# Official Journal C 186/29 J

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 186 |
| | |
| English edition | Information and Notices | Volume 4829 July 2005 |

ISSN 1725-2423

Official Journal

of the European Union

C 186

English edition

Information and Notices

Volume 4829 July 2005

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| Notice No | Contents | page |
| --- | --- | --- |
| | I   Information |
| | Commission |
| 2005/C 186/1 | Euro exchange rates | 1 |
| 2005/C 186/2 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 June 2005 to 30 June 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93) | 2 |

Notice No

Contents

page

I   Information

Commission

2005/C 186/1

Euro exchange rates

1

2005/C 186/2

Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 June 2005 to 30 June 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)

2

| | Corrigenda |
| --- | --- |
| 2005/C 186/3 | Corrigendum to the summary of Community decisions on marketing authorisations in respect of medicinal products from 10 May 2005 to 15 June 2005(Decision taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
  (OJ C 153, 24.6.2005) | 4 |

Corrigenda

2005/C 186/3

Corrigendum to the summary of Community decisions on marketing authorisations in respect of medicinal products from 10 May 2005 to 15 June 2005(Decision taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
  (OJ C 153, 24.6.2005)

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

(OJ C 153, 24.6.2005)

4

| EN | |
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EN

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I Information

Commission

| 29.7.2005 | EN | Official Journal of the European Union | C 186/1 |
| --- | --- | --- | --- |

29.7.2005

EN

Official Journal of the European Union

C 186/1

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Euro exchange rates (1)

28 July 2005

(2005/C 186/01)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2100 |
| JPY | Japanese yen | 136,00 |
| DKK | Danish krone | 7,4610 |
| GBP | Pound sterling | 0,69070 |
| SEK | Swedish krona | 9,4000 |
| CHF | Swiss franc | 1,5625 |
| ISK | Iceland króna | 77,82 |
| NOK | Norwegian krone | 7,8985 |
| BGN | Bulgarian lev | 1,9560 |
| CYP | Cyprus pound | 0,5738 |
| CZK | Czech koruna | 30,186 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 245,08 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,6961 |
| MTL | Maltese lira | 0,4293 |
| PLN | Polish zloty | 4,0893 |
| RON | Romanian leu | 3,5191 |
| SIT | Slovenian tolar | 239,51 |
| SKK | Slovak koruna | 39,100 |
| TRY | Turkish lira | 1,6172 |
| AUD | Australian dollar | 1,5976 |
| CAD | Canadian dollar | 1,4940 |
| HKD | Hong Kong dollar | 9,4091 |
| NZD | New Zealand dollar | 1,7762 |
| SGD | Singapore dollar | 2,0151 |
| KRW | South Korean won | 1 243,88 |
| ZAR | South African rand | 8,0224 |
| CNY | Chinese yuan renminbi | 9,8107 |
| HRK | Croatian kuna | 7,3028 |
| IDR | Indonesian rupiah | 11 893,09 |
| MYR | Malaysian ringgit | 4,539 |
| PHP | Philippine peso | 67,899 |
| RUB | Russian rouble | 34,6830 |
| THB | Thai baht | 50,600 |

Currency

Exchange rate

USD

US dollar

1,2100

JPY

Japanese yen

136,00

DKK

Danish krone

7,4610

GBP

Pound sterling

0,69070

SEK

Swedish krona

9,4000

CHF

Swiss franc

1,5625

ISK

Iceland króna

77,82

NOK

Norwegian krone

7,8985

BGN

Bulgarian lev

1,9560

CYP

Cyprus pound

0,5738

CZK

Czech koruna

30,186

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

245,08

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,6961

MTL

Maltese lira

0,4293

PLN

Polish zloty

4,0893

RON

Romanian leu

3,5191

SIT

Slovenian tolar

239,51

SKK

Slovak koruna

39,100

TRY

Turkish lira

1,6172

AUD

Australian dollar

1,5976

CAD

Canadian dollar

1,4940

HKD

Hong Kong dollar

9,4091

NZD

New Zealand dollar

1,7762

SGD

Singapore dollar

2,0151

KRW

South Korean won

1 243,88

ZAR

South African rand

8,0224

CNY

Chinese yuan renminbi

9,8107

HRK

Croatian kuna

7,3028

IDR

Indonesian rupiah

11 893,09

MYR

Malaysian ringgit

4,539

PHP

Philippine peso

67,899

RUB

Russian rouble

34,6830

THB

Thai baht

50,600

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(1)

Source: reference exchange rate published by the ECB.

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| 29.7.2005 | EN | Official Journal of the European Union | C 186/2 |
| --- | --- | --- | --- |

29.7.2005

EN

Official Journal of the European Union

C 186/2

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 June 2005 to 30 June 2005

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

(2005/C 186/02)

—   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 |
| --- | --- | --- | --- | --- |
| 16.6.2005 | Tracleer | Actelion Registration Ltd, BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220/001-005 | 20.6.2005 |
| 20.6.2005 | Abilify | Otsuka Pharmaceutical Europe Ltd, Commonwealth House, 2 Chalkhill Road, Hammersmith, London W6 8DW, United Kingdom | EU/1/04/276/021-032 | 22.6.2005 |
| 24.6.2005 | Vistide | Pfizer Enterprises SARL, 51, Avenue Kennedy — Rond Point du Kirchberg, L-1855 Luxembourg, Grand-Duché de Luxembourg. | EU/1/97/037/001 | 28.6.2005 |
| 28.6.2005 | Taxotere | Aventis Pharma S.A., 20 avenue Raymond Aron, 92165 Antony Cedex, France | EU/1/95/002/001-002 | 30.6.2005 |
| 28.6.2005 | Invirase | Roche Registration Ltd., 40, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom | EU/1/96/026/001-002 | 30.6.2005 |
| 28.6.2005 | Osigraft | Howmedica International S. de R.L., Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland | EU/1/01/179/001 | 4.7.2005 |
| 28.6.2005 | Herceptin | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/00/145/001 | 30.6.2005 |
| 28.6.2005 | Remicade | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-003 | 30.6.2005 |
| 28.6.2005 | Remicade | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-003 | 30.6.2005 |

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

16.6.2005

Tracleer

Actelion Registration Ltd, BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/220/001-005

20.6.2005

20.6.2005

Abilify

Otsuka Pharmaceutical Europe Ltd, Commonwealth House, 2 Chalkhill Road, Hammersmith, London W6 8DW, United Kingdom

EU/1/04/276/021-032

22.6.2005

24.6.2005

Vistide

Pfizer Enterprises SARL, 51, Avenue Kennedy — Rond Point du Kirchberg, L-1855 Luxembourg, Grand-Duché de Luxembourg.

EU/1/97/037/001

28.6.2005

28.6.2005

Taxotere

Aventis Pharma S.A., 20 avenue Raymond Aron, 92165 Antony Cedex, France

EU/1/95/002/001-002

30.6.2005

28.6.2005

Invirase

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

EU/1/96/026/001-002

30.6.2005

28.6.2005

Osigraft

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

EU/1/01/179/001

4.7.2005

28.6.2005

Herceptin

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

EU/1/00/145/001

30.6.2005

28.6.2005

Remicade

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

EU/1/99/116/001-003

30.6.2005

28.6.2005

Remicade

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

EU/1/99/116/001-003

30.6.2005

—   Withdrawal of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93)

| 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 |
| --- | --- | --- | --- | --- |
| 24.6.2005 | Valdyn | Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/244/001-024 | 28.6.2005 |
| 24.6.2005 | Rayzon | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/210/001-008 | 29.6.2005 |

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

24.6.2005

Valdyn

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

EU/1/02/244/001-024

28.6.2005

24.6.2005

Rayzon

Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/02/210/001-008

29.6.2005

—   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 |
| --- | --- | --- | --- | --- |
| 16.6.2005 | Aivlosin | ECO Animal Health Ltd, 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom | EU/2/04/044/001 | 20.6.2005 |
| 21.6.2005 | Dexdomitor | Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi | EU/2/02/033/001 | 23.6.2005 |
| 24.6.2005 | Dexdomitor | Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi | EU/2/02/033/001 | 28.6.2005 |
| 24.6.2005 | DRAXXIN | PFIZER Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/2/03/041/001-005 | 28.6.2005 |
| 24.6.2005 | Metacam | Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim am Rhein, Deutschland | EU/2/97/004/001-011 | 28.6.2005 |
| 24.6.2005 | Porcilis Pesti | Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/99/016/001-006 | 28.6.2005 |

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

16.6.2005

Aivlosin

ECO Animal Health Ltd, 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom

EU/2/04/044/001

20.6.2005

21.6.2005

Dexdomitor

Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi

EU/2/02/033/001

23.6.2005

24.6.2005

Dexdomitor

Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi

EU/2/02/033/001

28.6.2005

24.6.2005

DRAXXIN

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

EU/2/03/041/001-005

28.6.2005

24.6.2005

Metacam

Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim am Rhein, Deutschland

EU/2/97/004/001-011

28.6.2005

24.6.2005

Porcilis Pesti

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

EU/2/99/016/001-006

28.6.2005

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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Corrigenda

| 29.7.2005 | EN | Official Journal of the European Union | C 186/4 |
| --- | --- | --- | --- |

29.7.2005

EN

Official Journal of the European Union

C 186/4

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Corrigendum to the summary of Community decisions on marketing authorisations in respect of medicinal products from 10 May 2005 to 15 June 2005

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

(
  Official Journal of the European Union C 153 of 24 June 2005
  )

(2005/C 186/03)

On page 6, in the table, second column:

for:

‘Regividon’,

read:

read:

‘Rigevidon’.

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