# Official Journal C 209/26 A

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 209 |
| | |
| English edition | Information and Notices | Volume 4826 August 2005 |

ISSN 1725-2423

Official Journal

of the European Union

C 209

English edition

Information and Notices

Volume 4826 August 2005

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| Notice No | Contents | page |
| --- | --- | --- |
| | I   Information |
| | Commission |
| 2005/C 209/1 | Euro exchange rates | 1 |
| 2005/C 209/2 | Notice of the impending expiry of certain anti-dumping measures | 2 |
| 2005/C 209/3 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2005 to 31 July 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93) | 3 |

Notice No

Contents

page

I   Information

Commission

2005/C 209/1

Euro exchange rates

1

2005/C 209/2

Notice of the impending expiry of certain anti-dumping measures

2

2005/C 209/3

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2005 to 31 July 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)

3

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

EN

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I Information

Commission

| 26.8.2005 | EN | Official Journal of the European Union | C 209/1 |
| --- | --- | --- | --- |

26.8.2005

EN

Official Journal of the European Union

C 209/1

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Euro exchange rates (1)

25 August 2005

(2005/C 209/01)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2272 |
| JPY | Japanese yen | 135,02 |
| DKK | Danish krone | 7,4573 |
| GBP | Pound sterling | 0,68200 |
| SEK | Swedish krona | 9,3313 |
| CHF | Swiss franc | 1,5478 |
| ISK | Iceland króna | 77,89 |
| NOK | Norwegian krone | 7,9255 |
| BGN | Bulgarian lev | 1,9557 |
| CYP | Cyprus pound | 0,5729 |
| CZK | Czech koruna | 29,698 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 245,60 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,6961 |
| MTL | Maltese lira | 0,4293 |
| PLN | Polish zloty | 4,0430 |
| RON | Romanian leu | 3,5144 |
| SIT | Slovenian tolar | 239,50 |
| SKK | Slovak koruna | 38,865 |
| TRY | Turkish lira | 1,6760 |
| AUD | Australian dollar | 1,6173 |
| CAD | Canadian dollar | 1,4621 |
| HKD | Hong Kong dollar | 9,5376 |
| NZD | New Zealand dollar | 1,7575 |
| SGD | Singapore dollar | 2,0521 |
| KRW | South Korean won | 1 256,90 |
| ZAR | South African rand | 7,9609 |
| CNY | Chinese yuan renminbi | 9,9406 |
| HRK | Croatian kuna | 7,3865 |
| IDR | Indonesian rupiah | 12 670,84 |
| MYR | Malaysian ringgit | 4,625 |
| PHP | Philippine peso | 68,785 |
| RUB | Russian rouble | 34,9710 |
| THB | Thai baht | 50,409 |

Currency

Exchange rate

USD

US dollar

1,2272

JPY

Japanese yen

135,02

DKK

Danish krone

7,4573

GBP

Pound sterling

0,68200

SEK

Swedish krona

9,3313

CHF

Swiss franc

1,5478

ISK

Iceland króna

77,89

NOK

Norwegian krone

7,9255

BGN

Bulgarian lev

1,9557

CYP

Cyprus pound

0,5729

CZK

Czech koruna

29,698

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

245,60

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,6961

MTL

Maltese lira

0,4293

PLN

Polish zloty

4,0430

RON

Romanian leu

3,5144

SIT

Slovenian tolar

239,50

SKK

Slovak koruna

38,865

TRY

Turkish lira

1,6760

AUD

Australian dollar

1,6173

CAD

Canadian dollar

1,4621

HKD

Hong Kong dollar

9,5376

NZD

New Zealand dollar

1,7575

SGD

Singapore dollar

2,0521

KRW

South Korean won

1 256,90

ZAR

South African rand

7,9609

CNY

Chinese yuan renminbi

9,9406

HRK

Croatian kuna

7,3865

IDR

Indonesian rupiah

12 670,84

MYR

Malaysian ringgit

4,625

PHP

Philippine peso

68,785

RUB

Russian rouble

34,9710

THB

Thai baht

50,409

---

(1)

Source: reference exchange rate published by the ECB.

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| 26.8.2005 | EN | Official Journal of the European Union | C 209/2 |
| --- | --- | --- | --- |

26.8.2005

EN

Official Journal of the European Union

C 209/2

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Notice of the impending expiry of certain anti-dumping measures

(2005/C 209/02)

| 1. | As provided for in Article 11(2) of Council Regulation (EC) No 384/96 of 22 December 1995 (1) on protection against dumped imports from countries not members of the European Community, the Commission gives notice that, unless a review is initiated in accordance with the following procedure, the anti-dumping measures mentioned below will expire on the date mentioned in the table below. |
| --- | --- |

1.

As provided for in Article 11(2) of Council Regulation (EC) No 384/96 of 22 December 1995 (1) on protection against dumped imports from countries not members of the European Community, the Commission gives notice that, unless a review is initiated in accordance with the following procedure, the anti-dumping measures mentioned below will expire on the date mentioned in the table below.

2.   Procedure

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

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

3.   Time limit

Community producers may submit a written request for a review on the above basis, to reach the European Commission, Directorate-General for Trade (Division B-1), J-79 5/16, B-1049 Brussels (2) at any time from the date of the publication of the present notice but no later than three months before the date mentioned in the table below.

| 4. | This notice is published in accordance with Article 11(2) of Council Regulation (EC) No 384/96 of 22 December 1995. |
| --- | --- |

4.

This notice is published in accordance with Article 11(2) of Council Regulation (EC) No 384/96 of 22 December 1995.

| Product | Country(ies) of origin or exportation | Measures | Reference | Date of expiry |
| --- | --- | --- | --- | --- |
| Urea | Russia | Anti-dumping duty | Council Regulation (EC) No 901/2001 (OJ L 127, 9.5.2001, p. 11) | 10.5.2006 |
| Aluminium foil | People's Republic of China
  Russia | Anti-dumping duty | Council Regulation (EC) No 950/2001 (OJ L 134, 17.5.2001, p. 1) as last amended by Regulation (EC) No 998/2004 (OJ L 183, 20.5.2004, p. 4) | 18.5.2006 |
| Russia | Undertaking | Commission Decision No 2001/381/EC (OJ L 134, 17.5.2001, p. 67) | 18.5.2006 |

Product

Country(ies) of origin or exportation

Measures

Reference

Date of expiry

Urea

Russia

Anti-dumping duty

Council Regulation (EC) No 901/2001 (OJ L 127, 9.5.2001, p. 11)

10.5.2006

Aluminium foil

People's Republic of China

Russia

Anti-dumping duty

Council Regulation (EC) No 950/2001 (OJ L 134, 17.5.2001, p. 1) as last amended by Regulation (EC) No 998/2004 (OJ L 183, 20.5.2004, p. 4)

18.5.2006

Russia

Undertaking

Commission Decision No 2001/381/EC (OJ L 134, 17.5.2001, p. 67)

18.5.2006

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(1)  OJ L 56, 6.3.1996, p. 1. Regulation as last amended by Council Regulation (EC) No 461/2004 (OJ L 77, 13.3.2004, p. 12).

(2)  Telefax : (32-2) 295 65 05.

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| 26.8.2005 | EN | Official Journal of the European Union | C 209/3 |
| --- | --- | --- | --- |

26.8.2005

EN

Official Journal of the European Union

C 209/3

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2005 to 31 July 2005

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93 (1))

(2005/C 209/03)

—   Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93): 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 |
| --- | --- | --- | --- | --- |
| 4.7.2005 | Apidra | Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main | EU/1/04/285/001-028 | 6.7.2005 |
| 4.7.2005 | Forcaltonin | Unigene UK Limited, 63 High Road, Bushey Heath, Herts, WD2 1EE, United Kingdom | EU/1/98/093/002 | 6.7.2005 |
| 4.7.2005 | Trisenox | Cell Therapeutics (UK) Ltd, 100 Pall Mall, London SW1Y 5HP, United Kingdom | EU/1/02/204/001 | 6.7.2005 |
| 4.7.2005 | Levemir | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd | EU/1/04/278/001-009 | 6.7.2005 |
| 4.7.2005 | Zerene | Wyeth Research (UK) Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/099/001-006 | 6.7.2005 |
| 4.7.2005 | Sonata | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/102/001-008 | 6.7.2005 |
| 4.7.2005 | Cymbalta | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/04/296/001-006 | 6.7.2005 |
| 4.7.2005 | Cymbalta | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/04/296/001-006 | 6.7.2005 |
| 4.7.2005 | Xeristar | Boehringer Ingelheim International GmbH, Binger Strasse 173 — D-55216 Ingelheim am Rhein | EU/1/04/297/001-006 | 6.7.2005 |
| 4.7.2005 | Xeristar | Boehringer Ingelheim International GmbH, Binger Strasse 173 — D-55216 Ingelheim am Rhein | EU/1/04/297/001-006 | 6.7.2005 |
| 4.7.2005 | Visudyne | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/00/140/001 | 6.7.2005 |
| 4.7.2005 | Xigris | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/02/225/001-002 | 6.7.2005 |
| 7.7.2005 | Invanz | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/02/216/001-002 | 11.7.2005 |
| 7.7.2005 | Arixtra | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/02/206/001-008 | 11.7.2005 |
| 7.7.2005 | Quixidar | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/02/207/001-008 | 11.7.2005 |
| 7.7.2005 | Cystagon | Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense | EU/1/97/039/001-004 | 11.7.2005 |
| 8.7.2005 | Glivec | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/198/001-013 | 12.7.2005 |
| 8.7.2005 | Aranesp | Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland | EU/1/01/185/001-056 | 12.7.2005 |
| 8.7.2005 | Nespo | Dompé Biotec SpA, Via San Martino, 12, I-20122 Milano | EU/1/01/184/001-056 | 12.7.2005 |
| 8.7.2005 | Lyrica | PFIZER Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/04/279/030-032 | 12.7.2005 |
| 8.7.2005 | Fortovase | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/98/075/001-002 | 12.7.2005 |
| 8.7.2005 | AVANDIA | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/137/001-012 | 12.7.2005 |
| 8.7.2005 | NovoRapid | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd | EU/1/99/119/003
  EU/1/99/119/005-007
  EU/1/99/119/009-014 | 12.7.2005 |
| 8.7.2005 | NeuroBloc | Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland | EU/1/00/166/001-003 | 13.7.2005 |
| 8.7.2005 | Simulect | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/084/001-002 | 12.7.2005 |
| 8.7.2005 | Zevalin | Schering AG, Müllerstrasse 170-178, D-13342 Berlin | EU/1/03/264/001 | 12.7.2005 |
| 8.7.2005 | Viread | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | EU/1/01/200/001 | 12.7.2005 |
| 8.7.2005 | Keppra | UCB SA, Allée de la recherche, 60, B-1070 Bruxelles/Researchdreef, 60, B-1070 Brussel | EU/1/00/146/001-027 | 12.7.2005 |
| 8.7.2005 | Lantus | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main | EU/1/00/134/001-029 | 12.7.2005 |
| 8.7.2005 | Optisulin | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main | EU/1/00/133/001-008 | 12.7.2005 |
| 13.7.2005 | NeoRecormon | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/97/031/001-003
  EU/1/97/031/019-046 | 15.7.2005 |
| 22.7.2005 | Enbrel | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-011 | 26.7.2005 |
| 22.7.2005 | KOGENATE Bayer | Bayer AG, D-51368 Leverkusen | EU/1/00/143/001-006 | 26.7.2005 |
| 27.7.2005 | Vaniqa | Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/01/173/001-003 | 29.7.2005 |
| 27.7.2005 | Infergen | Yamanouchi Europe B.V., Elisabethhof 19, 2353 EW Leiderdorp, Nederland | EU/1/98/087/001-003 | 29.7.2005 |
| 27.7.2005 | Zevalin | Schering AG, Müllerstrasse 170-178, D-13342 Berlin | EU/1/03/264/001 | 29.7.2005 |
| 27.7.2005 | Replagal | TKT Europe AB, Rinkebyvägen 11B, S-182 36 Danderyd | EU/1/01/189/001-006 | 29.7.2005 |
| 27.7.2005 | Velcade | Janssen-Cilag International NV, Turnhoutseweg, 30 B-2340 Beerse | EU/1/04/274/001 | 29.7.2005 |
| 27.7.2005 | AVANDIA | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/137/001-012 | 29.7.2005 |
| 27.7.2005 | ReFacto | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/103/001-004 | 29.7.2005 |
| 28.7.2005 | Kineret | Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland | EU/1/02/203/001-004 | 1.8.2005 |

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

4.7.2005

Apidra

Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main

EU/1/04/285/001-028

6.7.2005

4.7.2005

Forcaltonin

Unigene UK Limited, 63 High Road, Bushey Heath, Herts, WD2 1EE, United Kingdom

EU/1/98/093/002

6.7.2005

4.7.2005

Trisenox

Cell Therapeutics (UK) Ltd, 100 Pall Mall, London SW1Y 5HP, United Kingdom

EU/1/02/204/001

6.7.2005

4.7.2005

Levemir

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd

EU/1/04/278/001-009

6.7.2005

4.7.2005

Zerene

Wyeth Research (UK) Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/099/001-006

6.7.2005

4.7.2005

Sonata

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

EU/1/99/102/001-008

6.7.2005

4.7.2005

Cymbalta

Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/296/001-006

6.7.2005

4.7.2005

Cymbalta

Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/296/001-006

6.7.2005

4.7.2005

Xeristar

Boehringer Ingelheim International GmbH, Binger Strasse 173 — D-55216 Ingelheim am Rhein

EU/1/04/297/001-006

6.7.2005

4.7.2005

Xeristar

Boehringer Ingelheim International GmbH, Binger Strasse 173 — D-55216 Ingelheim am Rhein

EU/1/04/297/001-006

6.7.2005

4.7.2005

Visudyne

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/00/140/001

6.7.2005

4.7.2005

Xigris

Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/02/225/001-002

6.7.2005

7.7.2005

Invanz

Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/02/216/001-002

11.7.2005

7.7.2005

Arixtra

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

EU/1/02/206/001-008

11.7.2005

7.7.2005

Quixidar

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

EU/1/02/207/001-008

11.7.2005

7.7.2005

Cystagon

Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense

EU/1/97/039/001-004

11.7.2005

8.7.2005

Glivec

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/198/001-013

12.7.2005

8.7.2005

Aranesp

Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland

EU/1/01/185/001-056

12.7.2005

8.7.2005

Nespo

Dompé Biotec SpA, Via San Martino, 12, I-20122 Milano

EU/1/01/184/001-056

12.7.2005

8.7.2005

Lyrica

PFIZER Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/04/279/030-032

12.7.2005

8.7.2005

Fortovase

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/98/075/001-002

12.7.2005

8.7.2005

AVANDIA

SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom

EU/1/00/137/001-012

12.7.2005

8.7.2005

NovoRapid

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd

EU/1/99/119/003

EU/1/99/119/005-007

EU/1/99/119/009-014

12.7.2005

8.7.2005

NeuroBloc

Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland

EU/1/00/166/001-003

13.7.2005

8.7.2005

Simulect

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/084/001-002

12.7.2005

8.7.2005

Zevalin

Schering AG, Müllerstrasse 170-178, D-13342 Berlin

EU/1/03/264/001

12.7.2005

8.7.2005

Viread

Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom

EU/1/01/200/001

12.7.2005

8.7.2005

Keppra

UCB SA, Allée de la recherche, 60, B-1070 Bruxelles/Researchdreef, 60, B-1070 Brussel

EU/1/00/146/001-027

12.7.2005

8.7.2005

Lantus

Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main

EU/1/00/134/001-029

12.7.2005

8.7.2005

Optisulin

Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main

EU/1/00/133/001-008

12.7.2005

13.7.2005

NeoRecormon

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/97/031/001-003

EU/1/97/031/019-046

15.7.2005

22.7.2005

Enbrel

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

EU/1/99/126/001-011

26.7.2005

22.7.2005

KOGENATE Bayer

Bayer AG, D-51368 Leverkusen

EU/1/00/143/001-006

26.7.2005

27.7.2005

Vaniqa

Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/01/173/001-003

29.7.2005

27.7.2005

Infergen

Yamanouchi Europe B.V., Elisabethhof 19, 2353 EW Leiderdorp, Nederland

EU/1/98/087/001-003

29.7.2005

27.7.2005

Zevalin

Schering AG, Müllerstrasse 170-178, D-13342 Berlin

EU/1/03/264/001

29.7.2005

27.7.2005

Replagal

TKT Europe AB, Rinkebyvägen 11B, S-182 36 Danderyd

EU/1/01/189/001-006

29.7.2005

27.7.2005

Velcade

Janssen-Cilag International NV, Turnhoutseweg, 30 B-2340 Beerse

EU/1/04/274/001

29.7.2005

27.7.2005

AVANDIA

SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom

EU/1/00/137/001-012

29.7.2005

27.7.2005

ReFacto

Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/103/001-004

29.7.2005

28.7.2005

Kineret

Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/203/001-004

1.8.2005

—   Issuing of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93): 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 |
| --- | --- | --- | --- | --- |
| 8.7.2005 | Equilis Prequenza | Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/05/056/001-002 | 12.7.2005 |
| 8.7.2005 | Equilis Prequenza Te | Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/05/057/001-002 | 12.7.2005 |
| 8.7.2005 | Equilis Te | Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/05/055/001-002 | 12.7.2005 |
| 27.7.2005 | Profender | Bayer Healthcare AG, D-51368 Leverkusen | EU/2/05/054/001-017 | 29.7.2005 |

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

8.7.2005

Equilis Prequenza

Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/056/001-002

12.7.2005

8.7.2005

Equilis Prequenza Te

Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/057/001-002

12.7.2005

8.7.2005

Equilis Te

Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/055/001-002

12.7.2005

27.7.2005

Profender

Bayer Healthcare AG, D-51368 Leverkusen

EU/2/05/054/001-017

29.7.2005

—   Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.7.2005 | Neocolipor | Merial, 29 avenue Tony Garnier, F-69007 Lyon | EU/2/98/008/001-004 | 11.7.2005 |
| 8.7.2005 | Ibaflin | Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/00/022/001a-001b, 002a-002b, 003a-003b, 004a-004b,
  EU/2/00/022/005-017, | 12.7.2005 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

7.7.2005

Neocolipor

Merial, 29 avenue Tony Garnier, F-69007 Lyon

EU/2/98/008/001-004

11.7.2005

8.7.2005

Ibaflin

Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/00/022/001a-001b, 002a-002b, 003a-003b, 004a-004b,

EU/2/00/022/005-017,

12.7.2005

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

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(1)  OJ L 214 of 24.8.1993, p. 1.

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