# Official Journal C 121/2009

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2009.121.eng |
| --- | --- |
| Official Journal
  of the European Union | C 121 |
| | |
| English edition | Information and Notices | Volume 5229 May 2009 |

ISSN 1725-2423

doi:10.3000/17252423.C_2009.121.eng

Official Journal

of the European Union

C 121

English edition

Information and Notices

Volume 5229 May 2009

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 121/01 | Non-opposition to a notified concentration — (Case COMP/M.5483 — TOSHIBA/FUJITSU HDD BUSINESS) (
  1
  ) | 1 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 121/01

Non-opposition to a notified concentration — (Case COMP/M.5483 — TOSHIBA/FUJITSU HDD BUSINESS) (
  1
  )

1

1

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 121/02 | Euro exchange rates | 2 |
| 2009/C 121/03 | Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 April 2009 to 30 April 2009(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 3 |
| 2009/C 121/04 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2009 to 30 April 2009(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  ) | 14 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 121/02

Euro exchange rates

2

2009/C 121/03

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 April 2009 to 30 April 2009(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

)

3

2009/C 121/04

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2009 to 30 April 2009(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

)

14

| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2009/C 121/05 | Prior notification of a concentration — (Case COMP/M.5520 — Itochu/Mitsubishi/Enolia/JV) — Candidate case for simplified procedure (
  1
  ) | 27 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2009/C 121/05

Prior notification of a concentration — (Case COMP/M.5520 — Itochu/Mitsubishi/Enolia/JV) — Candidate case for simplified procedure (
  1
  )

1

27

| | Corrigenda |
| --- | --- |
| 2009/C 121/06 | Corrigendum to Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (OJ C 112, 16.5.2009) | 28 |

Corrigenda

2009/C 121/06

Corrigendum to Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (OJ C 112, 16.5.2009)

(OJ C 112, 16.5.2009)

28

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

---

(1)   Text with EEA relevance

1

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

EN

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 29.5.2009 | EN | Official Journal of the European Union | C 121/1 |
| --- | --- | --- | --- |

29.5.2009

EN

Official Journal of the European Union

C 121/1

---

Non-opposition to a notified concentration

(Case COMP/M.5483 — TOSHIBA/FUJITSU HDD BUSINESS)

(Text with EEA relevance)

2009/C 121/01

On 11 May 2009, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

| — | from the Europa competition website (http://ec.europa.eu/comm/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
| --- | --- |

—

from the Europa competition website (http://ec.europa.eu/comm/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,

| — | in electronic form on the EUR-Lex website under document number 32009M5483. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu). |
| --- | --- |

—

in electronic form on the EUR-Lex website under document number 32009M5483. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 29.5.2009 | EN | Official Journal of the European Union | C 121/2 |
| --- | --- | --- | --- |

29.5.2009

EN

Official Journal of the European Union

C 121/2

---

Euro exchange rates (1)

28 May 2009

2009/C 121/02

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,3856 |
| JPY | Japanese yen | 134,38 |
| DKK | Danish krone | 7,4445 |
| GBP | Pound sterling | 0,87000 |
| SEK | Swedish krona | 10,7353 |
| CHF | Swiss franc | 1,5117 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 8,9615 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 26,761 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 284,75 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7093 |
| PLN | Polish zloty | 4,4910 |
| RON | Romanian leu | 4,1975 |
| TRY | Turkish lira | 2,1775 |
| AUD | Australian dollar | 1,7753 |
| CAD | Canadian dollar | 1,5544 |
| HKD | Hong Kong dollar | 10,7427 |
| NZD | New Zealand dollar | 2,2223 |
| SGD | Singapore dollar | 2,0146 |
| KRW | South Korean won | 1 736,18 |
| ZAR | South African rand | 11,2268 |
| CNY | Chinese yuan renminbi | 9,4610 |
| HRK | Croatian kuna | 7,3305 |
| IDR | Indonesian rupiah | 14 306,32 |
| MYR | Malaysian ringgit | 4,8669 |
| PHP | Philippine peso | 65,504 |
| RUB | Russian rouble | 43,3105 |
| THB | Thai baht | 47,685 |
| BRL | Brazilian real | 2,8136 |
| MXN | Mexican peso | 18,3176 |
| INR | Indian rupee | 65,9680 |

Currency

Exchange rate

USD

US dollar

1,3856

JPY

Japanese yen

134,38

DKK

Danish krone

7,4445

GBP

Pound sterling

0,87000

SEK

Swedish krona

10,7353

CHF

Swiss franc

1,5117

ISK

Iceland króna

NOK

Norwegian krone

8,9615

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

26,761

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

284,75

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7093

PLN

Polish zloty

4,4910

RON

Romanian leu

4,1975

TRY

Turkish lira

2,1775

AUD

Australian dollar

1,7753

CAD

Canadian dollar

1,5544

HKD

Hong Kong dollar

10,7427

NZD

New Zealand dollar

2,2223

SGD

Singapore dollar

2,0146

KRW

South Korean won

1 736,18

ZAR

South African rand

11,2268

CNY

Chinese yuan renminbi

9,4610

HRK

Croatian kuna

7,3305

IDR

Indonesian rupiah

14 306,32

MYR

Malaysian ringgit

4,8669

PHP

Philippine peso

65,504

RUB

Russian rouble

43,3105

THB

Thai baht

47,685

BRL

Brazilian real

2,8136

MXN

Mexican peso

18,3176

INR

Indian rupee

65,9680

---

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

---

| 29.5.2009 | EN | Official Journal of the European Union | C 121/3 |
| --- | --- | --- | --- |

29.5.2009

EN

Official Journal of the European Union

C 121/3

---

Summary of Community decisions on marketing authorisations in respect of medicinal products

from 1 April 2009 to 30 April 2009

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

2009/C 121/03

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.4.2009 | Rivastigmine Teva | Rivastigmine | Teva Pharma B.V. |
| Computerweg 10 |
| 3542 DR Utrecht |
| NEDERLAND |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

17.4.2009

Rivastigmine Teva

Rivastigmine

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/513/001-020

Capsule, hard

N06DA03

21.4.2009

17.4.2009

CONBRIZA

Bazedoxifene

| 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/1/09/511/001-004

Film-coated tablet

G03XC02

21.4.2009

20.4.2009

Removab

Catumaxomab

| Fresenius Biotech GmbH |
| --- |
| Am Haag 6-7 |
| 82166 Graefelfing |
| DEUTSCHLAND |

Fresenius Biotech GmbH

Am Haag 6-7

82166 Graefelfing

DEUTSCHLAND

EU/1/09/512/001-002

Concentrate for solution for infusion

L01XC09

22.4.2009

21.4.2009

Exalief

Eslicarbazepine acetate

| BIAL - Portela & Ca, SA, A |
| --- |
| Av. da Siderurgia Nacional |
| 4745-457 S. Mamede do Coronado |
| PORTUGAL |

BIAL - Portela & Ca, SA, A

Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado

PORTUGAL

EU/1/09/520/001-020

Tablet

N03AF04

23.4.2009

21.4.2009

Zebinix

Eslicarbazepine acetate

| BIAL - Portela & Ca, SA, A |
| --- |
| Av. da Siderurgia Nacional |
| 4745-457 S. Mamede do Coronado |
| PORTUGAL |

BIAL - Portela & Ca, SA, A

Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado

PORTUGAL

EU/1/09/514/001-020

Tablet

N03AF04

23.4.2009

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 27.4.2009 | Sovrima | Santhera Pharmaceuticals (Deutschland) GmbH |
| Wallbrunnstr. 24 |
| 79539 Lörrach |
| DEUTSCHLAND |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

27.4.2009

Sovrima

Santhera Pharmaceuticals (Deutschland) GmbH

Wallbrunnstr. 24

79539 Lörrach

DEUTSCHLAND

—

29.4.2009

—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.4.2009 | Xarelto | Bayer Schering Pharma AG |
| 13342 Berlin |
| DEUTSCHLAND |
| Bayer HealthCare AG |
| 51368 Leverkusen |
| DEUTSCHLAND |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

2.4.2009

Xarelto

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/08/472/001-008

6.4.2009

2.4.2009

Altargo

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

Glaxo Group Limited Glaxo Wellcome House

Berkely Avenue Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/07/390/001-004

4.4.2009

2.4.2009

Neupro

| Schwarz Pharma Ltd |
| --- |
| Shannon Industrial Estate |
| Co. Clare |
| IRELAND |

Schwarz Pharma Ltd

Shannon Industrial Estate

Co. Clare

IRELAND

EU/1/05/331/001-055

6.4.2009

2.4.2009

Abraxane

| Abraxis BioScience Limited |
| --- |
| Hatfield |
| AL10 9NA |
| UNITED KINGDOM |

Abraxis BioScience Limited

Hatfield

AL10 9NA

UNITED KINGDOM

EU/1/07/428/001

6.4.2009

2.4.2009

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

4.4.2009

3.4.2009

Optimark

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

Covidien Deutschland GmbH

Gewerbepark 1

93333 Neustadt/Donau

DEUTSCHLAND

EU/1/07/398/001-014

8.4.2008

3.4.2009

Intrinsa

| Procter & Gamble Pharmaceuticals UK Ltd |
| --- |
| Rusham Park Technical Centre |
| Whitehall Lane |
| Egham Surrey |
| TW20 9NW |
| UNITED KINGDOM |

Procter & Gamble Pharmaceuticals UK Ltd

Rusham Park Technical Centre

Whitehall Lane

Egham Surrey

TW20 9NW

UNITED KINGDOM

EU/1/06/352/001-003

8.4.2009

3.4.2009

Livensa

| Procter & Gamble Pharmaceuticals — Germany GmbH |
| --- |
| Dr Otto-Röhm-Strasse 2-4 |
| 64331 Weiterstadt |
| DEUTSCHLAND |

Procter & Gamble Pharmaceuticals — Germany GmbH

Dr Otto-Röhm-Strasse 2-4

64331 Weiterstadt

DEUTSCHLAND

EU/1/06/351/001-003

8.4.2009

3.4.2009

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

8.4.2009

3.4.2009

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

8.4.2009

3.4.2009

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

8.4.2009

3.4.2009

Tekturna

| 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/1/07/408/001-020

8.4.2009

3.4.2009

Rasilez

| 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/1/07/405/001-020

8.4.2009

3.4.2009

YENTREVE

| 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/1/04/280/001-008

8.4.2009

3.4.2009

DULOXETINE BOEHRINGER INGELHEIM

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/08/471/001-012

8.4.2009

7.4.2009

Vectibix

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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

NEDERLAND

EU/1/07/423/001-003

9.4.2009

7.4.2009

ADROVANCE

| 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/1/06/364/001-009

14.4.2009

7.4.2009

FOSAVANCE

| 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/1/05/310/001-009

14.4.2009

7.4.2009

Champix

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT 13 9NJ

UNITED KINGDOM

EU/1/06/360/001-012

9.4.2009

7.4.2009

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

9.4.2009

7.4.2009

Irbesartan

| 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/1/06/375/001-033

9.4.2009

7.4.2009

PritorPlus

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/02/215/001-021

9.4.2009

7.4.2009

KOGENATE Bayer

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |
| Bayer HealthCare AG |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/00/143/001-011

9.4.2009

7.4.2009

Tasigna

| 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/1/07/422/001-004

9.4.2009

7.4.2009

Irbesartan HCT BMS

| 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/1/06/369/001-028

9.4.2009

7.4.2009

Helixate NexGen

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |
| Bayer HealthCare AG |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/00/144/001-004

9.4.2009

7.4.2009

Kinzalkomb

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/02/214/001-015

9.4.2009

7.4.2009

Nexavar

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |
| Bayer HealthCare AG |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/06/342/001

9.4.2009

7.4.2009

Fluticasone furoate GSK

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

Glaxo Group Ltd

Greenford

Middlesex

UB6 ONN

UNITED KINGDOM

EU/1/08/474/001-003

9.4.2009

7.4.2009

Protopic

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19 |
| 2353 EW Leiderdorp |
| NEDERLAND |
| Astellas Pharma GmbH |
| Neumarkter Str. 61 |
| 81673 München |
| DEUTSCHLAND |

Astellas Pharma Europe B.V.

Elisabethhof 19

2353 EW Leiderdorp

NEDERLAND

Astellas Pharma GmbH

Neumarkter Str. 61

81673 München

DEUTSCHLAND

EU/1/02/201/001-006

9.4.2009

7.4.2009

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/1/07/400/001-021

9.4.2009

7.4.2009

Integrilin

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

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/99/109/001-002

9.4.2009

7.4.2009

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

9.4.2009

7.4.2009

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

9.4.2009

7.4.2009

MicardisPlus

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/02/213/001-023

9.4.2009

7.4.2009

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

9.4.2009

8.4.2009

Irbesartan 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/1/06/376/001-033

15.4.2009

8.4.2009

PEGASYS

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/02/221/001-010

15.4.2009

16.4.2009

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

20.4.2009

16.4.2009

Levemir

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

Novo Nordisk A/S

Novo Allé

2880 Bagsvaerd

DANMARK

EU/1/04/278/001-009

20.4.2009

16.4.2009

Thelin

| Encysive (UK) Limited |
| --- |
| Alder Castle House |
| 10 Noble Street |
| London |
| EC2V 7QJ |
| UNITED KINGDOM |

Encysive (UK) Limited

Alder Castle House

10 Noble Street

London

EC2V 7QJ

UNITED KINGDOM

EU/1/06/353/001-005

21.4.2009

17.4.2009

CUBICIN

| 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/1/05/328/001-002

21.4.2009

17.4.2009

Mirapexin

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/97/051/001-006

EU/1/97/051/009-012

21.4.2009

17.4.2009

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

21.4.2009

17.4.2009

Sifrol

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/97/050/001-006

EU/1/97/050/009-012

21.4.2009

21.4.2009

Trisenox

| Cephalon Europe |
| --- |
| 5 Rue Charles Martigny |
| 94700 Maisons Alfort |
| Cedex |
| FRANCE |

Cephalon Europe

5 Rue Charles Martigny

94700 Maisons Alfort

Cedex

FRANCE

EU/1/02/204/001

23.4.2009

21.4.2009

Kivexa

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

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/04/298/001-003

23.4.2009

21.4.2009

Prepandrix

| 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/1/08/453/001

23.4.2009

21.4.2009

Tasigna

| 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/1/07/422/001-004

23.4.2009

21.4.2009

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

23.4.2009

21.4.2009

Angiox

| The Medicines Company UK Ltd |
| --- |
| 115 L Milton Park |
| Abingdon |
| Oxfordshire |
| OX14 4SA |
| UNITED KINGDOM |

The Medicines Company UK Ltd

115 L Milton Park

Abingdon

Oxfordshire

OX14 4SA

UNITED KINGDOM

EU/1/04/289/001-002

23.4.2009

21.4.2009

Abilify

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House |
| Highbridge Business Park |
| Oxford Road |
| Uxbridge |
| Middlesex |
| UB8 1HU |
| UNITED KINGDOM |

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex

UB8 1HU

UNITED KINGDOM

EU/1/04/276/001-020

EU/1/04/276/024-036

23.4.2009

21.4.2009

ISENTRESS

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

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/436/001-002

23.4.2009

21.4.2009

Renagel

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/99/123/005-012

23.4.2009

22.4.2009

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

24.4.2009

22.4.2009

Liprolog

| 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/1/01/195/022-027

24.4.2009

22.4.2009

Sustiva

| 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/1/99/110/001-005

EU/1/99/110/008-010

24.4.2009

22.4.2009

Stocrin

| 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/1/99/111/001-005

EU/1/99/111/008-011

24.4.2009

22.4.2009

BeneFIX

| 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/1/97/047/001-007

24.4.2009

22.4.2009

Rebif

| Serono Europe Limited |
| --- |
| 56 Marsh Wall |
| London |
| E14 9TP |
| UNITED KINGDOM |

Serono Europe Limited

56 Marsh Wall

London

E14 9TP

UNITED KINGDOM

EU/1/98/063/001-010

24.4.2009

22.4.2009

Cervarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l'Institut 89 |
| 1330 Rixensart |
| BELGIQUE |

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/07/419/001-012

24.4.2009

22.4.2009

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

24.4.2009

22.4.2009

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

24.4.2009

22.4.2009

Tekturna

| 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/1/07/408/001-020

24.4.2009

22.4.2009

Rasilez

| 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/1/07/405/001-020

24.4.2009

22.4.2009

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

27.4.2009

23.4.2009

Rebetol

| Schering Plough Europe |
| --- |
| Rue de Stalle 73/Stallestraat 73 |
| 1180 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

Schering Plough Europe

Rue de Stalle 73/Stallestraat 73

1180 Bruxelles/Brussel

BELGIQUE/BELGIË

EU/1/99/107/001-005

28.4.2009

23.4.2009

Corlentor

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

Les Laboratoires Servier

22, rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/05/317/001-014

7.5.2009

23.4.2009

Procoralan

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

Les Laboratoires Servier

22, rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/05/316/001-014

7.5.2009

23.4.2009

INTELENCE

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIË |

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/08/468/001

28.4.2009

23.4.2009

EVICEL

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

OMRIX biopharmaceuticals S.A./N.V.

200 Chaussée de Waterloo/Waterloosesteenweg 200

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

BELGIQUE/BELGIË

EU/1/08/473/001-003

28.4.2009

24.4.2009

KOGENATE Bayer

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/00/143/001-011

28.4.2009

24.4.2009

Helixate NexGen

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/00/144/001-004

28.4.2009

27.4.2009

Advagraf

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

Astellas Pharma Europe B.V.

Elisabethhof 19

2353 EW Leiderdorp

NEDERLAND

EU/1/07/387/001-013

29.4.2009

29.4.2009

Glivec

| 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/1/01/198/001-013

5.5.2009

29.4.2009

Evoltra

| Genzyme Europe BV |
| --- |
| Gooimeer 10 |
| 1411 DD Naarden |
| NEDERLAND |

Genzyme Europe BV

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/06/334/001-004

5.5.2009

29.4.2009

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

5.5.2009

30.4.2009

NovoRapid

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

Novo Nordisk A/S Novo Allé

2880 Bagsvaerd

DANMARK

EU/1/99/119/001

EU/1/99/119/003

EU/1/99/119/005-015

5.5.2009

30.4.2009

TachoSil

| Nycomed Austria GmbH |
| --- |
| St.-Peter-Strasse 25 |
| 4020 Linz |
| ÖSTERREICH |

Nycomed Austria GmbH

St.-Peter-Strasse 25

4020 Linz

ÖSTERREICH

EU/1/04/277/001-004

5.5.2009

30.4.2009

Xagrid

| Shire Pharmaceutical Contracts Ltd |
| --- |
| Hampshire International Business Park |
| Chineham |
| Basingstoke |
| Hampshire |
| RG24 8EP |
| UNITED KINGDOM |

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park

Chineham

Basingstoke

Hampshire

RG24 8EP

UNITED KINGDOM

EU/1/04/295/001

5.5.2009

30.4.2009

Kentera

| Nicobrand Limited |
| --- |
| 189 Castleroe Road |
| Coleraine |
| Northern Ireland |
| BT51 3 RP |
| UNITED KINGDOM |

Nicobrand Limited

189 Castleroe Road

Coleraine

Northern Ireland

BT51 3 RP

UNITED KINGDOM

EU/1/03/270/001-003

5.5.2009

—   Suspension of a marketing authorisation (Article 20 of Regulation (EC) No 726/2004)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 17.4.2009 | Raptiva | Serono Europe Limited |
| 56 Marsh Wall |
| London |
| E14 9TP |
| UNITED KINGDOM |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

17.4.2009

Raptiva

Serono Europe Limited

56 Marsh Wall

London

E14 9TP

UNITED KINGDOM

EU/1/04/291/001-003

21.4.2009

—   Issuing of a marketing authorisation (Article 38 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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.4.2009 | Netvax | Clostridium perfringens type A toxoid | Intervet International B.V. |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| NEDERLAND |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

16.4.2009

Netvax

Clostridium perfringens type A toxoid

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/09/093/001-002

Emulsion for injection

QI01A08

20.4.2009

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 27.4.2009 | Equilis StrepE | 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 authorisation

Number of the entry in the Community Register

Date of notification

27.4.2009

Equilis StrepE

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/04/043/001

29.4.2009

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 4HB |
| UNITED KINGDOM |

The European Medicines Agency

7 Westferry Circus

Canary Wharf

London

E14 4HB

UNITED KINGDOM

---

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

---

| 29.5.2009 | EN | Official Journal of the European Union | C 121/14 |
| --- | --- | --- | --- |

29.5.2009

EN

Official Journal of the European Union

C 121/14

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2009 to 30 April 2009

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

2009/C 121/04

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 17.4.2009 | Thelin | Encysive (UK) Limited |
| Alder Castle House |
| 10 Noble Street |
| London |
| EC2V 7QJ |
| UNITED KINGDOM |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

17.4.2009

Thelin

Encysive (UK) Limited

Alder Castle House

10 Noble Street

London

EC2V 7QJ

UNITED KINGDOM

This Decision is addressed to the Member States

21.4.2009

30.4.2009

Alpha2-adrenoreceptor agonist (romifidine, xylazine, detomidine or medetomidine)

See Annex I

See Annex I

5.5.2009

---

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

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

---

ANNEX I

COUNTRY, PRODUCT INVENTED NAME, ACTIVE SUBSTANCE, MARKETING AUTHORISATION NUMBER, MARKETING AUTHORISATION HOLDER CONCERNED BY THE PROCEDURE

| Country | Product invented name | Active substance | Marketing Authorisation number | Marketing Authorisation Holder |
| --- | --- | --- | --- | --- |
| AT | Rompun | Xylazine | 14840 | Bayer Austria GmbH |
| AT | Chanazine 2 % | Xylazine | 8-00448 | Chanelle Pharmaceuticals Manufacturing Ltd. |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Country

Product invented name

Active substance

Marketing Authorisation number

Marketing Authorisation Holder

AT

Rompun

Xylazine

14840

Bayer Austria GmbH

AT

Chanazine 2 %

Xylazine

8-00448

Chanelle Pharmaceuticals Manufacturing Ltd.

Dublin Road

Loughrea

Co. Galway

IRELAND

AT

Domosedan

Detomidine

8-00128

| Pfizer Animal Health BV |
| --- |
| Postbus 37 |
| 2900 AA Capell a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health BV

Postbus 37

2900 AA Capell a/d Ijssel

THE NETHERLANDS

AT

Domitor

Medetomidine

8-00144

| Pfizer Animal Health BV |
| --- |
| Postbus 37 |
| 2900 AA Capell a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health BV

Postbus 37

2900 AA Capell a/d Ijssel

THE NETHERLANDS

BE

Rompun 2 %

Xylazine hydrochloride

0187IS0155F012

| BAYER N.V. |
| --- |
| Louizalaan 143 |
| 1050 Brussel |
| BELGIUM |

BAYER N.V.

Louizalaan 143

1050 Brussel

BELGIUM

BE

Rompun Droge Stof

Xylazine hydrochloride

0187IS0120F012

| BAYER N.V. |
| --- |
| Louizalaan 143 |
| 1050 Brussel |
| BELGIUM |

BAYER N.V.

Louizalaan 143

1050 Brussel

BELGIUM

BE

Domosedan 10 mg/ml

Dnretomidine hydrochloride

0419IS0001F012

| PFIZER ANIMAL HEALTH S.A. |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain-La-Neuve |
| BELGIUM |

PFIZER ANIMAL HEALTH S.A.

Rue Laid Burniat 1

1348 Louvain-La-Neuve

BELGIUM

BE

Domitor 1 mg/ml

Medetomidine hydrochloride

0419IS0003F012

| PFIZER ANIMAL HEALTH S.A. |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain-La-Neuve |
| BELGIUM |

PFIZER ANIMAL HEALTH S.A.

Rue Laid Burniat 1

1348 Louvain-La-Neuve

BELGIUM

BE

Sedivet 10 mg/ml

Romifidine hydrochloride

0205IS0127F012

| SCS BOEHRINGER INGELHEIM COMM.V |
| --- |
| Vesalius Science Park |
| Avenue Ariane 16 |
| 1200 Bruxelles |
| BELGIUM |

SCS BOEHRINGER INGELHEIM COMM.V

Vesalius Science Park

Avenue Ariane 16

1200 Bruxelles

BELGIUM

CY

Sedivet 1 % Solution for injection 10 mg/ml

Romifidine

CY004V-E

Boehringer Ingelheim Vetmedica GmbH

CZ

Domitor

Medetomidine hydrochloride

96/731/96-C

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

Pfizer Animal Health S.A.

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

CZ

Xylazine 2 % Alfasan

Xylazine hydrochloride

96/025/00-C

| ALFASAN INTERNATIONAL B.V. |
| --- |
| P.O. BOX 78 |
| 3440 AB Woerden |
| THE NETHERLANDS |

ALFASAN INTERNATIONAL B.V.

P.O. BOX 78

3440 AB Woerden

THE NETHERLANDS

CZ

Sedivet 1 %

Romifidine hydrochloride

96/039/01-C

| BOEHRINGER INGELHEIM VETMEDICA GMBH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| GERMANY |

BOEHRINGER INGELHEIM VETMEDICA GMBH

Binger Strasse 173

55216 Ingelheim am Rhein

GERMANY

CZ

Domosedan inj.

Detomidine hydrochloride

96/730/96-C

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

Pfizer Animal Health S.A.

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

DE

Sedivet

Romifidine hydrochloride

23715.00.00

| BOEHRINGER INGELHEIM VETMEDICA GMBH |
| --- |
| Binger Str. 173 |
| 55218 Ingelheim |
| GERMANY |

BOEHRINGER INGELHEIM VETMEDICA GMBH

Binger Str. 173

55218 Ingelheim

GERMANY

DE

Rompun TS

Xylazine hydrochloride

6293723.00.00

| Bayer Vital Gmbh |
| --- |
| 51368 Leverkusen |
| GERMANY |

Bayer Vital Gmbh

51368 Leverkusen

GERMANY

DE

Rompun 2 %

Xylazine hydrochloride

6293841.00.00

| Bayer Vital GmbH |
| --- |
| 51368 Leverkusen |
| GERMANY |

Bayer Vital GmbH

51368 Leverkusen

GERMANY

DE

Domosedan

Detomidine hydrochloride

15912.00.00

| Pfizer GmbH |
| --- |
| Pfizerstr. 1 |
| 76139 Karlsruhe |
| GERMANY |

Pfizer GmbH

Pfizerstr. 1

76139 Karlsruhe

GERMANY

DE

Domitor

Medetomidine hydrochloride

32457.00.00

| Pfizer GmbH |
| --- |
| Pfizerstr. 1 |
| 76139 Karlsruhe |
| GERMANY |

Pfizer GmbH

Pfizerstr. 1

76139 Karlsruhe

GERMANY

DE

Xylazin 2 %

Xylazine hydrochloride

6324464.00.00

| CEVA TIERGESUNDHEIT GmbH |
| --- |
| Kanzlerstr. 4 |
| 40472 Düsseldorf |
| GERMANY |

CEVA TIERGESUNDHEIT GmbH

Kanzlerstr. 4

40472 Düsseldorf

GERMANY

DK

Sedivet Vet.

Romifidine

14896

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Str. 173 |
| 55218 Ingelheim |
| GERMANY |

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

55218 Ingelheim

GERMANY

DK

Rompun Vet.

Xylazine

05669

Bayer A/S

Bayer HealthCare

ES

Rompun

Xylazine

7532 A

Química Farmacéutica Bayer

ES

Sedivet

Romifidine

1107 ESP

| Boehringer Ingelheim España S.A. |
| --- |
| Prat de la Riva s/n. |
| 08190 Sant Cugat del Valles |
| Barcelona |
| SPAIN |

Boehringer Ingelheim España S.A.

Prat de la Riva s/n.

08190 Sant Cugat del Valles

Barcelona

SPAIN

ES

Domosedan

Detomidine hydrochloride

9059 I

| Pfizer S.A. |
| --- |
| Avda. Europa, 20 B |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |
| SPAIN |

Pfizer S.A.

Avda. Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

SPAIN

ES

Domitor

Medetomidine hydrochloride

933 ESP

| Pfizer S.A. |
| --- |
| Avda. Europa, 20 B |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |
| SPAIN |

Pfizer S.A.

Avda. Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

SPAIN

FI

Rompun vet

Xylazine hydrochloride

6047

| Bayer HealthCare AG |
| --- |
| Animal Health Division |
| 51368 Leverkusen |
| GERMANY |

Bayer HealthCare AG

Animal Health Division

51368 Leverkusen

GERMANY

FI

Domosedan

Detomidine hydrochloride

8546

| Orion oyj |
| --- |
| P.O. Box 65 |
| 02201 Espoo |
| FINLAND |

Orion oyj

P.O. Box 65

02201 Espoo

FINLAND

FI

Domitor vet

Medetomidine hydrochloride

9501

| Orion oyj |
| --- |
| P.O. Box 65 |
| 02201 Espoo |
| FINLAND |

Orion oyj

P.O. Box 65

02201 Espoo

FINLAND

FR

Rompun 2 %

Xylazine chlorhydrate

255

BAYER SANTE

FR

Rompun Lyophilise

Xylazine chlorhydrate

8061

BAYER SANTE

FR

Domosedan

Detomidine chlorhydrate

10076

PFIZER

FR

Sedivet

Romifidine Chlorhydrate

11004

BOEHRINGER INGELHEIM FRANCE

FR

Domitor

Medetomidine Chlorhydrate

10718

PFIZER

GR

Domitor

Medetomidine

46335/06-12-00

PFIZER HELLAS

GR

Rompun 2 %

Xylazine

19605/23-06-93

ALAPIS

GR

Chanazine

Xylazine

11188/30-03-99

FARMAZAC SYNVET

GR

Sedivet

Romifidine

44613/22-11-00

BOEHRINGER INGELHEIM VETMEDICA GMBH. GERMANY

HU

Rompun

Xylazine

411/1991.

| Bayer Hungária Ltd. |
| --- |
| 1123 Budapest |
| Alkotás u. 50 |
| HUNGARY |

Bayer Hungária Ltd.

1123 Budapest

Alkotás u. 50

HUNGARY

HU

Domosedan

Detomodine hydrochloride

2079/2006.

| Pfizer Co. Ltd. |
| --- |
| 1123 Budapest |
| Alkotás u. 53 |
| HUNGARY |

Pfizer Co. Ltd.

1123 Budapest

Alkotás u. 53

HUNGARY

HU

Domitor

Medetomidine hydrochloride

891/1999.

| Pfizer Co. Ltd. |
| --- |
| 1123 Budapest |
| Alkotás u. 53 |
| HUNGARY |

Pfizer Co. Ltd.

1123 Budapest

Alkotás u. 53

HUNGARY

HU

Primazin 2 % injection

Xylazine

743/1997.

| Alfasan International B.V. |
| --- |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan International B.V.

3449 JA Woerden

THE NETHERLANDS

IE

Sedivet

Romifidine

10007/023/001

| Boehringer Ingelheim Ltd |
| --- |
| Ellesfield Avenue Bracknell |
| Berkshire RG12 8YS |
| UNITED KINGDOM |

Boehringer Ingelheim Ltd

Ellesfield Avenue Bracknell

Berkshire RG12 8YS

UNITED KINGDOM

IE

Chanazine 2 % Solution for Injection

Xylazine

10987/030/001

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

IRELAND

IE

Chanazine 10 % Solution for Injection

Xylazine

10987/031/001

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

IRELAND

IE

Domosedan Injection

Detomidine hydrochloride

10019/025/001

| Pfizer Animal Health |
| --- |
| Ringaskiddy |
| Co. Cork |
| IRELAND |

Pfizer Animal Health

Ringaskiddy

Co. Cork

IRELAND

IE

Domitor Injection

Medetomodine hydrochloride

10019/026/001

| Pfizer Animal Health |
| --- |
| Ringaskiddy |
| Co. Cork |
| IRELAND |

Pfizer Animal Health

Ringaskiddy

Co. Cork

IRELAND

IS

Domosedan, vet.

Detomidine

890003

| Orion Corporation |
| --- |
| Orionintie 1 |
| FUB-0220 Espoo |
| FINLAND |

Orion Corporation

Orionintie 1

FUB-0220 Espoo

FINLAND

IS

Chanazine 2 %, vet.

Xylazine

IS/2/01/003/02

| Icepharma hf. |
| --- |
| Lynhálsi 13 |
| 110 Reykjavík |
| ICELAND |

Icepharma hf.

Lynhálsi 13

110 Reykjavík

ICELAND

IS

Chanazine 10 %, vet.

Xylazine

IS/2/01/003/01

| Icepharma hf. |
| --- |
| Lynhálsi 13 |
| 110 Reykjavík |
| ICELAND |

Icepharma hf.

Lynhálsi 13

110 Reykjavík

ICELAND

IS

Rompun, vet.

Xylazine

691254

| Bayer HealthCare AG |
| --- |
| Animal Health Division |
| 51368 Leverkusen |
| GERMANY |

Bayer HealthCare AG

Animal Health Division

51368 Leverkusen

GERMANY

IT

Sedivet

Romifidine

102196

| Boehringer Ingelheim |
| --- |
| Località Prulli 103/c |
| 50066 Regello |
| FINLAND |

Boehringer Ingelheim

Località Prulli 103/c

50066 Regello

FINLAND

IT

Rompum

Xylazine

100390032

| Bayer |
| --- |
| Viale Certosa 130 |
| 20156 Milano |
| ITALY |

Bayer

Viale Certosa 130

20156 Milano

ITALY

IT

Rompum 2 %

Xylazine

100390018

| Bayer |
| --- |
| Viale Certosa 130 |
| 20156 Milano |
| ITALY |

Bayer

Viale Certosa 130

20156 Milano

ITALY

IT

Domosedan

Detomidine

100102

Orion

IT

Domitor

Medetomidine

100103

Orion Corporation animal health

LV

Xylazine 2 %

Xylazine

NRP/VFP-00544-05

| Alfasan International B.V. |
| --- |
| Kuipersweg 9 |
| P.O. Box 78 |
| NL-3440 AB Woerden |
| THE NETHERLANDS |

Alfasan International B.V.

Kuipersweg 9

P.O. Box 78

NL-3440 AB Woerden

THE NETHERLANDS

LV

Domitor

Medetomidine

NRP/VFP-01453-07

| Alfasan International B.V. |
| --- |
| Kuipersweg 9 |
| P.O. Box 78 |
| NL-3440 AB Woerden |
| THE NETHERLANDS |

Alfasan International B.V.

Kuipersweg 9

P.O. Box 78

NL-3440 AB Woerden

THE NETHERLANDS

NL

Sedivet

Romifidine

7232

| Boehringer Ingelheim |
| --- |
| Postbus 8037 |
| 1802 KA Alkmaar |
| THE NETHERLANDS |

Boehringer Ingelheim

Postbus 8037

1802 KA Alkmaar

THE NETHERLANDS

NL

Xylalin

Xylazine

3886

| CEVA Santé BV |
| --- |
| Tiendweg 8c |
| 2671 SB Naaldwijk |
| THE NETHERLANDS |

CEVA Santé BV

Tiendweg 8c

2671 SB Naaldwijk

THE NETHERLANDS

NL

Rompun droog

Xylazine

5407

| Bayer BV Animal Health |
| --- |
| Postbus 80 |
| 3640 AB Mijdrecht |
| THE NETHERLANDS |

Bayer BV Animal Health

Postbus 80

3640 AB Mijdrecht

THE NETHERLANDS

NL

Rompun

Xylazine

5409

| Bayer BV Animal Health |
| --- |
| Postbus 80 |
| 3640 AB Mijdrecht |
| THE NETHERLANDS |

Bayer BV Animal Health

Postbus 80

3640 AB Mijdrecht

THE NETHERLANDS

NL

Xylazine 5'+mg

Xylazine

7695

| Dopharma Research BV |
| --- |
| Postbus 205 |
| 4940 AE Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research BV

Postbus 205

4940 AE Raamsdonksveer

THE NETHERLANDS

NL

Aescoket Plus

Xylazine, Ketamine, Atropine

7986

| Aesculaap BV |
| --- |
| Mijlstraat 35 |
| 5281 LJ Boxtel |
| THE NETHERLANDS |

Aesculaap BV

Mijlstraat 35

5281 LJ Boxtel

THE NETHERLANDS

NL

Sedazine 20 Inj.

Xylazine

8066

| A.S.T. Farma BV |
| --- |
| Willeskop 206a |
| 4321 GW Oudewater |
| THE NETHERLANDS |

A.S.T. Farma BV

Willeskop 206a

4321 GW Oudewater

THE NETHERLANDS

NL

Rompun 2 % Injectievloeistof

Xylazine

8210

| Bayer BV Animal Health |
| --- |
| Postbus 80 |
| 3640 AB Mijdrecht |
| THE NETHERLANDS |

Bayer BV Animal Health

Postbus 80

3640 AB Mijdrecht

THE NETHERLANDS

NL

A.A. Xylazine P.I.

Xylazine

9759

| CEVA Santé BV |
| --- |
| Tiendweg 8c |
| 2671 SB Naaldwijk |
| THE NETHERLANDS |

CEVA Santé BV

Tiendweg 8c

2671 SB Naaldwijk

THE NETHERLANDS

NL

Xylazine 20 Inj.

Xylazine

10080

| Kepro BV |
| --- |
| Maadgenburgstraat 38 |
| 7421 ZE Deventer |
| THE NETHERLANDS |

Kepro BV

Maadgenburgstraat 38

7421 ZE Deventer

THE NETHERLANDS

NL

Xylasan 2 % Pro Inj.

Xylazine

10253

| Alfasan Nederland BV |
| --- |
| Postbus 78 |
| 3440 AB Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Postbus 78

3440 AB Woerden

THE NETHERLANDS

NL

Chanazine 2 %

Xylazine

7756

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Ltd.

Dublin Road

Loughrea

Co. Galway

IRELAND

NL

Domosedan

Detomidine

2973

| Pfizer Animal Health BV |
| --- |
| Postbus 37 |
| 2900 AA Capell a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health BV

Postbus 37

2900 AA Capell a/d Ijssel

THE NETHERLANDS

NL

Domosedan

Detomidine

9713

| Equi Products Holland BV |
| --- |
| Hermelijnkoog 44 |
| 1822 CB Alkmaar |
| THE NETHERLANDS |

Equi Products Holland BV

Hermelijnkoog 44

1822 CB Alkmaar

THE NETHERLANDS

NL

Domosedan

Detomidine

10032

| Equi Products Holland BV |
| --- |
| Hermelijnkoog 44 |
| 1822 CB Alkmaar |
| THE NETHERLANDS |

Equi Products Holland BV

Hermelijnkoog 44

1822 CB Alkmaar

THE NETHERLANDS

NL

Domosedan

Detomidine

10131

| Equi Products Holland BV |
| --- |
| Hermelijnkoog 44 |
| 1822 CB Alkmaar |
| THE NETHERLANDS |

Equi Products Holland BV

Hermelijnkoog 44

1822 CB Alkmaar

THE NETHERLANDS

NL

Domosedan

Detomidine

10295

| Novivet BV |
| --- |
| Albert Cuyplaan 2B |
| 7482 JA Haaksbergen |
| THE NETHERLANDS |

Novivet BV

Albert Cuyplaan 2B

7482 JA Haaksbergen

THE NETHERLANDS

NL

Domosedan

Detomidine

10403

| Wirtz Farma BV |
| --- |
| Albert Cuyplaan 2B |
| 7482 JA Haaksbergen |
| THE NETHERLANDS |

Wirtz Farma BV

Albert Cuyplaan 2B

7482 JA Haaksbergen

THE NETHERLANDS

NL

Domitor

Medetomidine

7823

| Pfizer Animal Health BV |
| --- |
| Postbus 37 |
| 2900 AA Capell a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health BV

Postbus 37

2900 AA Capell a/d Ijssel

THE NETHERLANDS

NL

Domitor

Medetomidine

10354

| Wirtz Farma BV |
| --- |
| Albert Cuyplaan 2B |
| 7482 JA Haaksbergen |
| THE NETHERLANDS |

Wirtz Farma BV

Albert Cuyplaan 2B

7482 JA Haaksbergen

THE NETHERLANDS

NO

Sedivet vet

Romifidine

0000/7913

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| GERMANY |

Boehringer Ingelheim Vetmedica GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

GERMANY

NO

Rompun vet

Xylazine

0000/05588

| Bayer Healthcare AG |
| --- |
| Animal Health Division |
| 51368 Leverkusen |
| GERMANY |

Bayer Healthcare AG

Animal Health Division

51368 Leverkusen

GERMANY

PL

Sedivet 1 %

Romifidine

P-1257/02

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Str. 173 |
| 55218 Ingelheim |
| GERMANY |

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

55218 Ingelheim

GERMANY

PL

Domosedan

Detomidine hydrochloride

P3-0505/98

| Orion Corporation Orion Pharma |
| --- |
| Tengstromink 8 |
| Box 65 |
| Turku 0101 |
| FINLAND |

Orion Corporation Orion Pharma

Tengstromink 8

Box 65

Turku 0101

FINLAND

PL

Domitor

Medetomidine hydrochloride

P2-0118/95

| Orion Corporation Orion Pharma |
| --- |
| Tengstromink 8 |
| Box 65 |
| Turku 0101 |
| FINLAND |

Orion Corporation Orion Pharma

Tengstromink 8

Box 65

Turku 0101

FINLAND

PT

Romidys 1 mg/ml Solução Injectável para cães e gatos

Romifidine

51498

| Virbac S.A. |
| --- |
| 1ère avenue |
| 2065 m, L.I.D. |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue

2065 m, L.I.D.

06516 Carros Cedex

FRANCE

PT

Domitor

Medetomidine

50855P

| Laboratórios Pzifer |
| --- |
| AS Laboratórios Pfizer |
| Lda Lagoas Park |
| Edifício 10 |
| 2740-271 Porto Salvo |
| PORTUGAL |

Laboratórios Pzifer

AS Laboratórios Pfizer

Lda Lagoas Park

Edifício 10

2740-271 Porto Salvo

PORTUGAL

PT

Domosedan

Detomidine

50820P

| Laboratórios Pzifer |
| --- |
| AS Laboratórios Pfizer |
| Lda Lagoas Park |
| Edifício 10 |
| 2740-271 Porto Salvo |
| PORTUGAL |

Laboratórios Pzifer

AS Laboratórios Pfizer

Lda Lagoas Park

Edifício 10

2740-271 Porto Salvo

PORTUGAL

PT

Chanazine 2 %

Xylazine

51188

| Agrovete |
| --- |
| Organização Técnica Agro Pecuária |
| S.A R. Alto B Vista Pavilhão 40 Agualva-Cacém |
| 2735-340 Agualva, Cacém |
| Lisbon |
| PORTUGAL |

Agrovete

Organização Técnica Agro Pecuária

S.A R. Alto B Vista Pavilhão 40 Agualva-Cacém

2735-340 Agualva, Cacém

Lisbon

PORTUGAL

PT

Rompun

Xylazine

4770

| Bayer Portugal |
| --- |
| S.A Rua da Quinta do Pinheiro 5 |
| 2794-003 Carnaxide |
| PORTUGAL |

Bayer Portugal

S.A Rua da Quinta do Pinheiro 5

2794-003 Carnaxide

PORTUGAL

RO

Xylazine 2 % xylazine

Xylazine

161895/3 of 6.12.2002 (expired)

| ALFASAN INTERNATIONAL B.V. |
| --- |
| Kuipersweg 9 |
| 3449 Ja Woerden |
| THE NETHERLANDS |

ALFASAN INTERNATIONAL B.V.

Kuipersweg 9

3449 Ja Woerden

THE NETHERLANDS

RO

Domosedan

Detomidine

221972/2 of 23.1.2004 (valid until 23.1.2009)

| PFIZER GLOBAL MANUFACTURING |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain La Nueve |
| BELGIUM |

PFIZER GLOBAL MANUFACTURING

Rue Laid Burniat 1

1348 Louvain La Nueve

BELGIUM

(Variation IA,1 – pending

| 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)

RO

Domitor

Medetomidine

221972/3 of 23.1.2004 (valid until 23.1.2009)

| PFIZER GLOBAL MANUFACTURING |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain La Nueve |
| BELGIUM |

PFIZER GLOBAL MANUFACTURING

Rue Laid Burniat 1

1348 Louvain La Nueve

BELGIUM

(Variation IA,1 – pending

| 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)

SE

Sedivet vet.

Romifidine hydrochloride

11753

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Str. 173 |
| 55218 Ingelheim |
| GERMANY |

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

55218 Ingelheim

GERMANY

SE

Rompun vet.

Xylazine hydrochloride

8534

Bayer HealthCare AG

SE

Domosedan vet.

Detomidine hydrochloride

10243

| Orion Corporation |
| --- |
| Box 65 |
| 02101 Esbo |
| FINLAND |

Orion Corporation

Box 65

02101 Esbo

FINLAND

SE

Domitor vet.

Medetomidine hydrochloride

10574

| Orion Corporation |
| --- |
| Box 65 |
| 02101 Esbo |
| FINLAND |

Orion Corporation

Box 65

02101 Esbo

FINLAND

SK

Chanazine 2 %

Xylazine

96/174/00-S

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Ltd.

Dublin Road

Loughrea

Co. Galway

IRELAND

SL

Chanazine 2 %

Xylazine

323-03-8/01-42

| VET4VET |
| --- |
| Gerbičeva 50 |
| 1000 Ljubljana |
| SLOVENIA |

VET4VET

Gerbičeva 50

1000 Ljubljana

SLOVENIA

SL

Domitor

Medetomidine

5363-783/2005

| Pfizer Luxembourg SARL PFIZER |
| --- |
| podružnica Ljubljana |
| Letališka 3 c |
| 1000 Ljubljana |
| SLOVENIA |

Pfizer Luxembourg SARL PFIZER

podružnica Ljubljana

Letališka 3 c

1000 Ljubljana

SLOVENIA

SL

Domosedan

Detomodine

5363-959/2004

| Pfizer Luxembourg SARL PFIZER |
| --- |
| podružnica Ljubljana |
| Letališka 3 c |
| 1000 Ljubljana |
| SLOVENIA |

Pfizer Luxembourg SARL PFIZER

podružnica Ljubljana

Letališka 3 c

1000 Ljubljana

SLOVENIA

UK

Sedivet 10 mg/ml Solution for Injection

Romifidine

00015/4033

| Boehringer Ingelheim Ltd |
| --- |
| Ellesfield Avenue |
| Bracknell |
| Berkshire RG12 8YS |
| UNITED KINGDOM |

Boehringer Ingelheim Ltd

Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

UNITED KINGDOM

UK

Domosedan 10 mg/ml Injection

Detomidine hydrochloride

03649/4000

| Orion Corporation Orion Pharma |
| --- |
| Tengstromink 8 |
| Box 65 |
| Turku 20101 |
| FINLAND |

Orion Corporation Orion Pharma

Tengstromink 8

Box 65

Turku 20101

FINLAND

UK

Domosedan 10 mg/ml Injection

Detomidine hydrochloride

24939/4001

| Globalmed Ltd |
| --- |
| Ground Floor |
| 134 Church Hill |
| Loughton |
| Essex IG10 1LH |
| UNITED KINGDOM |

Globalmed Ltd

Ground Floor

134 Church Hill

Loughton

Essex IG10 1LH

UNITED KINGDOM

UK

Domosedan 10 mg/ml Injection

Detomidine hydrochloride

20860/4005

| Quvera Ltd |
| --- |
| Unit 8 |
| Brember Road |
| Harrow |
| Middlesex HA2 8AX |
| UNITED KINGDOM |

Quvera Ltd

Unit 8

Brember Road

Harrow

Middlesex HA2 8AX

UNITED KINGDOM

UK

Domitor 1 mg/ml Solution for Injection

Medetomidine hydrochloride

03649/4001

| Orion Corporation Orion Pharma |
| --- |
| Tengstromink 8 |
| Box 65 |
| Turku 20101 |
| FINLAND |

Orion Corporation Orion Pharma

Tengstromink 8

Box 65

Turku 20101

FINLAND

UK

Domitor Injection (Strength 1 mg/ml)

Medetomidine hydrochloride

20860/4002

| Quvera Ltd |
| --- |
| Unit 8 |
| Brember Road |
| Harrow |
| Middlesex HA2 8AX |
| UNITED KINGDOM |

Quvera Ltd

Unit 8

Brember Road

Harrow

Middlesex HA2 8AX

UNITED KINGDOM

UK

Chanazine 10 % Solution for Injection

Xylazine

11990/4006

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool L1 9HZ

UNITED KINGDOM

UK

Chanazine 2 % Solution for Injection

Xylazine

11990/4005

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool L1 9HZ

UNITED KINGDOM

UK

Rompun 2 % w/v Solution for Injection

Xylazine

00010/4093

| Bayer plc |
| --- |
| Animal Health Division |
| Bayer House |
| Strawberry Hill |
| Newbury |
| Berkshire RG14 1JA |
| UNITED KINGDOM |

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

UNITED KINGDOM

---

V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 29.5.2009 | EN | Official Journal of the European Union | C 121/27 |
| --- | --- | --- | --- |

29.5.2009

EN

Official Journal of the European Union

C 121/27

---

Prior notification of a concentration

(Case COMP/M.5520 — Itochu/Mitsubishi/Enolia/JV)

Candidate case for simplified procedure

(Text with EEA relevance)

2009/C 121/05

| 1. | On 19 May 2009, 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 Itochu Corporation (‘Itochu’, Japan), Mitsubishi Heavy Industries Ltd. (‘Mitsubishi’, Japan) and Enolia Energy S.A. (‘Enolia’, Greece) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of Enolia Solar Systems S.A., Greece (‘JV’) by way of purchase of shares. |
| --- | --- |

1.

On 19 May 2009, 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 Itochu Corporation (‘Itochu’, Japan), Mitsubishi Heavy Industries Ltd. (‘Mitsubishi’, Japan) and Enolia Energy S.A. (‘Enolia’, Greece) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of Enolia Solar Systems S.A., Greece (‘JV’) by way of purchase of shares.

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






  — | for Itochu: import and export in diversified product areas, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Itochu: import and export in diversified product areas,

| — | for Mitsubishi: diversified manufacturing, |
| --- | --- |

—

for Mitsubishi: diversified manufacturing,

| — | for Enolia: renewable electricity generation, |
| --- | --- |

—

for Enolia: renewable electricity generation,

| — | for JV: supply of photovoltaic modules and integration and installation of photovoltaic systems. |
| --- | --- |

—

for JV: supply of photovoltaic modules and integration and installation of photovoltaic systems.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (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 Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (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 2 2964301 or 2967244) or by post, under reference number COMP/M.5520 — Itochu/Mitsubishi/Enolia/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 2 2964301 or 2967244) or by post, under reference number COMP/M.5520 — Itochu/Mitsubishi/Enolia/JV, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  OJ L 24, 29.1.2004, p. 1.

(2)  OJ C 56, 5.3.2005, p. 32.

---

Corrigenda

| 29.5.2009 | EN | Official Journal of the European Union | C 121/28 |
| --- | --- | --- | --- |

29.5.2009

EN

Official Journal of the European Union

C 121/28

---

Corrigendum to Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections

(
  Official Journal of the European Union C 112 of 16 May 2009
  )

2009/C 121/06

On page 2, second row:

for:

‘Reference number of the aid | N 274/07’,

read:

‘Reference number of the aid | N 274/08’.

---