# Official Journal C 111/2010

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2010.111.eng |
| --- | --- |
| Official Journal
  of the European Union | C 111 |
| | |
| English edition | Information and Notices | Volume 5330 April 2010 |

ISSN 1725-2423

doi:10.3000/17252423.C_2010.111.eng

Official Journal

of the European Union

C 111

English edition

Information and Notices

Volume 5330 April 2010

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2010/C 111/01 | Euro exchange rates | 1 |
| 2010/C 111/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 2 |
| 2010/C 111/03 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
  ) | 16 |
| 2010/C 111/04 | Commission notice on current State aid recovery interest rates and reference/discount rates for 27 Member States applicable as from 1 May 2010(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 of 21 April 2004 (OJ L 140, 30.4.2004, p. 1)) | 28 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2010/C 111/01

Euro exchange rates

1

2010/C 111/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 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

)

2

2010/C 111/03

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council

or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council

)

16

2010/C 111/04

Commission notice on current State aid recovery interest rates and reference/discount rates for 27 Member States applicable as from 1 May 2010(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 of 21 April 2004 (OJ L 140, 30.4.2004, p. 1))

(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 of 21 April 2004 (OJ L 140, 30.4.2004, p. 1))

28

| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY |
| | European Commission |
| 2010/C 111/05 | Notice of the impending expiry of certain anti-dumping measures | 29 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2010/C 111/06 | Prior notification of a concentration (Case COMP/M.5860 — Cooper/Danaher/JV) — Candidate case for simplified procedure (
  1
  ) | 30 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

European Commission

2010/C 111/05

Notice of the impending expiry of certain anti-dumping measures

29

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2010/C 111/06

Prior notification of a concentration (Case COMP/M.5860 — Cooper/Danaher/JV) — Candidate case for simplified procedure (
  1
  )

1

30

| | |
| --- | --- |
| 2010/C 111/07 | Note to the reader (see page 3 of the cover) | s3 |

2010/C 111/07

Note to the reader (see page 3 of the cover)

Note to the reader

s3

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

---

(1)   Text with EEA relevance

1

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 30.4.2010 | EN | Official Journal of the European Union | C 111/1 |
| --- | --- | --- | --- |

30.4.2010

EN

Official Journal of the European Union

C 111/1

---

Euro exchange rates (1)

29 April 2010

2010/C 111/01

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,3256 |
| JPY | Japanese yen | 124,76 |
| DKK | Danish krone | 7,4421 |
| GBP | Pound sterling | 0,86785 |
| SEK | Swedish krona | 9,6267 |
| CHF | Swiss franc | 1,4348 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 7,8430 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 25,540 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 268,28 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7081 |
| PLN | Polish zloty | 3,9153 |
| RON | Romanian leu | 4,1370 |
| TRY | Turkish lira | 1,9673 |
| AUD | Australian dollar | 1,4272 |
| CAD | Canadian dollar | 1,3292 |
| HKD | Hong Kong dollar | 10,2936 |
| NZD | New Zealand dollar | 1,8339 |
| SGD | Singapore dollar | 1,8145 |
| KRW | South Korean won | 1 477,79 |
| ZAR | South African rand | 9,7596 |
| CNY | Chinese yuan renminbi | 9,0484 |
| HRK | Croatian kuna | 7,2460 |
| IDR | Indonesian rupiah | 11 948,32 |
| MYR | Malaysian ringgit | 4,2320 |
| PHP | Philippine peso | 59,186 |
| RUB | Russian rouble | 38,7577 |
| THB | Thai baht | 42,797 |
| BRL | Brazilian real | 2,3044 |
| MXN | Mexican peso | 16,2651 |
| INR | Indian rupee | 59,0090 |

Currency

Exchange rate

USD

US dollar

1,3256

JPY

Japanese yen

124,76

DKK

Danish krone

7,4421

GBP

Pound sterling

0,86785

SEK

Swedish krona

9,6267

CHF

Swiss franc

1,4348

ISK

Iceland króna

NOK

Norwegian krone

7,8430

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

25,540

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

268,28

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7081

PLN

Polish zloty

3,9153

RON

Romanian leu

4,1370

TRY

Turkish lira

1,9673

AUD

Australian dollar

1,4272

CAD

Canadian dollar

1,3292

HKD

Hong Kong dollar

10,2936

NZD

New Zealand dollar

1,8339

SGD

Singapore dollar

1,8145

KRW

South Korean won

1 477,79

ZAR

South African rand

9,7596

CNY

Chinese yuan renminbi

9,0484

HRK

Croatian kuna

7,2460

IDR

Indonesian rupiah

11 948,32

MYR

Malaysian ringgit

4,2320

PHP

Philippine peso

59,186

RUB

Russian rouble

38,7577

THB

Thai baht

42,797

BRL

Brazilian real

2,3044

MXN

Mexican peso

16,2651

INR

Indian rupee

59,0090

---

(1)  Source: reference exchange rate published by the ECB.

---

| 30.4.2010 | EN | Official Journal of the European Union | C 111/2 |
| --- | --- | --- | --- |

30.4.2010

EN

Official Journal of the European Union

C 111/2

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 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 111/02

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1.2010 | Leflunomide Winthrop | leflunomide | Sanofi-Aventis Deutschland GmbH |
| 65926 Frankfurt am Main |
| DEUTSCHLAND |

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

8.1.2010

Leflunomide Winthrop

leflunomide

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/09/604/001-010

Film-coated tablet

L04AA13

12.1.2010

11.1.2010

Scintimun

besilesomab

| CIS bio international |
| --- |
| 32 Boite Postale |
| 91192 Gif-sur-Yvette |
| FRANCE |

CIS bio international

32 Boite Postale

91192 Gif-sur-Yvette

FRANCE

EU/1/09/602/001-002

Kit for radiopharmaceutical preparation

V09HA03

15.1.2010

25.1.2010

Elonva

corifollitropin alfa

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| 5349 AB Oss |
| NEDERLAND |

N.V. Organon

Kloosterstraat 6

5349 AB Oss

NEDERLAND

EU/1/09/609/001-002

Solution for injection

GO3GA09

27.1.2010

25.1.2010

Temomedac

temozolomide

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Straße 1 |
| 22767 Hamburg |
| DEUTSCHLAND |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Straße 1

22767 Hamburg

DEUTSCHLAND

EU/1/09/605/001-012

Capsule, hard

L01AX03

27.1.2010

26.1.2010

Docetaxel Teva

Docetaxel

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/611/001-002

Concentrate and solvent for solution for infusion

L01CD02

28.1.2010

26.1.2010

Telmisartan Teva

telmisartan

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/610/001-030

Tablet

C09CA07

28.1.2010

28.1.2010

Temozolomide Teva

temozolomide

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/606/001-012

Capsule, hard

L01AX03

1.2.2010

29.1.2010

Silodyx

silodosin

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

Recordati Ireland Ltd

Raheens East

Ringaskiddy Co. Cork

IRELAND

EU/1/09/607/001-014

Capsule, hard

G04CA04

2.2.2010

29.1.2010

Urorec

silodosin

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

Recordati Ireland Ltd

Raheens East

Ringaskiddy Co. Cork

IRELAND

EU/1/09/608/001-014

Capsule, hard

G04CA04

2.2.2010

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
| --- | --- | --- | --- | --- |
| 29.1.2010 | Gemesis | BioMimetic Therapeutics Ltd |
| Arnold & Porter |
| Tower 42 |
| 25 Old Broad Street |
| London |
| EC2N 1HQ |
| 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

29.1.2010

Gemesis

BioMimetic Therapeutics Ltd

Arnold & Porter

Tower 42

25 Old Broad Street

London

EC2N 1HQ

UNITED KINGDOM

2.2.2010

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
| --- | --- | --- | --- | --- |
| 7.1.2010 | Lumigan | Allergan Pharmaceuticals Ireland |
| Castlebar Road |
| Westport |
| Co. Mayo |
| IRELAND |

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

7.1.2010

Lumigan

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

IRELAND

EU/1/02/205/001-004

11.1.2010

8.1.2010

Kaletra

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

Abbott Laboratories Ltd

Abbott House

Vanwall Business Park

Vanwall Road

Maidenhead

Berkshire

SL6 4XE

UNITED KINGDOM

EU/1/01/172/001-007

12.1.2010

8.1.2010

Osseor

| Les Laboratoires Servier |
| --- |
| 22 rue Garnier |
| 92200 Neuilly-sur-Seine |
| FRANCE |

Les Laboratoires Servier

22 rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/04/287/001-006

12.1.2010

8.1.2010

Protelos

| Les Laboratoires Servier |
| --- |
| 22 rue Garnier |
| 92200 Neuilly-sur-Seine |
| FRANCE |

Les Laboratoires Servier

22 rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/04/288/001-006

12.1.2010

8.1.2010

Ratiograstim

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| 89079 Ulm |
| DEUTSCHLAND |

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

DEUTSCHLAND

EU/1/08/444/001-012

13.1.2010

8.1.2010

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

12.1.2010

11.1.2010

CoAprovel

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

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France

75013 Paris

FRANCE

EU/1/98/086/001-034

13.1.2010

11.1.2010

Nplate

| Amgen Europe B.V. |
| --- |
| Minervum 7061 |
| 4817 ZK Breda |
| NEDERLAND |

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

NEDERLAND

EU/1/08/497/001-008

13.1.2010

12.1.2010

Apidra

| Sanofi-Aventis Deutschland GmbH |
| --- |
| 65926 Frankfurt am Main |
| DEUTSCHLAND |

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/04/285/001-004

14.1.2010

12.1.2010

EMEND

| 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/1/03/262/001-008

14.1.2010

12.1.2010

Prialt

| Eisai Limited |
| --- |
| European Knowledge Centre |
| Mosquito Way |
| Hatfield |
| Herts |
| AL10 9SN |
| UNITED KINGDOM |

Eisai Limited

European Knowledge Centre

Mosquito Way

Hatfield

Herts

AL10 9SN

UNITED KINGDOM

EU/1/04/302/001-004

14.1.2010

12.1.2010

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

14.1.2010

15.1.2010

Thyrogen

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/99/122/001-002

19.1.2010

19.1.2010

Gardasil

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

Sanofi Pasteur MSD SNC

8 rue Jonas Salk

69007 Lyon

FRANCE

EU/1/06/357/001-021

21.1.2010

19.1.2010

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

21.1.2010

19.1.2010

IRESSA

| AstraZeneca AB |
| --- |
| SE-151 85 Sodertalje |
| SVERIGE |

AstraZeneca AB

SE-151 85 Sodertalje

SVERIGE

EU/1/09/526/001-002

21.1.2010

19.1.2010

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

21.1.2010

19.1.2010

Orfadin

| Swedish Orphan International AB |
| --- |
| Drottninggatan 98 |
| SE-111 60 Stockholm |
| SVERIGE |

Swedish Orphan International AB

Drottninggatan 98

SE-111 60 Stockholm

SVERIGE

EU/1/04/303/001-003

21.1.2010

19.1.2010

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

21.1.2010

20.1.2010

Abseamed

| Medice Arzneimittel Pütter GmbH & Co KG |
| --- |
| Kuhloweg 37 |
| 58638 Iserlohn |
| DEUTSCHLAND |

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

58638 Iserlohn

DEUTSCHLAND

EU/1/07/412/001-020

22.1.2010

20.1.2010

Arixtra

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

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/02/206/001-035

22.1.2010

20.1.2010

Atriance

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

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/07/403/001

22.1.2010

20.1.2010

Avaglim

| 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/1/06/349/001-010

22.1.2010

20.1.2010

Avandamet

| 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/1/03/258/001-022

22.1.2010

20.1.2010

AVANDIA

| 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/1/00/137/002-018

22.1.2010

20.1.2010

Binocrit

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| ÖSTERREICH |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

ÖSTERREICH

EU/1/07/410/001-026

22.1.2010

20.1.2010

Elaprase

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D |
| SE-182 33 Danderyd |
| SVERIGE |

Shire Human Genetic Therapies AB

Svärdvägen 11D

SE-182 33 Danderyd

SVERIGE

EU/1/06/365/001-003

25.1.2010

20.1.2010

Epoetin alfa Hexal

| Hexal AG. |
| --- |
| Industriestraße 25 |
| 83607 Holzkirchen |
| DEUTSCHLAND |

Hexal AG.

Industriestraße 25

83607 Holzkirchen

DEUTSCHLAND

EU/1/07/411/001-026

25.1.2010

20.1.2010

HBVAXPRO

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

Sanofi Pasteur MSD SNC

8 rue Jonas Salk

69007 Lyon

FRANCE

EU/1/01/183/001 EU/1/01/183/004-005 EU/1/01/183/007-008 EU/1/01/183/011 EU/1/01/183/013 EU/1/01/183/015 EU/1/01/183/018-032

22.1.2010

20.1.2010

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

22.1.2010

20.1.2010

Integrilin

| Glaxo Group Ltd |
| --- |
| Greenford |
| Middlesex |
| UB6 ONN |
| UNITED KINGDOM |

Glaxo Group Ltd

Greenford

Middlesex

UB6 ONN

UNITED KINGDOM

EU/1/99/109/001-002

22.1.2010

20.1.2010

NeoRecormon

| 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/1/97/031/019-046

22.1.2010

20.1.2010

ORENCIA

| 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/1/07/389/001-003

22.1.2010

20.1.2010

Orgalutran

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

N.V. Organon

P.O. Box 20

Kloosterstraat 6

5340 BH Oss

NEDERLAND

EU/1/00/130/001-002

22.1.2010

20.1.2010

RotaTeq

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

Sanofi Pasteur MSD SNC

8 rue Jonas Salk

69007 Lyon

FRANCE

EU/1/06/348/001-002

22.1.2010

20.1.2010

Tamiflu

| Roche Registration Limited |
| --- |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City |
| AL7 1TW |
| UNITED KINGDOM |

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/02/222/001-004

22.1.2010

20.1.2010

Telzir

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

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/04/282/001-002

22.1.2010

20.1.2010

Thyrogen

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/99/122/001-002

22.1.2010

20.1.2010

Tracleer

| Actelion Registration Ltd |
| --- |
| BSI Building 13th Floor |
| 389 Chiswick High |
| London |
| W4 4AL |
| UNITED KINGDOM |

Actelion Registration Ltd

BSI Building 13th Floor

389 Chiswick High

London

W4 4AL

UNITED KINGDOM

EU/1/02/220/001-006

22.1.2010

20.1.2010

Truvada

| Gilead Sciences International Limited |
| --- |
| Cambridge |
| CB21 6GT |
| UNITED KINGDOM |

Gilead Sciences International Limited

Cambridge

CB21 6GT

UNITED KINGDOM

EU/1/04/305/001-002

22.1.2010

20.1.2010

Tyverb

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

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/07/440/001-002

22.1.2010

20.1.2010

Viracept

| 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/1/97/054/001 EU/1/97/054/004-005

22.1.2010

20.1.2010

Volibris

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

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/08/451/001-004

22.1.2010

20.1.2010

Ziagen

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

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/99/112/001-002

22.1.2010

20.1.2010

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

22.1.2010

25.1.2010

Alisade

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

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/08/474/001-003

28.1.2010

25.1.2010

Altargo

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

Glaxo Group Limited

Glaxo Wellcome House

Berkeley Avenue

Greenford, Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/07/390/001-004

28.1.2010

25.1.2010

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

28.1.2010

25.1.2010

Betaferon

| Bayer Schering Pharma AG |
| --- |
| Müllerstraße 170—178 |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

Müllerstraße 170—178

13342 Berlin

DEUTSCHLAND

EU/1/95/003/003-010

27.1.2010

25.1.2010

Bondronat

| 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/1/96/012/004 EU/1/96/012/009-013

27.1.2010

25.1.2010

Combivir

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

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/98/058/001-002

28.1.2010

25.1.2010

Fabrazyme

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/01/188/001-006

27.1.2010

25.1.2010

Kiovig

| Baxter AG |
| --- |
| Industriesstrasse 67 |
| 1220 Wien |
| ÖSTERREICH |

Baxter AG

Industriesstrasse 67

1220 Wien

ÖSTERREICH

EU/1/05/329/001-005

27.1.2010

25.1.2010

Norvir

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

Abbott Laboratories Ltd

Abbott House

Vanwall Business Park

Vanwall Road

Maidenhead

Berkshire

SL6 4XE

UNITED KINGDOM

EU/1/96/016/001 EU/1/96/016/003-006

27.1.2010

25.1.2010

Pelzont

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/08/460/001-014

27.1.2010

25.1.2010

Qutenza

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

Astellas Pharma Europe B.V.

Elisabethhof 19

2353 EW Leiderdorp

NEDERLAND

EU/1/09/524/001-002

27.1.2010

25.1.2010

Sebivo

| 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/1/07/388/001-003

27.1.2010

25.1.2010

Somavert

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/02/240/001-004

27.1.2010

25.1.2010

TORISEL

| Wyeth Europa Ltd |
| --- |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire |
| SL6 0PH |
| UNITED KINGDOM |

Wyeth Europa Ltd

Huntercombe Lane South

Taplow

Maidenhead

Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/07/424/001

27.1.2010

25.1.2010

Tredaptive

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/08/459/001-014

27.1.2010

25.1.2010

Trevaclyn

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/08/458/001-014

27.1.2010

25.1.2010

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

27.1.2010

25.1.2010

Zometa

| 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/1/01/176/001-006

27.1.2010

27.1.2010

Arava

| Sanofi-Aventis Deutschland GmbH |
| --- |
| 65926 Frankfurt am Main |
| DEUTSCHLAND |

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/99/118/001-010

29.1.2010

27.1.2010

Privigen

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Straße 76 |
| 35041 Marburg |
| DEUTSCHLAND |

CSL Behring GmbH

Emil-von-Behring-Straße 76

35041 Marburg

DEUTSCHLAND

EU/1/08/446/001-006

29.1.2010

27.1.2010

Rivastigmine Teva

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/513/001-020

29.1.2010

27.1.2010

Sonata

| Meda AB |
| --- |
| Pipers väg 2A |
| SE-170 09 Solna |
| SVERIGE |

Meda AB

Pipers väg 2A

SE-170 09 Solna

SVERIGE

EU/1/99/102/001-006

29.1.2010

27.1.2010

Zerene

| Meda AB |
| --- |
| Pipers väg 2A |
| SE-170 09 Solna |
| SVERIGE |

Meda AB

Pipers väg 2A

SE-170 09 Solna

SVERIGE

EU/1/99/099/001-006

29.1.2010

28.1.2010

Rapamune

| 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/1/01/171/001 EU/1/01/171/007-010

1.2.2010

29.1.2010

Azopt

| 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/1/00/129/001-003

2.2.2010

29.1.2010

Clopidogrel Winthrop

| 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/1/08/465/001-020

2.2.2010

29.1.2010

INTANZA

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

Sanofi Pasteur MSD SNC

8 rue Jonas Salk

69007 Lyon

FRANCE

EU/1/08/505/001-006

3.2.2010

2.2.2010

Yttriga

| Eckert & Ziegler Nuclitec GmbH |
| --- |
| Gieselweg 1 |
| 38110 Braunschweig |
| DEUTSCHLAND |

Eckert & Ziegler Nuclitec GmbH

Gieselweg 1

38110 Braunschweig

DEUTSCHLAND

EU/1/05/322/001

4.2.2010

3.2.2010

CoAprovel

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

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France

75013 Paris

FRANCE

EU/1/98/086/001-034

5.2.2010

3.2.2010

Karvezide

| 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/1/98/085/001-034

5.2.2010

3.2.2010

Temodal

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

Schering Plough Europe

Rue de Stalle 73

1180 Bruxelles

BELGIQUE

| Stallestraat 73 |
| --- |
| 1180 Brussel |
| BELGIË |

Stallestraat 73

1180 Brussel

BELGIË

EU/1/98/096/001-025

5.2.2010

4.2.2010

Irbesartan HCT Winthrop

| 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/1/06/377/001-028

8.2.2010

8.2.2010

Bondenza (Ibandronic Acid Roche)

| 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/1/03/266/003-004

10.2.2010

8.2.2010

Bonviva

| 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/1/03/265/003-004

10.2.2010

8.2.2010

Pandemrix

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l'Institut 89 |
| 1330 Rixensart |
| BELGIQUE |

GlaxoSmithKline Biologicals s.a.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/08/452/001

10.2.2010

8.2.2010

ReFacto AF

| Wyeth Europa Ltd |
| --- |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire |
| SL6 0PH |
| UNITED KINGDOM |

Wyeth Europa Ltd

Huntercombe Lane South

Taplow

Maidenhead

Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/99/103/001-004

10.2.2010

8.2.2010

TOVIAZ

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/07/386/017-018

10.2.2010

9.2.2010

Bridion

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| 5349 AB Oss |
| NEDERLAND |

N.V. Organon

Kloosterstraat 6

5349 AB Oss

NEDERLAND

EU/1/08/466/001-002

11.2.2010

9.2.2010

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/1/02/237/001-008

11.2.2010

9.2.2010

Clopidogrel 1A Pharma

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35 |
| 83714 Miesbach |
| DEUTSCHLAND |

Acino Pharma GmbH

Am Windfeld 35

83714 Miesbach

DEUTSCHLAND

EU/1/09/542/001-007

11.2.2010

9.2.2010

Exforge

| 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/1/06/370/001-036

11.2.2010

9.2.2010

Fertavid

| SP Europe |
| --- |
| Rue de Stalle 73 |
| 1180 Bruxelles |
| BELGIQUE |

SP Europe

Rue de Stalle 73

1180 Bruxelles

BELGIQUE

EU/1/09/510/001-019

11.2.2010

9.2.2010

Imprida

| 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/1/06/373/001-036

11.2.2010

9.2.2010

Kaletra

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

Abbott Laboratories Limited

Abbott House

Vanwall Business Park

Vanwall Road

Maidenhead

Berkshire

SL6 4XE

UNITED KINGDOM

EU/1/01/172/001-007

11.2.2010

9.2.2010

Kineret

| Biovitrum AB (publ) |
| --- |
| SE-112 76 Stockholm |
| SVERIGE |

Biovitrum AB (publ)

SE-112 76 Stockholm

SVERIGE

EU/1/02/203/001-004

11.2.2010

9.2.2010

NovoSeven

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| 2880 Bagsvaerd |
| DANMARK |

Novo Nordisk A/S

Novo Allé

2880 Bagsvaerd

DANMARK

EU/1/96/006/001-006

11.2.2010

9.2.2010

Temodal

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

Schering Plough Europe

Rue de Stalle 73

1180 Bruxelles

BELGIQUE

| Stallestraat 73 |
| --- |
| 1180 Brussel |
| BELGIË |

Stallestraat 73

1180 Brussel

BELGIË

EU/1/98/096/001-025

11.2.2010

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
| --- | --- | --- | --- | --- |
| 20.1.2010 | Avastin | Roche Registration Limited |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City |
| AL7 1TW |
| 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

20.1.2010

Avastin

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/04/300/001-002

22.1.2010

20.1.2010

Erbitux

| Merck KGaA |
| --- |
| Frankfurter Straße 250 |
| 64271 Darmstadt |
| DEUTSCHLAND |

Merck KGaA

Frankfurter Straße 250

64271 Darmstadt

DEUTSCHLAND

EU/1/04/281/001-005

22.1.2010

9.2.2010

EVICEL

| OMRIX biopharmaceuticals S.A./N.V. |
| --- |
| Chaussée de Waterloo/Waterloosesteenweg 200 |
| 1640 Rhode-St-Genèse/Sint-Genesius-Rode |
| BELGIQUE/BELGIË |

OMRIX biopharmaceuticals S.A./N.V.

Chaussée de Waterloo/Waterloosesteenweg 200

1640 Rhode-St-Genèse/Sint-Genesius-Rode

BELGIQUE/BELGIË

EU/1/08/473/001-003

15.2.2010

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004
   (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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.1.2010 | Gripovac 3 | Inactivated vaccine against swine influenza in pigs | MERIAL |
| 29 avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

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

14.1.2010

Gripovac 3

Inactivated vaccine against swine influenza in pigs

MERIAL

29 avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/09/102/001-006

Suspension for injection

QI09AA03

18.1.2010

14.1.2010

RESPIPORC FLU3

Inactivated vaccine against swine influenza in pigs

| IDT Biologika GmbH |
| --- |
| Am Pharmapark |
| 06861 Dessau-Rosslau |
| DEUTSCHLAND |

IDT Biologika GmbH

Am Pharmapark

06861 Dessau-Rosslau

DEUTSCHLAND

EU/2/09/103/001-006

Suspension for injection

QI09AA03

18.1.2010

15.1.2010

Zulvac 8 Bovis

Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02

| 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/2/09/105/001-002

Suspension for injection

QI02AA08(cattle)

19.1.2010

15.1.2010

Zulvac 8 Ovis

Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02

| 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/2/09/104/001-002

Suspension for injection

QIO4AA02

19.1.2010

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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 |
| --- | --- | --- | --- | --- |
| 12.1.2010 | BTVPUR Alsap 8 | Merial |
| 29 avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

12.1.2010

BTVPUR Alsap 8

Merial

29 avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/09/094/001-005

14.1.2010

12.1.2010

METACAM

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/2/97/004/035-038

14.1.2010

12.1.2010

Porcilis PCV

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/08/091/001-010

14.1.2010

12.1.2010

Previcox

| Merial |
| --- |
| 29 avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial

29 avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/045/001-006

14.1.2010

14.1.2010

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

18.1.2010

14.1.2010

Purevax RCPCh

| Merial |
| --- |
| 29 avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial

29 avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/050/001-002

15.1.2010

15.1.2010

Convenia

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT 13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT 13 9NJ

UNITED KINGDOM

EU/2/06/059/001

19.1.2010

15.1.2010

Purevax RC

| Merial |
| --- |
| 29 avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial

29 avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/051/001-002

19.1.2010

15.1.2010

Purevax RCCh

| Merial |
| --- |
| 29 avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial

29 avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/049/001-002

19.1.2010

15.1.2010

Purevax RCPCh FeLV

| Merial |
| --- |
| 29 avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial

29 avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/047/001-002

19.1.2010

15.1.2010

Purevax RCP FeLV

| Merial |
| --- |
| 29 avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial

29 avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/048/001-002

19.1.2010

25.1.2010

Purevax RCP

| Merial |
| --- |
| 29 avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial

29 avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/052/001-002

27.1.2010

29.1.2010

Quadrisol

| 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/2/97/005/001 EU/2/97/005/005

2.2.2010

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 |
| London |
| E14 4H |
| UNITED KINGDOM |

The European Medicines Agency

7 Westferry Circus

Canary Wharf

London

E14 4H

UNITED KINGDOM

---

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

(2)  See footnote 1.

---

| 30.4.2010 | EN | Official Journal of the European Union | C 111/16 |
| --- | --- | --- | --- |

30.4.2010

EN

Official Journal of the European Union

C 111/16

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
   (1)
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
   (2)
  )

2010/C 111/03

—   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 |
| --- | --- | --- | --- | --- |
| 20.1.2010 | Extraneal | See Annex I | See Annex I | 22.1.2010 |
| 26.1.2010 | Antiadiposo — iodocasein/thiamine nitrate | See Annex II | See Annex II | 27.1.2010 |
| 25.1.2010 | Poulvac Bursa Plus and associated names | See Annex III | See Annex III | 26.1.2010 |
| 8.1.2010 | Revlimid | Celgene Europe Limited |
| Riverside House |
| Riverside Walk |
| Windsor |
| Berkshire |
| SL4 1NA |
| UNITED KINGDOM |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

20.1.2010

Extraneal

See Annex I

See Annex I

22.1.2010

26.1.2010

Antiadiposo — iodocasein/thiamine nitrate

See Annex II

See Annex II

27.1.2010

25.1.2010

Poulvac Bursa Plus and associated names

See Annex III

See Annex III

26.1.2010

8.1.2010

Revlimid

Celgene Europe Limited

Riverside House

Riverside Walk

Windsor

Berkshire

SL4 1NA

UNITED KINGDOM

This Decision is addressed to the Member States

11.1.2010

29.1.2010

Urorec

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

Recordati Ireland Ltd.

Raheens East

Ringaskiddy Co. Cork

IRELAND

This Decision is addressed to the Member States

1.2.2010

29.1.2010

Silodyx

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

Recordati Ireland Ltd.

Raheens East

Ringaskiddy Co. Cork

IRELAND

This Decision is addressed to the Member States

1.2.2010

—   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 |
| --- | --- | --- | --- | --- |
| 29.1.2010 | Teicoplanin Hospira and associated names | See Annex IV | See Annex IV | 2.2.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

29.1.2010

Teicoplanin Hospira and associated names

See Annex IV

See Annex IV

2.2.2010

—   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 |
| --- | --- | --- | --- | --- |
| 27.1.2010 | APPM Respipharm | See Annex V | See Annex V | 28.1.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

27.1.2010

APPM Respipharm

See Annex V

See Annex V

28.1.2010

---

(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, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing autorisation Holder | Invented Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Baxter Vertriebs GmbH |
| Landstraßer Hauptstraße 99/Top2A |
| 1031 Wien |
| ÖSTERREICH |

Member State EU/EEA

Marketing autorisation Holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Austria

Baxter Vertriebs GmbH

Landstraßer Hauptstraße 99/Top2A

1031 Wien

ÖSTERREICH

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| BELGIQUE/BELGIË |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

BELGIQUE/BELGIË

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| DANMARK |

Baxter A/S

Gydevang 43

3450 Allerød

DANMARK

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Finland

| Baxter Oy |
| --- |
| P.O. Box 270 |
| Valimotie 15A |
| FI-00381 Helsinski |
| SUOMI/FINLAND |

Baxter Oy

P.O. Box 270

Valimotie 15A

FI-00381 Helsinski

SUOMI/FINLAND

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter S.A.S |
| --- |
| 6 av. Louis Pasteur |
| 78310 Maurepas |
| FRANCE |

Baxter S.A.S

6 av. Louis Pasteur

78310 Maurepas

FRANCE

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edissontrasse 3—4 |
| 85716 Unterschleissheim |
| DEUTSCHLAND |

Baxter Deutschland GmbH

Edissontrasse 3—4

85716 Unterschleissheim

DEUTSCHLAND

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Greece

| Diophar A.E. |
| --- |
| Kiphissias 368 |
| 152 33 Halandri Athens |
| GREECE |

Diophar A.E.

Kiphissias 368

152 33 Halandri Athens

GREECE

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford |
| IP24 3SE |
| UNITED KINGDOM |

Baxter Healthcare Ltd

Caxton Way

Thetford

IP24 3SE

UNITED KINGDOM

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Italy

| Baxter S.p.A. |
| --- |
| Piazzale dell’Industria 20 |
| 00144 Roma RM |
| ITALIA |

Baxter S.p.A.

Piazzale dell’Industria 20

00144 Roma RM

ITALIA

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Luxembourg

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| BELGIQUE/BELGIË |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

BELGIQUE/BELGIË

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Netherlands

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| NEDERLAND |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

NEDERLAND

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

| Baxter Médico Farmacêutica Lda |
| --- |
| Sintra Business Park |
| Zona Industrial da Abrunheira |
| Edificio 10 |
| 2710-089 Sintra |
| PORTUGAL |

Baxter Médico Farmacêutica Lda

Sintra Business Park

Zona Industrial da Abrunheira

Edificio 10

2710-089 Sintra

PORTUGAL

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Spain

| Baxter S.L |
| --- |
| Poligono Industrial Sector 14 |
| C/ Pouet de Camilo, 2 |
| 46394 Ribarroja del Turia (Valencia) |
| ESPAÑA |

Baxter S.L

Poligono Industrial Sector 14

C/ Pouet de Camilo, 2

46394 Ribarroja del Turia (Valencia)

ESPAÑA

Extraneal

Icodextrina 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

| Baxter AB |
| --- |
| Box 63 |
| SE-164 94 Kista |
| SVERIGE |

Baxter AB

Box 63

SE-164 94 Kista

SVERIGE

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford |
| IP24 3SE |
| UNITED KINGDOM |

Baxter Healthcare Ltd

Caxton Way

Thetford

IP24 3SE

UNITED KINGDOM

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

---

ANNEX II

LIST OF THE INVENTED NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES (EEA)

Iodocasein/thiamine containing medicinal products with marketing authorisation in the European Union

| Member State | Marketing Authorisation Holder | Invented Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Italy | TEOFARMA SRL |
| Via Fratelli Cervi 8 |
| Valle Salimbene |
| 27010 Pavia PV |
| ITALIA |

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Italy

TEOFARMA SRL

Via Fratelli Cervi 8

Valle Salimbene

27010 Pavia PV

ITALIA

ANTIADIPOSO

125 mg + 12,33 mg

Coated tablet

Oral use

---

ANNEX III

THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, RECOMMENDED DOSE, WITHDRAWAL PERIOD, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Applicant/Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Route of administration | Recommended dose | Withdrawal period
  (meat) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Belgium | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Bulgaria | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Czech Republic | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Denmark | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Estonia | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Spain | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Germany | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Greece | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Hungary | Fort Dodge Animal Health | Poulvac Bursa Plus vakcina A.U.V. | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Ireland | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Italy | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Latvia | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Lithuania | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| The Netherlands | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Poland | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Portugal | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Romania | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Slovakia | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Slovenia | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| United Kingdom | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |

Member State

Applicant/Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Route of administration

Recommended dose

Withdrawal period

(meat)

Belgium

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Bulgaria

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Czech Republic

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Denmark

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Estonia

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Spain

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Germany

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Greece

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Hungary

Fort Dodge Animal Health

Poulvac Bursa Plus vakcina A.U.V.

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Ireland

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Italy

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Latvia

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Lithuania

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

The Netherlands

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Poland

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Portugal

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Romania

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Slovakia

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Slovenia

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

United Kingdom

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | | Hospira UK Limited |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Content (concentration)

Austria

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin Hospira 200 mg

Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung

200 mg

Powder and solvent for solution for injection or infusion

Intravenous use (injection or infusion)

Intramuscular use

200 mg/vial

(66,7 mg/ml)

Austria

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin Hospira 400 mg

Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung

400 mg

Powder and solvent for solution for injection or infusion

Intravenous use (injection or infusion)

Intramuscular use

400 mg/vial

(133,4 mg/ml)

Germany

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin Mayne Hospira 200 mg

Trockensubstanz

200 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

200 mg/vial

Germany

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin Mayne Hospira 400 mg

Trockensubstanz

400 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

400 mg/vial

Ireland

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin 200 mg

Powder and Solvent for Solution for Injection or Infusion

200 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

200 mg/vial

Ireland

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin 400 mg

Powder and Solvent for Solution for Injection or Infusion

400 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

400 mg/vial

Italy

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanina Hospira

200 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

200 mg/vial

Italy

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanina Hospira

400 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

400 mg/vial

Portugal

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanina Hospira 200 mg

Pó e solvente para solução injectável ou solução para perfusão

200 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

200 mg/vial

Portugal

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanina Hospira 400 mg

Pó e solvente para solução injectável ou solução para perfusão

400 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

400 mg/vial

Spain

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanina Hospira 200 mg

Polvo y disolvente para solución inyectable o para perfusión

200 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

200 mg/vial

Spain

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanina Hospira 400 mg

Polvo y disolvente para solución inyectable o para perfusión

400 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

400 mg/vial

United Kingdom

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin 200 mg

Powder and Solvent for Solution for Injection or Infusion

200 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use

200 mg/vial

United Kingdom

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin 400 mg

Powder and Solvent for Solution for Injection or Infusion

400 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use

400 mg/vial

---

ANNEX V

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, WITHDRAWAL PERIOD AND APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Applicant or Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose | Withdrawal period |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Slovak Republic (1) | Pharmagal Bio, s.r.o. |
| Murgašova 5 |
| 949 01 Nitra |
| SLOVENSKO/SLOVAKIA |

Member State

Applicant or Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Withdrawal period

Slovak Republic (1)

Pharmagal Bio, s.r.o.

Murgašova 5

949 01 Nitra

SLOVENSKO/SLOVAKIA

APPM Respipharm

Suspension for injection

Strains of Actinobacillus pleuropneumoniae producing Apx I, Apx II and Apx III toxins:

| | Actinobacillus pleuropneumoniae

  serotype 2 ≥ 4,8 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 2 ≥ 4,8 log2
   (2)

| | Actinobacillus pleuropneumoniae

  serotype 9 ≥ 5,2 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 9 ≥ 5,2 log2
   (2)

| | Actinobacillus pleuropneumoniae

  serotype 11 ≥ 4,9 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 11 ≥ 4,9 log2
   (2)

| | Pasteurella multocida

  serotype A ≥ 2,1 log2
   (2) |
| --- | --- |

Pasteurella multocida

serotype A ≥ 2,1 log2
   (2)

Pigs

Intramuscularly deep into the neck muscle.

| | Pregnant sows: | Primary vaccination: First injection 4-5 weeks before expected farrowing.
  Second injection at least 2 weeks before expected farrowing. |
| --- | --- | --- |

Pregnant sows:

Primary vaccination: First injection 4-5 weeks before expected farrowing.

Second injection at least 2 weeks before expected farrowing.

| | Booster: One injection 2-3 weeks before each farrowing. |
| --- | --- |

Booster: One injection 2-3 weeks before each farrowing.

| | Weaned piglets: | First injection: At the age of 6-8 weeks. |
| --- | --- | --- |

Weaned piglets:

First injection: At the age of 6-8 weeks.

| | Revaccination: After 14-21 days. |
| --- | --- |

Revaccination: After 14-21 days.

| | Pregnant sows:
  Vaccine dose: 3 ml |
| --- | --- |

Pregnant sows:

Vaccine dose: 3 ml

| | Weaned piglets:
  Vaccine dose: 2 ml |
| --- | --- |

Weaned piglets:

Vaccine dose: 2 ml

Zero days

Spain

| Pharmagal Bio, s.r.o. |
| --- |
| Murgašova 5 |
| 949 01 Nitra |
| SLOVENSKO/SLOVAKIA |

Pharmagal Bio, s.r.o.

Murgašova 5

949 01 Nitra

SLOVENSKO/SLOVAKIA

APPM Respipharm

Suspension for injection

Strains of Actinobacillus pleuropneumoniae producing Apx I, Apx II and Apx III toxins:

| | Actinobacillus pleuropneumoniae

  serotype 2 ≥ 4,8 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 2 ≥ 4,8 log2
   (2)

| | Actinobacillus pleuropneumoniae

  serotype 9 ≥ 5,2 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 9 ≥ 5,2 log2
   (2)

| | Actinobacillus pleuropneumoniae

  serotype 11 ≥ 4,9 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 11 ≥ 4,9 log2
   (2)

| | Pasteurella multocida

  serotype A ≥ 2,1 log2
   (2) |
| --- | --- |

Pasteurella multocida

serotype A ≥ 2,1 log2
   (2)

Pigs

Intramuscularly deep into the neck muscle.

| | Pregnant sows: | Primary vaccination: First injection 4-5 weeks before expected farrowing.
  Second injection at least 2 weeks before expected farrowing. |
| --- | --- | --- |

Pregnant sows:

Primary vaccination: First injection 4-5 weeks before expected farrowing.

Second injection at least 2 weeks before expected farrowing.

| | Booster: One injection 2-3 weeks before each farrowing. |
| --- | --- |

Booster: One injection 2-3 weeks before each farrowing.

| | Weaned piglets: | First injection: At the age of 6-8 weeks. |
| --- | --- | --- |

Weaned piglets:

First injection: At the age of 6-8 weeks.

| | Revaccination: After 14-21 days. |
| --- | --- |

Revaccination: After 14-21 days.

| | Pregnant sows:
  Vaccine dose: 3 ml |
| --- | --- |

Pregnant sows:

Vaccine dose: 3 ml

| | Weaned piglets:
  Vaccine dose: 2 ml |
| --- | --- |

Weaned piglets:

Vaccine dose: 2 ml

Zero days

Poland

Pharmagal Bio, s.r.o.

Murgašova 5

949 01 Nitra

SLOVENSKO/SLOVAKIA

APPM Respipharm

Suspension for injection

Strains of Actinobacillus pleuropneumoniae producing Apx I, Apx II and Apx III toxins:

| | Actinobacillus pleuropneumoniae

  serotype 2 ≥ 4,8 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 2 ≥ 4,8 log2
   (2)

| | Actinobacillus pleuropneumoniae

  serotype 9 ≥ 5,2 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 9 ≥ 5,2 log2
   (2)

| | Actinobacillus pleuropneumoniae

  serotype 11 ≥ 4,9 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 11 ≥ 4,9 log2
   (2)

| | Pasteurella multocida

  serotype A ≥ 2,1 log2
   (2) |
| --- | --- |

Pasteurella multocida

serotype A ≥ 2,1 log2
   (2)

Pigs

Intramuscularly deep into the neck muscle.

| | Pregnant sows: | Primary vaccination: First injection 4-5 weeks before expected farrowing.
  Second injection at least 2 weeks before expected farrowing. |
| --- | --- | --- |

Pregnant sows:

Primary vaccination: First injection 4-5 weeks before expected farrowing.

Second injection at least 2 weeks before expected farrowing.

| | Booster: One injection 2-3 weeks before each farrowing. |
| --- | --- |

Booster: One injection 2-3 weeks before each farrowing.

| | Weaned piglets: | First injection: At the age of 6-8 weeks. |
| --- | --- | --- |

Weaned piglets:

First injection: At the age of 6-8 weeks.

| | Revaccination: After 14-21 days. |
| --- | --- |

Revaccination: After 14-21 days.

| | Pregnant sows:
  Vaccine dose: 3 ml |
| --- | --- |

Pregnant sows:

Vaccine dose: 3 ml

| | Weaned piglets:
  Vaccine dose: 2 ml |
| --- | --- |

Weaned piglets:

Vaccine dose: 2 ml

Zero days

---

(1)  Marketing Authorisation granted.

(2)  Mean titre of agglutination antibodies after vaccination in rabbits.

---

| 30.4.2010 | EN | Official Journal of the European Union | C 111/28 |
| --- | --- | --- | --- |

30.4.2010

EN

Official Journal of the European Union

C 111/28

---

Commission notice on current State aid recovery interest rates and reference/discount rates for 27 Member States applicable as from 1 May 2010

(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 of 21 April 2004 (OJ L 140, 30.4.2004, p. 1))

2010/C 111/04

Base rates calculated in accordance with the Communication from the Commission on the revision of the method for setting the reference and discount rates (OJ C 14, 19.1.2008, p. 6). Depending on the use of the reference rate, the appropriate margins have still to be added as defined in this communication. For the discount rate this means that a margin of 100 basis points has to be added. The Commission Regulation (EC) No 271/2008 of 30 January 2008 amending the implementing Regulation (EC) No 794/2004 foresees that, unless otherwise provided for in a specific decision, the recovery rate will also be calculated by adding 100 basis points to the base rate.

Modified rates are indicated in bold.

Previous table published in OJ C 85, 31.3.2010, p. 11.

| From | To | AT | BE | BG | CY | CZ | DE | DK | EE | EL | ES | FI | FR | HU | IE | IT | LT | LU | LV | MT | NL | PL | PT | RO | SE | SI | SK | UK |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1.5.2010 | | 1,24 | 1,24 | 4,92 | 1,24 | 2,03 | 1,24 | 1,88 | 2,77 | 1,24 | 1,24 | 1,24 | 1,24 | 5,97 | 1,24 | 1,24 | 4,46 | 1,24 | 6,47 | 1,24 | 1,24 | 4,49 | 1,24 | 7,82 | 1,02 | 1,24 | 1,24 | 1,16 |
| 1.4.2010 | 30.4.2010 | 1,24 | 1,24 | 4,92 | 1,24 | 2,39 | 1,24 | 1,88 | 3,47 | 1,24 | 1,24 | 1,24 | 1,24 | 5,97 | 1,24 | 1,24 | 5,90 | 1,24 | 8,97 | 1,24 | 1,24 | 4,49 | 1,24 | 9,92 | 1,02 | 1,24 | 1,24 | 1,16 |
| 1.3.2010 | 31.3.2010 | 1,24 | 1,24 | 4,92 | 1,24 | 2,39 | 1,24 | 1,88 | 4,73 | 1,24 | 1,24 | 1,24 | 1,24 | 7,03 | 1,24 | 1,24 | 7,17 | 1,24 | 11,76 | 1,24 | 1,24 | 4,49 | 1,24 | 9,92 | 1,02 | 1,24 | 1,24 | 1,16 |
| 1.1.2010 | 28.2.2010 | 1,24 | 1,24 | 4,92 | 1,24 | 2,39 | 1,24 | 1,88 | 6,94 | 1,24 | 1,24 | 1,24 | 1,24 | 7,03 | 1,24 | 1,24 | 8,70 | 1,24 | 15,11 | 1,24 | 1,24 | 4,49 | 1,24 | 9,92 | 1,02 | 1,24 | 1,24 | 1,16 |

From

To

AT

BE

BG

CY

CZ

DE

DK

EE

EL

ES

FI

FR

HU

IE

IT

LT

LU

LV

MT

NL

PL

PT

RO

SE

SI

SK

UK

1.5.2010

1,24

1,24

4,92

1,24

2,03

1,24

1,88

2,77

1,24

1,24

1,24

1,24

5,97

1,24

1,24

4,46

1,24

6,47

1,24

1,24

4,49

1,24

7,82

1,02

1,24

1,24

1,16

1.4.2010

30.4.2010

1,24

1,24

4,92

1,24

2,39

1,24

1,88

3,47

1,24

1,24

1,24

1,24

5,97

1,24

1,24

5,90

1,24

8,97

1,24

1,24

4,49

1,24

9,92

1,02

1,24

1,24

1,16

1.3.2010

31.3.2010

1,24

1,24

4,92

1,24

2,39

1,24

1,88

4,73

1,24

1,24

1,24

1,24

7,03

1,24

1,24

7,17

1,24

11,76

1,24

1,24

4,49

1,24

9,92

1,02

1,24

1,24

1,16

1.1.2010

28.2.2010

1,24

1,24

4,92

1,24

2,39

1,24

1,88

6,94

1,24

1,24

1,24

1,24

7,03

1,24

1,24

8,70

1,24

15,11

1,24

1,24

4,49

1,24

9,92

1,02

1,24

1,24

1,16

---

V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

European Commission

| 30.4.2010 | EN | Official Journal of the European Union | C 111/29 |
| --- | --- | --- | --- |

30.4.2010

EN

Official Journal of the European Union

C 111/29

---

Notice of the impending expiry of certain anti-dumping measures

2010/C 111/05

1.   As provided for in Article 11(2) of Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community (1), the European Commission gives notice that, unless a review is initiated in accordance with the following procedure, the anti-dumping measures mentioned below will expire on the date mentioned in the table below.

2.   Procedure

Union producers may lodge a written request for a review. This request must contain sufficient evidence that the expiry of the measures would be likely to result in a continuation or recurrence of dumping and injury.

Should the Commission decide to review the measures concerned, importers, exporters, representatives of the exporting country and Union producers will then be provided with the opportunity to amplify, rebut or comment on the matters set out in the review request.

3.   Time limit

Union producers may submit a written request for a review on the above basis, to reach the European Commission, Directorate-General for Trade (Unit H-1), N-105 4/92, 1049 Bruxelles/Brussel, BELGIQUE/ BELGIË (2) at any time from the date of the publication of the present notice but no later than three months before the date mentioned in the table below.

4.   This notice is published in accordance with Article 11(2) of Council Regulation (EC) No 1225/2009.

| Product | Country(ies) of origin or exportation | Measures | Reference | Date of expiry |
| --- | --- | --- | --- | --- |
| Certain magnesia bricks | People's Republic of China | Anti-dumping duty | Council Regulation (EC) No 1659/2005 (OJ L 267, 12.10.2005, p. 1) as last amended by Council Regulations (EC) No 825/2009 (OJ L 240, 11.9.2009, p. 1) and (EC) No 826/2009 (OJ L 240, 11.9.2009, p. 7) | 13.10.2010 |

Product

Country(ies) of origin or exportation

Measures

Reference

Date of expiry

Certain magnesia bricks

People's Republic of China

Anti-dumping duty

Council Regulation (EC) No 1659/2005 (OJ L 267, 12.10.2005, p. 1) as last amended by Council Regulations (EC) No 825/2009 (OJ L 240, 11.9.2009, p. 1) and (EC) No 826/2009 (OJ L 240, 11.9.2009, p. 7)

13.10.2010

---

(1)  OJ L 343, 22.12.2009, p. 51.

(2)  Fax +32 22956505.

---

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 30.4.2010 | EN | Official Journal of the European Union | C 111/30 |
| --- | --- | --- | --- |

30.4.2010

EN

Official Journal of the European Union

C 111/30

---

Prior notification of a concentration

(Case COMP/M.5860 — Cooper/Danaher/JV)

Candidate case for simplified procedure

(Text with EEA relevance)

2010/C 111/06

| 1. | On 23 April 2010, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings Cooper Industries plc. (‘Cooper’, Ireland) and Danaher Corporation (‘Danaher’, USA) acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of a JV which combines parts of their respective tools businesses by way of transfer of assets. |
| --- | --- |

1.

On 23 April 2010, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings Cooper Industries plc. (‘Cooper’, Ireland) and Danaher Corporation (‘Danaher’, USA) acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of a JV which combines parts of their respective tools businesses by way of transfer of assets.

| 2. | The business activities of the undertakings concerned are:






  — | for undertaking Cooper: manufacturing, marketing and selling of electrical products and tools, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for undertaking Cooper: manufacturing, marketing and selling of electrical products and tools,

| — | for undertaking Danaher: design, manufacturing and marketing of industrial and consumer products in the business area of professional instrumentation, medical technologies, industrial technologies, and tools, |
| --- | --- |

—

for undertaking Danaher: design, manufacturing and marketing of industrial and consumer products in the business area of professional instrumentation, medical technologies, industrial technologies, and tools,

| — | for the JV: manufacturing and selling of hand tools, power tools, chain products, soldering products, and specialty products. |
| --- | --- |

—

for the JV: manufacturing and selling of hand tools, power tools, chain products, soldering products, and specialty products.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the EC Merger Regulation. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the EC Merger Regulation (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the EC Merger Regulation. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the EC Merger Regulation (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number COMP/M.5860 — Cooper/Danaher/JV, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number COMP/M.5860 — Cooper/Danaher/JV, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

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(1)  OJ L 24, 29.1.2004, p. 1 (the ‘EC Merger Regulation’).

(2)  OJ C 56, 5.3.2005, p. 32 (‘Notice on a simplified procedure’).

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30.4.2010

| 30.4.2010 | EN | Official Journal of the European Union | C 111/s3 |
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EN

Official Journal of the European Union

C 111/s3

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NOTICE

On 30 April 2010, in Official Journal of the European Union C 111 A, the ‘Common catalogue of varieties of vegetable species — Third supplement to the 28th complete edition’ and the ‘Common catalogue of varieties of agricultural plant species — Fourth supplement to the 28th complete edition’ will be published.

Subscribers to the Official Journal may obtain the same number of copies and language versions of this Official Journal as those to which they subscribe free of charge. They are requested to return the attached order form, duly completed and bearing their subscription registration number (code appearing on the left of each label and beginning with: O/...). This Official Journal will remain available free of charge for one year from the date of its publication.

Non-subscribers can order this Official Journal against payment from one of our sales offices (see http://publications.europa.eu/others/agents/index_en.htm).

This Official Journal — like all Official Journals (L, C, CA, CE) — can be consulted free of charge online at http://eur-lex.europa.eu

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