# Official Journal C 264/2012

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2012.264.eng |
| --- | --- |
| Official Journal
  of the European Union | C 264 |
| | |
| English edition | Information and Notices | Volume 5531 August 2012 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2012.264.eng

Official Journal

of the European Union

C 264

English edition

Information and Notices

Volume 5531 August 2012

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| 2012/C 264/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 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 264/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 2012(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 9 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

2012/C 264/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 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 264/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 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)

9

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

| 31.8.2012 | EN | Official Journal of the European Union | C 264/1 |
| --- | --- | --- | --- |

31.8.2012

EN

Official Journal of the European Union

C 264/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 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 264/01

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 20.7.2012 | Bretaris Genuair | aclidinium bromide | Almirall, S.A. |
| Ronda General Mitre, 151, 08022 Barcelona, España |

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

20.7.2012

Bretaris Genuair

aclidinium bromide

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/12/781/001-003

Inhalation powder

R03BB05

25.7.2012

20.7.2012

Eklira Genuair

aclidinium bromide

| Almirall, S.A. |
| --- |
| Ronda General Mitre, 151, 08022 Barcelona, España |

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/12/778/001-003

Inhalation powder

R03BB05

25.7.2012

20.7.2012

Jentadueto

linagliptin/metformin hydrochloride

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/12/780/001-028

Film-coated tablet

A10BD11

25.7.2012

23.7.2012

Fycompa

Perampanel

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

Eisai Europe Limited

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

EU/1/12/776/001-016

Film-coated tablet

N03AX22

25.7.2012

23.7.2012

Kalydeco

ivacaftor

| Vertex Pharmaceuticals (U.K.) Limited |
| --- |
| 88 Milton Park, Abingdon, Oxfordshire OX14 4RY, United Kingdom |

Vertex Pharmaceuticals (U.K.) Limited

88 Milton Park, Abingdon, Oxfordshire OX14 4RY, United Kingdom

EU/1/12/782/001-002

Film-coated tablet

Pending

25.7.2012

—   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 |
| --- | --- | --- | --- | --- |
| 3.7.2012 | Insuman | Sanofi-Aventis Deutschland GmbH |
| D-65926 Frankfurt am Main, 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

3.7.2012

Insuman

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030/028-201

5.7.2012

3.7.2012

Kinzalkomb

| Bayer Pharma AG |
| --- |
| Berlin 13342, Deutschland |

Bayer Pharma AG

Berlin 13342, Deutschland

EU/1/02/214/001-015

5.7.2012

3.7.2012

MicardisPlus

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

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

EU/1/02/213/001-023

5.7.2012

3.7.2012

Prevenar 13

| Wyeth-Lederle Vaccines S.A. |
| --- |
| Pleinlaan 17 Boulevard de la Plaine, 1050 Brussel - Bruxelles, Belgïe-Belgique |

Wyeth-Lederle Vaccines S.A.

Pleinlaan 17 Boulevard de la Plaine, 1050 Brussel - Bruxelles, Belgïe-Belgique

EU/1/09/590/001-006

5.7.2012

4.7.2012

Arixtra

| Glaxo Group Ltd. |
| --- |
| Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Ltd.

Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/02/206/001-035

6.7.2012

4.7.2012

Iasibon

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

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/10/659/001-010

6.7.2012

4.7.2012

Potactasol

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland |

Actavis Group PTC ehf.

Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland

EU/1/10/660/001-002

6.7.2012

6.7.2012

Ganfort

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

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/06/340/001-002

10.7.2012

6.7.2012

Olazax

| Glenmark Pharmaceuticals s.r.o. |
| --- |
| City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika

EU/1/09/597/001-005

10.7.2012

6.7.2012

Simulect

| 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/1/98/084/001-002

10.7.2012

6.7.2012

Trizivir

| ViiV Healthcare UK Limited |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

ViiV Healthcare UK Limited

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

EU/1/00/156/002-004

10.7.2012

12.7.2012

Edarbi

| 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/1/11/734/001-018

17.7.2012

12.7.2012

Ipreziv

| 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/1/11/735/001-018

17.7.2012

16.7.2012

Olanzapine Glenmark

| Glenmark Generics (Europe) Limited |
| --- |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom |

Glenmark Generics (Europe) Limited

Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom

EU/1/09/587/001-017

18.7.2012

20.7.2012

Arzerra

| 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

EU/1/10/625/001

EU/1/10/625/003

24.7.2012

20.7.2012

Avamys

| Glaxo Group Ltd |
| --- |
| Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Ltd

Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/434/001-003

24.7.2012

20.7.2012

BeneFIX

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

Pfizer Limited

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

EU/1/97/047/004-007

25.7.2012

20.7.2012

Celsentri

| ViiV Healthcare UK Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

ViiV Healthcare UK Ltd

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

EU/1/07/418/001-010

25.7.2012

20.7.2012

Cyanokit

| Merck Santé s.a.s. |
| --- |
| 37, rue Saint-Romain, 69379 Lyon Cedex 08, France |

Merck Santé s.a.s.

37, rue Saint-Romain, 69379 Lyon Cedex 08, France

EU/1/07/420/001-002

25.7.2012

20.7.2012

InductOs

| Medtronic Biopharma BV |
| --- |
| Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland |

Medtronic Biopharma BV

Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland

EU/1/02/226/001

25.7.2012

20.7.2012

Intelence

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/468/001-002

24.7.2012

23.7.2012

Afinitor

| 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/1/09/538/001-008

25.7.2012

23.7.2012

Alimta

| 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/1/04/290/001-002

27.7.2012

23.7.2012

Bridion

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/08/466/001-002

25.7.2012

23.7.2012

Cayston

| Gilead Sciences International Limited |
| --- |
| Granta Park, Abington, Cambridge CB21 6GT, United Kingdom |

Gilead Sciences International Limited

Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543/001-002

25.7.2012

23.7.2012

Epivir

| ViiV Healthcare UK Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

ViiV Healthcare UK Ltd

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

EU/1/96/015/001-005

27.7.2012

23.7.2012

Eucreas

| 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/1/07/425/001-018

25.7.2012

23.7.2012

Galvus

| 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/1/07/414/001-010

EU/1/07/414/018

27.7.2012

23.7.2012

Humira

| 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/1/03/256/001-010

27.7.2012

23.7.2012

Ketek

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, F-92160 Antony, France |

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92160 Antony, France

EU/1/01/191/001-005

25.7.2012

23.7.2012

Lumigan

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

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/02/205/001-004

25.7.2012

23.7.2012

Oslif Breezhaler

| 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/1/09/586/001-010

25.7.2012

26.7.2012

Celvapan

| Baxter AG |
| --- |
| Industriestraße 67, A-1221 Wien, Österreich |

Baxter AG

Industriestraße 67, A-1221 Wien, Österreich

EU/1/08/506/001

30.7.2012

26.7.2012

Esmya

| PregLem France SAS. |
| --- |
| 32, route de l'Eglise, 74140 Massongy, France |

PregLem France SAS.

32, route de l'Eglise, 74140 Massongy, France

EU/1/12/750/001

30.7.2012

26.7.2012

Evicel

| Omrix Biopharmaceuticals N.V. |
| --- |
| Leonardo Da Vinci Laan 15, B-1831 Diegem, België |

Omrix Biopharmaceuticals N.V.

Leonardo Da Vinci Laan 15, B-1831 Diegem, België

EU/1/08/473/001-003

30.7.2012

26.7.2012

Grepid

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

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535/001-016

30.7.2012

26.7.2012

Onbrez Breezhaler

| 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/1/09/593/001-010

30.7.2012

26.7.2012

Pradaxa

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

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

EU/1/08/442/001-016

30.7.2012

26.7.2012

Silapo

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland |

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland

EU/1/07/432/001-022

30.7.2012

26.7.2012

Votubia

| 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/1/11/710/001-007

30.7.2012

26.7.2012

Zalasta

| 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/1/07/415/001-056

30.7.2012

31.7.2012

Enbrel

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

Pfizer Limited

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

EU/1/99/126/001-022

3.8.2012

31.7.2012

Isentress

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

Merck Sharp & Dohme Limited

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

EU/1/07/436/001-002

3.8.2012

31.7.2012

NovoRapid

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/99/119/001

EU/1/99/119/003

EU/1/99/119/005-015

EU/1/99/119/017-023

3.8.2012

31.7.2012

Tyverb

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

Glaxo Group Limited

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

EU/1/07/440/001-007

2.8.2012

31.7.2012

Victrelis

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

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

EU/1/11/704/001-002

3.8.2012

—   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 |
| --- | --- | --- | --- | --- |
| 4.7.2012 | Sprimeo | Novartis Europharm Ltd |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

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

4.7.2012

Sprimeo

Novartis Europharm Ltd

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

EU/1/07/407/001-040

6.7.2012

6.7.2012

Sprimeo HCT

| 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/1/11/683/001-080

10.7.2012

16.7.2012

Regranex

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/99/101/001

18.7.2012

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (2)
  ): Accepted

| Date of the Décision | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.7.2012 | Nobivac L4 | — | Intervet International B.V. |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Date of the Décision

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

16.7.2012

Nobivac L4

—

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/12/143/001-005

Suspension for injection

QI07AB01

18.7.2012

23.7.2012

Cardalis

Benazepril hydrochloride, Spironolactone

| CEVA SANTE ANIMALE |
| --- |
| 10 avenue de la Ballastière, 33500 Libourne, France |

CEVA SANTE ANIMALE

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/12/142/001-006

Tablet

QC09BA07

25.7.2012

—   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 |
| --- | --- | --- | --- | --- |
| 4.7.2012 | Proteq West Nile | 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

4.7.2012

Proteq West Nile

MERIAL

29 avenue Tony Garnier, 69007 LYON, France

EU/2/11/129/001-004

6.7.2012

6.7.2012

Vaxxitek HVT+ IBD

| Merial |
| --- |
| 29 Avenue Tony Garnier, 69007 Lyon, France |

Merial

29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/02/032/001-002

10.7.2012

12.7.2012

Ingelvac CircoFLEX

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/07/079/001-008

17.7.2012

12.7.2012

Novem

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/04/042/001-014

17.7.2012

20.7.2012

ProMeris

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

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/2/06/064/001-004

25.7.2012

20.7.2012

ProMeris Duo

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

Pfizer Limited

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

EU/2/06/065/001-010

25.7.2012

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.

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

---

| 31.8.2012 | EN | Official Journal of the European Union | C 264/9 |
| --- | --- | --- | --- |

31.8.2012

EN

Official Journal of the European Union

C 264/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 2012

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

2012/C 264/02

—   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 |
| --- | --- | --- | --- | --- |
| 31.7.2012 | Tavanic and associated names | See Annex I | See Annex I | 2.8.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

31.7.2012

Tavanic and associated names

See Annex I

See Annex I

2.8.2012

—   Refusal of 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 |
| --- | --- | --- | --- | --- |
| 6.7.2012 | Ethinylestradiol-Drospirenone 24 + 4 and associated names | See Annex II | See Annex II | 10.7.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

6.7.2012

Ethinylestradiol-Drospirenone 24 + 4 and associated names

See Annex II

See Annex II

10.7.2012

---

(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 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 |
| --- | --- | --- | --- | --- | --- |
| Austria | Sanofi-aventis GmbH |
| Leonard-Bernstein-Straße 10, A-1220 Vienna |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Sanofi-aventis GmbH

Leonard-Bernstein-Straße 10, A-1220 Vienna

Tavanic 250 mg Filmtabletten

250 mg

Film-coated tablets

Oral use

Austria

| Sanofi-aventis GmbH |
| --- |
| Leonard-Bernstein-Straße 10, A-1220 Vienna |

Sanofi-aventis GmbH

Leonard-Bernstein-Straße 10, A-1220 Vienna

Tavanic 500 mg Filmtabletten

500 mg

Film-coated tablets

Oral use

Austria

| Sanofi-aventis GmbH |
| --- |
| Leonard-Bernstein-Straße 10, A-1220 Vienna |

Sanofi-aventis GmbH

Leonard-Bernstein-Straße 10, A-1220 Vienna

Tavanic Infusionsflasche

5 mg/ml

Solution for infusion

Intravenous use

Belgium

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem - Belgium |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem - Belgium

Tavanic 250 mg filmomhulde tabletten

250 mg

Film-coated tablets

Oral use

Belgium

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem - Belgium |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem - Belgium

Tavanic 500 mg filmomhulde tabletten

500 mg

Film-coated tablets

Oral use

Belgium

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem - Belgium |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem - Belgium

Tavanic 5 mg/ml oplossing voor infusie

5 mg/ml

Solution for infusion

Intravenous use

Bulgaria

| Sanofi-Avenstis Bulgaria EOOD, |
| --- |
| Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8 |

Sanofi-Avenstis Bulgaria EOOD,

Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8

Tavanic

250 mg

Film-coated tablets

Oral use

Bulgaria

| Sanofi-Avenstis Bulgaria EOOD, |
| --- |
| Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8 |

Sanofi-Avenstis Bulgaria EOOD,

Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8

Tavanic

500 mg

Film-coated tablets

Oral use

Bulgaria

| Sanofi-Avenstis Bulgaria EOOD, |
| --- |
| Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8 |

Sanofi-Avenstis Bulgaria EOOD,

Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

Cyprus

| Sanofi-aventis Cyprus Ltd, |
| --- |
| 14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus |

Sanofi-aventis Cyprus Ltd,

14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus

Tavanic

250 mg

Film-coated tablets

Oral use

Cyprus

| Sanofi-aventis Cyprus Ltd, |
| --- |
| 14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus |

Sanofi-aventis Cyprus Ltd,

14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus

Tavanic

500 mg

Film-coated tablets

Oral use

Cyprus

| Sanofi-aventis Cyprus Ltd, |
| --- |
| 14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus |

Sanofi-aventis Cyprus Ltd,

14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

Czech Republic

| sanofi-aventis, s.r.o. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Czech Republic |

sanofi-aventis, s.r.o.

Evropská 846/176a

160 00 Praha 6

Czech Republic

Tavanic i.v.

5 mg/ml

Solution for infusion

Intravenous use

Estonia

| sanofi-aventis Estonia OÜ, |
| --- |
| Pärnu mnt 139 E/2, 11317 Tallinn, Estonia |

sanofi-aventis Estonia OÜ,

Pärnu mnt 139 E/2, 11317 Tallinn, Estonia

Tavanic

250 mg

Film-coated tablets

Oral use

Estonia

| sanofi-aventis Estonia OÜ, |
| --- |
| Pärnu mnt 139 E/2, 11317 Tallinn, Estonia |

sanofi-aventis Estonia OÜ,

Pärnu mnt 139 E/2, 11317 Tallinn, Estonia

Tavanic

500 mg

Film-coated tablets

Oral use

Estonia

| sanofi-aventis Estonia OÜ, |
| --- |
| Pärnu mnt 139 E/2, 11317 Tallinn, Estonia |

sanofi-aventis Estonia OÜ,

Pärnu mnt 139 E/2, 11317 Tallinn, Estonia

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki, Finland |

sanofi-aventis Oy

Huopalahdentie 24

00350 Helsinki, Finland

Tavanic

250 mg

Film-coated tablets

Oral use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki, Finland |

sanofi-aventis Oy

Huopalahdentie 24

00350 Helsinki, Finland

Tavanic

500 mg

Film-coated tablets

Oral use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki, Finland |

sanofi-aventis Oy

Huopalahdentie 24

00350 Helsinki, Finland

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

France

| Sanofi-aventis France |
| --- |
| 1-13 Boulevard Romain Rolland |
| 75014 Paris |
| FRANCE |

Sanofi-aventis France

1-13 Boulevard Romain Rolland

75014 Paris

FRANCE

TAVANIC 250 mg comprimé pelliculé sécable

250 mg

Film-coated tablets

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

TAVANIC 500 mg comprimé pelliculé sécable

500 mg

Film-coated tablets

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

TAVANIC 5 mg/ml solution pour perfusion

5 mg/ml

Solution for infusion

Intravenous use

Germany

| Sanofi-Aventis Deutschland GmbH, |
| --- |
| Industriepark Höchst, |
| Gebäude K703 |
| 65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH,

Industriepark Höchst,

Gebäude K703

65926 Frankfurt am Main, Deutschland

Tavanic 250 mg Filmtabletten

250 mg

Film-coated tablets

Oral use

Germany

| Sanofi-Aventis Deutschland GmbH, |
| --- |
| Industriepark Höchst, |
| Gebäude K703 |
| 65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH,

Industriepark Höchst,

Gebäude K703

65926 Frankfurt am Main, Deutschland

Tavanic 500 mg Filmtabletten

500 mg

Film-coated tablets

Oral use

Germany

| Sanofi-Aventis Deutschland GmbH, |
| --- |
| Industriepark Höchst, |
| Gebäude K703 |
| 65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH,

Industriepark Höchst,

Gebäude K703

65926 Frankfurt am Main, Deutschland

Tavanic 5 mg/ml Infusionslösung

5 mg/ml

Solution for infusion

Intravenous use

Greece

| sanofi-aventis AEBE |
| --- |
| 348 Syngrou avenue-Building A |
| 176 74 Kalithea – Athens |
| GR-Greece |

sanofi-aventis AEBE

348 Syngrou avenue-Building A

176 74 Kalithea – Athens

GR-Greece

Tavanic

250 mg

Film-coated tablets

Oral use

Greece

| sanofi-aventis AEBE |
| --- |
| 348 Syngrou avenue-Building A |
| 176 74 Kalithea – Athens |
| GR-Greece |

sanofi-aventis AEBE

348 Syngrou avenue-Building A

176 74 Kalithea – Athens

GR-Greece

Tavanic

500 mg

Film-coated tablets

Oral use

Greece

| sanofi-aventis AEBE |
| --- |
| 348 Syngrou avenue-Building A |
| 176 74 Kalithea – Athens |
| GR-Greece |

sanofi-aventis AEBE

348 Syngrou avenue-Building A

176 74 Kalithea – Athens

GR-Greece

Tavanic

5 mg/1 ml

Solution for infusion

Intravenous use

Hungary

| sanofi-aventis Zrt. |
| --- |
| To u. 1-5. |
| 1045 Budapest, |
| Hungary |

sanofi-aventis Zrt.

To u. 1-5.

1045 Budapest,

Hungary

Tavanic

250 mg

Film-coated tablets

Oral use

Hungary

| sanofi-aventis Zrt. |
| --- |
| To u. 1-5. |
| 1045 Budapest, |
| Hungary |

sanofi-aventis Zrt.

To u. 1-5.

1045 Budapest,

Hungary

Tavanic

500 mg

Film-coated tablets

Oral use

Hungary

| sanofi-aventis Zrt. |
| --- |
| To u. 1-5. |
| 1045 Budapest, |
| Hungary |

sanofi-aventis Zrt.

To u. 1-5.

1045 Budapest,

Hungary

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

Ireland

| sanofi-aventis Ireland Ltd., |
| --- |
| Citywest Business Campus, Dublin 24, Ireland |

sanofi-aventis Ireland Ltd.,

Citywest Business Campus, Dublin 24, Ireland

Tavanic 250 mg film-coated tablets

250 mg

Film-coated tablets

Oral use

Ireland

| sanofi-aventis Ireland Ltd., |
| --- |
| Citywest Business Campus, Dublin 24, Ireland |

sanofi-aventis Ireland Ltd.,

Citywest Business Campus, Dublin 24, Ireland

Tavanic 500 mg film-coated tablets

500 mg

Film-coated tablets

Oral use

Ireland

| sanofi-aventis Ireland Ltd., |
| --- |
| Citywest Business Campus, Dublin 24, Ireland |

sanofi-aventis Ireland Ltd.,

Citywest Business Campus, Dublin 24, Ireland

Tavanic 5 mg/ml solution for infusion

5 mg/ml

Solution for infusion

Intravenous use

Italy

| sanofi-aventis S.p.A. |
| --- |
| Viale Luigi Bodio 37/B |
| 20158 Milan |
| Italy |

sanofi-aventis S.p.A.

Viale Luigi Bodio 37/B

20158 Milan

Italy

TAVANIC

250 mg

Film-coated tablets

Oral use

Italy

| sanofi-aventis S.p.A. |
| --- |
| Viale Luigi Bodio 37/B |
| 20158 Milan |
| Italy |

sanofi-aventis S.p.A.

Viale Luigi Bodio 37/B

20158 Milan

Italy

TAVANIC

500 mg

Film-coated tablets

Oral use

Italy

| sanofi-aventis S.p.A. |
| --- |
| Viale Luigi Bodio 37/B |
| 20158 Milan |
| Italy |

sanofi-aventis S.p.A.

Viale Luigi Bodio 37/B

20158 Milan

Italy

TAVANIC

5 mg/ml

Solution for infusion

Intravenous use

Lithuania

| UAB ‘SANOFI-AVENTIS LIETUVA’, |
| --- |
| A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania |

UAB ‘SANOFI-AVENTIS LIETUVA’,

A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania

Tavanic

250 mg

Film-coated tablets

Oral use

Lithuania

| UAB ‘SANOFI-AVENTIS LIETUVA’, |
| --- |
| A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania |

UAB ‘SANOFI-AVENTIS LIETUVA’,

A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania

Tavanic

500 mg

Film-coated tablets

Oral use

Lithuania

| UAB ‘SANOFI-AVENTIS LIETUVA’, |
| --- |
| A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania |

UAB ‘SANOFI-AVENTIS LIETUVA’,

A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

Luxembourg

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem - Belgium |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem - Belgium

Tavanic 250 mg comprimés pelliculés

250 mg

Film-coated tablets

Oral use

Luxembourg

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem - Belgium |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem - Belgium

Tavanic 500 mg comprimés pelliculés

500 mg

Film-coated tablets

Oral use

Luxembourg

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem - Belgium |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem - Belgium

Tavanic 5 mg/ml solution pour perfusion

5 mg/ml

Solution for infusion

Intravenous use

Malta

| Sanofi-Aventis Malta Ltd, |
| --- |
| Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta |

Sanofi-Aventis Malta Ltd,

Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta

Tavanic 250 mg film coated tablets

250 mg

Film-coated tablets

Oral use

Malta

| Sanofi-Aventis Malta Ltd, |
| --- |
| Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta |

Sanofi-Aventis Malta Ltd,

Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta

Tavanic 500 mg film coated tablets

500 mg

Film-coated tablets

Oral use

Malta

| Sanofi-Aventis Malta Ltd, |
| --- |
| Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta |

Sanofi-Aventis Malta Ltd,

Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta

Tavanic 5 mg/ml solution for infusion

5 mg/ml

Solution for infusion

Intravenous use

Netherlands

| sanofi-aventis Netherlands B.V., |
| --- |
| Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands |

sanofi-aventis Netherlands B.V.,

Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands

Tavanic 250

250 mg

Film-coated tablets

Oral use

Netherlands

| sanofi-aventis Netherlands B.V., |
| --- |
| Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands |

sanofi-aventis Netherlands B.V.,

Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands

Tavanic 500

500 mg

Film-coated tablet

Oral use

Netherlands

| sanofi-aventis Netherlands B.V., |
| --- |
| Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands |

sanofi-aventis Netherlands B.V.,

Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands

Tavanic IV

5 mg/ml

Solution for infusion

Intravenous use

Poland

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Brüningstrasse 50 |
| D-65926 Frankfurt am Main, Germany |

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50

D-65926 Frankfurt am Main, Germany

Tavanic 250

250 mg

Film-coated tablets

Oral use

Poland

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Brüningstrasse 50 |
| D-65926 Frankfurt am Main, Germany |

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50

D-65926 Frankfurt am Main, Germany

Tavanic 500

500 mg

Film-coated tablets

Oral use

Poland

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Brüningstrasse 50 |
| D-65926 Frankfurt am Main, Germany |

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50

D-65926 Frankfurt am Main, Germany

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

Portugal

| SANOFI-AVENTIS – Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 – 3o Piso |
| 2740-244 Porto Salvo |

SANOFI-AVENTIS – Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

TAVANIC

250 mg

Film-coated tablets

Oral use

Portugal

| SANOFI-AVENTIS – Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 – 3o Piso |
| 2740-244 Porto Salvo |

SANOFI-AVENTIS – Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

TAVANIC

500 mg

Film-coated tablets

Oral use

Portugal

| SANOFI-AVENTIS – Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 – 3o Piso |
| 2740-244 Porto Salvo |

SANOFI-AVENTIS – Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

TAVANIC

5 mg/ml

Solution for infusion

Intravenous use

Slovak Republic

| sanofi-aventis Slovakia s.r.o., |
| --- |
| Einsteinova 24, 85101 Bratislava, Slovak Republic |

sanofi-aventis Slovakia s.r.o.,

Einsteinova 24, 85101 Bratislava, Slovak Republic

Tavanic 500 mg

500 mg

Film-coated tablets

Oral use

Slovak Republic

| sanofi-aventis Slovakia s.r.o., |
| --- |
| Einsteinova 24, 85101 Bratislava, Slovak Republic |

sanofi-aventis Slovakia s.r.o.,

Einsteinova 24, 85101 Bratislava, Slovak Republic

Tavanic i.v. 500 mg

5 mg/ml

Solution for infusion

Intravenous use

Slovenia

| sanofi-aventis d.o.o, |
| --- |
| Dunajska 151, 1000 Ljubljana, Slovenia |

sanofi-aventis d.o.o,

Dunajska 151, 1000 Ljubljana, Slovenia

Tavanic 250 mg filmsko obložene tablete

250 mg

Film-coated tablets

Oral use

Slovenia

| sanofi-aventis d.o.o, |
| --- |
| Dunajska 151, 1000 Ljubljana, Slovenia |

sanofi-aventis d.o.o,

Dunajska 151, 1000 Ljubljana, Slovenia

Tavanic 500 mg filmsko obložene tablete

500 mg

Film-coated tablets

Oral use

Slovenia

| sanofi-aventis d.o.o, |
| --- |
| Dunajska 151, 1000 Ljubljana, Slovenia |

sanofi-aventis d.o.o,

Dunajska 151, 1000 Ljubljana, Slovenia

Tavanic 5 mg/ml raztopina za infundiranje

5 mg/ml

Solution for infusion

Intravenous use

Spain

| Sanofi-aventis, S.A. |
| --- |
| Josep Pla, 2 |
| 08019 – Barcelona |
| Spain |

Sanofi-aventis, S.A.

Josep Pla, 2

08019 – Barcelona

Spain

Tavanic 500 mg comprimidos recubiertos con película

500 mg

Film-coated tablets

Oral use

Spain

| Sanofi-aventis, S.A. |
| --- |
| Josep Pla, 2 |
| 08019 – Barcelona |
| Spain |

Sanofi-aventis, S.A.

Josep Pla, 2

08019 – Barcelona

Spain

Tavanic 5 mg/ml solución para perfusión

5 mg/ml

Solution for infusion

Intravenous use

Sweden

| sanofi-aventis AB |
| --- |
| Box 141 42 |
| 167 14 Bromma |
| Sweden |

sanofi-aventis AB

Box 141 42

167 14 Bromma

Sweden

Tavanic

250 mg

Film-coated tablets

Oral use

Sweden

| sanofi-aventis AB |
| --- |
| Box 141 42 |
| 167 14 Bromma |
| Sweden |

sanofi-aventis AB

Box 141 42

167 14 Bromma

Sweden

Tavanic

500 mg

Film-coated tablets

Oral use

Sweden

| sanofi-aventis AB |
| --- |
| Box 141 42 |
| 167 14 Bromma |
| Sweden |

sanofi-aventis AB

Box 141 42

167 14 Bromma

Sweden

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

United Kingdom

| Aventis Pharma Limited, |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent |
| ME19 4AH |
| United Kingdom |

Aventis Pharma Limited,

50 Kings Hill Avenue

Kings Hill

West Malling

Kent

ME19 4AH

United Kingdom

(Trading as:

| Sanofi-aventis |
| --- |
| One Onslow Street, Guildford, Surrey, |
| GU1 4YS, United Kingdom) |

Sanofi-aventis

One Onslow Street, Guildford, Surrey,

GU1 4YS, United Kingdom)

Tavanic 250 mg film-coated tablets

250 mg

Film-coated tablets

Oral use

United Kingdom

| Aventis Pharma Limited, |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent |
| ME19 4AH |
| United Kingdom |

Aventis Pharma Limited,

50 Kings Hill Avenue

Kings Hill

West Malling

Kent

ME19 4AH

United Kingdom

(Trading as:

| Sanofi-aventis |
| --- |
| One Onslow Street, Guildford, Surrey, |
| GU1 4YS, United Kingdom) |

Sanofi-aventis

One Onslow Street, Guildford, Surrey,

GU1 4YS, United Kingdom)

Tavanic 500 mg film-coated tablets

500 mg

Film-coated tablets

Oral use

United Kingdom

| Aventis Pharma Limited, |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent |
| ME19 4AH |
| United Kingdom |

Aventis Pharma Limited,

50 Kings Hill Avenue

Kings Hill

West Malling

Kent

ME19 4AH

United Kingdom

(Trading as:

| Sanofi-aventis |
| --- |
| One Onslow Street, Guildford, Surrey, |
| GU1 4YS, United Kingdom) |

Sanofi-aventis

One Onslow Street, Guildford, Surrey,

GU1 4YS, United Kingdom)

Tavanic 5 mg/ml solution for infusion

5 mg/ml

Solution for infusion

Intravenous use

---

ANNEX II

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

| Member State
  EU/EEA | Marketing authorisaton holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Bayer Austria GmbH |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Member State

EU/EEA

Marketing authorisaton holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Bayer Austria GmbH

Herbststrasse 6-10

1160 Wien

Austria

Eloine 0,02 mg/3 mg Filmtabletten

0,02 mg/3 mg

Film-coated tablet

Oral use

Bulgaria

| Bayer Pharma AG, |
| --- |
| Mullerstrasse 170-178 |
| Berlin |
| 13342 |
| Germany |

Bayer Pharma AG,

Mullerstrasse 170-178

Berlin

13342

Germany

ELOINE

0,02 mg/3 mg

Film-coated tablet

Oral use

Cyprus

| Bayer Hellas ABEE |
| --- |
| Sorou 18-20 |
| 151 25 Marousi |
| Greece |

Bayer Hellas ABEE

Sorou 18-20

151 25 Marousi

Greece

LINATERA FC TABLETS

0,02 mg/3 mg

Film-coated tablet

Oral use

Czech Republic

| Bayer Pharma AG Müllerstrasse |
| --- |
| 178 D-13342 Berlin |
| Germany |

Bayer Pharma AG Müllerstrasse

178 D-13342 Berlin

Germany

ELOINE 0,02 MG/3 MG POTAHOVANÉ TABLETY

0,02 mg/3 mg

Film-coated tablet

Oral use

Denmark

| Bayer AB |
| --- |
| Gustav III:s Boulevard 56 |
| Postbox 606 |
| SE-16926 Solna |
| Sweden |

Bayer AB

Gustav III:s Boulevard 56

Postbox 606

SE-16926 Solna

Sweden

Eloine

0,02 mg/3 mg

Film-coated tablet

Oral use

Finland

| Bayer Oy |
| --- |
| Pansiontie 47 |
| PO Box 415 |
| 20101 Turku |
| Finland |

Bayer Oy

Pansiontie 47

PO Box 415

20101 Turku

Finland

Linatera

0,02 mg/3 mg

Film-coated tablet

Oral use

France

| BAYER SANTE |
| --- |
| 220 avenue de la Recherche |
| 59120 Loos |
| France |

BAYER SANTE

220 avenue de la Recherche

59120 Loos

France

RIMENDIA 0,02 mg/3 mg comprimé pelliculé

0,02 mg/3 mg

Film-coated tablet

Oral use

Germany

| Jenapharm GmbH & Co. KG |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |
| Germany |

Jenapharm GmbH & Co. KG

Otto-Schott-Str. 15

D-07745 Jena

Germany

Eloine 0,02 mg/3 mg Filmtabletten

0,02 mg/3 mg

Film-coated tablet

Oral use

Greece

| BAYER HELLAS ABEE |
| --- |
| Sorou 18-20 |
| Maroussi 15127 |
| Greece |

BAYER HELLAS ABEE

Sorou 18-20

Maroussi 15127

Greece

LINATERA

0,02 mg/3 mg

Film-coated tablet

Oral use

Iceland

| Bayer AB |
| --- |
| Gustav III:s Boulevard 56 |
| 169 26 Solna |
| Sweden |

Bayer AB

Gustav III:s Boulevard 56

169 26 Solna

Sweden

Eloine

0,02 mg/3 mg

Film-coated tablet

Oral use

Italy

| Bayer S.p.A. |
| --- |
| Viale Certosa 130 |
| Milano 20156 |
| Italy |

Bayer S.p.A.

Viale Certosa 130

Milano 20156

Italy

ELOINE

0,02 mg/3 mg

Film-coated tablet

Oral use

Malta

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

Bayer plc

Bayer House

Strawberry Hill, Newbury

Berkshire, RG14 1JA

United Kingdom

ELOINE 0.02 mg/3 mg film coated tablets

0,02 mg/3 mg

Film-coated tablet

Oral use

Norway

| Bayer AB |
| --- |
| Gustav III's Boulevard 56 |
| 169 26 Solna |
| Sweden |

Bayer AB

Gustav III's Boulevard 56

169 26 Solna

Sweden

Eloine

0,02 mg/3 mg

Film-coated tablet

Oral use

Poland

| Bayer Pharma AG |
| --- |
| Müllerstr. 178, Berlin |
| D-13342 |
| Germany |

Bayer Pharma AG

Müllerstr. 178, Berlin

D-13342

Germany

Linatera

0,02 mg/3 mg

Film-coated tablet

Oral use

Portugal

| Berlifarma - Especialidades Farmacêuticas, Lda. |
| --- |
| Rua Quinta Pinheiro, 5, Outurela |
| 2794-003 Carnaxide |
| Portugal |

Berlifarma - Especialidades Farmacêuticas, Lda.

Rua Quinta Pinheiro, 5, Outurela

2794-003 Carnaxide

Portugal

Linatera

0,02 mg/3 mg

Film-coated tablet

Oral use

Slovak Republic

| Bayer spol. s r.o. |
| --- |
| Einsteinova 25 |
| 851 01 Bratislava |
| Slovak Republic |

Bayer spol. s r.o.

Einsteinova 25

851 01 Bratislava

Slovak Republic

Linatera

0,02 mg/3 mg

Film-coated tablet

Oral use

Slovenia

| Bayer d.o.o. |
| --- |
| Bravničarjeva 13 |
| SI-1000 Ljubljana |
| Slovenia |

Bayer d.o.o.

Bravničarjeva 13

SI-1000 Ljubljana

Slovenia

Linatera 0,02 mg/3 mg filmsko obložene tablete

0,02 mg/3 mg

Film-coated tablet

Oral use

Spain

| BAYHEALTH S.L. |
| --- |
| Avda. Baix Llobregat 3 y 5 |
| 08970 Sant Joan Despi |
| Barcelona |
| Spain |

BAYHEALTH S.L.

Avda. Baix Llobregat 3 y 5

08970 Sant Joan Despi

Barcelona

Spain

ELOINE 0,02 mg/3 mg comprimidos recubiertos con película

0,02 mg/3 mg

Film-coated tablet

Oral use

Sweden

| Bayer AB |
| --- |
| Box 606 |
| SE-16929 Solna |
| Sweden |

Bayer AB

Box 606

SE-16929 Solna

Sweden

Eloine

0,02 mg/3 mg

Film-coated tablet

Oral use

The Netherlands

| Berlipharm BV. |
| --- |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| The Netherlands |

Berlipharm BV.

Energieweg 1

3641 RT Mijdrecht

The Netherlands

Ethinylestradiol/Drospirenon 24 + 4 0,02 mg/3 mg Berlipharm, filmomhulde tabletten

0,02 mg/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

ELOINE Film-Coated Tablets 0.02 mg/3 mg

0,02 mg/3 mg

Film-coated tablet

Oral use

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