# Official Journal C 285/28 A

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 285 |
| | |
| English edition | Information and Notices | Volume 5828 August 2015 |

ISSN 1977-091X

Official Journal

of the European Union

C 285

English edition

Information and Notices

Volume 5828 August 2015

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2015/C 285/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2015 to 31 July 2015(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2015/C 285/02 | 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) | 11 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2015/C 285/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2015 to 31 July 2015(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2015/C 285/02

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)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

11

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.8.2015 | EN | Official Journal of the European Union | C 285/1 |
| --- | --- | --- | --- |

28.8.2015

EN

Official Journal of the European Union

C 285/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2015 to 31 July 2015

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2015/C 285/01)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.7.2015 | Hetlioz | tasimelteon | Vanda Pharmaceuticals Limited
  222 Regent Street, London W1B 5TR, United Kingdom | EU/1/15/1008 | Capsule, hard | N05CH03 | 7.7.2015 |
| 13.7.2015 | EVOTAZ | atazanavir/cobicistat | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1025 | Film-coated tablet | J05AR15 | 15.7.2015 |
| 17.7.2015 | KEYTRUDA | pembrolizumab | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | Powder for concentrate for solution for infusion | L01XC18 | 21.7.2015 |
| 17.7.2015 | Pregabalin Zentiva | pregabalin | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1021 | Capsule, hard | N03AX16 | 21.7.2015 |
| 17.7.2015 | Repatha | evolocumab | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1016 | Solution for injection in a pre-filled syringe | C10AX13 | 21.7.2015 |
| 20.7.2015 | Bortezomib Accord | bortezomib | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1019 | Powder for solution for injection | L01XX32 | 23.7.2015 |
| 20.7.2015 | Nivolumab BMS | nivolumab | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1026 | Concentrate for solution for infusion | L01XC17 | 23.7.2015 |
| 28.7.2015 | Omidria | phenylephrine/ketorolac | Omeros London Limited
  Berkeley Square, London, W1J 6BD, United Kingdom | EU/1/15/1018 | Concentrate for solution for intraocular irrigation | Pending | 30.7.2015 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

3.7.2015

Hetlioz

tasimelteon

Vanda Pharmaceuticals Limited

222 Regent Street, London W1B 5TR, United Kingdom

EU/1/15/1008

Capsule, hard

N05CH03

7.7.2015

13.7.2015

EVOTAZ

atazanavir/cobicistat

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/15/1025

Film-coated tablet

J05AR15

15.7.2015

17.7.2015

KEYTRUDA

pembrolizumab

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/15/1024

Powder for concentrate for solution for infusion

L01XC18

21.7.2015

17.7.2015

Pregabalin Zentiva

pregabalin

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1021

Capsule, hard

N03AX16

21.7.2015

17.7.2015

Repatha

evolocumab

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1016

Solution for injection in a pre-filled syringe

C10AX13

21.7.2015

20.7.2015

Bortezomib Accord

bortezomib

Accord Healthcare Limited

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

EU/1/15/1019

Powder for solution for injection

L01XX32

23.7.2015

20.7.2015

Nivolumab BMS

nivolumab

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/15/1026

Concentrate for solution for infusion

L01XC17

23.7.2015

28.7.2015

Omidria

phenylephrine/ketorolac

Omeros London Limited

Berkeley Square, London, W1J 6BD, United Kingdom

EU/1/15/1018

Concentrate for solution for intraocular irrigation

Pending

30.7.2015

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.7.2015 | Lympreva | Biovest Europe Limited
  Evershed House, 70 Great Bridgewater St., Manchester M1 5ES, United Kingdom | — | 7.7.2015 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.7.2015

Lympreva

Biovest Europe Limited

Evershed House, 70 Great Bridgewater St., Manchester M1 5ES, United Kingdom

—

7.7.2015

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.7.2015 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 7.7.2015 |
| 3.7.2015 | Bemfola | FINOX Biotech AG
  Gewerbestrasse 7, FL-9496 Balzers, Liechtenstein | EU/1/13/909 | 8.7.2015 |
| 3.7.2015 | Competact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/354 | 7.7.2015 |
| 3.7.2015 | Docetaxel Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/769 | 7.7.2015 |
| 3.7.2015 | Docetaxel Kabi | Fresenius Kabi Oncology Plc.
  Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom | EU/1/12/770 | 7.7.2015 |
| 3.7.2015 | Fampyra | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/11/699 | 7.7.2015 |
| 3.7.2015 | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/677 | 7.7.2015 |
| 3.7.2015 | Hemangiol | Pierre Fabre Dermatologie
  45 place Abel Gance, F-92100 Boulogne, France | EU/1/14/919 | 7.7.2015 |
| 3.7.2015 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/945 | 7.7.2015 |
| 3.7.2015 | Neuraceq | Piramal Imaging Limited
  Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom | EU/1/13/906 | 7.7.2015 |
| 3.7.2015 | Pradaxa | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/08/442 | 7.7.2015 |
| 3.7.2015 | Viramune | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/055 | 7.7.2015 |
| 3.7.2015 | Zoledronic acid medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/12/779 | 7.7.2015 |
| 3.7.2015 | Zometa | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/01/176 | 7.7.2015 |
| 8.7.2015 | Ambirix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/02/224 | 10.7.2015 |
| 8.7.2015 | CONTROLOC Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/515 | 10.7.2015 |
| 8.7.2015 | DuoResp Spiromax | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/920 | 13.7.2015 |
| 8.7.2015 | Flebogamma DIF | Instituto Grifols, S.A.
  Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa | EU/1/07/404 | 10.7.2015 |
| 8.7.2015 | Foscan | biolitec pharma ltd.
  Unit 9A, Plato Business Park, Damastown, Dublin 15, Ireland. | EU/1/01/197 | 10.7.2015 |
| 8.7.2015 | Iasibon | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/10/659 | 10.7.2015 |
| 8.7.2015 | Mimpara | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/04/292 | 10.7.2015 |
| 8.7.2015 | PANTECTA Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/518 | 10.7.2015 |
| 8.7.2015 | PANTOLOC Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/519 | 10.7.2015 |
| 8.7.2015 | PANTOZOL Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/517 | 10.7.2015 |
| 8.7.2015 | Perjeta | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/813 | 10.7.2015 |
| 8.7.2015 | Pregabalin Pfizer | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/14/916 | 10.7.2015 |
| 8.7.2015 | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/462 | 10.7.2015 |
| 8.7.2015 | Remicade | Janssen Biologics B.V.
  Einsteinweg 101, NL-2333 CB Leiden, Nederland | EU/1/99/116 | 10.7.2015 |
| 8.7.2015 | SOMAC Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/516 | 10.7.2015 |
| 8.7.2015 | Tandemact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/366 | 10.7.2015 |
| 8.7.2015 | Vaniqa | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/01/173 | 10.7.2015 |
| 8.7.2015 | Vimizim | BioMarin Europe Ltd
  164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | EU/1/14/914 | 10.7.2015 |
| 8.7.2015 | Yttriga | Eckert & Ziegler Radiopharma GmbH
  Robert-Rössle-Str. 10, D-13125 Berlin, Deutschland | EU/1/05/322 | 10.7.2015 |
| 13.7.2015 | Xgeva | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/11/703 | 15.7.2015 |
| 13.7.2015 | Zoledronic acid Teva Generics | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/912 | 15.7.2015 |
| 17.7.2015 | Aflunov | Novartis Vaccines Influenza S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/10/658 | 22.7.2015 |
| 17.7.2015 | Brilique | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/10/655 | 21.7.2015 |
| 17.7.2015 | Circadin | RAD Neurim Pharmaceuticals EEC Limited
  One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom | EU/1/07/392 | 21.7.2015 |
| 17.7.2015 | Exjade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/356 | 21.7.2015 |
| 17.7.2015 | HALAVEN | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/11/678 | 21.7.2015 |
| 17.7.2015 | JETREA | ThromboGenics NV
  Gaston Geenslaan 1, B-3001 Leuven, België | EU/1/13/819 | 22.7.2015 |
| 17.7.2015 | Latuda | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/913 | 21.7.2015 |
| 17.7.2015 | PecFent | Archimedes Development Ltd
  Albert Einstein Centre, Nottingham Science and Technology Park, University Boulevard NG7 2 TN Nottingham, United Kingdom | EU/1/10/644 | 21.7.2015 |
| 17.7.2015 | Rapiscan | Rapidscan Pharma Solutions EU Ltd
  Regent’s Place, 338 Euston Road, London NW1 3BT, United Kingdom | EU/1/10/643 | 21.7.2015 |
| 17.7.2015 | RoActemra | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/08/492 | 21.7.2015 |
| 17.7.2015 | Somavert | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/240 | 21.7.2015 |
| 17.7.2015 | Sylvant | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/928 | 22.7.2015 |
| 17.7.2015 | Votrient | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/628 | 21.7.2015 |
| 17.7.2015 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 21.7.2015 |
| 20.7.2015 | Lucentis | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/374 | 23.7.2015 |
| 20.7.2015 | Replagal | Shire Human Genetic Therapies AB
  Svärdvägen 11D, SE-182 33 Danderyd, Sverige | EU/1/01/189 | 23.7.2015 |
| 20.7.2015 | Soliris | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/07/393 | 23.7.2015 |
| 28.7.2015 | Abraxane | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/07/428 | 30.7.2015 |
| 28.7.2015 | Brinavess | Cardiome UK Limited
  Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom | EU/1/10/645 | 30.7.2015 |
| 28.7.2015 | Humira | AbbVie Ltd
  Maidenhead, SL6 4XE, United Kingdom | EU/1/03/256 | 30.7.2015 |
| 28.7.2015 | Lantus | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/00/134 | 30.7.2015 |
| 28.7.2015 | Levemir | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/04/278 | 30.7.2015 |
| 28.7.2015 | Mycamine | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/08/448 | 30.7.2015 |
| 28.7.2015 | Neoclarityn | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/161 | 31.7.2015 |
| 28.7.2015 | Nimenrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/12/767 | 31.7.2015 |
| 28.7.2015 | Opsumit | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/13/893 | 30.7.2015 |
| 28.7.2015 | Osigraft | Olympus Biotech International Limited
  40 Upper Mount Street, Dublin 2, Ireland | EU/1/01/179 | 30.7.2015 |
| 28.7.2015 | Perjeta | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/813 | 30.7.2015 |
| 28.7.2015 | Prepandemic Influenza | Novartis Vaccines and Diagnostics S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/10/657 | 31.7.2015 |
| 28.7.2015 | Stayveer | Marklas Nederland B.V.
  Beneluxlaan 2b, NL-3446 GR Woerden, Nederland | EU/1/13/832 | 30.7.2015 |
| 28.7.2015 | Temomedac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/09/605 | 30.7.2015 |
| 28.7.2015 | Temozolomide SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/11/697 | 30.7.2015 |
| 28.7.2015 | Tivicay | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/13/892 | 30.7.2015 |
| 28.7.2015 | Translarna | PTC Therapeutics International Limited
  77 Sir John Rogerson’s Quay, Dublin 2, Ireland | EU/1/13/902 | 30.7.2015 |
| 28.7.2015 | Vizarsin | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/551 | 31.7.2015 |
| 28.7.2015 | Votubia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/710 | 30.7.2015 |
| 28.7.2015 | Xarelto | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/08/472 | 30.7.2015 |
| 28.7.2015 | Zebinix | BIAL — Portela & Ca, SA
  A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | EU/1/09/514 | 30.7.2015 |
| 28.7.2015 | Zytiga | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/714 | 30.7.2015 |
| 29.7.2015 | Glubrava | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/07/421 | 31.7.2015 |
| 29.7.2015 | Ketek | Aventis Pharma S.A.
  20, Avenue Raymond Aron, F-92160 ANTONY, France | EU/1/01/191 | 31.7.2015 |
| 31.7.2015 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37, D-58638 Iserlohn, Deutschland | EU/1/07/412 | 4.8.2015 |
| 31.7.2015 | Binocrit | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/07/410 | 4.8.2015 |
| 31.7.2015 | Epoetin alfa Hexal | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/07/411 | 4.8.2015 |
| 31.7.2015 | Picato | Leo Pharma A/S
  Industriparken 55, DK-2750 Ballerup, Danmark | EU/1/12/796 | 4.8.2015 |
| 31.7.2015 | Voncento | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/13/857 | 4.8.2015 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.7.2015

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

7.7.2015

3.7.2015

Bemfola

FINOX Biotech AG

Gewerbestrasse 7, FL-9496 Balzers, Liechtenstein

EU/1/13/909

8.7.2015

3.7.2015

Competact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/354

7.7.2015

3.7.2015

Docetaxel Accord

Accord Healthcare Limited

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

EU/1/12/769

7.7.2015

3.7.2015

Docetaxel Kabi

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom

EU/1/12/770

7.7.2015

3.7.2015

Fampyra

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/11/699

7.7.2015

3.7.2015

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/677

7.7.2015

3.7.2015

Hemangiol

Pierre Fabre Dermatologie

45 place Abel Gance, F-92100 Boulogne, France

EU/1/14/919

7.7.2015

3.7.2015

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/945

7.7.2015

3.7.2015

Neuraceq

Piramal Imaging Limited

Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom

EU/1/13/906

7.7.2015

3.7.2015

Pradaxa

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

7.7.2015

3.7.2015

Viramune

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/055

7.7.2015

3.7.2015

Zoledronic acid medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/779

7.7.2015

3.7.2015

Zometa

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/01/176

7.7.2015

8.7.2015

Ambirix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/02/224

10.7.2015

8.7.2015

CONTROLOC Control

Takeda GmbH, (HRB 701016)

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/515

10.7.2015

8.7.2015

DuoResp Spiromax

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/920

13.7.2015

8.7.2015

Flebogamma DIF

Instituto Grifols, S.A.

Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa

EU/1/07/404

10.7.2015

8.7.2015

Foscan

biolitec pharma ltd.

Unit 9A, Plato Business Park, Damastown, Dublin 15, Ireland.

EU/1/01/197

10.7.2015

8.7.2015

Iasibon

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/10/659

10.7.2015

8.7.2015

Mimpara

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/04/292

10.7.2015

8.7.2015

PANTECTA Control

Takeda GmbH, (HRB 701016)

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/518

10.7.2015

8.7.2015

PANTOLOC Control

Takeda GmbH, (HRB 701016)

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/519

10.7.2015

8.7.2015

PANTOZOL Control

Takeda GmbH, (HRB 701016)

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/517

10.7.2015

8.7.2015

Perjeta

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/13/813

10.7.2015

8.7.2015

Pregabalin Pfizer

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/14/916

10.7.2015

8.7.2015

Ranexa

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/08/462

10.7.2015

8.7.2015

Remicade

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/99/116

10.7.2015

8.7.2015

SOMAC Control

Takeda GmbH, (HRB 701016)

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/516

10.7.2015

8.7.2015

Tandemact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/366

10.7.2015

8.7.2015

Vaniqa

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/01/173

10.7.2015

8.7.2015

Vimizim

BioMarin Europe Ltd

164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/14/914

10.7.2015

8.7.2015

Yttriga

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Str. 10, D-13125 Berlin, Deutschland

EU/1/05/322

10.7.2015

13.7.2015

Xgeva

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/11/703

15.7.2015

13.7.2015

Zoledronic acid Teva Generics

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/912

15.7.2015

17.7.2015

Aflunov

Novartis Vaccines Influenza S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/658

22.7.2015

17.7.2015

Brilique

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/10/655

21.7.2015

17.7.2015

Circadin

RAD Neurim Pharmaceuticals EEC Limited

One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom

EU/1/07/392

21.7.2015

17.7.2015

Exjade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/356

21.7.2015

17.7.2015

HALAVEN

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

EU/1/11/678

21.7.2015

17.7.2015

JETREA

ThromboGenics NV

Gaston Geenslaan 1, B-3001 Leuven, België

EU/1/13/819

22.7.2015

17.7.2015

Latuda

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/913

21.7.2015

17.7.2015

PecFent

Archimedes Development Ltd

Albert Einstein Centre, Nottingham Science and Technology Park, University Boulevard NG7 2 TN Nottingham, United Kingdom

EU/1/10/644

21.7.2015

17.7.2015

Rapiscan

Rapidscan Pharma Solutions EU Ltd

Regent’s Place, 338 Euston Road, London NW1 3BT, United Kingdom

EU/1/10/643

21.7.2015

17.7.2015

RoActemra

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/08/492

21.7.2015

17.7.2015

Somavert

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/02/240

21.7.2015

17.7.2015

Sylvant

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/928

22.7.2015

17.7.2015

Votrient

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/628

21.7.2015

17.7.2015

XALKORI

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/12/793

21.7.2015

20.7.2015

Lucentis

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/374

23.7.2015

20.7.2015

Replagal

Shire Human Genetic Therapies AB

Svärdvägen 11D, SE-182 33 Danderyd, Sverige

EU/1/01/189

23.7.2015

20.7.2015

Soliris

Alexion Europe SAS

1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

EU/1/07/393

23.7.2015

28.7.2015

Abraxane

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom

EU/1/07/428

30.7.2015

28.7.2015

Brinavess

Cardiome UK Limited

Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom

EU/1/10/645

30.7.2015

28.7.2015

Humira

AbbVie Ltd

Maidenhead, SL6 4XE, United Kingdom

EU/1/03/256

30.7.2015

28.7.2015

Lantus

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134

30.7.2015

28.7.2015

Levemir

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/04/278

30.7.2015

28.7.2015

Mycamine

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/08/448

30.7.2015

28.7.2015

Neoclarityn

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/00/161

31.7.2015

28.7.2015

Nimenrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/12/767

31.7.2015

28.7.2015

Opsumit

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/13/893

30.7.2015

28.7.2015

Osigraft

Olympus Biotech International Limited

40 Upper Mount Street, Dublin 2, Ireland

EU/1/01/179

30.7.2015

28.7.2015

Perjeta

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/13/813

30.7.2015

28.7.2015

Prepandemic Influenza

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/657

31.7.2015

28.7.2015

Stayveer

Marklas Nederland B.V.

Beneluxlaan 2b, NL-3446 GR Woerden, Nederland

EU/1/13/832

30.7.2015

28.7.2015

Temomedac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/09/605

30.7.2015

28.7.2015

Temozolomide SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/11/697

30.7.2015

28.7.2015

Tivicay

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/13/892

30.7.2015

28.7.2015

Translarna

PTC Therapeutics International Limited

77 Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/13/902

30.7.2015

28.7.2015

Vizarsin

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/551

31.7.2015

28.7.2015

Votubia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/710

30.7.2015

28.7.2015

Xarelto

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/08/472

30.7.2015

28.7.2015

Zebinix

BIAL — Portela & Ca, SA

A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal

EU/1/09/514

30.7.2015

28.7.2015

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/714

30.7.2015

29.7.2015

Glubrava

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/07/421

31.7.2015

29.7.2015

Ketek

Aventis Pharma S.A.

20, Avenue Raymond Aron, F-92160 ANTONY, France

EU/1/01/191

31.7.2015

31.7.2015

Abseamed

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37, D-58638 Iserlohn, Deutschland

EU/1/07/412

4.8.2015

31.7.2015

Binocrit

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/07/410

4.8.2015

31.7.2015

Epoetin alfa Hexal

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/07/411

4.8.2015

31.7.2015

Picato

Leo Pharma A/S

Industriparken 55, DK-2750 Ballerup, Danmark

EU/1/12/796

4.8.2015

31.7.2015

Voncento

CSL Behring GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/13/857

4.8.2015

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.7.2015 | Sonata | Meda AB
  Pipers väg 2A, S-170 09 Solna, Sverige | EU/1/99/102 | 7.7.2015 |
| 13.7.2015 | Zoledronic acid Teva Generics | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/912 | 15.7.2015 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.7.2015

Sonata

Meda AB

Pipers väg 2A, S-170 09 Solna, Sverige

EU/1/99/102

7.7.2015

13.7.2015

Zoledronic acid Teva Generics

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/912

15.7.2015

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.7.2015 | Canigen L4 | Leptospira interrogans serogroup Canicola serovar Portland-vere/Leptospira interrogans serogroup Icterohaemorrhagiae serovar Copenhageni/Leptospira interrogans serogroup Australis serovar Bratislava/Leptospira kirschneri serogroup Grippotyphosa serovar Dadas | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/15/183 | Suspension for injection | QI07AB01 | 7.7.2015 |
| 3.7.2015 | Innovax-ILT | Live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/15/182 | Suspension and solvent for suspension for injection | QI01AD | 7.7.2015 |
| 31.7.2015 | UpCard | Torasemide | Vétoquinol SA
  Magny-Vernois, 70200 Lure, France | EU/2/15/184 | Tablet | QC03CA04 | 4.8.2015 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

3.7.2015

Canigen L4

Leptospira interrogans serogroup Canicola serovar Portland-vere/Leptospira interrogans serogroup Icterohaemorrhagiae serovar Copenhageni/Leptospira interrogans serogroup Australis serovar Bratislava/Leptospira kirschneri serogroup Grippotyphosa serovar Dadas

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/15/183

Suspension for injection

QI07AB01

7.7.2015

3.7.2015

Innovax-ILT

Live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/15/182

Suspension and solvent for suspension for injection

QI01AD

7.7.2015

31.7.2015

UpCard

Torasemide

Vétoquinol SA

Magny-Vernois, 70200 Lure, France

EU/2/15/184

Tablet

QC03CA04

4.8.2015

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.7.2015 | Lodipressin | Le Vet Beheer B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | — | 10.7.2015 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

8.7.2015

Lodipressin

Le Vet Beheer B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

—

10.7.2015

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 13.7.2015 | SevoFlo | Abbott Laboratories Ltd
  Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead Berkshire SL6 4XE, United Kingdom | EU/2/02/035 | 15.7.2015 |
| 17.7.2015 | Incurin | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/00/018 | 21.7.2015 |
| 20.7.2015 | Contacera | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/144 | 23.7.2015 |
| 28.7.2015 | Poulvac E. coli | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/140 | 30.7.2015 |
| 31.7.2015 | BTVPUR AlSap 2-4 | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/10/108 | 4.8.2015 |
| 31.7.2015 | Coxevac | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | EU/2/10/110 | 4.8.2015 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

13.7.2015

SevoFlo

Abbott Laboratories Ltd

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead Berkshire SL6 4XE, United Kingdom

EU/2/02/035

15.7.2015

17.7.2015

Incurin

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/00/018

21.7.2015

20.7.2015

Contacera

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/12/144

23.7.2015

28.7.2015

Poulvac E. coli

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/12/140

30.7.2015

31.7.2015

BTVPUR AlSap 2-4

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/108

4.8.2015

31.7.2015

Coxevac

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

EU/2/10/110

4.8.2015

—   Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.7.2015 | ProMeris | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/2/06/064 | 10.7.2015 |
| 8.7.2015 | ProMeris Duo | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/2/06/065 | 10.7.2015 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

8.7.2015

ProMeris

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/2/06/064

10.7.2015

8.7.2015

ProMeris Duo

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/2/06/065

10.7.2015

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK — LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK — LONDON E14 5EU

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 28.8.2015 | EN | Official Journal of the European Union | C 285/11 |
| --- | --- | --- | --- |

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 |

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 |

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 |

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 |

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

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