# Official Journal C 148/2012

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2012.148.eng |
| --- | --- |
| Official Journal
  of the European Union | C 148 |
| | |
| English edition | Information and Notices | Volume 5525 May 2012 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2012.148.eng

Official Journal

of the European Union

C 148

English edition

Information and Notices

Volume 5525 May 2012

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2012/C 148/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2012 to 30 April 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 148/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2012 to 30 April 2012(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 12 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2012/C 148/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2012 to 30 April 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 148/02

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

12

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 25.5.2012 | EN | Official Journal of the European Union | C 148/1 |
| --- | --- | --- | --- |

25.5.2012

EN

Official Journal of the European Union

C 148/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2012 to 30 April 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 148/01

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.4.2012 | Bronchitol | Mannitol | Pharmaxis Pharmaceuticals Limited |
| The Priory, Stomp Road, Burnham, |
| Buckinghamshire, |
| SL1 7LW, |
| 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

13.4.2012

Bronchitol

Mannitol

Pharmaxis Pharmaceuticals Limited

The Priory, Stomp Road, Burnham,

Buckinghamshire,

SL1 7LW,

United Kingdom

EU/1/12/760/001-002

Inhalation powder, hard capsule

R05CB16

18.4.2012

13.4.2012

Sabervel

Irbesartan

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

Pharmathen S.A.

6 Dervenakion,

15351 Pallini Attiki,

Ελλάδα

EU/1/12/765/001-006

Film-coated tablet

C09CA04

17.4.2012

20.4.2012

Capecitabine Accord

capecitabine

| Accord Healthcare Limited |
| --- |
| Sage house, 319 Pinner road, North Harrow, |
| Middlesex |
| HA1 4HF |
| United Kingdom |

Accord Healthcare Limited

Sage house, 319 Pinner road, North Harrow,

Middlesex

HA1 4HF

United Kingdom

EU/1/12/762/001-018

Film-coated tablet

L01BC06

25.4.2012

20.4.2012

Capecitabine Krka

capecitabine

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

KRKA, d.d

Novo mesto, Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

EU/1/12/763/001-018

Film-coated tablet

L01BC06

25.4.2012

20.4.2012

Capecitabine Teva

capecitabine

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

TEVA Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/12/761/001-002

Film-coated tablet

L01BC06

25.4.2012

20.4.2012

Nimenrix

Meningococcal group A, C, W-135 and Y conjugate vaccine

| 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/1/12/767/001-007

Powder and solvent for solution for injection

J07AH08

25.4.2012

20.4.2012

SANCUSO

granisetron

| ProStrakan Limited |
| --- |
| Galabank Business Park, |
| Galashiels, |
| TD1 1QH, |
| United Kingdom |

ProStrakan Limited

Galabank Business Park,

Galashiels,

TD1 1QH,

United Kingdom

EU/1/12/766/001

Transdermal patch

A04AA02

25.4.2012

20.4.2012

Zoledronic acid Actavis

zoledronic acid

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

Actavis Group PTC ehf.

ReykjavÍkurvegur 76-78,

Hafnarfjörður 220,

Iceland

EU/1/12/759/001-003

Concentrate for solution for infusion

M05BA08

26.4.2012

24.4.2012

Signifor

pasireotide

| 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/1/12/753/001-012

Solution for injection

H01CB05

27.4.2012

—   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 |
| --- | --- | --- | --- | --- |
| 3.4.2012 | Kinzalkomb | Bayer Pharma AG |
| 13342 Berlin, |
| 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

3.4.2012

Kinzalkomb

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/02/214/001-015

5.4.2012

4.4.2012

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

10.4.2012

4.4.2012

Plavix

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 174 avenue de France - |
| 75013 Paris, |
| France |

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France -

75013 Paris,

France

EU/1/98/069/001a-001b

EU/1/98/069/002a-002b

EU/1/98/069/003a-003b

EU/1/98/069/004a-004b

EU/1/98/069/005a-005b

EU/1/98/069/006a-006b

EU/1/98/069/007a-007b

EU/1/98/069/008-010

EU/1/98/069/011a-011b

EU/1/98/069/012

11.4.2012

4.4.2012

Rebetol

| Schering Plough Europe |
| --- |
| Clos du Lynx 5, |
| 1200 Bruxelles, |
| Belgique – |

Schering Plough Europe

Clos du Lynx 5,

1200 Bruxelles,

Belgique –

| Lynx Binnenhof 5, |
| --- |
| 1200 Brussel, |
| België |

Lynx Binnenhof 5,

1200 Brussel,

België

EU/1/99/107/001-005

11.4.2012

4.4.2012

Telzir

| 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/1/04/282/001-002

11.4.2012

10.4.2012

Vedrop

| Orphan Europe SARL |
| --- |
| Immeuble Le Wilson - |
| 70 Avenue du Général de Gaulle - |
| F 92 800 Puteaux - |
| France |

Orphan Europe SARL

Immeuble Le Wilson -

70 Avenue du Général de Gaulle -

F 92 800 Puteaux -

France

EU/1/09/533/001-003

12.4.2012

13.4.2012

Advagraf

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19, |
| NL-2353 EW Leiderdorp, |
| Nederland |

Astellas Pharma Europe B.V.

Elisabethhof 19,

NL-2353 EW Leiderdorp,

Nederland

EU/1/07/387/001-026

17.4.2012

13.4.2012

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

17.4.2012

13.4.2012

Champix

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

Pfizer Ltd

Ramsgate Road, Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/06/360/001-013

17.4.2012

13.4.2012

Evoltra

| Genzyme Europe BV |
| --- |
| Gooimeer 10, |
| 1411 DD Naarden, |
| Nederland |

Genzyme Europe BV

Gooimeer 10,

1411 DD Naarden,

Nederland

EU/1/06/334/001-005

17.4.2012

13.4.2012

Foscan

| Biolitec pharma Ltd |
| --- |
| United Drug House, Magna Drive, |
| Dublin 24, |
| Ireland |

Biolitec pharma Ltd

United Drug House, Magna Drive,

Dublin 24,

Ireland

EU/1/01/197/003-005

17.4.2012

13.4.2012

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/1/08/442/001-014

17.4.2012

13.4.2012

Prometax

| 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/1/98/092/001-026

17.4.2012

13.4.2012

Revatio

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

Pfizer Limited

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

EU/1/05/318/001

17.4.2012

13.4.2012

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/1/07/391/001-004

17.4.2012

13.4.2012

Soliris

| Alexion Europe S.A.S. |
| --- |
| 25, boulevard de l'Amiral Bruix, |
| 75016 Paris, |
| France |

Alexion Europe S.A.S.

25, boulevard de l'Amiral Bruix,

75016 Paris,

France

EU/1/07/393/001

17.4.2012

13.4.2012

Tyverb

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

Glaxo Group Limited

Berkeley Avenue, Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/07/440/001-006

17.4.2012

13.4.2012

Viramune

| 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/1/97/055/001-009

17.4.2012

13.4.2012

Volibris

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

Glaxo Group Ltd

Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/08/451/001-004

17.4.2012

20.4.2012

Abraxane

| 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/1/07/428/001

24.4.2012

20.4.2012

Aclasta

| 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/1/05/308/001-002

25.4.2012

20.4.2012

Aflunov

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, |
| 53100 Siena, |
| Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/10/658/001-002

26.4.2012

20.4.2012

Altargo

| 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/1/07/390/001-004

26.4.2012

20.4.2012

Apidra

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/04/285/001-036

26.4.2012

20.4.2012

Ceplene

| EpiCept GmbH |
| --- |
| Goethestrasse 4, |
| D-80336 München, |
| Deutschland |

EpiCept GmbH

Goethestrasse 4,

D-80336 München,

Deutschland

EU/1/08/477/001

24.4.2012

20.4.2012

Circadin

| RAD Neurim Pharmaceuticals EEC Limited |
| --- |
| One Forbury Square, The Forbury, Reading, |
| Berkshire |
| RG1 3EB, |
| United Kingdom |

RAD Neurim Pharmaceuticals EEC Limited

One Forbury Square, The Forbury, Reading,

Berkshire

RG1 3EB,

United Kingdom

EU/1/07/392/001-003

25.4.2012

20.4.2012

Exelon

| 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/1/98/066/001-026

26.3.2012

20.4.2012

Focetria

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, |
| 53100 Siena, |
| Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/07/385/001-002

EU/1/07/385/004

26.4.2012

20.4.2012

HALAVEN

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

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield,

Herts

AL10 9SN,

United Kingdom

EU/1/11/678/001-002

25.4.2012

20.4.2012

Helixate NexGen

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

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/00/144/001-005

25.4.2012

20.4.2012

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/1/03/256/002-010

25.4.2012

20.4.2012

Insulin Human Winthrop

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/06/368/001-015

EU/1/06/368/020-024

EU/1/06/368/029-033

EU/1/06/368/037-042

EU/1/06/368/047-051

EU/1/06/368/056-057

EU/1/06/368/088-102

EU/1/06/368/113-150

EU/1/06/368/163-168

25.4.2012

20.4.2012

Insuman

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/97/030/028-195

26.4.2012

20.4.2012

IOA

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

N.V. Organon

Kloosterstraat 6,

5349 AB Oss,

Nederland

EU/1/11/689/001-002

24.4.2012

20.4.2012

Iressa

| AstraZeneca AB |
| --- |
| S 151 85 Sodertalje, |
| Sverige |

AstraZeneca AB

S 151 85 Sodertalje,

Sverige

EU/1/09/526/001-002

26.4.2012

20.4.2012

Kogenate Bayer

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

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/00/143/004-013

25.4.2012

20.4.2012

Lantus

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/00/134/001-037

25.4.2012

20.4.2012

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

26.4.2012

20.4.2012

NovoNorm

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/98/076/004-006

EU/1/98/076/011-013

EU/1/98/076/018-020

EU/1/98/076/022-024

26.3.2012

20.4.2012

Opgenra

| Olympus Biotech International Limited |
| --- |
| Raheen Business Park, Limerick, |
| Ireland |

Olympus Biotech International Limited

Raheen Business Park, Limerick,

Ireland

EU/1/08/489/001-002

24.4.2012

20.4.2012

Optimark

| Covidien Deutschland GmbH |
| --- |
| Gewerbepark 1, |
| 93333 Neustadt/Donau, |
| Deutschland |

Covidien Deutschland GmbH

Gewerbepark 1,

93333 Neustadt/Donau,

Deutschland

EU/1/07/398/001-014

26.3.2012

20.4.2012

Optisulin

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/00/133/001-032

25.4.2012

20.4.2012

Pelzont

| 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/1/08/460/001-014

25.4.2012

20.4.2012

Prandin

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/00/162/003-005

EU/1/00/162/009-011

EU/1/00/162/015-017

EU/1/00/162/019-021

26.4.2012

20.4.2012

Preotact

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1, |
| DK-4000 Roskilde, |
| Danmark |

Nycomed Danmark ApS

Langebjerg 1,

DK-4000 Roskilde,

Danmark

EU/1/06/339/001-003

25.4.2012

20.4.2012

Prolia

| Amgen Europe B.V. |
| --- |
| Minervum 7061, |
| NL-4817 ZK Breda, |
| Nederland |

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/10/618/001-004

24.4.2012

20.4.2012

ProQuad

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/05/323/001-013

26.4.2012

20.4.2012

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

24.4.2012

20.4.2012

Rasilez

| 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/1/07/405/001-040

24.4.2012

20.4.2012

Riprazo

| 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/1/07/409/001-040

24.4.2012

20.4.2012

Riprazo 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/1/11/680/001-080

24.4.2012

20.4.2012

Samsca

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, |
| Middlesex |
| UB8 1LX, |
| United Kingdom |

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Business Park, Oxford Road, Uxbridge,

Middlesex

UB8 1LX,

United Kingdom

EU/1/09/539/001-004

24.4.2012

20.4.2012

Sebivo

| 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/1/07/388/001-003

26.4.2012

20.4.2012

Silodyx

| Recordati Ireland Ltd. |
| --- |
| Raheens East, Ringaskiddy Co. Cork, |
| Ireland |

Recordati Ireland Ltd.

Raheens East, Ringaskiddy Co. Cork,

Ireland

EU/1/09/607/001-014

24.4.2012

20.4.2012

Sprimeo

| 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/1/07/407/001-040

24.4.2012

20.4.2012

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

24.4.2012

20.4.2012

Tracleer

| Actelion Registration Ltd |
| --- |
| BSI Building 13th Floor, 389 Chiswick High Road, |
| London |
| W4 4AL, |
| United Kingdom |

Actelion Registration Ltd

BSI Building 13th Floor, 389 Chiswick High Road,

London

W4 4AL,

United Kingdom

EU/1/02/220/001-006

26.4.2012

20.4.2012

Tredaptive

| 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/1/08/459/001-014

25.4.2012

20.4.2012

Trevaclyn

| 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/1/08/458/001-014

25.4.2012

20.4.2012

Urorec

| Recordati Ireland Ltd. |
| --- |
| Raheens East, Ringaskiddy Co. Cork, |
| Ireland |

Recordati Ireland Ltd.

Raheens East, Ringaskiddy Co. Cork,

Ireland

EU/1/09/608/001-014

24.4.2012

20.4.2012

Ventavis

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

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/03/255/001-008

26.4.2012

20.4.2012

Vfend

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

Pfizer Ltd

Ramsgate Road, Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/02/212/001-026

25.4.2012

20.4.2012

Victoza

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/09/529/001-005

24.4.2012

20.4.2012

Vidaza

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

Celgene Europe Ltd

1 Longwalk Road, Stockley Park,

Uxbridge,

UB11 1DB,

United Kingdom

EU/1/08/488/001

24.4.2012

20.4.2012

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

24.4.2012

20.4.2012

Yttriga

| Eckert & Ziegler Radiopharma GmbH |
| --- |
| Robert-Rössle-Str. 10, |
| 13125 Berlin, |
| Deutschland |

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Str. 10,

13125 Berlin,

Deutschland

EU/1/05/322/001-002

26.4.2012

20.4.2012

Zoely

| Theramex S.r.l. |
| --- |
| Via Messina 38, |
| 20154 Milano, |
| Italia |

Theramex S.r.l.

Via Messina 38,

20154 Milano,

Italia

EU/1/11/690/001-002

24.4.2012

24.4.2012

Menveo

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, |
| 53100 Siena, |
| Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/10/614/001-003

27.4.2012

24.4.2012

Rasilez HCT

| 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/1/08/491/001-080

27.4.2012

24.4.2012

Temomedac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Fehlandtstrasse 3, |
| D-20354 Hamburg - |
| Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstrasse 3,

D-20354 Hamburg -

Deutschland

EU/1/09/605/001-012

27.4.2012

26.4.2012

Revolade

| GlaxoSmithKline Trading Services Limited |
| --- |
| 6900 Cork Airport Business Park, Kinsale Road, Cork, |
| Ireland |

GlaxoSmithKline Trading Services Limited

6900 Cork Airport Business Park, Kinsale Road, Cork,

Ireland

EU/1/10/612/001-006

30.4.2012

26.4.2012

Yervoy

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, |
| Uxbridge |
| UB8 1DH, |
| United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road,

Uxbridge

UB8 1DH,

United Kingdom

EU/1/11/698/001-002

30.4.2012

—   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 |
| --- | --- | --- | --- | --- |
| 20.4.2012 | PhotoBarr | Pinnacle Biologics B.V. |
| p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, |
| 1043 DP Amsterdam, |
| 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

20.4.2012

PhotoBarr

Pinnacle Biologics B.V.

p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10,

1043 DP Amsterdam,

Nederland

EU/1/04/272/001-002

25.4.2012

24.4.2012

Refludan

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

Celgene Europe Ltd

1 Longwalk Road, Stockley Park,

Uxbridge,

UB11 1DB,

United Kingdom

EU/1/97/035/001-004

27.4.2012

—   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 |
| --- | --- | --- | --- | --- |
| 10.4.2012 | Slentrol | Pfizer Ltd |
| Ramsgate Road, Sandwich, |
| Kent |
| CT 13 9NJ, |
| 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

10.4.2012

Slentrol

Pfizer Ltd

Ramsgate Road, Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/2/07/071/001-003

12.4.2012

13.4.2012

Cerenia

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

Pfizer Ltd

Ramsgate Road, Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/2/06/062/005

17.4.2012

20.4.2012

BTVPUR AlSap 1

| MERIAL |
| --- |
| 29 avenue Tony Garnier, |
| 69007 LYON, |
| France |

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/112/001-005

25.4.2012

20.4.2012

BTVPUR AlSap 1-8

| MERIAL |
| --- |
| 29 avenue Tony Garnier, |
| 69007 LYON, |
| France |

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/113/001-005

25.4.2012

20.4.2012

Loxicom

| Norbrook Laboratories Limited |
| --- |
| Station Works, Newry, |
| Co. Down, |
| BT35 6JP, |
| United Kindgom |

Norbrook Laboratories Limited

Station Works, Newry,

Co. Down,

BT35 6JP,

United Kindgom

EU/2/08/090/001-027

24.4.2012

20.4.2012

Meloxivet

| Janssen Pharmaceutica N.V. |
| --- |
| Turnhoutseweg 30, |
| B-2340 Beerse, |
| België |

Janssen Pharmaceutica N.V.

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/2/07/077/001-005

25.4.2012

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.

---

| 25.5.2012 | EN | Official Journal of the European Union | C 148/12 |
| --- | --- | --- | --- |

25.5.2012

EN

Official Journal of the European Union

C 148/12

---

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

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

2012/C 148/02

—   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 |
| --- | --- | --- | --- | --- |
| 24.4.2012 | Orlistat | See Annex I | See Annex I | 26.4.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

24.4.2012

Orlistat

See Annex I

See Annex I

26.4.2012

---

(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, ROUTE OF ADMINISTRATIONS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State /EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Eurogenerics NV |
| Heizel Esplanade b22 |
| 1020 Brussel |
| Belgium |

Member State /EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Belgium

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Orlistat EG

60 mg

capsule, hard

oral use

Belgium

| Eurogenerics NV |
| --- |
| Heizel Esplanade b22 |
| 1020 Brussel |
| Belgium |

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Orlistat EG

120 mg

capsule, hard

oral use

Belgium

| Pharmaceuticals Works Pharma SA |
| --- |
| 19, Pelplinska street |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceuticals Works Pharma SA

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

60 mg

capsule, hard

oral use

Belgium

| Pharmaceuticals Works Pharma SA |
| --- |
| 19, Pelplinska street |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceuticals Works Pharma SA

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Belgium

| Sandoz NV/SA |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| B-Vilvoorde |
| Belgium |

Sandoz NV/SA

Telecom Gardens

Medialaan 40

B-Vilvoorde

Belgium

Orlistat Sandoz

60 mg

capsule, hard

oral use

Belgium

| Sandoz NV/SA |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| B-Vilvoorde |
| Belgium |

Sandoz NV/SA

Telecom Gardens

Medialaan 40

B-Vilvoorde

Belgium

Orlistat Sandoz

120 mg

capsule, hard

oral use

Bulgaria

| Pharmaceutical Works Polpharma S.A |
| --- |
| 19, Peplinska Street |
| 83-200 Starogar Gdanski |
| Poland |

Pharmaceutical Works Polpharma S.A

19, Peplinska Street

83-200 Starogar Gdanski

Poland

Orlistat Polpharma

60 mg

capsule, hard

oral use

Bulgaria

| Pharmaceutical Works Polpharma S.A |
| --- |
| 19, Peplinska Street |
| 83-200 Starogar Gdanski |
| Poland |

Pharmaceutical Works Polpharma S.A

19, Peplinska Street

83-200 Starogar Gdanski

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Bulgaria

| Teva Pharmaceuticals Bulgaria EOOD |
| --- |
| 15 N.V Gogol Str. |
| 1124 Sofia |
| Bulgaria |

Teva Pharmaceuticals Bulgaria EOOD

15 N.V Gogol Str.

1124 Sofia

Bulgaria

Orlistat Teva

60 mg

capsule, hard

oral use

Bulgaria

| Teva Pharmaceuticals Bulgaria EOOD |
| --- |
| 15 N.V Gogol Str. |
| 1124 Sofia |
| Bulgaria |

Teva Pharmaceuticals Bulgaria EOOD

15 N.V Gogol Str.

1124 Sofia

Bulgaria

Orlistat Teva

120 mg

capsule, hard

oral use

Czech Republic

| Sandoz s.r.o |
| --- |
| U Nákladového nádraží 10 |
| CZ-130 00, Praha 3, |
| Czech Republic |

Sandoz s.r.o

U Nákladového nádraží 10

CZ-130 00, Praha 3,

Czech Republic

Orlistat Sandoz 60 mg

60 mg

capsule, hard

oral use

Czech Republic

| Sandoz s.r.o |
| --- |
| U Nákladového nádraží 10 |
| CZ-130 00, Praha 3, |
| Czech Republic |

Sandoz s.r.o

U Nákladového nádraží 10

CZ-130 00, Praha 3,

Czech Republic

Orlistat Sandoz 120 mg

120 mg

capsule, hard

oral use

Czech Republic

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

Teva Pharmaceuticals CR s.r.o.

Radlická 3185/1c

150 00 Prague

Czech Republic

Orlistat Teva 60 mg

60 mg

capsule, hard

oral use

Czech Republic

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

Teva Pharmaceuticals CR s.r.o.

Radlická 3185/1c

150 00 Prague

Czech Republic

Orlistat Teva 120 mg

120 mg

capsule, hard

oral use

Denmark

| Sandoz A/S, |
| --- |
| Edvard Thomsens Vej 14, |
| DK-2300 Copenhagen S, |
| Denmark |

Sandoz A/S,

Edvard Thomsens Vej 14,

DK-2300 Copenhagen S,

Denmark

Orlistat "Sandoz"

60 mg

capsule, hard

oral use

Denmark

| Teva Denmark A/S, |
| --- |
| Parallelvej 10-12, |
| DK-2800 Kongens Lyngby, |
| Denmark |

Teva Denmark A/S,

Parallelvej 10-12,

DK-2800 Kongens Lyngby,

Denmark

Orlistat "Teva"

60 mg

capsule, hard

oral use

Denmark

| Teva Denmark A/S, |
| --- |
| Parallelvej 10-12, |
| DK-2800 Kongens Lyngby, |
| Denmark |

Teva Denmark A/S,

Parallelvej 10-12,

DK-2800 Kongens Lyngby,

Denmark

Orlistat "Teva"

120 mg

capsule, hard

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

ORLISTAT TEVA 60 MG

60 mg

capsule, hard

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

ORLISTAT TEVA 120 MG

120 mg

capsule, hard

oral use

Estonia

| Pharmaceutical Works Polpharma S.A. |
| --- |
| 19 Pelplinska Str. |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Str.

83-200 Starogard Gdanski

Poland

ORLISTAT POLPHARMA 60 MG

60 mg

capsule, hard

oral use

Estonia

| Pharmaceutical Works Polpharma S.A. |
| --- |
| 19 Pelplinska Str. |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Str.

83-200 Starogard Gdanski

Poland

ORLISTAT POLPHARMA 120 MG

120 mg

capsule, hard

oral use

Estonia

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

ORLISTAT SANDOZ 60 MG

60 mg

capsule, hard

oral use

Estonia

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

ORLISTAT SANDOZ 120 MG

120 mg

capsule, hard

oral use

Finland

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

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Orlistat ratiopharm

120 mg

capsule, hard

oral use

Finland

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

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Orlistat ratiopharm

60 mg

capsule, hard

oral use

Finland

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| S 2300 Copenhagen |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

S 2300 Copenhagen

Denmark

Orlistat Sandoz

60 mg

capsule, hard

oral use

Finland

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

Stada Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

Orlistat Stada

120 mg

capsule, hard

oral use

Finland

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

Stada Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

Orlistat Stada

60 mg

capsule, hard

oral use

France

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

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

ORLISTAT SANDOZ 120 mg, gélule

120 mg

capsule, hard

oral use

France

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

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

ORLISTAT SANDOZ 60 mg, gélule

60 mg

capsule, hard

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

ORLISTAT EG 120 mg, gélule

120 mg

capsule, hard

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

ORLISTAT EG 60 mg, gélule

60 mg

capsule, hard

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

ORLISTAT TEVA 120 mg, gélule

120 mg

capsule, hard

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

ORLISTAT TEVA 60 mg, gélule

60 mg

capsule, hard

oral use

Germany

| Aliud Pharma GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |
| Germany |

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Germany

Orlistat AL 60 mg Hartkapseln

60 mg

capsule, hard

oral use

Germany

| HEXAL Aktiengesellschaft |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL Aktiengesellschaft

Industriestr. 25

D-83607 Holzkirchen

Germany

Orlistat HEXAL 120 mg Hartkapseln

120 mg

capsule, hard

oral use

Germany

| HEXAL Aktiengesellschaft |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL Aktiengesellschaft

Industriestr. 25

D-83607 Holzkirchen

Germany

Orlistat HEXAL 60 mg Hartkapseln

60 mg

capsule, hard

oral use

Germany

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

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Orlistat-ratiopharm 120 mg Hartkapseln

120 mg

capsule, hard

oral use

Germany

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

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Orlistat-ratiopharm 60 mg Hartkapseln

60 mg

capsule, hard

oral use

Italy

| EG S.P.A. |
| --- |
| Via Scarlatti, 31 |
| 20124 Milano |
| Italy |

EG S.P.A.

Via Scarlatti, 31

20124 Milano

Italy

ORLSTAT EUROGENERICI

60 mg

capsule, hard

oral use

Italy

| EG S.P.A. |
| --- |
| Via Scarlatti, 31 |
| 20124 Milano |
| Italy |

EG S.P.A.

Via Scarlatti, 31

20124 Milano

Italy

ORLISTAT EG

120 mg

capsule, hard

oral use

Latvia

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

Sandoz d.d.,

Verovškova 57,

SI-1000 Ljubljana,

Slovenia

Orlistat Sandoz

60 mg

capsule, hard

oral use

Latvia

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

Sandoz d.d.,

Verovškova 57,

SI-1000 Ljubljana,

Slovenia

Orlistat Sandoz

120 mg

capsule, hard

oral use

Latvia

| Pharmaceutical Works POLPHARMA SA, |
| --- |
| 19 Pelplińska Street, |
| 83-200 Starogard Gdański, |
| Poland |

Pharmaceutical Works POLPHARMA SA,

19 Pelplińska Street,

83-200 Starogard Gdański,

Poland

Orlistat Polpharma

60 mg

capsule, hard

oral use

Latvia

| Pharmaceutical Works POLPHARMA SA, |
| --- |
| 19 Pelplińska Street, |
| 83-200 Starogard Gdański, |
| Poland |

Pharmaceutical Works POLPHARMA SA,

19 Pelplińska Street,

83-200 Starogard Gdański,

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Latvia

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

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

The Netherlands

Orlistat Teva

60 mg

capsule, hard

oral use

Latvia

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

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

The Netherlands

Orlistat Teva

120 mg

capsule, hard

oral use

Lithuania

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

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

the Netherlands

Orlistat Teva

60 mg

capsule, hard

oral use

Lithuania

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

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

The Netherlands

Orlistat Teva

120 mg

capsule, hard

oral use

Lithuania

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| SI-1000 Ljubljana |
| Slovėnia |

Sandoz d.d.

Verovškova 57

SI-1000 Ljubljana

Slovėnia

Orlistat Sandoz

120 mg

capsule, hard

oral use

Lithuania

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| SI-1000 Ljubljana |
| Slovėnia |

Sandoz d.d.

Verovškova 57

SI-1000 Ljubljana

Slovėnia

Orlistat Sandoz

60 mg

capsule, hard

oral use

Lithuania

| Pharmaceutical Works POLPHARMA S.A., |
| --- |
| 19 Pelplinska Street, |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceutical Works POLPHARMA S.A.,

19 Pelplinska Street,

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

60 mg

capsule, hard

oral use

Lithuania

| Pharmaceutical Works POLPHARMA S.A., |
| --- |
| 19 Pelplinska Street, |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceutical Works POLPHARMA S.A.,

19 Pelplinska Street,

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Norway

| Teva Sweden AB |
| --- |
| Järnvägsgatan 11, |
| Box 1070, |
| 251 10 Helsingborg |
| Sweden |

Teva Sweden AB

Järnvägsgatan 11,

Box 1070,

251 10 Helsingborg

Sweden

Orlistat Teva

60 mg

capsule, hard

oral use

Norway

| Teva Sweden AB |
| --- |
| Järnvägsgatan 11, |
| Box 1070, |
| 251 10 Helsingborg |
| Sweden |

Teva Sweden AB

Järnvägsgatan 11,

Box 1070,

251 10 Helsingborg

Sweden

Orlistat Teva

120 mg

capsule, hard

oral use

Norway

| Sandoz A/S, |
| --- |
| Edvard Thomsens Vej 14, |
| 2300 København S, |
| Denmark |

Sandoz A/S,

Edvard Thomsens Vej 14,

2300 København S,

Denmark

Orlistat Sandoz

60 mg

capsule, hard

oral use

Poland

| Pharmaceutical Works POLPHARMA SA |
| --- |
| 19, Pelplińska Street |
| 83-200 Starogard Gdański |
| Poland |

Pharmaceutical Works POLPHARMA SA

19, Pelplińska Street

83-200 Starogard Gdański

Poland

Orlistat Polpharma 120 mg

120 mg

capsule, hard

oral use

Poland

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

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl,

Austria

Orlistat Sandoz 120 mg

120 mg

capsule, hard

oral use

Poland

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| D-61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Orlistat STADA 120 mg

120 mg

capsule, hard

oral use

Poland

| Teva Pharmaceuticals Polska Sp. z o.o. |
| --- |
| ul. Emilii Plater 53 |
| 00-113 Warszawa |
| Poland |

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warszawa

Poland

Orlistat Teva 120 mg

120 mg

capsule, hard

oral use

Poland

| Pharmaceutical Works POLPHARMA SA |
| --- |
| 19, Pelplińska Street |
| 83-200 Starogard Gdański |
| Poland |

Pharmaceutical Works POLPHARMA SA

19, Pelplińska Street

83-200 Starogard Gdański

Poland

Orlistat Polpharma 60 mg

60 mg

capsule, hard

oral use

Poland

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

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl,

Austria

Orlistat Sandoz 60 mg

60 mg

capsule, hard

oral use

Poland

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| D-61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Orlistat STADA 60 mg

60 mg

capsule, hard

oral use

Portugal

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B |
| 2770-229 Paço de Arcos |
| Portugal |

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B

2770-229 Paço de Arcos

Portugal

Orlistato Ciclum

60 mg

capsule, hard

oral use

Portugal

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B |
| 2770-229 Paço de Arcos |
| Portugal |

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B

2770-229 Paço de Arcos

Portugal

Orlistato Ciclum

120 mg

capsule, hard

oral use

Portugal

| Pharmaceutical Works Polpharma S.A. |
| --- |
| 19, Pelplinska street |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceutical Works Polpharma S.A.

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistato Ratiopharm

60 mg

capsule, hard

oral use

Portugal

| Pharmaceutical Works Polpharma S.A. |
| --- |
| 19, Pelplinska street |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceutical Works Polpharma S.A.

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistato Ratiopharm

120 mg

capsule, hard

oral use

Romania

| Pharmaceutical Works Polpharma SA, |
| --- |
| Address: 19, Pelplińska Street, |
| 83-200 Starogard Gdański, |
| Poland |

Pharmaceutical Works Polpharma SA,

Address: 19, Pelplińska Street,

83-200 Starogard Gdański,

Poland

Sulixa

60 mg

capsule, hard

oral use

Romania

| Pharmaceutical Works Polpharma SA, |
| --- |
| Address: 19, Pelplińska Street, |
| 83-200 Starogard Gdański, |
| Poland |

Pharmaceutical Works Polpharma SA,

Address: 19, Pelplińska Street,

83-200 Starogard Gdański,

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Slovak Republic

| TEVA Pharmaceuticals Slovakia s.r.o |
| --- |
| Teslova 26 |
| 821 02 Bratislava |
| Slovak Republic |

TEVA Pharmaceuticals Slovakia s.r.o

Teslova 26

821 02 Bratislava

Slovak Republic

Orlistat Teva 60 mg

60 mg

capsule, hard

oral use

Slovak Republic

| TEVA Pharmaceuticals Slovakia s.r.o. |
| --- |
| Teslova 26 |
| 821 02 Bratislava |
| Slovak Republic |

TEVA Pharmaceuticals Slovakia s.r.o.

Teslova 26

821 02 Bratislava

Slovak Republic

Orlistat Teva 120 mg

120 mg

capsule, hard

oral use

Slovak Republic

| Pharmaceutical Works POLPHARMA SA |
| --- |
| 19, Pelpliňska Str. |
| 83-200 Starogard Gdaňski |
| Poland |

Pharmaceutical Works POLPHARMA SA

19, Pelpliňska Str.

83-200 Starogard Gdaňski

Poland

Orlistat Polpharma 60 mg

60 mg

capsule, hard

oral use

Slovak Republic

| Pharmaceutical Works POLPHARMA SA |
| --- |
| 19, Pelpliňska Str. |
| 83-200 Starogard Gdaňski |
| Poland |

Pharmaceutical Works POLPHARMA SA

19, Pelpliňska Str.

83-200 Starogard Gdaňski

Poland

Orlistat Polpharma 120 mg

120 mg

capsule, hard

oral use

Sweden

| Sandoz A/S,, Edvard Thomsens Vej 14 |
| --- |
| DK-2300 Köpenhamn S, |
| Denmark |

Sandoz A/S,, Edvard Thomsens Vej 14

DK-2300 Köpenhamn S,

Denmark

Orlistat Sandoz

60 mg

capsule, hard

oral use

The Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH ALMERE |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Orlistat Sandoz 60 mg

60 mg

capsule, hard

oral use

The Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH ALMERE |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Orlistat Sandoz 120 mg

120 mg

capsule, hard

oral use

United Kingdom

| Teva UK Limited, |
| --- |
| Brampton Road, |
| Hampden Park, |
| Eastbourne, |
| East Sussex |
| BN22 9AG |
| United Kingdom |

Teva UK Limited,

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex

BN22 9AG

United Kingdom

TEVA UK Orlistat capsules 60 mg

60 mg

capsule, hard

oral use

United Kingdom

| Teva UK Limited, |
| --- |
| Brampton Road, |
| Hampden Park, |
| Eastbourne, |
| East Sussex |
| BN22 9AG |
| United Kingdom |

Teva UK Limited,

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex

BN22 9AG

United Kingdom

TEVA UK Orlistat capsules 120 mg

120 mg

capsule, hard

oral use

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