# Official Journal C 328/2012

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2012.328.eng |
| --- | --- |
| Official Journal
  of the European Union | C 328 |
| | |
| English edition | Information and Notices | Volume 5526 October 2012 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2012.328.eng

Official Journal

of the European Union

C 328

English edition

Information and Notices

Volume 5526 October 2012

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| 2012/C 328/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 2012(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 1 |
| 2012/C 328/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 2012(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 8 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

2012/C 328/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 2012(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

2012/C 328/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 2012(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)

8

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

| 26.10.2012 | EN | Official Journal of the European Union | C 328/1 |
| --- | --- | --- | --- |

26.10.2012

EN

Official Journal of the European Union

C 328/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 2012

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

2012/C 328/01

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.9.2012 | Inlyta | Axitinib | Pfizer Limited |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |

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

3.9.2012

Inlyta

Axitinib

Pfizer Limited

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

EU/1/12/777/001-006

Film-coated tablet

L01XE17

5.9.2012

3.9.2012

NovoThirteen

catridecacog

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/775/001

Powder and solvent for solution for injection

B02BD11

5.9.2012

20.9.2012

Dacogen

Decitabine

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/12/792/001

powder for concentrate for solution for infusion

L01BC08

24.9.2012

28.9.2012

Enurev Breezhaler

glycopyrronium bromide

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/12/789/001-006

Inhalation powder, hard capsule

R03BB06

3.10.2012

28.9.2012

Seebri Breezhaler

glycopyrronium bromide

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/12/788/001-006

Inhalation powder, hard capsule

R03BB06

3.10.2012

28.9.2012

Tovanor Breezhaler

glycopyrronium bromide

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/12/790/001-006

Inhalation powder, hard capsule

R03BB06

3.10.2012

—   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 |
| --- | --- | --- | --- | --- |
| 10.9.2012 | Advate | Baxter AG |
| Industriesstrasse 67, 1221 Wien, Österreich |

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

10.9.2012

Advate

Baxter AG

Industriesstrasse 67, 1221 Wien, Österreich

EU/1/03/271/007-010

12.9.2012

10.9.2012

Cialis

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/02/237/001-009

12.9.2012

10.9.2012

Entacapone Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/665/001-004

12.9.2012

10.9.2012

JEVTANA

| Sanofi-aventis groupe |
| --- |
| 54, rue de la Boétie, F-75008 France |

Sanofi-aventis groupe

54, rue de la Boétie, F-75008 France

EU/1/11/676/001

12.9.2012

10.9.2012

Levetiracetam ratiopharm

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/11/702/001-031

12.9.2012

10.9.2012

Norvir

| Abbott Laboratories Ltd |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom |

Abbott Laboratories Ltd

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

EU/1/96/016/001

EU/1/96/016/003-008

12.9.2012

10.9.2012

Orgalutran

| N.V. Organon |
| --- |
| P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland |

N.V. Organon

P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland

EU/1/00/130/001-002

12.9.2012

10.9.2012

Ozurdex

| Allergan Pharmaceuticals (Ireland) Ltd |
| --- |
| Castlebar Road, Westport, Co. Mayo, Ireland |

Allergan Pharmaceuticals (Ireland) Ltd

Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/10/638/001

12.9.2012

10.9.2012

Rasilamlo

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/11/686/001-056

12.9.2012

10.9.2012

Rasitrio

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/11/730/001-060

12.9.2012

10.9.2012

Revlimid

| Celgene Europe Limited |
| --- |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom |

Celgene Europe Limited

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

EU/1/07/391/001-006

12.9.2012

10.9.2012

Sildenafil Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/584/002-006

EU/1/09/584/008-012

EU/1/09/584/014-018

12.9.2012

10.9.2012

Simponi

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, CB Leiden 2333, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, CB Leiden 2333, Nederland

EU/1/09/546/001-004

12.9.2012

10.9.2012

Somavert

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/02/240/001-004

12.9.2012

10.9.2012

Tamiflu

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

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

EU/1/02/222/001-005

12.9.2012

10.9.2012

Trobalt

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/11/681/001-013

12.9.2012

10.9.2012

Xelevia

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

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

EU/1/07/382/001-018

12.9.2012

11.9.2012

Clopidogrel ratiopharm

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, 83714 Miesbach, Deutschland |

Acino Pharma GmbH

Am Windfeld 35, 83714 Miesbach, Deutschland

EU/1/09/554/001-008

13.9.2012

11.9.2012

Docetaxel Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/611/001-002

13.9.2012

12.9.2012

Clopidogrel Krka

| KRKA, d. d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA, d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556/001-011

14.9.2012

12.9.2012

Clopidogrel Krka d.d.

| KRKA, d.d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562/001-009

14.9.2012

12.9.2012

Clopidogrel TAD

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland |

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland

EU/1/09/555/001-009

14.9.2012

17.9.2012

Atripla

| Bristol-Myers Squibb and Gilead Sciences Limited |
| --- |
| IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland |

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

EU/1/07/430/001-002

19.9.2012

17.9.2012

Cervarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/07/419/001-012

19.9.2012

17.9.2012

Clopidogrel ratiopharm GmbH

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, 83714 Miesbach, Deutschland |

Acino Pharma GmbH

Am Windfeld 35, 83714 Miesbach, Deutschland

EU/1/09/541/001-008

19.9.2012

17.9.2012

Glubrava

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, London WC2B 4AE, United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/07/421/001-009

19.9.2012

17.9.2012

Levetiracetam Accord

| Accord Healthcare Limited |
| --- |
| 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom |

Accord Healthcare Limited

5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom

EU/1/11/712/001-040

19.9.2012

17.9.2012

Replagal

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D, 182 33 Danderyd, Sverige |

Shire Human Genetic Therapies AB

Svärdvägen 11D, 182 33 Danderyd, Sverige

EU/1/01/189/001-006

19.9.2012

20.9.2012

Azarga

| Alcon Laboratories (UK) Ltd. |
| --- |
| Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |

Alcon Laboratories (UK) Ltd.

Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom

EU/1/08/482/001-002

24.9.2012

20.9.2012

Leflunomide ratiopharm

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/10/654/001-004

24.9.2012

20.9.2012

Mircera

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

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

EU/1/07/400/008-013

EU/1/07/400/017-024

24.9.2012

20.9.2012

Olanzapine Apotex

| Apotex Europe B.V. |
| --- |
| Darwingweg 20, 2333 CR Leiden, Nederland |

Apotex Europe B.V.

Darwingweg 20, 2333 CR Leiden, Nederland

EU/1/10/635/001-018

24.9.2012

20.9.2012

Optaflu

| Novartis Vaccines and Diagnostics GmbH |
| --- |
| Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland |

Novartis Vaccines and Diagnostics GmbH

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

EU/1/07/394/001-009

24.9.2012

20.9.2012

Prialt

| Eisai Limited |
| --- |
| European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom |

Eisai Limited

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

EU/1/04/302/001-004

24.9.2012

20.9.2012

Sutent

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/06/347/001-008

24.9.2012

20.9.2012

Tasigna

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/422/001-012

24.9.2012

20.9.2012

Tesavel

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

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

EU/1/07/435/001-018

24.9.2012

20.9.2012

Torisel

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited

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

EU/1/07/424/001

24.9.2012

20.9.2012

VELCADE

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274/001-002

24.10.2012

20.9.2012

Xeloda

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

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

EU/1/00/163/001-002

24.9.2012

24.9.2012

alli

| Glaxo Group Limited |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/401/007-016

26.9.2012

24.9.2012

Elaprase

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D, 182 33 Danderyd, Sverige |

Shire Human Genetic Therapies AB

Svärdvägen 11D, 182 33 Danderyd, Sverige

EU/1/06/365/001-003

26.9.2012

24.9.2012

Komboglyze

| Bristol Myers Squibb/AstraZeneca EEIG |
| --- |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |

Bristol Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/11/731/004-005

EU/1/11/731/010-011

EU/1/11/731/013-014

24.9.2012

24.9.2012

Nevanac

| Alcon Laboratories (UK) Ltd. |
| --- |
| Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |

Alcon Laboratories (UK) Ltd.

Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom

EU/1/07/433/001

26.9.2012

24.9.2012

PecFent

| Archimedes Development Ltd |
| --- |
| Nottingham, NGT7 2TN, United Kingdom |

Archimedes Development Ltd

Nottingham, NGT7 2TN, United Kingdom

EU/1/10/644/001-006

27.9.2012

24.9.2012

Pramipexole Accord

| Accord Healthcare Limited |
| --- |
| 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom |

Accord Healthcare Limited

5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom

EU/1/11/728/001-010

24.9.2012

24.9.2012

Revasc

| Canyon Pharmaceuticals Ltd |
| --- |
| 7th Floor, 52-54 Gracechurch Street, London EC3V OEH, United Kingdom |

Canyon Pharmaceuticals Ltd

7th Floor, 52-54 Gracechurch Street, London EC3V OEH, United Kingdom

EU/1/97/043/001-003

26.9.2012

24.9.2012

Torisel

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited

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

EU/1/07/424/001

26.9.2012

24.9.2012

Xenical

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

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

EU/1/98/071/001-006

26.9.2012

28.9.2012

Irbesartan Zentiva

| Sanofi |
| --- |
| 54, rue La Boétie, 75008 Paris, France |

Sanofi

54, rue La Boétie, 75008 Paris, France

EU/1/06/376/001-039

3.10.2012

28.9.2012

Matever

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/11/711/001-030

3.10.2012

28.9.2012

Pegasys

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

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

EU/1/02/221/001-016

3.10.2012

—   Modification 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 |
| --- | --- | --- | --- | --- |
| 28.9.2012 | Libertek | Nycomed GmbH |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

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

28.9.2012

Libertek

Nycomed GmbH

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

–

4.10.2012

—   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 |
| --- | --- | --- | --- | --- |
| 10.9.2012 | Rivastigmine Teva | Teva Pharma B.V. |
| Computerweg 10, 3542 DR Utrecht, Nederland |

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

10.9.2012

Rivastigmine Teva

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/513/001-020

12.9.2012

—   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 |
| --- | --- | --- | --- | --- |
| 3.9.2012 | BTVPUR AlSap 8 | MERIAL |
| 29 avenue Tony Garnier, 69007 LYON, France |

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

3.9.2012

BTVPUR AlSap 8

MERIAL

29 avenue Tony Garnier, 69007 LYON, France

EU/2/09/094/001-005

5.9.2012

10.9.2012

TruScient

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited

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

EU/2/11/136/001

12.9.2012

10.9.2012

Veraflox

| Bayer Animal Health GmbH |
| --- |
| 51368 Leverkusen, Deutschland |

Bayer Animal Health GmbH

51368 Leverkusen, Deutschland

EU/2/10/107/001-014

12.9.2012

11.9.2012

Porcilis PCV

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/08/091/001-010

13.9.2012

28.9.2012

SevoFlo

| Abbott Laboratories Limited |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM |

Abbott Laboratories Limited

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM

EU/2/02/035/007

5.10.2012

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 |
| --- |
| 7, Westferry Circus, |
| Canary Wharf |
| UK - LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK - LONDON E14 4H

---

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

---

| 26.10.2012 | EN | Official Journal of the European Union | C 328/8 |
| --- | --- | --- | --- |

26.10.2012

EN

Official Journal of the European Union

C 328/8

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 2012

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
   (1)
  or Article 38 of Directive 2001/82/EC
   (2)
  )

2012/C 328/02

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 17.9.2012 | Nuflor 300 mg/ml | See Annex I | See Annex I | 18.9.2012 |
| 28.9.2012 | Yvidually and associated names | See Annex II | See Annex II | 3.10.2012 |
| 11.9.2012 | Mifepristone Linepharma and associated names | See Annex III | See Annex III | 13.9.2012 |
| 10.9.2012 | Zinacef and associated names | See Annex IV | See Annex IV | 11.9.2012 |
| 3.9.2012 | Trimetazidine | See Annex V | See Annex V | 4.9.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

17.9.2012

Nuflor 300 mg/ml

See Annex I

See Annex I

18.9.2012

28.9.2012

Yvidually and associated names

See Annex II

See Annex II

3.10.2012

11.9.2012

Mifepristone Linepharma and associated names

See Annex III

See Annex III

13.9.2012

10.9.2012

Zinacef and associated names

See Annex IV

See Annex IV

11.9.2012

3.9.2012

Trimetazidine

See Annex V

See Annex V

4.9.2012

---

(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 FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| Member State EU/EEA | Applicant | Name | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Belgium | Intervet International B.V. |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Member State EU/EEA

Applicant

Name

Pharmaceutical form

Strength

Animal species

Route of administration

Belgium

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor 300 mg/ml solution for injection for cattle and sheep

Solution for injection

300 mg/ml

Cattle and sheep

Cattle – subcutaneous and intramuscular

Sheep – intramuscular

Denmark

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor 300 mg/ml solution for injection for cattle and sheep

Solution for injection

300 mg/ml

Cattle and sheep

Cattle – subcutaneous and intramuscular

Sheep – intramuscular

France

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor 300 mg/ml solution for injection for cattle and sheep

Solution for injection

300 mg/ml

Cattle and sheep

Cattle – subcutaneous and intramuscular

Sheep – intramuscular

Germany

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor 300 mg/ml solution for injection for cattle and sheep

Solution for injection

300 mg/ml

Cattle and sheep

Cattle – subcutaneous and intramuscular

Sheep – intramuscular

Greece

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor 300 mg/ml solution for injection for cattle and sheep

Solution for injection

300 mg/ml

Cattle and sheep

Cattle – subcutaneous and intramuscular

Sheep – intramuscular

Ireland

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor 300 mg/ml solution for injection for cattle and sheep

Solution for injection

300 mg/ml

Cattle and sheep

Cattle – subcutaneous and intramuscular

Sheep – intramuscular

Italy

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor 300 mg/ml solution for injection for cattle and sheep

Solution for injection

300 mg/ml

Cattle and sheep

Cattle – subcutaneous and intramuscular

Sheep – intramuscular

Luxembourg

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor 300 mg/ml solution for injection for cattle and sheep

Solution for injection

300 mg/ml

Cattle and sheep

Cattle – subcutaneous and intramuscular

Sheep – intramuscular

The Netherlands

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor 300 mg/ml solution for injection for cattle and sheep

Solution for injection

300 mg/ml

Cattle and sheep

Cattle – subcutaneous and intramuscular

Sheep – intramuscular

Portugal

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor 300 mg/ml solution for injection for cattle and sheep

Solution for injection

300 mg/ml

Cattle and sheep

Cattle – subcutaneous and intramuscular

Sheep – intramuscular

Spain

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor 300 mg/ml solution for injection for cattle and sheep

Solution for injection

300 mg/ml

Cattle and sheep

Cattle – subcutaneous and intramuscular

Sheep – intramuscular

United Kingdom

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor 300 mg/ml solution for injection for cattle and sheep

Solution for injection

300 mg/ml

Cattle and sheep

Cattle – subcutaneous and intramuscular

Sheep – intramuscular

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES

| Member State EU/EEA | Applicant | Invented Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Bayer B.V. |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Member State EU/EEA

Applicant

Invented Name

Strength

Pharmaceutical form

Route of administration

Austria

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Delivrie 0,02 mg/3 mg Filmtabletten

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Belgium

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Yvidually

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Bulgaria

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Cyprus

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Czech Republic

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Denmark

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Delivrie

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Estonia

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Yvidually

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Finland

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

France

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Germany

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Greece

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Hungary

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Iceland

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Delivrie

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Ireland

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Delivrie

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Italy

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Yvidually

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Latvia

| Bayer Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| D-13353, Berlin |
| Germany |

Bayer Pharma AG

Müllerstrasse 170-178

D-13353, Berlin

Germany

Yvidually 0,02 mg/3 mg apvalkotās tabletes

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Lithuania

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Luxembourg

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Delivrie

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Malta

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

The Netherlands

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Yvidually

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Norway

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Poland

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Portugal

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Romania

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Yvidually

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Slovak Republic

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Slovenia

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Flexyess

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Spain

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Delivrie

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

Sweden

| Bayer B.V. |
| --- |
| Energieweg 1, |
| 3641 RT Mijdrecht |
| the Netherlands |

Bayer B.V.

Energieweg 1,

3641 RT Mijdrecht

the Netherlands

Delivrie

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

United Kingdom

| Bayer plc, Bayer House Strawberry Hill |
| --- |
| Newbury, Berkshire RG14 1JA |
| United Kingdom |

Bayer plc, Bayer House Strawberry Hill

Newbury, Berkshire RG14 1JA

United Kingdom

Delivrie

ethinylestradiol: 0.02 mg

Drospirenone: 3 mg

film-coated tablet

Oral use

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing authorisation holder | Applicant | Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | Linepharma France, |
| 140 bis rue de Rennes 75006 Paris |
| France |

Member State EU/EEA

Marketing authorisation holder

Applicant

Name

Strength

Pharmaceutical form

Route of administration

Denmark

Linepharma France,

140 bis rue de Rennes 75006 Paris

France

Mifepriston

Linepharma

200 mg

Tablet

Oral use

Finland

| Linepharma France, |
| --- |
| 140 bis rue de Rennes 75006 Paris |
| France |

Linepharma France,

140 bis rue de Rennes 75006 Paris

France

Mifepristone Linepharma

200 mg

Tablet

Oral use

France

| Linepharma France, |
| --- |
| 140 bis rue de Rennes 75006 Paris |
| France |

Linepharma France,

140 bis rue de Rennes 75006 Paris

France

Mifepristone

Linepharma

200 mg comprimé

200 mg

Tablet

Oral use

Iceland

| Linepharma France, |
| --- |
| 140 bis rue de Rennes 75006 Paris |
| France |

Linepharma France,

140 bis rue de Rennes 75006 Paris

France

Mifepristone

Linepharma

200 mg Tafla

200 mg

Tablet

Oral use

Norway

| Linepharma France, |
| --- |
| 140 bis rue de Rennes 75006 Paris |
| France |

Linepharma France,

140 bis rue de Rennes 75006 Paris

France

Mifepristone

Linepharma

200 mg

Tablet

Oral use

Sweden

| Linepharma France, |
| --- |
| 140 bis rue de Rennes 75006 Paris |
| France |

Linepharma France,

140 bis rue de Rennes 75006 Paris

France

Mifepristone

Linepharma

200 mg

Tablet

Oral use

United Kingdom

| Linepharma France, |
| --- |
| 140 bis rue de Rennes 75006 Paris |
| France |

Linepharma France,

140 bis rue de Rennes 75006 Paris

France

Mifepristone

Linepharma

200 mg tablet

200 mg

Tablet

Oral use

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  (EU/EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| A-1140 Wien |
| AUSTRIA |

Member State

(EU/EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Curocef 1 500 mg - Trockenstechampullen

1,5 g

Powder for Injection or Infusion

Intravenous Use

Injection: 1,5 g/15 ml

Infusion: 1,5 g/15 ml + 50 ml or 100 ml

Austria

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| AUSTRIA |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Curocef 1 500 mg - Trockensubstanz zur Infusionsbereitung

1,5 g

Powder for Infusion

Intravenous Use

1,5 g/15 ml + 50 ml or 100 ml

Austria

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| AUSTRIA |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Curocef 250 mg - Trockenstechamupllen

250 mg

Powder for Injection

Intramuscular Use or Intravenous Use

250 mg/1 ml or 250 mg/2-5 ml

Austria

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| AUSTRIA |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Curocef 750 mg - Trockenstechampullen

750 mg

Powder for Injection

Intramuscular Use or Intravenous Use

750 mg/3 ml or 750 mg/6-10 ml

Belgium

| GlaxoSmithKline s.a./n.v. |
| --- |
| Rue du Tilleul 13 |
| 1332 Genval |
| BELGIUM |

GlaxoSmithKline s.a./n.v.

Rue du Tilleul 13

1332 Genval

BELGIUM

Zinacef

1,5 g

Powder for Solution for Infusion

Intravenous Use

1,5 g 50 ml

Belgium

| GlaxoSmithKline s.a./n.v. |
| --- |
| Rue du Tilleul 13 |
| 1332 Genval |
| BELGIUM |

GlaxoSmithKline s.a./n.v.

Rue du Tilleul 13

1332 Genval

BELGIUM

Zinacef

1,5 g

Powder for Solution for Injection

Intravenous Use

1,5 g 15 ml

Belgium

| GlaxoSmithKline s.a./n.v. |
| --- |
| Rue du Tilleul 13 |
| 1332 Genval |
| BELGIUM |

GlaxoSmithKline s.a./n.v.

Rue du Tilleul 13

1332 Genval

BELGIUM

Zinacef

750 mg

Powder for Solution for Injection

Intravenous Use

750 mg 6 ml

Bulgaria

| Glaxo Group Ltd., |
| --- |
| Greenford, Middlesex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd.,

Greenford, Middlesex UB6 0NN

UNITED KINGDOM

Zinacef

1,5 g

Powder for Solution for Injection

Intravenous Use

1,5 g 15 ml

Bulgaria

| Glaxo Group Ltd., |
| --- |
| Greenford, Middlesex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd.,

Greenford, Middlesex UB6 0NN

UNITED KINGDOM

Zinacef

750 mg

Powder for Solution for Injection

Intravenous Use

750 mg 6 ml

Bulgaria

| Glaxo Group Ltd., |
| --- |
| Greenford, Middlesex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd.,

Greenford, Middlesex UB6 0NN

UNITED KINGDOM

Zinacef

750 mg

Powder for Solution for Injection

Intramuscular Use

750 mg 3 ml

Cyprus

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlex UB6 0NN

UNITED KINGDOM

Zinacef

1,5 g

Powder for Infusion

Intravenous Use

1,5 g 50 ml

Cyprus

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlex UB6 0NN

UNITED KINGDOM

Zinacef

1,5 g

Powder for Injection

Intravenous Use

1,5 g 15 ml

Cyprus

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlex UB6 0NN

UNITED KINGDOM

Zinacef

750 mg

Powder for Infusion

Intravenous Use

750 mg 6 ml

Cyprus

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlex UB6 0NN

UNITED KINGDOM

Zinacef

750 mg

Powder for Injection

Intramuscular Use

750 mg 3 ml

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinacef 1,5 g

1,5 g

Powder for Injection

Intravenous Use

1,5 g 50 ml

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinacef 1,5 g

1,5 g

Powder for Injection

Intravenous Use

1,5 g 15 ml

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinacef 750 mg

750 mg

Powder for Injection

Intramuscular Use

750 mg 3 ml

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinacef 750 mg

750 mg

Powder for Injection

Intravenous Use

750 mg 6 ml

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinacef

1,5 g

Powder for Solution for Infusion

Intravenous Use

1,5 g 50 ml

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinacef

1,5 g

Powder for Solution for Injection

Intravenous Use

1,5 g 15 ml

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinacef

250 mg

Powder for Solution for Injection

Intramuscular Use

250 mg 1 ml

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinacef

250 mg

Powder for Solution for Injection

Intravenous Use

250 mg 2 ml

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinacef

750 mg

Powder for Solution for Infusion

Intramuscular Use

750 mg 3 ml

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinacef

750 mg

Powder for Solution for Injection

Intravenous Use

750 mg 6 ml

Estonia

| Glaxo Group Ltd, |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd,

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN

UNITED KINGDOM

Zinacef

1,5 g

Powder for solution for injection

Intravenous use, intramuscular use

1,5 g

Estonia

| Glaxo Group Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN |
| --- |
| UNITED KINGDOM |

Glaxo Group Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN

UNITED KINGDOM

Zinacef

750 mg

Powder for solution for injection

Intravenous use, intramuscular use

750 mg

Finland

| GlaxoSmithKline Oy |
| --- |
| P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND |

GlaxoSmithKline Oy

P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND

Zinacef

1,5 g

Powder for solution/suspension for injection/infusion

Intravenous Use

1,5 g/15 ml

Finland

| GlaxoSmithKline Oy |
| --- |
| P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND |

GlaxoSmithKline Oy

P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND

Zinacef

1,5 g

Powder for solution/suspension for injection/infusion

Intravenous Use

1,5 g/50-100 ml

Finland

| GlaxoSmithKline Oy |
| --- |
| P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND |

GlaxoSmithKline Oy

P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND

Zinacef

250 mg

Powder for solution/suspension for injection

Intramuscular Use

250 mg/2 ml

Finland

| GlaxoSmithKline Oy |
| --- |
| P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND |

GlaxoSmithKline Oy

P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND

Zinacef

250 mg

Powder for solution/suspension for injection/infusion

Intravenous Use

250 mg/2 ml

Finland

| GlaxoSmithKline Oy |
| --- |
| P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND |

GlaxoSmithKline Oy

P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND

Zinacef

750 mg

Powder for solution/suspension for injection

Intramuscular Use

750 mg/3 ml

Finland

| GlaxoSmithKline Oy |
| --- |
| P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND |

GlaxoSmithKline Oy

P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND

Zinacef

750 mg

Powder for solution/suspension for injection

Intravenous Use

750 mg/6 ml

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat

1,5 g

Powder for solution for Infusion

Intravenous Use

1,5 g 50 ml

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat

250 mg

Powder for solution for Injection

Intravenous Use and Intramuscular use

(Only one MA for 250 mg strength)

250 mg

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat

750 mg

Powder and solvent for suspension for Injection

Intramuscular Use

750 mg

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat

750 mg

Powder for solution for Injection

Intravenous Use and Intramuscular use

750 mg

Greece

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens |
| GREECE |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens

GREECE

Zinacef

1,5 g

Powder for Infusion

Intravenous Use

1,5 g/VIAL

Greece

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens |
| GREECE |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens

GREECE

Zinacef

250 mg

Powder for Injection

Intravenous Use Intramuscular Use

250 mg/VIAL

Greece

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens |
| GREECE |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens

GREECE

Zinacef

750 mg

Powder for Injection

Intravenous Use Intramuscular Use

750 mg/VIAL

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| HUNGARY |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

HUNGARY

Zinacef

1,5 g

Powder for Injection

Intravenous Use

1,5 g

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| HUNGARY |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

HUNGARY

Zinacef

250 mg

Solution for injection

Intravenous Use

250 mg + 1 x 2 ml solvent

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| HUNGARY |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

HUNGARY

Zinacef

250 mg

Powder for Injection

Intramuscular Use

250 mg

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| HUNGARY |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

HUNGARY

Zinacef

750 mg

Solution for injection

Intravenous Use

750 mg + 1 x 6 ml solvent

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| HUNGARY |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

HUNGARY

Zinacef

750 mg

Powder for Injection

Intramuscular Use

750 mg

Iceland

| GlaxoSmithKline ehf. |
| --- |
| Thverholt 14 |
| 105 Reykjavík. |
| ICELAND |

GlaxoSmithKline ehf.

Thverholt 14

105 Reykjavík.

ICELAND

Zinacef

1,5 g

Powder for Infusion

Intravenous Use

1,5 g 50 ml

Iceland

| GlaxoSmithKline ehf. |
| --- |
| Thverholt 14 |
| 105 Reykjavík. |
| ICELAND |

GlaxoSmithKline ehf.

Thverholt 14

105 Reykjavík.

ICELAND

Zinacef

1,5 g

Powder for Injection

Intravenous Use

1,5 g 15 ml

Iceland

| GlaxoSmithKline ehf. |
| --- |
| Thverholt 14 |
| 105 Reykjavík. |
| ICELAND |

GlaxoSmithKline ehf.

Thverholt 14

105 Reykjavík.

ICELAND

Zinacef

750 mg

Powder for Infusion

Intramuscular Use

750 mg 3 ml

Iceland

| GlaxoSmithKline ehf. |
| --- |
| Thverholt 14 |
| 105 Reykjavík. |
| ICELAND |

GlaxoSmithKline ehf.

Thverholt 14

105 Reykjavík.

ICELAND

Zinacef

750 mg

Powder for Injection

Intravenous Use

750 mg 6 ml

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |
| IRELAND |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRELAND

Zinacef

1,5 g

Powder for injection or solution for infusion

Intravenous Use

1,5 g

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |
| IRELAND |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRELAND

Zinacef

250 mg

Powder for solution or suspension for injection

Intravenous or Intramuscular Use

250 mg

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |
| IRELAND |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRELAND

Zinacef

750 mg

Powder for solution for injection

Intravenous or IntramuscularUse

750 mg

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Curoxim

250 mg

Powder and solvent for suspension for Injection

Intramuscular Use

250 mg/ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Curoxim

500 mg

Powder and solvent for suspension for Injection

Intramuscular Use

500 mg/2 ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Curoxim

750 mg

Powder and solvent for suspension for Injection

Intramuscular Use

750 mg/3 ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Curoxim

1 g

Powder and solvent for suspension for Injection

Intravenous Use

1 g/10 ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Curoxim

1 g

Powder and solvent for suspension for Injection

Intramuscular Use

1 g/4 ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Curoxim

2 g

Powder for solution for Infusion

Intravenous Use

2 g

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Curoxim

1,5 g

Powder for solution for Infusion

Intravenous Use

1,5 g

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Curoxim

750 mg

Powder for solution for Infusion

Intravenous Use

750 mg

Lithuania

| Glaxo Operations UK Limited, Greenford, Middlesex, |
| --- |
| UB6 0HE, |
| UNITED KINGDOM |

Glaxo Operations UK Limited, Greenford, Middlesex,

UB6 0HE,

UNITED KINGDOM

Zinacef

1,5 g

Powder for Injection

Intravenous Use/Intramuscular Use

Lithuania

| Glaxo Operations UK Limited, Greenford, Middlesex, |
| --- |
| UB6 0HE, |
| UNITED KINGDOM |

Glaxo Operations UK Limited, Greenford, Middlesex,

UB6 0HE,

UNITED KINGDOM

Zinacef

250 mg

Powder and Solvant for Solution for Injection

Intravenous Us/Intramuscular Use

Lithuania

| Glaxo Operations UK Limited, Greenford, Middlesex, |
| --- |
| UB6 0HE, |
| UNITED KINGDOM |

Glaxo Operations UK Limited, Greenford, Middlesex,

UB6 0HE,

UNITED KINGDOM

Zinacef

750 mg

Powder and Solvant for Solution for Injection

Intravenous Use/Intramuscular Use

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinacef

1,5 g

Powder for Solution for Infusion

Intravenous Use

1,5 g 50 ml

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinacef

1,5 g

Powder for Solution for Injection

Intravenous Use

1,5 g 15 ml

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinacef

750 mg

Powder for Solution for Injection

Intravenous Use

750 mg 6 ml

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinacef

750 mg

Powder for Solution for Infusion

Intravenous Use

750 mg 50 ml

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinacef

750 mg

Powder for Solution for Injection

Intramuscular Use

750 mg 3 ml

Malta

| Glaxo Operations UK Limited |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0HE |
| UNITED KINGDOM |

Glaxo Operations UK Limited

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex UB6 0HE

UNITED KINGDOM

Zinacef

250 mg

Powder for suspension for Injection

Intravenous Use

250 mg 2 ml

Malta

| Glaxo Operations UK Limited |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0HE |
| UNITED KINGDOM |

Glaxo Operations UK Limited

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex UB6 0HE

UNITED KINGDOM

Zinacef

250 mg

Powder for suspension for Injection

Intramuscular Use

250 mg 1 ml

Malta

| Glaxo Operations UK Limited |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0HE |
| UNITED KINGDOM |

Glaxo Operations UK Limited

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex UB6 0HE

UNITED KINGDOM

Zinacef

750 mg

Powder for suspension for Injection

Intravenous Use

750 mg 6 ml

Malta

| Glaxo Operations UK Limited |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0HE |
| UNITED KINGDOM |

Glaxo Operations UK Limited

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex UB6 0HE

UNITED KINGDOM

Zinacef

750 mg

Powder for suspension for Injection

Intramuscular Use

750 mg 3 ml

Netherlands

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NETHERLANDS

Zinacef

1,5 g

Powder for suspension for Injection

Intravenous Use

1,5 g 15 ml

Netherlands

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NETHERLANDS

Zinacef

1,5 g

Powder for suspension for Infusion

Intravenous Use

1,5 g 100 ml

Netherlands

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NETHERLANDS

Zinacef

250 mg

Powder for suspension for Injection

Intravenous Use Intrarmuscular Use

250 mg 2 ml (intravenous)

250 mg 1 ml (intramuscular)

Netherlands

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NETHERLANDS

Zinacef

750 mg

Powder for suspension for Injection

Intravenous Use Intrarmuscular Use

750 mg 6 ml (intravenous)

750 mg 3 ml (intramuscular)

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo |
| NORWAY |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo

NORWAY

Zinacef

1,5 g

Powder for Infusion

Intravenous Use

1,5 g 50 ml

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo |
| NORWAY |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo

NORWAY

Zinacef

1,5 g

Powder for Injection

Intravenous Use

1,5 g 15 ml

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo |
| NORWAY |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo

NORWAY

Zinacef

250 mg

Powder for Injection

Intermuscular Use

250 mg 1 ml

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo |
| NORWAY |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo

NORWAY

Zinacef

250 mg

Powder for Injection

Intravenous Use

250 mg 2 ml

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo |
| NORWAY |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo

NORWAY

Zinacef

750 mg

Powder for Injection

Intravenous Use

750 mg 6 ml

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo |
| NORWAY |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo

NORWAY

Zinacef

750 mg

Powder for Injection

Intermuscular Use

750 mg 3 ml

Poland

| GlaxoSmithKline Export Ltd. 980 Great West Road |
| --- |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd. 980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinacef

1,5 g

Powder for solution for injection and infusion

Intravenous Use

1,5 g/15 ml

1,5 g/50-100 ml

1,5 g (Monovial)

Poland

| GlaxoSmithKline Export Ltd. 980 Great West Road |
| --- |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd. 980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinacef

750 mg

Powder for suspension for injection or solution for injection and infusion

Intramuscular Use, Intravenous Use

750 mg/3 ml IM

750 mg/6 ml IV

750 mg IV (Monovial)

Portugal

| GlaxoWellcome Farmacêutica Lda |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

GlaxoWellcome Farmacêutica Lda

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Curoxime

750 mg

Powder and solvent for solution for injection

Intravenous Use

750 mg 6 ml

Portugal

| GlaxoWellcome Farmacêutica Lda |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

GlaxoWellcome Farmacêutica Lda

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Curoxime

750 mg

Powder and solvent for solution for injection

Intramuscular Use

750 mg 3 ml

Romania

| Glaxo Operations UK Limited, GlaxoSmithKline House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, |
| --- |
| UNITED KINGDOM |

Glaxo Operations UK Limited, GlaxoSmithKline House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,

UNITED KINGDOM

Zinacef

750 mg

Powder for Injection

Intravenous Use

750 mg 6 ml

Romania

| Glaxo Operations UK Limited, GlaxoSmithKline House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, |
| --- |
| UNITED KINGDOM |

Glaxo Operations UK Limited, GlaxoSmithKline House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,

UNITED KINGDOM

Zinacef

750 mg

Powder for Injection

Intramuscular Use

750 mg 3 ml

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Cvetkova ulica 29 |
| SI-1000 Ljubljana |
| SLOVENIA |

GSK d.o.o., Ljubljana

Cvetkova ulica 29

SI-1000 Ljubljana

SLOVENIA

Zinacef 1 500 mg prašek za raztopino za injiciranje ali infundiranje

1,5 g

Powder for Solution for injection or Infusion

Intravenous Use

1,5 g 15 ml/

1,5 g 50 ml

Slovenia

| GSK d.o.o., Ljubljana Cvetkova ulica 29SI-1000 Ljubljana |
| --- |
| SLOVENIA |

GSK d.o.o., Ljubljana Cvetkova ulica 29SI-1000 Ljubljana

SLOVENIA

Zinacef 750 mg prašek za raztopino za injiciranje ali infundiranje

750 mg

Powder for solution for injection or infusion

Intramuscular Use/Intravenous Use

750 mg/3 ml 750 mg 6 ml

Sweden

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna |
| SWEDEN |

GlaxoSmithKline AB

Box 516

169 29 Solna

SWEDEN

Zinacef

Powder for solution for Infusion

Intravenous Use

Sweden

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna |
| SWEDEN |

GlaxoSmithKline AB

Box 516

169 29 Solna

SWEDEN

Zinacef

Powder for solution for Injection

Intravenous Use

Sweden

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna |
| SWEDEN |

GlaxoSmithKline AB

Box 516

169 29 Solna

SWEDEN

Zinacef

Powder for Solution/Suspension for Injection

Intramuscular Use

United Kingdom

| Glaxo Operations UK Ltd, |
| --- |
| Stockley Park West, Uxbridge, Middlesex, UB11 1BT |

Glaxo Operations UK Ltd,

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Zinacef

1,5 g

Powder for Injection

Intravenous Use and intramuscular use

United Kingdom

| Glaxo Operations UK Ltd, |
| --- |
| Stockley Park West, Uxbridge, Middlesex, UB11 1BT |

Glaxo Operations UK Ltd,

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Zinacef

250 mg

Powder for Injection

Intravenous Use and intramuscular use

United Kingdom

| Glaxo Operations UK Ltd, |
| --- |
| Stockley Park West, Uxbridge, Middlesex, UB11 1BT |

Glaxo Operations UK Ltd,

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Zinacef

750 mg

Powder for Injection

Intravenous Use and intramuscular use

---

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

| Member State
  EU/EEA | Marketing authorisation holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Servier Austria GmbH |
| Mariahilfer Straße 20/5 |
| Vienna 1070 |
| Austria |

Member State

EU/EEA

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Servier Austria GmbH

Mariahilfer Straße 20/5

Vienna 1070

Austria

Vastarel 35 mg - Filmtabletten mit veränderter Wirkstofffreisetzung

35 mg

Modified-release film-coated tablet

Oral use

Bulgaria

| Les Laboratoires Servier, |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier,

50, rue Carnot

92284 Suresnes cedex

France

Preductal MR

35 mg

Modified-release tablet

Oral use

Bulgaria

| Medica AD |
| --- |
| Industrial area |
| Sandanski 2800 |
| Bulgaria |

Medica AD

Industrial area

Sandanski 2800

Bulgaria

Prectazidine MR

35 mg

Modified-release tablet

Oral use

Bulgaria

| Actavis Group PTC ehf., |
| --- |
| Reykjavikurvegi 76-78 |
| 220 Hafnarfjordur |
| Iceland |

Actavis Group PTC ehf.,

Reykjavikurvegi 76-78

220 Hafnarfjordur

Iceland

Vascotasin

35 mg

Modified-release tablet

Oral use

Bulgaria

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Trimetazidine-ratiopharm

35 mg

Modified-release tablet

Oral use

Bulgaria

| S.C. Labormed Pharma S.A. |
| --- |
| 44 B, Theodor Pallady, sector 3 Bucharest |
| Romania |

S.C. Labormed Pharma S.A.

44 B, Theodor Pallady, sector 3 Bucharest

Romania

Predozone

20 mg

Coated tablet

Oral use

Bulgaria

| Sopharma AD |
| --- |
| 16 Iliensko shosse str. |
| 1220 Sofia |
| Bulgaria |

Sopharma AD

16 Iliensko shosse str.

1220 Sofia

Bulgaria

Trimductal

20 mg

Film-coated tablet

Oral use

Bulgaria

| Mylan S.A.S. |
| --- |
| 117 Allee des Parcs 69800 Saint Priest |
| France |

Mylan S.A.S.

117 Allee des Parcs 69800 Saint Priest

France

Trimetazigen MR

35 mg

Prolonged - release tablet

Oral use

Bulgaria

| Glenmark Pharmaceuticals s.r.o. |
| --- |
| Hvezdova 1716/2b |
| Prague 4, 140 78 |
| Czech Republic |

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b

Prague 4, 140 78

Czech Republic

Apstar

35 mg

Modified-release tablet

Oral use

Bulgaria

| Gedeon Richter Plc. |
| --- |
| Gyomroi ut 19-21 |
| H- 1103 Budapest |
| Hungary |

Gedeon Richter Plc.

Gyomroi ut 19-21

H- 1103 Budapest

Hungary

Moduxin MR

35 mg

Prolonged release tablets

Oral use

Bulgaria

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

Trimeluzine

35 mg

Modified-release tablet

Oral use

Cyprus

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

VASTAREL 20 mg

20 mg

Film-coated tablet

Oral use

Cyprus

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

VASTAREL

20 mg/ml

Oral drops

Oral use

Cyprus

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

VASTAREL MR

35 mg

Modified-release film-coated tablet

Oral use

Czech Republic

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

PREDUCTAL MR

35 mg

Modified-release tablet

Oral use

Czech Republic

| Actavis Group PTC ehf., Hafnarfjördur |
| --- |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf., Hafnarfjördur

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

TRIMETAZIDIN ACTAVIS 35 MG

35 mg

Modified-release tablet

Oral use

Czech Republic

| Mylan S.A.S |
| --- |
| 117 Alleé des Parcs |
| 69 800, Saint-Priest |
| France |

Mylan S.A.S

117 Alleé des Parcs

69 800, Saint-Priest

France

TRIMETAZIDIN MYLAN 35 MG

35 mg

Prolonged-release tablet

Oral use

Czech Republic

| SANDOZ s.r.o. |
| --- |
| U Nákladového nádraží 10 |
| 130 00 Prague |
| Czech Republic |

SANDOZ s.r.o.

U Nákladového nádraží 10

130 00 Prague

Czech Republic

TRIMETAZIDIN SANDOZ 35 MG

35 mg

Prolonged-release tablet

Oral use

Czech Republic

| Glenmark Pharmaceuticals s.r.o |
| --- |
| Hvezdova 1716/2b |
| Prague 4, 140 78 |
| Czech Republic |

Glenmark Pharmaceuticals s.r.o

Hvezdova 1716/2b

Prague 4, 140 78

Czech Republic

PORTORA 35 MG TABLETY S PRODLOUŽENÝM UVOLŇOVÁNÍM

35 mg

Prolonged-release tablet

Oral use

Czech Republic

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

Teva Pharmaceuticals CR, s.r.o.

Radlická 3185/1c

150 00 Prague 5

Czech Republic

TRIMETAZIDIN TEVA RETARD 35 MG

35 mg

Prolonged-release tablet

Oral use

Denmark

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

Vastarel

20 mg

Film-coated tablet

Oral use

Estonia

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

TRIMETAZIDINE MR SERVIER

35 mg

Modified-release tablet

Oral use

Estonia

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

PREDUCTAL MR

35 mg

Modified-release tablet

Oral use

Estonia

| Actavis Group PTC ehf Reykjavikurvegi 76-78 |
| --- |
| 220 Hafnarfjördur |
| Island |

Actavis Group PTC ehf Reykjavikurvegi 76-78

220 Hafnarfjördur

Island

TRIMETAZIDINE ACTAVIS

35 mg

Modified-release tablet

Oral use

Estonia

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

TRIMETAZIDINE TEVA 35 MG

35 mg

Film-coated tablet

Oral use

Estonia

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

ZIDMETIN

35 mg

Prolonged-release tablet

Oral use

France

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92707 Colombes Cedex |
| France |

BIOGARAN

15, boulevard Charles de Gaulle

92707 Colombes Cedex

France

TRIMETAZIDINE ALMUS

20 mg

Film-coated tablet

Oral use

France

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92707 Colombes Cedex |
| France |

BIOGARAN

15, boulevard Charles de Gaulle

92707 Colombes Cedex

France

TRIMETAZIDINE BIOGARAN

20 mg

Film-coated tablet

Oral use

France

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92707 Colombes Cedex |
| France |

BIOGARAN

15, boulevard Charles de Gaulle

92707 Colombes Cedex

France

TRIMETAZIDINE BIOGARAN

20 mg/ml

Oral solution

Oral use

France

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92707 Colombes Cedex |
| France |

BIOGARAN

15, boulevard Charles de Gaulle

92707 Colombes Cedex

France

TRIMETAZIDINE BIOGARAN

35 mg

Modified-release film-coated tablet

Oral use

France

| CRISTERS |
| --- |
| 22 quai Gallieni |
| 92150 Suresnes |
| France |

CRISTERS

22 quai Gallieni

92150 Suresnes

France

TRIMETAZIDINE CRISTERS

20 mg

Film-coated tablet

Oral use

France

| QUALIMED |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

QUALIMED

117, allée des Parcs

69800 Saint-Priest

France

TRIMETAZIDINE QUALIMED

20 mg/ml

Oral drops, solution

Oral use

France

| QUALIMED |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

QUALIMED

117, allée des Parcs

69800 Saint-Priest

France

TRIMETAZIDINE QUALIMED

35 mg

Modified-release film-coated tablet

Oral use

France

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

VASTAREL

20 mg

Film-coated tablet

Oral use

France

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

VASTAREL

20 mg/ml

Oral drops, solution

Oral use

France

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

VASTAREL

35 mg

Modified-release film-coated tablet

Oral use

France

| VENIPHARM |
| --- |
| 4, bureaux de la Colline |
| 92213 Saint-Cloud |
| France |

VENIPHARM

4, bureaux de la Colline

92213 Saint-Cloud

France

TRANETIZ

35 mg

Modified-release film-coated tablet

Oral use

France

| VENIPHARM |
| --- |
| 4, bureaux de la Colline |
| 92213 Saint-Cloud |
| France |

VENIPHARM

4, bureaux de la Colline

92213 Saint-Cloud

France

TRIGEMAX

35 mg

Modified-release film-coated tablet

Oral use

France

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92707 Colombes Cedex |
| France |

BIOGARAN

15, boulevard Charles de Gaulle

92707 Colombes Cedex

France

TRIMETAZIDINE BGR

35 mg

Modified-release film-coated tablet

Oral use

France

| CLL PHARMA |
| --- |
| Nice Premier - Arénas |
| 455, Promenade des Anglais |
| 06299 Nice Cedex 03 France |

CLL PHARMA

Nice Premier - Arénas

455, Promenade des Anglais

06299 Nice Cedex 03 France

TRIMETAZIDINE CLL PHARMA

35 mg

Modified-release film-coated tablet

Oral use

France

| SOCIÉTÉ IPSOR GENERIQUES - IGEN |
| --- |
| 18, avenue des Champs-Elysées |
| 75008 Paris |
| France |

SOCIÉTÉ IPSOR GENERIQUES - IGEN

18, avenue des Champs-Elysées

75008 Paris

France

TRIMETAZIDINE IGEN

20 mg/ml

Oral drops, solution

Oral use

France

| LABORATOIRES IPSOR |
| --- |
| 18 Avenue des Champs Elysees |
| 75008 Paris |
| France |

LABORATOIRES IPSOR

18 Avenue des Champs Elysees

75008 Paris

France

TRIMETAZIDINE IPSOR

20 mg

Film-coated tablet

Oral use

France

| LABORATOIRES IPSOR |
| --- |
| 18 Avenue des Champs Elysees |
| 75008 Paris |
| France |

LABORATOIRES IPSOR

18 Avenue des Champs Elysees

75008 Paris

France

TRIMETAZIDINE IPSOR

20 mg/ml

Oral drops, solution

Oral use

France

| PLUS PHARMACIE SA |
| --- |
| 26, boulevard Paul Vaillant-Couturier |
| 94200 Ivry-sur-Seine France |

PLUS PHARMACIE SA

26, boulevard Paul Vaillant-Couturier

94200 Ivry-sur-Seine France

TRIMETAZIDINE ISOMED

35 mg

Modified-release film-coated tablet

Oral use

France

| CLL PHARMA |
| --- |
| Nice Premier - Arénas |
| 455, Promenade des Anglais |
| 06299 Nice Cedex 03 France |

CLL PHARMA

Nice Premier - Arénas

455, Promenade des Anglais

06299 Nice Cedex 03 France

TRIMETAZIDINE MILGEN

20 mg

Film-coated tablet

Oral use

France

| CLL PHARMA |
| --- |
| Nice Premier - Arénas |
| 455, Promenade des Anglais |
| 06299 Nice Cedex 03 France |

CLL PHARMA

Nice Premier - Arénas

455, Promenade des Anglais

06299 Nice Cedex 03 France

TRIMETAZIDINE MILGEN

20 mg/ml

Oral drops, solution

Oral use

France

| RATIOPHARM GMBH |
| --- |
| Graf Arco Strasse 3 |
| 89079 Ulm |
| Germany |

RATIOPHARM GMBH

Graf Arco Strasse 3

89079 Ulm

Germany

TRIMETAZIDINE RATIOPHARM

35 mg

Modified-release film-coated tablet

Oral use

France

| SUBSTIPHARM |
| --- |
| 8, rue Bellini |
| 75116 Paris |
| France |

SUBSTIPHARM

8, rue Bellini

75116 Paris

France

TRIMETAZIDINE SUBSTIPHARM

20 mg/ml

Oral drops, solution

Oral use

France

| ZYDUS FRANCE |
| --- |
| 25, rue des Peupliers |
| ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers |
| 92000 Nanterre |
| France |

ZYDUS FRANCE

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers

92000 Nanterre

France

TRIMETAZIDINE ZYDUS

20 mg

Film-coated tablet

Oral use

France

| ZYDUS FRANCE |
| --- |
| 25, rue des Peupliers |
| ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers |
| 92000 Nanterre |
| France |

ZYDUS FRANCE

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers

92000 Nanterre

France

TRIMETAZIDINE ZYDUS

20 mg/ml

Oral solution

Oral use

France

| VENIPHARM |
| --- |
| 4, bureaux de la Colline |
| 92213 Saint-Cloud |
| France |

VENIPHARM

4, bureaux de la Colline

92213 Saint-Cloud

France

TRIMEVENI

35 mg

Modified-release film-coated tablet

Oral use

France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

France

TRIMETAZIDINE TEVA

20 mg/ml

Oral solution

Oral use

France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

France

TRIMETAZIDINE TEVA

20 mg

Film-coated tablet

Oral use

France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 9296 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

9296 Paris la Défense Cedex

France

TRIMETAZIDINE TEVA

35 mg

Modified-release film-coated tablet

Oral use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

TRIMETAZIDINE WINTHROP

20 mg

Film-coated tablet

Oral use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

TRIMETAZIDINE WINTHROP

20 mg/ml

Oral solution

Oral use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

TRIMETAZIDINE WINTHROP

35 mg

Modified-release film coated tablet

Oral use

France

| AJC INVEST |
| --- |
| 6, rue de la Rochefoucauld |
| 16000 Angoulême |
| France |

AJC INVEST

6, rue de la Rochefoucauld

16000 Angoulême

France

RIMETAZE

20 mg

Film coated tablet

Oral use

France

| AJC INVEST |
| --- |
| 6, rue de la Rochefoucauld |
| 16000 Angoulême |
| France |

AJC INVEST

6, rue de la Rochefoucauld

16000 Angoulême

France

RIMETAZE

20 mg/ml

Oral solution

Oral use

France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

TRIMETAZIDINE MYLAN

20 mg

Film coated tablet

Oral use

France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

TRIMETAZIDINE MYLAN

20 mg/ml

Oral solution

Oral use

France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

TRIMETAZIDINE MYLAN

35 mg

Modified-release film-coated tablet

Oral use

France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

TRIMETAZIDINE SANDOZ

20 mg

Film coated tablet

Oral use

France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

TRIMETAZIDINE SANDOZ

20 mg/ml

Oral solution

Oral use

France

| ACTAVIS France La Boursidière Centre d'Affaires 92357 Le Plessis Robinson |
| --- |
| France |

ACTAVIS France La Boursidière Centre d'Affaires 92357 Le Plessis Robinson

France

TRIMETAZIDINE ACTAVIS

20 mg

Film coated tablet

Oral use

France

| QUALIMED |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

QUALIMED

117, allée des Parcs

69800 Saint-Priest

France

TRIMETAZIDINE QUALIMED

20 mg

Film coated tablet

Oral use

France

| PLUS PHARMACIE SA |
| --- |
| 26, boulevard Paul Vaillant-Couturier |
| 94200 Ivry-sur-Seine |
| France |

PLUS PHARMACIE SA

26, boulevard Paul Vaillant-Couturier

94200 Ivry-sur-Seine

France

TRIMETAZIDINE ISOMED

20 mg

Coated tablet

Oral use

France

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| ‘Le Quintet’ - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - LABORATOIRES EUROGENERICS

‘Le Quintet’ - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

TRIMETAZIDINE EG

20 mg

Film coated tablet

Oral use

France

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| ‘Le Quintet’ - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - LABORATOIRES EUROGENERICS

‘Le Quintet’ - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

TRIMETAZIDINE EG

20 mg/ml

Oral solution

Oral use

France

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| ‘Le Quintet’ - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - LABORATOIRES EUROGENERICS

‘Le Quintet’ - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

TRIMETAZIDINE EG

35 mg

Modified-release film-coated tablet

Oral use

France

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| France |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

TRIMETAZIDINE ARROW

20 mg

Film coated tablet

Oral use

France

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| France |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

TRIMETAZIDINE ARROW

20 mg/ml

Oral solution

Oral use

France

| RATIOPHARM GMBH |
| --- |
| Graf Arco Strasse 3 |
| 89079 Ulm |
| Germany |

RATIOPHARM GMBH

Graf Arco Strasse 3

89079 Ulm

Germany

TRIMETAZIDINE RATIOPHARM

20 mg

Coated tablet

Oral use

France

| RATIOPHARM GMBH |
| --- |
| Graf Arco Strasse 3 |
| 89079 Ulm |
| Germany |

RATIOPHARM GMBH

Graf Arco Strasse 3

89079 Ulm

Germany

TRIMETAZIDINE RATIOPHARM

20 mg/ml

Oral solution

Oral use

France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

TRIMETAZIDINE SANDOZ

35 mg

modified-release film-coated tablet

Oral use

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Trimetazidin-ratiopharm 35 mg Retardtabletten

35 mg

Prolonged release tablet

Oral use

Germany

| Mepha Investigacao, Desenvolvimento e Fabricacao Farmaceutica, Lda. |
| --- |
| Lagoas Park, Edificio 5A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigacao, Desenvolvimento e Fabricacao Farmaceutica, Lda.

Lagoas Park, Edificio 5A, Piso 2

2740-298 Porto Salvo

Portugal

Mephatrim 35 mg Retardtabletten

35 mg

Prolonged release tablet

Oral use

Greece

| HELP ABEE, Valaoritou 10 |
| --- |
| Metamorfosi Attikis 14452 |
| Greece |

HELP ABEE, Valaoritou 10

Metamorfosi Attikis 14452

Greece

NOVAZIDINE

20 mg/ml

Oral drops, solution

Oral use

Greece

| FOINIXFARM EPE |
| --- |
| Dervenakion 38 & Sachini |
| Gerakas 15344 |
| Greece |

FOINIXFARM EPE

Dervenakion 38 & Sachini

Gerakas 15344

Greece

ZIDIN

20 mg/ml

Oral drops, solution

Oral use

Greece

| SERVIER HELLAS PHARMACEUTICALS Ltd, Ethnikis Antistaseos 72 & Agamemnonos |
| --- |
| Greece |

SERVIER HELLAS PHARMACEUTICALS Ltd, Ethnikis Antistaseos 72 & Agamemnonos

Greece

VASTAREL

20 mg/tab

Film-coated tablet

Oral use

Greece

| SERVIER HELLAS PHARMACEUTICALS Ltd, Ethnikis Antistaseos 72 & Agamemnonos |
| --- |
| Greece |

SERVIER HELLAS PHARMACEUTICALS Ltd, Ethnikis Antistaseos 72 & Agamemnonos

Greece

VASTAREL

20 mg/ml

Oral drops, solution

Oral use

Greece

| SERVIER HELLAS PHARMACEUTICALS Ltd, Ethnikis Antistaseos 72 & Agamemnonos |
| --- |
| Greece |

SERVIER HELLAS PHARMACEUTICALS Ltd, Ethnikis Antistaseos 72 & Agamemnonos

Greece

VASTAREL

35 mg/tab

Controlled release tablet

Oral use

Hungary

| Richter Gedeon nyrt. |
| --- |
| Gyömrői út 19-21. |
| 1103 Budapest |
| Hungary |

Richter Gedeon nyrt.

Gyömrői út 19-21.

1103 Budapest

Hungary

Moduxin MR

35 mg

Prolonged-release tablet

Oral use

Hungary

| Les Laboratoires Servier, |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier,

50, rue Carnot

92284 Suresnes cedex

France

Preductal MR

35 mg

Modified-release film-coated tablet

Oral use

Hungary

| EGIS Gyógyszergyár nyrt. |
| --- |
| Keresztúri út 30-38. |
| 1106 Budapest |
| Hungary |

EGIS Gyógyszergyár nyrt.

Keresztúri út 30-38.

1106 Budapest

Hungary

Adexor MR

35 mg

Modified-release film-coated tablet

Oral use

Hungary

| Glenmark Pharmaceuticals s.r.o |
| --- |
| Hvezdova 1716/2b |
| Prague 4, 140 78 |
| Czech Republic |

Glenmark Pharmaceuticals s.r.o

Hvezdova 1716/2b

Prague 4, 140 78

Czech Republic

APSTAR 35 mg retard tabletta

35 mg

Prolonged-release tablet

Oral use

Hungary

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

TRIMETAZIDIN- RATIOPHARM 35 mg retard tabletta

35 mg

Prolonged-release tablet

Oral use

Hungary

| Mylan S.A.S |
| --- |
| 117 Allee des Parcs |
| 69800 Saint Priest |
| France |

Mylan S.A.S

117 Allee des Parcs

69800 Saint Priest

France

TRIMETAZIDINE MYLAN 35 mg retard tabletta

35 mg

Prolonged-release tablet

Oral use

Hungary

| Actavis Group PTC ehf., Hafnarfjördur |
| --- |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf., Hafnarfjördur

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

VASCOTASIN 35 mg módosított hatóanyagleadású tabletta

35 mg

modified release tablet

Oral use

Hungary

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

Sandoz Hungária Kft.

1114 Budapest

Bartók Béla út 43-47.

Magyarország

Hungary

TRIMETAZIDINE SANDOZ 35 mg retard tabletta

35 mg

Prolonged-release tablet

Oral use

Ireland

| Servier Laboratories (Ireland) Ltd |
| --- |
| First Floor, Block 2 |
| West Pier BusinessCampus |
| Old Dunleary Road, |
| Dun Laoghaire |
| Dublin |
| Ireland |

Servier Laboratories (Ireland) Ltd

First Floor, Block 2

West Pier BusinessCampus

Old Dunleary Road,

Dun Laoghaire

Dublin

Ireland

Vastarel

20 mg

Film-coated tablet

Oral use

Ireland

| Servier Laboratories (Ireland) Ltd |
| --- |
| First Floor, Block 2 |
| West Pier BusinessCampus |
| Old Dunleary Road, |
| Dun Laoghaire |
| Dublin |
| Ireland |

Servier Laboratories (Ireland) Ltd

First Floor, Block 2

West Pier BusinessCampus

Old Dunleary Road,

Dun Laoghaire

Dublin

Ireland

Trimetazidine

35 mg

Prolonged-release film-coated tablet

Oral use

Ireland

| Servier Laboratories (Ireland) Ltd |
| --- |
| First Floor, Block 2 |
| West Pier BusinessCampus |
| Old Dunleary Road, |
| Dun Laoghaire |
| Dublin |
| Ireland |

Servier Laboratories (Ireland) Ltd

First Floor, Block 2

West Pier BusinessCampus

Old Dunleary Road,

Dun Laoghaire

Dublin

Ireland

Vastarel

35 mg

Prolonged-release film-coated tablet

Oral use

Italy

| Istituto Farmaco Biologico Stroder S.R.L. |
| --- |
| Via di Ripoli, 207V - 50126 Firenze |
| Italy |

Istituto Farmaco Biologico Stroder S.R.L.

Via di Ripoli, 207V - 50126 Firenze

Italy

VASTAREL

20 mg

Coated tablet

Oral use

Latvia

| Gedeon Richter Plc. |
| --- |
| H-1103 Budapest |
| Gyömrői út 19-21 |
| Hungary |

Gedeon Richter Plc.

H-1103 Budapest

Gyömrői út 19-21

Hungary

Moduxin 35 mg ilgstošās darbības tabletes

35 mg

Prolonged-release tablet

Oral use

Latvia

| Actavis Group PTC ehf., Reykjavikurvegi 76-78, |
| --- |
| 220 Hafnarfjorður |
| Iceland |

Actavis Group PTC ehf., Reykjavikurvegi 76-78,

220 Hafnarfjorður

Iceland

Trimetazidine Actavis 35 mg ilgstošās darbības tabletes

35 mg

Modified-release tablet

Oral use

Latvia

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

Preductal MR 35 mg ilgstošās darbības apvalkotās tabletes

35 mg

Modified-release tablet

Oral use

Latvia

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

Trimetazidine MR Servier 35 mg ilgstošās darbības apvalkotās tabletes

35 mg

Modified-release tablet

Oral use

Latvia

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Ultrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10, 3542 DR Ultrecht

The Netherlands

Trimetazidine Teva 35 mg ilgstošās darbības tabletes

35 mg

Prolonged-release tablet

Oral use

Latvia

| Sandoz d.d |
| --- |
| Verovskova 57, |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d

Verovskova 57,

SI-1000 Ljubljana

Slovenia

Zidmetin 35 mg ilgstošās darbības tabletes

35 mg

Modified-release tablet

Oral use

Lithuania

| Sandoz d.d |
| --- |
| Verovskova 57, |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d

Verovskova 57,

SI-1000 Ljubljana

Slovenia

Zidmetin

35 mg

Prolonged-release tablet

Oral use

Lithuania

| Les Laboratoires Servier, |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier,

50, rue Carnot

92284 Suresnes cedex

France

Preductal MR

35 mg

Modified-release film-coated tablet tablet

Oral use

Lithuania

| Les Laboratoires Servier, |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier,

50, rue Carnot

92284 Suresnes cedex

France

Trimetazidine MR Servier

35 mg

Modified-release film-coated tablet tablet

Oral use

Lithuania

| Teva Pharma B.V. |
| --- |
| Computerweg 10 3542 DR Ultrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10 3542 DR Ultrecht

The Netherlands

Trimetazidine-Teva

35 mg

Prolonged-release tablet

Oral use

Lithuania

| Actavis Group PTC ehf., Reykjavikurvegi 76-78 |
| --- |
| 220 Hafnarfjorður |
| Iceland |

Actavis Group PTC ehf., Reykjavikurvegi 76-78

220 Hafnarfjorður

Iceland

Trimetazidine Actavis

35 mg

Modified-release tablet

Oral use

Luxembourg

| Les Laboratoires Servier, |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier,

50, rue Carnot

92284 Suresnes cedex

France

Vastarel-20

20 mg

Coated tablet

Oral use

Luxembourg

| Les Laboratoires Servier, |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier,

50, rue Carnot

92284 Suresnes cedex

France

Vastarel

20 mg/ml

Drops

Oral use

Luxembourg

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

Vastarel-35

35 mg

Prolonged-release tablet

Oral use

Malta

| Les Laboratoires Servier, |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier,

50, rue Carnot

92284 Suresnes cedex

France

VASTAREL 20 mg

20 mg

Film-coated tablet

Oral use

Malta

| Les Laboratoires Servier, |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier,

50, rue Carnot

92284 Suresnes cedex

France

VASTAREL MR

35 mg

Modified release film coated tablet

Oral use

Poland

| Ethifarm Sp. z o. o. |
| --- |
| ul. Hiacyntowa 39 |
| 60-175 Poznań |
| Poland |

Ethifarm Sp. z o. o.

ul. Hiacyntowa 39

60-175 Poznań

Poland

Cyto-Protectin MR

35 mg

Prolonged-release tablet

Oral use

Poland

| Przedsiębiorstwo Farmaceutyczne |
| --- |
| LEK-AM Sp. z o.o. |
| Ostrzykowizna 14A |
| 05-170 Zakroczym |
| Poland |

Przedsiębiorstwo Farmaceutyczne

LEK-AM Sp. z o.o.

Ostrzykowizna 14A

05-170 Zakroczym

Poland

Trimeductan MR

35 mg

Prolonged-release tablet

Oral use

Poland

| Pabianickie Zakłady Farmaceutyczne Polfa S.A. |
| --- |
| Marszałka J. Piłsudskiego 5, 95-200 Pabianice |
| Poland |

Pabianickie Zakłady Farmaceutyczne Polfa S.A.

Marszałka J. Piłsudskiego 5, 95-200 Pabianice

Poland

Metazydyna

20 mg

Film-coated tablet

Oral use

Poland

| Les Laboratoires Servier, |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier,

50, rue Carnot

92284 Suresnes cedex

France

Preductal

20 mg

Film-coated tablet

Oral use

Poland

| ANPHARM Przedsiębiorstwo Farmaceutyczne S.A. |
| --- |
| ul. Annopol 6B |
| 03-236 Warszawa |
| Poland |

ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.

ul. Annopol 6B

03-236 Warszawa

Poland

Preductal MR

35 mg

Modified-release film-coated tablet

Oral use

Poland

| Gedeon Richter Polska Sp. z o.o. |
| --- |
| Graniczna str. 35 |
| 05-825 Grodzisk Mazowiecki |
| Poland |

Gedeon Richter Polska Sp. z o.o.

Graniczna str. 35

05-825 Grodzisk Mazowiecki

Poland

Protevasc SR

35 mg

Modified-release film-coated tablet

Oral use

Poland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm, 89079 |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm, 89079

Germany

Trimetaratio

20 mg

Film-coated tablet

Oral use

Poland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm, 89079 |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm, 89079

Germany

Trimetazidine-ratiopharm PR

35 mg

Prolonged-release tablet

Oral use

Poland

| Ethifarm Sp. z o. o. |
| --- |
| ul. Hiacyntowa 39 |
| 60-175 Poznań |
| Poland |

Ethifarm Sp. z o. o.

ul. Hiacyntowa 39

60-175 Poznań

Poland

Cyto-Protectin MR

35 mg

Prolonged-release tablet

Oral use

Poland

| Glenmark Pharmaceuticals s.r.o. |
| --- |
| Hvezdova 1716/2b |
| Praga 4 |
| CZ-140 78 |
| Czech Republic |

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b

Praga 4

CZ-140 78

Czech Republic

Portora

35 mg

Prolonged-release tablet

Oral use

Poland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| Praga 10, Dolni Mecholupy |
| 10237 Dolni Mecholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

Praga 10, Dolni Mecholupy

10237 Dolni Mecholupy

Czech Republic

Trimedal

35 mg

Prolonged-release tablet

Oral use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Dimesar

35 mg

Prolonged-release tablet

Oral use

Portugal

Servier Portugal - Especialidades Farmacêuticas, Lda. Av. António Augusto de Aguiar, 128 1069-133 Lisboa Portugal

Vastarel

20 mg

Coated tablets

Oral use

Portugal

Servier Portugal - Especialidades Farmacêuticas, Lda. Av. António Augusto de Aguiar, 128 1069-133 Lisboa Portugal

Vastarel

20 mg/ml

Oral solution

Oral use

Portugal

Sanofi-Aventis - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal

Trimetazidina Zentiva

20 mg

Coated tablets

Oral use

Portugal

Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros Portugal

Trimetazidina Labesfal 20 mg Comprimidos Revestidos

20 mg

Coated tablets

Oral use

Portugal

Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés Portugal

Trimetazidina Mylan

20 mg

Coated tablets

Oral use

Portugal

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

Trimetazidina Generis 20 mg Comprimidos Revestidos

20 mg

Coated tablets

Oral use

Portugal

Servier Portugal - Especialidades Farmacêuticas, Lda. Av. António Augusto de Aguiar, 128 1069-133 Lisboa Portugal

Vastarel LM

35 mg

Modified-release tablet

Oral use

Portugal

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

Trimetazidina Bluepharma 20 mg Comprimidos

20 mg

Coated tablets

Oral use

Portugal

Vida - Produtos Farmacêuticos, S.A. Rua da Estação, 42 - Vala do Carregado 2600-726 Castanheira do Ribatejo Portugal

Trimetazidina Vida

20 mg

Coated tablets

Oral use

Portugal

Helm Portugal, Lda. Estrada Nacional n.o 10, Km 140, 260 2695-066 Bobadela - Loures Portugal

Trimetazidina Baldacci 20 mg Comprimidos

20 mg

Coated tablets

Oral use

Portugal

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2 2740-298 Porto Salvo Portugal

Trimetazidina Mepha 20 mg Comprimidos Revestidos

20 mg

Coated tablets

Oral use

Portugal

Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal

Trimetazidina Jaba 20 mg Comprimidos revestidos

20 mg

Coated tablets

Oral use

Portugal

Teva Pharma - Produtos Farmacêuticos, Lda Lagoas Park, Edifício 1 - 3o 2740-264 Porto Salvo Portugal

Trimetazidina Teva

20 mg

Coated tablets

Oral use

Portugal

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

Tacirel LM

35 mg

Modified-release tablet

Oral use

Portugal

Cinfa Portugal, Lda. Av.Tomás Ribeiro, 43 - Bloco 1, 4o B - Edifício Neopark 2790-221 Carnaxide Portugal

Trimetazidina Cinfa 20 mg Comprimidos revestidos por película

20 mg

Film-coated tablets

Oral use

Portugal

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso 2790-143 Carnaxide Portugal

Trimetazidina Ratiopharm

20 mg

Film-coated tablets

Oral use

Portugal

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso 2790-143 Carnaxide Portugal

Trimetazidina Ratiopharm

35 mg

Prolonged-release tablets

Oral use

Portugal

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

Trimetazidina Generis

35 mg

Prolonged-release tablets

Oral use

Portugal

Teva Pharma - Produtos Farmacêuticos, Lda Lagoas Park, Edifício 1 - 3o 2740-264 Porto Salvo Portugal

Trimetazidina Teva

35 mg

Prolonged-release tablets

Oral use

Portugal

Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros Portugal

Trimetazidina Labesfal

35 mg

Prolonged-release tablets

Oral use

Portugal

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal

Trimetazidina Sandoz

35 mg

Prolonged-release tablets

Oral use

Portugal

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2 2740-298 Porto Salvo Portugal

Trimetazidina Mepha LP

35 mg

Prolonged-release tablets

Oral use

Portugal

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

Trimetazidina Bluepharma LP

35 mg

Prolonged-release tablets

Oral use

Portugal

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal

Trimetazidina Itraxel

35 mg

Prolonged-release tablets

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 |

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

Lupamadazine

35 mg

Prolonged-release tablets

Oral use

Portugal

Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés Portugal

Trimetazidina Mylan

35 mg

Prolonged-release tablets

Oral use

Portugal

Sanofi-Aventis - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal

Zilutra

35 mg

Prolonged-release tablets

Oral use

Romania

| MYLAN S.A.S. |
| --- |
| 117, Allée des Parcs |
| 69800 Saint Priest |
| France |

MYLAN S.A.S.

117, Allée des Parcs

69800 Saint Priest

France

Trimetazidina Mylan

35 mg

Prolonged-release tablet

Oral use

Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii nr. 124 |
| Cluj Napoca |
| România |

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj Napoca

România

DILATAN MR 35 mg, comprimate filmate cu eliberare modificată, 35 mg

35 mg

Prolonged-release tablet

Oral use

Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii nr. 124 |
| Cluj Napoca |
| România |

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj Napoca

România

DILATAN 20 mg, comprimate filmate, 20 mg

20 mg

Film-coated tablet

Oral use

Romania

| S.C. VIM SPECTRUM S.R.L., Șos. Sighișoarei nr. 409, Sat Corunca, Com. Livezeni |
| --- |
| Jud. Mureș |
| România |

S.C. VIM SPECTRUM S.R.L., Șos. Sighișoarei nr. 409, Sat Corunca, Com. Livezeni

Jud. Mureș

România

TRIMETAZIDIN VIM SPECTRUM 20 mg, capsule

20 mg

Capsule

Oral use

Romania

| Les Laboratoires Servier, |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier,

50, rue Carnot

92284 Suresnes cedex

France

PREDUCTAL MR 35 mg, comprimate filmate cu eliberare modificată

35 mg

Modified-release tablet

Oral use

Romania

| Les Laboratoires Servier, |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier,

50, rue Carnot

92284 Suresnes cedex

France

PREDUCTAL 20 mg, comprimate filmate

20 mg

Film-coated tablet

Oral use

Romania

| GEDEON RICHTER |
| --- |
| ROMÂNIA S. A. |
| Str. Cuza - Vodă nr. 99 – 105 |
| Târgu – Mureș |
| România |

GEDEON RICHTER

ROMÂNIA S. A.

Str. Cuza - Vodă nr. 99 – 105

Târgu – Mureș

România

MODUXIN MR 35 mg, comprimate filmate cu eliberare prelungită

35 mg

Prolonged-release tablet

Oral use

Romania

| GEDEON RICHTER |
| --- |
| ROMÂNIA S. A. |
| Str. Cuza - Vodă nr. 99 – 105 |
| Târgu – Mureș |
| România |

GEDEON RICHTER

ROMÂNIA S. A.

Str. Cuza - Vodă nr. 99 – 105

Târgu – Mureș

România

MODUXIN 20 mg, comprimate filmate

20 mg

Film-coated tablet

Oral use

Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii nr. 124 |
| Cluj Napoca |
| România |

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj Napoca

România

TRIMETAZIDINA 20 mg, drajeuri

20 mg

Coated tablet

Oral use

Romania

| LABORMED PHARMA S.A. Bd. Theodor Pallady nr. 44B |
| --- |
| sector 3, București |
| România |

LABORMED PHARMA S.A. Bd. Theodor Pallady nr. 44B

sector 3, București

România

TRIMETAZIDINĂ LPH 35 mg, comprimate filmate cu eliberare modificată

35 mg

Modified-release tablet

Oral use

Romania

| LABORMED PHARMA S.A. Bd. Theodor Pallady nr. 44B |
| --- |
| sector 3, București |
| România |

LABORMED PHARMA S.A. Bd. Theodor Pallady nr. 44B

sector 3, București

România

TRIMETAZIDINĂ LPH 20 mg, comprimate filmate

20 mg

Film-coated tablet

Oral use

Romania

| LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44B |
| sector 3, București |
| România |

LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44B

sector 3, București

România

Oxcardin 20 mg, comprimate filmate

20 mg

Film-coated tablet

Oral use

Romania

| LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44B |
| sector 3, București |
| România |

LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44B

sector 3, București

România

Oxcardin MR 35 mg, comprimate filmate cu eliberare modificată

35 mg

Modified-release tablet

Oral use

Romania

| GLENMARK PHARMACEUTICALS s.r.o. |
| --- |
| Hvezdova 1716/2b, Prague 4, 140 78 |
| Czech Republic |

GLENMARK PHARMACEUTICALS s.r.o.

Hvezdova 1716/2b, Prague 4, 140 78

Czech Republic

APSTAR 35 mg comprimate cu eliberare prelungită

35 mg

Prolonged-release tablet

Oral use

Romania

| S.C.SANDOZ S.R.L. |
| --- |
| Str. Livezeni nr. 7A |
| 540472 Târgu Mureș |
| România |

S.C.SANDOZ S.R.L.

Str. Livezeni nr. 7A

540472 Târgu Mureș

România

TRIMELUZINE 35 mg comprimate cu eliberare prelungită

35 mg

Prolonged-release tablet

Oral use

Slovak Republic

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Trimetazidin-ratiopharm 20 mg

20 mg

Film-coated tablet

Oral use

Slovak Republic

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Trimetazidin ratiopharm retard 35 mg

35 mg

Modified-release film-coated tablet

Oral use

Slovak Republic

| PRO.MED.CS PRAHA a.s. Telčská 1 |
| --- |
| 140 00 Praha |
| Czech Republic |

PRO.MED.CS PRAHA a.s. Telčská 1

140 00 Praha

Czech Republic

Angitrim

20 mg

Film-coated tablet

Oral use

Slovak Republic

| EGIS Pharmaceuticals PLC |
| --- |
| Keresztúri út 30-38, 1106 Budapest |
| Hungary |

EGIS Pharmaceuticals PLC

Keresztúri út 30-38, 1106 Budapest

Hungary

Adexor

20 mg

Film-coated tablet

Oral use

Slovak Republic

| Les Laboratoires Servier, |
| --- |
| 50, rue Carnot |
| 92284 Suresnes cedex |
| France |

Les Laboratoires Servier,

50, rue Carnot

92284 Suresnes cedex

France

PREDUCTAL MR

35 mg

Modified-release film-coated tablet

Oral use

Slovak Republic

| Mylan S.A.S |
| --- |
| 117, Allée des Parcs |
| 69800 Saint Priest |
| France |

Mylan S.A.S

117, Allée des Parcs

69800 Saint Priest

France

Trimetazidin Mylan 35 mg

35 mg

Prolonged-release tablet

Oral use

Slovak Republic

| Deml Group s.r.o. |
| --- |
| Jeneweinova 51a |
| 617 00 Brno |
| Czech Republic |

Deml Group s.r.o.

Jeneweinova 51a

617 00 Brno

Czech Republic

Trimetazidin - DemlGroup PR 35 mg

35 mg

Prolonged-release film-coated tablet

Oral use

Slovak Republic

| Actavis Group PTC ehf Reykjavkurvegi 76-78 |
| --- |
| 220 Hafnarfiroi |
| Iceland |

Actavis Group PTC ehf Reykjavkurvegi 76-78

220 Hafnarfiroi

Iceland

Vascotazin 35 mg

35 mg

Modified-release tablet

Oral use

Slovak Republic

| Glenmark Pharmaceuticals s.r.o. |
| --- |
| Hvezdova 1716/2b 140 78 Praha 4 |
| Czech Republic |

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b 140 78 Praha 4

Czech Republic

Apstar 35 mg tablety s predĺženým uvoľňovaním

35 mg

Prolonged-release tablet

Oral use

Slovenia

| Servier Pharma d.o.o. |
| --- |
| Pot k sejmiscu 33 |
| SI-1231 Ljubljana Crnuce |
| Slovenia |

Servier Pharma d.o.o.

Pot k sejmiscu 33

SI-1231 Ljubljana Crnuce

Slovenia

PREDUCTAL MR 35 mg filmsko oblozene tablete s prirejenim sproscanjem

35 mg

Modified-release film-coated tablet

Oral use

Slovenia

| Servier Pharma d.o.o. |
| --- |
| Pot k sejmiscu 33 |
| SI-1231 Ljubljana Crnuce |
| Slovenia |

Servier Pharma d.o.o.

Pot k sejmiscu 33

SI-1231 Ljubljana Crnuce

Slovenia

TRIMETAZIDIN SERVIER 35 mg filmsko obložene tablete s prirejenim sproščanjem

35 mg

Modified-release film-coated tablet

Oral use

Spain

| LABORATORIOS DAVUR, S.L. |
| --- |
| C/Teide, 4- planta baja |
| Polígono Empresarial La Marina |
| 28703 San Sebastian de los Reyes (MADRID) |
| Spain |

LABORATORIOS DAVUR, S.L.

C/Teide, 4- planta baja

Polígono Empresarial La Marina

28703 San Sebastian de los Reyes (MADRID)

Spain

TRIMETAZIDINA DAVUR 20 mg comprimidos recubiertos EFG

20 mg

Film-coated tablet

Oral use

Spain

| RIMAFAR, S.L. |
| --- |
| Polígono Industrial Malpica Calle C, No 4 |
| 50016 ZARAGOZA |
| Spain |

RIMAFAR, S.L.

Polígono Industrial Malpica Calle C, No 4

50016 ZARAGOZA

Spain

TRIMETAZIDINA RIMAFAR 20 mg comprimidos recubiertos EFG

20 mg

Film-coated tablet

Oral use

Spain

| RATIOPHARM ESPAÑA, S.A. Avda. Burgos, 16 D-5a planta |
| --- |
| 28036 MADRID |
| Spain |

RATIOPHARM ESPAÑA, S.A. Avda. Burgos, 16 D-5a planta

28036 MADRID

Spain

TRIMETAZIDINA RATIOPHARM 20 mg comprimidos recubiertos con película EFG

20 mg

Film-coated tablet

Oral use

Spain

| DANVAL, S.A. |
| --- |
| Avda. de los Madroños, 33 |
| 28043 Madrid |
| Spain |

DANVAL, S.A.

Avda. de los Madroños, 33

28043 Madrid

Spain

IDAPTAN 20 mg comprimidos recubiertos con película

20 mg

Film-coated tablet

Oral use

Spain

| DANVAL, S.A. |
| --- |
| Avda. de los Madroños, 33 |
| 28043 Madrid |
| Spain |

DANVAL, S.A.

Avda. de los Madroños, 33

28043 Madrid

Spain

IDAPTAN 20 mg/ml solución oral

20 mg/ml

Oral solution

Oral use

Spain

| LABORATORIOS CINFA, S.A. |
| --- |
| C/Olaz-Chipi, 10 |
| Polígono Industrial Areta |
| 31620 Huarte (PAMPLONA) |
| Spain |

LABORATORIOS CINFA, S.A.

C/Olaz-Chipi, 10

Polígono Industrial Areta

31620 Huarte (PAMPLONA)

Spain

TRIMETAZIDINA CINFA 20 mg comprimidos recubiertos con película EFG

20 mg

Film-coated tablet

Oral use

Spain

| PENSA PHARMA, S.A.U. |
| --- |
| C/Jorge Comín (Médico Pediatra) |
| 3-bajos |
| 46015 Valencia |
| Spain |

PENSA PHARMA, S.A.U.

C/Jorge Comín (Médico Pediatra)

3-bajos

46015 Valencia

Spain

TRIMETAZIDINA PENSA 20 mg comprimidos recubiertos con película EFG

20 mg

Film-coated tablet

Oral use

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