# Official Journal C 152/2006

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 152 |
| | |
| English edition | Information and Notices | Volume 4930 June 2006 |

ISSN 1725-2423

Official Journal

of the European Union

C 152

English edition

Information and Notices

Volume 4930 June 2006

---

| Notice No | Contents | page |
| --- | --- | --- |
| | I   Information |
| | Commission |
| 2006/C 152/1 | Euro exchange rates | 1 |
| 2006/C 152/2 | Withdrawal of notification of a concentration (Case COMP/M.4269 — Goldman Sachs/Borealis/GICSI/Associated British Ports Holdings) (
  1
  ) | 2 |
| 2006/C 152/3 | Prior notification of a concentration (Case COMP/M.4257 — Smithfield/Sara Lee Foods Europe) (
  1
  ) | 3 |
| 2006/C 152/4 | Prior notification of a concentration (Case COMP/M.4270 — Platinum Equity/Textron Fastening Systems) — Candidate case for simplified procedure (
  1
  ) | 4 |
| 2006/C 152/5 | Opinion of the Advisory Committee on restrictive practices and dominant positions at its meeting on given at its 406th meeting on 27 March 2006 concerning a draft decision relating to case COMP/B1-38.348 — Repsol CPP (
  1
  ) | 5 |
| 2006/C 152/6 | Final report of the Hearing Officer in case COMP/B1-38.348 — Repsol (pursuant to Articles 15 and 16 of Commission Decision (2001/462/EC, ECSC) of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)
   (
  1
  ) | 6 |
| 2006/C 152/7 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.5.2006 to 31.5.2006(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 8 |
| 2006/C 152/8 | Summary of Community decisions on marketing authorisations in respect of medicinal products from 1.5.2006 to 31.5.2006(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 14 |
| 2006/C 152/9 | Non-opposition to a notified concentration (Case COMP/M.4231 — Arcelor/Mitsui/Amsa JV) (
  1
  ) | 20 |

Notice No

Contents

page

I   Information

Commission

2006/C 152/1

Euro exchange rates

1

2006/C 152/2

Withdrawal of notification of a concentration (Case COMP/M.4269 — Goldman Sachs/Borealis/GICSI/Associated British Ports Holdings) (
  1
  )

1

2

2006/C 152/3

Prior notification of a concentration (Case COMP/M.4257 — Smithfield/Sara Lee Foods Europe) (
  1
  )

1

3

2006/C 152/4

Prior notification of a concentration (Case COMP/M.4270 — Platinum Equity/Textron Fastening Systems) — Candidate case for simplified procedure (
  1
  )

1

4

2006/C 152/5

Opinion of the Advisory Committee on restrictive practices and dominant positions at its meeting on given at its 406th meeting on 27 March 2006 concerning a draft decision relating to case COMP/B1-38.348 — Repsol CPP (
  1
  )

1

5

2006/C 152/6

Final report of the Hearing Officer in case COMP/B1-38.348 — Repsol (pursuant to Articles 15 and 16 of Commission Decision (2001/462/EC, ECSC) of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)
   (
  1
  )

(pursuant to Articles 15 and 16 of Commission Decision (2001/462/EC, ECSC) of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)

1

6

2006/C 152/7

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.5.2006 to 31.5.2006(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

8

2006/C 152/8

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1.5.2006 to 31.5.2006(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

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

14

2006/C 152/9

Non-opposition to a notified concentration (Case COMP/M.4231 — Arcelor/Mitsui/Amsa JV) (
  1
  )

1

20

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

---

(1)   Text with EEA relevance

1

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

EN

---

I Information

Commission

| 30.6.2006 | EN | Official Journal of the European Union | C 152/1 |
| --- | --- | --- | --- |

30.6.2006

EN

Official Journal of the European Union

C 152/1

---

Euro exchange rates (1)

29 June 2006

(2006/C 152/01)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2529 |
| JPY | Japanese yen | 146,00 |
| DKK | Danish krone | 7,4583 |
| GBP | Pound sterling | 0,69110 |
| SEK | Swedish krona | 9,2373 |
| CHF | Swiss franc | 1,5644 |
| ISK | Iceland króna | 96,45 |
| NOK | Norwegian krone | 7,8825 |
| BGN | Bulgarian lev | 1,9558 |
| CYP | Cyprus pound | 0,5750 |
| CZK | Czech koruna | 28,503 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 283,20 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,6960 |
| MTL | Maltese lira | 0,4293 |
| PLN | Polish zloty | 4,0818 |
| RON | Romanian leu | 3,5863 |
| SIT | Slovenian tolar | 239,62 |
| SKK | Slovak koruna | 38,320 |
| TRY | Turkish lira | 2,0115 |
| AUD | Australian dollar | 1,7180 |
| CAD | Canadian dollar | 1,4025 |
| HKD | Hong Kong dollar | 9,7326 |
| NZD | New Zealand dollar | 2,1093 |
| SGD | Singapore dollar | 2,0031 |
| KRW | South Korean won | 1 203,54 |
| ZAR | South African rand | 9,1759 |
| CNY | Chinese yuan renminbi | 10,0233 |
| HRK | Croatian kuna | 7,2450 |
| IDR | Indonesian rupiah | 11 734,66 |
| MYR | Malaysian ringgit | 4,619 |
| PHP | Philippine peso | 67,093 |
| RUB | Russian rouble | 33,9480 |
| THB | Thai baht | 48,199 |

Currency

Exchange rate

USD

US dollar

1,2529

JPY

Japanese yen

146,00

DKK

Danish krone

7,4583

GBP

Pound sterling

0,69110

SEK

Swedish krona

9,2373

CHF

Swiss franc

1,5644

ISK

Iceland króna

96,45

NOK

Norwegian krone

7,8825

BGN

Bulgarian lev

1,9558

CYP

Cyprus pound

0,5750

CZK

Czech koruna

28,503

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

283,20

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,6960

MTL

Maltese lira

0,4293

PLN

Polish zloty

4,0818

RON

Romanian leu

3,5863

SIT

Slovenian tolar

239,62

SKK

Slovak koruna

38,320

TRY

Turkish lira

2,0115

AUD

Australian dollar

1,7180

CAD

Canadian dollar

1,4025

HKD

Hong Kong dollar

9,7326

NZD

New Zealand dollar

2,1093

SGD

Singapore dollar

2,0031

KRW

South Korean won

1 203,54

ZAR

South African rand

9,1759

CNY

Chinese yuan renminbi

10,0233

HRK

Croatian kuna

7,2450

IDR

Indonesian rupiah

11 734,66

MYR

Malaysian ringgit

4,619

PHP

Philippine peso

67,093

RUB

Russian rouble

33,9480

THB

Thai baht

48,199

---

(1)

Source: reference exchange rate published by the ECB.

---

| 30.6.2006 | EN | Official Journal of the European Union | C 152/2 |
| --- | --- | --- | --- |

30.6.2006

EN

Official Journal of the European Union

C 152/2

---

Withdrawal of notification of a concentration

(Case COMP/M.4269 — Goldman Sachs/Borealis/GICSI/Associated British Ports Holdings)

(2006/C 152/02)

(Text with EEA relevance)

COUNCIL REGULATION (EC) No 139/2004

On 22 June 2006, the Commission of the European Communities received notification of a proposed concentration between The Goldman Sachs Group, Inc., Borealis Infrastructure Management Inc, and GIC Special Investments Pte Ltd. On 23 June 2006, the notifying parties informed the Commission that they withdrew their notification.

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| 30.6.2006 | EN | Official Journal of the European Union | C 152/3 |
| --- | --- | --- | --- |

30.6.2006

EN

Official Journal of the European Union

C 152/3

---

Prior notification of a concentration

(Case COMP/M.4257 — Smithfield/Sara Lee Foods Europe)

(2006/C 152/03)

(Text with EEA relevance)

| 1. | On 22 June 2006, 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 Smithfield Foods Inc. (‘Smithfields’, USA) and Oaktree Capital Management LLC (‘Oaktree’, USA) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertaking Sara Lee Foods Europe (‘SLFE’, The Netherlands) by way of purchase of shares in a newly created company constituting a joint venture. |
| --- | --- |

1.

On 22 June 2006, 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 Smithfield Foods Inc. (‘Smithfields’, USA) and Oaktree Capital Management LLC (‘Oaktree’, USA) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertaking Sara Lee Foods Europe (‘SLFE’, The Netherlands) 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 Smithfields: Production and supply of life hogs, fresh meat and processed meat products, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Smithfields: Production and supply of life hogs, fresh meat and processed meat products,

| — | Oaktree: Investment management, |
| --- | --- |

—

Oaktree: Investment management,

| — | SLFE: Production and supply of processed meat products. |
| --- | --- |

—

SLFE: Production and supply of processed meat 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) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4257 — Smithfield/Sara Lee Foods Europe, 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) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4257 — Smithfield/Sara Lee Foods Europe, 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.

---

| 30.6.2006 | EN | Official Journal of the European Union | C 152/4 |
| --- | --- | --- | --- |

30.6.2006

EN

Official Journal of the European Union

C 152/4

---

Prior notification of a concentration

(Case COMP/M.4270 — Platinum Equity/Textron Fastening Systems)

Candidate case for simplified procedure

(2006/C 152/04)

(Text with EEA relevance)

| 1. | On 23 June 2006 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 Platinum Equity LLC (‘Platinum’, USA) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the Fastening Systems Business of Textron, Inc. (‘TFS’, USA) by way of purchase of shares and assets. |
| --- | --- |

1.

On 23 June 2006 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 Platinum Equity LLC (‘Platinum’, USA) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the Fastening Systems Business of Textron, Inc. (‘TFS’, USA) by way of purchase of shares and assets.

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






  — | for Platinum: private equity firm specializing in acquisition of companies with a broad range of business markets; |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Platinum: private equity firm specializing in acquisition of companies with a broad range of business markets;

| — | for TFS: fasteners (such as nuts, bolts and screws), fastening systems and services. |
| --- | --- |

—

for TFS: fasteners (such as nuts, bolts and screws), fastening systems and services.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (fax No (32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4270 — Platinum Equity/Textron Fastening Systems, 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) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4270 — Platinum Equity/Textron Fastening Systems, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

---

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

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

---

| 30.6.2006 | EN | Official Journal of the European Union | C 152/5 |
| --- | --- | --- | --- |

30.6.2006

EN

Official Journal of the European Union

C 152/5

---

Opinion of the Advisory Committee on restrictive practices and dominant positions at its meeting on given at its 406th meeting on 27 March 2006 concerning a draft decision relating to case COMP/B1-38.348 — Repsol CPP

(2006/C 152/05)

(Text with EEA relevance)

| (1) | The Advisory Committee shares the Commission's concern expressed in its preliminary assessment about the risk of foreclosure on fuel supply in Spain raised by long-term supply agreements between REPSOL CPP and the service stations of its distribution network. |
| --- | --- |

(1)

The Advisory Committee shares the Commission's concern expressed in its preliminary assessment about the risk of foreclosure on fuel supply in Spain raised by long-term supply agreements between REPSOL CPP and the service stations of its distribution network.

| (2) | The Advisory Committee agrees with the Commission that such agreements may have for effect to reinforce the partitioning of markets on national basis and thereby may affect trade between Member States. |
| --- | --- |

(2)

The Advisory Committee agrees with the Commission that such agreements may have for effect to reinforce the partitioning of markets on national basis and thereby may affect trade between Member States.

| (3) | The Advisory Committee agrees with the Commission that the proceedings opened with a preliminary assessment under Article 81 of the Treaty in June 2004, can be concluded by means of a decision pursuant to Article 9(1) of Regulation (EC) No 1/2003 which will make commitments binding on REPSOL CPP, without prejudice to Article 9(2) of Regulation (EC) No 1/2003. |
| --- | --- |

(3)

The Advisory Committee agrees with the Commission that the proceedings opened with a preliminary assessment under Article 81 of the Treaty in June 2004, can be concluded by means of a decision pursuant to Article 9(1) of Regulation (EC) No 1/2003 which will make commitments binding on REPSOL CPP, without prejudice to Article 9(2) of Regulation (EC) No 1/2003.

| (4) | The Advisory Committee recommends the publication of its opinion in the Official Journal of the European Union. |
| --- | --- |

(4)

The Advisory Committee recommends the publication of its opinion in the Official Journal of the European Union.

| (5) | The Advisory Committee asks the Commission to take into account all the other points raised during the discussion. |
| --- | --- |

(5)

The Advisory Committee asks the Commission to take into account all the other points raised during the discussion.

---

| 30.6.2006 | EN | Official Journal of the European Union | C 152/6 |
| --- | --- | --- | --- |

30.6.2006

EN

Official Journal of the European Union

C 152/6

---

Final report of the Hearing Officer in case COMP/B1-38.348 — Repsol

(pursuant to Articles 15 and 16 of Commission Decision (2001/462/EC, ECSC) of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)

(2006/C 152/06)

(Text with EEA relevance)

The draft Decision presented to the Commission under Article 9 of Regulation (EC) No 1/2003 concerns possible foreclosure of competitors in the market of distribution of motor fuel to service stations in Spain which might result from long term exclusive supply contracts used by the Spanish wholesale supplier Repsol commercial de productos petroliferos S.A. (‘REPSOL CPP’).

On 20 December 2001, REPSOL CPP notified in accordance with Articles 2 and 4 of Regulation No 17, the applicable law at the time, contracts and contract models that it uses for the distribution of fuels for motor vehicles with a view to obtaining negative clearance or, alternatively, an individual exemption under Article 81(3) of the EC Treaty.

On 19 March 2002, the Commission published a notice in the Official Journal of the European Community, inviting interested companies to transmit their potential observations on this notification. In response to this invitation, 69 observations of interested third parties were received (1).

As a result of the applicability as from 1 May 2004 of Regulation (EC) No 1/2003, the application made by REPSOL lapsed. On 16 June 2004, the Commission opened proceedings with a view to adopting a decision under Chapter III of Regulation (EC) No 1/2003.

On 18 June 2004, the Commission issued a preliminary assessment under Article 9 of Regulation (EC) No 1/2003 addressed to REPSOL. REPSOL was given the opportunity to comment within a month. Within this time-period, it submitted commitment proposals.

On 20 October 2004, the Commission published a notice according to Article 27(4) of Regulation (EC) No 1/2003 in the Official Journal of the European Union. The Notice informed the public of the Commission's perceived competition concerns, the corresponding remedies, and invited interested parties to submit comments (‘the market test’) (2).

In response to the Notice, the Commission received 25 observations from interested third parties. The effectiveness of the commitments proposed by REPSOL to remedy the market foreclosure was called into question. On 7 March 2005 the Commission informed REPSOL of these observations and handed over a non-confidential summary thereof. Subsequently, REPSOL submitted an amended commitment proposal, which it further revised several times.

The Commission has now come to the conclusion that, in view of the commitments proposed by REPSOL in response to the preliminary assessment and as finally amended to take account of the relevant observations by interested third parties, and without prejudice to Article 9(2) of Regulation (EC) No 1/2003, there are no longer grounds for action by the Commission.

In a Decision under Article 9 of Regulation (EC) No 1/2003, no violation of the Community competition rules is established, but the Parties accept to remedy the concerns expressed by the Commission in a preliminary assessment. Therefore, in several Decisions taken already by the Commission (3), it has been accepted that due process is satisfied when the Parties inform the Commission that they have received sufficient access to the information that they considered necessary to propose commitments in order to meet the concerns expressed by the Commission.

This case has also been dealt with in the same manner, REPSOL having submitted a Declaration to the Commission to this effect after having received the results of the market test.

In the light of the above, I consider that the right to be heard of REPSOL has been respected.

Brussels, 27 March 2006

Serge DURANDE

---

(1)  OJ C 70, 19.3.2002, p. 29.

1

(2)  OJ C 258, 20.10.2004, p. 7.

2

(3)  Cf. decision of 22.6.2005 COMP/39.116 — Coca-Cola and decision of 19.1.2005 COMP/37.214 — DFB.

3

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| 30.6.2006 | EN | Official Journal of the European Union | C 152/8 |
| --- | --- | --- | --- |

30.6.2006

EN

Official Journal of the European Union

C 152/8

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.5.2006 to 31.5.2006

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

(2006/C 152/07)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) — Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.5.2006 | M-M-RVAXPRO | Measles, Mumps and Rubella Vaccine (Live) | Sanofi Pasteur MSD |
| SNC |
| 8, rue Jonas Salk |
| F-69007 Lyon |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

5.5.2006

M-M-RVAXPRO

Measles, Mumps and Rubella Vaccine (Live)

Sanofi Pasteur MSD

SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/06/337/001-013

Powder and solvent for suspension for injection

J07BD52

11.5.2006

19.5.2006

Zostavax

Zoster vaccine (Live)

| Sanofi Pasteur MSD |
| --- |
| SNC |
| 8, rue Jonas Salk |
| F-69007 Lyon |

Sanofi Pasteur MSD

SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/06/341/001-002

Powder and solvent for suspension for injection

(Non applicable)

23.5.2006

EU/1/06/341/003-013

Powder and solvent for suspension for injection in a pre-filled syringe

19.5.2006

Ganfort

bimatoprost/timolol

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road |
| Westport |
| Co. Mayo |
| Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland

EU/1/06/340/001-002

Eye drops, solution

S01ED 51

23.5.2006

29.5.2006

Evoltra

clofarabine

| Bioenvision Limited |
| --- |
| Bassett House |
| 5 Southwell Park Road |
| Camberley |
| Surrey, GU15 3PU |
| United Kingdom |

Bioenvision Limited

Bassett House

5 Southwell Park Road

Camberley

Surrey, GU15 3PU

United Kingdom

EU/1/06/334/001-004

Concentrate for solution for infusion

L01BB0680

31.5.2006

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) — Rejected

| 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 |
| --- | --- | --- | --- | --- |
| 19.5.2006 | Zelnorm | Novartis Europharm Limited |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

19.5.2006

Zelnorm

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

—

24.5.2006

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) — 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 |
| --- | --- | --- | --- | --- |
| 2.5.2006 | Agenerase | Glaxo Group Ltd, |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

2.5.2006

Agenerase

Glaxo Group Ltd,

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/148/001-004

4.5.2006

2.5.2006

Ventavis

| Schering AG |
| --- |
| Müllerstraße 170-178 |
| D-13342 Berlin |

Schering AG

Müllerstraße 170-178

D-13342 Berlin

EU/1/03/255/001-005

4.5.2006

5.5.2006

Vivanza

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

Bayer AG

D-51368 Leverkusen

EU/1/03/249/001-012

11.5.2006

5.5.2006

AVANDIA

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

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex, TW8 9GS

United Kingdom

EU/1/00/137/001-018

11.5.2006

5.5.2006

Lantus

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/00/134/001-029

11.5.2006

5.5.2006

Dynastat

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

Pfizer Ltd,

Ramsgate Road

Sandwich, Kent CT 13 9NJ

United Kingdom

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

Pharmacia Europe EEIG

Sandwich

Kent, CT13 9NJ

United Kingdom

EU/1/02/209/001-008

11.5.2006

5.5.2006

Insuman

| Aventis Pharma Deutschland GmbH |
| --- |
| Brueningstraße 50 |
| D-65926 Frankfurt am Main |

Aventis Pharma Deutschland GmbH

Brueningstraße 50

D-65926 Frankfurt am Main

EU/1/97/030/065-084

11.5.2006

5.5.2006

Apidra

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/04/285/013-020

11.5.2006

5.5.2006

Levitra

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

Bayer AG

D-51368 Leverkusen

EU/1/03/248/001-012

11.5.2006

10.5.2006

GONAL-f

| Serono Europe Limited |
| --- |
| 56, Marsh Wall |
| London E14 9TP |
| United Kingdom |

Serono Europe Limited

56, Marsh Wall

London E14 9TP

United Kingdom

EU/1/95/001/001

EU/1/95/001/003-005

EU/1/95/001/009

EU/1/95/001/012

EU/1/95/001/021-022

EU/1/95/001/035

12.5.2006

10.5.2006

Forcaltonin

| Unigene UK Limited |
| --- |
| 191 Sparrows Herne |
| Bushey Heath |
| Hertfordshire WD23 1AJ |
| United Kingdom |

Unigene UK Limited

191 Sparrows Herne

Bushey Heath

Hertfordshire WD23 1AJ

United Kingdom

EU/1/98/093/002

16.5.2006

16.5.2006

Lyrica

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

PFIZER Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/04/279/033-035

17.5.2006

19.5.2006

Caelyx

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73/Stallestraat 73 |
| B-1180 Bruxelles/Brussel |

Schering Plough Europe

Rue de Stalle, 73/Stallestraat 73

B-1180 Bruxelles/Brussel

EU/1/96/011/001-004

23.5.2006

19.5.2006

Osigraft

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

Howmedica International S. de R.L.

Division of Stryker Corporation

Raheen Industrial Estate

Raheen, Limerick

Ireland

EU/1/01/179/001

24.5.2006

19.5.2006

Xagrid

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

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park

Chineham, Basingstoke

Hampshire RG24 8EP

United Kingdom

EU/1/04/295/001

23.5.2006

19.5.2006

Nespo

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

Dompé Biotec S.p.A.

Via San Martino 12

I-20122 Milano

EU/1/01/184/001-056

23.5.2006

19.5.2006

Aranesp

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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/01/185/001-056

23.5.2006

19.5.2006

IntronA

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73/Stallestraat 73 |
| B-1180 Bruxelles/Brussel |

Schering Plough Europe

Rue de Stalle, 73/Stallestraat 73

B-1180 Bruxelles/Brussel

EU/1/99/127/001-039

23.5.2006

19.5.2006

PegIntron

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73/Stallestraat 73 |
| B-1180 Bruxelles/Brussel |

Schering Plough Europe

Rue de Stalle, 73/Stallestraat 73

B-1180 Bruxelles/Brussel

EU/1/00/131/001-050

23.5.2006

19.5.2006

Viraferon

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73/Stallestraat 73 |
| B-1180 Bruxelles/Brussel |

Schering Plough Europe

Rue de Stalle, 73/Stallestraat 73

B-1180 Bruxelles/Brussel

EU/1/99/128/001-037

23.5.2006

19.5.2006

ViraferonPeg

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73/Stallestraat 73 |
| B-1180 Bruxelles/Brussel |

Schering Plough Europe

Rue de Stalle, 73/Stallestraat 73

B-1180 Bruxelles/Brussel

EU/1/00/132/001-046

23.5.2006

22.5.2006

Prandin

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

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/00/162/019-021

24.5.2006

22.5.2006

Herceptin

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/00/145/001

24.5.2006

29.5.2006

NovoNorm

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

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/98/076/022-024

31.5.2006

29.5.2006

Puregon

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

Organon N.V

P.O. Box 20

5340 BH Oss

Nederland

EU/1/96/008/001-041

31.5.2006

29.5.2006

PEGASYS

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/02/221/001-010

31.5.2006

29.5.2006

Emend

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

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/03/262/001-008

31.5.2006

29.5.2006

Emend

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

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/03/262/007-008

31.5.2006

31.5.2006

Xeristar

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

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/04/297/001-008

2.6.2006

31.5.2006

Viramune

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

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/055/001-003

2.6.2006

31.5.2006

Aldurazyme

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

Genzyme Europe B.V

Gooimeer 10

1411 DD Naarden

Nederland

EU/1/03/253/001-003

2.6.2006

31.5.2006

Kineret

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

Amgen Europe B.V

Minervum 7061

4817 ZK Breda

Nederland

EU/1/02/203/001-004

2.6.2006

31.5.2006

Prialt

| Elan Pharma International Ltd |
| --- |
| WIL House |
| Shannon Business Park |
| Shannon |
| County Clare |
| Ireland |

Elan Pharma International Ltd

WIL House

Shannon Business Park

Shannon

County Clare

Ireland

EU/1/04/302/001-004

2.6.2006

31.5.2006

Trudexa

| Abbott Laboratories Ltd |
| --- |
| Queenborough |
| Kent ME11 5EL |
| United Kingdom |

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/257/001-006

2.6.2006

31.5.2006

Ariclaim

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

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/04/283/001-007

2.6.2006

31.5.2006

Xenical

| Roche Registration Limited |
| --- |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City |
| Hertfordshire AL7 1TW |
| United Kingdom |

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

Hertfordshire AL7 1TW

United Kingdom

EU/1/98/071/001-006

2.6.2006

31.5.2006

AVANDIA

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

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex, TW8 9GS

United Kingdom

EU/1/00/137/002-018

2.6.2006

31.5.2006

Rebif

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

Serono Europe Ltd.

56, Marsh Wall

London E14 9TP

United Kingdom

EU/1/98/063/001-007

2.6.2006

31.5.2006

YENTREVE

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

Eli Lilly Nederland B.V

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/280/001-007

2.6.2006

31.5.2006

Enbrel

| Abbott Laboratories Ltd. |
| --- |
| Queenborough |
| Kent ME11 5EL |
| United Kingdom |

Abbott Laboratories Ltd.

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/06/350/001-011

2.6.2006

31.5.2006

Abilify

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

Otsuka Pharmaceutical Europe Ltd

Commonwealth House

2 Chalkhill Road

Hammersmith

London W6 8DW

United Kingdom

EU/1/04/276/001-035

2.6.2006

31.5.2006

Vfend

| Pfizer Limited |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/02/212/001-026

2.6.2006

31.5.2006

Rapamune

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

Wyeth Europa Limited

Huntercombe Lane South

Taplow, Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/01/171/007-010

2.6.2006

31.5.2006

Xeloda

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

Roche Registration Limited

40 Broadwater Road

Welwyn Garden City

Hertfordshire AL7 3AY

United Kingdom

EU/1/00/163/001-002

2.6.2006

31.5.2006

Aprovel -77

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

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France

F-75013 Paris

EU/1/97/046/001-033

2.6.2006

31.5.2006

Cymbalta

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

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/296/001-008

2.6.2006

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 5.5.2006 | Infergen | Astellas Pharma Europe B.V |
| Elisabethhof 19 |
| 2353 EW Leiderdorp |
| Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

5.5.2006

Infergen

Astellas Pharma Europe B.V

Elisabethhof 19

2353 EW Leiderdorp

Nederland

EU/1/98/087/001-003

11.5.2006

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) — 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 |
| --- | --- | --- | --- | --- |
| 22.5.2006 | Aivlosin W 04-W 05 | ECO Animal Health Ltd |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

22.5.2006

Aivlosin W 04-W 05

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

EU/2/04/044/001-005

24.5.2006

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| London E14 4HB |
| United Kingdom |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

London E14 4HB

United Kingdom

---

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

---

| 30.6.2006 | EN | Official Journal of the European Union | C 152/14 |
| --- | --- | --- | --- |

30.6.2006

EN

Official Journal of the European Union

C 152/14

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1.5.2006 to 31.5.2006

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

(2006/C 152/08)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 22.5.2006 | Atorvastatin | See Annex I | See Annex I | 23.5.2006 |
| 29.5.2006 | Pimecrolimus | See Annex II | See Annex II | 30.5.2006 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

22.5.2006

Atorvastatin

See Annex I

See Annex I

23.5.2006

29.5.2006

Pimecrolimus

See Annex II

See Annex II

30.5.2006

---

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

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

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, 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. | Sortis | 10 mg | Film-coated tablet | Oral use |
| Austria | Pfizer Corporation Austria Ges.m.b.H. | Sortis | 20 mg | Film-coated tablet | Oral use |
| Austria | Pfizer Corporation Austria Ges.m.b.H. | Sortis | 40 mg | Film-coated tablet | Oral use |
| Austria | Pfizer Corporation Austria Ges.m.b.H. | Sortis | 80 mg | Film-coated tablet | Oral use |
| Belgium | Pfizer S.A. | Lipitor | 10 mg | Film-coated tablet | Oral use |
| Belgium | Pfizer S.A. | Lipitor | 20 mg | Film-coated tablet | Oral use |
| Belgium | Pfizer S.A. | Lipitor | 40 mg | Film-coated tablet | Oral use |
| Belgium | Pfizer S.A. | Lipitor | 80 mg | Film-coated tablet | Oral use |
| Denmark | Pfizer ApS | Zarator | 10 mg | Film-coated tablet | Oral use |
| Denmark | Pfizer ApS | Zarator | 20 mg | Film-coated tablet | Oral use |
| Denmark | Pfizer ApS | Zarator | 40 mg | Film-coated tablet | Oral use |
| Denmark | Pfizer ApS | Zarator | 80 mg | Film-coated tablet | Oral use |
| Finland | Pfizer Oy | Lipitor | 10 mg | Film-coated tablet | Oral use |
| Finland | Pfizer Oy | Lipitor | 20 mg | Film-coated tablet | Oral use |
| Finland | Pfizer Oy | Lipitor | 40 mg | Film-coated tablet | Oral use |
| Finland | Pfizer Oy | Lipitor | 80 mg | Film-coated tablet | Oral use |
| Germany | PARKE-DAVIS GmbH | Sortis | 10 mg | Film-coated tablet | Oral use |
| Germany | PARKE-DAVIS GmbH | Sortis | 20 mg | Film-coated tablet | Oral use |
| Germany | PARKE-DAVIS GmbH | Sortis | 40 mg | Film-coated tablet | Oral use |
| Germany | PARKE-DAVIS GmbH | Sortis | 80 mg | Film-coated tablet | Oral use |
| Greece | Pfizer Hellas AE | Lipitor | 10 mg | Film-coated tablet | Oral use |
| Greece | Pfizer Hellas AE | Lipitor | 20 mg | Film-coated tablet | Oral use |
| Greece | Pfizer Hellas AE | Lipitor | 40 mg | Film-coated tablet | Oral use |
| Greece | Pfizer Hellas AE | Lipitor | 80 mg | Film-coated tablet | Oral use |
| Italy | PARKE-DAVIS SpA | Xarator | 10 mg | Film-coated tablet | Oral use |
| Italy | PARKE-DAVIS SpA | Xarator | 20 mg | Film-coated tablet | Oral use |
| Italy | PARKE-DAVIS SpA | Xarator | 40 mg | Film-coated tablet | Oral use |
| Italy | PARKE-DAVIS SpA | Xarator | 80 mg | Film-coated tablet | Oral use |
| Luxembourg | Pfizer S.A. | Lipitor | 10 mg | Film-coated tablet | Oral use |
| Luxembourg | Pfizer S.A. | Lipitor | 20 mg | Film-coated tablet | Oral use |
| Luxembourg | Pfizer S.A. | Lipitor | 40 mg | Film-coated tablet | Oral use |
| Luxembourg | Pfizer S.A. | Lipitor | 80 mg | Film-coated tablet | Oral use |
| Netherlands | Pfizer bv | Lipitor | 10 mg | Film-coated tablet | Oral use |
| Netherlands | Pfizer bv | Lipitor | 20 mg | Film-coated tablet | Oral use |
| Netherlands | Pfizer bv | Lipitor | 40 mg | Film-coated tablet | Oral use |
| Netherlands | Pfizer bv | Lipitor | 80 mg | Film-coated tablet | Oral use |
| Portugal | Laboratórios Pfizer, Lda | Zarator | 10 mg | Film-coated tablet | Oral use |
| Portugal | Laboratórios Pfizer, Lda | Zarator | 20 mg | Film-coated tablet | Oral use |
| Portugal | Laboratórios Pfizer, Lda | Zarator | 40 mg | Film-coated tablet | Oral use |
| Portugal | Laboratórios Pfizer, Lda | Zarator | 80 mg | Film-coated tablet | Oral use |
| Spain | PARKE-DAVIS, S.L. | Zarator | 10 mg | Film-coated tablet | Oral use |
| Spain | PARKE-DAVIS, S.L. | Zarator | 20 mg | Film-coated tablet | Oral use |
| Spain | PARKE-DAVIS, S.L. | Zarator | 40 mg | Film-coated tablet | Oral use |
| Spain | PARKE-DAVIS, S.L. | Zarator | 80 mg | Film-coated tablet | Oral use |
| Sweden | Pfizer AB | Lipitor | 10 mg | Film-coated tablet | Oral use |
| Sweden | Pfizer AB | Lipitor | 20 mg | Film-coated tablet | Oral use |
| Sweden | Pfizer AB | Lipitor | 40 mg | Film-coated tablet | Oral use |
| Sweden | Pfizer AB | Lipitor | 80 mg | Film-coated tablet | Oral use |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Pfizer Corporation Austria Ges.m.b.H.

Sortis

10 mg

Film-coated tablet

Oral use

Austria

Pfizer Corporation Austria Ges.m.b.H.

Sortis

20 mg

Film-coated tablet

Oral use

Austria

Pfizer Corporation Austria Ges.m.b.H.

Sortis

40 mg

Film-coated tablet

Oral use

Austria

Pfizer Corporation Austria Ges.m.b.H.

Sortis

80 mg

Film-coated tablet

Oral use

Belgium

Pfizer S.A.

Lipitor

10 mg

Film-coated tablet

Oral use

Belgium

Pfizer S.A.

Lipitor

20 mg

Film-coated tablet

Oral use

Belgium

Pfizer S.A.

Lipitor

40 mg

Film-coated tablet

Oral use

Belgium

Pfizer S.A.

Lipitor

80 mg

Film-coated tablet

Oral use

Denmark

Pfizer ApS

Zarator

10 mg

Film-coated tablet

Oral use

Denmark

Pfizer ApS

Zarator

20 mg

Film-coated tablet

Oral use

Denmark

Pfizer ApS

Zarator

40 mg

Film-coated tablet

Oral use

Denmark

Pfizer ApS

Zarator

80 mg

Film-coated tablet

Oral use

Finland

Pfizer Oy

Lipitor

10 mg

Film-coated tablet

Oral use

Finland

Pfizer Oy

Lipitor

20 mg

Film-coated tablet

Oral use

Finland

Pfizer Oy

Lipitor

40 mg

Film-coated tablet

Oral use

Finland

Pfizer Oy

Lipitor

80 mg

Film-coated tablet

Oral use

Germany

PARKE-DAVIS GmbH

Sortis

10 mg

Film-coated tablet

Oral use

Germany

PARKE-DAVIS GmbH

Sortis

20 mg

Film-coated tablet

Oral use

Germany

PARKE-DAVIS GmbH

Sortis

40 mg

Film-coated tablet

Oral use

Germany

PARKE-DAVIS GmbH

Sortis

80 mg

Film-coated tablet

Oral use

Greece

Pfizer Hellas AE

Lipitor

10 mg

Film-coated tablet

Oral use

Greece

Pfizer Hellas AE

Lipitor

20 mg

Film-coated tablet

Oral use

Greece

Pfizer Hellas AE

Lipitor

40 mg

Film-coated tablet

Oral use

Greece

Pfizer Hellas AE

Lipitor

80 mg

Film-coated tablet

Oral use

Italy

PARKE-DAVIS SpA

Xarator

10 mg

Film-coated tablet

Oral use

Italy

PARKE-DAVIS SpA

Xarator

20 mg

Film-coated tablet

Oral use

Italy

PARKE-DAVIS SpA

Xarator

40 mg

Film-coated tablet

Oral use

Italy

PARKE-DAVIS SpA

Xarator

80 mg

Film-coated tablet

Oral use

Luxembourg

Pfizer S.A.

Lipitor

10 mg

Film-coated tablet

Oral use

Luxembourg

Pfizer S.A.

Lipitor

20 mg

Film-coated tablet

Oral use

Luxembourg

Pfizer S.A.

Lipitor

40 mg

Film-coated tablet

Oral use

Luxembourg

Pfizer S.A.

Lipitor

80 mg

Film-coated tablet

Oral use

Netherlands

Pfizer bv

Lipitor

10 mg

Film-coated tablet

Oral use

Netherlands

Pfizer bv

Lipitor

20 mg

Film-coated tablet

Oral use

Netherlands

Pfizer bv

Lipitor

40 mg

Film-coated tablet

Oral use

Netherlands

Pfizer bv

Lipitor

80 mg

Film-coated tablet

Oral use

Portugal

Laboratórios Pfizer, Lda

Zarator

10 mg

Film-coated tablet

Oral use

Portugal

Laboratórios Pfizer, Lda

Zarator

20 mg

Film-coated tablet

Oral use

Portugal

Laboratórios Pfizer, Lda

Zarator

40 mg

Film-coated tablet

Oral use

Portugal

Laboratórios Pfizer, Lda

Zarator

80 mg

Film-coated tablet

Oral use

Spain

PARKE-DAVIS, S.L.

Zarator

10 mg

Film-coated tablet

Oral use

Spain

PARKE-DAVIS, S.L.

Zarator

20 mg

Film-coated tablet

Oral use

Spain

PARKE-DAVIS, S.L.

Zarator

40 mg

Film-coated tablet

Oral use

Spain

PARKE-DAVIS, S.L.

Zarator

80 mg

Film-coated tablet

Oral use

Sweden

Pfizer AB

Lipitor

10 mg

Film-coated tablet

Oral use

Sweden

Pfizer AB

Lipitor

20 mg

Film-coated tablet

Oral use

Sweden

Pfizer AB

Lipitor

40 mg

Film-coated tablet

Oral use

Sweden

Pfizer AB

Lipitor

80 mg

Film-coated tablet

Oral use

---

ANNEX II

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

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH, |
| Brunnerstraße 59, |
| A-1235 Wien |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Novartis Pharma GmbH,

Brunnerstraße 59,

A-1235 Wien

Elidel

1%

Cream

Cutaneous use

Belgium

| Novartis Pharma |
| --- |
| N.V.Medialaan 40 |
| B-1800 Vilvoorde |

Novartis Pharma

N.V.Medialaan 40

B-1800 Vilvoorde

Elidel 1 %

10 mg/g

Cream

Cutaneous use

Belgium

| Novartis Pharma |
| --- |
| N.V.Medialaan 40 |
| B-1800 Vilvoorde |

Novartis Pharma

N.V.Medialaan 40

B-1800 Vilvoorde

Isaplic 1 %

10 mg/g

Cream

Cutaneous use

Czech Republic

| Novartis s.r.o Praha |
| --- |
| Nagano III |
| U Nákladového Nádraží 10 |
| CZ-130 00 Praha 3 |

Novartis s.r.o Praha

Nagano III

U Nákladového Nádraží 10

CZ-130 00 Praha 3

Elidel 1 % Krém

1%

Cream

Cutaneous use

Cyprus

| Demetriades & Papaellinas Ltd |
| --- |
| 21 Kassou street |
| P.O. Box 23490 Acropolis |
| CY-1683 Lefkosia |

Demetriades & Papaellinas Ltd

21 Kassou street

P.O. Box 23490 Acropolis

CY-1683 Lefkosia

Elidel cream 1 %

1%

Cream 15 g

Cutaneous use

Cyprus

| Demetriades & Papaellinas Ltd |
| --- |
| 21 Kassou street |
| P.O. Box 23490 Acropolis |
| CY-1683 Lefkosia |

Demetriades & Papaellinas Ltd

21 Kassou street

P.O. Box 23490 Acropolis

CY-1683 Lefkosia

Elidel cream 1 %

1%

Cream 30 g

Cutaneous use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Elidel

1%

Cream

Cutaneous use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Aregen

1%

Cream

Cutaneous use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Velov

1%

Cream

Cutaneous use

Estonia

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Elidel

1% cream

Cream

Cutaneous use

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Elidel

1%

Cream

Cutaneous use

France

| Novartis Pharma |
| --- |
| 2-4, rue Lionel Terray |
| F-92500 Rueil-Malmaison |

Novartis Pharma

2-4, rue Lionel Terray

F-92500 Rueil-Malmaison

Elidel

1%

Cream 15 g

Cutaneous use

France

| Novartis Pharma |
| --- |
| 2-4, rue Lionel Terray |
| F-92500 Rueil-Malmaison |

Novartis Pharma

2-4, rue Lionel Terray

F-92500 Rueil-Malmaison

Elidel

1%

Cream 30 g

Cutaneous use

France

| Novartis Pharma |
| --- |
| 2-4, rue Lionel Terray |
| F-92500 Rueil-Malmaison |

Novartis Pharma

2-4, rue Lionel Terray

F-92500 Rueil-Malmaison

Elidel

1%

Cream 60 g

Cutaneous use

France

| Novartis Pharma |
| --- |
| 2-4, rue Lionel Terray |
| F-92500 Rueil-Malmaison |

Novartis Pharma

2-4, rue Lionel Terray

F-92500 Rueil-Malmaison

Elidel

1%

Cream 100 g

Cutaneous use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Elidel 1 % Creme

10 mg/ 1g

Cream

Cutaneous use

Germany

| 3M Medica |
| --- |
| Zweigniederlassung der 3M Deutschland GmbH |
| Hammfelddamm 11 |
| D-41460 Neuss |

3M Medica

Zweigniederlassung der 3M Deutschland GmbH

Hammfelddamm 11

D-41460 Neuss

Douglan 1 % Creme

10 mg/ 1g

Cream

Cutaneous use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Velov 1 % Crème

10 mg/ 1g

Cream

Cutaneous use

Greece

| Novartis (Hellas) AEBE |
| --- |
| 12 km Athens-Lamia |
| Metamorfosi |
| GR-14451 Athens |

Novartis (Hellas) AEBE

12 km Athens-Lamia

Metamorfosi

GR-14451 Athens

Elidel

1%

Cream

Cutaneous use

Greece

| Novartis (Hellas) AEBE |
| --- |
| 12 km Athens-Lamia |
| Metamorfosi |
| GR-14451 Athens |

Novartis (Hellas) AEBE

12 km Athens-Lamia

Metamorfosi

GR-14451 Athens

Aregen

1%

Cream

Cutaneous use

Hungary

| Novartis Hungária Kft. Pharma |
| --- |
| Bartók Béla út 43-47 |
| Bartók-Ház, V. em. |
| H-1114 Budapest |

Novartis Hungária Kft. Pharma

Bartók Béla út 43-47

Bartók-Ház, V. em.

H-1114 Budapest

Elidel 1 % krém

1% (10mg/g)

Cream

Cutaneous use

Iceland

| Novaris Healthcare A/S, |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø, |

Novaris Healthcare A/S,

Lyngbyvej 172

DK-2100 København Ø,

Elidel cream 1 %

1%

Cream

Cutaneous use

Italy

| Novartis Farma S.p.A. |
| --- |
| Via Umberto Boccioni, 1 |
| I-21040 Origgio, Varese |

Novartis Farma S.p.A.

Via Umberto Boccioni, 1

I-21040 Origgio, Varese

Elidel

1%

Cream

Cutaneous use

Italy

| L.P.B. Istituto Farmaceutico S.p.A |
| --- |
| Via Umberto Boccioni, 1 |
| I-21040 Origgio, Varese |

L.P.B. Istituto Farmaceutico S.p.A

Via Umberto Boccioni, 1

I-21040 Origgio, Varese

Ombex

1%

Cream

Cutaneous use

Latvia

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Elidel

1%

Cream

Cutaneous use

Lithuania

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Elidel

10 mg/g

Cream

Cutaneous use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Elidel

1%

Cream

Cutaneous use

Malta

| Novartis Pharmaceuticals UK Ltd. |
| --- |
| Frimley Business Park, |
| Frimley, |
| Camberley, |
| Surrey GUI6 7SR, |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd.

Frimley Business Park,

Frimley,

Camberley,

Surrey GUI6 7SR,

United Kingdom

Elidel

1% w/w

Cream

Cutaneous use

Norway

| Novartis Norge AS |
| --- |
| Postboks 237 Økern |
| N-0510 Oslo |

Novartis Norge AS

Postboks 237 Økern

N-0510 Oslo

Elidel

1%

Cream

Cutaneous use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Elidel

10 mg/g

Cream

Cutaneous use

Portugal

| Laboratório Normal — Produtos Farmacêuticos, SA |
| --- |
| Rua do Centro Empresarial |
| Edifício 8 - |
| P-Quinta da Beloura 2710-444 |

Laboratório Normal — Produtos Farmacêuticos, SA

Rua do Centro Empresarial

Edifício 8 -

P-Quinta da Beloura 2710-444

Aregen

10 mg/g

Cream

Cutaneous use

Portugal

| Novartis Farma — Produtos Farmacêuticos, SA |
| --- |
| Rua do Centro Empresarial |
| Edifício 8 - |
| P-Quinta da Beloura 2710-444 |

Novartis Farma — Produtos Farmacêuticos, SA

Rua do Centro Empresarial

Edifício 8 -

P-Quinta da Beloura 2710-444

Elidel

10 mg/g

Cream

Cutaneous use

Slovak Republic

| Novartis s.r.o. |
| --- |
| U nákladového nádraží 10 |
| CZ-130 00 Praha 3 |

Novartis s.r.o.

U nákladového nádraží 10

CZ-130 00 Praha 3

Elidel 1 %

10mg in 1g (1%)

Cream

Cutaneous use

Slovenia

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Elidel

1%

Cream

Cutaneous use

Spain

| Novartis Farmaceutica, SA |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |

Novartis Farmaceutica, SA

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Elidel 1 % cream

1 %

Cream

Cutaneous use

Spain

| Novartis Farmaceutica, SA |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |

Novartis Farmaceutica, SA

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Pimecrolimus Novartis 1 % cream

1 %

Cream

Cutaneous use

Spain

| Novartis Farmaceutica, SA |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |

Novartis Farmaceutica, SA

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Rizan 1 % cream

1 %

Cream

Cutaneous use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| S-183 11 Täby |

Novartis Sverige AB

Box 1150

S-183 11 Täby

Elidel

1% cream

Cream

Cutaneous use

The Netherlands

| Novartis Pharma B.V. |
| --- |
| P.O. Box 241 |
| 6800 LZ Arnhem |
| Nederland |

Novartis Pharma B.V.

P.O. Box 241

6800 LZ Arnhem

Nederland

Elidel, crème 10 mg/g

10 mg per g

Cream

Cutaneous use

United Kingdom

| Novartis Pharmaceuticals UK Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

United Kingdom

Elidel 1 % Cream

1% w/w

Cream

Cutaneous use

---

| 30.6.2006 | EN | Official Journal of the European Union | C 152/20 |
| --- | --- | --- | --- |

30.6.2006

EN

Official Journal of the European Union

C 152/20

---

Non-opposition to a notified concentration

(Case COMP/M.4231 — Arcelor/Mitsui/Amsa JV)

(2006/C 152/09)

(Text with EEA relevance)

On 22 June 2006, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No. 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

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

—

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

| — | in electronic form on the EUR-Lex website under document number 32006M4231. EUR-Lex is the on-line access to European law. (http://ec.europa.eu/eur-lex/lex) |
| --- | --- |

—

in electronic form on the EUR-Lex website under document number 32006M4231. EUR-Lex is the on-line access to European law. (http://ec.europa.eu/eur-lex/lex)

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