# Official Journal C 77/2008

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 77 |
| | |
| English edition | Information and Notices | Volume 5128 March 2008 |

ISSN 1725-2423

Official Journal

of the European Union

C 77

English edition

Information and Notices

Volume 5128 March 2008

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2008/C 077/01 | Euro exchange rates | 1 |
| 2008/C 077/02 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2008 to 29 February 2008(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 2 |
| 2008/C 077/03 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2008 to 29 February 2008(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
  ) | 9 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2008/C 077/01

Euro exchange rates

1

2008/C 077/02

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2008 to 29 February 2008(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

2008/C 077/03

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2008 to 29 February 2008(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

)

9

| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2008/C 077/04 | Prior notification of a concentration (Case COMP/M.5084 — PARE/Acea/JV) — Candidate case for simplified procedure (
  1
  ) | 18 |
| 2008/C 077/05 | Prior notification of a concentration (Case COMP/M.5092 — GDF/Suez/Teesside Power) — Candidate case for simplified procedure (
  1
  ) | 19 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2008/C 077/04

Prior notification of a concentration (Case COMP/M.5084 — PARE/Acea/JV) — Candidate case for simplified procedure (
  1
  )

1

18

2008/C 077/05

Prior notification of a concentration (Case COMP/M.5092 — GDF/Suez/Teesside Power) — Candidate case for simplified procedure (
  1
  )

1

19

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

---

(1)   Text with EEA relevance

1

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 28.3.2008 | EN | Official Journal of the European Union | C 77/1 |
| --- | --- | --- | --- |

28.3.2008

EN

Official Journal of the European Union

C 77/1

---

Euro exchange rates (1)

27 March 2008

(2008/C 77/01)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,5786 |
| JPY | Japanese yen | 157,53 |
| DKK | Danish krone | 7,4588 |
| GBP | Pound sterling | 0,78290 |
| SEK | Swedish krona | 9,3937 |
| CHF | Swiss franc | 1,5688 |
| ISK | Iceland króna | 118,52 |
| NOK | Norwegian krone | 8,0170 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 25,383 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 256,05 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,6966 |
| PLN | Polish zloty | 3,5256 |
| RON | Romanian leu | 3,7165 |
| SKK | Slovak koruna | 32,556 |
| TRY | Turkish lira | 2,0004 |
| AUD | Australian dollar | 1,7088 |
| CAD | Canadian dollar | 1,6085 |
| HKD | Hong Kong dollar | 12,2837 |
| NZD | New Zealand dollar | 1,9590 |
| SGD | Singapore dollar | 2,1790 |
| KRW | South Korean won | 1 558,47 |
| ZAR | South African rand | 12,6095 |
| CNY | Chinese yuan renminbi | 11,0668 |
| HRK | Croatian kuna | 7,2586 |
| IDR | Indonesian rupiah | 14 523,12 |
| MYR | Malaysian ringgit | 5,0665 |
| PHP | Philippine peso | 66,017 |
| RUB | Russian rouble | 37,0850 |
| THB | Thai baht | 49,544 |
| BRL | Brazilian real | 2,7275 |
| MXN | Mexican peso | 16,8760 |

Currency

Exchange rate

USD

US dollar

1,5786

JPY

Japanese yen

157,53

DKK

Danish krone

7,4588

GBP

Pound sterling

0,78290

SEK

Swedish krona

9,3937

CHF

Swiss franc

1,5688

ISK

Iceland króna

118,52

NOK

Norwegian krone

8,0170

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

25,383

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

256,05

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,6966

PLN

Polish zloty

3,5256

RON

Romanian leu

3,7165

SKK

Slovak koruna

32,556

TRY

Turkish lira

2,0004

AUD

Australian dollar

1,7088

CAD

Canadian dollar

1,6085

HKD

Hong Kong dollar

12,2837

NZD

New Zealand dollar

1,9590

SGD

Singapore dollar

2,1790

KRW

South Korean won

1 558,47

ZAR

South African rand

12,6095

CNY

Chinese yuan renminbi

11,0668

HRK

Croatian kuna

7,2586

IDR

Indonesian rupiah

14 523,12

MYR

Malaysian ringgit

5,0665

PHP

Philippine peso

66,017

RUB

Russian rouble

37,0850

THB

Thai baht

49,544

BRL

Brazilian real

2,7275

MXN

Mexican peso

16,8760

---

(1)

Source: reference exchange rate published by the ECB.

---

| 28.3.2008 | EN | Official Journal of the European Union | C 77/2 |
| --- | --- | --- | --- |

28.3.2008

EN

Official Journal of the European Union

C 77/2

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2008 to 29 February 2008

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

(2008/C 77/02)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.2.2008 | Myfenax | Mycophénolate mofétil | Teva Pharma B.V. |
| Computerweg 10 |
| DR Utrecht 3542 |
| Nederland |

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

21.2.2008

Myfenax

Mycophénolate mofétil

Teva Pharma B.V.

Computerweg 10

DR Utrecht 3542

Nederland

EU/1/07/438/001-002

Capsule, hard

L04AA06

25.2.2008

EU/1/07/438/003-004

Film-coated tablet

21.2.2008

Mycophenolate mofetil Teva

Mycophénolate mofétil

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

Teva Pharma B.V.

Computerweg 10

DR Utrecht 3542

Nederland

EU/1/07/439/001-002

Capsule, hard

L04AA06

25.2.2008

EU/1/07/439/003-004

Film-coated tablet

—   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 |
| --- | --- | --- | --- | --- |
| 6.2.2008 | Sebivo | Novartis Europharm Limited |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

6.2.2008

Sebivo

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/388/001-002

8.2.2008

6.2.2008

Prevenar

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

Wyeth-Lederle Vaccines S.A.

Rue du Bosquet, 15

B-1348 Louvain-La-Neuve

EU/1/00/167/001-007

8.2.2008

6.2.2008

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

8.2.2008

7.2.2008

Ytracis

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

CIS bio international

Boite Postale 32

F-91192 Gif-sur-Yvette Cedex

EU/1/03/250/001

11.2.2008

7.2.2008

Levitra

| Bayer AG |
| --- |
| D-51368 Leverkusen |

Bayer AG

D-51368 Leverkusen

EU/1/03/248/001-012

11.2.2008

7.2.2008

Vivanza

| Bayer AG |
| --- |
| D-51368 Leverkusen |

Bayer AG

D-51368 Leverkusen

EU/1/03/249/001-012

11.2.2008

13.2.2008

Eucreas

| 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/1/07/425/001-018

15.2.2008

13.2.2008

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

15.2.2008

14.2.2008

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

18.2.2008

18.2.2008

ATryn

| LEO Pharma A/S |
| --- |
| Industriparken 55 |
| DK-2750 Ballerup |

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

EU/1/06/355/001-003

20.2.2008

26.2.2008

Januvia

| 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/1/07/383/001-018

28.2.2008

26.2.2008

Aranesp

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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/01/185/001-073

28.2.2008

26.2.2008

Abseamed

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

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

D-58638 Iserlohn

EU/1/07/412/001-016

28.2.2008

26.2.2008

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

28.2.2008

26.2.2008

Nespo

| Dompé Biotec S.p.A. |
| --- |
| Via San Martino, 12 |
| I-20122 Milano |

Dompé Biotec S.p.A.

Via San Martino, 12

I-20122 Milano

EU/1/01/184/001-073

28.2.2008

26.2.2008

Xelevia

| 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/1/07/382/001-018

28.2.2008

26.2.2008

Arava

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/99/118/001-010

28.2.2008

26.2.2008

NeuroBloc

| Eisai Limited |
| --- |
| 3, Shortlands |
| London W6 8EE |
| United Kingdom |

Eisai Limited

3, Shortlands

London W6 8EE

United Kingdom

EU/1/00/166/001-003

28.2.2008

26.2.2008

Avastin

| 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/1/04/300/001-002

28.2.2008

26.2.2008

Kepivance

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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/05/314/001

28.2.2008

28.2.2008

Erbitux

| Merck KgaA |
| --- |
| Frankfurter Straße 250 |
| D-64293 Darmstadt |

Merck KgaA

Frankfurter Straße 250

D-64293 Darmstadt

EU/1/04/281/002-005

3.3.2008

28.2.2008

Hepsera

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

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/03/251/001-002

3.3.2008

28.2.2008

Fasturtec

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

Sanofi-Aventis

174, avenue de France

F-75013 Paris

EU/1/00/170/001-002

3.3.2008

28.2.2008

TRIZIVIR

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

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/156/002-003

3.3.2008

28.2.2008

Truvada

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

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/04/305/001

3.3.2008

28.2.2008

Champix

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/360/001-011

3.3.2008

28.2.2008

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/1/07/388/001-002

3.3.2008

28.2.2008

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

3.3.2008

28.2.2008

CellCept

| 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/1/96/005/001-006

3.3.2008

28.2.2008

Sifrol

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173 |
| D-55216 Ingelheim am Rhein |

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/050/001-006

EU/1/97/050/009-012

3.3.2008

29.2.2008

Osigraft

| Howmedica International S. de R.L. |
| --- |
| Division of Stryker Corporation |
| Raheen Industrial Estate |
| Raheen |
| Limerick |
| Ireland |

Howmedica International S. de R.L.

Division of Stryker Corporation

Raheen Industrial Estate

Raheen

Limerick

Ireland

EU/1/01/179/001

4.3.2008

29.2.2008

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

4.3.2008

29.2.2008

Epoetin alfa Hexal

| HEXAL Biotech Forschungs GmbH |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL Biotech Forschungs GmbH

Industriestraße 25

D-83607 Holzkirchen

EU/1/07/411/001-016

4.3.2008

29.2.2008

Lyrica

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/04/279/001-043

4.3.2008

29.2.2008

Dynepo

| 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/1/02/211/001-005

EU/1/02/211/010-012

4.3.2008

29.2.2008

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

4.3.2008

29.2.2008

Mirapexin

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173 |
| D-55216 Ingelheim am Rhein |

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/051/001-006

EU/1/97/051/009-012

4.3.2008

29.2.2008

Binocrit

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

EU/1/07/410/001-016

4.3.2008

29.2.2008

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/1/04/276/001-032

4.3.2008

29.2.2008

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

4.3.2008

—   Issuing of a marketing authorization (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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
  (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.2.2008 | Ingelvac CircoFLEX | Porcine circovirus type 2 ORF2 protein minimum RP 1,0, maximum RP 3,75 | Boehringer Ingelheim Vetmedica GmbH |
| D-55216 Ingelheim am Rhein |

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

13.2.2008

Ingelvac CircoFLEX

Porcine circovirus type 2 ORF2 protein minimum RP 1,0, maximum RP 3,75

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein

EU/2/07/079/001-004

Suspension for injection

QI09AA07

15.2.2008

—   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 |
| --- | --- | --- | --- | --- |
| 5.2.2008 | Aivlosin | ECO Animal Health Ltd |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| 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

5.2.2008

Aivlosin

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

EU/2/04/044/001-002

7.2.2008

7.2.2008

Nobilis Influenza H5N2

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/06/061/001-004

11.2.2008

7.2.2008

Advocate

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

EU/2/03/039/001-030

11.2.2008

—   Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.2.2008 | Advasure | Pfizer Ltd |
| Ramsgate Road |
| Sandwich |
| Kent CT 13 9NJ |
| United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

6.2.2008

Advasure

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/2/00/025/001-004

8.2.2008

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.

---

| 28.3.2008 | EN | Official Journal of the European Union | C 77/9 |
| --- | --- | --- | --- |

28.3.2008

EN

Official Journal of the European Union

C 77/9

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2008 to 29 February 2008

(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)
  )

(2008/C 77/03)

—   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 |
| --- | --- | --- | --- | --- |
| 5.1.2008 | Carisoprodol | See Annex I | See Annex I | 6.2.2008 |
| 15.2.2008 | Aprotinin | See Annex II | See Annex II | 19.2.2008 |
| 15.2.2008 | Simvastatin Krka | See Annex III | See Annex III | 19.2.2008 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

5.1.2008

Carisoprodol

See Annex I

See Annex I

6.2.2008

15.2.2008

Aprotinin

See Annex II

See Annex II

19.2.2008

15.2.2008

Simvastatin Krka

See Annex III

See Annex III

19.2.2008

---

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

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

---

ANNEX I

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

| Member State | Marketing Authorisation Holder | Invented Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Czech Republic | EGIS Pharmaceuticals PLC |
| Keresztúri út 30-38 |
| H-1106 Budapest |

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Czech Republic

EGIS Pharmaceuticals PLC

Keresztúri út 30-38

H-1106 Budapest

Scutamil C

150 mg carisoprodol/100 mg paracetamol

Coated tablet

Oral use

Denmark

| Actavis Group hf |
| --- |
| Reykjavíkurvegur 76-78 |
| IS-220 Hafnafjördur |

Actavis Group hf

Reykjavíkurvegur 76-78

IS-220 Hafnafjördur

Somadril

350 mg

Film coated tablet

Oral use

Finland

| Actavis Group hf. |
| --- |
| Reykjavíkurvegi 76-78 |
| IS-220 Hafnafjördur |

Actavis Group hf.

Reykjavíkurvegi 76-78

IS-220 Hafnafjördur

Somadril Comp

200 mg carisoprodol/160 mg paracetamol/32 mg caffeine

Film coated tablet

Oral use

Greece

| Uni Pharma Kleon Tsetis Pharmaceutical Laboratories ABEE |
| --- |
| 14 km National Highway Athens-Lamia |
| GR-14564 K. Kifissia |

Uni Pharma Kleon Tsetis Pharmaceutical Laboratories ABEE

14 km National Highway Athens-Lamia

GR-14564 K. Kifissia

Artifar

350 mg

Film coated tablet

Oral use

Greece

| Uni Pharma Kleon Tsetis Pharmaceutical Laboratories ABEE |
| --- |
| 14 km National Highway Athens-Lamia |
| GR-14564 K. Kifissia |

Uni Pharma Kleon Tsetis Pharmaceutical Laboratories ABEE

14 km National Highway Athens-Lamia

GR-14564 K. Kifissia

Relacton-C

200 mg carisoprodol/300 mg paracetamol

Tablet

Oral use

Greece

| Uni Pharma Kleon Tsetis Pharmaceutical Laboratories ABEE |
| --- |
| 14 km National Highway Athens-Lamia |
| GR-14564 K. Kifissia |

Uni Pharma Kleon Tsetis Pharmaceutical Laboratories ABEE

14 km National Highway Athens-Lamia

GR-14564 K. Kifissia

Relacton-C

400 mg carisoprodol/600 mg paracetamol

Suppository

Rectal use

Hungary

| EGIS Pharmaceuticals PLC |
| --- |
| Keresztúri út 30-38 |
| H-1106 Budapest |

EGIS Pharmaceuticals PLC

Keresztúri út 30-38

H-1106 Budapest

Scutamil-C

150 mg carisoprodol,

100 mg paracetamol

Tablet

Oral use

Iceland

| Actavis Group hf. |
| --- |
| Reykjavíkurvegi 76-78 |
| IS-220 Hafnarfjörður |

Actavis Group hf.

Reykjavíkurvegi 76-78

IS-220 Hafnarfjörður

Somadril

350 mg

Film coated tablet

Oral use

Iceland

| Actavis Group hf. |
| --- |
| Reykjavíkurvegi 76-78 |
| IS-220 Hafnarfjörður |

Actavis Group hf.

Reykjavíkurvegi 76-78

IS-220 Hafnarfjörður

Somadril Comp

200 mg carisoprodol/160 mg paracetamol

Film coated tablet

Oral use

Italy

| TEOFARMA Srl |
| --- |
| Sede legale: via F.lli Cervi, 8 |
| I-27010 Valle Salimbene (PV) |

TEOFARMA Srl

Sede legale: via F.lli Cervi, 8

I-27010 Valle Salimbene (PV)

Soma complex

140 mg carisoprodol/500 mg metamizole sodium

Film coated tablet

Oral use

Italy

| TEOFARMA Srl |
| --- |
| Sede legale: via F.lli Cervi, 8 |
| I-27010 Valle Salimbene (PV) |

TEOFARMA Srl

Sede legale: via F.lli Cervi, 8

I-27010 Valle Salimbene (PV)

Soma complex

600 mg carisoprodol/1 000 mg metamizole sodium

Suppository

Rectal use

Norway

| Actavis Group hf. |
| --- |
| Reykjavíkurvegi 76-78 |
| IS-220 Hafnarfjörður |

Actavis Group hf.

Reykjavíkurvegi 76-78

IS-220 Hafnarfjörður

Somadril

350 mg

Film coated tablet

Oral use

Slovak Republic

| EGIS Pharmaceuticals PLC |
| --- |
| Keresztúri út 30-38 |
| H-1106 Budapest |

EGIS Pharmaceuticals PLC

Keresztúri út 30-38

H-1106 Budapest

Scutamil C

150 mg carisoprodol/100 mg paracetamol

Film coated tablet

Oral use

Spain

| Laboratorios BELMAC SA |
| --- |
| Teide, 4-planta baj. Polígono Empresarial |
| La Marina |
| E-28700 San Sebastian de los Reyes |
| Madrid |

Laboratorios BELMAC SA

Teide, 4-planta baj. Polígono Empresarial

La Marina

E-28700 San Sebastian de los Reyes

Madrid

Mio Relax

350 mg

Tablet

Oral use

Spain

| Laboratorios Rimafar |
| --- |
| Polígono industrial Malpica |
| c, no 4 |
| E-50057 Zaragoza |

Laboratorios Rimafar

Polígono industrial Malpica

c, no 4

E-50057 Zaragoza

Relaxibys

200 mg carisoprodol/500 mg paracetamol

Tablet

Oral use

Sweden

| Actavis Group hf |
| --- |
| Reykjavíkurvegur 76-78 |
| IS-220 Hafnafjördur |

Actavis Group hf

Reykjavíkurvegur 76-78

IS-220 Hafnafjördur

Somadril

350 mg

Tablet

Oral use

Sweden

| Actavis Group hf |
| --- |
| Reykjavíkurvegur 76-78 |
| IS-220 Hafnafjördur |

Actavis Group hf

Reykjavíkurvegur 76-78

IS-220 Hafnafjördur

Somadril comp.

200 mg carisoprodol/160 mg paracetamol/32 mg caffeine

Tablet

Oral use

United Kingdom

| Forest Laboratories UK Limited Bourne Road |
| --- |
| Bexley |
| Kent DA5 1NX |
| United Kingdom |

Forest Laboratories UK Limited Bourne Road

Bexley

Kent DA5 1NX

United Kingdom

Carisoma

125 mg

Tablet

Oral use

United Kingdom

| Forest Laboratories UK Limited Bourne Road |
| --- |
| Bexley |
| Kent DA5 1NX |
| United Kingdom |

Forest Laboratories UK Limited Bourne Road

Bexley

Kent DA5 1NX

United Kingdom

Carisoma

350 mg

Tablet

Oral use

---

ANNEX II

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

Aprotinin containing medicinal products with marketing authorisation in the European Union

| Member State | Marketing Authorisation Holder | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Gerot Pharmazeutika Gesellschaft m.b.H. |
| Arnethgasse 3 |
| A-1160 Wien |

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Gerot Pharmazeutika Gesellschaft m.b.H.

Arnethgasse 3

A-1160 Wien

Pantinol

100 000 KIU/10 ml

Solution for injection and solution for infusion

Intravenous use

Austria

| Gerot Pharmazeutika Gesellschaft m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |

Gerot Pharmazeutika Gesellschaft m.b.H.

Arnethgasse 3

A-1160 Wien

Pantinol

200 000 KIU/10 ml

Solution for injection and solution for infusion

Intravenous use

Austria

| Gerot Pharmazeutika Gesellschaft m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |

Gerot Pharmazeutika Gesellschaft m.b.H.

Arnethgasse 3

A-1160 Wien

Pantinol

500 000 KIU/15 ml

Solution for injection and solution for infusion

Intravenous use

Austria

| Bayer Austria GmbH |
| --- |
| Herbststraße 6-10 |
| A-1160 Wien |

Bayer Austria GmbH

Herbststraße 6-10

A-1160 Wien

Trasylol 10 000 KIU/ml

500 000 KIU/50 ml

Solution for injection and solution for infusion

Intravenous use

Belgium

| Bayer NV |
| --- |
| Avenue Louise 143 |
| B-1050 Bruxelles |

Bayer NV

Avenue Louise 143

B-1050 Bruxelles

Trasylol

20 000 KIU/ml

Solution

Intravenous use

Belgium

| Bayer NV |
| --- |
| Avenue Louise 143 |
| B-1050 Bruxelles |

Bayer NV

Avenue Louise 143

B-1050 Bruxelles

Trasylol

10 000 KIU/ml

Solution

Intravenous use

Bulgaria

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21 |
| H-1103 Budapest |

Gedeon Richter Plc.

Gyömrői út 19-21

H-1103 Budapest

Gordox

100 000 KIU

Solution for injection

Intravenous use

Bulgaria

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21 |
| H-1103 Budapest |

Gedeon Richter Plc.

Gyömrői út 19-21

H-1103 Budapest

Gordox

500 000 KIU

Solution for infusion

Intravenous use

Bulgaria

| Bayer AG |
| --- |
| D-51368 Leverkusen |

Bayer AG

D-51368 Leverkusen

Trasylol

500 000 KIU/50 ml

Solution for infusion

Intravenous use

Cyprus

| Bayer Hellas Abee |
| --- |
| Σορού 18-20/Sorou 18-20 |
| GR-15125 Μαρούσι-Αθήνα |
| GR-15125 Marousi-Athens |

Bayer Hellas Abee

Σορού 18-20/Sorou 18-20

GR-15125 Μαρούσι-Αθήνα

GR-15125 Marousi-Athens

Trasylol

500 000 KIU/50 ml

Solution for infusion

Intravenous use

Czech Republic

| Spofa a. s. |
| --- |
| Poděbradská 5 |
| CZ-180 47 Praha 9 |

Spofa a. s.

Poděbradská 5

CZ-180 47 Praha 9

Antilysin Spofa

55,55 Ph.Eur.U./10 ml

Solution for injection

Intravenous use

Czech Republic

| Chemical Works of Gedeon Richter Ltd. |
| --- |
| Gyömrői út 19-21 |
| H-1103 Budapest |

Chemical Works of Gedeon Richter Ltd.

Gyömrői út 19-21

H-1103 Budapest

Gordox

60 Ph.Eur.U./10 ml

Solution for injection

Intravenous use

Czech Republic

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Trasylol 500 000 KIU

70 mg

Solution for infusion

Intravenous use

Denmark

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Trasylol

10 000 KIU/ml

Solution for injection

Intravenous use

Estonia

| Gedeon Richter Ltd |
| --- |
| Gyömrői út 19-21 |
| H-1103 Budapest |

Gedeon Richter Ltd

Gyömrői út 19-21

H-1103 Budapest

Gordox

10 000 KIU/50 ml

Concentrate for solution for infusion

Intravenous use

Finland

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Trasylol

10 000 KIU/ml

Solution for injection and solution for infusion

Intravenous use

France

| Bayer Pharma SA |
| --- |
| 13, rue Jean Jaurès |
| F-92807 Puteaux Cedex |

Bayer Pharma SA

13, rue Jean Jaurès

F-92807 Puteaux Cedex

Trasylol

1 000 000 KIU/100 ml

Solution for injection

Intravenous use

France

| Bayer Pharma SA |
| --- |
| 13, rue Jean Jaurès |
| F-92807 Puteaux Cedex |

Bayer Pharma SA

13, rue Jean Jaurès

F-92807 Puteaux Cedex

Trasylol

2 000 000 KIU/200 ml

Solution for injection

Intravenous use

France

| Bayer Pharma SA |
| --- |
| 13, rue Jean Jaurès |
| F-92807 Puteaux Cedex |

Bayer Pharma SA

13, rue Jean Jaurès

F-92807 Puteaux Cedex

Trasylol

500 000 KIU/50 ml

Solution for injection

Intravenous use

Germany

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Trasynin 0,5

70,0 mg/50 ml

Solution for infusion

Intravenous use

Germany

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Trasynin 1,0

140,0 mg/100 ml

Solution for infusion

Intravenous use

Germany

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Trasynin 2,0

280,0 mg/200 ml

Solution for infusion

Intravenous use

Germany

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |

Bayer Vital GmbH

D-51368 Leverkusen

Trasylol 0,5

70,0 mg/50 ml

Solution for infusion

Intravenous use

Germany

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |

Bayer Vital GmbH

D-51368 Leverkusen

Trasylol 1,0

140,0 mg/100 ml

Solution for infusion

Intravenous use

Germany

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |

Bayer Vital GmbH

D-51368 Leverkusen

Trasylol 2,0

280,0 mg/200 ml

Solution for infusion

Intravenous use

Germany

| EMRA-MED Arzneimittel GmbH |
| --- |
| Otto-Han-Str. 11 |
| D-22946 Trittau |

EMRA-MED Arzneimittel GmbH

Otto-Han-Str. 11

D-22946 Trittau

Trasylol 0,5

70,0 mg/50 ml

Solution for infusion

Intravenous use

Greece

| Bayer Hellas Abee |
| --- |
| Σορού 18-20/Sorou 18-20 |
| GR-15125 Μαρούσι-Αθήνα |
| GR-15125 Marousi-Athens |

Bayer Hellas Abee

Σορού 18-20/Sorou 18-20

GR-15125 Μαρούσι-Αθήνα

GR-15125 Marousi-Athens

Trasylol

500 000 KIU/50 ml

Solution for infusion

Intravenous use

Hungary

| Bayer Hungária Kft |
| --- |
| Alkotás u. 50. |
| H-1123 Budapest |

Bayer Hungária Kft

Alkotás u. 50.

H-1123 Budapest

Trasylol

500 000 KIU

Solution for infusion

Intravenous use

Hungary

| Richter Gedeon NyRt. |
| --- |
| Gyömrői út 19-21. |
| H-1103 Budapest |

Richter Gedeon NyRt.

Gyömrői út 19-21.

H-1103 Budapest

Gordox

500 000 KIU

Solution for infusion

Intravenous use

Hungary

| Richter Gedeon NyRt. |
| --- |
| Gyömrői út 19-21. |
| H-1103 Budapest |

Richter Gedeon NyRt.

Gyömrői út 19-21.

H-1103 Budapest

Gordox

100 000 KIU

Solution for injection

Intravenous use

Latvia

| Bayer Healthcare AG |
| --- |
| D-51368 Leverkusen |

Bayer Healthcare AG

D-51368 Leverkusen

Trasylol 0,5

10 000 KIU/ml

Solution for injection

Intravenous use

Latvia

| Bayer Healthcare AG |
| --- |
| D-51368 Leverkusen |

Bayer Healthcare AG

D-51368 Leverkusen

Trasylol 1,0

10 000 KIU/ml

Solution for injection

Intravenous use

Latvia

| Bayer Healthcare AG |
| --- |
| D-51368 Leverkusen |

Bayer Healthcare AG

D-51368 Leverkusen

Trasylol 2,0

10 000 KIU/ml

Solution for injection

Intravenous use

Latvia

| Gedeon Richter Ltd. |
| --- |
| Gyömrői út 19-21 |
| H-1103 Budapest |

Gedeon Richter Ltd.

Gyömrői út 19-21

H-1103 Budapest

Gordox

10 000 KIU/ml

Solution for injection

Intravenous use

Lithuania

| Gedeon Richter Ltd. |
| --- |
| Gyömrői út 19-21 |
| H-1103 Budapest |

Gedeon Richter Ltd.

Gyömrői út 19-21

H-1103 Budapest

Gordox

10 000 KIU/ml

Solution for injection

Intravenous use

Luxembourg

| Bayer S.A |
| --- |
| 143, avenue Louise |
| B-1050 Bruxelles |

Bayer S.A

143, avenue Louise

B-1050 Bruxelles

Trasylol

500 000 KIU/50 ml

Solution for injection

Intravenous use/subcutaneous use

Malta

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

Bayer plc Pharmaceutical Division

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

United Kingdom

Trasylol

500 000 KIU (50 ml vial)

Solution for infusion

Intravenous use

Malta

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

Bayer plc Pharmaceutical Division

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

United Kingdom

Trasylol

1 000 000 KIU (100 ml vial)

Solution for infusion

Intravenous use

Malta

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

Bayer plc Pharmaceutical Division

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

United Kingdom

Trasylol

2 000 000 KIU (200 ml vial)

Solution for infusion

Intravenous use

Malta

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

Bayer plc Pharmaceutical Division

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

United Kingdom

Trasylol

10 000 KIU/ml

Solution for infusion

Intravenous use

Netherlands

| Bayer B.V. |
| --- |
| Postbus 80 |
| 3640 AB Mijdrecht |
| Nederland |

Bayer B.V.

Postbus 80

3640 AB Mijdrecht

Nederland

Trasylol

10 000 KIU/ml

Solution for infusion

Intravenous use

Poland

| Przedsiębiorstwo Farmaceutyczne Jelfa S.A. |
| --- |
| ul. Wincentego Pola 21 |
| PL-58-500 Jelenia Góra |

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.

ul. Wincentego Pola 21

PL-58-500 Jelenia Góra

Traskolan

500 000 KIU/10 ml

Solution for injection

Intravenous use

Poland

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Trasylol

277,8 Ph.Eur.U.

Solution for infusion

Intravenous use

Poland

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Trasylol

555,6 Ph.Eur.U.

Solution for infusion

Intravenous use

Poland

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Trasylol

1 111,1 Ph.Eur.U.

Solution for infusion

Intravenous use

Portugal

| Bayer Portugal, S.A. PRT |
| --- |
| Rua Quinta do Pinheiro, 5 |
| P-2794-003 Carnaxide |

Bayer Portugal, S.A. PRT

Rua Quinta do Pinheiro, 5

P-2794-003 Carnaxide

Trasylol

500 000 KIU/50 ml

Solution for infusion

Intravenous use

Portugal

| Bayer Portugal, S.A. PRT |
| --- |
| Rua Quinta do Pinheiro, 5 |
| P-2794-003 Carnaxide |

Bayer Portugal, S.A. PRT

Rua Quinta do Pinheiro, 5

P-2794-003 Carnaxide

Trasylol

1 000 000 KIU/100 ml

Solution for infusion

Intravenous use

Portugal

| Bayer Portugal, S.A. PRT |
| --- |
| Rua Quinta do Pinheiro, 5 |
| P-2794-003 Carnaxide |

Bayer Portugal, S.A. PRT

Rua Quinta do Pinheiro, 5

P-2794-003 Carnaxide

Trasylol

2 000 000 KIU/200 ml

Solution for infusion

Intravenous use

Romania

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Trasylol

500 000 KIU

Solution for infusion

Intravenous use

Romania

| Gedeon Richter Ltd. |
| --- |
| Győmrői ut 19-21 |
| H-1103 Budapest |

Gedeon Richter Ltd.

Győmrői ut 19-21

H-1103 Budapest

Gordox

100 000 KIU

Solution for injection

Intramuscular use

Slovakia

| SPOFA a. s. |
| --- |
| Husinecká 11a |
| CZ-130 00 Praha 3 |

SPOFA a. s.

Husinecká 11a

CZ-130 00 Praha 3

Antilysin Spofa

100 000 KIU/10 ml

Solution for injection

Intravenous use

Slovakia

| Gedeon Richter Ltd. |
| --- |
| Győmrői ut 19-21 |
| H-1103 Budapest |

Gedeon Richter Ltd.

Győmrői ut 19-21

H-1103 Budapest

Gordox

100 000 KIU/10 ml

Solution for injection

Intravenous use

Slovenia

| Bayer d.o.o. |
| --- |
| Bravničarjeva 13 |
| SLO-1000 Ljubljana |

Bayer d.o.o.

Bravničarjeva 13

SLO-1000 Ljubljana

Trasylol

10 000 KIU/ml

Solution for injection and solution for infusion

Intravenous use

Sweden

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Trasylol

10 000 KIU/ml

Solution for injection and solution for infusion

Intravenous use

United Kingdom

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

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

United Kingdom

Trasylol

10 000 KIU/ml

Solution for injection

Intravenous use

United Kingdom

| Nordic Pharma Limited |
| --- |
| Abbey House |
| 1650 Arlington Business Park |
| Theale, Reading |
| Berkshire RG7 4SA |
| United Kinddom |

Nordic Pharma Limited

Abbey House

1650 Arlington Business Park

Theale, Reading

Berkshire RG7 4SA

United Kinddom

Aprotinine

10 000 KIU/ml

Solution for injection

Intravenous use

---

ANNEX III

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | KRKA Sverige AB |
| Göta Ark 175, Medborgarplatsen 25 |
| S-118 72 Stockholm |

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Denmark

KRKA Sverige AB

Göta Ark 175, Medborgarplatsen 25

S-118 72 Stockholm

Simvastatin Krka

80 mg

Film-coated tablets

Oral use

Finland

| KRKA Sverige AB |
| --- |
| Göta Ark 175, Medborgarplatsen 25 |
| S-118 72 Stockholm |

KRKA Sverige AB

Göta Ark 175, Medborgarplatsen 25

S-118 72 Stockholm

Simvastatin Krka

80 mg

Film-coated tablets

Oral use

Norway

| KRKA Sverige AB |
| --- |
| Göta Ark 175, Medborgarplatsen 25 |
| S-118 72 Stockholm |

KRKA Sverige AB

Göta Ark 175, Medborgarplatsen 25

S-118 72 Stockholm

Simvastatin Krka

80 mg

Film-coated tablets

Oral use

Sweden

| KRKA Sverige AB |
| --- |
| Göta Ark 175, Medborgarplatsen 25 |
| S-118 72 Stockholm |

KRKA Sverige AB

Göta Ark 175, Medborgarplatsen 25

S-118 72 Stockholm

Simvastatin Krka

80 mg

Film-coated tablets

Oral use

---

V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 28.3.2008 | EN | Official Journal of the European Union | C 77/18 |
| --- | --- | --- | --- |

28.3.2008

EN

Official Journal of the European Union

C 77/18

---

Prior notification of a concentration

(Case COMP/M.5084 — PARE/Acea/JV)

Candidate case for simplified procedure

(Text with EEA relevance)

(2008/C 77/04)

| 1. | On 17 March 2008, 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 Pirelli & C. Ambiente Renewable Energy SpA (‘PARE’, Italy) and ACEA SpA (‘Acea’, Italy) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of a newly created company constituting a joint venture (JV). |
| --- | --- |

1.

On 17 March 2008, 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 Pirelli & C. Ambiente Renewable Energy SpA (‘PARE’, Italy) and ACEA SpA (‘Acea’, Italy) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of a newly created company constituting a joint venture (JV).

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






  — | for PARE: active in the sector of renewables and in particular in the treatment of waste for the production of combustibles, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for PARE: active in the sector of renewables and in particular in the treatment of waste for the production of combustibles,

| — | for Acea: active in the generation and distribution of electricity, gas distribution and waste management, |
| --- | --- |

—

for Acea: active in the generation and distribution of electricity, gas distribution and waste management,

| — | for JV: active in the production of CDR-Q (combustible derived from high quality waste). |
| --- | --- |

—

for JV: active in the production of CDR-Q (combustible derived from high quality waste).

| 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 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 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) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5084 — PARE/Acea/JV, to the following address:





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

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) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5084 — PARE/Acea/JV, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

---

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

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

---

| 28.3.2008 | EN | Official Journal of the European Union | C 77/19 |
| --- | --- | --- | --- |

28.3.2008

EN

Official Journal of the European Union

C 77/19

---

Prior notification of a concentration

(Case COMP/M.5092 — GDF/Suez/Teesside Power)

Candidate case for simplified procedure

(Text with EEA relevance)

(2008/C 77/05)

| 1. | On 17 March 2008, 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 Gaz de France (‘GDF’, France), through its subsidiary GDF International, and Suez (‘Suez’, France), through its subsidiary Electrabel, acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertaking Teesside Power Limited (‘TPL’, United Kingdom) by way of purchase of shares. |
| --- | --- |

1.

On 17 March 2008, 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 Gaz de France (‘GDF’, France), through its subsidiary GDF International, and Suez (‘Suez’, France), through its subsidiary Electrabel, acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertaking Teesside Power Limited (‘TPL’, United Kingdom) by way of purchase of shares.

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






  — | for Gaz de France: active in the gas sector at all levels, in electricity generation, electricity retail, and in energy services, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Gaz de France: active in the gas sector at all levels, in electricity generation, electricity retail, and in energy services,

| — | for Suez: active in the gas and electricity sectors, in energy services and in water and environmental services, |
| --- | --- |

—

for Suez: active in the gas and electricity sectors, in energy services and in water and environmental services,

| — | for Teesside Power Limited: source of gas for the generation of electricity and steam at a Combined Cycle Gas Turbine CHP plant located at Wilton, Teesside, England. |
| --- | --- |

—

for Teesside Power Limited: source of gas for the generation of electricity and steam at a Combined Cycle Gas Turbine CHP plant located at Wilton, Teesside, England.

| 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) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5092 — GDF/Suez/Teesside Power, to the following address:





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

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) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5092 — GDF/Suez/Teesside Power, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

---

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

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

---