# Official Journal C 359/2010

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2010.359.eng |
| --- | --- |
| Official Journal
  of the European Union | C 359 |
| | |
| English edition | Information and Notices | Volume 5331 December 2010 |

ISSN 1725-2423

doi:10.3000/17252423.C_2010.359.eng

Official Journal

of the European Union

C 359

English edition

Information and Notices

Volume 5331 December 2010

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2010/C 359/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2010 to 31 October 2010(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 1 |
| 2010/C 359/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  ) | 17 |
| 2010/C 359/03 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2010 to 31 October 2010(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  ) | 18 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2010/C 359/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2010 to 31 October 2010(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

2010/C 359/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010(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

)

17

2010/C 359/03

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2010 to 31 October 2010(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

)

18

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 31.12.2010 | EN | Official Journal of the European Union | C 359/1 |
| --- | --- | --- | --- |

31.12.2010

EN

Official Journal of the European Union

C 359/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2010 to 31 October 2010

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

2010/C 359/01

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.9.2010 | Brinavess | vernakalant hydrochloride | Merck Sharp & Dohme Limited |
| Hertford Road, |
| Hodderson, |
| Hertfordshire |
| EN11 9BU, |
| 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

1.9.2010

Brinavess

vernakalant hydrochloride

Merck Sharp & Dohme Limited

Hertford Road,

Hodderson,

Hertfordshire

EN11 9BU,

United Kingdom

EU/1/10/645/001-002

Concentrate for solution for infusion

C01BG11

6.9.2010

1.9.2010

Sycrest

Asenapine

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

N.V. Organon

Kloosterstraat 6,

5349 AB Oss,

Nederland

EU/1/10/640/001-006

Sublingual tablet

N05AH05

6.9.2010

6.9.2010

Rapiscan

regadenoson

| Gilead Sciences International Limited |
| --- |
| Cambridge |
| CB21 6GT |
| United Kingdom |

Gilead Sciences International Limited

Cambridge

CB21 6GT

United Kingdom

EU/1/10/643/001

Solution for injection

C01EB21

8.9.2010

17.9.2010

Ibandronic Acid Teva

Ibandronic acid

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/10/642/001-004

Film-coated tablet

M05BA06

21.9.2010

30.9.2010

Telmisartan Actavis

telmisartan

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

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78,

220 Hafnarfjörður,

Iceland

EU/1/10/639/001-030

Tablet

C09CA07

5.10.2010

7.10.2010

Myclausen

mycophenolate mofetil

| Herbert J. Passauer GmbH & Co. KG |
| --- |
| Stubenrauchstrasse 33, |
| 14167 Berlin, |
| Deutschland |

Herbert J. Passauer GmbH & Co. KG

Stubenrauchstrasse 33,

14167 Berlin,

Deutschland

EU/1/10/647/001-002

Film-coated tablet

L04AA06

11.10.2010

7.10.2010

Twynsta

telmisartan/amlodipine

| 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/1/10/648/001-028

Tablet

C09DB04

11.10.2010

28.10.2010

Clopidogrel HCS

Clopidogrel

| HCS bvba |
| --- |
| H. Kennisstraat 53, |
| B 2650 Edegem, |
| Belgïe |

HCS bvba

H. Kennisstraat 53,

B 2650 Edegem,

Belgïe

EU/1/10/651/001-015

Film-coated tablet

B01AC04

2.11.2010

28.10.2010

Clopidogrel Teva Generics B.V.

Clopidogrel

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

Teva Generics B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/10/650/001-015

Film-coated tablet

B01AC04

4.11.2010

28.10.2010

Ruconest

Conestat alfa

| Pharming Group N.V. |
| --- |
| Darwinweg 24, |
| NL-2333 CR Leiden, |
| Nederland |

Pharming Group N.V.

Darwinweg 24,

NL-2333 CR Leiden,

Nederland

EU/1/10/641/001

Powder for solution for injection

Pending

4.11.2010

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 16.9.2010 | Zeftera | Janssen-Cilag International NV |
| Turnhoutseweg 30, |
| B-2340 Beerse, |
| België |

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

16.9.2010

Zeftera

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

20.9.2010

—   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 |
| --- | --- | --- | --- | --- |
| 1.9.2010 | Altargo | Glaxo Group Limited |
| Glaxo Wellcome House, |
| Berkeley Avenue, |
| Greenford, |
| Middlesex UB6 0NN, |
| 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

1.9.2010

Altargo

Glaxo Group Limited

Glaxo Wellcome House,

Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/07/390/001-004

8.9.2010

1.9.2010

Ecalta

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/07/416/001-002

6.9.2010

1.9.2010

Keppra

| UCB Pharma SA. |
| --- |
| Allée de la Recherche 60, |
| 1070 Bruxelles, |
| Belgique/Researchdreef, 60, |
| Brussel 1070, |
| België |

UCB Pharma SA.

Allée de la Recherche 60,

1070 Bruxelles,

Belgique/Researchdreef, 60,

Brussel 1070,

België

EU/1/00/146/001-032

6.9.2010

1.9.2010

Levitra

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

Bayer Schering Pharma AG

13342 Berlin,

Deutschland

EU/1/03/248/001-015

6.9.2010

1.9.2010

Prevenar 13

| Wyeth Lederle Vaccines S.A. |
| --- |
| Rue du Bosquet, 15 |
| B-1348 Louvain-la-Neuve, |
| Belgique |

Wyeth Lederle Vaccines S.A.

Rue du Bosquet, 15

B-1348 Louvain-la-Neuve,

Belgique

EU/1/09/590/001-006

6.9.2010

1.9.2010

Regranex

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/99/101/001

6.9.2010

1.9.2010

Relistor

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane South, Taplow, |
| Maidenhead, |
| Berkshire, SL6 0PH, |
| United Kingdom |

Wyeth Europa Limited

Huntercombe Lane South, Taplow,

Maidenhead,

Berkshire, SL6 0PH,

United Kingdom

EU/1/08/463/001-003

6.9.2010

1.9.2010

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

6.9.2010

1.9.2010

Zypadhera

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

Eli Lilly Nederland B.V.

Grootslag 1-5,

NL-3991 RA, Houten,

Nederland

EU/1/08/479/001-003

6.9.2010

6.9.2010

Abraxane

| Abraxis BioScience Limited |
| --- |
| Rosanne House, Parkway, |
| Welwyn Garden City, |
| Herts, AL8 6HG, |
| United Kingdom |

Abraxis BioScience Limited

Rosanne House, Parkway,

Welwyn Garden City,

Herts, AL8 6HG,

United Kingdom

EU/1/07/428/001

9.9.2010

6.9.2010

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

9.9.2010

6.9.2010

Cialis

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

Eli Lilly Nederland B.V.

Grootslag 1-5,

3991 RA Houten,

Nederland

EU/1/02/237/001-009

9.9.2010

6.9.2010

Clopidogrel Winthrop

| Sanofi-Aventis |
| --- |
| 174, avenue de France, |
| F-75013 Paris, |
| France |

Sanofi-Aventis

174, avenue de France,

F-75013 Paris,

France

EU/1/08/465/001-020

9.9.2010

6.9.2010

Cymbalta

| 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/1/04/296/001-009

8.9.2010

6.9.2010

Dynastat

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

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 9NJ,

United Kingdom

EU/1/02/209/001-008

8.9.2010

6.9.2010

Emadine

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

Alcon Laboratories (UK) Ltd.

Pentagon Park, Boundary Way,

Hemel Hempstead,

Herts HP2 7UD,

United Kingdom

EU/1/98/095/001-004

9.9.2010

6.9.2010

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

9.9.2010

6.9.2010

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

9.9.2010

6.9.2010

M-M-RVAXPRO

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/337/001-013

9.9.2010

6.9.2010

Onglyza

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

Bristol Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park,

Sanderson Road,

Uxbridge,

Middlesex UB8 1DH,

United Kingdom

EU/1/09/545/001-010

9.9.2010

6.9.2010

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

9.9.2010

6.9.2010

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

9.9.2010

6.9.2010

Relistor

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane South, Taplow, |
| Maidenhead, |
| Berkshire, SL6 0PH, |
| United Kingdom |

Wyeth Europa Limited

Huntercombe Lane South, Taplow,

Maidenhead,

Berkshire, SL6 0PH,

United Kingdom

EU/1/08/463/001-011

8.9.2010

6.9.2010

Renvela

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10, |
| 1411 DD Naarden, |
| Nederland |

Genzyme Europe B.V.

Gooimeer 10,

1411 DD Naarden,

Nederland

EU/1/09/521/001-007

9.9.2010

6.9.2010

Thyrogen

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10, |
| NL-1411 DD Naarden, |
| Nederland |

Genzyme Europe B.V.

Gooimeer 10,

NL-1411 DD Naarden,

Nederland

EU/1/99/122/001-002

9.9.2010

6.9.2010

Vimpat

| UCB Pharma SA. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, |
| Belgique/Researchdreef, 60, |
| Brussel 1070, |
| België |

UCB Pharma SA.

Allée de la Recherche 60, 1070 Bruxelles,

Belgique/Researchdreef, 60,

Brussel 1070,

België

EU/1/08/470/001-017

8.9.2010

6.9.2010

Viread

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT |
| United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/01/200/001-002

9.9.2010

6.9.2010

Xeristar

| 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/1/04/297/001-008

8.9.2010

6.9.2010

Xolair

| 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/1/05/319/001-010

8.9.2010

6.9.2010

Zerit

| 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/1/96/009/001-009

9.9.2010

6.9.2010

Zyprexa

| 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/1/96/022/002

EU/1/96/022/004

EU/1/96/022/006

EU/1/96/022/009-012

EU/1/96/022/014

EU/1/96/022/016-017

EU/1/96/022/019-034

8.9.2010

6.9.2010

Zyprexa Velotab

| 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/1/99/125/001-016

8.9.2010

10.9.2010

Pandemrix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

Rixensart,

B-1330 Belgique

EU/1/08/452/001

14.9.2010

10.9.2010

Siklos

| ADDMEDICA |
| --- |
| 101, rue Saint Lazare, |
| Paris 75009, |
| FRANCE |

ADDMEDICA

101, rue Saint Lazare,

Paris 75009,

FRANCE

EU/1/07/397/001

14.9.2010

16.9.2010

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

20.9.2010

16.9.2010

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

20.9.2010

17.9.2010

Xyrem

| UCB Pharma Ltd. |
| --- |
| 208 Bath Road, Slough, |
| Berkshire SL1 3WE, |
| United Kingdom |

UCB Pharma Ltd.

208 Bath Road, Slough,

Berkshire SL1 3WE,

United Kingdom

EU/1/05/312/001

21.9.2010

23.9.2010

Kepivance

| Biovitrum AB (publ) |
| --- |
| SE-112 76 Stockholm, |
| Sverige |

Biovitrum AB (publ)

SE-112 76 Stockholm,

Sverige

EU/1/05/314/001

27.9.2010

23.9.2010

Levemir

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/04/278/001-011

27.9.2010

23.9.2010

Revatio

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

Pfizer Limited

Sandwich,

Kent, CT13 9NJ,

United Kingdom

EU/1/05/318/001-002

27.9.2010

27.9.2010

Caelyx

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, |
| België |

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel,

België

EU/1/96/011/001-004

29.9.2010

27.9.2010

Panretin

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

Eisai Limited

European Knowledge Centre, Mosquito Way,

Hatfield,

Hertfordshire,

AL10 9SN, United Kingdom

EU/1/00/149/001

29.9.2010

30.9.2010

Clopidogrel Apotex

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

Apotex Europe B.V.

Darwingweg 20,

2333 CR Leiden,

Nederland

EU/1/09/568/001-018

5.10.2010

30.9.2010

Mepact

| IDM PHARMA SAS |
| --- |
| 11-15 Quai De Dion Bouton, |
| 92816 Puteaux Cedex, |
| France |

IDM PHARMA SAS

11-15 Quai De Dion Bouton,

92816 Puteaux Cedex,

France

EU/1/08/502/001

6.10.2010

30.9.2010

Noxafil

| SP Europe |
| --- |
| Rue de Stalle, 73, 1180 Bruxelles, |
| Belgique - Stallestraat, 73 - 1180 Brussel, |
| België |

SP Europe

Rue de Stalle, 73, 1180 Bruxelles,

Belgique - Stallestraat, 73 - 1180 Brussel,

België

EU/1/05/320/001

5.10.2010

30.9.2010

Rotarix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

Rixensart,

B-1330 Belgique

EU/1/05/330/001-011

5.10.2010

30.9.2010

Sprycel

| 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/1/06/363/001-015

5.10.2010

30.9.2010

Thalidomide Celgene

| Celgene Europe Limited |
| --- |
| Riverside House, |
| Riverside Walk, |
| Windsor SL4 1NA, |
| United Kingdom |

Celgene Europe Limited

Riverside House,

Riverside Walk,

Windsor SL4 1NA,

United Kingdom

EU/1/08/443/001

5.10.2010

5.10.2010

APTIVUS

| 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/1/05/315/001-002

7.10.2010

5.10.2010

Mircera

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

Roche Registration Limited

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/07/400/001-024

7.10.2010

5.10.2010

Revlimid

| Celgene Europe Limited |
| --- |
| Riverside House, Riverside Walk, |
| Windsor, |
| Berkshire SL4 1NA, |
| United Kingdom |

Celgene Europe Limited

Riverside House, Riverside Walk,

Windsor,

Berkshire SL4 1NA,

United Kingdom

EU/1/07/391/001-004

7.10.2010

7.10.2010

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

11.10.2010

7.10.2010

DuoTrav

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

Alcon Laboratories (UK) Ltd.

Pentagon Park, Boundary Way,

Hemel Hempstead,

Herts HP2 7UD,

United Kingdom

EU/1/06/338/001-003

11.10.2010

7.10.2010

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

11.10.2010

11.10.2010

Retacrit

| HOSPIRA Enterprises B.V. |
| --- |
| Randstad 22-11, |
| 1316 BN, Almere, |
| Nederland |

HOSPIRA Enterprises B.V.

Randstad 22-11,

1316 BN, Almere,

Nederland

EU/1/07/431/001-025

13.10.2010

14.10.2010

Alisade

| Glaxo Group Ltd |
| --- |
| Greenford, |
| Middlesex, UB6 ONN, |
| United Kingdom |

Glaxo Group Ltd

Greenford,

Middlesex, UB6 ONN,

United Kingdom

EU/1/08/474/001-003

19.10.2010

14.10.2010

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

19.10.2010

14.10.2010

Biograstim

| CT Arzneimittel GmbH |
| --- |
| Lengeder Straße 42a, |
| D-13407 Berlin, |
| Deutschland |

CT Arzneimittel GmbH

Lengeder Straße 42a,

D-13407 Berlin,

Deutschland

EU/1/08/450/001-010

18.10.2010

14.10.2010

Firmagon

| Ferring Pharmaceuticals A/S |
| --- |
| Kay Fiskers Plads 11, |
| Copenhagen S 2300, |
| Danmark |

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11,

Copenhagen S 2300,

Danmark

EU/1/08/504/001-003

18.10.2010

14.10.2010

Multaq

| Sanofi-Aventis |
| --- |
| 174, avenue de France, |
| F-75013 Paris, |
| France |

Sanofi-Aventis

174, avenue de France,

F-75013 Paris,

France

EU/1/09/591/001-004

18.10.2010

14.10.2010

Ratiograstim

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

ratiopharm GmbH

Graf-Arco-Straße 3,

D-89079 Ulm,

Deutschland

EU/1/08/444/001-012

18.10.2010

14.10.2010

Vidaza

| Celgene Europe Ltd |
| --- |
| Riverside House, Riverside Walk, |
| Windsor, SL4 1NA, |
| United Kingdom |

Celgene Europe Ltd

Riverside House, Riverside Walk,

Windsor, SL4 1NA,

United Kingdom

EU/1/08/488/001

18.10.2010

14.10.2010

Xarelto

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

Bayer Schering Pharma AG

13342 Berlin,

Deutschland

EU/1/08/472/001-010

18.10.2010

15.10.2010

Riprazo

| 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/1/07/409/001-020

19.10.2010

15.10.2010

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

19.10.2010

15.10.2010

Sprimeo

| 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/1/07/407/001-020

19.10.2010

25.10.2010

Axura

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstr. 100, |
| D-60318 Frankfurt/Main - Deutschland |

Merz Pharmaceuticals GmbH

Eckenheimer Landstr. 100,

D-60318 Frankfurt/Main - Deutschland

EU/1/02/218/001-003

EU/1/02/218/005-030

27.10.2010

25.10.2010

Azilect

| Teva Pharma GmbH |
| --- |
| Kandelstrasse 10, |
| Kirchzarten 79199, |
| Deutschland |

Teva Pharma GmbH

Kandelstrasse 10,

Kirchzarten 79199,

Deutschland

EU/1/04/304/001-007

29.10.2010

25.10.2010

Baraclude

| 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/1/06/343/001-007

27.10.2010

25.10.2010

Cerezyme

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10, |
| NL-1411 DD Naarden, |
| Nederland |

Genzyme Europe B.V.

Gooimeer 10,

NL-1411 DD Naarden,

Nederland

EU/1/97/053/001-005

27.10.2010

25.10.2010

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

27.10.2010

25.10.2010

Ebixa

| H. Lundbeck A/S |
| --- |
| Ottiliavej 9, |
| DK-2500 Valby, |
| Danmark |

H. Lundbeck A/S

Ottiliavej 9,

DK-2500 Valby,

Danmark

EU/1/02/219/001-049

27.10.2010

25.10.2010

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

27.10.2010

25.10.2010

Faslodex

| AstraZeneca UK Limited |
| --- |
| Alderley Park, |
| Macclesfield, |
| Cheshire, SK10 4TG |
| United Kingdom |

AstraZeneca UK Limited

Alderley Park,

Macclesfield,

Cheshire, SK10 4TG

United Kingdom

EU/1/03/269/001-002

27.10.2010

25.10.2010

Forsteo

| 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/1/03/247/001-002

27.10.2010

25.10.2010

Herceptin

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

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City, AL7 1TW,

United Kingdom

EU/1/00/145/001

27.10.2010

25.10.2010

Irbesartan/Hydrochlorothiazide Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/583/001-072

27.10.2010

25.10.2010

Karvea

| 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/1/97/049/001-039

27.10.2010

25.10.2010

Mabthera

| 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/1/98/067/001-002

27.10.2010

25.10.2010

Mirapexin

| 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/1/97/051/001-006

EU/1/97/051/009-033

27.10.2010

25.10.2010

M-M-RVAXPRO

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/337/001-013

27.10.2010

25.10.2010

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/1/08/442/001-008

27.10.2010

25.10.2010

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

27.10.2010

25.10.2010

Puregon

| Organon N.V. |
| --- |
| Kloosterstraat 6, Postbus 20, |
| 5340 BH Oss, |
| Nederland |

Organon N.V.

Kloosterstraat 6, Postbus 20,

5340 BH Oss,

Nederland

EU/1/96/008/001-041

27.10.2010

25.10.2010

Revlimid

| Celgene Europe Limited |
| --- |
| Riverside House, Riverside Walk, |
| Windsor, |
| Berkshire SL4 1NA, |
| United Kingdom |

Celgene Europe Limited

Riverside House, Riverside Walk,

Windsor,

Berkshire SL4 1NA,

United Kingdom

EU/1/07/391/001-004

27.10.2010

25.10.2010

Sifrol

| 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/1/97/050/001-006

EU/1/97/050/009-033

27.10.2010

25.10.2010

Simponi

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

Centocor B.V.

Einsteinweg 101,

2333 CB Leiden,

Nederland

EU/1/09/546/001-004

27.10.2010

25.10.2010

Sprimeo

| 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/1/07/407/001-020

27.10.2010

25.10.2010

Sprycel

| 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/1/06/363/001-015

27.10.2010

25.10.2010

Toviaz

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

Pfizer Limited

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/07/386/001-018

27.10.2010

25.10.2010

Vantavo

| 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/1/09/572/001-009

27.10.2010

25.10.2010

Vasovist

| TMC Pharma Services Ltd. |
| --- |
| Finchampstead, |
| Berks, RG40 4LJ, |
| UK |

TMC Pharma Services Ltd.

Finchampstead,

Berks, RG40 4LJ,

UK

EU/1/05/313/001-009

27.10.2010

25.10.2010

Vimpat

| UCB Pharma SA. |
| --- |
| Allée de la Recherche 60, |
| 1070 Bruxelles, |

UCB Pharma SA.

Allée de la Recherche 60,

1070 Bruxelles,

| Belgique/Researchdreef, 60, |
| --- |
| Brussel 1070, |
| België |

Belgique/Researchdreef, 60,

Brussel 1070,

België

EU/1/08/470/001-017

27.10.2010

25.10.2010

Zonegran

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

Eisai Limited

European Knowledge Centre, Mosquito Way,

Hatfield,

Hertfordshire, AL10 9SN,

United Kingdom

EU/1/04/307/001-013

27.10.2010

25.10.2010

Zostavax

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/341/001-013

27.10.2010

28.10.2010

Ambirix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

Rixensart,

B-1330 Belgique

EU/1/02/224/001-005

2.11.2010

28.10.2010

Aprovel

| 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/1/97/046/001-039

2.11.2010

28.10.2010

Fertavid

| SP Europe |
| --- |
| Rue de Stalle, 73 |
| B-1180 Bruxelles, |
| Belgique |

SP Europe

Rue de Stalle, 73

B-1180 Bruxelles,

Belgique

EU/1/09/510/001-019

2.11.2010

28.10.2010

Hycamtin

| SmithKline Beecham Ltd. |
| --- |
| 980 Great West Road, |
| Brentford, |
| Middlesex, TW8 9GS |
| United Kingdom |

SmithKline Beecham Ltd.

980 Great West Road,

Brentford,

Middlesex, TW8 9GS

United Kingdom

EU/1/96/027/001

EU/1/96/027/003-007

4.11.2010

28.10.2010

Mimpara

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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/04/292/001-012

4.11.2010

28.10.2010

NovoSeven

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/96/006/001-007

4.11.2010

28.10.2010

Olanzapine Neopharma

| Neopharma Limited |
| --- |
| 57 High Street, Odiham, |
| Hampshire RG29 1LF, |
| United Kingdom |

Neopharma Limited

57 High Street, Odiham,

Hampshire RG29 1LF,

United Kingdom

EU/1/07/426/001-011

1.11.2010

28.10.2010

Olanzapine Teva

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

Teva Pharma B.V.

Computerweg 10,

DR Utrecht 3542,

Nederland

EU/1/07/427/001-057

1.11.2010

28.10.2010

PegIntron

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73, |
| 1180 Bruxelles, |

Schering Plough Europe

Rue de Stalle, 73,

1180 Bruxelles,

| Belgique - Stallestraat, 73 - |
| --- |
| 1180 Brussel, |
| België |

Belgique - Stallestraat, 73 -

1180 Brussel,

België

EU/1/00/131/001-050

4.11.2010

28.10.2010

Travatan

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

Alcon Laboratories (UK) Ltd.

Boundary Way,

Hemel Hempstead,

Herts HP2 7UD,

United Kingdom

EU/1/01/199/001-002

4.11.2010

28.10.2010

ViraferonPeg

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73, |
| 1180 Bruxelles, |

Schering Plough Europe

Rue de Stalle, 73,

1180 Bruxelles,

| Belgique - Stallestraat, 73 - |
| --- |
| 1180 Brussel, |
| België |

Belgique - Stallestraat, 73 -

1180 Brussel,

België

EU/1/00/132/001-050

4.11.2010

29.10.2010

Mycamine

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

Astellas Pharma Europe B.V.

Elisabethhof 19,

2353 EW Leiderdorp,

Nederland

EU/1/08/448/001-002

5.11.2010

—   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 |
| --- | --- | --- | --- | --- |
| 6.9.2010 | ImmunoGam | Cangene Europe Limited |
| Parkshot House, |
| 5 Kew Road, |
| Richmond, |
| Surrey TW9 2PR, |
| 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

6.9.2010

ImmunoGam

Cangene Europe Limited

Parkshot House,

5 Kew Road,

Richmond,

Surrey TW9 2PR,

United Kingdom

EU/1/10/613/001-002

9.9.2010

27.9.2010

Enviage

| 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/1/07/406/001-020

29.9.2010

28.10.2010

NeoSpect

| CIS bio international |
| --- |
| Boite Postale 32 - |
| F-91192 Gif-sur-Yvette – France |

CIS bio international

Boite Postale 32 -

F-91192 Gif-sur-Yvette – France

EU/1/00/154/001-002

5.11.2010

—   Suspension of a marketing authorization (Article 20 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 |
| --- | --- | --- | --- | --- |
| 16.9.2010 | Clopidogrel 1A Pharma | Acino Pharma GmbH |
| Am Windfeld 35, |
| 83714 Miesbach, |
| 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

16.9.2010

Clopidogrel 1A Pharma

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/542/001-007

20.9.2010

16.9.2010

Clopidogrel Acino

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

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/532/001-007

20.9.2010

16.9.2010

Clopidogrel Acino Pharma

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

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/549/001-007

20.9.2010

16.9.2010

Clopidogrel Acino Pharma GmbH

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

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/548/001-007

20.9.2010

16.9.2010

Clopidogrel Hexal

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

Acino Pharma GmbH

Am Windfeld 35,

Miesbach 83714,

Deutschland

EU/1/09/534/001-007

20.9.2010

16.9.2010

Clopidogrel ratiopharm

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

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/554/001-008

20.9.2010

16.9.2010

Clopidogrel ratiopharm GmbH

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

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/541/001-008

20.9.2010

16.9.2010

Clopidogrel Sandoz

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

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/547/001-007

20.9.2010

—   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 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.9.2010 | Bovilis BTV8 | Inactivated Bluetongue virus | Intervet International B.V. |
| Wim de Körverstraat 35, |
| NL - 5831 Boxmeer, |
| Nederland |

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

6.9.2010

Bovilis BTV8

Inactivated Bluetongue virus

Intervet International B.V.

Wim de Körverstraat 35,

NL - 5831 Boxmeer,

Nederland

EU/2/10/106/001-014

Suspension for injection

QI02AA08(cattle)

QI04AA02(sheep)

8.9.2010

16.9.2010

Rhiniseng

inactivated vaccine against atrophic rhinitis in pigs

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, |
| 17170- Amer (Girona), |
| España |

Laboratorios Hipra, S.A.

Avda. La Selva, 135,

17170- Amer (Girona),

España

EU/2/10/109/001-009

Suspension for injection

QI09AB04

21.9.2010

30.9.2010

Coxevac

Inactivated Coxiella burnetii vaccine

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

CEVA SANTE ANIMALE

10 avenue de la Ballastière,

33500 Libourne,

France

EU/2/10/110/001-002

Suspension for injection

QI03AB

ngi

5.10.2010

—   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 |
| --- | --- | --- | --- | --- |
| 1.9.2010 | Acticam | Ecuphar NV |
| Legeweg 157-I, |
| B-8020 Oostkamp, |
| Belgïe |

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

1.9.2010

Acticam

Ecuphar NV

Legeweg 157-I,

B-8020 Oostkamp,

Belgïe

EU/2/08/088/001-004

6.9.2010

17.9.2010

Porcilis AR-T DF

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

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/00/026/001-004

21.9.2010

23.9.2010

Porcilis AR-T DF

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

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/00/026/001-006

27.9.2010

30.9.2010

Poulvac FluFend H5N3 RG

| Fort Dodge Animal Health Ltd |
| --- |
| Flanders Road, Hedge End, |
| Southampton SO30 4QH, |
| United Kingdom |

Fort Dodge Animal Health Ltd

Flanders Road, Hedge End,

Southampton SO30 4QH,

United Kingdom

EU/2/06/060/001-002

13.10.2010

30.9.2010

Prac-Tic

| Novartis Sanidad Animal S.L. |
| --- |
| Calle de la Marina, 206, |
| E - Barcelona 08013, |
| ESPANA |

Novartis Sanidad Animal S.L.

Calle de la Marina, 206,

E - Barcelona 08013,

ESPANA

EU/2/06/066/001-012

5.10.2010

5.10.2010

Nobilis Influenza H5N2

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

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/06/061/001-004

7.10.2010

11.10.2010

Equioxx

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

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/08/083/001-005

13.10.2010

14.10.2010

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

18.10.2010

14.10.2010

Improvac

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

Pfizer Limited

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/2/09/095/001-006

18.10.2010

14.10.2010

Novem

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

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein,

Deutschland

EU/2/04/042/001-002

EU/2/04/042/007-010

18.10.2010

14.10.2010

Posatex

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

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/08/081/001-003

18.10.2010

14.10.2010

Quadrisol

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

Pfizer Limited

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/2/97/005/001

EU/2/97/005/005

18.10.2010

28.10.2010

Trocoxil

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

Pfizer Limited

Ramsgate Road, Sandwich,

Kent CT13 9NJ

United Kingdom

EU/2/08/084/001-005

4.11.2010

28.10.2010

Zactran

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

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/08/082/001-006

4.11.2010

—   Suspension of a marketing authorization (Article 45 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 |
| --- | --- | --- | --- | --- |
| 27.9.2010 | Flexicam | Dechra Veterinary Products A/S |
| Mekuvej 9, |
| 7171 Uldum, |
| Danmark |

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

27.9.2010

Flexicam

Dechra Veterinary Products A/S

Mekuvej 9,

7171 Uldum,

Danmark

EU/2/06/058/001-003

29.9.2010

—   Lift of suspension of a marketing authorization (Article 45 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 |
| --- | --- | --- | --- | --- |
| 1.9.2010 | Porcilis Pesti | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| 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

1.9.2010

Porcilis Pesti

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/99/016/001-006

6.9.2010

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.

---

| 31.12.2010 | EN | Official Journal of the European Union | C 359/17 |
| --- | --- | --- | --- |

31.12.2010

EN

Official Journal of the European Union

C 359/17

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010

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

2010/C 359/02

—   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 |
| --- | --- | --- | --- | --- |
| 31.8.2010 | PecFent | Archimedes Development Ltd, |
| Nottingham, |
| NGT7 2TN, |
| United Kingdom |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

31.8.2010

PecFent

Archimedes Development Ltd,

Nottingham,

NGT7 2TN,

United Kingdom

These Decisions are addressed to the Member States

3.9.2010

—   Refusal 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 |
| --- | --- | --- | --- | --- |
| 6.8.2010 | Myderison | See Annex I | See Annex I | 10.8.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

6.8.2010

Myderison

See Annex I

See Annex I

10.8.2010

—   Suspension 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 |
| --- | --- | --- | --- | --- |
| 10.8.2010 | Pregsure BVD and associated names | See Annex II | See Annex II | 11.8.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

10.8.2010

Pregsure BVD and associated names

See Annex II

See Annex II

11.8.2010

—   Revocation 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 |
| --- | --- | --- | --- | --- |
| 6.8.2010 | Myderison | See Annex I | See Annex I | 10.8.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

6.8.2010

Myderison

See Annex I

See Annex I

10.8.2010

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

| 31.12.2010 | EN | Official Journal of the European Union | C 359/18 |
| --- | --- | --- | --- |

31.12.2010

EN

Official Journal of the European Union

C 359/18

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2010 to 31 October 2010

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

2010/C 359/03

—   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 |
| --- | --- | --- | --- | --- |
| 15.10.2010 | Xalatan and associated names | See Annex III | See Annex III | 18.10.2010 |
| 5.10.2010 | Norsed Combi D and associated names | See Annex IV | See Annex IV | 6.10.2010 |
| 16.9.2010 | Atacand Plus and associated names | See Annex V | See Annex V | 20.9.2010 |
| 30.9.2010 | Daivobet | See Annex VI | See Annex VI | 4.10.2010 |
| 5.10.2010 | Fortipan Combi D and associated names | See Annex VII | See Annex VII | 6.10.2010 |
| 1.9.2010 | Brinavess | Merck Sharp & Dohme Limited, |
| Hertford Road, |
| Hodderson, |
| Hertfordshire EN11 9BU, |
| United Kingdom |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

15.10.2010

Xalatan and associated names

See Annex III

See Annex III

18.10.2010

5.10.2010

Norsed Combi D and associated names

See Annex IV

See Annex IV

6.10.2010

16.9.2010

Atacand Plus and associated names

See Annex V

See Annex V

20.9.2010

30.9.2010

Daivobet

See Annex VI

See Annex VI

4.10.2010

5.10.2010

Fortipan Combi D and associated names

See Annex VII

See Annex VII

6.10.2010

1.9.2010

Brinavess

Merck Sharp & Dohme Limited,

Hertford Road,

Hodderson,

Hertfordshire EN11 9BU,

United Kingdom

These Decisions are addressed to the Member States

3.9.2010

28.10.2010

Ruconest

| Pharming Group N.V., |
| --- |
| Darwinweg 24, |
| NL-2333 CR Leiden, |
| Nederland |

Pharming Group N.V.,

Darwinweg 24,

NL-2333 CR Leiden,

Nederland

These Decisions are addressed to the Member States

4.11.2010

—   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 |
| --- | --- | --- | --- | --- |
| 1.9.2010 | Genotropin | See Annex VIII | See Annex VIII | 2.9.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

1.9.2010

Genotropin

See Annex VIII

See Annex VIII

2.9.2010

—   Suspension 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 |
| --- | --- | --- | --- | --- |
| 7.10.2010 | Pregsure BVD and associated names | See Annex IX | See Annex IX | 8.10.2010 |
| 4.10.2010 | Octagam | See Annex X | See Annex X | 5.10.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

7.10.2010

Pregsure BVD and associated names

See Annex IX

See Annex IX

8.10.2010

4.10.2010

Octagam

See Annex X

See Annex X

5.10.2010

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

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

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Czech Republic | | Meditop Pharmaceutical Co. Ltd. |
| Ady Endre u. 1. Pilisborosjenő 2097 Hungary |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Czech Republic

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Hungary

Myderison

50 mg

150 mg

film-coated tablet

oral use

Germany

| Meditop Pharmaceutical Co. Ltd. |
| --- |
| Ady Endre u. 1. Pilisborosjenő 2097 Hungary |

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Hungary

Myderison

50 mg

150 mg

film-coated tablet

oral use

Hungary

| Meditop Pharmaceutical Co. Ltd. |
| --- |
| Ady Endre u. 1. Pilisborosjenő 2097 Hungary |

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Hungary

Myderison

50 mg

150 mg

film-coated tablet

oral use

Lithuania

| Meditop Pharmaceutical Co. Ltd. |
| --- |
| Ady Endre u. 1. Pilisborosjenő 2097 Hungary |

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Hungary

Myderison

50 mg

150 mg

film-coated tablet

oral use

Poland

| Meditop Pharmaceutical Co. Ltd. |
| --- |
| Ady Endre u. 1. Pilisborosjenő 2097 Hungary |

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Hungary

Myderison

50 mg

150 mg

film-coated tablet

oral use

Romania

| Meditop Pharmaceutical Co. Ltd. |
| --- |
| Ady Endre u. 1. Pilisborosjenő 2097 Hungary |

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Hungary

Myderison

50 mg

150 mg

film-coated tablet

oral use

Slovak Republic

| Meditop Pharmaceutical Co. Ltd. |
| --- |
| Ady Endre u. 1. Pilisborosjenő 2097 Hungary |

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Hungary

Myderison

50 mg

150 mg

film-coated tablet

oral use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Product name | Pharmaceutical form | Strength | Target animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Belgium | Pfizer Animal Health |
| Rue Laid Burniat 1 |
| 1348 - Louvain-la-Neuve |
| BELGIUM |

Member State

Marketing Authorisation Holder

Product name

Pharmaceutical form

Strength

Target animal species

Route of administration

Belgium

Pfizer Animal Health

Rue Laid Burniat 1

1348 - Louvain-la-Neuve

BELGIUM

PREGSURE BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Bulgaria

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

PregSure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Czech Republic

| Pfizer, spol. s r.o. |
| --- |
| Stroupežnického 17 |
| 150 00 Praha |
| CZECH REPUBLIC |

Pfizer, spol. s r.o.

Stroupežnického 17

150 00 Praha

CZECH REPUBLIC

PregSure BVD injekční emulze

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Estonia

| Pfizer Animal Health |
| --- |
| Rue Laid Burniat 1 |
| 1348 - Louvain-la-Neuve |
| BELGIUM |

Pfizer Animal Health

Rue Laid Burniat 1

1348 - Louvain-la-Neuve

BELGIUM

PregSure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

France

| PFIZER |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANCE |

PFIZER

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCE

PREGSURE BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Germany

| Pfizer GmbH |
| --- |
| Linkstraße 10 |
| D-10785 Berlin |
| GERMANY |

Pfizer GmbH

Linkstraße 10

D-10785 Berlin

GERMANY

PregSure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Greece

| PFIZER HELLAS S.A |
| --- |
| 243 Messogeion Ave. |
| Neo Psychiko |
| GR-154 51 |
| GREECE |

PFIZER HELLAS S.A

243 Messogeion Ave.

Neo Psychiko

GR-154 51

GREECE

PREGSURE BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Hungary

| Pfizer Kft. |
| --- |
| Alkotas u 53 |
| MOM Park ‘F’ Épület |
| Budapest H-1123 |
| HUNGARY |

Pfizer Kft.

Alkotas u 53

MOM Park ‘F’ Épület

Budapest H-1123

HUNGARY

PregSure BVD vakcina A.U.V.

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Ireland

| Pfizer Healthcare Ireland trading as Pfizer Animal Health |
| --- |
| Ringaskiddy |
| County Cork |
| IRELAND |

Pfizer Healthcare Ireland trading as Pfizer Animal Health

Ringaskiddy

County Cork

IRELAND

PregSure BVD Emulsion for Injection

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Italy

| Pfizer Italia Srl |
| --- |
| Via Isonzo 71 |
| 04100 – Latina |
| ITALY |

Pfizer Italia Srl

Via Isonzo 71

04100 – Latina

ITALY

Pregsure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Lithuania

| Pfizer Animal Health S.A. |
| --- |
| Rue Laid Burniat 1 |
| B-1348 - Louvain-la-Neuve |
| BELGIUM |

Pfizer Animal Health S.A.

Rue Laid Burniat 1

B-1348 - Louvain-la-Neuve

BELGIUM

PREGSURE BVD, injekcinė emulsija

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Latvia

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

PregSure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Poland

| Pfizer Trading Polska Sp. z o.o. |
| --- |
| ul. Rzymowskiego 34 |
| 02-697 Warszawa |
| POLAND |

Pfizer Trading Polska Sp. z o.o.

ul. Rzymowskiego 34

02-697 Warszawa

POLAND

PregSure BVD emulsja do wstrzykiwań

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Portugal

| Laboratórios Pfizer Lda |
| --- |
| Lagoas Park – Edifício 10 |
| 2740-244 Porto Salvo |
| PORTUGAL |

Laboratórios Pfizer Lda

Lagoas Park – Edifício 10

2740-244 Porto Salvo

PORTUGAL

Pregsure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Romania

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent |
| CT 13 9NJ |
| UNITED KINGDOM |

Pfizer Animal Health MA EEIG

Ramsgate Road, Sandwich, Kent

CT 13 9NJ

UNITED KINGDOM

Pregsure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| Gran Duchy of Luxembourg |
| 51, Avenue J.F. Kennedy |
| L-1855 - Luxembourg |

Pfizer Luxembourg SARL

Gran Duchy of Luxembourg

51, Avenue J.F. Kennedy

L-1855 - Luxembourg

Pregsure BVD emulzija za injiciranje

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Slovak republic

| Pfizer Luxembourg SARL o.z. |
| --- |
| Pfizer AH |
| Pribinova 25 |
| 81109 Bratislava |
| SLOVAK REPUBLIC |

Pfizer Luxembourg SARL o.z.

Pfizer AH

Pribinova 25

81109 Bratislava

SLOVAK REPUBLIC

Pregsure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Spain

| Pfizer SA |
| --- |
| Avda. De Europa, 20 B |
| Parque Empresarial la Moraleja (Alcobendas) |
| 28108 |
| SPAIN |

Pfizer SA

Avda. De Europa, 20 B

Parque Empresarial la Moraleja (Alcobendas)

28108

SPAIN

PREGSURE BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

The Netherlands

| Pfizer Animal Health BV |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| P.O. Box 37 |
| 2900 AA Capelle a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health BV

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

P.O. Box 37

2900 AA Capelle a/d Ijssel

THE NETHERLANDS

PREGSURE BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

Pregsure BVD Emulsion for Injection

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

---

ANNEX III

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

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration | Content |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria Ges.m.b.H. |
| Floridsdorfer Hauptstrasse 1 |
| A - 1210 Wien, Austria |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

A - 1210 Wien, Austria

Xalatan

0,005 % w/v

Eye drops, solution

Ocular use

2,5 ml

Belgium

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels, Belgium

Xalatan

0,005 %

Eye drops, solution

Ocular use

2,5 ml

Bulgaria

Pfizer Enterprises SARL, Rond-point du Kirchberg, 51, Avenue J.F. Kennedy, L-1855 Luxembourg, G. D. of Luxembourg

Xalatan

50 micrograms/ ml

Eye drops, solution

Topical use

2,5 ml

Czech Republic

Pfizer. s r.o., Stroupežnického 17, 150 00 Prague 5, Czech Republic

Xalatan

0,005 % w/v

Eye drops, solution

Topical use

2,5 ml

Denmark

Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Denmark

Xalatan

50 microg/ ml

Eye drops, solution

Topical use

2,5 ml

Estonia

| Pfizer Enterprises SARL |
| --- |
| 51, Avenue J.F. Kennedy |
| Rond-Point du Kirchberg |
| L-1855 Luxembourg |

Pfizer Enterprises SARL

51, Avenue J.F. Kennedy

Rond-Point du Kirchberg

L-1855 Luxembourg

Xalatan

50 micrograms / ml

Eye drops, solution

Ocular use

2,5 ml

Finland

Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland

Xalatan

50 microg/ml

Eye drops, solution

Topical use

2,5 ml

France

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Xalatan

0,005 % w/v

Eye drops, solution

Topical use

2,5 ml

Germany

Pharmacia GmbH Linkstraße 10 10785 Berlin, Germany

Xalatan

0,005 % w/v

Eye drops, solution

Ocular use

2,5 ml

Germany

Pharmacia GmbH, Linkstraße 10 10785 Berlin, Germany

Latanoprost Pharmacia & Upjohn

0,005 % w/v

Eye drops, solution

Ocular use

2,5 ml

Greece

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Xalatan

50 mcg/ ml

Eye drops, solution

Topical use

2,5 ml

Hungary

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park ‘F’ Ép., |
| Hungary |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park ‘F’ Ép.,

Hungary

Xalatan

0,05 mg/ml

Eye drops, solution

Topical use

2,5 ml

Iceland

Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Denmark

Xalatan

50 microg/ ml

Eye drops, solution

Topical use

2,5 ml

Ireland

| Pharmacia Ireland Limited |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pharmacia Ireland Limited

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Xalatan

0,005 % w/v

Eye drops, solution

Topical use

2,5 ml

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina - Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina - Italy

Xalatan

0,005

Eye drops, solution

Topical use

2,5 ml

Latvia

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Xalatan

0,005 % w/v

Eye drops, solution

Topical use

2,5 ml

Lithuania

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich, Kent CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich, Kent CT13 9NJ

United Kingdom

Xalatan

0,005 % w/v

Eye drops, solution

Ocular use

2,5 ml

Luxembourg

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels, Belgium

Xalatan

0,005 %

Eye drops, solution

Ocular use

2,5 ml

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Xalatan

0,005 % w/v

Eye drops, solution

Topical use

2,5 ml

Netherlands

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| The Netherlands |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Xalatan

50 microgram/ml

Eye drops, solution

Topical use

2,5 ml

Norway

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Xalatan

0,005 % w/v

Eye drops, solution

Topical use

2,5 ml

Poland

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Xalatan

0,005 % w/v

Eye drops, solution

Ocular use

2,5 ml

Portugal

Laboratorios Pfizer, Lda., Lagoas Park, Edifício 10, 2740-271 Porto Salvo, Portugal

Xalatan

0,005 % w/v

Eye drops, solution

Topical use

2,5 ml

Romania

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Xalatan

0,005 % w/v

Eye drops, solution

Ocular use

2,5 ml

Slovak Republic

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Xalatan

0,005 % w/v

Eye drops, solution

Topical use

2,5 ml

Slovenia

Pfizer Luxembourg SARL, 51, Avenue J. F. Kennedy, L-1855 Luxembourg, Luxembourg

Xalatan 50 mikrogramov/ml kapljice za oko, raztopina

0,005 % w/v

Eye drops, solution

Topical use

2,5 ml

Spain

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Xalatan

0,005 % w/v

Eye drops, solution

Ocular use

2,5 ml

Sweden

| Pfizer AB |
| --- |
| Vetenskapsvagen 10, |
| SE 191 90 Sollentuna |
| Sweden |

Pfizer AB

Vetenskapsvagen 10,

SE 191 90 Sollentuna

Sweden

Xalatan

0,005 % w/v

Eye drops, solution

Topical use

2,5 ml

United Kingdom

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

Pfizer Limited

Ramsgate Road

Sandwich, Kent

CT13 9NJ

United Kingdom

Xalatan

0,005 % w/v

Eye drops, solution

Topical use

2,5 ml

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State EU/EEA | Marketing authorisation holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Bulgaria | | Sanofi-Aventis Bulgaria EOOD |
| 103, blvd Alexander Stamboliiski |
| 1303 Sofia |
| Bulgaria |

Member State EU/EEA

Marketing authorisation holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Bulgaria

Sanofi-Aventis Bulgaria EOOD

103, blvd Alexander Stamboliiski

1303 Sofia

Bulgaria

Actonel Combi D

35 mg +

1 000 mg/880 IU

film-coated tablets + effervescent granules

Oral use

France

| Procter & Gamble Pharmaceuticals France |
| --- |
| 163-165 Quai Aulagnier |
| 92600 Asnières-sur-Seine |
| France |

Procter & Gamble Pharmaceuticals France

163-165 Quai Aulagnier

92600 Asnières-sur-Seine

France

Norsedcombi

35 mg +

1 000 mg/880 IU

film-coated tablets + effervescent granules

Oral use

Germany

| Warner Chilcott Deutschland GmbH |
| --- |
| Dr.-Otto-Röhm-Strasse 2-4 |
| 64331 Weiterstadt |
| Germany |

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Strasse 2-4

64331 Weiterstadt

Germany

Norsed plus Calcium D

35 mg +

1 000 mg/880 IU

film-coated tablets + effervescent granules

Oral use

Ireland

| Warner Chilcott UK Limited, |
| --- |
| Old Belfast Road, Millbrook, Larne, County Antrim, |
| BT40 2SH |
| United Kingdom |

Warner Chilcott UK Limited,

Old Belfast Road, Millbrook, Larne, County Antrim,

BT40 2SH

United Kingdom

Optinate Plus Ca &D

35 mg +

1 000 mg/880 IU

film-coated tablets + effervescent granules

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

Opticalcio D3

35 mg +

1 000 mg/880 IU

film-coated tablets + effervescent granules

Oral use

Sweden

| sanofi-aventis S.p.A. |
| --- |
| Viale Luigi Bodio, 37/b |
| 20158 Milano |
| Italy |

sanofi-aventis S.p.A.

Viale Luigi Bodio, 37/b

20158 Milano

Italy

Norsed Combi D

35 mg +

1 000 mg/880 IU

film-coated tablets + effervescent granules

Oral use

---

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE 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 | AstraZeneca Österreich GmbH., |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of administration

Austria

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Atacand plus mite 8 mg/12,5 mg Tabletten

8 mg/12,5 mg

Tablet

Oral use

Austria

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Atacand plus

16 mg/12,5 mg Tabletten

16 mg/12,5 mg

Tablet

Oral use

Austria

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Atacand Plus

32 mg/12,5 mg Tabletten

32 mg/12,5 mg

Tablet

Oral use

Austria

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Atacand Plus

32 mg/25 mg Tabletten

32 mg/25 mg

Tablet

Oral use

Austria

| Takeda Pharma Ges.m.b.H., |
| --- |
| Seidengasse 33-35, |
| 1070 Wien, |
| Austria |

Takeda Pharma Ges.m.b.H.,

Seidengasse 33-35,

1070 Wien,

Austria

Blopress Plus 8 mg/12,5 mg - Tabletten

8 mg/12,5 mg

Tablet

Oral use

Austria

| Takeda Pharma Ges.m.b.H., |
| --- |
| Seidengasse 33-35, |
| 1070 Wien, |
| Austria |

Takeda Pharma Ges.m.b.H.,

Seidengasse 33-35,

1070 Wien,

Austria

Blopress Plus 16 mg/12,5 mg - Tabletten

16 mg/12,5 mg

Tablet

Oral use

Austria

| Takeda Pharma Ges.m.b.H., |
| --- |
| Seidengasse 33-35, |
| 1070 Wien, |
| Austria |

Takeda Pharma Ges.m.b.H.,

Seidengasse 33-35,

1070 Wien,

Austria

Blopress Plus 32 mg/ 12,5 mg - Tabletten

32 mg/12,5 mg

Tablet

Oral use

Austria

| Takeda Pharma Ges.m.b.H., |
| --- |
| Seidengasse 33-35, |
| 1070 Wien, |
| Austria |

Takeda Pharma Ges.m.b.H.,

Seidengasse 33-35,

1070 Wien,

Austria

Blopress Plus 32 mg/ 25 mg - Tabletten

32 mg/25 mg

Tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand Plus

8 mg/12,5 mg

Tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand Plus

16 mg/12,5 mg

Tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand Plus

32 mg/12,5 mg

Tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand Plus

32 mg/25 mg

Tablet

Oral use

Cyprus

| AstraZeneca AB, S-151 85 Södertälje, |
| --- |
| Sweden |

AstraZeneca AB, S-151 85 Södertälje,

Sweden

Atacand Plus

16 mg/12,5 mg

Tablet

Oral use

Czech Republic

| AstraZeneca UK Ltd., |
| --- |
| Macclesfield, |
| Cheshire, |
| United Kingdom |

AstraZeneca UK Ltd.,

Macclesfield,

Cheshire,

United Kingdom

Atacand Plus

16 + 12,5 mg

16 mg/12,5 mg

Tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand Zid

8 mg/12,5 mg

8 mg/12,5 mg

Tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand Zid 16 mg/12,5 mg

16 mg/12,5 mg

Tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand Zid

32 mg/12,5 mg

32 mg/12,5 mg

Tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand Zid

32 mg/25 mg

32 mg/25 mg

Tablet

Oral use

Estonia

| AstraZeneca AB, |
| --- |
| Strängnäsvägen 44, |
| S-151 85 Södertälje, |
| Sweden |

AstraZeneca AB,

Strängnäsvägen 44,

S-151 85 Södertälje,

Sweden

ATACAND PLUS

16 mg/12,5 mg

Tablet

Oral use

Estonia

| AstraZeneca AB, |
| --- |
| Strängnäsvägen 44, |
| S-151 85 Södertälje, |
| Sweden |

AstraZeneca AB,

Strängnäsvägen 44,

S-151 85 Södertälje,

Sweden

ATACAND PLUS

32 mg/12,5 mg

Tablet

Oral use

Estonia

| AstraZeneca AB, Strängnäsvägen 44, |
| --- |
| S-151 85 Södertälje, |
| Sweden |

AstraZeneca AB, Strängnäsvägen 44,

S-151 85 Södertälje,

Sweden

ATACAND PLUS

32 mg/25 mg

Tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand Plus

8 mg/12,5 mg

Tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand Plus

16 mg/12,5 mg

Tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand Plus

32 mg/12,5 mg

Tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand Plus

32 mg/25 mg

Tablet

Oral use

France

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil-Malmaison Cedex |
| France |

AstraZeneca

1, Place Renault

92844 Rueil-Malmaison Cedex

France

Hytacand

8 mg/12,5 mg comprimé

8 mg/12,5 mg

Tablet

Oral use

France

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil-Malmaison Cedex |
| France |

AstraZeneca

1, Place Renault

92844 Rueil-Malmaison Cedex

France

Hytacand

16 mg/12,5 mg comprimé

16 mg/12,5 mg

Tablet

Oral use

France

| Laboratoires Takeda, |
| --- |
| 11-15, quai de Dion Bouton, |
| 92816 Puteaux Cedex, |
| France |

Laboratoires Takeda,

11-15, quai de Dion Bouton,

92816 Puteaux Cedex,

France

CoKenzen 8 mg/12,5 mg comprimé

8 mg/12,5 mg

Tablet

Oral use

France

| Laboratoires Takeda, |
| --- |
| 11-15, quai de Dion Bouton, |
| 92816 Puteaux Cedex, |
| France |

Laboratoires Takeda,

11-15, quai de Dion Bouton,

92816 Puteaux Cedex,

France

CoKenzen 16 mg/12,5 mg comprimé

16 mg/12,5 mg

Tablet

Oral use

Germany

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, |
| Germany |

AstraZeneca GmbH

22876 Wedel,

Germany

Atacand Plus 8/12,5 mg

8 mg/12,5 mg

Tablet

Oral use

Germany

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, |
| Germany |

AstraZeneca GmbH

22876 Wedel,

Germany

Atacand Plus 16/12,5 mg

16 mg/12,5 mg

Tablet

Oral use

Germany

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, |
| Germany |

AstraZeneca GmbH

22876 Wedel,

Germany

Atacand Plus 32/12,5 mg Tabletten

32 mg/12,5 mg

Tablet

Oral use

Germany

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, |
| Germany |

AstraZeneca GmbH

22876 Wedel,

Germany

Atacand Plus forte 32/25 mg Tabletten

32 mg/25 mg

Tablet

Oral use

Germany

| Takeda Pharma GmbH, |
| --- |
| Viktoriaallee 3-5, |
| 52066 Aachen, |
| Germany |

Takeda Pharma GmbH,

Viktoriaallee 3-5,

52066 Aachen,

Germany

Blopress 8 mg Plus 12,5 mg Tabletten.

8 mg/12,5 mg

Tablet

Oral use

Germany

| Takeda Pharma GmbH, |
| --- |
| Viktoriaallee 3-5, |
| 52066 Aachen, |
| Germany |

Takeda Pharma GmbH,

Viktoriaallee 3-5,

52066 Aachen,

Germany

Blopress 16 mg Plus 12,5 mg Tabletten

16 mg/12,5 mg

Tablet

Oral use

Germany

| Takeda Pharma GmbH, |
| --- |
| Viktoriaallee 3-5, |
| 52066 Aachen, |
| Germany |

Takeda Pharma GmbH,

Viktoriaallee 3-5,

52066 Aachen,

Germany

Blopress 32 mg Plus 12,5 mg Tabletten

32 mg/12,5 mg

Tablet

Oral use

Germany

| Takeda Pharma GmbH, |
| --- |
| Viktoriaallee 3-5, |
| 52066 Aachen, |
| Germany |

Takeda Pharma GmbH,

Viktoriaallee 3-5,

52066 Aachen,

Germany

Blopress forte 32 mg Plus 25 mg Tabletten

32 mg/25 mg

Tablet

Oral use

Greece

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand Plus

8 mg/12,5 mg

Tablet

Oral use

Greece

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand Plus

16 mg/12,5 mg

Tablet

Oral use

Greece

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand Plus

32 mg/12,5 mg

Tablet

Oral use

Greece

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand Plus

32 mg/25 mg

Tablet

Oral use

Hungary

| AstraZeneca Kft. |
| --- |
| 1113 Budapest, Bocskai út 134-146 |
| Hungary |

AstraZeneca Kft.

1113 Budapest, Bocskai út 134-146

Hungary

Atacand Plus

16 mg/12,5 mg

Tablet

Oral use

Iceland

| AstraZeneca A/S Roskildevej 22, |
| --- |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S Roskildevej 22,

DK-2620 Albertslund,

Denmark

Atacand Plus

16 mg/12,5 mg

Tablet

Oral use

Iceland

| AstraZeneca A/S Roskildevej 22, |
| --- |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S Roskildevej 22,

DK-2620 Albertslund,

Denmark

Atacand Plus

32 mg/12,5 mg

Tablet

Oral use

Iceland

| AstraZeneca A/S Roskildevej 22, |
| --- |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S Roskildevej 22,

DK-2620 Albertslund,

Denmark

Atacand Plus

32 mg/25 mg

Tablet

Oral use

Ireland

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, |
| Luton, |
| LU1 3LU, |
| United Kingdom |

AstraZeneca UK Limited,

600 Capability Green,

Luton,

LU1 3LU,

United Kingdom

Atacand Plus 8/12,5 mg

8 mg/12,5 mg

Tablet

Oral use

Ireland

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, |
| Luton, |
| LU1 3LU, |
| United Kingdom |

AstraZeneca UK Limited,

600 Capability Green,

Luton,

LU1 3LU,

United Kingdom

Atacand Plus 16/12,5 mg

16 mg/12,5 mg

Tablet

Oral use

Ireland

| Takeda UK Limited, |
| --- |
| Takeda House, |
| Mercury Park, |
| Wycombe Lane, |
| Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom. |

Takeda UK Limited,

Takeda House,

Mercury Park,

Wycombe Lane,

Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom.

Blopress Plus 8 mg/12,5 mg tablets

8 mg/12,5 mg

Tablet

Oral use

Ireland

| Takeda UK Limited, |
| --- |
| Takeda House, |
| Mercury Park, |
| Wycombe Lane, |
| Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom. |

Takeda UK Limited,

Takeda House,

Mercury Park,

Wycombe Lane,

Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom.

Blopress Plus 16 mg/12,5 mg tablets

16 mg/12,5 mg

Tablet

Oral use

Ireland

| Takeda UK Limited, |
| --- |
| Takeda House, |
| Mercury Park, |
| Wycombe Lane, |
| Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom. |

Takeda UK Limited,

Takeda House,

Mercury Park,

Wycombe Lane,

Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom.

Blopress Plus 32 mg/12,5 mg tablets

32 mg/12,5 mg

Tablet

Oral use

Ireland

| Takeda UK Limited, |
| --- |
| Takeda House, |
| Mercury Park, |
| Wycombe Lane, |
| Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom. |

Takeda UK Limited,

Takeda House,

Mercury Park,

Wycombe Lane,

Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom.

Blopress Plus

32 mg/25 mg tablets

32 mg/25 mg

Tablet

Oral use

Italy

| AstraZeneca SpA |
| --- |
| Palazzo Volta-via F Sforza – 20080 Basiglio (MI) – |
| Italy |

AstraZeneca SpA

Palazzo Volta-via F Sforza – 20080 Basiglio (MI) –

Italy

Ratacand Plus

8 mg/12,5 mg

Tablet

Oral use

Italy

| AstraZeneca SpA |
| --- |
| Palazzo Volta-via F Sforza – 20080 Basiglio (MI) – |
| Italy |

AstraZeneca SpA

Palazzo Volta-via F Sforza – 20080 Basiglio (MI) –

Italy

Ratacand Plus

16 mg/12,5 mg

Tablet

Oral use

Italy

| AstraZeneca SpA |
| --- |
| Palazzo Volta-via F Sforza – 20080 Basiglio (MI) – |
| Italy |

AstraZeneca SpA

Palazzo Volta-via F Sforza – 20080 Basiglio (MI) –

Italy

Ratacand Plus

32 mg/12,5 mg

Tablet

Oral use

Italy

| AstraZeneca SpA |
| --- |
| Palazzo Volta-via F Sforza – 20080 Basiglio (MI) – |
| Italy |

AstraZeneca SpA

Palazzo Volta-via F Sforza – 20080 Basiglio (MI) –

Italy

Ratacand Plus

32 mg/25 mg

Tablet

Oral use

Italy

| Takeda Italia Farmaceutici S.p.A., |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.,

Via Elio Vittorini, 129

00144 Roma

Italy

Blopresid 8/12,5 mg compresse

8 mg/12,5 mg

Tablet

Oral use

Italy

| Takeda Italia Farmaceutici S.p.A., |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.,

Via Elio Vittorini, 129

00144 Roma

Italy

Blopresid 16/12,5 mg compresse

16 mg/12,5 mg

Tablet

Oral use

Italy

| Takeda Italia Farmaceutici S.p.A., |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.,

Via Elio Vittorini, 129

00144 Roma

Italy

Blopresid 32 mg/12,5 mg compresse

32 mg/12,5 mg

Tablet

Oral use

Italy

| Takeda Italia Farmaceutici S.p.A., |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.,

Via Elio Vittorini, 129

00144 Roma

Italy

Blopresid 32 mg/25 mg compresse

32 mg/25 mg

Tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand Plus

8 mg/12,5 mg

Tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand Plus

16 mg/12,5 mg

Tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand Plus

32 mg/12,5 mg

Tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand Plus

32 mg/25 mg

Tablet

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Atacand Plus 8/12,5

8 mg/12,5 mg

Tablet

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Atacand Plus 16/12,5

16 mg/12,5 mg

Tablet

Oral use

Norway

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, |
| Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo,

Norway

Atacand Plus Mite

8 mg/12,5 mg

Tablet

Oral use

Norway

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, |
| Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo,

Norway

Atacand Plus

16 mg/12,5 mg

Tablet

Oral use

Norway

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, |
| Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo,

Norway

Atacand Plus

32 mg/12,5 mg

Tablet

Oral use

Norway

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, |
| Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo,

Norway

Atacand Plus

32 mg/25 mg

Tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Queluz de Baixo 2730-097 Barcarena, |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Queluz de Baixo 2730-097 Barcarena,

Portugal

Hytacand

8 mg/12,5 mg

Tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Queluz de Baixo 2730-097 Barcarena, |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Queluz de Baixo 2730-097 Barcarena,

Portugal

Hytacand 16 mg

16 mg/12,5 mg

Tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Queluz de Baixo 2730-097 Barcarena, |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Queluz de Baixo 2730-097 Barcarena,

Portugal

Hytacand

32 mg/12,5 mg

Tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Queluz de Baixo 2730-097 Barcarena, |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Queluz de Baixo 2730-097 Barcarena,

Portugal

Hytacand

32 mg/25 mg

Tablet

Oral use

Portugal

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A., |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena, |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.,

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena,

Portugal

Blopress

8 mg/12,5 mg

Tablet

Oral use

Portugal

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A., |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena, |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.,

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena,

Portugal

Blopress

16 mg/12,5 mg

Tablet

Oral use

Portugal

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena, |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena,

Portugal

Blopress

32 mg/12,5 mg

Tablet

Oral use

Portugal

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A., |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena, |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.,

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena,

Portugal

Blopress

32 mg/25 mg

Tablet

Oral use

Slovak Republic

| AstraZeneca AB, S-151 85 Södertälje, |
| --- |
| Sweden |

AstraZeneca AB, S-151 85 Södertälje,

Sweden

Atacand Plus 16/12,5 mg

16 mg/12,5 mg

Tablet

Oral use

Slovak Republic

| AstraZeneca AB, S-151 85 Södertälje, |
| --- |
| Sweden |

AstraZeneca AB, S-151 85 Södertälje,

Sweden

Atacand Plus

32 mg/12,5 mg

Tablet

Oral use

Slovak Republic

| AstraZeneca AB, S-151 85 Södertälje, |
| --- |
| Sweden |

AstraZeneca AB, S-151 85 Södertälje,

Sweden

Atacand Plus

32 mg/25 mg

Tablet

Oral use

Slovenia

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Atacand Plus 16/12,5 mg

16 mg/12,5 mg

Tablet

Oral use

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid,

Spain

Atacand Plus 16 mg/12,5 mg

16 mg/12,5 mg

Tablet

Oral use

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid,

Spain

Atacand Plus

32 mg/12,5 mg

32 mg/12,5 mg

Tablet

Oral use

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid,

Spain

Atacand Plus Forte

32 mg/25 mg

32 mg/25 mg

Tablet

Oral use

Spain

| 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

Blopress Plus 8/12,5 mg comprimidos

8 mg/12,5 mg

Tablet

Oral use

Spain

| 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

Blopress Plus 16/12,5 mg comprimidos

16 mg/12,5 mg

Tablet

Oral use

Spain

| 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

Blopress Plus 32 mg/12,5 mg comprimidos

32 mg/12,5 mg

Tablet

Oral use

Spain

| 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

Blopress Forte 32 mg/25 mg comprimidos

32 mg/25 mg

Tablet

Oral use

Spain

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

Almirall S.A.,

Ronda General Mitre,

151 08022 Barcelona,

Spain

Parapres Plus 16 mg/12,5 mg comprimidos

16 mg/12,5 mg

Tablet

Oral use

Spain

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

Almirall S.A.,

Ronda General Mitre,

151 08022 Barcelona,

Spain

Parapres Plus 32 mg/12,5 mg comprimidos

32 mg/12,5 mg

Tablet

Oral use

Spain

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

Almirall S.A.,

Ronda General Mitre,

151 08022 Barcelona,

Spain

Parapres Plus Forte 32 mg/25 mg comprimidos

32 mg/25 mg

Tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, |
| Sweden |

AstraZeneca AB

151 85 Södertälje,

Sweden

Atacand Plus

8 mg/12,5 mg

Tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, |
| Sweden |

AstraZeneca AB

151 85 Södertälje,

Sweden

Atacand Plus

16 mg/12,5 mg

Tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, |
| Sweden |

AstraZeneca AB

151 85 Södertälje,

Sweden

Atacand Plus

32 mg/12,5 mg

Tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, |
| Sweden |

AstraZeneca AB

151 85 Södertälje,

Sweden

Atacand Plus

32 mg/25 mg

Tablet

Oral use

Sweden

| 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

Blopress Comp

8 mg/12,5 mg

Tablet

Oral use

Sweden

| 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

Blopress Comp

16 mg/12,5 mg

Tablet

Oral use

Sweden

| 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

Blopress Comp

32 mg/12,5 mg

Tablet

Oral use

Sweden

| 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

Blopress Comp

32 mg/25 mg

Tablet

Oral use

Sweden

| 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

Parapres Comp Forte

16 mg/12,5 mg

Tablet

Oral use

Sweden

| 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

Parapres Comp

32 mg/12,5 mg

Tablet

Oral use

Sweden

| 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

Parapres Comp

32 mg/25 mg

Tablet

Oral use

---

ANNEX VI

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

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | LEO Pharmaceutical Products Ltd. A/S |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Belgium

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet 50 microgram/0,5 mg/g gel

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Belgium

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet 50 microgram/g + 0,5 mg/g, zalf

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Bulgaria

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet®

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Cyprus

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet® 50 microgram/g + 0,5 mg/g ointment

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Czech Republic

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet mast

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Denmark

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Denmark

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Estonia

| LEO Pharmaceutical Products |
| --- |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products

Industriparken 55

DK-2750 Ballerup

Denmark

DAIVOBET

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Finland

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet 50 mikrogram/g + 0,5 mg/g geeli

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Finland

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet 50/500 mikrog/g voide

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

France

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

DAIVOBET 50 microgrammes/0,5 mg/g, gel

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

France

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

DAIVOBET 50 microgrammes/0,5 mg/g, pommade

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Germany

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet 50 Mikrogramm/g + 0,5 mg/g Gel

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Germany

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet® 50 Mikrogramm/g + 0,5 mg/g Salbe

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Greece

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet 50 microgram/ 0,5 mg/g gel

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Greece

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet 50 microgram/g + 0,5 mg/g

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Hungary

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet ointment

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Iceland

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet 50 míkrógrömm/0,5 mg/g hlaup

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Iceland

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet 50 míkróg/g + 0,5 mg/g smyrsli

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Ireland

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet 50 microgram/g + 0,5 mg/g gel

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Ireland

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet 50 microgram/g + 0,5 mg/g ointment

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Italy

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Italy

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Latvia

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet® 50 μg/g + 0,5 mg/g ziede

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Lithuania

| LEO Pharmaceutical Products |
| --- |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Luxembourg

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet Scalp 50 microgram/0,5 mg/g gel

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Luxembourg

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet 50 microgrammes/g + 0,5 mg/g, onguent

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Malta

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet® 50 micrograms/g + 0,5 mg/g ointment

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Netherlands

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet gel 50 microgram/0,5 mg/g gel

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Netherlands

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet zalf 50 microgram/g + 0,5 mg/g

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Norway

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet 50 mikrogram/g + 0,5 mg/g gel

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Norway

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet 50 mikrogram/g + 0,5 mg/g salve

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Poland

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

Industriparken 55

DK-2750 Ballerup

Denmark

DAIVOBET

(50 μg + 0,5 mg)/g

Ointment

Cutaneous use

Portugal

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Portugal

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Romania

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

DAIVOBET® UNGUENT

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Slovenia

| Pharmagan, d.o.o. |
| --- |
| Vodopivceva 9 |
| SI-4000 Kranj |
| Slovenia |

Pharmagan, d.o.o.

Vodopivceva 9

SI-4000 Kranj

Slovenia

Daivobet 50 mikrogramov/500 mikrogramov v 1 g mazilo

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Spain

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet 50 microgramos/g + 0,5 mg/g gel

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Spain

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet 50 microgramos/g + 0,5 mg/g pomada

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

Sweden

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

Sweden

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Daivobet

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

United Kingdom

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet 50 microgram/g + 0,5 mg/g gel

50 μg/g + 0,5 mg/g

Gel

Cutaneous use

United Kingdom

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Denmark |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Denmark

Dovobet® 50 microgram/g + 0,5 mg/g ointment

50 μg/g + 0,5 mg/g

Ointment

Cutaneous use

---

ANNEX VII

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

| Member State EU/EEA | Marketing authorisation holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Italy | | Warner Chilcott UK Limited, |
| Old Belfast Road, Millbrook, Larne, County Antrim, |
| BT40 2SH |
| United Kingdom |

Member State EU/EEA

Marketing authorisation holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Italy

Warner Chilcott UK Limited,

Old Belfast Road, Millbrook, Larne, County Antrim,

BT40 2SH

United Kingdom

Actocalcio D3

35 mg +

1 000 mg/880 IU

film-coated tablets + effervescent granules

Oral use

Spain

| PROCTER AND GAMBLE PHARMACEUTICALS IBERIA, S.L. |
| --- |
| WTC Almeda Park, Ed. 1, 2a pl. |
| Plaça de la Pau s/n |
| 08940 Cornellà de Llobregat (Barcelona) |
| Spain |

PROCTER AND GAMBLE PHARMACEUTICALS IBERIA, S.L.

WTC Almeda Park, Ed. 1, 2a pl.

Plaça de la Pau s/n

08940 Cornellà de Llobregat (Barcelona)

Spain

Acrelcombi

35 mg +

1 000 mg/880 IU

film-coated tablets + effervescent granules

Oral use

Sweden

| Warner Chilcott UK Limited, |
| --- |
| Old Belfast Road, Millbrook, Larne, County Antrim, |
| BT40 2SH |
| United Kingdom |

Warner Chilcott UK Limited,

Old Belfast Road, Millbrook, Larne, County Antrim,

BT40 2SH

United Kingdom

Fortipan Combi D

35 mg +

1 000 mg/880 IU

film-coated tablets + effervescent granules

Oral use

---

ANNEX VIII

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

| Member State EU/EEA | Marketing Authorisation Holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria GmbH |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Austria

Genotropin 12 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

12 mg

Powder and solvent for solution for injection

Subcutaneous use

Austria

| Pfizer Corporation Austria |
| --- |
| GmbH |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |
| Austria |

Pfizer Corporation Austria

GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Austria

Genotropin 5,3 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

5,3 mg

Powder and solvent for solution for injection

Subcutaneous use

Austria

| Pfizer Corpoation Austria |
| --- |
| GmbH |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |
| Austria |

Pfizer Corpoation Austria

GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Austria

Genotropin MiniQuick 0,2 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

0,2 mg

Powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm

1,3 mg

powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm

5,0 mg

powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm

5,3 mg

powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm

12 mg

powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

0,2 mg

powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

0,4 mg

powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

0,6 mg

powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

0,8 mg

powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

1,0 mg

powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

1,2 mg

powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

1,4 mg

powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

1,6 mg

powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

1,8 mg

powder and solvent for solution for injection

Subcutaneous use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

2,0 mg

powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin

1,3 mg

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin

5 mg

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin

5,3 mg

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin

12 mg

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

0,2 mg

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

0,4 mg

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

0,6 mg

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

0,8 mg

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,0 mg

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,2 mg

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,4 mg

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,6 mg

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,8 mg

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

2,0 mg

Powder and solvent for solution for injection

Subcutaneous use

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, |
| 00330 Helsinki, |
| Finland |

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Genotropin

5 mg

Powder and solvent for solution for injection

Subcutaneous use

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, |
| 00330 Helsinki, |
| Finland |

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Genotropin

12 mg

Powder and solvent for solution for injection

Subcutaneous use

France

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM 5 mg, poudre et solvant pour solution injectable

5 mg

Powder and solvent for solution for injection

Subcutaneous use

France

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM 5,3 mg, poudre et solvant pour solution injectable

5,3 mg

Powder and solvent for solution for injection

Subcutaneous use

France

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM 12 mg, poudre et solvant pour solution injectable

12 mg

Powder and solvent for solution for injection

Subcutaneous use

France

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 0,2 mg, poudre et solvant pour solution injectable

0,2 mg

Powder and solvent for solution for injection

Subcutaneous use

France

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 0,4 mg, poudre et solvant pour solution injectable

0,4 mg

Powder and solvent for solution for injection

Subcutaneous use

France

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 0,6 mg, poudre et solvant pour solution injectable

0,6 mg

Powder and solvent for solution for injection

Subcutaneous use

France

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 0,8 mg, poudre et solvant pour solution injectable

0,8 mg

Powder and solvent for solution for injection

Subcutaneous use

France

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 1 mg, poudre et solvant pour solution injectable

1 mg

Powder and solvent for solution for injection

Subcutaneous use

France

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 1,2 mg, poudre et solvant pour solution injectable

1,2 mg

Powder and solvent for solution for injection

Subcutaneous use

France

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 1,4 mg, poudre et solvant pour solution injectable

1,4 mg

Powder and solvent for solution for injection

Subcutaneous use

France

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 1,6 mg, poudre et solvant pour solution injectable

1,6 mg

Powder and solvent for solution for injection

Subcutaneous use

France

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 1,8 mg, poudre et solvant pour solution injectable

1,8 mg

Powder and solvent for solution for injection

Subcutaneous use

France

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 2 mg, poudre et solvant pour solution injectable

2 mg

Powder and solvent for solution for injection

Subcutaneous use

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

Genotropin 5 mg/ml

5,0 mg

Powder and solvent for solution for injection

Subcutaneous use

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

Genotropin 5,3 mg/ml

5,3 mg

Powder and solvent for solution for injection

Subcutaneous use

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

Genotropin 12 mg/ml

12,0 mg

Powder and solvent for solution for injection

Subcutaneous use

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 0,2 mg

0,2 mg

Powder and solvent for solution for injection

Subcutaneous use

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 0,4 mg

0,4 mg

Powder and solvent for solution for injection

Subcutaneous use

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 0,6 mg

0,6 mg

Powder and solvent for solution for injection

Subcutaneous use

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 0,8 mg

0,8 mg

Powder and solvent for solution for injection

Subcutaneous use

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 1,0 mg

1,0 mg

Powder and solvent for solution for injection

Subcutaneous use

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 1,2 mg

1,2 mg

Powder and solvent for solution for injection

Subcutaneous use

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 1,4 mg

1,4 mg

Powder and solvent for solution for injection

Subcutaneous use

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 1,6 mg

1,6 mg

Powder and solvent for solution for injection

Subcutaneous use

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GENOTROPIN MiniQuick 1,8 mg

1,8 mg

Powder and solvent for solution for injection

Subcutaneous use

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 2,0 mg

2,0 mg

Powder and solvent for solution for injection

Subcutaneous use

Greece

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN

1 mg

Powder and Solution for solution for injection

Subcutaneous use

Greece

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN

1,4 mg

Powder and Solution for solution for injection

Subcutaneous use

Greece

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN

2 mg

Powder and Solution for solution for injection

Subcutaneous use

Greece

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN

5 mg

Powder and Solution for solution for injection

Subcutaneous use

Greece

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN (WITH PRESERVATIVE)

5,3 mg

Powder and Solution for solution for injection

Subcutaneous use

Greece

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN (WITH PRESERVATIVE)

12 mg

Powder and Solution for solution for injection

Subcutaneous use

Greece

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN

1,3 mg

Powder and Solution for solution for injection

Subcutaneous use

Ireland

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN 5,3 MG

5,3 mg

Powder and solvent for Solution for injection

Subcutaneous Use

Ireland

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN 12 MG

12 mg

Powder and solvent for Solution for injection

Subcutaneous Use

Ireland

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,2 MG

0,2 mg

Powder and solvent for Solution for injection

Subcutaneous Use

Ireland

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,4 MG

0,4 mg

Powder and solvent for Solution for injection

Subcutaneous Use

Ireland

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,6 MG

0,6 mg

Powder and solvent for Solution for injection

Subcutaneous Use

Ireland

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,8 MG

0,8 mg

Powder and solvent for Solution for injection

Subcutaneous Use

Ireland

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1 MG

1 mg

Powder and solvent for Solution for injection

Subcutaneous Use

Ireland

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,2 MG

1,2 mg

Powder and solvent for Solution for injection

Subcutaneous Use

Ireland

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,4 MG

1,4 mg

Powder and solvent for Solution for injection

Subcutaneous Use

Ireland

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,6 MG

1,6 mg

Powder and solvent for Solution for injection

Subcutaneous Use

Ireland

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,8 MG

1,8 mg

Powder and solvent for Solution for injection

Subcutaneous Use

Ireland

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 2 MG

2 mg

Powder and solvent for Solution for injection

Subcutaneous Use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin

5,3 mg

powder and solvent for solution for injection

subcutaneous use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin

12 mg

powder and solvent for solution for injection

subcutaneous use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

0,2 mg

powder and solvent for solution for injection

subcutaneous use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

0,4 mg

powder and solvent for solution for injection

subcutaneous use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

0,6 mg

powder and solvent for solution for injection

subcutaneous use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

0,8 mg

powder and solvent for solution for injection

subcutaneous use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1 mg

powder and solvent for solution for injection

subcutaneous use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1,2 mg

powder and solvent for solution for injection

subcutaneous use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1,4 mg

powder and solvent for solution for injection

subcutaneous use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1,6 mg

powder and solvent for solution for injection

subcutaneous use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1,8 mg

powder and solvent for solution for injection

subcutaneous use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

2 mg

powder and solvent for solution for injection

subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm

1,3 mg

powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm

5 mg

powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm

5,3 mg

powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm

12 mg

powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

0,2 mg

powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

0,4 mg

powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

0,6 mg

powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

0,8 mg

powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

1 mg

powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

1,2 mg

powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

1,4 mg

powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

1,6 mg

powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

1,8 mg

powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

2 mg

powder and solvent for solution for injection

Subcutaneous use

Netherlands

| Pfizer BV |
| --- |
| Postbus 37 |
| 2900AA Capelle aan den Ijssel |
| The Netherlands |

Pfizer BV

Postbus 37

2900AA Capelle aan den Ijssel

The Netherlands

Genotropin 5 mg, poeder en oplosmiddel voor oplossing voor injectie

5 mg

powder and solvent for solution for injection

Subcutaneous use

Netherlands

| Pfizer BV |
| --- |
| Postbus 37 |
| 2900AA Capelle aan den Ijssel |
| The Netherlands |

Pfizer BV

Postbus 37

2900AA Capelle aan den Ijssel

The Netherlands

Genotropin 12 mg, poeder en oplosmiddel voor oplossing voor injectie

12 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin 1,3 mg

1,3 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin 12 mg

12 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin 5,3 mg

5,3 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Mixer

5,3 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

2 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

0,2 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

0,4 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

0,6 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

0,8 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1,2 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1,4 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1,6 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1,8 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Mixer

1,3 mg

powder and solvent for solution for injection

Subcutaneous use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin

5 mg

powder and solvent for solution for injection

Subcutaneous use

Spain

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM KABIPEN 12 mg polvo y disolvente para solución inyectable

12 mg

Powder and solvent for solution for injection

Subcutaneous use

Spain

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM KABIPEN 5,3 mg polvo y disolvente para solución inyectable

5,3 mg

Powder and solvent for solution for injection

Subcutaneous use

Spain

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 0,2 mg polvo y disolvente para solución inyectable

0,2 mg

Powder and solvent for solution for injection

Subcutaneous use

Spain

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 0,4 mg polvo y disolvente para solución inyectable

0,4 mg

Powder and solvent for solution for injection

Subcutaneous use

Spain

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 0,6 mg polvo y disolvente para solución inyectable

0,6 mg

Powder and solvent for solution for injection

Subcutaneous use

Spain

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 0,8 mg polvo y disolvente para solución inyectable

0,8 mg

Powder and solvent for solution for injection

Subcutaneous use

Spain

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 1 mg polvo y disolvente para solución inyectable

1 mg

Powder and solvent for solution for injection

Subcutaneous use

Spain

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 1,2 mg polvo y disolvente para solución inyectable

1,2 mg

Powder and solvent for solution for injection

Subcutaneous use

Spain

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 1,4 mg polvo y disolvente para solución inyectable

1,4 mg

Powder and solvent for solution for injection

Subcutaneous use

Spain

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 1,6 mg polvo y disolvente para solución inyectable

1,6 mg

Powder and solvent for solution for injection

Subcutaneous use

Spain

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 1,8 mg polvo y disolvente para solución inyectable

1,8 mg

Powder and solvent for solution for injection

Subcutaneous use

Spain

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 2 mg polvo y disolvente para solución inyectable

2 mg

Powder and solvent for solution for injection

Subcutaneous use

Sweden

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin

5,3 mg

Powder and solution for injection

Subcutaneous use

Sweden

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin

12 mg

Powder and solution for injection

Subcutaneous use

Sweden

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin

5 mg

Powder and solution for injection

Subcutaneous use

Sweden

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

0,2 mg

Powder and solution for injection

Subcutaneous use

Sweden

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

0,4 mg

Powder and solution for injection

Subcutaneous use

Sweden

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

0,6 mg

Powder and solution for injection

Subcutaneous use

Sweden

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

0,8 mg

Powder and solution for injection

Subcutaneous use

Sweden

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

1 mg

Powder and solution for injection

Subcutaneous use

Sweden

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

1,2 mg

Powder and solution for injection

Subcutaneous use

Sweden

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

1,4 mg

Powder and solution for injection

Subcutaneous use

Sweden

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

1,6 mg

Powder and solution for injection

Subcutaneous use

Sweden

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

1,8 mg

Powder and solution for injection

Subcutaneous use

Sweden

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

2 mg

Powder and solution for injection

Subcutaneous use

United Kingdom

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

GENOTROPIN 5,3 MG

5,3 mg

Powder and solvent for solution for injection

Subcutaneous Use

United Kingdom

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN 12 MG

12 mg

Powder and solvent for solution for injection

Subcutaneous Use

United Kingdom

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,2 MG

0,2 mg

Powder and solvent for solution for injection

Subcutaneous Use

United Kingdom

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,4 MG

0,4 mg

Powder and solvent for solution for injection

Subcutaneous Use

United Kingdom

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,6 MG

0,6 mg

Powder and solvent for solution for injection

Subcutaneous Use

United Kingdom

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,8 MG

0,8 mg

Powder and solvent for solution for injection

Subcutaneous Use

United Kingdom

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1 MG

1 mg

Powder and solvent for solution for injection

Subcutaneous Use

United Kingdom

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,2 MG

1,2 mg

Powder and solvent for solution for injection

Subcutaneous Use

United Kingdom

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,4 MG

1,4 mg

Powder and solvent for solution for injection

Subcutaneous Use

United Kingdom

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,6 MG

1,6 mg

Powder and solvent for solution for injection

Subcutaneous Use

United Kingdom

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,8 MG

1,8 mg

Powder and solvent for solution for injection

Subcutaneous Use

United Kingdom

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 2 MG

2 mg

Powder and solvent for solution for injection

Subcutaneous Use

---

ANNEX IX

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Product name | Pharmaceutical form | Strength | Target animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Belgium | Pfizer Animal Health |
| Rue Laid Burniat 1 |
| 1348 - Louvain-la-Neuve |
| BELGIUM |

Member State

Marketing Authorisation Holder

Product name

Pharmaceutical form

Strength

Target animal species

Route of administration

Belgium

Pfizer Animal Health

Rue Laid Burniat 1

1348 - Louvain-la-Neuve

BELGIUM

PREGSURE BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Bulgaria

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

PregSure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Czech Republic

| Pfizer, spol. s r.o. |
| --- |
| Stroupežnického 17 |
| 150 00 Praha |
| CZECH REPUBLIC |

Pfizer, spol. s r.o.

Stroupežnického 17

150 00 Praha

CZECH REPUBLIC

PregSure BVD injekční emulze

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Estonia

| Pfizer Animal Health |
| --- |
| Rue Laid Burniat 1 |
| 1348 - Louvain-la-Neuve |
| BELGIUM |

Pfizer Animal Health

Rue Laid Burniat 1

1348 - Louvain-la-Neuve

BELGIUM

PregSure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

France

| PFIZER |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANCE |

PFIZER

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCE

PREGSURE BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Germany

| Pfizer GmbH |
| --- |
| Linkstraße 10 |
| D-10785 Berlin |
| GERMANY |

Pfizer GmbH

Linkstraße 10

D-10785 Berlin

GERMANY

PregSure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Greece

| PFIZER HELLAS S.A |
| --- |
| 243 Messogeion Ave. |
| Neo Psychiko |
| GR-154 51 |
| GREECE |

PFIZER HELLAS S.A

243 Messogeion Ave.

Neo Psychiko

GR-154 51

GREECE

PREGSURE BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Hungary

| Pfizer Kft. |
| --- |
| Alkotas u 53 |
| MOM Park ‘F’ Épület |
| Budapest H-1123 |
| HUNGARY |

Pfizer Kft.

Alkotas u 53

MOM Park ‘F’ Épület

Budapest H-1123

HUNGARY

PregSure BVD vakcina A.U.V.

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Ireland

| Pfizer Healthcare Ireland trading as Pfizer Animal Health |
| --- |
| Ringaskiddy |
| County Cork |
| IRELAND |

Pfizer Healthcare Ireland trading as Pfizer Animal Health

Ringaskiddy

County Cork

IRELAND

PregSure BVD Emulsion for Injection

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Italy

| Pfizer Italia Srl |
| --- |
| Via Isonzo 71 |
| 04100 – Latina |
| ITALY |

Pfizer Italia Srl

Via Isonzo 71

04100 – Latina

ITALY

Pregsure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Lithuania

| Pfizer Animal Health S.A. |
| --- |
| Rue Laid Burniat 1 |
| B-1348 - Louvain-la-Neuve |
| BELGIUM |

Pfizer Animal Health S.A.

Rue Laid Burniat 1

B-1348 - Louvain-la-Neuve

BELGIUM

PREGSURE BVD, injekcinė emulsija

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Latvia

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

PregSure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Poland

| Pfizer Trading Polska Sp. z o.o. |
| --- |
| ul. Rzymowskiego 34 |
| 02-697 Warszawa |
| POLAND |

Pfizer Trading Polska Sp. z o.o.

ul. Rzymowskiego 34

02-697 Warszawa

POLAND

PregSure BVD emulsja do wstrzykiwań

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Portugal

| Laboratórios Pfizer Lda |
| --- |
| Lagoas Park – Edifício 10 |
| 2740-244 Porto Salvo |
| PORTUGAL |

Laboratórios Pfizer Lda

Lagoas Park – Edifício 10

2740-244 Porto Salvo

PORTUGAL

Pregsure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Romania

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent |
| CT 13 9NJ |
| UNITED KINGDOM |

Pfizer Animal Health MA EEIG

Ramsgate Road, Sandwich, Kent

CT 13 9NJ

UNITED KINGDOM

Pregsure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| Gran Duchy of Luxembourg |
| 51, Avenue J.F. Kennedy |
| L-1855 - Luxembourg |

Pfizer Luxembourg SARL

Gran Duchy of Luxembourg

51, Avenue J.F. Kennedy

L-1855 - Luxembourg

Pregsure BVD emulzija za injiciranje

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Slovak republic

| Pfizer Luxembourg SARL o.z. |
| --- |
| Pfizer AH |
| Pribinova 25 |
| 81109 Bratislava |
| SLOVAK REPUBLIC |

Pfizer Luxembourg SARL o.z.

Pfizer AH

Pribinova 25

81109 Bratislava

SLOVAK REPUBLIC

Pregsure BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

Spain

| Pfizer SA |
| --- |
| Avda. De Europa, 20 B |
| Parque Empresarial la Moraleja (Alcobendas) |
| 28108 |
| SPAIN |

Pfizer SA

Avda. De Europa, 20 B

Parque Empresarial la Moraleja (Alcobendas)

28108

SPAIN

PREGSURE BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

The Netherlands

| Pfizer Animal Health BV |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| P.O. Box 37 |
| 2900 AA Capelle a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health BV

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

P.O. Box 37

2900 AA Capelle a/d Ijssel

THE NETHERLANDS

PREGSURE BVD

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

Pregsure BVD Emulsion for Injection

Emulsion for injection

to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log2

Cattle at breeding age (cows and heifers)

Subcutaneous

---

ANNEX X

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

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | Octapharma Pharmazeutika |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

AT - Austria

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Austria

Octagam 100 mg/ml Infusionslösung

100 mg/ml

Solution for infusion

Intravenous Use

AT - Austria

| Octapharma Pharmazeutika |
| --- |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Austria |

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Austria

Octagam 50 mg/ml Infusionslösung

50 mg/ml

Solution for infusion

Intravenous Use

BE - Belgium

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam 10 %, solution pour perfusion

10 % (100 mg/ml)

Solution for infusion

Intravenous Use

BE - Belgium

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam 50 mg/ml solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

BG - Bulgaria

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

CY - Cyprus

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM INFUSION 10 %

10 %

Solution for infusion

Intravenous use

CY - Cyprus

| Hospitec Co Ltd |
| --- |
| 5 Thessalonikis, Block B |
| 2085 Lefkosia |
| Cyprus |

Hospitec Co Ltd

5 Thessalonikis, Block B

2085 Lefkosia

Cyprus

OCTAGAM INFUSION 5 %

5 %

Solution for infusion

Intravenous use

CZ - Czech Republic

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM

50 mg/ml

Solution for infusion

Intravenous Use

CZ - Czech Republic

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 50 mg/ml

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

EL - Greece

| Octapharma Hellas SA |
| --- |
| George Kalbitzer |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Greece |

Octapharma Hellas SA

George Kalbitzer

60, posidonos Ave.

166 75 Glyfada Attiki

Greece

OCTAGAM

5 % (W/V)

Solution for infusion

Intravenous Use

EL - Greece

| Octapharma Hellas SA |
| --- |
| George Kalbitzer |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Greece |

Octapharma Hellas SA

George Kalbitzer

60, posidonos Ave.

166 75 Glyfada Attiki

Greece

OCTAGAM

10 % (100MG/ML)

Solution for infusion

Intravenous Use

ES - Spain

| OCTAPHARMA, S.A. |
| --- |
| C/ Velázquez, 150 |
| 28002 Madrid |
| ESPAÑA |

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

ESPAÑA

Octagamocta 100 mg/ml solución para perfusión

100 mg/ml

Solution for infusion

Intravenous use

ES - Spain

| OCTAPHARMA, S.A. |
| --- |
| C/ Velázquez, 150 |
| 28002 Madrid |
| ESPAÑA |

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

ESPAÑA

Octagamocta 50 mg/ml solución para perfusión

50 mg/ml

Solution for infusion

Intravenous use

ET - Estonia

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

OCTAGAM

50 mg/ml

Solution for infusion

Intravenous Use

ET - Estonia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 10 %

100 mg/1ml

Solution for infusion

Intravenous Use

FI - Finland

| OCTAPHARMA |
| --- |
| Rajatorpantie 41 C |
| 01640 Vantaa |
| FINLAND |

OCTAPHARMA

Rajatorpantie 41 C

01640 Vantaa

FINLAND

OCTAGAM

50 mg/ml

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

| Octapharma France SAS |
| --- |
| Laurent de Narbonne |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| France |

Octapharma France SAS

Laurent de Narbonne

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

France

OCTAGAM 100 mg/ml, solution pour perfusion

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

| Octapharma France SAS |
| --- |
| Laurent de Narbonne |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| France |

Octapharma France SAS

Laurent de Narbonne

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

France

OCTAGAM 50 mg/ml, solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 50 mg/ml oldatos infúzió

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 100 mg/ml oldatos infúzió

100 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

| Octapharma AB |
| --- |
| Nordenflychtsvägen 55 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

| Octapharma AB |
| --- |
| Nordenflychtsvägen 55 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

IT - Italy

| Octapharma Ltd |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Ltd

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM

5 %

Solution for infusion

Intravenous Use

LT - Lithuania

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

octagam

100 mg/ml

Solution for infusion

Intravenous Use

LU - Luxembourg

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam

5 %

Solution for infusion

Intravenous use

LU - Luxembourg

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam-10

10 %

Solution for infusion

Intravenous use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

1 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

2,5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

5 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

10 g/200 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml šķīdums infūzijām, 2 g/20 ml

2 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml šķīdums infūzijām, 5 g/50 ml

5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml šķīdums infūzijām, 10 g/100 ml

10 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml šķīdums infūzijām, 20 g/200 ml

20 g/200 ml

Solution for infusion

Intravenous Use

MT - Malta

| Octapharma (IP) Limited, |
| --- |
| The Zenith Building, |
| 26 Spring Gardens, Manchester M2 1AB, |
| United Kingdom |

Octapharma (IP) Limited,

The Zenith Building,

26 Spring Gardens, Manchester M2 1AB,

United Kingdom

OCTAGAM 10 %

1ml contains: protein 100mg (of which ≥ 95 % is human Immunoglobulin G), IgA ≤ 0,4 mg, IgM ≤ 0,3mg

Solution for infusion

Intravenous use

NL - Netherlands

| Octapharma GmbH |
| --- |
| Reinhard Rettinghaus |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

Octapharma GmbH

Reinhard Rettinghaus

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

NL - Netherlands

| Octapharma GmbH |
| --- |
| Reinhard Rettinghaus |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

Octapharma GmbH

Reinhard Rettinghaus

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

| Octapharma AG |
| --- |
| Kim Björnstrup |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Switzerland |

Octapharma AG

Kim Björnstrup

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

| Octapharma AG |
| --- |
| Kim Björnstrup |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Switzerland |

Octapharma AG

Kim Björnstrup

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

2,5 g/50 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

5 g/100 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

20 g/200 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

PT - Portugal

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Paulo Castro |
| Rua da Graca, 14 |
| P-1170-169 Lisboa |
| Portugal |

Octapharma

Produtos Farmaceuticos, Lda.

Paulo Castro

Rua da Graca, 14

P-1170-169 Lisboa

Portugal

Octagam

50 mg/ml

Solution for infusion

Intravenous use

PT - Portugal

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Paulo Castro |
| Rua da Graca, 14 |
| P-1170-169 Lisboa |
| Portugal |

Octapharma

Produtos Farmaceuticos, Lda.

Paulo Castro

Rua da Graca, 14

P-1170-169 Lisboa

Portugal

Octagam

100 mg/ml

Solution for infusion

Intravenous use

RO - Romania

| OCTAPHARMA (IP) Ltd. |
| --- |
| The Zenith Building 26 Spring Gardens |
| Manchester, M2 1AB |
| United Kingdom |

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

United Kingdom

OCTAGAM

50 mg/ml

Solution for infusion

Intravenous use

RO - Romania

| OCTAPHARMA (IP) Ltd. |
| --- |
| The Zenith Building 26 Spring Gardens |
| Manchester, M2 1AB |
| United Kingdom |

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

United Kingdom

OCTAGAM 10 %

100 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

| Octapharma AB |
| --- |
| Olivier Clairotte |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Olivier Clairotte

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagem

50 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

| Octapharma AB |
| --- |
| Olivier Clairotte |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Olivier Clairotte

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagem

100 mg/ml

Solution for infusion

Intravenous use

SI - Slovenia

| Zavod Republike Slovenije za transfuzijsko medicino |
| --- |
| Šlajmerjeva 6 |
| 1000 Ljubljana |
| Slovenija |

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenija

Octagam 50 mg/ml raztopina za infundiranje

50 mg/ ml

Solution for infusion

Intravenous use

SI - Slovenia

| Zavod Republike Slovenije za transfuzijsko medicino |
| --- |
| Šlajmerjeva 6 |
| 1000 Ljubljana |
| Slovenija |

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenija

Octagam 100 mg/ml raztopina za infundiranje

100 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

20 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

50 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

100 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

200 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

20 ml 100 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

50 ml 100 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 ml 100 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

200 ml 100 mg/ml

Solution for infusion

Intravenous use

UK - United Kingdom

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam Infusion

5 % w/v

Solution for infusion

Intravenous use

UK - United Kingdom

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 % solution for Infusion

10 % w/v

Solution for infusion

Intravenous use

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