Film-coated tablet


Oral use




Bulgaria


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirole Accord


5 mg


Film-coated tablet


Oral use




Bulgaria


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Cefpodoxime


FOXERO


200 mg


Tablet


Oral use




Bulgaria


Aquachim AD
blvd. Prof. Tsvetan Lazarov 83
Sofia 1582
Bulgaria


Quetiapine


Aquatiapine


25 mg


Film-coated tablet


Oral use




Bulgaria


Aquachim AD
blvd. Prof. Tsvetan Lazarov 83
Sofia 1582
Bulgaria


Quetiapine


Aquatiapine


100 mg


Film-coated tablet


Oral use




Bulgaria


Aquachim AD
blvd. Prof. Tsvetan Lazarov 83
Sofia 1582
Bulgaria


Quetiapine


Aquatiapine


200 mg


Film-coated tablet


Oral use




Bulgaria


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Esomeprazole magnesium


Esopragen


20 mg


Gastro-resistant capsule, hard


Oral use




Bulgaria


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Esomeprazole magnesium


Esopragen


40 mg


Gastro-resistant capsule, hard


Oral use




Bulgaria


Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
14078 Praha 4
Czech Republic


Trimetazidine


Apstar 35 mg
prolonged-release tablets


35 mg


Prolonged — release tablet


Oral use




Bulgaria


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Trimetazidine


Trimetazigen MR


35 mg


Prolonged — release tablet


Oral use




Bulgaria


Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia


Trimetazidine


Energotrim


35 mg


Prolonged — release tablet


Oral use




Bulgaria


Tchaikapharma Highquality Medicines
1 G. M. Dimitrov Blvd.
Sofia 1172
Bulgaria


Bosentan


Pulmohyperta


62,5 mg


Film-coated tablet


Oral use




Bulgaria


Tchaikapharma Highquality Medicines
1 G. M. Dimitrov Blvd.
Sofia 1172
Bulgaria


Bosentan


Pulmohyperta


125 mg


Film-coated tablet


Oral use




Croatia


Alkaloid d.o.o.
Ulica grada Vukovara 226 F
Zagreb 10000
Croatia


Cefpodoxime


Rexocef 200 mg filmom obložene tablete


200 mg


Film-coated tablet


Oral use




Croatia


Belupo, lijekovi i kozmetika d.d.
Ulica Danica 5
Koprivnica 48000
Croatia


Desloratadine


Alerdin 2,5 mg raspadljive tablete za usta


2,5 mg


Orodispersible tablet


Oral use




Croatia


Belupo, lijekovi i kozmetika d.d.
Ulica Danica 5
Koprivnica 48000
Croatia


Desloratadine


Alerdin 5 mg raspadljive tablete za usta


5 mg


Orodispersible tablet


Oral use




Croatia


Fidifarm d.o.o.
Obrtnička 37, Bestovje
Rakitje 10437
Croatia


Desloratadine


Sinalerg 5 mg filmom obložene tablete


5 mg


Film-coated tablet


Oral use




Croatia


Jadran Galenski Laboratorij d.d.
Svilno 20, Rijeka
51000
Croatia


Desloratadine


Escontral direkt 2,5 mg raspadljiva tableta za usta


2,5 mg


Orodispersible tablet


Oral use




Croatia


Jadran Galenski Laboratorij d.d.
Svilno 20, Rijeka
51000
Croatia


Desloratadine


Escontral direkt 5 mg raspadljiva tableta za usta


5 mg


Orodispersible tablet


Oral use




Croatia


PharmaS d.o.o.
Radnička cesta 47
Zagreb 10000
Croatia


Tramadol/paracetamol


Tramadol/Paracetamol PharmaS 37,5 mg/
325 mg filmom obložene tablete


37,5 mg/325 mg


Film-coated tablet


Oral use




Croatia


PharmaS d.o.o.
Radnička cesta 47
Zagreb 10000
Croatia


Escitalopram


Escitalopram PharmaS 10 mg filmom
obložene tablete


10 mg


Film-coated tablet


Oral use




Croatia


Sandoz d.o.o.
Maksimirska 120
Zagreb 10000
Croatia


Trimetazidine hydrochloride


Vazidin 35 mg tablete s produljenim oslobađanjem


35 mg


Prolonged — release tablet


Oral use




Cyprus


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Alendronic acid


Alendronic Acid Accord


70 mg


Tablet


Oral use




Cyprus


Delorbis Pharmaceuticals Ltd
17 Athinon Street
Ergates Industrial Area
2643 Ergates
P.O. Box 28629
2081 Lefkosia
Cyprus


Entacapone


Nobat


200 mg


Film-coated tablet


Oral use




Cyprus


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/Hctz Fair-med


160 mg/12,5 mg


Film-coated tablet


Oral use




Cyprus


Generics Pharma Hellas Ltd
577a Vouliagmenis Avenue
Argyroupoli
164-51 Athens
Greece


Donepezil hydrochloride


Donepezil/Generics


5 mg


Orodispersible tablet


Oral use




Cyprus


Generics Pharma Hellas Ltd
577a Vouliagmenis Avenue
Argyroupoli
164-51 Athens
Greece


Donepezil hydrochloride


Donepezil/Generics


10 mg


Orodispersible tablet


Oral use




Cyprus


Lambda Therapeutic Limited
Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF
United Kingdom


Ropinirole hydrochloride


Ropinirole Lambda


0,25 mg


Film-coated tablet


Oral use




Cyprus


Lambda Therapeutic Limited
Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF
United Kingdom


Ropinirole hydrochloride


Ropinirole Lambda


0,5 mg


Film-coated tablet


Oral use




Cyprus


Lambda Therapeutic Limited
Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF
United Kingdom


Ropinirole hydrochloride


Ropinirole Lambda


1 mg


Film-coated tablet


Oral use




Cyprus


Lambda Therapeutic Limited
Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF
United Kingdom


Ropinirole hydrochloride


Ropinirole Lambda


2 mg


Film-coated tablet


Oral use




Cyprus


Lambda Therapeutic Limited
Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF
United Kingdom


Ropinirole hydrochloride


Ropinirole Lambda


5 mg


Film-coated tablet


Oral use




Cyprus


Wockhardt UK Limited
Ash Road North
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom


Clopidogrel hydrochloride


Clopidogrel/Wockhardt


75 mg


Film-coated tablet


Oral use




Czech Republic


Abbott Laboratories, s.r.o.
Evropská 2591/33d
160 00 Praha 6 — Hadovka Office Park
Czech Republic


Escitalopram oxalate


Purcema 5 mg


5 mg


Film-coated tablet


Oral use




Czech Republic


Abbott Laboratories, s.r.o.
Evropská 2591/33d
160 00 Praha 6 — Hadovka Office Park
Czech Republic


Escitalopram oxalate


Purcema 10 mg


10 mg


Film-coated tablet


Oral use




Czech Republic


Abbott Laboratories, s.r.o.
Evropská 2591/33d
160 00 Praha 6 — Hadovka Office Park
Czech Republic


Escitalopram oxalate


Purcema 15 mg


15 mg


Film-coated tablet


Oral use




Czech Republic


Abbott Laboratories, s.r.o.
Evropská 2591/33d
160 00 Praha 6 — Hadovka Office Park
Czech Republic


Escitalopram oxalate


Purcema 20 mg


20 mg


Film-coated tablet


Oral use




Czech Republic


Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Metformin hydrochloride


Metformin Actavis Retard 500 mg


500 mg


Prolonged — release tablet


Oral use




Czech Republic


Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Metformin hydrochloride


Metformin Actavis Retard 750 mg


750 mg


Prolonged — release tablet


Oral use




Czech Republic


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Cefpodoxime


Forexo 200 mg potahované tablety


200 mg


Film-coated tablet


Oral use




Czech Republic


Alvogen IPCo S.ar.l.
Rue Heienhaff 5
L-1736 Senningerberg
Luxembourg


Desloratadine


Desloratadin Alvogen 5 mg potahované tablety


5 mg


Film-coated tablet


Oral use




Czech Republic


Apotex Europe B.V.
Darwinweg 20
NL 2333 CR Leiden
Netherlands


Trimetazidine dihydrochloride


Apo-trimetazidin 35 mg


35 mg


Prolonged — release tablet


Oral use




Czech Republic


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Esomeprazole magnesium


Esomylan 40 mg


40 mg


Gastro-resistant capsule, hard


Oral use




Czech Republic


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Rizatriptan benzoate


Rizatriptan Mylan 5 mg


5 mg


Orodispersible tablet


Oral use




Czech Republic


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Rizatriptan benzoate


Rizatriptan Mylan 10 mg


10 mg


Orodispersible tablet


Oral use




Czech Republic


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Donepezil hydrochloride


Donepezil Mylan 10 mg


10 mg


Orodispersible tablet


Oral use




Czech Republic


Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
14078 Praha 4
Czech Republic


Trimetazidine dihydrochloride


Portora 35 mg tablety s prodlouženým uvolňováním


35 mg


Prolonged — release tablet


Oral use




Czech Republic


GNR Czech s.r.o.
Slavojova 579/9
128 00 Praha 2
Czech Republic


Desloratadine


Geslora 5 mg


5 mg


Film-coated tablet


Oral use




Czech Republic


Labormed-Pharma, SA
Theodor Pallady, 44B
032266 Bucharest
Romania


Desloratadine


Desloratadin Labormed 2,5 mg tablety dispergovatelné v ústech


2,5 mg


Orodispersible tablet


Oral use




Czech Republic


Labormed-Pharma, SA
Theodor Pallady, 44B
032266 Bucharest
Romania


Desloratadine


Desloratadin Labormed 5 mg tablety dispergovatelné v ústech


5 mg


Orodispersible tablet


Oral use




Czech Republic


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Trimetazidine


Trimetazidin Mylan 35 mg


35 mg


Prolonged — release tablet


Oral use




Czech Republic


SVUS Pharma a.s.
Smetanovo nábřeží 1238/20a
500 02 Hradec Králové
Czech Republic


Desloratadine


Lotera 5 mg potahované tablety


5 mg


Film-coated tablet


Oral use




Denmark


Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Metformin


Metformin ‘Actavis PTC’


500 mg


Prolonged — release tablet


Oral use




Denmark


Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Metformin


Metformin ‘Actavis PTC’


750 mg


Prolonged — release tablet


Oral use




Denmark


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Fluconazole


Fluconazol ‘Bluefish’


50 mg


Capsule, hard


Oral use




Denmark


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Fluconazole


Fluconazol ‘Bluefish’


150 mg


Capsule, hard


Oral use




Denmark


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Fluconazole


Fluconazol ‘Bluefish’


200 mg


Capsule, hard


Oral use




Denmark


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/hydrochlorthiazid ‘Fair-Med’


160 mg/12,5 mg


Film-coated tablet


Oral use




Denmark


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/hydrochlorthiazid ‘Fair-Med’


320 mg/12,5 mg


Film-coated tablet


Oral use




Denmark


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/hydrochlorthiazid ‘Fair-Med’


320 mg/25 mg


Film-coated tablet


Oral use




Denmark


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Eletriptan


Eletriptan Mylan


40 mg


Film-coated tablet


Oral use




Denmark


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Esomeprazole


Esomeprazol Mylan


20 mg


Gastro-resistant capsule, hard


Oral use




Denmark


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Esomeprazole


Esomeprazol Mylan


40 mg


Gastro-resistant capsule, hard


Oral use




Denmark


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Rizatriptan


Rizatriptan Mylan


10 mg


Orodispersible tablet


Oral use




Denmark


Stadapharm GmbH
Stadastr. 2-18
D-61118 Bad Vilbel
Germany


Entacapone


Entacapon STADA


200 mg


Film-coated tablet


Oral use




Estonia


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Alendronic acid


ALENDRONIC ACID ACCORD 70 mg


70 mg


Tablet


Oral use




Estonia


Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia


Trimetazidine


ZIDMETIN


35 mg


Modified-release tablet


Oral use




Finland


Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Metformin


Metformin Actavis


500 mg


Prolonged — release tablet


Oral use




Finland


Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Metformin


Metformin Actavis


750 mg


Prolonged — release tablet


Oral use




Finland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Fluconazole


Fluconazol Bluefish


50 mg


Capsule, hard


Oral use




Finland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Fluconazole


Fluconazol Bluefish


150 mg


Capsule, hard


Oral use




Finland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Fluconazole


Fluconazol Bluefish


200 mg


Capsule, hard


Oral use




Finland


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Eletriptan


Eletriptan Mylan


40 mg


Film-coated tablet


Oral use




Finland


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Repaglinide


Repaglinid Mylan


0,5 mg


Tablet


Oral use




Finland


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Repaglinide


Repaglinid Mylan


1 mg


Tablet


Oral use




Finland


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Repaglinide


Repaglinid Mylan


2 mg


Tablet


Oral use




Finland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Valsartan


VALSARTAN ORION


40 mg


Film-coated tablet


Oral use




Finland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Valsartan


VALSARTAN ORION


80 mg


Film-coated tablet


Oral use




Finland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Valsartan


VALSARTAN ORION


160 mg


Film-coated tablet


Oral use




Finland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Valsartan


VALSARTAN ORION


320 mg


Film-coated tablet


Oral use




Finland


Ratiopharm GmbH
Graf-Arco-Strasse 3
D-89079 Ulm
Germany


Desloratadine


Desloratadine Ratiopharm


2,5 mg


Orodispersible tablet


Oral use




Finland


Ratiopharm GmbH
Graf-Arco-Strasse 3
D-89079 Ulm
Germany


Desloratadine


Desloratadine Ratiopharm


5 mg


Orodispersible tablet


Oral use




France


Abbott Products SAS
42 rue Rouget de Lisle
92150 Suresnes
France


Escitalopram


ESCITALOPRAM ABBOTT 5 mg, comprimé pelliculé


5 mg


Film-coated tablet


Oral use




France


Abbott Products SAS
42 rue Rouget de Lisle
92150 Suresnes
France


Escitalopram


ESCITALOPRAM ABBOTT 10 mg, comprimé pelliculé


10 mg


Film-coated tablet


Oral use




France


Abbott Products SAS
42 rue Rouget de Lisle
92150 Suresnes
France


Escitalopram


ESCITALOPRAM ABBOTT 15 mg, comprimé pelliculé


15 mg


Film-coated tablet


Oral use




France


Abbott Products SAS
42 rue Rouget de Lisle
92150 Suresnes
France


Escitalopram


ESCITALOPRAM ABBOTT 20 mg, comprimé pelliculé


20 mg


Film-coated tablet


Oral use




France


ACCORD HEALTHCARE France SAS
45 Rue de Fbg de Roubaix
59000 Lille
France


Ropinirole


Ropinirole Accord 0,25 mg, comprimé pelliculé


0,25 mg


Film-coated tablet


Oral use




France


ACCORD HEALTHCARE France SAS
45 Rue de Fbg de Roubaix
59000 Lille
France


Ropinirole


Ropinirole Accord 0,5 mg, comprimé pelliculé


0,5 mg


Film-coated tablet


Oral use




France


ACCORD HEALTHCARE France SAS
45 Rue de Fbg de Roubaix
59000 Lille
France


Ropinirole


Ropinirole Accord 1 mg, comprimé pelliculé


1 mg


Film-coated tablet


Oral use




France


ACCORD HEALTHCARE France SAS
45 Rue de Fbg de Roubaix
59000 Lille
France


Ropinirole


Ropinirole Accord 2 mg, comprimé pelliculé


2 mg


Film-coated tablet


Oral use




France


ACCORD HEALTHCARE France SAS
45 Rue de Fbg de Roubaix
59000 Lille
France


Ropinirole


Ropinirole Accord 5 mg, comprimé pelliculé


5 mg


Film-coated tablet


Oral use




France


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Escitalopram


ESCITALOPRAM BROWN 5 mg, comprimé pelliculé sécable


5 mg


Film-coated tablet


Oral use




France


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Escitalopram


ESCITALOPRAM BROWN 10 mg, comprimé pelliculé sécable


10 mg


Film-coated tablet


Oral use




France


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Escitalopram


ESCITALOPRAM BROWN 15 mg, comprimé pelliculé sécable


15 mg


Film-coated tablet


Oral use




France


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Escitalopram


ESCITALOPRAM BROWN 20 mg, comprimé pelliculé sécable


20 mg


Film-coated tablet


Oral use




France


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Ebastine


EBASTINE BROWN & BURK 10 mg, comprimé orodispersible


10 mg


Orodispersible tablet


Oral use




France


Cristers
22, quai Galliéni
92150 Suresnes
France


Desloratadine


DESLORATADINE CRISTERS
5 mg
comprimé pelliculé


5 mg


Film-coated tablet


Oral use




France


Cristers
22, quai Galliéni
92150 Suresnes
France


Ibuprofen


IBUPROFENE CRISTERS
400 mg
comprimé pelliculé


400 mg


Film-coated tablet


Oral use




France


Laboratoires Biogaran
15, boulevard Charles de Gaulle
92707 Colombes Cedex
France


Ebastine


EBASTINE BIOGARAN 10 mg comprimé pelliculé


10 mg


Film-coated tablet


Oral use




France


Laboratoires Biogaran
15, boulevard Charles de Gaulle
92707 Colombes Cedex
France


Ebastine


EBASTINE BIOGARAN 10 mg comprimé orodispersible


10 mg


Orodispersible tablet


Oral use




France


Laboratoires GERDA
24 rue Erlanger
75016 PARIS
France


Desloratadine


DESLORATADINE ARROW
5 mg
comprimé pelliculé


5 mg


Film-coated tablet


Oral use




France


Medipha Sante
Les Fjords — Immeuble Oslo
19 avenue de Norvège
91953 Courtaboeuf Cedex
France


Tramadol/paracetamol


TRAMADOL PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé


37,5 mg/325 mg


Film-coated tablet


Oral use




France


Medipha Sante
Les Fjords — Immeuble Oslo
19 avenue de Norvège
91953 Courtaboeuf Cedex
France


Desloratadine


DESLORATADINE GNR
5 mg
comprimé pelliculé


5 mg


Film-coated tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Rizatriptan


RIZATRIPTAN MYLAN 5 mg, orodispersible tablet


5 mg


Orodispersible tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Rizatriptan


RIZATRIPTAN MYLAN 10 mg, orodispersible tablet


10 mg


Orodispersible tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Ebastine


EBASTINE MYLAN 10 mg, film-coated tablet


10 mg


Film-coated tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Ebastine


EBASTINE MYLAN 10 mg, orodispersible tablet


10 mg


Orodispersible tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Trimetazidine


TRIMETAZIDINE MYLAN 35 mg Modified Release Tablets


35 mg


Modified-release tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Candesartan


CANDESARTAN MYLAN 32 mg, comprimé secable


32 mg


Tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Donepezil


DONEPEZIL MYLAN 5 mg, orodispersible tablet


5 mg


Orodispersible tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Donepezil


DONEPEZIL MYLAN 10 mg, orodispersible tablet


10 mg


Orodispersible tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Esomeprazole


ESOMEPRAZOLE MYLAN PHARMA 20 mg, DR capsule


20 mg


Gastro-resistant capsule, hard


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Esomeprazole


ESOMEPRAZOLE MYLAN PHARMA 40 mg, DR capsule


40 mg


Gastro-resistant capsule, hard


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Desmopressin


DESMOPRESSINE MYLAN 60 μg, orodispersible tablet


0,06 mg


Orodispersible tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Desmopressin


DESMOPRESSINE MYLAN 120 μg, orodispersible tablet


0,12 mg


Orodispersible tablet


Oral use




France


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Desmopressin


DESMOPRESSINE MYLAN 240 μg, orodispersible tablet


0,24 mg


Orodispersible tablet


Oral use




France


Ranbaxy Pharmacie Generiques
11-15 Quai Dion Bouton
92800 Puteaux
France


Aciclovir


Aciclovir Ranbaxy 800 mg, comprimé


800 mg


Tablet


Oral use




France


Ranbaxy Pharmacie Generiques
11-15 Quai Dion Bouton
92800 Puteaux
France


Aciclovir


Aciclovir Ranbaxy 200 mg, comprimé


200 mg


Tablet


Oral use




France


Ranbaxy Pharmacie Generiques
11-15 Quai Dion Bouton
92800 Puteaux
France


Aciclovir


Aciclovir Almus 200 mg, comprimé


200 mg


Tablet


Oral use




France


Ranbaxy Pharmacie Generiques
11-15 Quai Dion Bouton
92800 Puteaux
France


Alendronic acid


Acide Alendronique Ranbaxy 70 mg, comprimé


70 mg


Tablet


Oral use




France


Sanofi Aventis France
1-13 bd Romain Rolland
75159 Paris Cedex 14
France


Ebastine


EBASTINE ZENTIVA 10 mg comprimé pelliculé


10 mg


Film-coated tablet


Oral use




France


Sanofi Aventis France
1-13 bd Romain Rolland
75159 Paris Cedex 14
France


Ebastine


EBASTINE ZENTIVA 10 mg comprimé orodispersible


10 mg


Orodispersible tablet


Oral use




France


Teva Sante
Cœur Défense — 100-110
Esplanade du Général de Gaulle
92931 La Défense Cedex
France


Desloratadine


DESLORATADINE TEVA SANTE
5 mg
comprimé pelliculé


5 mg


Film-coated tablet


Oral use




France


Venipharm SAS
4 Bureaux de la Colline
92213 Saint-Cloud
France


Ebastine


EBOUDA 10 mg comprimé pelliculé


10 mg


Film-coated tablet


Oral use




France


Venipharm SAS
4 Bureaux de la Colline
92213 Saint-Cloud
France


Ebastine


EBARREN 10 mg comprimé pelliculé


10 mg


Film-coated tablet


Oral use




France


Venipharm SAS
4 Bureaux de la Colline
92213 Saint-Cloud
France


Ebastine


EBONDE 10 mg comprimé pelliculé


10 mg


Film-coated tablet


Oral use




France


Venipharm SAS
4 Bureaux de la Colline
92213 Saint-Cloud
France


Ebastine


EBONTAN 10 mg comprimé orodispersible


10 mg


Orodispersible tablet


Oral use




France


Venipharm SAS
4 Bureaux de la Colline
92213 Saint-Cloud
France


Ebastine


EBACHOI 10 mg comprimé orodispersible


10 mg


Orodispersible tablet


Oral use




France


Venipharm SAS
4 Bureaux de la Colline
92213 Saint-Cloud
France


Ibuprofen


IBUPROFENE ZYDUS FRANCE 200 mg comprimé pelliculé


200 mg


Film-coated tablet


Oral use




France


Zydus France
Zacles Hautes Patures
25 Rue des Peupliers
92752 Nanterre Cedes
France


Ibuprofen


IBUPROFENE ZYDUS FRANCE 400 mg comprimé pelliculé


400 mg


Film-coated tablet


Oral use




France


Zydus France
Zacles Hautes Patures
25 Rue des Peupliers
92752 Nanterre Cedes
France


Tramadol/paracetamol


TRAMADOL PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé


37,5 mg/325 mg


Film-coated tablet


Oral use




France


Zydus France
Zacles Hautes Patures
25 Rue des Peupliers
92752 Nanterre Cedes
France


Ibuprofen


IBUPROFENE ZF 400 mg comprimé pelliculé


400 mg


Film-coated tablet


Oral use




France


Zydus France
Zacles Hautes Patures
25 Rue des Peupliers
92752 Nanterre Cedes
France


Desloratadine


DESLORATADINE ZYDUS 5 mg comprimé pelliculé


5 mg


Film-coated tablet


Oral use




France


Zydus France
Zacles Hautes Patures
25 Rue des Peupliers
92752 Nanterre Cedes
France


Escitalopram


ESCITALOPRAM ZYDUS 5 mg, comprimé pelliculé


5 mg


Film-coated tablet


Oral use




France


Zydus France
Zacles Hautes Patures
25 Rue des Peupliers
92752 Nanterre Cedes
France


Escitalopram


ESCITALOPRAM ZYDUS 10 mg, comprimé pelliculé sécable


10 mg


Film-coated tablet


Oral use




France


Zydus France
Zacles Hautes Patures
25 Rue des Peupliers
92752 Nanterre Cedes
France


Escitalopram


ESCITALOPRAM ZYDUS 15 mg, comprimé pelliculé sécable


15 mg


Film-coated tablet


Oral use




France


Zydus France
Zacles Hautes Patures
25 Rue des Peupliers
92752 Nanterre Cedes
France


Escitalopram


ESCITALOPRAM ZYDUS 20 mg, comprimé pelliculé sécable


20 mg


Film-coated tablet


Oral use




Germany


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Alendronic acid


ALENDRONIC ACID ACCORD 70 MG


70 mg


Tablet


Oral use




Germany


Betapharm Arzneimittel GmbH
Kobelweg 95
D-86156 Augsburg
Germany


Levetiracetam


Levetiracetam beta 250 mg, Filmtabletten


250 mg


Film-coated tablet


Oral use




Germany


Betapharm Arzneimittel GmbH
Kobelweg 95
D-86156 Augsburg
Germany


Levetiracetam


Levetiracetam beta 500 mg, Filmtabletten


500 mg


Film-coated tablet


Oral use




Germany


Betapharm Arzneimittel GmbH
Kobelweg 95
D-86156 Augsburg
Germany


Levetiracetam


Levetiracetam beta 750 mg, Filmtabletten


750 mg


Film-coated tablet


Oral use




Germany


Betapharm Arzneimittel GmbH
Kobelweg 95
D-86156 Augsburg
Germany


Levetiracetam


Levetiracetam beta 1  000 mg, Filmtabeltten


1  000 mg


Film-coated tablet


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan


Irbesartan Tablets
75 mg


75 mg


Film-coated tablet


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan


Irbesartan Tablets
150 mg


150 mg


Film-coated tablet


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan


Irbesartan Tablets
300 mg


300 mg


Film-coated tablet


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan HCTZ Fair-Med 150 +  12,5 mg Filmtabletten


150 mg/12,5 mg


Film-coated tablet


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan HCTZ Fair-Med 300 +  12,5 mg Filmtabletten


300 mg/12,5 mg


Film-coated tablet


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan HCTZ Fair-Med 300 + 25 mg Filmtabletten


300 mg/25 mg


Film-coated tablet


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/HCTZ Fair-Med Healthcare 160 mg/12,5 mg Filmtabletten


160 mg/12,5 mg


Film-coated tablet


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/HCTZ Fair-Med Healthcare 320 mg/12,5 mg Filmtabletten


320 mg/12,5 mg


Film-coated tablet


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/HCTZ Fair-Med Healthcare 320 mg/25 mg Filmtabletten


320 mg/25 mg


Film-coated tablet


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Venlafaxine


Venlafaxin Fair-Med 37,5 mg Hartkapseln, retardiert


37,5 mg


Prolonged — release capsule, hard


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Venlafaxine


Venlafaxin Fair-Med 75 mg Hartkapseln, retardiert


75 mg


Prolonged — release capsule, hard


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Venlafaxine


Venlafaxin Fair-Med 150 mg Hartkapseln, retardiert


150 mg


Prolonged — release capsule, hard


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Ciprofloxacin


Ciprofloxacin Fair-Med Healthcare 500 mg Filmtabletten


500 mg


Film-coated tablet


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Ciprofloxacin


Ciprofloxacin Fair-Med Healthcare 750 mg Filmtabletten


750 mg


Film-coated tablet


Oral use




Germany


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Ciprofloxacin


Ciprofloxacin Fair-Med Healthcare 250 mg Filmtabletten


250 mg


Film-coated tablet


Oral use




Germany


Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan


Irbesartan Heumann 75 mg Filmtabletten


75 mg


Film-coated tablet


Oral use




Germany


Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan


Irbesartan Heumann 150 mg Filmtabletten


150 mg


Film-coated tablet


Oral use




Germany


Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan


Irbesartan Heumann 300 mg Filmtabletten


300 mg


Film-coated tablet


Oral use




Germany


Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan/Hydrochlorothiazid Heumann 150 mg/12,5 mg Filmtabletten


150 mg/12,5 mg


Film-coated tablet


Oral use




Germany


Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan/Hydrochlorothiazid Heumann 300 mg/12,5 mg Filmtabletten


300 mg/12,5 mg


Film-coated tablet


Oral use




Germany


Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan/Hydrochlorothiazid Heumann 300 mg/25 mg Filmtabletten


300 mg/25 mg


Film-coated tablet


Oral use




Germany


Hormosan Pharma GmbH
Wilhelmshoeher Str. 106
D-60389 Frankfurt
06 Hessen
Germany


Cefpodoxime proxetil


Cefpodoxim-
Hormosan
200 mg
Filmtabletten


200 mg


Film-coated tablet


Oral use




Germany


Lupin (Europe) Limited
Victoria Court, Bexton Road
Knutsford, Cheshire WA16 0PF
United Kingdom


Trimetazidine hydrochloride


Lupamadazine 35 mg Retardtabletten


35 mg


Controlled — release tablet


Oral use




Germany


Micro Labs GmbH
Lyoner Str. 14
D-60528 Frankfurt/Main
Germany


Escitalopram


Escitalopram-Micro Labs 5 mg Filmtabletten


5 mg


Film-coated tablet


Oral use




Germany


Micro Labs GmbH
Lyoner Str. 14
D-60528 Frankfurt/Main
Germany


Escitalopram


Escitalopram-Micro Labs 10 mg Filmtabletten


10 mg


Film-coated tablet


Oral use




Germany


Micro Labs GmbH
Lyoner Str. 14
D-60528 Frankfurt/Main
Germany


Escitalopram


Escitalopram-Micro Labs 15 mg Filmtabletten


15 mg


Film-coated tablet


Oral use




Germany


Micro Labs GmbH
Lyoner Str. 14
D-60528 Frankfurt/Main
Germany


Escitalopram


Escitalopram-Micro Labs 20 mg Filmtabletten


20 mg


Film-coated tablet


Oral use




Germany


Mylan dura GmBh
Wittichstrasse 6
64295 Darmstadt
Germany


Repaglinide


Repaglinid Mylan 0,5 mg Tabletten


0,5 mg


Tablet


Oral use




Germany


Mylan dura GmBh
Wittichstrasse 6
64295 Darmstadt
Germany


Repaglinide


Repaglinid Mylan 1 mg Tabletten


1 mg


Tablet


Oral use




Germany


Mylan dura GmBh
Wittichstrasse 6
64295 Darmstadt
Germany


Repaglinide


Repaglinid Mylan 2 mg Tabletten


2 mg


Tablet


Oral use




Germany


Mylan dura GmBh
Wittichstrasse 6
64295 Darmstadt
Germany


Rizatriptan


Rizatriptan Mylan dura 5 mg Schmelztabletten


5 mg


Orodispersible tablet


Oral use




Germany


Mylan dura GmBh
Wittichstrasse 6
64295 Darmstadt
Germany


Rizatriptan


Rizatriptan Mylan dura 10 mg Schmelztabletten


10 mg


Orodispersible tablet


Oral use




Germany


Panacea Biotec Germany GmbH
Landshuter Allee 8-10
D-80637 München
Germany


Tacrolimus


Tacpan 0,5 mg Hartkapseln


0,5 mg


Capsule, hard


Oral use




Germany


Panacea Biotec Germany GmbH
Landshuter Allee 8-10
D-80637 München
Germany


Tacrolimus


Tacpan 1 mg Hartkapseln


1 mg


Capsule, hard


Oral use




Germany


Panacea Biotec Germany GmbH
Landshuter Allee 8-10
D-80637 München
Germany


Tacrolimus


Tacpan 5 mg Hartkapseln


5 mg


Capsule, hard


Oral use




Germany


Stadapharm GmbH
Stadastr. 2-18
D-61118 Bad Vilbel
Germany


Entacapone


Entacapon STADA 200 mg Filmtabletten


200 mg


Film-coated tablet


Oral use




Germany


Unichem Laboratories Ltd
Studio 8B Ard Gaoithe Commercial Centre, Business Park
Cashel Road Clonmel,
Co Tipperary
Ireland


Irbesartan


Irbesartan Unichem 150 mg Filmtabletten


150 mg


Film-coated tablet


Oral use




Germany


Unichem Laboratories Ltd
Studio 8B Ard Gaoithe Commercial Centre, Business Park
Cashel Road Clonmel,
Co Tipperary
Ireland


Irbesartan


Irbesartan Unichem 300 mg Filmtabletten


300 mg


Film-coated tablet


Oral use




Germany


Welding GmbH & Co. KG
Esplanade 39
D-20354 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan + Hidroclorotiazida Welding


300 mg/12,5 mg


Film-coated tablet


Oral use




Germany


Welding GmbH & Co. KG
Esplanade 39
D-20354 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan + Hidroclorotiazida Welding


150 mg/12,5 mg


Film-coated tablet


Oral use




Germany


Welding GmbH & Co. KG
Esplanade 39
D-20354 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan + Hidroclorotiazida Welding


300 mg/25 mg


Film-coated tablet


Oral use




Germany


Welding GmbH & Co. KG
Esplanade 39
D-20354 Hamburg
Germany


Irbesartan


Irbesartan Welding


75 mg


Film-coated tablet


Oral use




Germany


Welding GmbH & Co. KG
Esplanade 39
D-20354 Hamburg
Germany


Irbesartan


Irbesartan Welding


150 mg


Film-coated tablet


Oral use




Germany


Welding GmbH & Co. KG
Esplanade 39
D-20354 Hamburg
Germany


Irbesartan


Irbesartan Welding


300 mg


Film-coated tablet


Oral use




Greece


Abbott Laboratories
Hellas ΑΒΕΕ
Agiou Dimitriou 63
Alimos 17456
Greece


Escitalopram oxalate


Savandra


5 mg


Film-coated tablet


Oral use




Greece


Abbott Laboratories
Hellas ΑΒΕΕ
Agiou Dimitriou 63
Alimos 17456
Greece


Escitalopram oxalate


Savandra


10 mg


Film-coated tablet


Oral use




Greece


Abbott Laboratories
Hellas ΑΒΕΕ
Agiou Dimitriou 63
Alimos 17456
Greece


Escitalopram oxalate


Savandra


15 mg


Film-coated tablet


Oral use




Greece


Abbott Laboratories
Hellas ΑΒΕΕ
Agiou Dimitriou 63
Alimos 17456
Greece


Escitalopram oxalate


Savandra


20 mg


Film-coated tablet


Oral use




Greece


Genepharm S.A.
18 Km Marathon Avenue, 15351 Pallini
Greece


Desloratadine


Desloratadine/Genepharm 5 mg δισκία επικαλυμμένα με υμένιο,


5 mg


Film-coated tablet


Oral use




Greece


Genepharm S.A.
18 Km Marathon Avenue, 15351 Pallini
Greece


Desloratadine


Desloratadine/Genepharm 2,5 mg δισκία διασπειρόμενα στο στόμα


2,5 mg


Orodispersible tablet


Oral use




Greece


Genepharm S.A.
18 Km Marathon Avenue, 15351 Pallini
Greece


Desloratadine


Desloratadine/Genepharm 5 mg δισκία διασπειρόμενα στο στόμα


5 mg


Orodispersible tablet


Oral use




Greece


Generics Pharma Hellas Ltd
577a Vouliagmenis Avenue
Argyroupoli
164-51 Athens
Greece


Donepezil hydrochloride


Donepezil/
Generics


5 mg


Orodispersible tablet


Oral use




Greece


Generics Pharma Hellas Ltd
577a Vouliagmenis Avenue
Argyroupoli
164-51 Athens
Greece


Donepezil hydrochloride


Donepezil/
Generics


10 mg


Orodispersible tablet


Oral use




Greece


Generics Pharma Hellas Ltd
577a Vouliagmenis Avenue
Argyroupoli
164-51 Athens
Greece


Esomeprazole magnesium


Esomeprazole/
Generics


40 mg


Prolonged — release capsule


Oral use




Greece


Sieger Pharma A.E.
Marathonos Avenue 106
Pikermi 19009
Greece


Desloratadine


Desloratadine/Sieger


5 mg


Film-coated tablet


Oral use




Greece


Sieger Pharma A.E.
Marathonos Avenue 106
Pikermi 19009
Greece


Desloratadine


Desloratadine/Sieger


2,5 mg


Orodispersible tablet


Oral use




Greece


Sieger Pharma A.E.
Marathonos Avenue 106
Pikermi 19009
Greece


Desloratadine


Desloratadine/Sieger


5 mg


Orodispersible tablet


Oral use




Hungary


Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Metformin hydrochloride


Gluforlyn XR 500 mg retard tabletta


500 mg


Prolonged — release tablet


Oral use




Hungary


Alvogen IPCo S.ar.l.
Rue Heienhaff 5
L-1736 Senningerberg
Luxembourg


Desloratadine


Alvotadin 5 mg filmtabletta


5 mg


Film-coated tablet


Oral use




Hungary


Alvogen IPCo S.ar.l.
Rue Heienhaff 5
L-1736 Senningerberg
Luxembourg


Desloratadine


Alvotadin 2,5 mg szájban diszpergálódó tabletta


2,5 mg


Orodispersible tablet


Oral use




Hungary


Alvogen IPCo S.ar.l.
Rue Heienhaff 5
L-1736 Senningerberg
Luxembourg


Desloratadine


Alvotadin 5 mg szájban diszpergálódó tabletta


5 mg


Orodispersible tablet


Oral use




Hungary


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Esomeprazole magnesium


Esomeprazol Mylan 20 mg gyomornedv-ellenálló kemény kapszula


20 mg


Gastro-resistant capsule, hard


Oral use




Hungary


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Esomeprazole magnesium


Esomeprazol Mylan 40 mg gyomornedv-ellenálló kemény kapszula


40 mg


Gastro-resistant capsule, hard


Oral use




Hungary


Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
14078 Praha 4
Czech Republic


Trimetazidine dihydrochloride


Apstar 35 mg retard tabletta


35 mg


Prolonged — release tablet


Oral use




Hungary


Goodwill Pharma Kft.
H-6724 Szeged
Cserzy Mihály u. 32.
Hungary


Desloratadine


Inaller 5 mg filmtabletta


5 mg


Film-coated tablet


Oral use




Hungary


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Trimetazidine


Trimetazidine Mylan 35 mg retard tabletta


35 mg


Prolonged — release tablet


Oral use




Hungary


Sandoz Hungária Kft.
H-1114 Budapest
Bartók Béla út 43-47.
Hungary


Trimetazidine dihydrochloride


Trimetazidine Sandoz 35 mg retard tabletta


35 mg


Prolonged — release tablet


Oral use




Hungary


Teva Gyógyszergyár Zrt.
H-4042 Debrecen
Pallagi út 13.
Hungary


Desloratadine


Desloratadin Teva 2,5 mg szájban diszpergálódó tabletta


2,5 mg


Orodispersible tablet


Oral use




Hungary


Teva Gyógyszergyár Zrt.
H-4042 Debrecen
Pallagi út 13.
Hungary


Desloratadine


Desloratadin Teva 5 mg szájban diszpergálódó tabletta


5 mg


Orodispersible tablet


Oral use




Iceland


Ratiopharm GmbH
Graf-Arco-Strasse 3
D-89079 Ulm
Germany


Desloratadine


Desloratadine ratiopharm


5 mg


Orodispersible tablet


Oral use




Ireland


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole hydrochloride


Ropinirole 0,25 mg Film-coated Tablets


0,25 mg


Film-coated tablet


Oral use




Ireland


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole hydrochloride


Ropinirole 0,5 mg Film-coated Tablets


0,5 mg


Film-coated tablet


Oral use




Ireland


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole hydrochloride


Ropinirole 1 mg Film-coated Tablets


1 mg


Film-coated tablet


Oral use




Ireland


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole hydrochloride


Ropinirole 2 mg Film-coated Tablets


2 mg


Film-coated tablet


Oral use




Ireland


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole hydrochloride


Ropinirole 5 mg Film-coated Tablets


5 mg


Film-coated tablet


Oral use




Ireland


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Alendronic acid


Alendronic Acid Once Weekly 70 mg Tablets


70 mg


Tablet


Oral use




Ireland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/Hydrochlorothiazide Fair-Med 160 mg/12,5 mg film-coated tablets.


160 mg/12,5 mg


Film-coated tablet


Oral use




Ireland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/Hydrochlorothiazide Fair-Med 320 mg/12,5 mg film-coated tablets


320 mg/12,5 mg


Film-coated tablet


Oral use




Ireland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/Hydrochlorothiazide Fair-Med 320 mg/25 mg film-coated tablets


320 mg/25 mg


Film-coated tablet


Oral use




Ireland


Fannin (UK) Ltd
42-46 Booth Drive
Park Farm South
Wellingborough
Northamptonshire NN8 6GT
United Kingdom


Fexofenadine hydrochloride


Fexofenadine 120 mg film-coated tablets


120 mg


Film-coated tablet


Oral use




Ireland


Fannin (UK) Ltd
42-46 Booth Drive
Park Farm South
Wellingborough
Northamptonshire NN8 6GT
United Kingdom


Fexofenadine hydrochloride


Fexofenadine 180 mg film-coated tablets


180 mg


Film-coated tablet


Oral use




Ireland


McDermott Laboratories Ltd
t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland


Donepezil


Aripil Orotab 5 mg Orodispersible Tablet


5 mg


Orodispersible tablet


Oral use




Ireland


McDermott Laboratories Ltd
t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland


Donepezil


Aripil Orotab 10 mg Orodispersible Tablet


10 mg


Orodispersible tablet


Oral use




Ireland


McDermott Laboratories Ltd
t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland


Esomeprazole


Esomeprazole Mylan 20 mg Gastro-resistant Capsules, hard


20 mg


Gastro-resistant capsule


Oral use




Ireland


McDermott Laboratories Ltd
t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland


Esomeprazole


Esomeprazole Mylan 40 mg Gastro-resistant Capsules, hard


40 mg


Gastro-resistant capsule


Oral use




Ireland


McDermott Laboratories Ltd
t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland


Candesartan


Candesartan Mylan 4 mg Tablets


4 mg


Tablet


Oral use




Ireland


McDermott Laboratories Ltd
t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland


Candesartan


Candesartan Mylan 8 mg Tablets


8 mg


Tablet


Oral use




Ireland


McDermott Laboratories Ltd
t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland


Candesartan


Candesartan Mylan 16 mg Tablets


16 mg


Tablet


Oral use




Ireland


McDermott Laboratories Ltd
t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland


Candesartan


Candesartan Mylan 32 mg Tablets


32 mg


Tablet


Oral use




Ireland


Morningside Healthcare Limited
115 Narborough Road
Leicester, LE3 0PA
United Kingdom


Phenoxymethyl penicillin


Phenoxymethylpenicillin 250 mg Film-coated Tablets


250 mg


Film-coated tablet


Oral use




Ireland


Niche Generics Limited
1 The Cam Centre
Wilbury Way, Hitchin
Hertfordshire SG4 0TW
United Kingdom


Amlodipine besilate


Amlodipine Niche 5 mg tablets


5 mg


Tablet


Oral use




Ireland


Niche Generics Limited
1 The Cam Centre
Wilbury Way, Hitchin
Hertfordshire SG4 0TW
United Kingdom


Amlodipine besilate


Amlodipine Niche 10 mg Tablets


10 mg


Tablet


Oral use




Ireland


Niche Generics Limited
1 The Cam Centre
Wilbury Way, Hitchin
Hertfordshire SG4 0TW
United Kingdom


Irbesartan


Irbesartan Niche 150 mg film-coated tablets


150 mg


Film-coated tablet


Oral use




Ireland


Niche Generics Limited
1 The Cam Centre
Wilbury Way, Hitchin
Hertfordshire SG4 0TW
United Kingdom


Irbesartan


Irbesartan Niche 300 mg film-coated tablets


300 mg


Film-coated tablet


Oral use




Ireland


Wockhardt UK Limited
Ash Road North
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom


Clopidogrel hydrochloride


Clopidogrel 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral use




Italy


Accord Healthcare Italia S.r.l.
Largo Esterle, 4
20052 Monza
Italy


Metoclopramide


METOCLOPRAMIDE ACCORD


10 mg


Tablet


Oral use




Italy


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Alendronic acid


ALENDRONATO AHCL


10 mg


Tablet


Oral use




Italy


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Alendronic acid


ALENDRONATO AHCL


70 mg


Tablet


Oral use




Italy


Doc Generici SRL
Via Turati, 40
20121 Milano
Italy


Desloratadine


DESLORATADINA DOC GENERICI


5 mg


Film-coated tablet


Oral use




Italy


Doc Generici SRL
Via Turati, 40
20121 Milano
Italy


Desloratadine


DESLORATADINA DOC GENERICI


2,5 mg


Orodispersible tablet


Oral use




Italy


Doc Generici SRL
Via Turati, 40
20121 Milano
Italy


Desloratadine


DESLORATADINA DOC GENERICI


5 mg


Orodispersible tablet


Oral use




Italy


Farmaceutici Caber S.P.A.
Viale Citta’ D’Europa, 681
00144 Rome
Italy


Valsartan


VALSOTEN


40 mg


Film-coated tablet


Oral use




Italy


Farmaceutici Caber S.P.A.
Viale Citta’ D’Europa, 681
00144 Rome
Italy


Valsartan


VALSOTEN


80 mg


Film-coated tablet


Oral use




Italy


Farmaceutici Caber S.P.A.
Viale Citta’ D’Europa, 681
00144 Rome
Italy


Valsartan


VALSOTEN


160 mg


Film-coated tablet


Oral use




Italy


Farmaceutici Caber S.P.A.
Viale Citta’ D’Europa, 681
00144 Rome
Italy


Valsartan


VALSOTEN


320 mg


Film-coated tablet


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Esomeprazole magnesium


ESOMEPRAZOLO MYLAN


20 mg


Gastro-resistant capsule, hard


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Esomeprazole magnesium


ESOMEPRAZOLO MYLAN


40 mg


Gastro-resistant capsule, hard


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Rizatriptan benzoate


RIAZATRIPTAN MYLAN GENERICS


5 mg


Orodispersible tablet


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Rizatriptan benzoate


RIAZATRIPTAN MYLAN GENERICS


10 mg


Orodispersible tablet


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Donepezil hydrochloride


DONEPEZIL MYLAN GENERICS ITALIA


5 mg


Orodispersible tablet


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Donepezil hydrochloride


DONEPEZIL MYLAN GENERICS ITALIA


10 mg


Orodispersible tablet


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Repaglinide


REPAGLINIDE MYLAN


0,5 mg


Tablet


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Repaglinide


REPAGLINIDE MYLAN


1 mg


Tablet


Oral use




Italy


Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy


Repaglinide


REPAGLINIDE MYLAN


2 mg


Tablet


Oral use




Italy


Pensa Pharma S.P.A.
Via Rossellini Ippolito, 12
20124 Milan
Italy


Alendronic acid


Alendronato Pensa
70 mg compresse


70 mg


Tablet


Oral use




Italy


Ranbaxy Italia S.P.A.
Piazza Filippo Meda, 4, 3
20121 — Milano
Italy


Alendronic acid


ALENDRONATO RANBAXY ITALIA


70 mg


Tablet


Oral use




Latvia


Sandoz Pharmaceuticals d.d.
Verovskova 57
Ljubljana SI-1000
Slovenia


Trimetazidine dihydrochloride


Zidmetin


35 mg


Modified-release tablet


Oral use




Lithuania


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Alendronic acid


Alendronic acid Accord


70 mg


Tablet


Oral use




Lithuania


Lambda Therapeutic Limited
Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF
United Kingdom


Ropinirole


Ropinirole Lambada


0,5 mg


Film-coated tablet


Oral use




Lithuania


Lambda Therapeutic Limited
Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF
United Kingdom


Ropinirole


Ropinirole Lambada


1 mg


Film-coated tablet


Oral use




Lithuania


Lambda Therapeutic Limited
Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF
United Kingdom


Ropinirole


Ropinirole Lambada


2 mg


Film-coated tablet


Oral use




Lithuania


Lambda Therapeutic Limited
Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF
United Kingdom


Ropinirole


Ropinirole Lambada


5 mg


Film-coated tablet


Oral use




Lithuania


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan


Irbesartanas Torrent


75 mg


Film-coated tablet


Oral use




Lithuania


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan


Irbesartanas Torrent


150 mg


Film-coated tablet


Oral use




Lithuania


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan


Irbesartanas Torrent


300 mg


Film-coated tablet


Oral use




Lithuania


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan/hydrochlorothiazide


Irbesartanas/Hidrochlorotiazidas Torrent


150 mg/12,5 mg


Film-coated tablet


Oral use




Lithuania


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan/hydrochlorothiazide


Irbesartanas/Hidrochlorotiazidas Torrent


300 mg/12,5 mg


Film-coated tablet


Oral use




Lithuania


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan/hydrochlorothiazide


Irbesartanas/Hidrochlorotiazidas Torrent


300 mg/25 mg


Film-coated tablet


Oral use




Luxembourg


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Repaglinide


Repaglinide Mylan Pharma 0,5 mg tabletten


0,5 mg


Tablet


Oral use




Luxembourg


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Repaglinide


Repaglinide Mylan Pharma 1 mg tabletten


1 mg


Tablet


Oral use




Luxembourg


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Repaglinide


Repaglinide Mylan Pharma 2 mg tabletten


2 mg


Tablet


Oral use




Luxembourg


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Esomeprazole


Esomeprazole Mylan


20 mg


Gastro-resistant capsule, hard


Oral use




Luxembourg


Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Esomeprazole


Esomeprazole Mylan


40 mg


Gastro-resistant capsule, hard


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/hydrochlorthiazid ‘Fair-Med’ Coated tablets


160 mg/12,5 mg


Film-coated tablet


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/hydrochlorthiazid ‘Fair-Med’ Coated tablets


320 mg/12,5 mg


Film-coated tablet


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/hydrochlorthiazid ‘Fair-Med’ Coated tablets


320 mg/25 mg


Film-coated tablet


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Ciprofloxacin


Ciprofloxacin Fair-Med Coated Tablets


250 mg


Film-coated tablet


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Ciprofloxacin


Ciprofloxacin Fair-Med Coated Tablets


500 mg


Film-coated tablet


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


irbesartan


Irbesartan Fairmed 75 mg Film-coated Tablets


75 mg


Film-coated tablet


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


irbesartan


Irbesartan Fairmed 150 mg Film-coated Tablets


150 mg


Film-coated tablet


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


irbesartan


Irbesartan Fairmed 300 mg Film-coated Tablets


300 mg


Film-coated tablet


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan/Hydrochlorothiazide Fairmed 150 mg/12,5 mg film-coated tablets


150 mg/12,5 mg


Film-coated tablet


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan/Hydrochlorothiazide Fairmed 300 mg/12,5 mg film-coated tablets


300 mg/12,5 mg


Film-coated tablet


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan/Hydrochlorothiazide Fairmed 300 mg/25 mg film-coated tablets


300 mg/25 mg


Film-coated tablet


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Venlafaxine


Venlafaxine Fair-Med


37,5 mg


Prolonged — release capsule, hard


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Venlafaxine


Venlafaxine Fair-Med


75 mg


Prolonged — release capsule, hard


Oral use




Malta


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Venlafaxine


Venlafaxine Fair-Med


150 mg


Prolonged — release capsule, hard


Oral use




Malta


Wockhardt UK Limited
Ash Road North
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom


Clopidogrel


Clopidogrel 75 mg Film-coated Tablets


75 mg


Film-coated tablet


Oral use




Malta


Wockhardt UK Limited
Ash Road North
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom


Clopidogrel


Clopidogrel 75 mg Coated Tablets


75 mg


Film-coated tablet


Oral use




Norway


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Fluconazole


Fluconazol Bluefish


50 mg


Capsule, hard


Oral use




Norway


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Fluconazole


Fluconazol Bluefish


150 mg


Capsule, hard


Oral use




Norway


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Fluconazole


Fluconazol Bluefish


200 mg


Capsule, hard


Oral use




Norway


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Esomeprazole


Esomeprazol Mylan


20 mg


Gastro-resistant capsule, hard


Oral use




Norway


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Esomeprazole


Esomeprazol Mylan


40 mg


Gastro-resistant capsule, hard


Oral use




Norway


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Eletriptan


Eletriptan Mylan


20 mg


Film-coated tablet


Oral use




Norway


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Eletriptan


Eletriptan Mylan


40 mg


Film-coated tablet


Oral use




Norway


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Candesartan cilexetil


Kandrozid


4 mg


tablet


Oral use




Norway


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Candesartan cilexetil


Kandrozid


8 mg


tablet


Oral use




Norway


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Candesartan cilexetil


Kandrozid


16 mg


tablet


Oral use




Norway


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Candesartan cilexetil


Kandrozid


32 mg


tablet


Oral use




Norway


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Candesartan cilexetil


Mylcande


8 mg


tablet


Oral use




Norway


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Candesartan cilexetil


Mylcande


16 mg


tablet


Oral use




Norway


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Candesartan cilexetil


Mylcande


32 mg


tablet


Oral use




Norway


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Rizatriptan


RIZATRIPTAN MYLAN 10 mg, orodispersible tablet


10 mg


Orodispersible tablet


Oral use




Norway


Ratiopharm GmbH
Graf-Arco-Strasse 3
D-89079 Ulm
Germany


Desloratadine


Desloratadin Ratiopharm


2,5 mg


Orodispersible tablet


Oral use




Norway


Ratiopharm GmbH
Graf-Arco-Strasse 3
D-89079 Ulm
Germany


Desloratadine


Desloratadin Ratiopharm


5 mg


Orodispersible tablet


Oral use




Poland


Abbott Laboratories Poland Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa
Poland


Escitalopram


Savandra


5 mg


Film-coated tablet


Oral use




Poland


Abbott Laboratories Poland Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa
Poland


Escitalopram


Savandra


10 mg


Film-coated tablet


Oral use




Poland


Abbott Laboratories Poland Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa
Poland


Escitalopram


Savandra


15 mg


Film-coated tablet


Oral use




Poland


Abbott Laboratories Poland Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa
Poland


Escitalopram


Savandra


20 mg


Film-coated tablet


Oral use




Poland


Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Metformin


Metformin SR Actavis


500 mg


Film-coated tablet


Oral use




Poland


Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Metformin


Metformin SR Actavis


750 mg


Film-coated tablet


Oral use




Poland


Adamed Sp. z o.o.
Pieńków 149
05-152 Czosnów k. Warszawy
Poland


Desloratadine


Desada


5 mg


Orodispersible tablet


Oral use




Poland


Adamed Sp. z o.o.
Pieńków 149
05-152 Czosnów k. Warszawy
Poland


Desloratadine


Hitaxa Fast


2,5 mg


Orodispersible tablet


Oral use




Poland


Adamed Sp. z o.o.
Pieńków 149
05-152 Czosnów k. Warszawy
Poland


Desloratadine


Hitaxa


2,5 mg


Orodispersible tablet


Oral use




Poland


Adamed Sp. z o.o.
Pieńków 149
05-152 Czosnów k. Warszawy
Poland


Desloratadine


Hitaxa


5 mg


Orodispersible tablet


Oral use




Poland


Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Poland


Desloratadine


Teslor


5 mg


Film-coated tablet


Oral use




Poland


Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Poland


Desloratadine


Teslor fast


5 mg


Orodispersible tablet


Oral use




Poland


Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Poland


Desloratadine


Teslor fast junior


2,5 mg


Orodispersible tablet


Oral use




Poland


Apotex Europe B.V.
Darwinweg 20
NL 2333 CR Leiden
Netherlands


Trimetazidine


ApoTrimet PR


35 mg


Prolonged — release tablet


Oral use




Poland


Bio-Profil Polska Sp. z o.o.
Trakt Lubelski 135
04-790 Warszawa
Poland


Desloratadine


Desloratadine Peseri


5 mg


Film-coated tablet


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan HCT Fair-Med


320 mg/12,5 mg


Film-coated tablet


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan HCT Fair-Med


320 mg/25 mg


Film-coated tablet


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Ciprofloxacin


Ciprofloxacin Fair-Med


250 mg


Film-coated tablet


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Ciprofloxacin


Ciprofloxacin Fair-Med


500 mg


Film-coated tablet


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan


Irbesartan Fair-Med


75 mg


Film-coated tablet


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan


Irbesartan Fair-Med


150 mg


Film-coated tablet


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan


Irbesartan Fair-Med


300 mg


Film-coated tablet


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan HCT Fair-Med


150 mg/12,5 mg


Film-coated tablet


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan HCT Fair-Med


300 mg/12,5 mg


Film-coated tablet


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan HCT Fair-Med


300 mg/25 mg


Film-coated tablet


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan HCT Fair-Med


160 mg/12,5 mg


Film-coated tablet


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Venlafaxine


VENLAFAXINE FAIR-MED


37,5 mg


Prolonged — release capsule, hard


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Venlafaxine


VENLAFAXINE FAIR-MED


75 mg


Prolonged — release capsule, hard


Oral use




Poland


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Venlafaxine


VENLAFAXINE FAIR-MED


150 mg


Prolonged — release capsule, hard


Oral use




Poland


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Candesartan cilexetil


Kangen


8 mg


Tablet


Oral use




Poland


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Candesartan cilexetil


Kangen


16 mg


Tablet


Oral use




Poland


Labormed-Pharma, SA
Theodor Pallady, 44B
032266 Bucharest
Romania


Desloratadine


Desloratadine Labormed


2,5 mg


Orodispersible tablet


Oral use




Poland


Labormed-Pharma, SA
Theodor Pallady, 44B
032266 Bucharest
Romania


Desloratadine


Desloratadine Labormed


5 mg


Orodispersible tablet


Oral use




Poland


Medicplast Polska Sp. z o.o
ul. Wólczyńska 232
01-919 Warszawa
Poland


Desloratadine


Desalergo


5 mg


Film-coated tablet


Oral use




Poland


Medicplast Polska Sp. z o.o
ul. Wólczyńska 232
01-919 Warszawa
Poland


Desloratadine


Desalergo


2,5 mg


Orodispersible tablet


Oral use




Poland


Medicplast Polska Sp. z o.o
ul. Wólczyńska 232
01-919 Warszawa
Poland


Desloratadine


Desalergo


5 mg


Orodispersible tablet


Oral use




Poland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Valsartan


Valsartan Orion


40 mg


Film-coated tablet


Oral use




Poland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Valsartan


Valsartan Orion


80 mg


Film-coated tablet


Oral use




Poland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Valsartan


Valsartan Orion


160 mg


Film-coated tablet


Oral use




Poland


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Valsartan


Valsartan Orion


320 mg


Film-coated tablet


Oral use




Poland


Peseri Trading Limited
20 Queen Frederica Street
El-Greco House, office 301
1066 Nicosia
Cyprus


Desloratadine


Desloratadine Peseri


2,5 mg


Orodispersible tablet


Oral use




Poland


Peseri Trading Limited
20 Queen Frederica Street
El-Greco House, office 301
1066 Nicosia
Cyprus


Desloratadine


Desloratadine Peseri


5 mg


Orodispersible tablet


Oral use




Poland


Ranbaxy (Poland) Sp. z o.o.
Kubickiego 11
02-954 Warszawa
Poland


Alendronic acid


Alendran 70


70 mg


Tablet


Oral use




Poland


Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl
Austria


Trimetazidine


Dimesar


35 mg


Prolonged — release tablet


Oral use




Poland


S-Lab Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
Poland


Desloratadine


Suprodeslon


5 mg


Film-coated tablet


Oral use




Poland


S-Lab Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
Poland


Desloratadine


Suprodeslon


2,5 mg


Orodispersible tablet


Oral use




Poland


S-Lab Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
Poland


Desloratadine


Suprodeslon


5 mg


Orodispersible tablet


Oral use




Poland


SymPhar Sp. z o.o.
ul. Włoska 1
00-777 Warszawa
Poland


Desloratadine


Symdes


5 mg


Film-coated tablet


Oral use




Poland


Tactica Pharmaceuticals sp. z o.o.
ul. Bankowa 4
44-100 Gliwice
Poland


Desloratadine


Goldesin


5 mg


Film-coated tablet


Oral use




Poland


US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
Poland


Desloratadine


Aleric Deslo


5 mg


Film-coated tablet


Oral use




Poland


US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
Poland


Desloratadine


Aleric Deslo


2,5 mg


Orodispersible tablet


Oral use




Poland


US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
Poland


Desloratadine


Aleric Deslo Active


5 mg


Orodispersible tablet


Oral use




Poland


Wockhardt UK Limited
Ash Road North
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom


Clopidogrel


Clopidogrel Wockhardt


75 mg


Film-coated tablet


Oral use




Portugal


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Alendronic acid


Ácido alendrónico Accord


70 mg


tablet


Oral use




Portugal


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Cefpodoxime


Cefpodoxima Alkaloid


200 mg


Tablet


Oral use




Portugal


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Tramadol/paracetamol


Tramadol + Paracetamol Brown


37,5 mg/325 mg


Film-coated tablet


Oral use




Portugal


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Trimetazidine


Trimetazidina Brown


35 mg


Modified-release tablet


Oral use




Portugal


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Escitalopram


Escitalopram Brown


10 mg


Film-coated tablet


Oral use




Portugal


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Escitalopram


Escitalopram Brown


15 mg


Film-coated tablet


Oral use




Portugal


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Escitalopram


Escitalopram Brown


5 mg


Film-coated tablet


Oral use




Portugal


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Escitalopram


Escitalopram Brown


20 mg


Film-coated tablet


Oral use




Portugal


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Ebastine


Ebastina Brown


10 mg


Film-coated tablet


Oral use




Portugal


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Ebastine


Ebastina Brown


20 mg


Film-coated tablet


Oral use




Portugal


Daquimed — Comércio de Produtos Farmacêuticos, S.A.
Av. Associação Comercial e Industrial de Gondomar, 330 — Zona Industrial da Portelinha
4510-688 Fânzeres
Portugal


Quetiapine


Quetiapina Daquimed


25 mg


Film-coated tablet


Oral use




Portugal


Daquimed — Comércio de Produtos Farmacêuticos, S.A.
Av. Associação Comercial e Industrial de Gondomar, 330 — Zona Industrial da Portelinha
4510-688 Fânzeres
Portugal


Quetiapine


Quetiapina Daquimed


100 mg


Film-coated tablet


Oral use




Portugal


Daquimed — Comércio de Produtos Farmacêuticos, S.A.
Av. Associação Comercial e Industrial de Gondomar, 330 — Zona Industrial da Portelinha
4510-688 Fânzeres
Portugal


Quetiapine


Quetiapina Daquimed


150 mg


Film-coated tablet


Oral use




Portugal


Daquimed — Comércio de Produtos Farmacêuticos, S.A.
Av. Associação Comercial e Industrial de Gondomar, 330 — Zona Industrial da Portelinha
4510-688 Fânzeres
Portugal


Quetiapine


Quetiapina Daquimed


200 mg


Film-coated tablet


Oral use




Portugal


Daquimed — Comércio de Produtos Farmacêuticos, S.A.
Av. Associação Comercial e Industrial de Gondomar, 330 — Zona Industrial da Portelinha
4510-688 Fânzeres
Portugal


Quetiapine


Quetiapina Daquimed


300 mg


Film-coated tablet


Oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Levodopa/carbidopa/entacapone


Levodopa + Carbidopa + Entacapona Generis


50 mg/12,5 mg/200 mg


Film-coated tablet


Oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Levodopa/carbidopa/entacapone


Levodopa + Carbidopa + Entacapona Generis


75 mg/18,75 mg/200 mg


Film-coated tablet


Oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Levodopa/carbidopa/entacapone


Levodopa + Carbidopa + Entacapona Generis


100 mg/25 mg/200 mg


Film-coated tablet


Oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Levodopa/carbidopa/entacapone


Levodopa + Carbidopa + Entacapona Generis


125 mg/31,250 mg/200 mg


Film-coated tablet


Oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Levodopa/carbidopa/entacapone


Levodopa + Carbidopa + Entacapona Generis


150 mg/37,5 mg/200 mg


Film-coated tablet


Oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Levodopa/carbidopa/entacapone


Levodopa + Carbidopa + Entacapona Generis


175 mg/43,75 mg/200 mg


Film-coated tablet


Oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Levodopa/carbidopa/entacapone


Levodopa + Carbidopa + Entacapona Generis


200 mg/50 mg/200 mg


Film-coated tablet


Oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Entacapone


Entacapona Generis


200 mg


Film-coated tablet


Oral use




Portugal


Labesfal, Genéricos, S.A.
Av. Dr Afonso Costa, no 1370
3465-051 Campo de Besteiros
Portugal


Desloratadine


Desloratadina Labesfal OD


2,5 mg


Orodispersible tablet


Oral use




Portugal


Labesfal, Genéricos, S.A.
Av. Dr Afonso Costa, no 1370
3465-051 Campo de Besteiros
Portugal


Desloratadine


Desloratadina Labesfal OD


5 mg


Orodispersible tablet


Oral use




Portugal


Labesfal, Genéricos, S.A.
Av. Dr Afonso Costa, no 1370
3465-051 Campo de Besteiros
Portugal


Alendronic acid


Ácido alendrónico Labesfal


70 mg


tablet


Oral use




Portugal


Laboratórios Anova — Produtos Farmacêuticos, Lda.
Rua Doutor António Loureiro Borges
Edíficio Arquiparque 1, R/C Esqo

1499-016 Algés
Portugal


Donepezil


Donepezilo Anova


5 mg


Orodispersible tablet


Oral use




Portugal


Laboratórios Anova — Produtos Farmacêuticos, Lda.
Rua Doutor António Loureiro Borges
Edíficio Arquiparque 1, R/C Esqo

1499-016 Algés
Portugal


Donepezil


Donepezilo Anova


10 mg


Orodispersible tablet


Oral use




Portugal


Laboratórios Anova — Produtos Farmacêuticos, Lda.
Rua Doutor António Loureiro Borges
Edíficio Arquiparque 1, R/C Esqo

1499-016 Algés
Portugal


Esomeprazole


Esomeprazol Anova


20 mg


Gastro-resistant capsule, hard


Oral use




Portugal


Laboratórios Anova — Produtos Farmacêuticos, Lda.
Rua Doutor António Loureiro Borges
Edíficio Arquiparque 1, R/C Esqo

1499-016 Algés
Portugal


Esomeprazole


Esomeprazol Anova


40 mg


Gastro-resistant capsule, hard


Oral use




Portugal


Laboratórios Azevedos — Indústria Farmacêutica, S.A.
Edifícios Azevedos — Estrada Nacional 117-2, Alfragide
2614-504 Amadora
Portugal


Venlafaxine


Venlafaxina Azevedos


37,5 mg


Prolonged — release capsule, hard


Oral use




Portugal


Laboratórios Azevedos — Indústria Farmacêutica, S.A.
Edifícios Azevedos — Estrada Nacional 117-2, Alfragide
2614-504 Amadora
Portugal


Venlafaxine


Venlafaxina Azevedos


75 mg


Prolonged — release capsule, hard


Oral use




Portugal


Laboratórios Azevedos — Indústria Farmacêutica, S.A.
Edifícios Azevedos — Estrada Nacional 117-2, Alfragide
2614-504 Amadora
Portugal


Venlafaxine


Venlafaxina Azevedos


150 mg


Prolonged — release capsule, hard


Oral use




Portugal


Laboratórios Basi — Indústria Farmacêutica, S.A
Parque Industrial Manuel Lourenço Ferreira, Lote 15
3450-232 Mortágua
Portugal


Fluconazole


Fluconazol Basi


50 mg


Capsule


Oral use




Portugal


Laboratórios Basi — Indústria Farmacêutica, S.A
Parque Industrial Manuel Lourenço Ferreira, Lote 15
3450-232 Mortágua
Portugal


Fluconazole


Fluconazol Basi


150 mg


Capsule


Oral use




Portugal


Laboratórios Basi — Indústria Farmacêutica, S.A
Parque Industrial Manuel Lourenço Ferreira, Lote 15
3450-232 Mortágua
Portugal


Fluconazole


Fluconazol Basi


200 mg


Capsule


Oral use




Portugal


Labormed-Pharma, SA
Theodor Pallady, 44B
032266 Bucharest
Romania


Desloratadine


Desloratadina Labormed


5 mg


Orodispersible tablet


Oral use




Portugal


Labormed-Pharma, SA
Theodor Pallady, 44B
032266 Bucharest
Romania


Desloratadine


Desloratadina Labormed


2,5 mg


Orodispersible tablet


Oral use




Portugal


Lupin (Europe) Limited
Victoria Court, Bexton Road
Knutsford, Cheshire WA16 0PF
United Kingdom


Cefpodoxime


Cefpodoxima Lupin


200 mg


Film-coated tablet


Oral use




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


Esomeprazole


Esomeprazol Mylan


20 mg


Gastro-resistant capsule, hard


Oral use




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


Esomeprazole


Esomeprazol Mylan


40 mg


Gastro-resistant capsule, hard


Oral use




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


Atorvastatin


Atorvastatina Anova


10 mg


Film-coated tablet


Oral use




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


Atorvastatin


Atorvastatina Anova


20 mg


Film-coated tablet


Oral use




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


Atorvastatin


Atorvastatina Anova


40 mg


Film-coated tablet


Oral use




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


Atorvastatin


Atorvastatina Anova


80 mg


Film-coated tablet


Oral use




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


Donepezil


Donepezilo Mylan


5 mg


Orodispersible tablet


Oral use




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


Donepezil


Donepezilo Mylan


10 mg


Orodispersible tablet


Oral use




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


Trimetazidine


Trimetazidina Mylan


35 mg


Modified-release tablet


Oral use




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


Candesartan


Candesartan Mylan


4 mg


Tablet


Oral use




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


Candesartan


Candesartan Mylan


8 mg


Tablet


Oral use




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


Candesartan


Candesartan Mylan


16 mg


Tablet


Oral use




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


Candesartan


Candesartan Mylan


32 mg


Tablet


Oral use




Portugal


Peseri Trading Limited
20 Queen Frederica Street
El-Greco House, office 301
1066 Nicosia
Cyprus


Desloratadine


Desloratadina Peseri


5 mg


Film-coated tablet


Oral use




Portugal


Peseri Trading Limited
20 Queen Frederica Street
El-Greco House, office 301
1066 Nicosia
Cyprus


Desloratadine


Desloratadina Peseri


5 mg


Orodispersible tablet


Oral use




Portugal


Peseri Trading Limited
20 Queen Frederica Street
El-Greco House, office 301
1066 Nicosia
Cyprus


Desloratadine


Desloratadina Peseri


2,5 mg


Orodispersible tablet


Oral use




Portugal


Pharmakern Portugal — Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 — 3o, Sala 31 — Miraflores
1495-139 Algés
Portugal


Trimetazidine


Trimetazidina Pharmakern


35 mg


Modified-release tablet


Oral use




Portugal


Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.
Lagoas Park, Edifício 5 A, Piso 2
2740-245 Porto Salvo
Portugal


Desloratadine


Desloratadina Ratiopharm


2,5 mg


Orodispersible tablet


Oral use




Portugal


Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.
Lagoas Park, Edifício 5 A, Piso 2
2740-245 Porto Salvo
Portugal


Desloratadine


Desloratadina Ratiopharm


5 mg


Orodispersible tablet


Oral use




Portugal


Sandoz Farmaceutica Lda.
Avenida Professor Doutor
Cavaco Silva, n. 10E Taguspark
2740-255 Porto Salvo
Portugal


Trimetazidine


Trimetazidina Itraxel


35 mg


Prolonged — release tablet


Oral use




Portugal


Teva Pharma — Produtos Farmacêuticos, Lda.
Edificio Tejo, Rua Quinta do Pinheiro, 16 — 6o

2790-143 Carnaxide
Portugal


Desloratadine


Desloratadina Teva


2,5 mg


Orodispersible tablet


Oral use




Portugal


Teva Pharma — Produtos Farmacêuticos, Lda.
Edificio Tejo, Rua Quinta do Pinheiro, 16 — 6o

2790-143 Carnaxide
Portugal


Desloratadine


Desloratadina Teva


5 mg


Orodispersible tablet


Oral use




Romania


Abbott Products SAS
42 rue Rouget de Lisle
92150 Suresnes
France


Escitalopram


SAVANDRA 5 mg comprimate filmate


5 mg


Film-coated tablet


Oral use




Romania


Abbott Products SAS
42 rue Rouget de Lisle
92150 Suresnes
France


Escitalopram


SAVANDRA 10 mg comprimate filmate


10 mg


Film-coated tablet


Oral use




Romania


Abbott Products SAS
42 rue Rouget de Lisle
92150 Suresnes
France


Escitalopram


SAVANDRA 15 mg comprimate filmate


15 mg


Film-coated tablet


Oral use




Romania


Abbott Products SAS
42 rue Rouget de Lisle
92150 Suresnes
France


Escitalopram


SAVANDRA 20 mg comprimate filmate


20 mg


Film-coated tablet


Oral use




Romania


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Cefpodoxime


Forexo 200 mg comprimate filmate


200 mg


Tablet


Oral use




Romania


Alvogen IPCo S.ar.l.
Rue Heienhaff 5
L-1736 Senningerberg
Luxembourg


Desloratadine


Desloratadina Alvogen 5 mg comprimate filmate


5 mg


Film-coated tablet


Oral use




Romania


Dr Reddy’s Laboratories Romania SRL
71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania


Levetiracetam


Levetiracetam Dr Reddy’s, 250 mg, comprimate filmate


250 mg


Tablet


Oral use




Romania


Dr Reddy’s Laboratories Romania SRL
71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania


Levetiracetam


Levetiracetam Dr Reddy’s, 500 mg, comprimate filmate


500 mg


Tablet


Oral use




Romania


Dr Reddy’s Laboratories Romania SRL
71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania


Levetiracetam


Levetiracetam Dr Reddy’s, 750 mg, comprimate filmate


750 mg


Tablet


Oral use




Romania


Dr Reddy’s Laboratories Romania SRL
71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania


Levetiracetam


Levetiracetam Dr Reddy’s, 1  000 mg, comprimate filmate


1  000 mg


Tablet


Oral use




Romania


Dr Reddy’s Laboratories Romania SRL
71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania


Telmisartan


Telmisartan Dr Reddy’s 40 mg comprimate


40 mg


Tablet


Oral use




Romania


Dr Reddy’s Laboratories Romania SRL
71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania


Telmisartan


Telmisartan Dr Reddy’s 80 mg comprimate


80 mg


Tablet


Oral use




Romania


Dr Reddy’s Laboratories Romania SRL
71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania


Telmisartan/
hydrochlorothiazide


Telmisartan HCT Dr Reddy’s 40 mg/12,5 mg comprimate


40 mg/12,5 mg


Tablet


Oral use




Romania


Dr Reddy’s Laboratories Romania SRL
71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania


Telmisartan/
hydrochlorothiazide


Telmisartan HCT Dr Reddy’s 80 mg/12,5 mg comprimate


80 mg/12,5 mg


Tablet


Oral use




Romania


Dr Reddy’s Laboratories Romania SRL
71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania


Telmisartan/
hydrochlorothiazide


Telmisartan HCT Dr Reddy’s 80 mg/25 mg comprimate


80 mg/25 mg


Tablet


Oral use




Romania


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Esomeprazole magnesium


Esomeprazol Mylan 20 mg capsule gastrorezistente


20 mg


Gastro-resistant capsule, hard


Oral use




Romania


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Esomeprazole magnesium


Esomeprazol Mylan 40 mg capsule gastrorezistente


40 mg


Gastro-resistant capsule, hard


Oral use




Romania


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Donepezil hydrochloride


Donepezil Mylan 5 mg comprimate orodispersabile


5 mg


Orodispersible tablet


Oral use




Romania


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Donepezil hydrochloride


Donepezil Mylan 10 mg comprimate orodispersabile


10 mg


Orodispersible tablet


Oral use




Romania


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Repaglinide


Repaglinida Generics 0,5 mg comprimate


0,5 mg


Tablet


Oral use




Romania


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Repaglinide


Repaglinida Genericsl 1 mg comprimate


1 mg


Tablet


Oral use




Romania


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Repaglinide


Repaglinida Generics 2 mg comprimate


2 mg


Tablet


Oral use




Romania


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Candesartan cilexetil


Candesartan Mylan 4 mg comprimate


4 mg


Tablet


Oral use




Romania


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Candesartan cilexetil


Candesartan Mylan 8 mg comprimate


8 mg


Tablet


Oral use




Romania


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Candesartan cilexetil


Candesartan Mylan 16 mg comprimate


16 mg


Tablet


Oral use




Romania


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Rizatriptan benzoate


Rizatriptan Mylan 5 mg comprimate orrodispersabile


5 mg


Orodispersible tablet


Oral use




Romania


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Rizatriptan benzoate


Rizatriptan Mylan 10 mg comprimate orrodispersabile


10 mg


Orodispersible tablet


Oral use




Romania


Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
14078 Praha 4
Czech Republic


Trimetazidine


Apstar 35 mg
Comprimate cu
eliberare
prelungită


35 mg


Modified-release tablet


Oral use




Romania


Labormed Pharma SA
Bd. Theodor Pallady nr. 44 B
032266, sector 3, Bucureşti
România


Desloratadine


Desloratadine Labormed 2,5 mg comprimate orodispersabile


2,5 mg


Orodispersible tablet


Oral use




Romania


Labormed Pharma SA
Bd. Theodor Pallady nr. 44 B
032266, sector 3, Bucureşti
România


Desloratadine


Desloratadine Labormed 5 mg comprimate orodispersabile


5 mg


Orodispersible tablet


Oral use




Romania


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Trimetazidine


Trimetazidina Mylan 35 mg comprimate filmate cu eliberare prelungita


35 mg


Prolonged — release tablet


Oral use




Romania


Sandoz Pharma Services SRL
Calea Floreasca Street
No 169A, district 2
Bucharest
Romania


Trimetazidine


Trimeluzine Limited 35 mg comprimate filmate cu eliberare modificata


35 mg


Modified-release tablet


Oral use




Romania


STADA Hemofarm S.R.L.
Calea Torontalului km 6 — PITT
300633 Timişoara
Romania


Entacapone


ENTTANIDA 200 comprimate filmate


200 mg


Film-coated tablet


Oral use




Romania


Teva Pharmaceuticals S.R.L.
Str. Domniţa Ruxandra nr. 12, parter, sector 2, Bucureşti, România


Desloratadine


Desloratadina Teva 5 mg comprimate orodispersabile


5 mg


Orodispersible tablet


Oral use




Romania


Torrent Pharma SRL
Str. Stirbei Voda nr. 36
et. 2, biroul A, sector 1
Bucharest
Romania


Irbesartan


Irbesartan Torrent 75 mg comprimate
filmate


75 mg


Film-coated tablet


Oral use




Romania


Torrent Pharma SRL
Str. Stirbei Voda nr. 36
et. 2, biroul A, sector 1
Bucharest
Romania


Irbesartan


Irbesartan Torrent 150 mg comprimate
filmate


150 mg


Film-coated tablet


Oral use




Romania


Torrent Pharma SRL
Str. Stirbei Voda nr. 36
et. 2, biroul A, sector 1
Bucharest
Romania


Irbesartan


Irbesartan Torrent 300 mg comprimate
filmate


300 mg


Film-coated tablet


Oral use




Romania


Torrent Pharma SRL
Str. Stirbei Voda nr. 36
et. 2, biroul A, sector 1
Bucharest
Romania


Irbesartan/hydrochlorothiazide


Irbesartan Torrent Hidrochlorotiazida
150/12,5 mg comprimate filmate


150 mg/12,5 mg


Film-coated tablet


Oral use




Romania


Torrent Pharma SRL
Str. Stirbei Voda nr. 36
et. 2, biroul A, sector 1
Bucharest
Romania


Irbesartan/hydrochlorothiazide


Irbesartan Torrent Hidrochlorotiazida
300/12,5 mg comprimate filmate


300 mg/12,5 mg


Film-coated tablet


Oral use




Romania


Torrent Pharma SRL
Str. Stirbei Voda nr. 36
et. 2, biroul A, sector 1
Bucharest
Romania


Irbesartan/hydrochlorothiazide


Irbesartan Torrent Hidrochlorotiazida
300/25 mg comprimate filmate


300 mg/25 mg


Film-coated tablet


Oral use




Slovak Republic


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Cefpodoxime


FOREXO 200 mg filmom obalené tablety


200 mg


Film-coated tablet


Oral use




Slovak Republic


Alvogen IPCo S.àr.l.
Rue Heienhaff 5
L-1736 Senningerberg
Luxembourg


Desloratadine


Dezloratadin Alvogen 5 mg filmom obalené tablety


5 mg


Film-coated tablet


Oral use




Slovak Republic


Genericon s.r.o.,
Anny Letenské 1108/15,
120 00 Praha 2 — Vinohrady
Czech Republic


Desloratadine


GESLORA 5 mg


5 mg


Film-coated tablet


Oral use




Slovak Republic


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Donepezil hydrochloride


Donepezil Mylan 5 mg orodispergovateľné tablety


5 mg


Orodispersible tablet


Oral use




Slovak Republic


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Donepezil hydrochloride


Donepezil Mylan 10 mg orodispergovateľné tablety


10 mg


Orodispersible tablet


Oral use




Slovak Republic


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Rizatriptan benzoate


Rizatriptan Mylan 10 mg


10 mg


Orodispersible tablet


Oral use




Slovak Republic


Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
14078 Praha 4
Czech Republic


Trimetazidine


Apstar 35 mg tablety s predĺženým uvoľňovaním


35 mg


Modified-release tablet


Oral use




Slovak Republic


Mylan SAS
117 allée des Parcs
69792 Saint-Priest Cedex
France


Trimetazidine


Trimetazidin Mylan 35 mg


35 mg


Modified-release tablet


Oral use




Slovak Republic


SVUS Pharma a.s.
Smetanovo nábřeží 1238/20a
500 02 Hradec Králové
Czech Republic


Desloratadine


LOTERA 5 mg filmom obalené tablety


5 mg


Film-coated tablet


Oral use




Slovak Republic


Teva Pharmaceuticals Slovakia s.r.o.
Teslova 26
821 02 Bratislava
Slovak Republic


Desloratadine


Dezloratadin Teva OROTAB 2,5 mg


2,5 mg


Orodispersible tablet


Oral use




Slovak Republic


Teva Pharmaceuticals Slovakia s.r.o.
Teslova 26
821 02 Bratislava
Slovak Republic


Desloratadine


Dezloratadin Teva OROTAB 5 mg


5 mg


Orodispersible tablet


Oral use




Slovenia


Alkaloid — INT d.o.o.
Šlandrova 4
1231 Ljubljana — Črnuče
Slovenia


Cefpodoxime


Trexodo 200 mg filmsko obložene tablete


200 mg


Film-coated tablet


Oral use




Slovenia


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Esomeprazole magnesium


Esomeprazol Mylan 20 mg trde gastrorezistentne kapsule


20 mg


Gastro-resistant capsule, hard


Oral use




Slovenia


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Esomeprazole magnesium


Esomeprazol Mylan 40 mg trde gastrorezistentne kapsule


40 mg


Gastro-resistant capsule, hard


Oral use




Slovenia


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Donepezil hydrochloride


Donepezil Mylan 5 mg orodisperzibilne tablete


5 mg


Orodispersible tablet


Oral use




Slovenia


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Donepezil hydrochloride


Donepezil Mylan 10 mg orodisperzibilne tablete


10 mg


Orodispersible tablet


Oral use




Slovenia


Lek farmacevtska družba d.d.
Verovškova 57
1526 Ljubljana
Slovenia


Trimetazidine hydrochloride


Trimeluzine 35 mg tablete s podaljšanim sproščanjem


35 mg


Prolonged — release tablet


Oral use




Spain


Accord Healthcare, S.L.U.
Moll de Barcelona s/n. World Trade Center. Edifici Est 6a planta,
8039 Barcelona
Spain


Metoclopramide


METOCLOPRAMIDA ACCORD 10 mg COMPRIMIDOS EFG


10 mg


Tablet


Oral use




Spain


Apotex Europe B.V.
Darwinweg 20
NL 2333 CR Leiden
Netherlands


Desloratadine


DESLORATADINA APOTEX 5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


5 mg


Film-coated tablet


Oral use




Spain


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Ebastine


EBASTINA BROWN 10 mg COMPRIMIDOS BUCODISPERSABLES EFG


10 mg


Orodispersible tablet


Oral use




Spain


Farmalider, S.A.
Aragoneses 15
28108 Madrid
Spain


Valsartan/hydrochlorothiazide


VALSARTAN/HIDROCLOROTIAZIDA CODRAMOL 160 MG/12,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


160 mg/12,5 mg


Film-coated tablet


Oral use




Spain


Farmalider, S.A.
Aragoneses 15
28108 Madrid
Spain


Valsartan/hydrochlorothiazide


VALSARTAN/HIDROCLOROTIAZIDA CODRAMOL 160/25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


160 mg/25 mg


Film-coated tablet


Oral use




Spain


Farmalider, S.A.
Aragoneses 15
28108 Madrid
Spain


Valsartan/hydrochlorothiazide


VALSARTAN/HIDROCLOROTIAZIDA CODRAMOL 320/12,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


320 mg/12,5 mg


Film-coated tablet


Oral use




Spain


Farmalider, S.A.
Aragoneses 15
28108 Madrid
Spain


Valsartan/hydrochlorothiazide


VALSARTAN/HIDROCLOROTIAZIDA CODRAMOL 320/25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


320 mg/25 mg


Film-coated tablet


Oral use




Spain


Farmalider, S.A.
Aragoneses 15
28108 Madrid
Spain


Valsartan/hydrochlorothiazide


VALSARTAN/HIDROCLOROTIAZIDA CODRAMOL 80/12,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


80 mg/12,5 mg


Film-coated tablet


Oral use




Spain


Laboratorios Combix, S.L.U.
C/Badajoz 2, Edificio 2
Pozuelo de Alarcon
Madrid 28223
Spain


Desloratadine


DESLORATADINA COMBIX 5 mg COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG


5 mg


Film-coated tablet


Oral use




Spain


Laboratorios Combix, S.L.U.
C/Badajoz 2, Edificio 2
Pozuelo de Alarcon
Madrid 28223
Spain


Desloratadine


DESLORATADINA FLAS COMBIX 5 mg COMPRIMIDOS BUCODISPERSABLES EFG


5 mg


Film-coated tablet


Oral use




Spain


Laboratorios Combix, S.L.U.
C/Badajoz 2, Edificio 2
Pozuelo de Alarcon
Madrid 28223
Spain


Escitalopram


ESCITALOPRAM COMBIX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


10 mg


Film-coated tablet


Oral use




Spain


Laboratorios Combix, S.L.U.
C/Badajoz 2, Edificio 2
Pozuelo de Alarcon
Madrid 28223
Spain


Escitalopram


ESCITALOPRAM COMBIX 15 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


15 mg


Film-coated tablet


Oral use




Spain


Laboratorios Combix, S.L.U.
C/Badajoz 2, Edificio 2
Pozuelo de Alarcon
Madrid 28223
Spain


Escitalopram


ESCITALOPRAM COMBIX 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


20 mg


Film-coated tablet


Oral use




Spain


Laboratorios Combix, S.L.U.
C/Badajoz 2, Edificio 2
Pozuelo de Alarcon
Madrid 28223
Spain


Escitalopram


ESCITALOPRAM COMBIX 5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


5 mg


Film-coated tablet


Oral use




Spain


Laboratorios Ranbaxy, S. L U.
Paseig de Gracia 9
7a Pl
Barcelona 08007
Spain


Alendronic acid


ACIDO ALENDRONICO SEMANAL RANBAXY 70 mg COMPRIMIDOS EFG


70 mg


Tablet


Oral use




Spain


Mylan Pharmaceuticals, S.L.
Plom 2-4, 5o Planta
8038 Barcelona
Spain


Donepezil


DONEPEZILO FLAS MYLAN PHARMACEUTICALS 10 mg COMPRIMIDOS BUCODISPERSABLES EFG


10 mg


Orodispersible tablet


Oral use




Spain


Mylan Pharmaceuticals, S.L.
Plom 2-4, 5o Planta
8038 Barcelona
Spain


Donepezil


DONEPEZILO FLAS MYLAN PHARMACEUTICALS 5 mg COMPRIMIDOS BUCODISPERSABLES EFG


5 mg


Orodispersible tablet


Oral use




Spain


Mylan Pharmaceuticals, S.L.
Plom 2-4, 5o Planta
8038 Barcelona
Spain


Esomeprazole


ESOMEPRAZOL MYLAN 20 mg CAPSULAS GASTRORRESISTENTES EFG


20 mg


Gastro-resistant capsule


Oral use




Spain


Mylan Pharmaceuticals, S.L.
Plom 2-4, 5o Planta
8038 Barcelona
Spain


Esomeprazole


ESOMEPRAZOL MYLAN 40 mg CAPSULAS GASTRORRESISTENTES EFG


40 mg


Gastro-resistant capsule


Oral use




Spain


Mylan Pharmaceuticals, S.L.
Plom 2-4, 5o Planta
8038 Barcelona
Spain


Repaglinide


REPAGLINIDA MYLAN 0,5 mg COMPRIMIDOS EFG


0,5 mg


Tablet


Oral use




Spain


Mylan Pharmaceuticals, S.L.
Plom 2-4, 5o Planta
8038 Barcelona
Spain


Repaglinide


REPAGLINIDA MYLAN 1 mg COMPRIMIDOS EFG


1 mg


Tablet


Oral use




Spain


Mylan Pharmaceuticals, S.L.
Plom 2-4, 5o Planta
8038 Barcelona
Spain


Repaglinide


REPAGLINIDA MYLAN 2 mg COMPRIMIDOS EFG


2 mg


Tablet


Oral use




Spain


Mylan Pharmaceuticals, S.L.
Plom 2-4, 5o Planta
8038 Barcelona
Spain


Rizatriptan


RIZATRIPTAN MAX MYLAN 10 mg COMPRIMIDOS BUCODISPERSABLES EFG


10 mg


Orodispersible tablet


Oral use




Spain


PENSA PHARMA, S.A.U
Jorge Comín (médico pediatra)
3 — bajos
46015– Valencia (Valencia)
Spain


Alendronic acid


ACIDO ALENDRONICO SEMANAL PENSA 70 mg COMPRIMIDOS EFG


70 mg


Tablet


Oral use




Spain


Pharmagenus, S.A.,
Avda. Camí Real, 51-57,
08184 Palau-solita i Plegamans (Barcelona)
Spain


Desloratadine


DESLORATADINA PHARMAGENUS 2,5 mg COMPRIMIDOS BUCODISPERSABLES EFG


2,5 mg


Orodispersible tablet


Oral use




Spain


Pharmagenus, S.A.,
Avda. Camí Real, 51-57,
08184 Palau-solita i Plegamans (Barcelona)
Spain


Desloratadine


DESLORATADINA PHARMAGENUS 5 mg COMPRIMIDOS BUCODISPERSABLES EFG


5 mg


Orodispersible tablet


Oral use




Spain


Teva Pharma S.L.U.
C/Anabel Segura, 11
Edificio Albatros B, 1a planta
Madrid 28108
Spain


Desloratadine


DESLORATADINA TEVA 5 mg COMPRIMIDOS BUCODISPERSABLES EFG


5 mg


Orodispersible tablet


Oral use




Spain


Welding GmbH & Co. KG
Esplanade 39
D-20354 Hamburg
Germany


Irbesartan


IRBESARTAN/HIDROCLOROTIAZIDA WELDING 150 mg/12,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


150 mg/12,5 mg


Film-coated tablet


Oral use




Spain


Welding GmbH & Co. KG
Esplanade 39
D-20354 Hamburg
Germany


Irbesartan


IRBESARTAN/HIDROCLOROTIAZIDA WELDING 300 mg/12,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


300 mg/12,5 mg


Film-coated tablet


Oral use




Spain


Welding GmbH & Co. KG
Esplanade 39
D-20354 Hamburg
Germany


Irbesartan


IRBESARTAN/HIDROCLOROTIAZIDA WELDING 300 mg/25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


300 mg/25 mg


Film-coated tablet


Oral use




Sweden


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Alendronic acid


Alendronat Accord Veckotablett


70 mg


Tablet


Oral use




Sweden


Alternova A/S
Lodshusvej 11
DK-4230 Skælskør
Denmark


Clindamycin hydrochloride


Clindamycin Alternova


150 mg


Capsule, hard


Oral use




Sweden


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Fluconazole


Fluconazol Bluefish


50 mg


Capsule, hard


Oral use




Sweden


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Fluconazole


Fluconazol Bluefish


150 mg


Capsule, hard


Oral use




Sweden


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden


Fluconazole


Fluconazol Bluefish


200 mg


Capsule, hard


Oral use




Sweden


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Donepezil hydrochloride


Donezil


5 mg


Orodispersible tablet


Oral use




Sweden


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Donepezil hydrochloride


Donezil


10 mg


Orodispersible tablet


Oral use




Sweden


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Donepezil


Donepezil Mylan


5 mg


Orodispersible tablet


Oral use




Sweden


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Donepezil


Donepezil Mylan


10 mg


Orodispersible tablet


Oral use




Sweden


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Rizatriptan


Rizatriptan Mylan


10 mg


Orodispersible tablet


Oral use




Sweden


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Repaglinide


Repaglinid Mylan


0,5 mg


Tablet


Oral use




Sweden


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Repaglinide


Repaglinid Mylan


1 mg


Tablet


Oral use




Sweden


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Repaglinide


Repaglinid Mylan


2 mg


Tablet


Oral use




Sweden


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Esomeprazole


Esomeprazol Mylan


20 mg


Gastro-resistant capsule, hard


Oral use




Sweden


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Esomeprazole


Esomeprazol Mylan


40 mg


Gastro-resistant capsule, hard


Oral use




Sweden


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Eletriptan


Eletriptan Mylan


20 mg


Film-coated tablet


Oral use




Sweden


Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden


Eletriptan


Eletriptan Mylan


40 mg


Film-coated tablet


Oral use




Sweden


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Valsartan


Valsartan Orion


40 mg


Film-coated tablet


Oral use




Sweden


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Valsartan


Valsartan Orion


80 mg


Film-coated tablet


Oral use




Sweden


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Valsartan


Valsartan Orion


160 mg


Film-coated tablet


Oral use




Sweden


Orion Corporation
Orion Pharma
PO BOX 65
02101 Espoo
Finland


Valsartan


Valsartan Orion


320 mg


Film-coated tablet


Oral use




Sweden


Ranbaxy UK Ltd
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom


Alendronic acid


Alendronat Ranbaxy
Veckotablett 70 mg
tabletter


70 mg


Tablet


Oral use




Sweden


Stada Arzneimittel AG
Stadastrasse 2-18
DE-61118 Bad Vilbel
Germany


Entacapone


Entakapon STADA


200 mg


Film-coated tablet


Oral use




The Netherlands


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirol Accord 5 mg, filmomhulde tabletten


5 mg


Film-coated tablet


Oral use




The Netherlands


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirol Accord 0,25 mg filmomhulde tabletten


0,25 mg


Film-coated tablet


Oral use




The Netherlands


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirol Accord 0,5 mg filmomhulde tabletten


0,5 mg


Film-coated tablet


Oral use




The Netherlands


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirol Accord 1 mg filmomhulde tabletten


1 mg


Film-coated tablet


Oral use




The Netherlands


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirol Accord 2 mg filmomhulde tabletten


2 mg


Film-coated tablet


Oral use




The Netherlands


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Alendronic acid


Alendroninezuur Accord 10 mg Tabletten


10 mg


Tablet


Oral use




The Netherlands


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Alendronic acid


Alendroninezuur Accord 70 mg Tabletten


70 mg


Tablet


Oral use




The Netherlands


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Metoclopramide hydrochloride


Metoclopramidemonohydrochloride Accord 10 mg, Tabletten


10 mg


Tablet


Oral use




The Netherlands


Alembic Pharmaceuticals Europe Limited
Palazzo Pietro Stiges, 103, Strait Street
VLT 1436 Valletta
Malta


Venlafaxine


Venlafaxine HCl Retard Alembic 37,5 mg, capsule met verlengde afgifte, hard


37,5 mg


Prolonged — release capsule, hard


Oral use




The Netherlands


Alembic Pharmaceuticals Europe Limited
Palazzo Pietro Stiges, 103, Strait Street
VLT 1436 Valletta
Malta


Venlafaxine


Venlafaxine HCl Retard Alembic 75 mg, capsule met verlengde afgifte, hard


75 mg


Prolonged — release capsule, hard


Oral use




The Netherlands


Alembic Pharmaceuticals Europe Limited
Palazzo Pietro Stiges, 103, Strait Street
VLT 1436 Valletta
Malta


Venlafaxine


Venlafaxine HCl Retard Alembic 150 mg, capsule met verlengde afgifte, hard


150 mg


Prolonged — release capsule, hard


Oral use




The Netherlands


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Ebastine


Ebastine BB 10 mg orodispergeerbare tabletten


10 mg


Orodispersible tablet


Oral use




The Netherlands


Centrafarm B.V.
Nieuwe Donk 3
4879 AC Etten Leur
The Netherlands


Entacapone


Entacapone CF 200 mg, filmomhulde tablet


200 mg


Film-coated tablet


Oral use




The Netherlands


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Ciprofloxacin


Ciprofloxacine Fair-Med 250 mg, filmomhulde tabletten


250 mg


Film-coated tablet


Oral use




The Netherlands


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Ciprofloxacin


Ciprofloxacine Fair-Med 500 mg, filmomhulde tabletten


500 mg


Film-coated tablet


Oral use




The Netherlands


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Ciprofloxacin


Ciprofloxacine Fair-Med 750 mg, filmomhulde tabletten


750 mg


Film-coated tablet


Oral use




The Netherlands


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/HCTZ Fair-Med 160 mg/12,5 mg, filmomhulde tabletten


160 mg/12,5 mg


Film-coated tablet


Oral use




The Netherlands


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/HCTZ Fair-Med 320 mg/12,5 mg, filmomhulde tabletten


320 mg/12,5 mg


Film-coated tablet


Oral use




The Netherlands


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Valsartan/hydrochlorothiazide


Valsartan/HCTZ Fair-Med 320 mg/25 mg, filmomhulde tabletten


320 mg/25 mg


Film-coated tablet


Oral use




The Netherlands


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Venlafaxine


Venlafaxine Fair-Med 37,5 mg capsules met verlengde afgifte, hard


37,5 mg


Prolonged — release capsule, hard


Oral use




The Netherlands


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Venlafaxine


Venlafaxine Fair-Med 75 mg capsules met verlengde afgifte, hard


75 mg


Prolonged — release capsule, hard


Oral use




The Netherlands


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Venlafaxine


Venlafaxine Fair-Med 150 mg capsules met verlengde afgifte, hard


150 mg


Prolonged — release capsule, hard


Oral use




The Netherlands


Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
The Netherlands


Esomeprazole


Esomeprazol Mylan 20 mg, maagsapresistente capsules, hard


20 mg


Gastro-resistant capsule, hard


Oral use




The Netherlands


Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
The Netherlands


Esomeprazole


Esomeprazol Mylan 40 mg, maagsapresistente capsules, hard


40 mg


Gastro-resistant capsule, hard


Oral use




The Netherlands


Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
The Netherlands


Rizatriptan


Rizatriptan SmeltTab Mylan 5 mg, orodispergeerbare tabletten


5 mg


Orodispersible tablet


Oral use




The Netherlands


Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
The Netherlands


Rizatriptan


Rizatriptan SmeltTab Mylan 10 mg, orodispergeerbare tabletten


10 mg


Orodispersible tablet


Oral use




The Netherlands


Ranbaxy UK Ltd
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom


Alendronic acid


Alendroninezuur 70 Ranbaxy, tabletten 70 mg


70 mg


Tablet


Oral use




The Netherlands


Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands


Clonazepam


Clonazepam Sandoz 0,5 mg, tabletten


0,5 mg


Tablet


Oral use




The Netherlands


Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands


Clonazepam


Clonazepam Sandoz 2 mg, tabletten


2 mg


Tablet


Oral use




The Netherlands


Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands


Clobazam


Clobazam Sandoz 10 mg, tabletten


10 mg


Tablet


Oral use




The Netherlands


Teva Nederland B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands


Desloratadine


Desloratadine Smelttablet 2,5 mg Teva, orodispergeerbare tabletten


2,5 mg


Orodispersible tablet


Oral use




The Netherlands


Teva Nederland B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands


Desloratadine


Desloratadine Smelttablet 5 mg Teva, orodispergeerbare tabletten


5 mg


Orodispersible tablet


Oral use




The Netherlands


TioFarma b.v.
Benjamin Franklinstraat 5-10
3261 LW Oud-Beyerland
The Netherlands


Clonazepam


Clonazepam TioFarma 0,5 mg tabletten, tabletten


0,5 mg


Tablet


Oral use




The Netherlands


TioFarma b.v.
Benjamin Franklinstraat 5-10
3261 LW Oud-Beyerland
The Netherlands


Clonazepam


Clonazepam TioFarma 2 mg tabletten, tabletten


2 mg


Tablet


Oral use




The Netherlands


TioFarma b.v.
Benjamin Franklinstraat 5-10
3261 LW Oud-Beyerland
The Netherlands


Clobazam


Clobazam TioFarma 10 mg, tabletten


10 mg


Tablet


Oral use




The Netherlands


TioFarma b.v.
Benjamin Franklinstraat 5-10
3261 LW Oud-Beyerland
The Netherlands


Clobazam


Clobazam TioFarma 20 mg, tabletten


20 mg


Tablet


Oral use




The Netherlands


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


irbesartan


Irbesartan Torrent 75 mg filmomhulde tabletten


75 mg


Film-coated tablet


Oral use




The Netherlands


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


irbesartan


Irbesartan Torrent 150 mg filmomhulde tabletten


150 mg


Film-coated tablet


Oral use




The Netherlands


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


irbesartan


Irbesartan Torrent 300 mg filmomhulde tabletten


300 mg


Film-coated tablet


Oral use




The Netherlands


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan Hydrochloorthiazide Torrent 150 mg/12,5 mg filmomhulde tabletten


150 mg/12,5 mg


Film-coated tablet


Oral use




The Netherlands


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan Hydrochloorthiazide Torrent 300 mg/12,5 mg filmomhulde tabletten


300 mg/12,5 mg


Film-coated tablet


Oral use




The Netherlands


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan Hydrochloorthiazide Torrent 300 mg/25 mg filmomhulde tabletten


300 mg/25 mg


Film-coated tablet


Oral use




The Netherlands


Unichem Laboratories Ltd
Studio 8B Ard Gaoithe Commercial Centre, Business Park
Cashel Road Clonmel,
Co Tipperary
Ireland


irbesartan


Irbesartan Unichem 150 mg filmomhulde tabletten


150 mg


Film-coated tablet


Oral use




The Netherlands


Unichem Laboratories Ltd
Studio 8B Ard Gaoithe Commercial Centre, Business Park
Cashel Road Clonmel,
Co Tipperary
Ireland


irbesartan


Irbesartan Unichem 300 mg filmomhulde tabletten


300 mg


Film-coated tablet


Oral use




United Kingdom


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirole 0,25 mg film-coated tablets


0,25 mg


Film-coated tablet


Oral use




United Kingdom


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirole 0,5 mg film-coated tablets


0,5 mg


Film-coated tablet


Oral use




United Kingdom


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirole 1 mg film-coated tablets


1 mg


Film-coated tablet


Oral use




United Kingdom


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirole 2 mg film-coated tablets


2 mg


Film-coated tablet


Oral use




United Kingdom


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Alendronic acid


alendronic acid 10 mg Tablets


10 mg


Tablet


Oral use




United Kingdom


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Alendronic acid


alendronic acid 70 mg Once Daily Tablets


70 mg


Tablet


Oral use




United Kingdom


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Metoclopramide hydrochloride


metoclopramide hydrochloride 10 mg tablets


10 mg


Tablet


Oral use




United Kingdom


Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom


Ropinirole


Ropinirole 5 mg film-coated tablets


5 mg


Film-coated tablet


Oral use




United Kingdom


Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road
London W5 5TL
United Kingdom


Fluconazole


Fluconazole 50 mg capsules


50 mg


Capsule, hard


Oral use




United Kingdom


Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road
London W5 5TL
United Kingdom


Fluconazole


Fluconazole 150 mg capsules


150 mg


Capsule, hard


Oral use




United Kingdom


Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road
London W5 5TL
United Kingdom


Fluconazole


Fluconazole 200 mg capsules


200 mg


Capsule, hard


Oral use




United Kingdom


Auden McKenzie Limited
McKenzie House
Bury Street, Ruislip
Middlesex HA4 7TL
United Kingdom


Dexamethasone


Dexamethasone 2 mg Tablets


2 mg


Tablet


Oral use




United Kingdom


Auden McKenzie Limited
McKenzie House
Bury Street, Ruislip
Middlesex HA4 7TL
United Kingdom


Thiamine hydrochloride


Tyvera 50 mg Tablets


50 mg


Tablet


Oral use




United Kingdom


Auden McKenzie Limited
McKenzie House
Bury Street, Ruislip
Middlesex HA4 7TL
United Kingdom


Thiamine hydrochloride


Tyvera 100 mg Tablets


100 mg


Tablet


Oral use




United Kingdom


Auden McKenzie Limited
McKenzie House
Bury Street, Ruislip
Middlesex HA4 7TL
United Kingdom


Clonazepam


Clonazepam 500 mcg Tablet


0,5 mg


Tablet


Oral use




United Kingdom


Auden McKenzie Limited
McKenzie House
Bury Street, Ruislip
Middlesex HA4 7TL
United Kingdom


Clonazepam


Clonazepam 2 mg Tablet


2 mg


Tablet


Oral use




United Kingdom


Auden McKenzie Limited
McKenzie House
Bury Street, Ruislip
Middlesex HA4 7TL
United Kingdom


Clobazam


CLOBAZAM AUDEN 10 mg TABLETS


10 mg


Tablet


Oral use




United Kingdom


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Phenoxymethyl penicillin


Phenoxymethylpenicillin 250 mg Film-coated Tablets


250 mg


Film-coated tablet


Oral use




United Kingdom


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Escitalopram oxalate


Escitalopram 5 mg Film-coated tablets


5 mg


Film-coated tablet


Oral use




United Kingdom


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Escitalopram oxalate


Escitalopram 10 mg Film-coated tablets


10 mg


Film-coated tablet


Oral use




United Kingdom


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Escitalopram oxalate


Escitalopram 15 mg Film-coated tablets


15 mg


Film-coated tablet


Oral use




United Kingdom


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Escitalopram oxalate


Escitalopram 20 mg Film-coated tablets


20 mg


Film-coated tablet


Oral use




United Kingdom


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Tramadol hydrochloride


Aceon 100 mg Prolonged-release tablets


100 mg


Prolonged-release tablet


Oral use




United Kingdom


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Tramadol hydrochloride


Aceon 150 mg Prolonged-release tablets


150 mg


Prolonged-release tablet


Oral use




United Kingdom


Brown & Burk UK, Ltd
5, Marryat Close
Hounslow
TW4 5DQ Middlesex
United Kingdom


Tramadol hydrochloride


Aceon 200 mg Prolonged-release tablets


200 mg


Prolonged-release tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Valsartan


Valsartan 40 mg Capsules


40 mg


Capsule


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Valsartan


Valsartan 80 mg Capsules


80 mg


Capsule


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Valsartan


Valsartan 160 mg Capsules


160 mg


Capsule


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Valsartan


Valsartan 320 mg Capsules


320 mg


Capsule


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Levetiracetam


Levetiracetam 250 mg film-coated tablets


250 mg


Film-coated tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Levetiracetam


Levetiracetam 500 mg film-coated tablets


500 mg


Film-coated tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Levetiracetam


Levetiracetam 750 mg film-coated tablets


750 mg


Film-coated tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Levetiracetam


Levetiracetam 1  000 mg film-coated tablets


1  000 mg


Film-coated tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Pioglitazone


Pioglitazone 15 mg Tablets


15 mg


Tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Pioglitazone


Pioglitazone 30 mg Tablets


30 mg


Tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Pioglitazone


Pioglitazone 45 mg Tablets


45 mg


Tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Dipyridamole


Attia 200 mg Modified Release Capsules


200 mg


Modified-release capsule, hard


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Telmisartan


Telmisartan 20 mg Tablets


20 mg


Tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Telmisartan


Telmisartan 40 mg Tablets


40 mg


Tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Telmisartan


Telmisartan 80 mg Tablets


80 mg


Tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Telmisartan/
hydrochlorothiazide


Telmisartan/Hydrochlorothiazide 40 mg/12,5 mg Tablets


40 mg/12,5 mg


Tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Telmisartan/
hydrochlorothiazide


Telmisartan/Hydrochlorothiazide 80 mg/12,5 mg Tablets


80 mg/12,5 mg


Tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (UK) Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom


Telmisartan/
hydrochlorothiazide


Telmisartan/Hydrochlorothiazide 80 mg/25 mg Tablets


80 mg/25 mg


Tablet


Oral use




United Kingdom


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


irbesartan


Irbesartan 75 mg Film-coated Tablets


75 mg


Film-coated tablet


Oral use




United Kingdom


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


irbesartan


Irbesartan 150 mg Film-coated Tablets


150 mg


Film-coated tablet


Oral use




United Kingdom


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


irbesartan


Irbesartan 300 mg Film-coated Tablets


300 mg


Film-coated tablet


Oral use




United Kingdom


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan/Hydrochlorothiazide 150 mg/12,5 mg film-coated tablets


150 mg/12,5 mg


Film-coated tablet


Oral use




United Kingdom


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan/Hydrochlorothiazide 300 mg/12,5 mg film-coated tablets


300 mg/12,5 mg


Film-coated tablet


Oral use




United Kingdom


Fair-Med Healthcare GmbH
Planckstrasse 13
DE-22765 Hamburg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan/Hydrochlorothiazide 300 mg/25 mg film-coated tablets


300 mg/25 mg


Film-coated tablet


Oral use




United Kingdom


Fannin (UK) Ltd
42-46 Booth Drive
Park Farm South
Wellingborough
Northamptonshire NN8 6GT
United Kingdom


Fluconazole


Fluconazole 150 mg capsule


150 mg


Capsule, hard


Oral use




United Kingdom


Fannin (UK) Ltd
42-46 Booth Drive
Park Farm South
Wellingborough
Northamptonshire NN8 6GT
United Kingdom


Fexofenadine


Fexofenadine 120 mg film-coated tablets


120 mg


Film-coated tablet


Oral use




United Kingdom


Fannin (UK) Ltd
42-46 Booth Drive
Park Farm South
Wellingborough
Northamptonshire NN8 6GT
United Kingdom


Fexofenadine


Fexofenadine 180 mg film-coated tablets


180 mg


Film-coated tablet


Oral use




United Kingdom


FDC Pharma
Unit 6, Fulcrum 1, Solent Way
Whiteley, Fareham
Hampshire PO15 7FE
United Kingdom


Amlodipine


Amlodipine 5 mg Tablets


5 mg


Tablet


Oral use




United Kingdom


FDC Pharma
Unit 6, Fulcrum 1, Solent Way
Whiteley, Fareham
Hampshire PO15 7FE
United Kingdom


Amlodipine


Amlodipine 10 mg Tablets


10 mg


Tablet


Oral use




United Kingdom


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Repaglinide


Repaglinide Mylan 0,5 mg Tablets


0,5 mg


Tablet


Oral use




United Kingdom


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Repaglinide


Repaglinide Mylan 1 mg Tablets


1 mg


Tablet


Oral use




United Kingdom


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Repaglinide


Repaglinide Mylan 2 mg Tablets


2 mg


Tablet


Oral use




United Kingdom


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Donepezil hydrochloride


Donepezil Hydrochloride 5 mg Orodispersible Tables


5 mg


Orodispersible tablet


Oral use




United Kingdom


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Donepezil hydrochloride


Donepezil Hydrochloride 10 mg Orodispersible Tables


10 mg


Orodispersible tablet


Oral use




United Kingdom


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Rizatriptan benzoate


Rizatriptan 10 mg Orodispersible Tablet


10 mg


Orodispersible tablet


Oral use




United Kingdom


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Esomeprazole magnesium


Esomeprazole 20 mg Gastro-resistant Capsules, hard


20 mg


Gastro-resistant capsule


Oral use




United Kingdom


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Esomeprazole magnesium


Esomeprazole 40 mg Gastro-resistant Capsules, hard


40 mg


Gastro-resistant capsule


Oral use




United Kingdom


Generics (UK) Ltd
Station Close, Potters Bar
Hertfordshire, EN6 1TL
United Kingdom


Levodopa/carbidopa/entacapone


Levodopa/Carbidopa/Entacapone film-coated tablets 150/37,5/200 mg


150 mg/37,5 mg/200 mg


Film-coated tablet


Oral use




United Kingdom


Lupin (Europe) Limited
Victoria Court, Bexton Road
Knutsford, Cheshire WA16 0PF
United Kingdom


Pantoprazole


Pantoprazole 20 mg Gastro-Resistant tablets


20 mg


Gastro-resistant tablet


Oral use




United Kingdom


Lupin (Europe) Limited
Victoria Court, Bexton Road
Knutsford, Cheshire WA16 0PF
United Kingdom


Pantoprazole


Pantoprazole 40 mg Gastro-Resistant tablets


40 mg


Gastro-resistant tablet


Oral use




United Kingdom


Morningside Healthcare Limited
115 Narborough Road
Leicester, LE3 0PA
United Kingdom


Phenoxymethyl penicillin


Phenoxymethylpenicillin 250 mg Film-coated Tablets


250 mg


Film-coated tablet


Oral use




United Kingdom


Morningside Healthcare Limited
115 Narborough Road
Leicester, LE3 0PA
United Kingdom


Metformin hydrochloride


Bolamyn/Metabet SR 1  000 mg Prolonged Release Tablets


1  000 mg


Prolonged-release tablet


Oral use




United Kingdom


Niche Generics Limited
1 The Cam Centre
Wilbury Way, Hitchin
Hertfordshire SG4 0TW
United Kingdom


irbesartan


Irbesartan Niche 150 mg film-coated tablets


150 mg


Film-coated tablet


Oral use




United Kingdom


Niche Generics Limited
1 The Cam Centre
Wilbury Way, Hitchin
Hertfordshire SG4 0TW
United Kingdom


irbesartan


Irbesartan Niche 150 mg film-coated tablets


150 mg


Film-coated tablet


Oral use




United Kingdom


Ranbaxy UK Ltd
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom


Alendronic acid


Alendronic Acid 70 mg Tablets


70 mg


Tablet


Oral use




United Kingdom


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan Hydrochlorothiazide 150 mg/12,5 mg Film-coated tablets


150 mg/12,5 mg


Film-coated tablet


Oral use




United Kingdom


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan Hydrochlorothiazide 300 mg/12,5 mg Film-coated tablets


300 mg/12,5 mg


Film-coated tablet


Oral use




United Kingdom


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


Irbesartan/hydrochlorothiazide


Irbesartan Hydrochlorothiazide 300 mg/25 mg Film-coated tablets


300 mg/25 mg


Film-coated tablet


Oral use




United Kingdom


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


irbesartan


Irbesartan 75 mg Film-coated tablets


75 mg


Film-coated tablet


Oral use




United Kingdom


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


irbesartan


Irbesartan 150 mg Film-coated tablets


150 mg


Film-coated tablet


Oral use




United Kingdom


Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany


irbesartan


Irbesartan 300 mg Film-coated tablets


300 mg


Film-coated tablet


Oral use




United Kingdom


Waymade PLC
Sovereign House
Miles Grat Road, Basildon
Essex SS14 3FR
United Kingdom


Venlafaxine hydrochloride


Venlasov XL 75 mg Modified Release Capsules


75 mg


Prolonged-release capsule, hard


Oral use




United Kingdom


Waymade PLC
Sovereign House
Miles Grat Road, Basildon
Essex SS14 3FR
United Kingdom


Venlafaxine hydrochloride


Venlasov XL 150 mg Modified Release Capsules


150 mg


Prolonged-release capsule, hard


Oral use




United Kingdom


Wockhardt UK Limited
Ash Road North
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom


Clopidogrel


Clopidogrel 75 mg Film-coated Tablets


75 mg


Film-coated tablet


Oral use




United Kingdom


YJBPort Limited
74 Briarwood Drive
Northwood Hills
Middlesex HA6 1PL
United Kingdom


Hydrocortisone


Hydrocortisone 10 mg Tablets


10 mg


Tablet


Oral use




United Kingdom


YJBPort Limited
74 Briarwood Drive
Northwood Hills
Middlesex HA6 1PL
United Kingdom


Hydrocortisone


Hydrocortisone 20 mg Tablets


20 mg


Tablet


Oral use