# Official Journal C 215/27 A

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 215 |
| | |
| English edition | Information and Notices | Volume 4727 August 2004 |

ISSN 1725-2423

Official Journal

of the European Union

C 215

English edition

Information and Notices

Volume 4727 August 2004

---

| Notice No | Contents | page |
| --- | --- | --- |
| | I   Information |
| | Commission |
| 2004/C 215/1 | Euro exchange rates | 1 |
| 2004/C 215/2 | Notice of the impending expiry of certain anti-dumping measures | 2 |
| 2004/C 215/3 | Exchange of letters between the Commission of the European Communities and the Office international des épizooties | 3 |
| 2004/C 215/4 | Exchange of letters between the Commission of the European Communities and the Office international des épizooties | 5 |
| 2004/C 215/5 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2004 to 15 August 2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93) | 7 |
| 2004/C 215/6 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2004 to 15 August 2004 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 11 |
| 2004/C 215/7 | Prior notification of a concentration (Case No COMP/M.3459 — EPSON/SANYO/JV) (
  1
  ) | 19 |
| 2004/C 215/8 | Prior notification of a concentration (Case No COMP/M.3410 — TOTAL/GDF) (
  1
  ) | 20 |

Notice No

Contents

page

I   Information

Commission

2004/C 215/1

Euro exchange rates

1

2004/C 215/2

Notice of the impending expiry of certain anti-dumping measures

2

2004/C 215/3

Exchange of letters between the Commission of the European Communities and the Office international des épizooties

3

2004/C 215/4

Exchange of letters between the Commission of the European Communities and the Office international des épizooties

5

2004/C 215/5

Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2004 to 15 August 2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)

7

2004/C 215/6

Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2004 to 15 August 2004 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

11

2004/C 215/7

Prior notification of a concentration (Case No COMP/M.3459 — EPSON/SANYO/JV) (
  1
  )

1

19

2004/C 215/8

Prior notification of a concentration (Case No COMP/M.3410 — TOTAL/GDF) (
  1
  )

1

20

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

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(1)   Text with EEA relevance

1

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

EN

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I Information

Commission

| 27.8.2004 | EN | Official Journal of the European Union | C 215/1 |
| --- | --- | --- | --- |

27.8.2004

EN

Official Journal of the European Union

C 215/1

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Euro exchange rates (1)

26 August 2004

(2004/C 215/01)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,21 |
| JPY | Japanese yen | 133,04 |
| DKK | Danish krone | 7,4364 |
| GBP | Pound sterling | 0,6732 |
| SEK | Swedish krona | 9,1405 |
| CHF | Swiss franc | 1,5398 |
| ISK | Iceland króna | 87,13 |
| NOK | Norwegian krone | 8,336 |
| BGN | Bulgarian lev | 1,9559 |
| CYP | Cyprus pound | 0,5775 |
| CZK | Czech koruna | 31,747 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 249,23 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,657 |
| MTL | Maltese lira | 0,4264 |
| PLN | Polish zloty | 4,4555 |
| ROL | Romanian leu | 41 012 |
| SIT | Slovenian tolar | 239,98 |
| SKK | Slovak koruna | 40,15 |
| TRL | Turkish lira | 1 823 200 |
| AUD | Australian dollar | 1,7141 |
| CAD | Canadian dollar | 1,5828 |
| HKD | Hong Kong dollar | 9,438 |
| NZD | New Zealand dollar | 1,8533 |
| SGD | Singapore dollar | 2,0739 |
| KRW | South Korean won | 1 395,92 |
| ZAR | South African rand | 8,0159 |

Currency

Exchange rate

USD

US dollar

1,21

JPY

Japanese yen

133,04

DKK

Danish krone

7,4364

GBP

Pound sterling

0,6732

SEK

Swedish krona

9,1405

CHF

Swiss franc

1,5398

ISK

Iceland króna

87,13

NOK

Norwegian krone

8,336

BGN

Bulgarian lev

1,9559

CYP

Cyprus pound

0,5775

CZK

Czech koruna

31,747

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

249,23

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,657

MTL

Maltese lira

0,4264

PLN

Polish zloty

4,4555

ROL

Romanian leu

41 012

SIT

Slovenian tolar

239,98

SKK

Slovak koruna

40,15

TRL

Turkish lira

1 823 200

AUD

Australian dollar

1,7141

CAD

Canadian dollar

1,5828

HKD

Hong Kong dollar

9,438

NZD

New Zealand dollar

1,8533

SGD

Singapore dollar

2,0739

KRW

South Korean won

1 395,92

ZAR

South African rand

8,0159

---

(1)

Source: reference exchange rate published by the ECB.

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| 27.8.2004 | EN | Official Journal of the European Union | C 215/2 |
| --- | --- | --- | --- |

27.8.2004

EN

Official Journal of the European Union

C 215/2

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Notice of the impending expiry of certain anti-dumping measures

(2004/C 215/02)

| 1. | 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, as provided 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. |
| --- | --- |

1.

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, as provided 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.

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.









  Product | Country(ies) of origin or exportation | Measures | Reference | Date of expiry |
| --- | --- | --- | --- | --- | --- |
| Seamless pipes and tubes of iron or non-alloy steel | Croatia
  Ukraine | Duty | Regulation (EC) No 348/2000 (OJ L 45, 17.2.2000, p. 1) as last amended by Regulation (EC) No 1515/2002 (OJ L 228, 24.8.2002, p. 8) | 18.2.2005 |
| Croatia | Undertaking | Decision No 2000/137/EC (OJ L 46, 18.2.2000, p. 34) as last amended by Decision No 2002/669/EC (OJ L 228, 24.8.2002, p. 20) |
| Dead-burned (sintered) magnesia | People's Republic of China | Duty | Regulation (EC) No 360/2000 (OJ L 46, 18.2.2000, p. 1) as last amended by Regulation (EC) No 986/2003 (OJ L 143, 11.6.2003, p. 5) | 19.2.2005 |

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

Seamless pipes and tubes of iron or non-alloy steel

Croatia

Ukraine

Duty

Regulation (EC) No 348/2000 (OJ L 45, 17.2.2000, p. 1) as last amended by Regulation (EC) No 1515/2002 (OJ L 228, 24.8.2002, p. 8)

18.2.2005

Croatia

Undertaking

Decision No 2000/137/EC (OJ L 46, 18.2.2000, p. 34) as last amended by Decision No 2002/669/EC (OJ L 228, 24.8.2002, p. 20)

Dead-burned (sintered) magnesia

People's Republic of China

Duty

Regulation (EC) No 360/2000 (OJ L 46, 18.2.2000, p. 1) as last amended by Regulation (EC) No 986/2003 (OJ L 143, 11.6.2003, p. 5)

19.2.2005

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

(2)  Telex COMEU B 21877; Telefax: (32-2) 295 65 05.

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| 27.8.2004 | EN | Official Journal of the European Union | C 215/3 |
| --- | --- | --- | --- |

27.8.2004

EN

Official Journal of the European Union

C 215/3

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EXCHANGE OF LETTERS

between the Commission of the European Communities

and

the Office international des épizooties

(2004/C 215/03)

Sir,

I have the honour to refer to the discussions between the representatives of the Office international des épizooties and of the Commission of the European Communities on the establishment of official relations between the two organisations.

Following these conversations, it seems to me that relations between the Office international des épizooties and the Commission of the European Communities should be based on the following:

| 1. | The Commission of the European Communities, hereinafter called the EC, and the Office international des épizooties, hereinafter called the OIE, agree that, with a view to facilitating the accomplishment of their respective tasks as defined by the relevant provisions of the Treaty establishing the European Community, in particular the Article 302, and by the International Agreement for the creation of an Office international des épizooties, signed in Paris on 25 January 1924, they will act in collaboration and keep one another informed concerning matters of common interest. |
| --- | --- |

1.

The Commission of the European Communities, hereinafter called the EC, and the Office international des épizooties, hereinafter called the OIE, agree that, with a view to facilitating the accomplishment of their respective tasks as defined by the relevant provisions of the Treaty establishing the European Community, in particular the Article 302, and by the International Agreement for the creation of an Office international des épizooties, signed in Paris on 25 January 1924, they will act in collaboration and keep one another informed concerning matters of common interest.

| 2. | Representatives of the EC will be invited to attend the annual sessions of the International Committee and the meetings of the Regional Commissions of the OIE and to take part, without the right to vote, in the open discussions of these bodies on subjects on the agenda in which the EC is interested. |
| --- | --- |

2.

Representatives of the EC will be invited to attend the annual sessions of the International Committee and the meetings of the Regional Commissions of the OIE and to take part, without the right to vote, in the open discussions of these bodies on subjects on the agenda in which the EC is interested.

| 3. | Each party will invite the other to participate in the work of relevant working groups, with respect to items on their agenda in which the EC and the OIE have a common interest, in conformity with their rules applicable to such participation. |
| --- | --- |

3.

Each party will invite the other to participate in the work of relevant working groups, with respect to items on their agenda in which the EC and the OIE have a common interest, in conformity with their rules applicable to such participation.

| 4. | Appropriate arrangements will be adopted to provide for the participation of the EC and the OIE in other meetings of a non-confidential nature held under the auspices of one of the organisations at which matters of common interest will be discussed, particularly in the context of those ensuing from the OIE's recognition by the World Trade Organisation as the world reference organisation for animal diseases and zoonoses. |
| --- | --- |

4.

Appropriate arrangements will be adopted to provide for the participation of the EC and the OIE in other meetings of a non-confidential nature held under the auspices of one of the organisations at which matters of common interest will be discussed, particularly in the context of those ensuing from the OIE's recognition by the World Trade Organisation as the world reference organisation for animal diseases and zoonoses.

| 5. | The two organisations agree to inform one another of all projects and work programmes of common interest. |
| --- | --- |

5.

The two organisations agree to inform one another of all projects and work programmes of common interest.

| 6. | Subject to any arrangements, which might be necessary to safeguard the confidential nature of certain documents, the EC and the OIE will exchange technical documents. |
| --- | --- |

6.

Subject to any arrangements, which might be necessary to safeguard the confidential nature of certain documents, the EC and the OIE will exchange technical documents.

| 7. | The EC and the OIE can agree on any joint measures, in particular aimed at developing international cooperation in order to protect animal health, ensure the sanitary safety of foodstuffs of animal origin, combat zoonoses and in relation to animal welfare, as well as the preparation and implementation by developing countries of international standards and guidelines related to above mentioned fields. These measures will be the subject of special agreements. |
| --- | --- |

7.

The EC and the OIE can agree on any joint measures, in particular aimed at developing international cooperation in order to protect animal health, ensure the sanitary safety of foodstuffs of animal origin, combat zoonoses and in relation to animal welfare, as well as the preparation and implementation by developing countries of international standards and guidelines related to above mentioned fields. These measures will be the subject of special agreements.

If these principles are acceptable to your organisation, I propose that this letter and your reply, drafted in similar terms, be considered as determining the basis for relations between the Office international des épizooties and the Commission of the European Communities.

Paris, 23 February 2004.

Image

David BYRNE

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| 27.8.2004 | EN | Official Journal of the European Union | C 215/5 |
| --- | --- | --- | --- |

27.8.2004

EN

Official Journal of the European Union

C 215/5

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EXCHANGE OF LETTERS

between the Commission of the European Communities

and

the Office international des épizooties

(2004/C 215/04)

Sir,

I have the honour to refer to your attached letter ref D/001782 of 17 September 2003 on the establishment of official relations between our two organisations.

I agree with your proposal to reinforce relations between the Office international des épizooties and the Commission of the European Communities based on the following:

| 1. | The Commission of the European Communities, hereinafter called the EC, and the Office international des épizooties, hereinafter called the OIE, agree that, with a view to facilitating the accomplishment of their respective tasks as defined by the relevant provisions of the Treaty establishing the European Community, in particular the Article 302, and by the International Agreement for the creation of an Office international des épizooties, signed in Paris on 25 January 1924, they will act in collaboration and keep one another informed concerning matters of common interest. |
| --- | --- |

1.

The Commission of the European Communities, hereinafter called the EC, and the Office international des épizooties, hereinafter called the OIE, agree that, with a view to facilitating the accomplishment of their respective tasks as defined by the relevant provisions of the Treaty establishing the European Community, in particular the Article 302, and by the International Agreement for the creation of an Office international des épizooties, signed in Paris on 25 January 1924, they will act in collaboration and keep one another informed concerning matters of common interest.

| 2. | Representatives of the EC will be invited to attend the annual sessions of the International Committee and the meetings of the Regional Commissions of the OIE and to take part, without the right to vote, in the open discussions of these bodies on subjects on the agenda in which the EC is interested. |
| --- | --- |

2.

Representatives of the EC will be invited to attend the annual sessions of the International Committee and the meetings of the Regional Commissions of the OIE and to take part, without the right to vote, in the open discussions of these bodies on subjects on the agenda in which the EC is interested.

| 3. | Each party will invite the other to participate in the work of relevant working groups, with respect to items on their agenda in which the EC and the OIE have a common interest, in conformity with their rules applicable to such participation. |
| --- | --- |

3.

Each party will invite the other to participate in the work of relevant working groups, with respect to items on their agenda in which the EC and the OIE have a common interest, in conformity with their rules applicable to such participation.

| 4. | Appropriate arrangements will be adopted to provide for the participation of the EC and the OIE in other meetings of a non-confidential nature held under the auspices of one of the organisations at which matters of common interest will be discussed, particularly in the context of those ensuing from the OIE's recognition by the World Trade Organisation as the world reference organisation for animal diseases and zoonoses. |
| --- | --- |

4.

Appropriate arrangements will be adopted to provide for the participation of the EC and the OIE in other meetings of a non-confidential nature held under the auspices of one of the organisations at which matters of common interest will be discussed, particularly in the context of those ensuing from the OIE's recognition by the World Trade Organisation as the world reference organisation for animal diseases and zoonoses.

| 5. | The two organisations agree to inform one another of all projects and work programmes of common interest. |
| --- | --- |

5.

The two organisations agree to inform one another of all projects and work programmes of common interest.

| 6. | Subject to any arrangements, which might be necessary to safeguard the confidential nature of certain documents, the EC and the OIE will exchange technical documents. |
| --- | --- |

6.

Subject to any arrangements, which might be necessary to safeguard the confidential nature of certain documents, the EC and the OIE will exchange technical documents.

| 7. | The EC and the OIE can agree on any joint measures, in particular aimed at developing international cooperation in order to protect animal health, ensure the sanitary safety of foodstuffs of animal origin, combat zoonoses and in relation to animal welfare, as well as the preparation and implementation by developing countries of international standards and guidelines related to above mentioned fields. These measures will be the subject of special agreements. |
| --- | --- |

7.

The EC and the OIE can agree on any joint measures, in particular aimed at developing international cooperation in order to protect animal health, ensure the sanitary safety of foodstuffs of animal origin, combat zoonoses and in relation to animal welfare, as well as the preparation and implementation by developing countries of international standards and guidelines related to above mentioned fields. These measures will be the subject of special agreements.

I agree that your attached letter and my reply, which use similar terms, be considered as determining the basis for relations between the OIE and the Commission of the European Communities.

Paris, 23 February 2004.

Image

Bernard VALLAT

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| 27.8.2004 | EN | Official Journal of the European Union | C 215/7 |
| --- | --- | --- | --- |

27.8.2004

EN

Official Journal of the European Union

C 215/7

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2004 to 15 August 2004

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

(2004/C 215/05)

| — | Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93
   (1)
  ) 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 |
| --- | --- | --- | --- | --- | --- |
| 29.7.2004 | Pedea | Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense, France | EU/1/04/284/001 | 2.8.2004 |
| 11.8.2004 | Yentreve | Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/04/280/001-006. | 13.8.2004 |
| 11.8.2004 | Ariclaim | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/04/283/001-006 | 13.8.2004 |

—

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

29.7.2004

Pedea

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

EU/1/04/284/001

2.8.2004

11.8.2004

Yentreve

Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/280/001-006.

13.8.2004

11.8.2004

Ariclaim

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

EU/1/04/283/001-006

13.8.2004

| — | Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93
   (1)
  ) 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 |
| --- | --- | --- | --- | --- | --- |
| 19.7.2004 | Reyataz | Bristol - Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom | EU/1/03/267/001-007 | 21.07.2004 |
| 19.7.2004 | Humira | Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom | EU/1/03/256/001-006 | 21.07.2004 |
| 19.7.2004 | Trudexa | Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom | EU/1/03/257/001-006 | 21.07.2004 |
| 19.7.2004 | Nyracta | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/139/001-012 | 21.07.2004 |
| 19.7.2004 | Avandia | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/137/001-012 | 21.07.2004 |
| 19.7.2004 | Venvia | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/138/001-012 | 21.07.2004 |
| 20.7.2004 | Rebif | Serono Europe Ltd., 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/98/063/001-006 | 23.07.2004 |
| 20.7.2004 | Replagal | TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige | EU/1/01/189/001-003 | 23.07.2004 |
| 20.7.2004 | Refacto | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/103/001-004 | 23.07.2004 |
| 22.7.2004 | Mirapexin | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland
  Pfizer Enterprises SARL, 6, Circuit de la Foire Internationale, 1347 Luxembourg, Grand-Duché du Luxembourg | EU/1/97/051/001-006 EU/1/97/051/009-012 | 26.07.2004 |
| 23.7.2004 | Enbrel | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-003 | 27.07.2004 |
| 23.7.2004 | Enbrel | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-003 | 27.07.2004 |
| 29.7.2004 | ReFacto | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/103/001-004 | 2.8.2004 |
| 29.7.2004 | Replagal | TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige | EU/1/01/189/004-006 | 2.8.2004 |
| 2.8.2004 | Procomvax | Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France | EU/1/99/104/001 | 4.8.2004 |
| 2.8.2004 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France | EU/1/98/086/001-020 | 4.8.2004 |
| 2.8.2004 | Aprovel | Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France | EU/1/97/046/001-030 | 4.8.2004 |
| 2.8.2004 | Karvezide | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom | EU/1/98/085/001-020 | 4.8.2004 |
| 2.8.2004 | Karvea | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom | EU/1/97/049/001-030 | 4.8.2004 |
| 2.8.2004 | MabThera | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/98/067/001-002 | 4.8.2004 |
| 2.8.2004 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France | EU/1/98/069/001a-001b, EU/1/98/069/002a-002b, EU/1/98/069/003a-003b, EU/1/98/069/004a-004b | 4.8.2004 |
| 2.8.2004 | Iscover | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom | EU/1/98/070/001a-001b, EU/1/98/070/002a-002b, EU/1/98/070/003a-003b, EU/1/98/070/004a-004b | 4.8.2004 |
| 2.8.2004 | Prevenar | Wyeth-Lederle Vaccines S.A., Rue du Bosquet, 15 - 1348 Louvain-La-Neuve - Belgique | EU/1/00/167/001-007 | 4.8.2004 |
| 2.8.2004 | Actrapid | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/230/001-017 | 4.8.2004 |
| 2.8.2004 | Mixtard | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/231/001-037 | 4.8.2004 |
| 2.8.2004 | Insulatard | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/233/001-017 | 4.8.2004 |
| 2.8.2004 | Velosulin | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/232/001-003 | 4.8.2004 |
| 2.8.2004 | Protaphane | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/234/001-017 | 4.8.2004 |
| 2.8.2004 | Puregon | Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland | EU/1/96/008/038-039 | 4.8.2004 |
| 2.8.2004 | Puregon, | Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland | EU/1/96/008/040-041 | 4.8.2004 |
| 2.8.2004 | Viread | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | EU/1/01/200/001 | 4.8.2004 |
| 2.8.2004 | Emtriva | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | EU/1/03/261/001-003 | 4.8.2004 |
| 2.8.2004 | Actraphane | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/229/001-037 | 4.8.2004 |
| 2.8.2004 | Norvir | Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United-Kingdom | EU/1/96/016/001 and EU/1/96/016/003 | 4.8.2004 |
| 2.8.2004 | Starlix | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/174/001-021 | 4.8.2004 |
| 2.8.2004 | Cellcept | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/96/005/001-006 | 4.8.2004 |
| 2.8.2004 | Protopy | Fujisawa GmbH, Neumarkter Str. 61, D-81673 München, Deutschland | EU/1/02/202/001-007 | 4.8.2004 |
| 2.8.2004 | Inomax | INO Therapeutics AB, SE-181 81 Lidingö, Sverige | EU/1/01/194/001-002 | 4.8.2004 |
| 2.8.2004 | Trazec | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/175/001-021 | 4.8.2004 |
| 4.8.2004 | Insuman | Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, Deutschland | EU/1/97/030/030, EU/1/97/030/035, EU/1/97/030/040, EU/1/97/030/045, EU/1/97/030/050, EU/1/97/030/055-064 | 6.8.2004 |
| 4.8.2004 | Somavert | Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/240/001-004 | 6.8.2004 |
| 9.8.2004 | Fabrazyme | Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland | EU/1/01/188/001-006 | 12.8.2004 |
| 11.8.2004 | Vfend | Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/212/001-026 | 13.8.2004 |
| 12.8.2004 | Infergen | Yamanouchi Europe B.V., Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | EU/1/98/087/001-003 | 16.8.2004 |
| 12.8.2004 | Optison | Amersham Health AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, 0401 Oslo, Norway | EU/1/98/065/001-002 | 16.8.2004 |

—

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

19.7.2004

Reyataz

Bristol - Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom

EU/1/03/267/001-007

21.07.2004

19.7.2004

Humira

Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom

EU/1/03/256/001-006

21.07.2004

19.7.2004

Trudexa

Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom

EU/1/03/257/001-006

21.07.2004

19.7.2004

Nyracta

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

EU/1/00/139/001-012

21.07.2004

19.7.2004

Avandia

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

EU/1/00/137/001-012

21.07.2004

19.7.2004

Venvia

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

EU/1/00/138/001-012

21.07.2004

20.7.2004

Rebif

Serono Europe Ltd., 56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/98/063/001-006

23.07.2004

20.7.2004

Replagal

TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige

EU/1/01/189/001-003

23.07.2004

20.7.2004

Refacto

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

EU/1/99/103/001-004

23.07.2004

22.7.2004

Mirapexin

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

Pfizer Enterprises SARL, 6, Circuit de la Foire Internationale, 1347 Luxembourg, Grand-Duché du Luxembourg

EU/1/97/051/001-006 EU/1/97/051/009-012

26.07.2004

23.7.2004

Enbrel

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

EU/1/99/126/001-003

27.07.2004

23.7.2004

Enbrel

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

EU/1/99/126/001-003

27.07.2004

29.7.2004

ReFacto

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

EU/1/99/103/001-004

2.8.2004

29.7.2004

Replagal

TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige

EU/1/01/189/004-006

2.8.2004

2.8.2004

Procomvax

Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France

EU/1/99/104/001

4.8.2004

2.8.2004

CoAprovel

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

EU/1/98/086/001-020

4.8.2004

2.8.2004

Aprovel

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

EU/1/97/046/001-030

4.8.2004

2.8.2004

Karvezide

Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom

EU/1/98/085/001-020

4.8.2004

2.8.2004

Karvea

Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom

EU/1/97/049/001-030

4.8.2004

2.8.2004

MabThera

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

EU/1/98/067/001-002

4.8.2004

2.8.2004

Plavix

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

EU/1/98/069/001a-001b, EU/1/98/069/002a-002b, EU/1/98/069/003a-003b, EU/1/98/069/004a-004b

4.8.2004

2.8.2004

Iscover

Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom

EU/1/98/070/001a-001b, EU/1/98/070/002a-002b, EU/1/98/070/003a-003b, EU/1/98/070/004a-004b

4.8.2004

2.8.2004

Prevenar

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

EU/1/00/167/001-007

4.8.2004

2.8.2004

Actrapid

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

EU/1/02/230/001-017

4.8.2004

2.8.2004

Mixtard

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

EU/1/02/231/001-037

4.8.2004

2.8.2004

Insulatard

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

EU/1/02/233/001-017

4.8.2004

2.8.2004

Velosulin

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

EU/1/02/232/001-003

4.8.2004

2.8.2004

Protaphane

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

EU/1/02/234/001-017

4.8.2004

2.8.2004

Puregon

Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland

EU/1/96/008/038-039

4.8.2004

2.8.2004

Puregon,

Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland

EU/1/96/008/040-041

4.8.2004

2.8.2004

Viread

Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom

EU/1/01/200/001

4.8.2004

2.8.2004

Emtriva

Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom

EU/1/03/261/001-003

4.8.2004

2.8.2004

Actraphane

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

EU/1/02/229/001-037

4.8.2004

2.8.2004

Norvir

Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United-Kingdom

EU/1/96/016/001 and EU/1/96/016/003

4.8.2004

2.8.2004

Starlix

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

EU/1/01/174/001-021

4.8.2004

2.8.2004

Cellcept

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

EU/1/96/005/001-006

4.8.2004

2.8.2004

Protopy

Fujisawa GmbH, Neumarkter Str. 61, D-81673 München, Deutschland

EU/1/02/202/001-007

4.8.2004

2.8.2004

Inomax

INO Therapeutics AB, SE-181 81 Lidingö, Sverige

EU/1/01/194/001-002

4.8.2004

2.8.2004

Trazec

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

EU/1/01/175/001-021

4.8.2004

4.8.2004

Insuman

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

EU/1/97/030/030, EU/1/97/030/035, EU/1/97/030/040, EU/1/97/030/045, EU/1/97/030/050, EU/1/97/030/055-064

6.8.2004

4.8.2004

Somavert

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

EU/1/02/240/001-004

6.8.2004

9.8.2004

Fabrazyme

Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland

EU/1/01/188/001-006

12.8.2004

11.8.2004

Vfend

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

EU/1/02/212/001-026

13.8.2004

12.8.2004

Infergen

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

EU/1/98/087/001-003

16.8.2004

12.8.2004

Optison

Amersham Health AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, 0401 Oslo, Norway

EU/1/98/065/001-002

16.8.2004

| — | Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93
   (1)
  ) 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 |
| --- | --- | --- | --- | --- | --- |
| 23.07.2004 | Eurifel RCP FeL V | Merial, 29 avenue Tony Garnier, 69007 Lyon, France | EU/2/02/031/001-002 | 27.07.2004 |
| 29-07-2004 | Virbagen Omega | VIRBAC S.A., 1ere Avenue 2065 m L.I.D. - 06516 Carros - France | EU/2/01/030/001-002 | 02-08-2004 |
| 11-08-2004 | Porcilis Porcoli | Intervet International B.V. (NL), Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/96/001/009-010 | 13-08-2004 |

—

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

23.07.2004

Eurifel RCP FeL V

Merial, 29 avenue Tony Garnier, 69007 Lyon, France

EU/2/02/031/001-002

27.07.2004

29-07-2004

Virbagen Omega

VIRBAC S.A., 1ere Avenue 2065 m L.I.D. - 06516 Carros - France

EU/2/01/030/001-002

02-08-2004

11-08-2004

Porcilis Porcoli

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

EU/2/96/001/009-010

13-08-2004

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 Agency for the Evaluation of Medicinal products |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK - LONDON E14 4HB |

The European Agency for the Evaluation of Medicinal products

7, Westferry Circus, Canary Wharf

UK - LONDON E14 4HB

---

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

---

| 27.8.2004 | EN | Official Journal of the European Union | C 215/11 |
| --- | --- | --- | --- |

27.8.2004

EN

Official Journal of the European Union

C 215/11

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2004 to 15 August 2004

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

(2004/C 215/06)

| — | 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 |
| --- | --- | --- | --- | --- | --- |
| 29.7.2004 | Lopid (art 30) | See Annex I | See Annex I | 30.7.2004 |
| 11.8.2004 | Eprinomectin (Art 34) | See Annex II | See Annex II | 12.8.2004 |

—

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

29.7.2004

Lopid (art 30)

See Annex I

See Annex I

30.7.2004

11.8.2004

Eprinomectin (Art 34)

See Annex II

See Annex II

12.8.2004

---

(1)  OJ L 311, 28.11.01, p. 67.

(2)  OJ L 311, 28.11.01, p. 1.

---

ANNEX I

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

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria Ges.m.b.H |
| Seidengasse 33–35 |
| A – 1070 Wien |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Pfizer Corporation Austria Ges.m.b.H

Seidengasse 33–35

A – 1070 Wien

Gevillon

450 mg

Film coated tablets

Oral use

Austria

| Pfizer Corporation Austria Ges.m.b.H |
| --- |
| Seidengasse 33–35 |
| A – 1070 Wien |

Pfizer Corporation Austria Ges.m.b.H

Seidengasse 33–35

A – 1070 Wien

Gevillon

900 mg

Film coated tablets

Oral use

Belgium

| Pfizer S.A. |
| --- |
| Rue Léon Theodor 102 |
| B–1090 Bruxelles |

Pfizer S.A.

Rue Léon Theodor 102

B–1090 Bruxelles

Lopid

300 mg

Capsules

Oral use

Belgium

| Pfizer S.A. |
| --- |
| Rue Léon Theodor 102 |
| B–1090 Bruxelles |

Pfizer S.A.

Rue Léon Theodor 102

B–1090 Bruxelles

Lopid

600 mg

Film-coated tablets

Oral use

Belgium

| Pfizer S.A. |
| --- |
| Rue Léon Theodor 102 |
| B–1090 Bruxelles |

Pfizer S.A.

Rue Léon Theodor 102

B–1090 Bruxelles

Lopid

900 mg

Film-coated tablets

Oral use

Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK–2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK–2750 Ballerup

Lopid

300 mg

Capsules

Oral use

Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK–2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK–2750 Ballerup

Lopid

450 mg

Film-coated tablets

Oral use

Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK–2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK–2750 Ballerup

Lopid

600 mg

Film-coated tablets

Oral use

Finland

| Pfizer Oy |
| --- |
| P.O. Box 45 |
| FIN–02601 Espoo |

Pfizer Oy

P.O. Box 45

FIN–02601 Espoo

Lopid

300 mg

Capsules

Oral use

Finland

| Pfizer Oy |
| --- |
| P.O. Box 45 |
| FIN–02601 Espoo |

Pfizer Oy

P.O. Box 45

FIN–02601 Espoo

Lopid

600 mg

Film-coated tablets

Oral use

France

| Pfizer |
| --- |
| 23-25 Avenue Du Dr. Lannelongue |
| F–75014 Paris |

Pfizer

23-25 Avenue Du Dr. Lannelongue

F–75014 Paris

Lipur

450 mg

Film-coated tablets

Oral use

Germany

| Parke-Davis GmbH |
| --- |
| Pfizerstrasse 1 |
| D–76139 Karlsruhe |

Parke-Davis GmbH

Pfizerstrasse 1

D–76139 Karlsruhe

Gevilon

450 mg

Film-coated tablets

Oral use

Germany

| Parke-Davis GmbH |
| --- |
| Pfizerstrasse 1 |
| D–76139 Karlsruhe |

Parke-Davis GmbH

Pfizerstrasse 1

D–76139 Karlsruhe

Gevilon

600 mg

Film-coated tablets

Oral use

Germany

| Parke-Davis GmbH |
| --- |
| Pfizerstrasse 1 |
| D–76139 Karlsruhe |

Parke-Davis GmbH

Pfizerstrasse 1

D–76139 Karlsruhe

Gevilon uno

900 mg

Film-coated tablets

Oral use

Germany

| Parke-Davis GmbH |
| --- |
| Pfizerstrasse 1 |
| D–76139 Karlsruhe |

Parke-Davis GmbH

Pfizerstrasse 1

D–76139 Karlsruhe

Continulipid

450 mg

Film-coated tablets

Oral use

Germany

| Parke-Davis GmbH |
| --- |
| Pfizerstrasse 1 |
| D–76139 Karlsruhe |

Parke-Davis GmbH

Pfizerstrasse 1

D–76139 Karlsruhe

Continulipid

600 mg

Film-coated tablets

Oral use

Greece

| Pfizer Hellas A.E. |
| --- |
| Alketou Street 5 |
| Athens |

Pfizer Hellas A.E.

Alketou Street 5

Athens

Lopid

600 mg

Film-coated tablets

Oral use

Greece

| Pfizer Hellas A.E. |
| --- |
| Alketou Street 5 |
| Athens |

Pfizer Hellas A.E.

Alketou Street 5

Athens

Lopid

900 mg

Film-coated tablets

Oral use

Iceland

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK–2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK–2750 Ballerup

Lopid

300 mg

Capsules

Oral use

Iceland

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK–2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK–2750 Ballerup

Lopid

450 mg

Film-coated tablets

Oral use

Iceland

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK–2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK–2750 Ballerup

Lopid

600 mg

Film-coated tablets

Oral use

Ireland

| Warner Lambert UK Ltd trading as: |
| --- |
| Parke Davis |
| Lambert Court |
| Chestnut Avenue |
| Eastleigh |
| Hampshire SO53 3ZQ |
| United Kingdom |

Warner Lambert UK Ltd trading as:

Parke Davis

Lambert Court

Chestnut Avenue

Eastleigh

Hampshire SO53 3ZQ

United Kingdom

Lopid

300 mg

Capsules

Oral use

Ireland

| Warner Lambert UK Ltd trading as: |
| --- |
| Parke Davis |
| Lambert Court |
| Chestnut Avenue |
| Eastleigh |
| Hampshire SO53 3ZQ |
| United Kingdom |

Warner Lambert UK Ltd trading as:

Parke Davis

Lambert Court

Chestnut Avenue

Eastleigh

Hampshire SO53 3ZQ

United Kingdom

Lopid

600 mg

Film coated tablets

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| I–00188 Roma |

Pfizer Italia S.r.l.

Via Valbondione 113

I–00188 Roma

Lopid

600 mg

Tablets

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| I–00188 Roma |

Pfizer Italia S.r.l.

Via Valbondione 113

I–00188 Roma

Lopid

900 mg

Tablets

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| I–00188 Roma |

Pfizer Italia S.r.l.

Via Valbondione 113

I–00188 Roma

Lopid TC

900 mg

Granules

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| I–00188 Roma |

Pfizer Italia S.r.l.

Via Valbondione 113

I–00188 Roma

Lopid TC

1200 mg

Granules

Oral use

Luxembourg

| Pfizer S.A. |
| --- |
| Rue Léon Theodor 102 |
| B–1090 Bruxelles |

Pfizer S.A.

Rue Léon Theodor 102

B–1090 Bruxelles

Lopid

300 mg

Capsules

Oral use

Luxembourg

| Pfizer S.A. |
| --- |
| Rue Léon Theodor 102 |
| B–1090 Bruxelles |

Pfizer S.A.

Rue Léon Theodor 102

B–1090 Bruxelles

Lopid

600 mg

Film-coated tablets

Oral use

Luxembourg

| Pfizer S.A. |
| --- |
| Rue Léon Theodor 102 |
| B–1090 Bruxelles |

Pfizer S.A.

Rue Léon Theodor 102

B–1090 Bruxelles

Lopid

900 mg

Film-coated tablets

Oral use

Netherlands

| Pfizer BV |
| --- |
| Postbus 37 |
| NL–2900 AA Capelle a/d Ijssel |

Pfizer BV

Postbus 37

NL–2900 AA Capelle a/d Ijssel

Lopid

600 mg

Coated tablets

Oral use

Netherlands

| Pfizer BV |
| --- |
| Postbus 37 |
| NL–2900 AA Capelle a/d Ijssel |

Pfizer BV

Postbus 37

NL–2900 AA Capelle a/d Ijssel

Lopid

900 mg

Coated tablets

Oral use

Portugal

| Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10 |
| --- |
| 2740-244 Porto Salvo |

Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10

2740-244 Porto Salvo

Lopid

300 mg

Capsules

Oral use

Portugal

| Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10 |
| --- |
| 2740-244 Porto Salvo |

Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10

2740-244 Porto Salvo

Lopid

600 mg

Coated tablets

Oral use

Portugal

| Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10 |
| --- |
| 2740-244 Porto Salvo |

Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10

2740-244 Porto Salvo

Lopid

900 mg

Coated tablets

Oral use

Spain

| Parke-Davis, S.L. (Pfizer Group) |
| --- |
| Av. de Europa 20-B |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |

Parke-Davis, S.L. (Pfizer Group)

Av. de Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Lopid

600 mg

Tablets

Oral use

Spain

| Parke-Davis, S.L. (Pfizer Group) |
| --- |
| Av. de Europa 20-B |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |

Parke-Davis, S.L. (Pfizer Group)

Av. de Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Lopid

900 mg

Tablets

Oral use

Sweden

| Pfizer AB |
| --- |
| Nytorpsvägen 36 |
| Box 501 |
| S–183 25 Täby |

Pfizer AB

Nytorpsvägen 36

Box 501

S–183 25 Täby

Lopid

300 mg

Capsules

Oral use

Sweden

| Pfizer AB |
| --- |
| Nytorpsvägen 36 |
| Box 501 |
| S–183 25 Täby |

Pfizer AB

Nytorpsvägen 36

Box 501

S–183 25 Täby

Lopid

450 mg

Film coated tablets

Oral use

Sweden

| Pfizer AB |
| --- |
| Nytorpsvägen 36 |
| Box 501 |
| S–183 25 Täby |

Pfizer AB

Nytorpsvägen 36

Box 501

S–183 25 Täby

Lopid

600 mg

Film coated tablets

Oral use

United Kingdom

| Warner Lambert UK Ltd trading as: |
| --- |
| Parke Davis |
| Lambert Court |
| Chestnut Avenue |
| Eastleigh,Hampshire SO53 3ZQ |
| United Kingdom |

Warner Lambert UK Ltd trading as:

Parke Davis

Lambert Court

Chestnut Avenue

Eastleigh,Hampshire SO53 3ZQ

United Kingdom

Lopid

300 mg

Capsules

Oral use

United Kingdom

| Warner Lambert UK Ltd trading as: |
| --- |
| Parke Davis |
| Lambert Court |
| Chestnut Avenue |
| Eastleigh,Hampshire SO53 3ZQ |
| United Kingdom |

Warner Lambert UK Ltd trading as:

Parke Davis

Lambert Court

Chestnut Avenue

Eastleigh,Hampshire SO53 3ZQ

United Kingdom

Lopid

600 mg

Film coated tablets

Oral use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTE OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY

| Member State | Marketing Authorisation Holder | Product trade name | Strength | Pharmaceutical form | Route of administration | Animal species |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Mérial SAS |
| 29 avenue Tony Garnier |
| F-69007 Lyon |
| France |

Member State

Marketing Authorisation Holder

Product trade name

Strength

Pharmaceutical form

Route of administration

Animal species

Austria

Mérial SAS

29 avenue Tony Garnier

F-69007 Lyon

France

Eprinex – Lösung zum Auftragen auf die Haut für Rinder

5 mg/ml

Solution

Topical

Cattle

Belgium

| Merial Belgium NV/SA |
| --- |
| Bld Sylvain Dupuislaan 243 |
| B-1070 Bruxelles |
| Belgium |

Merial Belgium NV/SA

Bld Sylvain Dupuislaan 243

B-1070 Bruxelles

Belgium

EPRINEX POUR-ON

5 mg/ml

Solution for external use

Topical

Cattle including lactating cows

Denmark

| Merial Ltd. |
| --- |
| P.O. Box 327 |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| UK-Essex CM19 5TG |
| United Kingdom |

Merial Ltd.

P.O. Box 327

Sandringham House

Harlow Business Park

Harlow

UK-Essex CM19 5TG

United Kingdom

Eprinex Vet

5 mg/ml

Pour-on solution

Topical

Cattle

Finland

| Merial SAS |
| --- |
| 29 avenue Tony Garnier |
| F-69007 Lyon |
| France |

Merial SAS

29 avenue Tony Garnier

F-69007 Lyon

France

Eprinex pour-on vet

5 mg/ml

Pour-on solution

Topical

Cattle

France

| Mérial |
| --- |
| 29 av Tony Garnier |
| F-69007 Lyon |
| France |

Mérial

29 av Tony Garnier

F-69007 Lyon

France

EPRINEX pour on pour bovins

5 mg/ml

Cutaneous solution

Topical

Cattle

Germany

| Merial GmbH |
| --- |
| Am Söldnermoos 6 |
| D-85399 Hallbergmoos |
| Germany |

Merial GmbH

Am Söldnermoos 6

D-85399 Hallbergmoos

Germany

Eprinex Pour-on

0.5 g/100 ml

Solution

Topical

Cattle

Ireland

| Merial Ltd Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| UK-Essex CM19 5TG |
| United Kingdom |

Merial Ltd Limited

Sandringham House

Harlow Business Park

Harlow

UK-Essex CM19 5TG

United Kingdom

Eprinex Pour-On for beef and dairy cattle

0.5 % w/v

Pour-on solution

Topical

Beef and dairy cattle including lactating dairy cattle

Italy

| MERIAL ITALIA spa |
| --- |
| Milanofiori – Strada 6 |
| Palazzo E/5 |
| I-20090 Assago (MI) |
| Italy |

MERIAL ITALIA spa

Milanofiori – Strada 6

Palazzo E/5

I-20090 Assago (MI)

Italy

EPRINEX pour-on

5 mg/ml

Solution for external use

Topical

Beef and dairy cattle (including lactating cows)

Luxembourg

| Merial Belgium NV/SA |
| --- |
| Bvd Sylvain Dupuislaan 243 |
| B-1070 Bruxelles |
| Belgium |

Merial Belgium NV/SA

Bvd Sylvain Dupuislaan 243

B-1070 Bruxelles

Belgium

Eprinex Pour-on

5 mg/ml

Solution for external use

Topical

Cattle including lactating cows

The Netherlands

| Merial BV |
| --- |
| Bovenkerkerweg 6-8 |
| 1185 XE AMSTELVEEN |
| The Netherlands |

Merial BV

Bovenkerkerweg 6-8

1185 XE AMSTELVEEN

The Netherlands

Ivomec-Eprinex Pour On voor vlees- en melkvee

REGNL 9033

5 mg/ml

Solution

Topical

Cattle

Portugal

| Merial Portuguesa |
| --- |
| Saúde Animal Lda |
| Avenida Maria Lamas Lote 19 B1 A, piso 2 |
| Serra das Minas |
| P-2635-432 Rio de Mouro |
| Portugal |

Merial Portuguesa

Saúde Animal Lda

Avenida Maria Lamas Lote 19 B1 A, piso 2

Serra das Minas

P-2635-432 Rio de Mouro

Portugal

Eprinex Pour-On

5 mg/ml

Pour-on

Topical

Beef and dairy cattle

Spain

| Merial Laboratorios S.A. |
| --- |
| Tarragona 161 |
| E-08014 Barcelona |
| Spain |

Merial Laboratorios S.A.

Tarragona 161

E-08014 Barcelona

Spain

EPRINEX POUR ON

5 mg/ml

Solution

Topical

Cattle and dairy cows

Sweden

| Merial SAS |
| --- |
| 29 avenue Tony Garnier |
| F-69007 Lyon |
| France |

Merial SAS

29 avenue Tony Garnier

F-69007 Lyon

France

Eprinex Pour-on

5 mg/ml

Pour-on solution

Topical

Lactating and non-lactating cattle

United Kingdom

| Merial Ltd |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| UK-Essex CM19 5TG |
| United Kingdom |

Merial Ltd

Sandringham House

Harlow Business Park

Harlow

UK-Essex CM19 5TG

United Kingdom

Eprinex Pour-On for Beef and Dairy Cattle

0.5% w/v

Pour-on solution

Topical

Beef and dairy cattle including lactating dairy cattle

Norway

| Merial SAS |
| --- |
| 29 avenue Tony Garnier |
| F-69007 Lyon |
| France |

Merial SAS

29 avenue Tony Garnier

F-69007 Lyon

France

Eprinex pour-on vet

5 mg/ml

Cutaneous solution

Topical

Cattle (including lactating dairy cows)

---

| 27.8.2004 | EN | Official Journal of the European Union | C 215/19 |
| --- | --- | --- | --- |

27.8.2004

EN

Official Journal of the European Union

C 215/19

---

Prior notification of a concentration

(Case No COMP/M.3459 — EPSON/SANYO/JV)

(2004/C 215/07)

(Text with EEA relevance)

| 1. | On 18 August 2004, 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 Seiko Epson Corporation (‘Seiko Epson’; Japan) and Sanyo Electric Co., Ltd. (‘Sanyo Electric’, Japan) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertaking Sanyo Epson Imaging Devices Corporation (‘Sanyo Epson’; Japan) by way of purchase of shares in a newly created company constituting a joint venture. |
| --- | --- |

1.

On 18 August 2004, 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 Seiko Epson Corporation (‘Seiko Epson’; Japan) and Sanyo Electric Co., Ltd. (‘Sanyo Electric’, Japan) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertaking Sanyo Epson Imaging Devices Corporation (‘Sanyo Epson’; Japan) by way of purchase of shares in a newly created company constituting a joint venture.

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






  — | for Seiko Epson: manufacture of information-related equipment, electronic devices and precision products, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Seiko Epson: manufacture of information-related equipment, electronic devices and precision products,

| — | for Sanyo Electric: manufacture of multimedia and information systems, home appliances, commercial equipment, electric devices and batteries, |
| --- | --- |

—

for Sanyo Electric: manufacture of multimedia and information systems, home appliances, commercial equipment, electric devices and batteries,

| — | for Sanyo Epson: manufacture of LCD panels for incorporation into consumer products. |
| --- | --- |

—

for Sanyo Epson: manufacture of LCD panels for incorporation into consumer products.

| 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. |
| --- | --- |

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.

| 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 (fax No +32/2/2964301 or 2967244) or by post, under reference number COMP/M.3459 — EPSON/SANYO/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 (fax No +32/2/2964301 or 2967244) or by post, under reference number COMP/M.3459 — EPSON/SANYO/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.

---

| 27.8.2004 | EN | Official Journal of the European Union | C 215/20 |
| --- | --- | --- | --- |

27.8.2004

EN

Official Journal of the European Union

C 215/20

---

Prior notification of a concentration

(Case No COMP/M.3410 — TOTAL/GDF)

(2004/C 215/08)

(Text with EEA relevance)

| 1. | On 20 August 2004, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Total S.A. (‘Total’, France) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of parts of the undertaking Gaz de France (‘GDF’, France) by way of purchase of shares and purchase of assets. |
| --- | --- |

1.

On 20 August 2004, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Total S.A. (‘Total’, France) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of parts of the undertaking Gaz de France (‘GDF’, France) by way of purchase of shares and purchase of assets.

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






  — | for Total: exploration, production, transport, storage and sale of oil and natural gas, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Total: exploration, production, transport, storage and sale of oil and natural gas,

| — | for the parts of GDF bought by Total: transport and storage facilities of natural gas in the South-West of France and transfer of a set of eligible customers in the South-West and the Centre of France. |
| --- | --- |

—

for the parts of GDF bought by Total: transport and storage facilities of natural gas in the South-West of France and transfer of a set of eligible customers in the South-West and the Centre of France.

| 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. |
| --- | --- |

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.

| 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 (fax No +32/2/2964301 or 2967244) or by post, under reference number COMP/M.3410 — Total/GDF, 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 (fax No +32/2/2964301 or 2967244) or by post, under reference number COMP/M.3410 — Total/GDF, 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.

---