# Official Journal C 231/2009

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2009.231.eng |
| --- | --- |
| Official Journal
  of the European Union | C 231 |
| | |
| English edition | Information and Notices | Volume 5225 September 2009 |

ISSN 1725-2423

doi:10.3000/17252423.C_2009.231.eng

Official Journal

of the European Union

C 231

English edition

Information and Notices

Volume 5225 September 2009

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 231/01 | Non-opposition to a notified concentration (Case COMP/M.5598 — Dragados/POL — AQUA Group) (
  1
  ) | 1 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 231/01

Non-opposition to a notified concentration (Case COMP/M.5598 — Dragados/POL — AQUA Group) (
  1
  )

1

1

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 231/02 | Euro exchange rates | 2 |
| 2009/C 231/03 | Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 July 2009 to 31 July 2009(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 3 |
| 2009/C 231/04 | Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 July 2009 to 31 July 2009(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
  ) | 18 |
| 2009/C 231/05 | Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 2009(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 20 |
| 2009/C 231/06 | Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 2009(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
  ) | 30 |
| | The Court of Auditors |
| 2009/C 231/07 | Special Report No 6/2009 European Union food aid for deprived persons: an assessment of the objectives, the means and the methods employed | 38 |
| | NOTICES FROM MEMBER STATES |
| 2009/C 231/08 | Extract from the Decision concerning Reykjavík Savings Bank pursuant to Directive 2001/24/EC of the European Parliament and of the Council on the reorganisation and winding-up of credit institutions | 39 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 231/02

Euro exchange rates

2

2009/C 231/03

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 July 2009 to 31 July 2009(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

)

3

2009/C 231/04

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 July 2009 to 31 July 2009(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council

or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council

)

18

2009/C 231/05

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 2009(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

)

20

2009/C 231/06

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 2009(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council

or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council

)

30

The Court of Auditors

2009/C 231/07

Special Report No 6/2009 European Union food aid for deprived persons: an assessment of the objectives, the means and the methods employed

38

NOTICES FROM MEMBER STATES

2009/C 231/08

Extract from the Decision concerning Reykjavík Savings Bank pursuant to Directive 2001/24/EC of the European Parliament and of the Council on the reorganisation and winding-up of credit institutions

39

| | V   Announcements |
| --- | --- |
| | ADMINISTRATIVE PROCEDURES |
| | Commission |
| 2009/C 231/09 | Call for proposals — EACEA/23/09 — MEDIA 2007: Audiovisual festivals | 41 |
| 2009/C 231/10 | MEDIA 2007 — Development, Distribution, Promotion And Training — Call for proposals — EACEA 18/09 — Support for television broadcasting of European audiovisual works | 43 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2009/C 231/11 | Prior notification of a concentration (Case COMP/M.5573 — Remeha Group/Baxi Holdings) (
  1
  ) | 45 |
| 2009/C 231/12 | Prior notification of a concentration (Case COMP/M.5649 — RREEF Fund/ENDESA/UFG/SAGGAS) (
  1
  ) | 46 |

V   Announcements

ADMINISTRATIVE PROCEDURES

Commission

2009/C 231/09

Call for proposals — EACEA/23/09 — MEDIA 2007: Audiovisual festivals

41

2009/C 231/10

MEDIA 2007 — Development, Distribution, Promotion And Training — Call for proposals — EACEA 18/09 — Support for television broadcasting of European audiovisual works

43

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2009/C 231/11

Prior notification of a concentration (Case COMP/M.5573 — Remeha Group/Baxi Holdings) (
  1
  )

1

45

2009/C 231/12

Prior notification of a concentration (Case COMP/M.5649 — RREEF Fund/ENDESA/UFG/SAGGAS) (
  1
  )

1

46

| | Corrigenda |
| --- | --- |
| 2009/C 231/13 | Corrigendum to training of national judges in EC competition law and judicial cooperation between national judges (OJ C 223, 16.9.2009) | 47 |

Corrigenda

2009/C 231/13

Corrigendum to training of national judges in EC competition law and judicial cooperation between national judges (OJ C 223, 16.9.2009)

(OJ C 223, 16.9.2009)

47

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

---

(1)   Text with EEA relevance

1

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

EN

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 25.9.2009 | EN | Official Journal of the European Union | C 231/1 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/1

---

Non-opposition to a notified concentration

(Case COMP/M.5598 — Dragados/POL — AQUA Group)

(Text with EEA relevance)

2009/C 231/01

On 16 September 2009, 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:

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

—

in the merger section of the Competition website of the Commission (http://ec.europa.eu/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 (http://eur-lex.europa.eu/en/index.htm) under document number 32009M5598. EUR-Lex is the on-line access to the European law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/en/index.htm) under document number 32009M5598. EUR-Lex is the on-line access to the European law.

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 25.9.2009 | EN | Official Journal of the European Union | C 231/2 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/2

---

Euro exchange rates (1)

24 September 2009

2009/C 231/02

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,4768 |
| JPY | Japanese yen | 133,85 |
| DKK | Danish krone | 7,4420 |
| GBP | Pound sterling | 0,91065 |
| SEK | Swedish krona | 10,1105 |
| CHF | Swiss franc | 1,5117 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 8,5100 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 25,159 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 270,15 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7075 |
| PLN | Polish zloty | 4,1686 |
| RON | Romanian leu | 4,2090 |
| TRY | Turkish lira | 2,1860 |
| AUD | Australian dollar | 1,6880 |
| CAD | Canadian dollar | 1,5843 |
| HKD | Hong Kong dollar | 11,4457 |
| NZD | New Zealand dollar | 2,0391 |
| SGD | Singapore dollar | 2,0849 |
| KRW | South Korean won | 1 766,10 |
| ZAR | South African rand | 10,9090 |
| CNY | Chinese yuan renminbi | 10,0824 |
| HRK | Croatian kuna | 7,2740 |
| IDR | Indonesian rupiah | 14 257,22 |
| MYR | Malaysian ringgit | 5,1149 |
| PHP | Philippine peso | 69,859 |
| RUB | Russian rouble | 44,2590 |
| THB | Thai baht | 49,539 |
| BRL | Brazilian real | 2,6401 |
| MXN | Mexican peso | 19,7197 |
| INR | Indian rupee | 70,8490 |

Currency

Exchange rate

USD

US dollar

1,4768

JPY

Japanese yen

133,85

DKK

Danish krone

7,4420

GBP

Pound sterling

0,91065

SEK

Swedish krona

10,1105

CHF

Swiss franc

1,5117

ISK

Iceland króna

NOK

Norwegian krone

8,5100

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

25,159

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

270,15

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7075

PLN

Polish zloty

4,1686

RON

Romanian leu

4,2090

TRY

Turkish lira

2,1860

AUD

Australian dollar

1,6880

CAD

Canadian dollar

1,5843

HKD

Hong Kong dollar

11,4457

NZD

New Zealand dollar

2,0391

SGD

Singapore dollar

2,0849

KRW

South Korean won

1 766,10

ZAR

South African rand

10,9090

CNY

Chinese yuan renminbi

10,0824

HRK

Croatian kuna

7,2740

IDR

Indonesian rupiah

14 257,22

MYR

Malaysian ringgit

5,1149

PHP

Philippine peso

69,859

RUB

Russian rouble

44,2590

THB

Thai baht

49,539

BRL

Brazilian real

2,6401

MXN

Mexican peso

19,7197

INR

Indian rupee

70,8490

---

(1)  Source: reference exchange rate published by the ECB.

---

| 25.9.2009 | EN | Official Journal of the European Union | C 231/3 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/3

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 July 2009 to 31 July 2009

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

2009/C 231/03

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.7.2009 | Ribavirin Teva Pharma BV | Ribavirin | Teva Pharma B.V. |
| Computerweg 10 |
| 3542 DR Utrecht |
| NEDERLAND |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

1.7.2009

Ribavirin Teva Pharma BV

Ribavirin

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/527/001-016

Film-coated tablet

J05A B04

3.7.2009

2.7.2009

Nymusa

Caffeine citrate

| CHIESI FARMACEUTICI SpA |
| --- |
| Via Palermo 26/A |
| 43100 Parma PR |
| ITALIA |

CHIESI FARMACEUTICI SpA

Via Palermo 26/A

43100 Parma PR

ITALIA

EU/1/09/528/001

Solution for infusion and oral solution

N06BC01

6.7.2009

20.7.2009

Instanyl

Fentanyl

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1 |
| 4000 Roskilde |
| DANMARK |

Nycomed Danmark ApS

Langebjerg 1

4000 Roskilde

DANMARK

EU/1/09/531/001-009

Nasal spray, solution

N02AB03

23.7.2009

24.7.2009

Vedrop

Tocofersolan

| Orphan Europe SARL |
| --- |
| Immeuble Le Wilson |
| 70 Avenue du Général de Gaulle |
| 92800 Puteaux |
| FRANCE |

Orphan Europe SARL

Immeuble Le Wilson

70 Avenue du Général de Gaulle

92800 Puteaux

FRANCE

EU/1/09/533/001-003

Oral solution

A11HA08

30.7.2009

24.7.2009

Topotecan Actavis

Topotecan

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegi 76-78 |
| 220 Hafnarfjordur |
| ICELAND |

Actavis Group PTC ehf.

Reykjavikurvegi 76-78

220 Hafnarfjordur

ICELAND

EU/1/09/536/001-002

Powder for concentrate for solution for infusion

L01XX17

30.7.2009

28.7.2009

Clopidogrel Acino

Clopidogrel

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35 |
| 83714 Miesbach |
| DEUTSCHLAND |

Acino Pharma GmbH

Am Windfeld 35

83714 Miesbach

DEUTSCHLAND

EU/1/09/532/001-007

Film-coated tablet

BO1AC04

31.7.2009

28.7.2009

Clopidogrel ratiopharm GmbH

Clopidogrel

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35 |
| 83714 Miesbach |
| DEUTSCHLAND |

Acino Pharma GmbH

Am Windfeld 35

83714 Miesbach

DEUTSCHLAND

EU/1/09/541/001-007

Film-coated tablet

BO1AC04

31.7.2009

28.7.2009

Clopidogrel 1A Pharma

Clopidogrel

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35 |
| 83714 Miesbach |
| DEUTSCHLAND |

Acino Pharma GmbH

Am Windfeld 35

83714 Miesbach

DEUTSCHLAND

EU/1/09/542/001-007

Film-coated tablet

BO1AC04

31.7.2009

28.7.2009

Clopidogrel Hexal

Clopidogrel

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35 |
| 83714 Miesbach |
| DEUTSCHLAND |

Acino Pharma GmbH

Am Windfeld 35

83714 Miesbach

DEUTSCHLAND

EU/1/09/534/001-007

Film-coated tablet

BO1AC04

31.7.2009

28.7.2009

Grepid

Clopidogrel

| Pharmathen S.A. |
| --- |
| 6 Dervenakion |
| 15351 Pallini Attiki |
| ΕΛΛAΔΑ |

Pharmathen S.A.

6 Dervenakion

15351 Pallini Attiki

ΕΛΛAΔΑ

EU/1/09/535/001-014

Film-coated tablet

B01AC-04

31.7.2009

28.7.2009

Clopidogrel Teva

Clopidogrel

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/540/001-009

Film-coated tablet

B01AC04

31.7.2009

31.7.2009

Mozobil

Plerixafor

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/09/537/001

Solution for injection

L03AX16

4.8.2009

—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.7.2009 | ReFacto AF | Wyeth Europa Ltd |
| Huntercombe Lane |
| South Taplow |
| Maidenhead Berkshire |
| SL6 0PH |
| UNITED KINGDOM |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

1.7.2009

ReFacto AF

Wyeth Europa Ltd

Huntercombe Lane

South Taplow

Maidenhead Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/99/103/001-004

2.7.2009

1.7.2009

Cymbalta

| 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/1/04/296/001-009

3.7.2009

1.7.2009

Cancidas

| 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/1/01/196/001

EU/1/01/196/003

3.7.2009

1.7.2009

Naglazyme

| BioMarin Europe Ltd |
| --- |
| 164 Shaftesbury Avenue |
| London |
| WC2H 8HL |
| UNITED KINGDOM |

BioMarin Europe Ltd

164 Shaftesbury Avenue

London

WC2H 8HL

UNITED KINGDOM

EU/1/05/324/001-002

3.7.2009

1.7.2009

Integrilin

| Glaxo Group Ltd |
| --- |
| Greenford |
| Middlesex |
| UB6 ONN |
| UNITED KINGDOM |

Glaxo Group Ltd

Greenford

Middlesex

UB6 ONN

UNITED KINGDOM

EU/1/99/109/001-002

3.7.2009

1.7.2009

Rebif

| Serono Europe Limited |
| --- |
| 56 Marsh Wall |
| London |
| E14 9TP |
| UNITED KINGDOM |

Serono Europe Limited

56 Marsh Wall

London

E14 9TP

UNITED KINGDOM

EU/1/98/063/008-010

3.7.2009

1.7.2009

ProQuad

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

Sanofi Pasteur MSD, SNC

8 rue Jonas Salk

69007 Lyon

FRANCE

EU/1/05/323/001-013

3.7.2009

1.7.2009

Liprolog

| 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/1/01/195/001-027

3.7.2009

1.7.2009

Norvir

| Abbott Laboratories Ltd |
| --- |
| Queenborough |
| Kent |
| ME11 5EL |
| UNITED KINGDOM |

Abbott Laboratories Ltd

Queenborough

Kent

ME11 5EL

UNITED KINGDOM

EU/1/96/016/001

EU/1/96/016/003-004

3.7.2009

1.7.2009

Humalog

| 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/1/96/007/002

EU/1/96/007/004-006

EU/1/96/007/008

EU/1/96/007/010

EU/1/96/007/015-021

EU/1/96/007/023-038

3.7.2009

1.7.2009

Xeristar

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/04/297/001-008

3.7.2009

1.7.2009

Tracleer

| Actelion Registration Ltd |
| --- |
| BSI Building 13th Floor |
| 389 Chiswick High Road |
| London |
| W4 4AL |
| UNITED KINGDOM |

Actelion Registration Ltd

BSI Building 13th Floor

389 Chiswick High Road

London

W4 4AL

UNITED KINGDOM

EU/1/02/220/006

3.7.2009

1.7.2009

Tracleer

| Actelion Registration Ltd |
| --- |
| BSI Building 13th Floor |
| 389 Chiswick High Road |
| London |
| W4 4AL |
| UNITED KINGDOM |

Actelion Registration Ltd

BSI Building 13th Floor

389 Chiswick High Road

London

W4 4AL

UNITED KINGDOM

EU/1/02/220/001-006

3.7.2009

1.7.2009

Arava

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

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/99/118/001-010

3.7.2009

2.7.2009

Remicade

| Centocor B.V. |
| --- |
| Einsteinweg 101 |
| 2333 CB Leiden |
| NEDERLAND |

Centocor B.V.

Einsteinweg 101

2333 CB Leiden

NEDERLAND

EU/1/99/116/001-005

7.7.2009

2.7.2009

Alimta

| 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/1/04/290/001-002

7.7.2009

2.7.2009

Mimpara

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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

NEDERLAND

EU/1/04/292/001-012

7.7.2009

2.7.2009

ADROVANCE

| 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/1/06/364/001-009

7.7.2009

2.7.2009

Bonviva

| 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/1/03/265/003-006

7.7.2009

2.7.2009

Bondenza

| 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/1/03/266/003-006

7.7.2009

2.7.2009

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

7.7.2009

2.7.2009

Angiox

| The Medicines Company UK Ltd |
| --- |
| 115 L Milton Park |
| Abingdon |
| Oxfordshire |
| OX14 4SA |
| UNITED KINGDOM |

The Medicines Company UK Ltd

115 L Milton Park

Abingdon

Oxfordshire

OX14 4SA

UNITED KINGDOM

EU/1/04/289/001-002

8.7.2009

3.7.2009

Prevenar

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

Wyeth-Lederle Vaccines S.A.

Rue du Bosquet 15

1348 Louvain-La-Neuve

BELGIQUE

EU/1/00/167/001-008

7.7.2009

3.7.2009

Remicade

| Centocor B.V. |
| --- |
| Einsteinweg 101 |
| 2333 CB Leiden |
| NEDERLAND |

Centocor B.V.

Einsteinweg 101

2333 CB Leiden

NEDERLAND

EU/1/99/116/001-005

7.7.2009

3.7.2009

Zyprexa

| 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/1/96/022/002

EU/1/96/022/004

EU/1/96/022/006

EU/1/96/022/008-012

EU/1/96/022/014

EU/1/96/022/016-017

EU/1/96/022/019-034

7.7.2009

3.7.2009

RELISTOR

| 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/1/08/463/001-003

7.7.2009

7.7.2009

Tracleer

| Actelion Registration Ltd |
| --- |
| BSI Building 13th Floor |
| 389 Chiswick High Road |
| London |
| W4 4AL |
| UNITED KINGDOM |

Actelion Registration Ltd

BSI Building 13th Floor

389 Chiswick High Road

London

W4 4AL

UNITED KINGDOM

EU/1/02/220/001-006

9.7.2009

7.7.2009

Zyprexa Velotab

| 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/1/99/125/001-016

9.7.2009

7.7.2009

Prepandrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l'Institut 89 |
| 1330 Rixensart |
| BELGIQUE |

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/08/453/001

9.7.2009

7.7.2009

Pre-pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l'Institut 89 |
| 1330 Rixensart |
| BELGIQUE |

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/08/478/001

9.7.2009

7.7.2009

Baraclude

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge |
| UB8 1DH |
| UNITED KINGDOM |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/06/343/005

9.7.2009

7.7.2009

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/1/04/280/001-008

9.7.2009

7.7.2009

Abilify

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House |
| Highbridge Business Park |
| Oxford Road |
| Uxbridge |
| Middlesex |
| UB8 1HU |
| UNITED KINGDOM |

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex

UB8 1HU

UNITED KINGDOM

EU/1/04/276/001-020

EU/1/04/276/024-036

9.7.2009

7.7.2009

Zonegran

| Eisai Limited |
| --- |
| European Knowledge Centre |
| Mosquito Way |
| Hatfield |
| Hertfordshire |
| AL10 9SN |
| UNITED KINGDOM |

Eisai Limited

European Knowledge Centre

Mosquito Way

Hatfield

Hertfordshire

AL10 9SN

UNITED KINGDOM

EU/1/04/307/001-013

9.7.2009

7.7.2009

CELSENTRI

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/07/418/001-010

9.7.2009

7.7.2009

Invega

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIË |

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/07/395/001-095

9.7.2009

7.7.2009

Tygacil

| Wyeth Europa Ltd |
| --- |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire |
| SL6 0PH |
| UNITED KINGDOM |

Wyeth Europa Ltd

Huntercombe Lane South

Taplow

Maidenhead

Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/06/336/001

9.7.2009

7.7.2009

FOSAVANCE

| 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/1/05/310/001-009

9.7.2009

7.7.2009

REYATAZ

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge |
| UB8 1DH |
| UNITED KINGDOM |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/03/267/001-010

9.7.2009

7.7.2009

Revatio

| Pfizer Limited |
| --- |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/05/318/001

9.7.2009

10.7.2009

Binocrit

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| ÖSTERREICH |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

ÖSTERREICH

EU/1/07/410/001-020

14.7.2009

10.7.2009

Pandemrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l'Institut 89 |
| 1330 Rixensart |
| BELGIQUE |

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/08/452/001

14.7.2009

10.7.2009

Epoetin alfa Hexal

| Hexal AG. |
| --- |
| Industriestrasse 25 |
| 83607 Holzkirchen |
| DEUTSCHLAND |

Hexal AG.

Industriestrasse 25

83607 Holzkirchen

DEUTSCHLAND

EU/1/07/411/001-020

14.7.2009

14.7.2009

INCRELEX

| Ipsen Pharma |
| --- |
| 65 quai Georges Gorse |
| 92100 Boulogne-Billancourt |
| FRANCE |

Ipsen Pharma

65 quai Georges Gorse

92100 Boulogne-Billancourt

FRANCE

| Tercica Europe Limited |
| --- |
| Riverside One, Sir John Rogerson's Quay |
| Dublin 2 |
| IRELAND |

Tercica Europe Limited

Riverside One, Sir John Rogerson's Quay

Dublin 2

IRELAND

EU/1/07/402/001

16.7.2009

14.7.2009

Zometa

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/01/176/001-006

16.7.2009

14.7.2009

Exjade

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/06/356/001-009

16.7.2009

14.7.2009

ISENTRESS

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/436/001-002

16.7.2009

14.7.2009

Thelin

| Encysive (UK) Limited |
| --- |
| Alder Castle House |
| 10 Noble Street |
| London |
| EC2V 7QJ |
| UNITED KINGDOM |

Encysive (UK) Limited

Alder Castle House

10 Noble Street

London

EC2V 7QJ

UNITED KINGDOM

EU/1/06/353/001-005

16.7.2009

14.7.2009

Abseamed

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

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

58638 Iserlohn

DEUTSCHLAND

EU/1/07/412/001-020

16.7.2009

14.7.2009

Dynastat

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/02/209/001-008

16.7.2009

14.7.2009

DULOXETINE BOEHRINGER INGELHEIM

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/08/471/001-012

16.7.2009

14.7.2009

Doribax

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIË |

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/08/467/001

16.7.2009

14.7.2009

Crixivan

| 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/1/96/024/001-005

EU/1/96/024/008

EU/1/96/024/010

16.7.2009

14.7.2009

Paxene

| Norton Healthcare Limited |
| --- |
| Albert Basin |
| Royal Docks |
| London |
| E16 2QJ |
| UNITED KINGDOM |

Norton Healthcare Limited

Albert Basin

Royal Docks

London

E16 2QJ

UNITED KINGDOM

EU/1/99/113/001-004

16.7.2009

16.7.2009

Neupro

| Schwarz Pharma Ltd |
| --- |
| Shannon |
| Industrial Estate |
| Co. Clare |
| IRELAND |

Schwarz Pharma Ltd

Shannon

Industrial Estate

Co. Clare

IRELAND

EU/1/05/331/001-055

21.7.2009

16.7.2009

Opgenra

| Howmedica International S. de R. L. |
| --- |
| Raheen Business Park |
| Limerick |
| IRELAND |

Howmedica International S. de R. L.

Raheen Business Park

Limerick

IRELAND

EU/1/08/489/001-002

21.7.2009

16.7.2009

ADROVANCE

| 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/1/06/364/001-009

21.7.2009

16.7.2009

ECALTA

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/07/416/001

21.7.2009

16.7.2009

ISENTRESS

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/436/001-002

21.7.2009

16.7.2009

CUBICIN

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/05/328/001-002

21.7.2009

16.7.2009

Olanzapine Neopharma

| Neopharma Limited |
| --- |
| 57 High Street |
| Odiham |
| Hampshire |
| RG29 1LF |
| UNITED KINGDOM |

Neopharma Limited

57 High Street

Odiham

Hampshire

RG29 1LF

UNITED KINGDOM

EU/1/07/426/001-011

21.7.2009

16.7.2009

Enbrel

| 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/1/99/126/001-021

21.7.2009

17.7.2009

Zalasta

| Krka d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| SI-8501 Novo mesto |
| SLOVENIJA |

Krka d.d.

Novo mesto

Šmarješka cesta 6

SI-8501 Novo mesto

SLOVENIJA

EU/1/07/415/001-056

21.7.2009

17.7.2009

Stocrin

| 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/1/99/111/001-005

EU/1/99/111/008-011

21.7.2009

17.7.2009

Olanzapine Mylan

| Generics (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Hertfordshire |
| EN6 1TL |
| UNITED KINGDOM |

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire

EN6 1TL

UNITED KINGDOM

EU/1/08/475/001-034

21.7.2009

20.7.2009

Olanzapine Teva

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/07/427/001-057

23.7.2009

23.7.2009

Dynastat

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/02/209/001-008

28.7.2009

23.7.2009

NeuroBloc

| Eisai Limited |
| --- |
| European Knowledge Centre |
| Mosquito Way |
| Hatfield |
| Hertfordshire |
| AL10 9SN |
| UNITED KINGDOM |

Eisai Limited

European Knowledge Centre

Mosquito Way

Hatfield

Hertfordshire

AL10 9SN

UNITED KINGDOM

EU/1/00/166/001-003

28.7.2009

23.7.2009

Xelevia

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/382/001-018

28.7.2009

23.7.2009

Cancidas

| 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/1/01/196/001

EU/1/01/196/003

28.7.2009

23.7.2009

Invanz

| 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/1/02/216/001-002

28.7.2009

23.7.2009

ATryn

| GTC Biotherapeutics UK Limited |
| --- |
| 10 Norwich Street |
| London |
| EC4A 1BD |
| UNITED KINGDOM |

GTC Biotherapeutics UK Limited

10 Norwich Street

London

EC4A 1BD

UNITED KINGDOM

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

LEO Pharma A/S

Industriparken 55

2750 Ballerup

DANMARK

EU/1/06/355/001-003

28.7.2009

23.7.2009

Avastin

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/04/300/001-002

28.7.2009

23.7.2009

Vistide

| Gilead Sciences International Limited |
| --- |
| Cambridge |
| CB21 6GT |
| UNITED KINGDOM |

Gilead Sciences International Limited

Cambridge

CB21 6GT

UNITED KINGDOM

EU/1/97/037/001

28.7.2009

23.7.2009

ECALTA

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/07/416/002

28.7.2009

24.7.2009

Vimpat

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60 |
| 1070 Bruxelles |
| BELGIQUE |

UCB Pharma S.A.

Allée de la Recherche 60

1070 Bruxelles

BELGIQUE

EU/1/08/470/001-017

31.7.2009

24.7.2009

Humira

| Abbott Laboratories Ltd |
| --- |
| Queenborough |
| Kent |
| ME11 5EL |
| UNITED KINGDOM |

Abbott Laboratories Ltd

Queenborough

Kent

ME11 5EL

UNITED KINGDOM

EU/1/03/256/001-010

30.7.2009

24.7.2009

ZYPADHERA

| 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/1/08/479/001-003

30.7.2009

24.7.2009

Macugen

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/05/325/002

30.7.2009

24.7.2009

Silgard

| 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/1/06/358/001-021

30.7.2009

24.7.2009

Flebogammadif

| Instituto Grifols S.A. |
| --- |
| Can Guasch |
| Parets del Vallès |
| 08150 Barcelona |
| ESPAÑA |

Instituto Grifols S.A.

Can Guasch

Parets del Vallès

08150 Barcelona

ESPAÑA

EU/1/07/404/001-005

30.7.2009

24.7.2009

FABLYN

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/08/500/001-004

30.7.2009

24.7.2009

Nexavar

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/06/342/001

30.7.2009

24.7.2009

FIRMAGON

| Ferring Pharmaceuticals A/S |
| --- |
| Kay Fiskers Plads 11 |
| 2300 København S |
| DANMARK |

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11

2300 København S

DANMARK

EU/1/08/504/001-002

30.7.2009

24.7.2009

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/1/95/001/025-028

EU/1/95/001/031-035

30.7.2009

24.7.2009

Cervarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l'Institut 89 |
| 1330 Rixensart |
| BELGIQUE |

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/07/419/001-012

30.7.2009

24.7.2009

Kuvan

| Merck KGaA |
| --- |
| Frankfurter Straße 250 |
| 64293 Darmstadt |
| DEUTSCHLAND |

Merck KGaA

Frankfurter Straße 250

64293 Darmstadt

DEUTSCHLAND

EU/1/08/481/001-003

30.7.2009

24.7.2009

Gardasil

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

Sanofi Pasteur MSD SNC

8 rue Jonas Salk

69007 Lyon

FRANCE

EU/1/06/357/001-021

30.7.2009

24.7.2009

Pedea

| Orphan Europe SARL |
| --- |
| Immeuble Le Wilson |
| 70 Avenue du Général de Gaulle |
| 92800 Puteaux |
| FRANCE |

Orphan Europe SARL

Immeuble Le Wilson

70 Avenue du Général de Gaulle

92800 Puteaux

FRANCE

EU/1/04/284/001

30.7.2009

27.7.2009

Synagis

| Abbott Laboratories Ltd |
| --- |
| Queenborough |
| Kent |
| ME11 5EL |
| UNITED KINGDOM |

Abbott Laboratories Ltd

Queenborough

Kent

ME11 5EL

UNITED KINGDOM

EU/1/99/117/001-002

30.7.2009

27.7.2009

Tasigna

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/422/001-004

30.7.2009

27.7.2009

Luminity

| Lantheus MI UK Limited |
| --- |
| One South Place |
| London |
| EC2M 2WG |
| UNITED KINGDOM |

Lantheus MI UK Limited

One South Place

London

EC2M 2WG

UNITED KINGDOM

| Bristol-Myers Squibb Pharma Belgium Sprl |
| --- |
| Chaussée de la Hulpe/Terhulpsesteenweg 185 |
| 1170 Brussels/Brussel |
| BELGIQUE/BELGIË |

Bristol-Myers Squibb Pharma Belgium Sprl

Chaussée de la Hulpe/Terhulpsesteenweg 185

1170 Brussels/Brussel

BELGIQUE/BELGIË

EU/1/06/361/001-002

30.7.2009

27.7.2009

NovoRapid

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

Novo Nordisk A/S

Novo Allé

2880 Bagsværd

DANMARK

EU/1/99/119/001

EU/1/99/119/003

EU/1/99/119/005-015

30.7.2009

27.7.2009

Xolair

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/05/319/001-010

30.7.2009

27.7.2009

Prevenar

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

Wyeth-Lederle Vaccines S.A.

Rue du Bosquet 15

1348 Louvain-La-Neuve

BELGIQUE

EU/1/00/167/001-008

30.7.2009

27.7.2009

Helixate NexGen

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/00/144/001-004

30.7.2009

27.7.2009

KOGENATE Bayer

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/00/143/001-011

30.7.2009

27.7.2009

ViraferonPeg

| Schering Plough Europe |
| --- |
| Rue de Stalle 73 |
| 1180 Bruxelles |
| BELGIQUE |

Schering Plough Europe

Rue de Stalle 73

1180 Bruxelles

BELGIQUE

| Stallestraat 73 |
| --- |
| 1180 Brussel |
| BELGIË |

Stallestraat 73

1180 Brussel

BELGIË

EU/1/00/132/001-050

30.7.2009

27.7.2009

Renagel

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/99/123/005-013

30.7.2009

28.7.2009

Osseor

| Les Laboratoires Servier |
| --- |
| 22 rue Garnier |
| 92200 Neuilly-sur-Seine |
| FRANCE |

Les Laboratoires Servier

22 rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/04/287/001-006

31.7.2009

28.7.2009

Protelos

| Les Laboratoires Servier |
| --- |
| 22 rue Garnier |
| 92200 Neuilly-sur-Seine |
| FRANCE |

Les Laboratoires Servier

22 rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/04/288/001-006

31.7.2009

28.7.2009

Sprycel

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge |
| UB8 1DH |
| UNITED KINGDOM |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/06/363/001-011

31.7.2009

29.7.2009

Ebixa

| H.Lundbeck A/S |
| --- |
| Ottiliavej 9 |
| 2500 Valby |
| DANMARK |

H.Lundbeck A/S

Ottiliavej 9

2500 Valby

DANMARK

EU/1/02/219/005-006

EU/1/02/219/013

31.7.2009

29.7.2009

Januvia

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/383/001-018

31.7.2009

29.7.2009

Firazyr

| Jerini AG |
| --- |
| Invalidenstr. 130 |
| 10115 Berlin |
| DEUTSCHLAND |

Jerini AG

Invalidenstr. 130

10115 Berlin

DEUTSCHLAND

EU/1/08/461/001

31.7.2009

29.7.2009

NutropinAq

| Ipsen Pharma |
| --- |
| 65 quai Georges Gorse |
| 92100 Boulogne-Billancourt |
| FRANCE |

Ipsen Pharma

65 quai Georges Gorse

92100 Boulogne-Billancourt

FRANCE

| IPSEN Limited |
| --- |
| 190 Bath Road |
| Slough |
| Berkshire |
| SLI 3XE |
| UNITED KINGDOM |

IPSEN Limited

190 Bath Road

Slough

Berkshire

SLI 3XE

UNITED KINGDOM

EU/1/00/164/003-005

31.7.2009

29.7.2009

Abraxane

| Abraxis BioScience Limited |
| --- |
| Hatfield |
| AL10 9NA |
| UNITED KINGDOM |

Abraxis BioScience Limited

Hatfield

AL10 9NA

UNITED KINGDOM

EU/1/07/428/001

31.7.2009

29.7.2009

Janumet

| 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/1/08/455/001-016

31.7.2009

29.7.2009

Velmetia

| 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/1/08/456/001-016

31.7.2009

29.7.2009

Efficib

| 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/1/08/457/001-016

31.7.2009

29.7.2009

IVEMEND

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/437/001-002

31.7.2009

29.7.2009

TOVIAZ

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/07/386/001-016

31.7.2009

31.7.2009

Axura

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstr. 100-104 |
| 60318 Frankfurt/Main |
| DEUTSCHLAND |

Merz Pharmaceuticals GmbH

Eckenheimer Landstr. 100-104

60318 Frankfurt/Main

DEUTSCHLAND

EU/1/02/218/004-006

4.8.2009

31.7.2009

Emselex

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/04/294/001-028

4.8.2009

31.7.2009

Kepivance

| Biovitrum AB (publ) |
| --- |
| SE-112 76 Stockholm |
| SVERIGE |

Biovitrum AB (publ)

SE-112 76 Stockholm

SVERIGE

EU/1/05/314/001

4.8.2009

31.7.2009

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

4.8.2009

—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.7.2009 | Melovem | Meloxicam | Dopharma Research B.V. |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| NEDERLAND |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

7.7.2009

Melovem

Meloxicam

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NEDERLAND

EU/2/09/098/001

Solution for injection

QM01AC06

9.7.2009

24.7.2009

Suvaxyn PCV

Porcine Circovirus recombinant virus (cPCV) 1-2, inactivated

| Fort Dodge Animal Health Ltd |
| --- |
| Flanders Road |
| Hedge End |
| Southampton |
| SO30 4QH |
| UNITED KINGDOM |

Fort Dodge Animal Health Ltd

Flanders Road

Hedge End

Southampton

SO30 4QH

UNITED KINGDOM

EU/2/09/099/001-006

Suspension for injection

QI09AA07

30.7.2009

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 14.7.2009 | Meloxivet | Janssen Pharmaceutica N.V. |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIË |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

14.7.2009

Meloxivet

Janssen Pharmaceutica N.V.

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/2/07/077/001-005

16.7.2009

16.7.2009

Nobivac Piro

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/04/046/001-003

21.7.2009

20.7.2009

PRILACTONE

| Ceva sante animale |
| --- |
| Z.I. la Ballastière |
| 33500 Libourne |
| FRANCE |

Ceva sante animale

Z.I. la Ballastière

33500 Libourne

FRANCE

EU/2/07/074/001-006

23.7.2009

20.7.2009

ZACTRAN

| Merial |
| --- |
| 29 avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial

29 avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/08/082/001-006

23.7.2009

31.7.2009

Nobilis Influenza H7N1

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/07/073/001-004

4.8.2009

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.

---

| 25.9.2009 | EN | Official Journal of the European Union | C 231/18 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/18

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 July 2009 to 31 July 2009

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
   (1)
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
   (2)
  )

2009/C 231/04

—   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 |
| --- | --- | --- | --- | --- |
| 2.7.2009 | Nymusa | Chiesi Farmaceutici SpA |
| Via Palermo 26/A |
| 43100 Parma PR |
| ITALIA |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

2.7.2009

Nymusa

Chiesi Farmaceutici SpA

Via Palermo 26/A

43100 Parma PR

ITALIA

This Decision is addressed to the Member States

3.7.2009

20.7.2009

Instanyl

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1 |
| 4000 Roskilde |
| DANMARK |

Nycomed Danmark ApS

Langebjerg 1

4000 Roskilde

DANMARK

This Decision is addressed to the Member States

22.7.2009

—   Suspension 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 |
| --- | --- | --- | --- | --- |
| 14.7.2009 | Prokanazol | See Annex I | See Annex I | 15.7.2009 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

14.7.2009

Prokanazol

See Annex I

See Annex I

15.7.2009

---

(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(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S)/MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Czech Republic | PRO.MED.CS Praha a.s. |
| Telčská 1 |
| 140 00 Prague 4 |
| CZECH REPUBLIC |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Czech Republic

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

CZECH REPUBLIC

Prokanazol

100 mg

Hard capsules

Oral use

Latvia

| PRO.MED.CS Praha a.s. |
| --- |
| Telčská 1 |
| 140 00 Prague 4 |
| CZECH REPUBLIC |

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

CZECH REPUBLIC

Prokanaz 100 mg cietās kapsulas

100 mg

Hard capsules

Oral use

Lithuania

| PRO.MED.CS Praha a.s. |
| --- |
| Telčská 1 |
| 140 00 Prague 4 |
| CZECH REPUBLIC |

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

CZECH REPUBLIC

Prokanaz

100 mg

Hard capsules

Oral use

Poland

| PRO.MED.CS Praha a.s. |
| --- |
| Telčská 1 |
| 140 00 Prague 4 |
| CZECH REPUBLIC |

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

CZECH REPUBLIC

Prokanazol

100 mg

Hard capsules

Oral use

Slovak Republic

| PRO.MED.CS Praha a.s. |
| --- |
| Telčská 1 |
| 140 00 Prague 4 |
| CZECH REPUBLIC |

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

CZECH REPUBLIC

Prokanazol

100 mg

Hard capsules

Oral use

Slovenia

| PRO.MED.CS Praha a.s. |
| --- |
| Telčská 1 |
| 140 00 Prague 4 |
| CZECH REPUBLIC |

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

CZECH REPUBLIC

Prokanazol 100 mg trde kapsule

100 mg

Hard capsules

Oral use

---

| 25.9.2009 | EN | Official Journal of the European Union | C 231/20 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/20

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 2009

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

2009/C 231/05

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.8.2009 | Afinitor | Everolimus | Novartis Europharm Limited |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

3.8.2009

Afinitor

Everolimus

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/09/538/001-006

Tablet

L01XE10

5.8.2009

3.8.2009

Samsca

Tolvaptan

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House Highbridge |
| Business Park |
| Oxford Road |
| Uxbridge |
| Middlesex |
| UB8 1HU |
| UNITED KINGDOM |

Otsuka Pharmaceutical Europe Ltd

Hunton House Highbridge

Business Park

Oxford Road

Uxbridge

Middlesex

UB8 1HU

UNITED KINGDOM

EU/1/09/539/001-004

Tablet

C03XA01

5.8.2009

—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.8.2009 | SUTENT | Pfizer Ltd |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

3.8.2009

SUTENT

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/06/347/001-008

5.8.2009

3.8.2009

Baraclude

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge |
| UB8 1DH |
| UNITED KINGDOM |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/06/343/001-007

5.8.2009

3.8.2009

INTELENCE

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIË |

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/08/468/001

5.8.2009

3.8.2009

Revatio

| Pfizer Limited |
| --- |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/05/318/001

5.8.2009

3.8.2009

PegIntron

| Schering Plough Europe |
| --- |
| Rue de Stalle 73 |
| 1180 Bruxelles |
| BELGIQUE |
| Stallestraat 73 |
| 1180 Brussel |
| BELGIË |

Schering Plough Europe

Rue de Stalle 73

1180 Bruxelles

BELGIQUE

Stallestraat 73

1180 Brussel

BELGIË

EU/1/00/131/001-050

5.8.2009

3.8.2009

Champix

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/06/360/001-012

5.8.2009

3.8.2009

FOSAVANCE

| 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/1/05/310/001-009

5.8.2009

6.8.2009

Lucentis

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/06/374/001

10.8.2009

6.8.2009

TESAVEL

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/435/001-018

10.8.2009

6.8.2009

Trevaclyn

| 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/1/08/458/001-014

10.8.2009

6.8.2009

Tasigna

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/422/001-004

10.8.2009

6.8.2009

Pelzont

| 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/1/08/460/001-014

10.8.2009

6.8.2009

Tredaptive

| 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/1/08/459/001-014

10.8.2009

7.8.2009

CELSENTRI

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/07/418/001-010

11.8.2009

7.8.2009

Prepandrix

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l'Institut 89 |
| 1330 Rixensart |
| BELGIQUE |

GlaxoSmithKline Biologicals s.a.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/08/453/002

11.8.2009

7.8.2009

Lyrica

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/04/279/001-043

11.8.2009

7.8.2009

Revlimid

| Celgene Europe Limited |
| --- |
| Riverside House |
| Riverside Walk |
| Windsor |
| Berkshire |
| SL4 1NA |
| UNITED KINGDOM |

Celgene Europe Limited

Riverside House

Riverside Walk

Windsor

Berkshire

SL4 1NA

UNITED KINGDOM

EU/1/07/391/001-004

11.8.2009

13.8.2009

Oprymea

| KRKA, d. d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| SI-8501 Novo mesto |
| SLOVENIJA |

KRKA, d. d.

Novo mesto

Šmarješka cesta 6

SI-8501 Novo mesto

SLOVENIJA

EU/1/08/469/001-025

17.8.2009

13.8.2008

Clopidogrel BMS

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge |
| UB8 1DH |
| UNITED KINGDOM |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/08/464/001-019

17.8.2009

13.8.2008

Clopidogrel Winthrop

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 174 Avenue de France |
| 75013 Paris |
| FRANCE |

Sanofi Pharma Bristol-Myers Squibb SNC

174 Avenue de France

75013 Paris

FRANCE

EU/1/08/465/001-019

17.8.2009

18.8.2009

Nobilis Influenza H5N6

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/07/076/001-004

20.8.2009

20.8.2009

Lyrica

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/04/279/001-043

24.8.2009

20.8.2009

SUTENT

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/06/347/001-008

24.8.2009

20.8.2009

TESAVEL

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/435/001-018

24.8.2009

20.8.2009

Pramipexole Teva

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/08/490/001-016

24.8.2009

20.8.2009

Pradaxa

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/08/442/001-008

24.8.2009

20.8.2009

Apidra

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

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/04/285/001-036

24.8.2009

21.8.2009

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

25.8.2009

21.8.2009

Galvus

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/414/001-010

EU/1/07/414/018

25.8.2009

21.8.2009

TORISEL

| Wyeth Europa Ltd |
| --- |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire |
| SL6 0PH |
| UNITED KINGDOM |

Wyeth Europa Ltd

Huntercombe Lane South

Taplow

Maidenhead

Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/07/424/001

25.8.2009

21.8.2009

Jalra

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/08/485/001-011

25.8.2009

21.8.2009

Mycophenolate mofetil Teva

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/07/439/001-004

25.8.2009

21.8.2009

TARGRETIN

| Eisai Limited, European Knowledge Centre |
| --- |
| Mosquito Way |
| Hatfield |
| Hertfordshire |
| AL10 9SN |
| UNITED KINGDOM |

Eisai Limited, European Knowledge Centre

Mosquito Way

Hatfield

Hertfordshire

AL10 9SN

UNITED KINGDOM

EU/1/01/178/001

25.8.2009

21.8.2009

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

25.8.2009

21.8.2009

Myfenax

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/07/438/001-004

25.8.2009

21.8.2009

Kaletra

| Abbott Laboratories Ltd |
| --- |
| Queenborough |
| Kent |
| ME11 5EL |
| UNITED KINGDOM |

Abbott Laboratories Ltd

Queenborough

Kent

ME11 5EL

UNITED KINGDOM

EU/1/01/172/001-006

25.8.2009

21.8.2009

Myozyme

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/06/333/001-003

25.8.2009

21.8.2009

Luminity

| Lantheus MI UK Limited |
| --- |
| One South Place |
| London |
| EC2M 2WG |
| UNITED KINGDOM |

Lantheus MI UK Limited

One South Place

London

EC2M 2WG

UNITED KINGDOM

EU/1/06/361/001-002

25.8.2009

21.8.2009

Januvia

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/383/001-018

25.8.2009

21.8.2009

Rotarix

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l'Institut 89 |
| 1330 Rixensart |
| BELGIQUE |

GlaxoSmithKline Biologicals s.a.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/05/330/001-011

25.8.2009

21.8.2009

Privigen

| CSL Behring GmbH |
| --- |
| Emil von Behring Strasse 76 |
| 35041 Marburg |
| DEUTSCHLAND |

CSL Behring GmbH

Emil von Behring Strasse 76

35041 Marburg

DEUTSCHLAND

EU/1/08/446/001-006

25.8.2009

21.8.2009

Competact

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| UNITED KINGDOM |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

UNITED KINGDOM

EU/1/06/354/001-009

25.8.2009

21.8.2009

Abilify

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House |
| Highbridge Business Park |
| Oxford Road |
| Uxbridge |
| Middlesex |
| UB8 1HU |
| UNITED KINGDOM |

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex

UB8 1HU

UNITED KINGDOM

EU/1/04/276/001-020

EU/1/04/276/024-036

25.8.2009

21.8.2009

Mabthera

| 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/1/98/067/001-002

25.8.2009

25.8.2009

Epoetin alfa Hexal

| Hexal AG. |
| --- |
| Industriestrasse 25 |
| 83607 Holzkirchen |
| DEUTSCHLAND |

Hexal AG.

Industriestrasse 25

83607 Holzkirchen

DEUTSCHLAND

EU/1/07/411/001-020

27.8.2009

25.8.2009

Avandamet

| 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/1/03/258/001-022

27.8.2009

25.8.2009

Ranexa

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1, Avenue de la Gare |
| 1611 Luxembourg |
| LUXEMBOURG |

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare

1611 Luxembourg

LUXEMBOURG

EU/1/08/462/001-012

27.8.2009

25.8.2009

Tasigna

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/422/001-004

27.8.2009

25.8.2009

Binocrit

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| ÖSTERREICH |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

ÖSTERREICH

EU/1/07/410/001-020

27.8.2009

25.8.2009

Xiliarx

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/08/486/001-011

27.8.2009

27.8.2009

Thalidomide Celgene

| Celgene Europe Limited |
| --- |
| Riverside House |
| Riverside Walk |
| Windsor |
| SL4 1NA |
| UNITED KINGDOM |

Celgene Europe Limited

Riverside House

Riverside Walk

Windsor

SL4 1NA

UNITED KINGDOM

EU/1/08/443/001

1.9.2009

27.8.2009

CELVAPAN

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Wien |
| ÖSTERREICH |

Baxter AG

Industriestraße 67

1221 Wien

ÖSTERREICH

EU/1/08/506/001

1.9.2009

27.8.2009

Champix

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/06/360/001-012

1.9.2009

27.8.2009

Zeffix

| Glaxo Group Ltd. |
| --- |
| Greenford Road |
| Greenford |
| Middlesex |
| UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd.

Greenford Road

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/99/114/001-003

1.9.2009

27.8.2009

Iscover

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge |
| UB8 1DH |
| UNITED KINGDOM |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

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

EU/1/98/070/005a-005b

EU/1/98/070/006a-006b

EU/1/98/070/007a-007b

EU/1/98/070/008-010

EU/1/98/070/011a-011b

1.9.2009

27.8.2009

Xeristar

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/04/297/001-008

31.8.2009

27.8.2009

Vfend

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/02/212/001-026

1.9.2009

28.8.2009

Pelzont

| 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/1/08/460/001-014

1.9.2009

28.8.2009

Tredaptive

| 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/1/08/459/001-014

1.9.2009

28.8.2009

Trevaclyn

| 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/1/08/458/001-014

1.9.2009

28.8.2009

Irbesartan Krka

| KRKA, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| SI-8501 Novo mesto |
| SLOVENIJA |

KRKA, d.d.

Novo mesto

Šmarješka cesta 6

SI-8501 Novo mesto

SLOVENIJA

EU/1/08/480/001-018

1.9.2009

28.8.2009

Volibris

| Glaxo Group Ltd |
| --- |
| Greenford |
| Middlesex |
| UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/08/451/001-004

1.9.2009

28.8.2009

Panretin

| Eisai Limited, European Knowledge Centre |
| --- |
| Mosquito Way |
| Hatfield |
| Hertfordshire |
| AL10 9SN |
| UNITED KINGDOM |

Eisai Limited, European Knowledge Centre

Mosquito Way

Hatfield

Hertfordshire

AL10 9SN

UNITED KINGDOM

EU/1/00/149/001

1.9.2009

28.8.2009

Humira

| Abbott Laboratories Ltd |
| --- |
| Queenborough |
| Kent |
| ME11 5EL |
| UNITED KINGDOM |

Abbott Laboratories Ltd

Queenborough

Kent

ME11 5EL

UNITED KINGDOM

EU/1/03/256/001-010

1.9.2009

28.8.2009

Forsteo

| 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/1/03/247/001-002

1.9.2009

28.8.2009

Invanz

| 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/1/02/216/001-002

1.9.2009

28.8.2009

Zerit

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge |
| UB8 1DH |
| UNITED KINGDOM |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/96/009/001-009

1.9.2009

28.8.2009

Plavix

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

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

EU/1/98/069/005a-005b

EU/1/98/069/006a-006b

EU/1/98/069/007a-007b

EU/1/98/069/008-010

EU/1/98/069/011a-011b

1.9.2009

28.8.2009

Abseamed

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

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

58638 Iserlohn

DEUTSCHLAND

EU/1/07/412/001-020

1.9.2009

28.8.2009

MicardisPlus

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/02/213/001-023

1.9.2009

28.8.2009

Eucreas

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/425/001-018

1.9.2009

28.8.2009

Aldara

| Meda AB |
| --- |
| Pipers väg 2 |
| SE-170 73 Solna |
| SVËRIGE |

Meda AB

Pipers väg 2

SE-170 73 Solna

SVËRIGE

EU/1/98/080/001

1.9.2009

28.8.2009

Xelevia

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/382/001-018

1.9.2009

31.8.2009

Betaferon

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

Müllerstrasse 170-178

13342 Berlin

DEUTSCHLAND

EU/1/95/003/009-010

2.9.2009

31.8.2009

Neupro

| Schwarz Pharma Ltd |
| --- |
| Shannon, Industrial Estate |
| Co.Clare |
| IRELAND |

Schwarz Pharma Ltd

Shannon, Industrial Estate

Co.Clare

IRELAND

EU/1/05/331/001-055

2.9.2009

31.8.2009

Icandra

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/08/484/001-018

2.9.2009

31.8.2009

Mimpara

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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

NEDERLAND

EU/1/04/292/001-012

2.9.2009

31.8.2009

Tandemact

| Takeda Global Research and Development Centre (Europe) Ltd. |
| --- |
| 61 Aldwich |
| London |
| WC2B 4AE |
| UNITED KINGDOM |

Takeda Global Research and Development Centre (Europe) Ltd.

61 Aldwich

London

WC2B 4AE

UNITED KINGDOM

EU/1/06/366/005-022

2.9.2009

31.8.2009

Gardasil

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

Sanofi Pasteur MSD, SNC

8 rue Jonas Salk

69007 Lyon

FRANCE

EU/1/06/357/001-021

2.9.2009

31.8.2009

Atripla

| Bristol-Myers Squibb and Gilead Sciences Limited |
| --- |
| Unit 13, Stillorgan Industrial Park |
| Blackrock, Co.Dublin |
| IRELAND |

Bristol-Myers Squibb and Gilead Sciences Limited

Unit 13, Stillorgan Industrial Park

Blackrock, Co.Dublin

IRELAND

EU/1/07/430/001-002

2.9.2009

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 27.8.2009 | Aivlosin | ECO Animal Health Ltd |
| 78 Coombe Road |
| New Malden |
| Surrey |
| KT3 4QS |
| UNITED KINGDOM |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

27.8.2009

Aivlosin

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey

KT3 4QS

UNITED KINGDOM

EU/2/04/044/001-010

31.8.2009

31.8.2009

Locatim

| Biokema Anstalt |
| --- |
| Pflugstrasse 12 |
| 9490 Vaduz, Fürstentum |
| LIECHTENSTEIN |

Biokema Anstalt

Pflugstrasse 12

9490 Vaduz, Fürstentum

LIECHTENSTEIN

EU/2/99/011/001

2.9.2009

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

| The European Medicines Agency |
| --- |
| 7 Westferry Circus |
| Canary Wharf |
| London |
| E14 4HB |
| UNITED KINGDOM |

The European Medicines Agency

7 Westferry Circus

Canary Wharf

London

E14 4HB

UNITED KINGDOM

---

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

---

| 25.9.2009 | EN | Official Journal of the European Union | C 231/30 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/30

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 2009

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
   (1)
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
   (2)
  )

2009/C 231/06

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 3.8.2009 | Fenflor | See Annex I | See Annex I | 5.8.2009 |
| 3.8.2009 | Shotaflor | See Annex II | See Annex II | 5.8.2009 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

3.8.2009

Fenflor

See Annex I

See Annex I

5.8.2009

3.8.2009

Shotaflor

See Annex II

See Annex II

5.8.2009

—   Suspension 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 |
| --- | --- | --- | --- | --- |
| 6.8.2009 | Loratadine Sandoz 10 | See Annex III | See Annex III | 7.8.2009 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

6.8.2009

Loratadine Sandoz 10

See Annex III

See Annex III

7.8.2009

---

(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, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER/APPLICANT IN THE MEMBER STATES

| Member State | Applicant/Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Gosmore Ltd |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Member State

Applicant/Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Austria

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Belgium

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Germany

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

France

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Ireland

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Italy

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Poland

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Portugal

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Spain

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

The Netherlands

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

United Kingdom

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER/APPLICANT IN THE MEMBER STATES

| Member State | Applicant/Marketing
  Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Virbac S.A. |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Member State

Applicant/Marketing

Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Austria

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Belgium

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Denmark

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Germany

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

France

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Greece

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Ireland

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Italy

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Portugal

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Spain

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

The Netherlands

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

United Kingdom

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Sandoz GmbH |
| Biochemiestrasse 10 |
| 6250 Kundl |
| AUSTRIA |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

AUSTRIA

Lictyn 10 mg — Tabletten

10 mg

Tablet

Oral use

Bulgaria

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadin Sandoz

10 mg

Tablet

Oral use

Czech Republic

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadin Sandoz 10 mg tablety

10 mg

Tablet

Oral use

Denmark

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| AUSTRIA |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

AUSTRIA

Loratadin Sandoz

10 mg

Tablet

Oral use

Estonia

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Lomilan

10 mg

Tablet

Oral use

Finland

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| AUSTRIA |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

AUSTRIA

Loratadin Sandoz 10 mg

10 mg

Tablet

Oral use

France

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadine Sandoz Conseil 10 mg comprimé

10 mg

Tablet

Oral use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| GERMANY |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

GERMANY

Loratadin Sandoz 10 mg Tabletten

10 mg

Tablet

Oral use

Greece

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| AUSTRIA |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

AUSTRIA

Tirlor

10 mg

Tablet

Oral use

Hungary

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadin Sandoz 10 mg tabletta

10 mg

Tablet

Oral use

Italy

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadina Hexal AG 10 mg compresse

10 mg

Tablet

Oral use

Latvia

| Sandoz B.V. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| SLOVENIA |

Sandoz B.V.

Verovskova 57

SI-1000 Ljubljana

SLOVENIA

Lomilan 10 mg tabletes

10 mg

Tablet

Oral use

Lithuania

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Lomilan

10 mg

Tablet

Oral use

Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadine Sandoz 10, tabletten 10 mg

10 mg

Tablet

Oral use

Norway

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| AUSTRIA |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

AUSTRIA

Loratadin Sandoz 10 mg

10 mg

Tablet

Oral use

Poland

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Flonidan tab

10 mg

Tablet

Oral use

Portugal

| Sandoz Farmacêutica, Lda. |
| --- |
| PRT Alameda da Beloura |
| Edifício 1, 2.o — Escritório 15 |
| 2710-693 Sintra |
| PORTUGAL |

Sandoz Farmacêutica, Lda.

PRT Alameda da Beloura

Edifício 1, 2.o — Escritório 15

2710-693 Sintra

PORTUGAL

Loratadina Sandoz 10 mg Comprimidos

10 mg

Tablet

Oral use

Romania

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadina Sandoz 10 mg comprimate

10 mg

Tablet

Oral use

Slovak Republic

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Flonidan 10 mg tablety

10 mg

Tablet

Oral use

Slovenia

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Florin 10 mg tablete

10 mg

Tablet

Oral use

Spain

| Sandoz Farmacéutica, S.A. |
| --- |
| Gran Via de los Corts Catalanes, 764 |
| 08013 Barcelona |
| SPAIN |

Sandoz Farmacéutica, S.A.

Gran Via de los Corts Catalanes, 764

08013 Barcelona

SPAIN

Loratadina Genpril 10 mg Comprimidos EFG

10 mg

Tablet

Oral use

Sweden

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| AUSTRIA |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

AUSTRIA

Loratadin Sandoz 10 mg

10 mg

Tablet

Oral use

United Kingdom

| Sandoz Limited |
| --- |
| Woolmer way |
| Bordon, Hants |
| GU35 9QE |
| UNITED KINGDOM |

Sandoz Limited

Woolmer way

Bordon, Hants

GU35 9QE

UNITED KINGDOM

Loratadine 10 mg Tablets

10 mg

Tablet

Oral use

---

The Court of Auditors

| 25.9.2009 | EN | Official Journal of the European Union | C 231/38 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/38

---

Special Report No 6/2009 ‘European Union food aid for deprived persons: an assessment of the objectives, the means and the methods employed’

2009/C 231/07

The European Court of Auditors hereby informs you that Special Report No 6/2009 ‘European Union food aid for deprived persons: an assessment of the objectives, the means and the methods employed’ has just been published.

The report can be accessed for consultation or downloading on the European Court of Auditors’ website: http://www.eca.europa.eu

A hard copy and a CD-ROM version of the report may be obtained free of charge on request to the Court of Auditors:

| European Court of Auditors |
| --- |
| Communication and Reports Unit |
| 12, rue Alcide De Gasperi |
| 1615 Luxembourg |
| LUXEMBOURG |
| Tel. +352 4398-1 |
| E-mail: euraud@eca.europa.eu |

European Court of Auditors

Communication and Reports Unit

12, rue Alcide De Gasperi

1615 Luxembourg

LUXEMBOURG

Tel. +352 4398-1

E-mail: euraud@eca.europa.eu

or by filling in an electronic order form at EU-Bookshop.

---

NOTICES FROM MEMBER STATES

| 25.9.2009 | EN | Official Journal of the European Union | C 231/39 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/39

---

Extract from the Decision concerning Reykjavík Savings Bank pursuant to Directive 2001/24/EC of the European Parliament and of the Council on the reorganisation and winding-up of credit institutions

2009/C 231/08

INVITATION TO LODGE A CLAIM — TIME LIMITS TO BE OBSERVED

Under the statutory authority of the Financial Institutions Act No 161/2002, Article 100a, cf. Article 5 of the Authority for Treasury Disbursements due to Unusual Financial Market Circumstances Act No 129/2008, that was in effect at the time, the Financial Supervisory Authority, on 21 March 2009, assumed the power of a shareholders’ meeting of Reykjavík Savings Bank (SPRON), and appointed a Resolution Committee. Under Act No 44/2009 the Resolution Committee of Reykjavík Savings Bank adopted the responsibility of an Interim Board. Under Act No 161/2002, Article 100a(3), the Interim Board completed its three-month fixed term on 23 June 2009, when Reykjavík District Court appointed a Winding-Up Board for Reykjavík Savings Bank which is responsible for the processing of claims against the bank during the winding-up proceedings, and overseeing the winding-up process.

The date of respite is 30 October 2008 under the Financial Institutions Act No 161/2002, Article 101(4). The initial date of the winding-up proceedings was decided on the basis of the ruling of the Reykjavík District Court on the appointment of the Winding-Up Board on 23 June 2009, cf. the Act No 44/2009, Article 102(3)(2).

Anyone who wishes to lodge a claim against Reykjavík Savings Bank, or assets under the auspices of the bank, are hereby urged to lodge their claims in writing to the Winding-Up Board of SPRON within six months from the published invitation to lodge a claim in your country, a global newspaper or the Official Journal of the European Union. The claims must be received by the Winding-Up Board within the aforementioned deadline, their content being in line with the instructions of the Act on Bankruptcy, etc., No 21/1991, Article 117(2) and (3).

The statements of claims should be submitted to:

| The Winding-Up Board of Reykjavík Savings Bank |
| --- |
| Lágmúli 6 |
| 108 Reykjavík |
| ICELAND |

The Winding-Up Board of Reykjavík Savings Bank

Lágmúli 6

108 Reykjavík

ICELAND

Due to the aforementioned provisions of law, the claimants, in the lodgement of claims, are requested to specify the total amount of the claim as of 23 June 2009.

Claims that are made in a foreign currency should be specified in the currency in question. However, claimants within the member countries of the European Economic Area and the European Free-Trade Association are authorised to lodge their claims in the language of their home country. Such lodgement of claims shall be accompanied by an Icelandic translation. However, claims may be lodged in English without an accompanying translation. Other claimants may specify their claims in Icelandic or English.

In the event that claims are not lodged within the aforementioned time limit, they shall be interpreted in the same manner as an inadequate specification of a claim under the Act on Bankruptcy, etc. No 21/1991, Article 118, thus ceasing to apply against Reykjavik Savings Bank, unless any of the sub-paragraphs No 1-6 of the provision apply.

It should be emphasized that by lodging a claim, the claimant will be considered to have rescinded any confidentiality (e.g. bank secrecy) regarding the claim in question.

A meeting of claimants will be held on Wednesday 17 March 2010 at 10.00 a.m., at the Hilton Hotel Nordica, Suðurlandsbraut 2, Reykjavík. Those who have lodged their claims against the bank have a right to attend the meeting. At the meeting, a list of the lodged claims will be presented as well as the Winding-Up Board’s position as it will be available at that time. At least one week before the aforementioned meeting, a list of the claims lodged will be available to those who have lodged their claims against the bank.

Further information on the lodging and processing of claims will be made available on the bank’s website, http://www.spron.is. The Winding-Up Board would like to make the following recommendations to the claimants:

| (a) | to specify their email address, or information regarding their representative, when lodging a claim, so as to facilitate the dissemination of information; |
| --- | --- |

(a)

to specify their email address, or information regarding their representative, when lodging a claim, so as to facilitate the dissemination of information;

| (b) | to specify a bank account so as to facilitate any disbursement if and when it would occur; |
| --- | --- |

(b)

to specify a bank account so as to facilitate any disbursement if and when it would occur;

| (c) | to lodge their claims as soon as possible subsequent to this invitation to lodge a claim. |
| --- | --- |

(c)

to lodge their claims as soon as possible subsequent to this invitation to lodge a claim.

Please note that a sample of a lodged claim can be found on http://www.spron.is

Reykjavík, 14 July 2009.

The Winding-Up Board of Reykjavík Savings Bank

Hildur Sólveig PÉTURSDÓTTIR, Attorney to the Supreme Court

Hlynur JÓNSSON, Attorney to the District Court

Jóhann PÉTURSSON, Attorney to the District Court

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V Announcements

ADMINISTRATIVE PROCEDURES

Commission

| 25.9.2009 | EN | Official Journal of the European Union | C 231/41 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/41

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Call for proposals — EACEA/23/09

MEDIA 2007: Audiovisual festivals

2009/C 231/09

1.   Objectives and Description

This notice of a call for proposals is based on Decision No 1718/2006/EC of the European Parliament and of the Council of 15 November 2006 concerning the implementation of a programme of support for the European audiovisual sector (MEDIA 2007).

The objectives of the above mentioned Council Decision include:

| — | facilitating and encouraging the promotion and movement of European audiovisual and cinema works at trade shows, fairs and audiovisual festivals in Europe and around the globe, insofar as such events may play an important role in the promotion of European works and the networking of professionals, |
| --- | --- |

—

facilitating and encouraging the promotion and movement of European audiovisual and cinema works at trade shows, fairs and audiovisual festivals in Europe and around the globe, insofar as such events may play an important role in the promotion of European works and the networking of professionals,

| — | improve access to European audiovisual works for the European and international public. |
| --- | --- |

—

improve access to European audiovisual works for the European and international public.

2.   Eligible applicants

The present notification is addressed to European organisations; those registered in and controlled by nationals from the Member States of the European Union and countries of the European Economic Agreement participating in the MEDIA 2007 programme (Iceland, Liechtenstein, Norway), Croatia and Switzerland.

3.   Eligible actions

Such organisations must implement audiovisual festivals which contribute to the aforementioned objectives and which screen a minimum of 70 % European films from at least 10 States participating in the MEDIA programme, in their total programme.

The present call for proposals is only valid for projects which start between 1 May 2010 and 30 April 2011.

4.   Award criteria

Points will be allocated out of a total of 100 on the basis of the following weighting:

| — | the European dimension of the programming (15 points) |
| --- | --- |

—

the European dimension of the programming (15 points)

| — | cultural and geographic diversity of the programming (20 points) |
| --- | --- |

—

cultural and geographic diversity of the programming (20 points)

| — | quality and innovative nature of the programming (10 points) |
| --- | --- |

—

quality and innovative nature of the programming (10 points)

| — | audience impact (30 points) |
| --- | --- |

—

audience impact (30 points)

| — | impact on the promotion and circulation of European audiovisual works (15 points) |
| --- | --- |

—

impact on the promotion and circulation of European audiovisual works (15 points)

| — | film professionals’ participation (10 points). |
| --- | --- |

—

film professionals’ participation (10 points).

5.   Budget

The maximum amount available under this call for proposals is EUR 3 500 000 (providing the EU budget for 2010 is approved).

The financial support from the Commission cannot exceed 50 % of the total eligible costs. The maximum grant will be EUR 75 000.

The Agency reserves the right not to allocate all the available funds.

6.   Deadline

Closing dates for submitting proposals:

—   27.11.2009: for projects starting between 1 May 2010 and 31 October 2010

—   30.4.2010: for projects starting between 1 November 2010 and 30 April 2011

Applications must be submitted to the Executive Agency (EACEA) to the following address:

| Agence Exécutive Education Audiovisuel et Culture (EACEA) |
| --- |
| Unité Programme MEDIA — P8 |
| Appel à Propositions — EACEA/23/2009 — FESTIVALS AUDIOVISUELS |
| M. Constantin DASKALAKIS |
| BOUR 03/30 |
| Avenue du Bourget 1 |
| 1140 Bruxelles |
| BELGIQUE |

Agence Exécutive Education Audiovisuel et Culture (EACEA)

Unité Programme MEDIA — P8

Appel à Propositions — EACEA/23/2009 — FESTIVALS AUDIOVISUELS

M. Constantin DASKALAKIS

BOUR 03/30

Avenue du Bourget 1

1140 Bruxelles

BELGIQUE

Only applications submitted on the official application form, duly signed by the person entitled to enter into legally binding commitments on behalf of the applicant organisation and containing all the information and annexes specified in the full text of the call will be accepted.

Applications sent by fax or email will be rejected.

7.   Further information

The guidelines, as well as the application forms are available on http://ec.europa.eu/media

Applications must comply with all the terms of the guidelines and be submitted on the forms provided. For general terms and conditions see http://ec.europa.eu/information_society/media/festiv/forms/index_en.htm

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| 25.9.2009 | EN | Official Journal of the European Union | C 231/43 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/43

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MEDIA 2007 — DEVELOPMENT, DISTRIBUTION, PROMOTION AND TRAINING

Call for proposals — EACEA 18/09

Support for television broadcasting of European audiovisual works

2009/C 231/10

1.   Objectives and description

This notice of a call for proposals is based on Decision No 1718/2006/EC of the European Parliament and of the Council of 15 November 2006 concerning the implementation of a programme of support for the European audiovisual sector (MEDIA 2007).

One of the objectives of the programme is to promote the transnational broadcasting of European audiovisual works produced by independent production companies by encouraging cooperation between broadcasters on one hand, and independent producers and distributors on the other.

2.   Eligible applicants

This notice is aimed at European companies whose activities contribute to the attainment of the above objectives, and in particular to independent TV production companies.

Applicants must be established in one of the following countries:

| — | the 27 countries of the European Union, |
| --- | --- |

—

the 27 countries of the European Union,

| — | the EFTA countries, Croatia and Switzerland. |
| --- | --- |

—

the EFTA countries, Croatia and Switzerland.

3.   Eligible actions

The audiovisual work proposed must be an independent European television production (fiction, animation or creative documentary) involving the participation of at least three broadcasting companies from several Member States of the European Union or countries participating in the MEDIA 2007 Programme.

The application must be submitted at the earliest six months before the first day of principal photography and at the latest on the first day of principal photography.

The maximum duration of the projects is 30 or 42 (in the case of series and animation projects) months.

4.   Award criteria

Points will be allocated out of a total of 100 on the basis of the following weighting; the aspects taken into account are mentioned below each criterion:

| — | The European dimension and financing of the work (45 points):






  — | the country of origin of the applicant company; |
| --- | --- | --- |

—

The European dimension and financing of the work (45 points):

—

the country of origin of the applicant company;

| — | the number of broadcasters attached to the work; |
| --- | --- |

—

the number of broadcasters attached to the work;

| — | the financial involvement of the broadcasters; |
| --- | --- |

—

the financial involvement of the broadcasters;

| — | the level of non-national financing. |
| --- | --- |

—

the level of non-national financing.

| — | International distributor's involvement (10 points):






  — | number and track record of the distributors involved in the work; |
| --- | --- | --- |

—

International distributor's involvement (10 points):

—

number and track record of the distributors involved in the work;

| — | amount of the distributor's involvement; |
| --- | --- |

—

amount of the distributor's involvement;

| — | existence of a distribution arm in the applicant production company. |
| --- | --- |

—

existence of a distribution arm in the applicant production company.

| — | International appeal of the work (25 points):






  — | the quality of the work; |
| --- | --- | --- |

—

International appeal of the work (25 points):

—

the quality of the work;

| — | the international sales potential; |
| --- | --- |

—

the international sales potential;

| — | the international marketing strategy. |
| --- | --- |

—

the international marketing strategy.

| — | Enhancement of European linguistic and cultural diversity (7 points):






  — | number of linguistic areas covered; |
| --- | --- | --- |

—

Enhancement of European linguistic and cultural diversity (7 points):

—

number of linguistic areas covered;

| — | promotion of European cultural diversity. |
| --- | --- |

—

promotion of European cultural diversity.

| — | Enhancement of the European audiovisual heritage (3 points):






  — | examination of the archive material used. |
| --- | --- | --- |

—

Enhancement of the European audiovisual heritage (3 points):

—

examination of the archive material used.

| — | Track record of international sales (10 points):






  — | international sales achieved in the last five years by the applicant company/producer. |
| --- | --- | --- |

—

Track record of international sales (10 points):

—

international sales achieved in the last five years by the applicant company/producer.

5.   Budget

The total budget available is EUR 10,4 million.

The financial contribution awarded is a subsidy. The maximum financial contribution which may be awarded is EUR 500 000 per work for fiction and animation projects and EUR 300 000 per work for documentary projects. The financial contribution awarded will in no event exceed 12,5 % of the eligible costs submitted by the producer for fiction and animated films and 20 % of the eligible costs for documentary films.

6.   Deadline for submission of applications

Applications must be submitted to the Executive Agency (EACEA) no later than 27 November 2009, 5 March 2010 and 28 June 2010 to the following address:

| Education, Audiovisual and Culture Executive Agency (EACEA) — MEDIA |
| --- |
| Constantin Daskalakis |
| BOUR 3/30 |
| Avenue du Bourget 1 |
| 1140 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

Education, Audiovisual and Culture Executive Agency (EACEA) — MEDIA

Constantin Daskalakis

BOUR 3/30

Avenue du Bourget 1

1140 Bruxelles/Brussel

BELGIQUE/BELGIË

Only applications submitted on the official application form, duly signed by the person entitled to enter into legally binding commitments on behalf of the applicant organisation and containing all the information and annexes specified in the full text of the call will be accepted.

Applications sent by fax or email will be rejected

7.   Full details

The full text of the guidelines together with the application forms, can be found at the following Internet address: http://ec.europa.eu/information_society/media/producer/tv/index_en.htm

Applications must comply with all the terms of the guidelines and be submitted on the forms provided.

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PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 25.9.2009 | EN | Official Journal of the European Union | C 231/45 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/45

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Prior notification of a concentration

(Case COMP/M.5573 — Remeha Group/Baxi Holdings)

(Text with EEA relevance)

2009/C 231/11

| 1. | On 16 September 2009 the Commission received a notification of a proposed concentration pursuant to Article 4 and following a referral pursuant to Article 4(5) of Council Regulation (EC) No 139/2004 (1) by which the undertakings De Dietrich Remeha Holding B.V. (‘Remeha’, The Netherlands) acquires within the meaning of Article 3(1)(b) of the Regulation control of the whole of the undertaking Baxi Holdings Limited (‘Baxi’, United Kingdom) by way of purchase of shares. |
| --- | --- |

1.

On 16 September 2009 the Commission received a notification of a proposed concentration pursuant to Article 4 and following a referral pursuant to Article 4(5) of Council Regulation (EC) No 139/2004 (1) by which the undertakings De Dietrich Remeha Holding B.V. (‘Remeha’, The Netherlands) acquires within the meaning of Article 3(1)(b) of the Regulation control of the whole of the undertaking Baxi Holdings Limited (‘Baxi’, United Kingdom) by way of purchase of shares.

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






  — | for Remeha: development, manufacture an sale of heating products, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Remeha: development, manufacture an sale of heating products,

| — | for Baxi: development, manufacture an sale of heating products. |
| --- | --- |

—

for Baxi: development, manufacture an sale of heating 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 (+32 22964301 or 22967244) or by post, under reference number COMP/M.5573 — Remeha Group/Baxi Holdings, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301 or 22967244) or by post, under reference number COMP/M.5573 — Remeha Group/Baxi Holdings, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

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

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| 25.9.2009 | EN | Official Journal of the European Union | C 231/46 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/46

---

Prior notification of a concentration

(Case COMP/M.5649 — RREEF Fund/ENDESA/UFG/SAGGAS)

(Text with EEA relevance)

2009/C 231/12

| 1. | On 17 September 2009, 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 RREEF Pan-European Infrastructure Fund LP (‘RREEF Fund’, United Kingdom), ultimately managed by Deutsche Bank (‘DB’, Germany), ENDESA Generación S.A. (‘ENDESA’, Spain), controlled by the group ENEL S.p.A. (‘ENEL’, Italy) and UNION FENOSA GAS, S.A. (‘UFG’, Spain), which is a joint venture between Unión Fenosa S.A. (now Gas Natural SDG, S.A. ‘GN’, Spain), and ENI S.p.A (‘ENI’, Italy), acquire, within the meaning of Article 3(1)(b) of the Council Regulation, joint control of the undertaking Planta De Regasification De Sagunto S.A. (‘SAGGAS’, Spain) by way of purchase of shares in an existing joint venture. Currently, SAGGAS is jointly controlled by UFG, Iberdrola S.A. (Spain) and ENDESA. |
| --- | --- |

1.

On 17 September 2009, 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 RREEF Pan-European Infrastructure Fund LP (‘RREEF Fund’, United Kingdom), ultimately managed by Deutsche Bank (‘DB’, Germany), ENDESA Generación S.A. (‘ENDESA’, Spain), controlled by the group ENEL S.p.A. (‘ENEL’, Italy) and UNION FENOSA GAS, S.A. (‘UFG’, Spain), which is a joint venture between Unión Fenosa S.A. (now Gas Natural SDG, S.A. ‘GN’, Spain), and ENI S.p.A (‘ENI’, Italy), acquire, within the meaning of Article 3(1)(b) of the Council Regulation, joint control of the undertaking Planta De Regasification De Sagunto S.A. (‘SAGGAS’, Spain) by way of purchase of shares in an existing joint venture. Currently, SAGGAS is jointly controlled by UFG, Iberdrola S.A. (Spain) and ENDESA.

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






  — | for RREEF Fund: investment fund active in banking, financial and related services worldwide, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for RREEF Fund: investment fund active in banking, financial and related services worldwide,

| — | for UFG: supply of gas to undertakings and individuals in Spain, |
| --- | --- |

—

for UFG: supply of gas to undertakings and individuals in Spain,

| — | for ENDESA: generation, distribution and supply of electricity in Europe, South America and North Africa. It is also active in electricity trading throughout Europe, and natural gas, coal mining and real estate in Spain, |
| --- | --- |

—

for ENDESA: generation, distribution and supply of electricity in Europe, South America and North Africa. It is also active in electricity trading throughout Europe, and natural gas, coal mining and real estate in Spain,

| — | for SAGGAS: regasification of liquid natural gas in Spain. |
| --- | --- |

—

for SAGGAS: regasification of liquid natural gas in Spain.

| 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 (+32 22964301 or 22967244) or by post, under reference number COMP/M.5649 — RREEF Fund/ENDESA/UFG/SAGGAS, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301 or 22967244) or by post, under reference number COMP/M.5649 — RREEF Fund/ENDESA/UFG/SAGGAS, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

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

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Corrigenda

| 25.9.2009 | EN | Official Journal of the European Union | C 231/47 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/47

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Corrigendum to training of national judges in EC competition law and judicial cooperation between national judges

(
  Official Journal of the European Union C 223 of 16 September 2009
  )

2009/C 231/13

On page 14, under ‘Deadline for application’:

for:

‘13 November 2009’,

read:

‘27 November 2009’.

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