# Official Journal C 48/2009

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 48 |
| | |
| English edition | Information and Notices | Volume 5227 February 2009 |

ISSN 1725-2423

Official Journal

of the European Union

C 48

English edition

Information and Notices

Volume 5227 February 2009

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 048/01 | Non-opposition to a notified concentration (Case COMP/M.5471 — Goldman Sachs/Constellation Energy Commodities) (
  1
  ) | 1 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 048/01

Non-opposition to a notified concentration (Case COMP/M.5471 — Goldman Sachs/Constellation Energy Commodities) (
  1
  )

1

1

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 048/02 | Euro exchange rates | 2 |
| 2009/C 048/03 | Commission notice on current State aid recovery interest rates and reference/discount rates for 27 Member States applicable as from 1 March 2009(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 (OJ L 140, 30.4.2004, p. 1)) | 3 |
| 2009/C 048/04 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 2009(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 4 |
| 2009/C 048/05 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 2009(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  ) | 12 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 048/02

Euro exchange rates

2

2009/C 048/03

Commission notice on current State aid recovery interest rates and reference/discount rates for 27 Member States applicable as from 1 March 2009(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 (OJ L 140, 30.4.2004, p. 1))

(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 (OJ L 140, 30.4.2004, p. 1))

3

2009/C 048/04

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 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)

4

2009/C 048/05

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 2009(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC

or Article 38 of Directive 2001/82/EC

)

12

| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2009/C 048/06 | Communication from the French Government concerning Directive 94/22/EC of the European Parliament and of the Council on the conditions for granting and using authorisations for the prospection, exploration and production of hydrocarbons (Notice regarding an application for an exclusive licence to prospect for oil and gas, designated the Permis de Champrose)
   (
  1
  ) | 25 |
| 2009/C 048/07 | Prior notification of a concentration (Case COMP/M.5455 — TPV/Philips Branded Monitors) (
  1
  ) | 27 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2009/C 048/06

Communication from the French Government concerning Directive 94/22/EC of the European Parliament and of the Council on the conditions for granting and using authorisations for the prospection, exploration and production of hydrocarbons (Notice regarding an application for an exclusive licence to prospect for oil and gas, designated the Permis de Champrose)
   (
  1
  )

(Notice regarding an application for an exclusive licence to prospect for oil and gas, designated the Permis de Champrose)

1

25

2009/C 048/07

Prior notification of a concentration (Case COMP/M.5455 — TPV/Philips Branded Monitors) (
  1
  )

1

27

| | |
| --- | --- |
| 2009/C 048/08 | Notice | s3 |

2009/C 048/08

Notice

Notice

s3

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

---

(1)   Text with EEA relevance

1

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

EN

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 27.2.2009 | EN | Official Journal of the European Union | C 48/1 |
| --- | --- | --- | --- |

27.2.2009

EN

Official Journal of the European Union

C 48/1

---

Non-opposition to a notified concentration

(Case COMP/M.5471 — Goldman Sachs/Constellation Energy Commodities)

(Text with EEA relevance)

(2009/C 48/01)

On 23 February 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:

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

—

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

| — | in electronic form on the EUR-Lex website under document number 32009M5471. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu). |
| --- | --- |

—

in electronic form on the EUR-Lex website under document number 32009M5471. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 27.2.2009 | EN | Official Journal of the European Union | C 48/2 |
| --- | --- | --- | --- |

27.2.2009

EN

Official Journal of the European Union

C 48/2

---

Euro exchange rates (1)

26 February 2009

(2009/C 48/02)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2782 |
| JPY | Japanese yen | 125,33 |
| DKK | Danish krone | 7,4499 |
| GBP | Pound sterling | 0,89130 |
| SEK | Swedish krona | 11,3175 |
| CHF | Swiss franc | 1,4848 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 8,7780 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 28,333 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 300,02 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7094 |
| PLN | Polish zloty | 4,6960 |
| RON | Romanian leu | 4,2904 |
| TRY | Turkish lira | 2,1580 |
| AUD | Australian dollar | 1,9590 |
| CAD | Canadian dollar | 1,5885 |
| HKD | Hong Kong dollar | 9,9108 |
| NZD | New Zealand dollar | 2,4953 |
| SGD | Singapore dollar | 1,9633 |
| KRW | South Korean won | 1 931,75 |
| ZAR | South African rand | 12,6350 |
| CNY | Chinese yuan renminbi | 8,7429 |
| HRK | Croatian kuna | 7,3860 |
| IDR | Indonesian rupiah | 15 386,97 |
| MYR | Malaysian ringgit | 4,6916 |
| PHP | Philippine peso | 61,900 |
| RUB | Russian rouble | 45,5350 |
| THB | Thai baht | 45,939 |
| BRL | Brazilian real | 3,0144 |
| MXN | Mexican peso | 19,0420 |
| INR | Indian rupee | 64,4150 |

Currency

Exchange rate

USD

US dollar

1,2782

JPY

Japanese yen

125,33

DKK

Danish krone

7,4499

GBP

Pound sterling

0,89130

SEK

Swedish krona

11,3175

CHF

Swiss franc

1,4848

ISK

Iceland króna

NOK

Norwegian krone

8,7780

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

28,333

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

300,02

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7094

PLN

Polish zloty

4,6960

RON

Romanian leu

4,2904

TRY

Turkish lira

2,1580

AUD

Australian dollar

1,9590

CAD

Canadian dollar

1,5885

HKD

Hong Kong dollar

9,9108

NZD

New Zealand dollar

2,4953

SGD

Singapore dollar

1,9633

KRW

South Korean won

1 931,75

ZAR

South African rand

12,6350

CNY

Chinese yuan renminbi

8,7429

HRK

Croatian kuna

7,3860

IDR

Indonesian rupiah

15 386,97

MYR

Malaysian ringgit

4,6916

PHP

Philippine peso

61,900

RUB

Russian rouble

45,5350

THB

Thai baht

45,939

BRL

Brazilian real

3,0144

MXN

Mexican peso

19,0420

INR

Indian rupee

64,4150

---

(1)

Source: reference exchange rate published by the ECB.

---

| 27.2.2009 | EN | Official Journal of the European Union | C 48/3 |
| --- | --- | --- | --- |

27.2.2009

EN

Official Journal of the European Union

C 48/3

---

Commission notice on current State aid recovery interest rates and reference/discount rates for 27 Member States applicable as from 1 March 2009

(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 (OJ L 140, 30.4.2004, p. 1))

(2009/C 48/03)

Base rates calculated in accordance with the Communication from the Commission on the revision of the method for setting the reference and discount rates (OJ C 14, 19.1.2008, p. 6). Depending on the use of the reference rate, the appropriate margins have still to be added as defined in this communication. For the discount rate this means that a margin of 100 basis points has to be added. The Commission Regulation (EC) No 271/2008 of 30 January 2008 amending the implementing Regulation (EC) No 794/2004 foresees that, unless otherwise provided for in a specific decision, the recovery rate will also be calculated by adding 100 basis points to the base rate.

| From | To | AT | BE | BG | CY | CZ | DE | DK | EE | EL | ES | FI | FR | HU | IE | IT | LT | LU | LV | MT | NL | PL | PT | RO | SE | SI | SK | UK |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1.3.2009 | ... | 3,47 | 3,47 | 7,63 | 3,47 | 3,74 | 3,47 | 6,00 | 7,34 | 3,47 | 3,47 | 3,47 | 3,47 | 10,01 | 3,47 | 3,47 | 9,53 | 3,47 | 13,20 | 3,47 | 3,47 | 6,78 | 3,47 | 17,29 | 3,31 | 3,47 | 3,47 | 3,58 |
| 1.2.2009 | 28.2.2009 | 4,99 | 4,99 | 7,63 | 4,99 | 4,53 | 4,99 | 6,00 | 7,34 | 4,99 | 4,99 | 4,99 | 4,99 | 10,01 | 4,99 | 4,99 | 7,81 | 4,99 | 13,20 | 4,99 | 4,99 | 6,78 | 4,99 | 17,29 | 4,31 | 4,99 | 4,99 | 4,81 |
| 1.1.2009 | 31.1.2009 | 4,99 | 4,99 | 7,63 | 4,99 | 4,53 | 4,99 | 6,00 | 7,34 | 4,99 | 4,99 | 4,99 | 4,99 | 10,01 | 4,99 | 4,99 | 7,81 | 4,99 | 11,05 | 4,99 | 4,99 | 6,78 | 4,99 | 17,29 | 5,18 | 4,99 | 4,99 | 5,70 |
| 1.12.2008 | 31.12.2008 | 5,36 | 5,36 | 6,70 | 5,36 | 4,20 | 5,36 | 5,55 | 6,43 | 5,36 | 5,36 | 5,36 | 5,36 | 8,58 | 5,36 | 5,36 | 7,10 | 5,36 | 9,44 | 5,36 | 5,36 | 6,42 | 5,36 | 15,87 | 5,49 | 5,36 | 5,00 | 5,66 |
| 1.11.2008 | 30.11.2008 | 5,36 | 5,36 | 6,70 | 5,36 | 4,20 | 5,36 | 5,55 | 6,43 | 5,36 | 5,36 | 5,36 | 5,36 | 8,58 | 5,36 | 5,36 | 6,10 | 5,36 | 9,44 | 5,36 | 5,36 | 6,42 | 5,36 | 11,02 | 5,49 | 5,36 | 5,00 | 5,66 |
| 1.10.2008 | 31.10.2008 | 5,36 | 5,36 | 6,70 | 5,36 | 4,20 | 5,36 | 5,55 | 6,43 | 5,36 | 5,36 | 5,36 | 5,36 | 8,58 | 5,36 | 5,36 | 6,10 | 5,36 | 9,44 | 5,36 | 5,36 | 6,42 | 5,36 | 11,02 | 5,49 | 5,36 | 4,34 | 5,66 |
| 1.9.2008 | 30.9.2008 | 4,59 | 4,59 | 6,70 | 4,59 | 4,20 | 4,59 | 5,55 | 6,43 | 4,59 | 4,59 | 4,59 | 4,59 | 8,58 | 4,59 | 4,59 | 6,10 | 4,59 | 9,44 | 4,59 | 4,59 | 6,42 | 4,59 | 11,02 | 5,49 | 4,59 | 4,34 | 5,66 |
| 1.7.2008 | 31.8.2008 | 4,59 | 4,59 | 6,70 | 4,59 | 4,20 | 4,59 | 4,81 | 6,43 | 4,59 | 4,59 | 4,59 | 4,59 | 8,58 | 4,59 | 4,59 | 6,10 | 4,59 | 9,44 | 4,59 | 4,59 | 6,42 | 4,59 | 11,02 | 4,75 | 4,59 | 4,34 | 5,66 |

From

To

AT

BE

BG

CY

CZ

DE

DK

EE

EL

ES

FI

FR

HU

IE

IT

LT

LU

LV

MT

NL

PL

PT

RO

SE

SI

SK

UK

1.3.2009

...

3,47

3,47

7,63

3,47

3,74

3,47

6,00

7,34

3,47

3,47

3,47

3,47

10,01

3,47

3,47

9,53

3,47

13,20

3,47

3,47

6,78

3,47

17,29

3,31

3,47

3,47

3,58

1.2.2009

28.2.2009

4,99

4,99

7,63

4,99

4,53

4,99

6,00

7,34

4,99

4,99

4,99

4,99

10,01

4,99

4,99

7,81

4,99

13,20

4,99

4,99

6,78

4,99

17,29

4,31

4,99

4,99

4,81

1.1.2009

31.1.2009

4,99

4,99

7,63

4,99

4,53

4,99

6,00

7,34

4,99

4,99

4,99

4,99

10,01

4,99

4,99

7,81

4,99

11,05

4,99

4,99

6,78

4,99

17,29

5,18

4,99

4,99

5,70

1.12.2008

31.12.2008

5,36

5,36

6,70

5,36

4,20

5,36

5,55

6,43

5,36

5,36

5,36

5,36

8,58

5,36

5,36

7,10

5,36

9,44

5,36

5,36

6,42

5,36

15,87

5,49

5,36

5,00

5,66

1.11.2008

30.11.2008

5,36

5,36

6,70

5,36

4,20

5,36

5,55

6,43

5,36

5,36

5,36

5,36

8,58

5,36

5,36

6,10

5,36

9,44

5,36

5,36

6,42

5,36

11,02

5,49

5,36

5,00

5,66

1.10.2008

31.10.2008

5,36

5,36

6,70

5,36

4,20

5,36

5,55

6,43

5,36

5,36

5,36

5,36

8,58

5,36

5,36

6,10

5,36

9,44

5,36

5,36

6,42

5,36

11,02

5,49

5,36

4,34

5,66

1.9.2008

30.9.2008

4,59

4,59

6,70

4,59

4,20

4,59

5,55

6,43

4,59

4,59

4,59

4,59

8,58

4,59

4,59

6,10

4,59

9,44

4,59

4,59

6,42

4,59

11,02

5,49

4,59

4,34

5,66

1.7.2008

31.8.2008

4,59

4,59

6,70

4,59

4,20

4,59

4,81

6,43

4,59

4,59

4,59

4,59

8,58

4,59

4,59

6,10

4,59

9,44

4,59

4,59

6,42

4,59

11,02

4,75

4,59

4,34

5,66

---

| 27.2.2009 | EN | Official Journal of the European Union | C 48/4 |
| --- | --- | --- | --- |

27.2.2009

EN

Official Journal of the European Union

C 48/4

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 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 48/04)

—   Issuing of a marketing authorization (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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
  (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.1.2009 | RoActemra | Tocilizumab | Roche Registration Limited |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City AL7 1TW |
| United Kingdom |

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

16.1.2009

RoActemra

Tocilizumab

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/08/492/001-006

Concentrate for solution for infusion

L04AC07

20.1.2009

16.1.2009

Rasilez HCT

Aliskiren hemifumarate/hydrochlorothiazide

| 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/1/08/491/001-080

Film-coated tablet

C09XA52

20.1.2009

16.1.2009

STELARA

Ustekinumab

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

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/08/494/001-002

Solution for injection

L04AC05

20.1.2009

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 5.1.2009 | Tasigna | Novartis Europharm Limited |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

5.1.2009

Tasigna

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/422/001-004

8.1.2009

5.1.2009

Irbesartan HCT 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/1/06/369/011-028

7.1.2009

6.1.2009

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

8.1.2009

6.1.2009

Prevenar

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

Wyeth-Lederle Vaccines S.A.

Rue du Bosquet, 15

B-1348 Louvain-La-Neuve

EU/1/00/167/001-008

8.1.2009

6.1.2009

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

8.1.2009

7.1.2009

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/1/96/007/010-011

EU/1/96/007/015-021

EU/1/96/007/023-030

EU/1/96/007/037-038

9.1.2009

7.1.2009

Irbesartan HCT Winthrop

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

Sanofi Pharma Bristol-Myers Squibb SNC

174, avenue de France

F-75013 Paris

EU/1/06/377/011-028

9.1.2009

7.1.2009

Levemir

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

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/04/278/001-009

9.1.2009

7.1.2009

Zevalin

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

Bayer Schering Pharma AG

D-13342 Berlin

EU/1/03/264/001

12.1.2009

7.1.2009

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

9.1.2009

7.1.2009

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

9.1.2009

7.1.2009

Retacrit

| HOSPIRA Enterprises B.V. |
| --- |
| Taurusavenue 19-21b |
| 2132 LS Hoofddorp |
| Nederland |

HOSPIRA Enterprises B.V.

Taurusavenue 19-21b

2132 LS Hoofddorp

Nederland

EU/1/07/431/001-025

12.1.2009

7.1.2009

BYETTA

| 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/1/06/362/001-004

9.1.2009

7.1.2009

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/1/05/319/001-004

9.1.2009

9.1.2009

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/1/06/363/010-011

13.1.2009

9.1.2009

IntronA

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

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

B-1180 Bruxelles/Brussel

EU/1/99/127/001-044

13.1.2009

9.1.2009

Rilutek

| Aventis Pharma S.A. |
| --- |
| 20, avenue Raymond Aron |
| F-92160 Antony |

Aventis Pharma S.A.

20, avenue Raymond Aron

F-92160 Antony

EU/1/96/010/001

13.1.2009

9.1.2009

Xyrem

| UCB Pharma Ltd |
| --- |
| 208 Bath Road |
| Slough |
| Berkshire SL1 3WE |
| United Kingdom |

UCB Pharma Ltd

208 Bath Road

Slough

Berkshire SL1 3WE

United Kingdom

EU/1/05/312/001

13.1.2009

12.1.2009

Invega

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

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/07/395/077-095

14.1.2009

12.1.2009

Invega

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

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/07/395/001-095

14.1.2009

13.1.2009

Emadine

| Alcon Laboratories (UK) Ltd |
| --- |
| Pentagon Park |
| Boundary Way |
| Hemel Hempstead |
| Herts HP2 7UD |
| United Kingdom |

Alcon Laboratories (UK) Ltd

Pentagon Park

Boundary Way

Hemel Hempstead

Herts HP2 7UD

United Kingdom

EU/1/98/095/001-004

15.1.2009

15.1.2009

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

20.1.2009

16.1.2009

Cyanokit

| Merck Santé s.a.s. |
| --- |
| 37, rue Saint-Romain |
| F-69379 Lyon Cedex 08 |

Merck Santé s.a.s.

37, rue Saint-Romain

F-69379 Lyon Cedex 08

EU/1/07/420/001

21.1.2009

16.1.2009

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

20.1.2009

16.1.2009

Regranex

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

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/99/101/001

20.1.2009

20.1.2009

Alli

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/07/401/007-010

22.1.2009

20.1.2009

Sebivo

| 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/1/07/388/003

22.1.2009

22.1.2009

Temodal

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

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

B-1180 Bruxelles/Brussel

EU/1/98/096/001-022

27.1.2009

23.1.2009

Tysabri

| Elan Pharma International Ltd |
| --- |
| Monksland |
| Athlone |
| County Westmeath |
| Ireland |

Elan Pharma International Ltd

Monksland

Athlone

County Westmeath

Ireland

EU/1/06/346/001

27.1.2009

26.1.2009

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

28.1.2009

26.1.2009

Keppra

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60/Researchdreef, 60 |
| B-1070 Bruxelles/Brussel |

UCB Pharma S.A.

Allée de la Recherche 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

EU/1/00/146/001-030

28.1.2009

26.1.2009

Zostavax

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

Sanofi Pasteur MSD SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/06/341/001-013

28.1.2009

26.1.2009

Plavix

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

Sanofi Pharma Bristol-Myers Squibb SNC

174, avenue de France

F-75013 Paris

EU/1/98/069/001a

EU/1/98/069/002a

EU/1/98/069/003a

EU/1/98/069/004a

EU/1/98/069/005a

EU/1/98/069/006a

EU/1/98/069/007a

EU/1/98/069/011a

EU/1/98/069/011b

28.1.2009

26.1.2009

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

28.1.2009

26.1.2009

Fasturtec

| Sanofi-Aventis |
| --- |
| 174, avenue de France |
| F-75013 Paris |

Sanofi-Aventis

174, avenue de France

F-75013 Paris

EU/1/00/170/001-002

28.1.2009

26.1.2009

Prometax

| 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/1/98/092/001-018

28.1.2009

26.1.2009

Zavesca

| 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/1/02/238/001

28.1.2009

26.1.2009

Mirapexin

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

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/051/001-006

EU/1/97/051/009-012

28.1.2009

26.1.2009

Tamiflu

| 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/1/02/222/001-004

28.1.2009

27.1.2009

Tritanrix HepB

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut, 89 |
| B-1330 Rixensart |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut, 89

B-1330 Rixensart

EU/1/96/014/001-003

29.1.2009

27.1.2009

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

29.1.2009

27.1.2009

PritorPlus

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

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/02/215/001-021

29.1.2009

27.1.2009

Hepsera

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT |
| United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/03/251/001-002

29.1.2009

27.1.2009

Viramune

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

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/055/001-003

29.1.2009

27.1.2009

MicardisPlus

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

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/02/213/001-023

29.1.2009

27.1.2009

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

EU/1/98/070/002a

EU/1/98/070/003a

EU/1/98/070/004a

EU/1/98/070/005a

EU/1/98/070/006a

EU/1/98/070/007a

EU/1/98/070/011a

EU/1/98/070/011b

29.1.2009

27.1.2009

Tarceva

| 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/1/05/311/001-003

29.1.2009

27.1.2009

Invirase

| 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/1/96/026/001-002

29.1.2009

28.1.2009

Diacomit

| Biocodex |
| --- |
| 7, avenue Gallieni |
| F-94250 Gentilly |

Biocodex

7, avenue Gallieni

F-94250 Gentilly

EU/1/06/367/001-012

30.1.2009

29.1.2009

Prezista

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

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/06/380/002-003

2.2.2009

29.1.2009

Aloxi

| Helsinn Birex Pharmaceuticals Ltd |
| --- |
| Damastown |
| Mulhuddart |
| Dublin 15 |
| Republic of Ireland |

Helsinn Birex Pharmaceuticals Ltd

Damastown

Mulhuddart

Dublin 15

Republic of Ireland

EU/1/04/306/001

2.2.2009

29.1.2009

Kinzalkomb

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

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/02/214/001-015

2.2.2009

29.1.2009

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

2.2.2009

30.1.2009

Exelon

| 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/1/98/066/001-018

4.2.2009

30.1.2009

NeuroBloc

| Eisai Limited |
| --- |
| 3, Shortlands |
| London W6 8EE |
| United Kingdom |

Eisai Limited

3, Shortlands

London W6 8EE

United Kingdom

EU/1/00/166/001-003

3.2.2009

30.1.2009

Sifrol

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

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/050/001-006

EU/1/97/050/009-012

4.2.2009

30.1.2009

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

3.2.2009

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 16.1.2009 | Zimulti | Sanofi-Aventis |
| 174, avenue de France |
| F-75013 Paris |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

16.1.2009

Zimulti

Sanofi-Aventis

174, avenue de France

F-75013 Paris

EU/1/06/345/001-011

20.1.2009

16.1.2009

ACOMPLIA

| Sanofi-Aventis |
| --- |
| 174, avenue de France |
| F-75013 Paris |

Sanofi-Aventis

174, avenue de France

F-75013 Paris

EU/1/06/344/001-011

20.1.2009

30.1.2009

Velosulin

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

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/02/232/001-003

3.2.2009

—   Suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 16.1.2009 | Ionsys | Janssen-Cilag International NV |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

16.1.2009

Ionsys

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

EU/1/05/326/001

20.1.2009

—   Issuing of a marketing authorization (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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
  (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.1.2009 | Porcilis PCV | Porcine circovirus type 2 ORF2 subunit antigen | Intervet International B.V. |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

12.1.2009

Porcilis PCV

Porcine circovirus type 2 ORF2 subunit antigen

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/08/091/001-010

Emulsion for injection

QI09AA07

14.1.2009

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 13.1.2009 | Novem | Boehringer Ingelheim Vetmedica GmbH |
| D-55216 Ingelheim am Rhein |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

13.1.2009

Novem

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein

EU/2/04/042/001-004

16.1.2009

20.1.2009

Fevaxyn Pentofel

| Fort Dodge Laboratories Ireland |
| --- |
| Finisklin Industrial Estate — Sligo |
| Ireland |

Fort Dodge Laboratories Ireland

Finisklin Industrial Estate — Sligo

Ireland

EU/2/96/002/001-003

22.1.2009

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.

---

| 27.2.2009 | EN | Official Journal of the European Union | C 48/12 |
| --- | --- | --- | --- |

27.2.2009

EN

Official Journal of the European Union

C 48/12

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 2009

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

(2009/C 48/05)

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 16.1.2009 | STELARA | Janssen-Cilag International NV |
| Turnhoutseweg, 30 |
| B-2340 Beerse |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

16.1.2009

STELARA

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

This Decision is addressed to the Member States

20.1.2009

16.1.2009

RoActemra

| 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

This Decision is addressed to the Member States

20.1.2009

22.1.2009

Cozaar

Voir annexe I

See Annex I

26.1.2009

30.1.2009

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

This Decision is addressed to the Member States

3.2.2009

---

(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), ROUTE(S) OF ADMINISTRATION OF THE MEDICINAL PRODUCT(S), MARKETING AUTHORIZATION HOLDER(S) IN THE MEMBER STATES

| Member State | Marketing Authorization Holder | Invented name
  Losartan potassium | Strength | Pharmaceutical Form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Merck Sharp & Dohme GmbH |
| Donau-City-Straße 6 |
| A-1220 Wien |

Member State

Marketing Authorization Holder

Invented name

Losartan potassium

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

Merck Sharp & Dohme GmbH

Donau-City-Straße 6

A-1220 Wien

Cosaar 12,5 mg — Filmtabletten

12,5 mg

Film-coated tablet

Oral use

N/A

Austria

| Merck Sharp & Dohme GmbH |
| --- |
| Donau-City-Straße 6 |
| A-1220 Wien |

Merck Sharp & Dohme GmbH

Donau-City-Straße 6

A-1220 Wien

Cosaar 50 mg — Filmtabletten

50 mg

Film-coated tablet

Oral use

N/A

Austria

| Merck Sharp & Dohme GmbH |
| --- |
| Donau-City-Straße 6 |
| A-1220 Wien |

Merck Sharp & Dohme GmbH

Donau-City-Straße 6

A-1220 Wien

Cosaar 100 mg — Filmtabletten

100 mg

Film-coated tablet

Oral use

N/A

Belgium

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Belgium

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Belgium

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

N/A

Belgium

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar Cardio Start

21 × 12,5 mg + 14 × 50 mg

Film-coated tablet

Oral use

N/A

Belgium

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Belgium

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Belgium

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan 12,50 mg

12,5 mg

Film-coated tablet

Oral use

N/A

Belgium

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan Cardio Start

21 × 12,5 mg + 14 × 50 mg

Film-coated tablet

Oral use

N/A

Bulgaria

| Merck Sharp & Dohme Bulgaria EOOD |
| --- |
| 55 Nikola Vaptzarov blvd. |
| EXPO 2000, east wing, sections B1 & B2, 1st fl. |
| BG-1407 Sofia |

Merck Sharp & Dohme Bulgaria EOOD

55 Nikola Vaptzarov blvd.

EXPO 2000, east wing, sections B1 & B2, 1st fl.

BG-1407 Sofia

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

Cyprus

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

Cyprus

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

100 mg

Film-coated tablet

Oral use

N/A

Czech Republic

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

N/A

Czech Republic

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Czech Republic

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Denmark

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

12,5 mg

Film-coated tablet

Oral use

N/A

Denmark

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

Denmark

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

100 mg

Film-coated tablet

Oral use

N/A

Denmark

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar Startpakke

12,5 mg + 50 mg

Film-coated tablet

Oral use

N/A

Estonia

| Merck Sharp & Dohme OÜ |
| --- |
| Peterburi tee 46 |
| EE-11415 Tallinn |

Merck Sharp & Dohme OÜ

Peterburi tee 46

EE-11415 Tallinn

Cozaar

100 mg

Film-coated tablet

Oral use

N/A

Estonia

| Merck Sharp & Dohme OÜ |
| --- |
| Peterburi tee 46 |
| EE-11415 Tallinn |

Merck Sharp & Dohme OÜ

Peterburi tee 46

EE-11415 Tallinn

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

Estonia

| Merck Sharp & Dohme OÜ |
| --- |
| Peterburi tee 46 |
| EE-11415 Tallinn |

Merck Sharp & Dohme OÜ

Peterburi tee 46

EE-11415 Tallinn

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

N/A

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| P.O. Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

P.O. Box 581

2003 PC Haarlem

Nederland

Cozaar

12,5 mg

Film-coated tablet

Oral use

N/A

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| P.O. Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

P.O. Box 581

2003 PC Haarlem

Nederland

Cozaar

12,5 mg and 50 mg (initiation pack)

Film-coated tablet

Oral use

N/A

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| P.O. Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

P.O. Box 581

2003 PC Haarlem

Nederland

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| P.O. Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

P.O. Box 581

2003 PC Haarlem

Nederland

Cozaar

100 mg

Film-coated tablet

Oral use

N/A

France

| Merck Sharp Dohme Chibret |
| --- |
| 3, av. Hoche |
| F-75114 Paris Cedex 08 |

Merck Sharp Dohme Chibret

3, av. Hoche

F-75114 Paris Cedex 08

Cozaar 100 mg film-coated tablets

100 mg

Film-coated tablet

Oral use

N/A

France

| Merck Sharp Dohme Chibret |
| --- |
| 3, av. Hoche |
| F-75114 Paris Cedex 08 |

Merck Sharp Dohme Chibret

3, av. Hoche

F-75114 Paris Cedex 08

Cozaar 50 mg scored coated tablets

50 mg

Scored coated tablet

Oral use

N/A

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Cardopal Start 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

N/A

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Lorzaar 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

N/A

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Lorzaar 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

N/A

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Lorzaar Protect 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

N/A

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Lorzaar Protect 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

N/A

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Lorzaar Start 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

N/A

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Pinzaar 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

N/A

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Pinzaar 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

N/A

Germany

| VARIPHARM Arzneimittel GmbH |
| --- |
| Lindenplatz 1 |
| D-85540 Haar |

VARIPHARM Arzneimittel GmbH

Lindenplatz 1

D-85540 Haar

Lorzaar Varipharmstart 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

N/A

Greece

| VIANEX A.E. |
| --- |
| Tatoiou Street |
| GR-14671 Nea Erythraia |

VIANEX A.E.

Tatoiou Street

GR-14671 Nea Erythraia

Cozaar

12,5 mg

Film-coated tablet

Oral use

N/A

Greece

| VIANEX A.E. |
| --- |
| Tatoiou Street |
| GR-14671 Nea Erythraia |

VIANEX A.E.

Tatoiou Street

GR-14671 Nea Erythraia

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

Greece

| VIANEX A.E. |
| --- |
| Tatoiou Street |
| GR-14671 Nea Erythraia |

VIANEX A.E.

Tatoiou Street

GR-14671 Nea Erythraia

Cozaar

100 mg

Film-coated tablet

Oral use

N/A

Hungary

| MSD Hungary Ltd |
| --- |
| Alkotás u. 50 |
| H-1123 Budapest |

MSD Hungary Ltd

Alkotás u. 50

H-1123 Budapest

Cozaar

12,5 mg

Tablets, film-coated

Oral use

N/A

Hungary

| MSD Hungary Ltd |
| --- |
| Alkotás u. 50 |
| H-1123 Budapest |

MSD Hungary Ltd

Alkotás u. 50

H-1123 Budapest

Cozaar

50 mg

Tablets, film-coated

Oral use

N/A

Hungary

| MSD Hungary Ltd |
| --- |
| Alkotás u. 50 |
| H-1123 Budapest |

MSD Hungary Ltd

Alkotás u. 50

H-1123 Budapest

Cozaar

100 mg

Tablets, film-coated

Oral use

N/A

Ireland

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar 50 mg Film-coated tablets

50 mg

Film-coated tablet

Oral use

N/A

Ireland

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar 100 mg Film-coated tablets

100 mg

Film-coated tablet

Oral use

N/A

Ireland

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar 12,5 mg Film-coated tablets

12,5 mg

Film-coated tablet

Oral use

N/A

Italy

| Merck Sharp & Dohme (Italia) SpA |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Merck Sharp & Dohme (Italia) SpA

Via G. Fabbroni 6

I-00191 Roma

Lortaan 50 mg compresse rivestite con film

50 mg

Film-coated tablet

Oral use

N/A

Italy

| Merck Sharp & Dohme (Italia) SpA |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Merck Sharp & Dohme (Italia) SpA

Via G. Fabbroni 6

I-00191 Roma

Lortaan 12,5 mg compresse rivestite con film

12,5 mg

Film-coated tablet

Oral use

N/A

Italy

| Merck Sharp & Dohme (Italia) SpA |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Merck Sharp & Dohme (Italia) SpA

Via G. Fabbroni 6

I-00191 Roma

Lortaan 100 mg compresse rivestite con film

100 mg

Film-coated tablet

Oral use

N/A

Italy

| Neopharmed SpA |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Neopharmed SpA

Via G. Fabbroni 6

I-00191 Roma

Neo-Lotan 50 mg compresse rivestite con film

50 mg

Film-coated tablet

Oral use

N/A

Italy

| Neopharmed SpA |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Neopharmed SpA

Via G. Fabbroni 6

I-00191 Roma

Neo-Lotan 12,5 mg compresse rivestite con film

12,5 mg

Film-coated tablet

Oral use

N/A

Italy

| Neopharmed SpA |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Neopharmed SpA

Via G. Fabbroni 6

I-00191 Roma

Neo-Lotan 100 mg compresse rivestite con film

100 mg

Film-coated tablet

Oral use

N/A

Italy

| Sigma-Tau Industrie Farmaceutiche Riunite SpA |
| --- |
| Viale Shakespeare 47 |
| I-00144 Roma |

Sigma-Tau Industrie Farmaceutiche Riunite SpA

Viale Shakespeare 47

I-00144 Roma

Losaprex 50 mg compresse rivestite con film

50 mg

Film-coated tablet

Oral use

N/A

Italy

| Sigma-Tau Industrie Farmaceutiche Riunite SpA |
| --- |
| Viale Shakespeare 47 |
| I-00144 Roma |

Sigma-Tau Industrie Farmaceutiche Riunite SpA

Viale Shakespeare 47

I-00144 Roma

Losaprex 12,5 mg compresse rivestite con film

12,5 mg

Film-coated tablet

Oral use

N/A

Italy

| Sigma-Tau Industrie Farmaceutiche Riunite SpA |
| --- |
| Viale Shakespeare 47 |
| I-00144 Roma |

Sigma-Tau Industrie Farmaceutiche Riunite SpA

Viale Shakespeare 47

I-00144 Roma

Losaprex 100 mg compresse rivestite con film

100 mg

Film-coated tablet

Oral use

N/A

Latvia

| SIA Merck Sharp & Dohme Latvia |
| --- |
| Skanstes iela 13 |
| LV-1013 Rīga |

SIA Merck Sharp & Dohme Latvia

Skanstes iela 13

LV-1013 Rīga

Cozaar 50 mg film-coated tablets

50 mg

Film-coated tablets

Oral use

N/A

Latvia

| SIA Merck Sharp & Dohme Latvia |
| --- |
| Skanstes iela 13 |
| LV-1013 Rīga |

SIA Merck Sharp & Dohme Latvia

Skanstes iela 13

LV-1013 Rīga

Cozaar 100 mg film-coated tablets

100 mg

Film-coated tablets

Oral use

N/A

Lithuania

| UAB Merck Sharp & Dohme |
| --- |
| Geležinio Vilko 18A |
| LT-01112 Vilnius |

UAB Merck Sharp & Dohme

Geležinio Vilko 18A

LT-01112 Vilnius

Cozaar (Losartan)

12,5 mg

film-coated tablet

oral use

N/A

Lithuania

| UAB Merck Sharp & Dohme |
| --- |
| Geležinio Vilko 18A |
| LT-01112 Vilnius |

UAB Merck Sharp & Dohme

Geležinio Vilko 18A

LT-01112 Vilnius

Cozaar (Losartan)

50 mg

film-coated tablet

oral use

N/A

Lithuania

| UAB Merck Sharp & Dohme |
| --- |
| Geležinio Vilko 18A |
| LT-01112 Vilnius |

UAB Merck Sharp & Dohme

Geležinio Vilko 18A

LT-01112 Vilnius

Cozaar (Losartan)

100 mg

film-coated tablet

oral use

N/A

Luxembourg

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Luxembourg

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Luxembourg

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

N/A

Luxembourg

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar Cardio Start

21 × 12,5 mg + 14 × 50 mg

Film-coated tablet

Oral use

N/A

Luxembourg

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Luxembourg

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Luxembourg

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan 12,50 mg

12,5 mg

Film-coated tablet

Oral use

N/A

Luxembourg

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan Cardio Start

21 × 12,5 mg + 14 × 50 mg

Film-coated tablet

Oral use

N/A

Malta

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

Merck Sharp & Dohme Ltd.

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

‘Cozaar 100 mg’ pilloli miksija b'rita

100 mg

Film-coated tablet

Oral use

N/A

Malta

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

Merck Sharp & Dohme Ltd.

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

‘Cozaar 50 mg’ pilloli miksija b'rita

50 mg

Film-coated tablet

Oral use

N/A

Netherlands

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar 50

50 mg

Film-coated tablet

Oral use

N/A

Netherlands

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar 100

100 mg

Film-coated tablet

Oral use

N/A

Poland

| MSD Polska Sp. z o.o. |
| --- |
| Chłodna 51 |
| PL-00-867 Warszawa |

MSD Polska Sp. z o.o.

Chłodna 51

PL-00-867 Warszawa

Cozaar

12,5 mg

Film-coated tablet

Oral use

N/A

Poland

| MSD Polska Sp. z o.o. |
| --- |
| Chłodna 51 |
| PL-00-867 Warszawa |

MSD Polska Sp. z o.o.

Chłodna 51

PL-00-867 Warszawa

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

Poland

| MSD Polska Sp. z o.o. |
| --- |
| Chłodna 51 |
| PL-00-867 Warszawa |

MSD Polska Sp. z o.o.

Chłodna 51

PL-00-867 Warszawa

Cozaar

100 mg

Film-coated tablet

Oral use

N/A

Portugal

| Merck Sharp & Dohme, Lda. |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

Portugal

| Merck Sharp & Dohme, Lda. |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Portugal

| Merck Sharp & Dohme, Lda. |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Cozaar IC

12,5 mg

Film-coated tablet

Oral use

N/A

Portugal

| Merck Sharp & Dohme, Lda. |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Cozaar IC — Titulação

12,5 mg + 50 mg

Film-coated tablet

Oral use

N/A

Portugal

| LABORATÓRIO MEDINFAR |
| --- |
| Produtos Farmacêuticos, SA |
| Rua Manuel Ribeiro de Pavia, 1-1 |
| Venda Nova |
| P-2700-547 Amadora |

LABORATÓRIO MEDINFAR

Produtos Farmacêuticos, SA

Rua Manuel Ribeiro de Pavia, 1-1

Venda Nova

P-2700-547 Amadora

Lortaan IC

12,5 mg

Film-coated tablet

Oral use

N/A

Portugal

| LABORATÓRIO MEDINFAR |
| --- |
| Produtos Farmacêuticos, SA |
| Rua Manuel Ribeiro de Pavia, 1-1 |
| Venda Nova |
| P-2700-547 Amadora |

LABORATÓRIO MEDINFAR

Produtos Farmacêuticos, SA

Rua Manuel Ribeiro de Pavia, 1-1

Venda Nova

P-2700-547 Amadora

Lortaan IC — Titulação

12,5 mg + 50 mg

Film-coated tablet

Oral use

N/A

Portugal

| LABORATÓRIO MEDINFAR |
| --- |
| Produtos Farmacêuticos, SA |
| Rua Manuel Ribeiro de Pavia, 1-1 |
| Venda Nova |
| P-2700-547 Amadora |

LABORATÓRIO MEDINFAR

Produtos Farmacêuticos, SA

Rua Manuel Ribeiro de Pavia, 1-1

Venda Nova

P-2700-547 Amadora

Lortaan

50 mg

Film-coated tablet

Oral use

N/A

Portugal

| LABORATÓRIO MEDINFAR |
| --- |
| Produtos Farmacêuticos, SA |
| Rua Manuel Ribeiro de Pavia, 1-1 |
| Venda Nova |
| P-2700-547 Amadora |

LABORATÓRIO MEDINFAR

Produtos Farmacêuticos, SA

Rua Manuel Ribeiro de Pavia, 1-1

Venda Nova

P-2700-547 Amadora

Lortaan 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Romania

| Merck Sharp & Dohme Romania S.R.L. |
| --- |
| Bucharest Business Park |
| Şos. Bucureşti-Ploieşti, Nr. 1A |
| Clădirea C1, etaj 3 |
| Sector 1, Bucureşti |
| România |

Merck Sharp & Dohme Romania S.R.L.

Bucharest Business Park

Şos. Bucureşti-Ploieşti, Nr. 1A

Clădirea C1, etaj 3

Sector 1, Bucureşti

România

Cozaar, comprimate filmate, 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Slovakia

| Merck Sharp & Dohme BV |
| --- |
| Waarderweg 39 |
| 2031 BN Haarlem |
| P.O. Box 581 |
| 2003 PC, Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem

P.O. Box 581

2003 PC, Haarlem

Nederland

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

N/A

Slovakia

| Merck Sharp & Dohme BV |
| --- |
| Waarderweg 39 |
| 2031 BN Haarlem |
| P.O. Box 581 |
| 2003 PC, Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem

P.O. Box 581

2003 PC, Haarlem

Nederland

Cozaar 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Slovakia

| Merck Sharp & Dohme BV |
| --- |
| Waarderweg 39 |
| 2031 BN Haarlem |
| P.O. Box 581 |
| 2003 PC, Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem

P.O. Box 581

2003 PC, Haarlem

Nederland

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Slovenia

| Merck Sharp & Dohme, inovativna zdravila d.o.o. |
| --- |
| Šmartinska cesta 140 |
| SLO-1000 Ljubljana |

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Šmartinska cesta 140

SLO-1000 Ljubljana

Cozaar 12,5 mg filmsko obložene tablete

12,5 mg

Film-coated tablet

Oral use

N/A

Slovenia

| Merck Sharp & Dohme, inovativna zdravila d.o.o. |
| --- |
| Šmartinska cesta 140 |
| SLO-1000 Ljubljana |

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Šmartinska cesta 140

SLO-1000 Ljubljana

Cozaar 50 mg filmsko obložene tablete

50 mg

Film-coated tablet

Oral use

N/A

Slovenia

| Merck Sharp & Dohme, inovativna zdravila d.o.o. |
| --- |
| Šmartinska cesta 140 |
| SLO-1000 Ljubljana |

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Šmartinska cesta 140

SLO-1000 Ljubljana

Cozaar 100 mg filmsko obložene tablete

100 mg

Film-coated tablet

Oral use

N/A

Spain

| Merck Sharp and Dohme de España, S.A. |
| --- |
| C/ Josefa Valcárcel, 38 |
| E-28027 Madrid |

Merck Sharp and Dohme de España, S.A.

C/ Josefa Valcárcel, 38

E-28027 Madrid

Cozaar 12,5 mg Inicio

12,5 mg

Film-coated tablet

Oral use

N/A

Spain

| Merck Sharp and Dohme de España, S.A. |
| --- |
| C/ Josefa Valcárcel, 38 |
| E-28027 Madrid |

Merck Sharp and Dohme de España, S.A.

C/ Josefa Valcárcel, 38

E-28027 Madrid

Cozaar 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Spain

| Merck Sharp and Dohme de España, S.A. |
| --- |
| C/ Josefa Valcárcel, 38 |
| E-28027 Madrid |

Merck Sharp and Dohme de España, S.A.

C/ Josefa Valcárcel, 38

E-28027 Madrid

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Sweden

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar 12,5 mg filmdragerade tabletter

12,5 mg

Film-coated tablet

Oral use

N/A

Sweden

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar 12,5 mg + 50 mg filmdragerade tabletter

12,5 + 50 mg

Film-coated tablet

Oral use

N/A

Sweden

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar 50 mg filmdragerade tabletter

50 mg

Film-coated tablet

Oral use

N/A

Sweden

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar 100 mg filmdragerade tabletter

100 mg

Film-coated tablet

Oral use

N/A

United Kingdom

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar 25 mg Film-coated tablets

25 mg

Film-coated tablet

Oral use

N/A

United Kingdom

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar 50 mg Film-coated tablets

50 mg

Film-coated tablet

Oral use

N/A

United Kingdom

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar 100 mg Film-coated tablets

100 mg

Film-coated tablet

Oral use

N/A

Iceland

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar

12,5 mg

Film-coated tablet

Oral use

N/A

Iceland

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

Iceland

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar

100 mg

Film-coated tablet

Oral use

N/A

Norway

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar

12,5 mg

Film-coated tablet

Oral use

N/A

Norway

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

Norway

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar

100 mg

Film-coated tablet

Oral use

N/A

---

V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 27.2.2009 | EN | Official Journal of the European Union | C 48/25 |
| --- | --- | --- | --- |

27.2.2009

EN

Official Journal of the European Union

C 48/25

---

Communication from the French Government concerning Directive 94/22/EC of the European Parliament and of the Council on the conditions for granting and using authorisations for the prospection, exploration and production of hydrocarbons (1)

(Notice regarding an application for an exclusive licence to prospect for oil and gas, designated the ‘Permis de Champrose’)

(Text with EEA relevance)

(2009/C 48/06)

On 5 August 2008, POROS SAS, a company with registered offices at 145 rue Michel Carré, BP 73, F-95100 Argenteuil, applied for an exclusive five-year licence, designated the ‘Permis de Champrose’, to prospect for oil and gas in an area of approximately 459 km2 in the department of Seine-et-Marne.

The perimeter of the area covered by this licence consists of the meridian and parallel arcs connecting in turn the points defined below by their geographical coordinates in grads, the prime meridian being that of Paris.

| Point | Latitude north | Longitude east |
| --- | --- | --- |
| A | 54,30° N | 0,40° E |
| B | 54,30° N | 0,80° E |
| C | 54,20° N | 0,80° E |
| D | 54,20° N | 0,70° E |
| E | 54,14° N | 0,70° E |
| F | 54,14° N | 0,69° E |
| G | 54,10° N | 0,69° E |
| H | 54,10° N | 0,40° E |

Point

Latitude north

Longitude east

A

54,30° N

0,40° E

B

54,30° N

0,80° E

C

54,20° N

0,80° E

D

54,20° N

0,70° E

E

54,14° N

0,70° E

F

54,14° N

0,69° E

G

54,10° N

0,69° E

H

54,10° N

0,40° E

Submission of applications and criteria for awarding rights

The initial applicant and competing applicants must prove that they meet the requirements specified in Articles 4 and 5 of Decree No 2006-648 of 2 June 2006 concerning mining rights and underground storage rights (‘décret relatif aux titres miniers et aux titres de stockage souterrain’) (Journal officiel de la République française of 3 June 2006).

Interested companies may, within ninety days of the publication of this notice, submit a competing application in accordance with the procedure summarised in the ‘Notice regarding the granting of mining rights for hydrocarbons in France’ published in
  Official Journal of the European Communities C 374 of 30 December 1994, p. 11, and established by Decree No 2006-648 concerning mining rights and underground storage rights. Competing applications must be sent to the Minister responsible for mines at the address below.

The decisions on the initial application and the competing applications will be based on the criteria governing the award of mining rights, as set out in Article 6 of the abovementioned Decree, and will be taken by 14 August 2010 at the latest.

Conditions and requirements regarding performance of the activity and cessation thereof

Applicants are referred to Articles 79 and 79.1 of the Mining Code (‘code minier’) and to Decree No 2006-649 of 2 June 2006 on mining and underground storage operations and the regulations governing mining and underground storage (‘décret relatif aux travaux miniers, aux travaux de stockage souterrain et à la police des mines et des stockages souterrains’), published in the Journal officiel de la République française of 3 June 2006.

Further information can be obtained from the following address: Ministère de l'écologie, de l'énergie, du développement durable et de l'aménagement du territoire (direction générale de l'énergie et climat, direction de l'énergie, Sous-direction de la Sécurité d'Approvisionnement et des Nouveaux Produits Energétiques, bureau exploration production des hydrocarbures), 41, boulevard Vincent Auriol, F-75703 Paris Cedex 13 (tel. (33) 153 94 14 81 fax (33) 153 94 14 40).

The laws and regulations referred to above can be consulted at:

http://www.legifrance.gouv.fr

---

(1)  OJ L 164, 30.6.1994, p. 3.

---

| 27.2.2009 | EN | Official Journal of the European Union | C 48/27 |
| --- | --- | --- | --- |

27.2.2009

EN

Official Journal of the European Union

C 48/27

---

Prior notification of a concentration

(Case COMP/M.5455 — TPV/Philips Branded Monitors)

(Text with EEA relevance)

(2009/C 48/07)

| 1. | On 20 February 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 TPV Technology Limited (‘TPV’, Bermuda) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of the undertaking MMD — Monitors & Displays Holding BV (‘Philips Holdco’, The Netherlands), currently controlled by Koninklijke Philips Electronics N.V. (‘Philips’, The Netherlands), by way of purchase of shares. |
| --- | --- |

1.

On 20 February 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 TPV Technology Limited (‘TPV’, Bermuda) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of the undertaking MMD — Monitors & Displays Holding BV (‘Philips Holdco’, The Netherlands), currently controlled by Koninklijke Philips Electronics N.V. (‘Philips’, The Netherlands), by way of purchase of shares.

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






  — | for TPV: solutions provider in monitor display technology; design and production of a wide range of computer monitors for distribution in Asia, Europe and the United States, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for TPV: solutions provider in monitor display technology; design and production of a wide range of computer monitors for distribution in Asia, Europe and the United States,

| — | for Philips Holdco: branding and distribution of computer monitors and public signage. |
| --- | --- |

—

for Philips Holdco: branding and distribution of computer monitors and public signage.

| 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 ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5455 — TPV/Philips Branded Monitors, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Brussels |

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 ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5455 — TPV/Philips Branded Monitors, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Brussels

---

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

---

27.2.2009

| 27.2.2009 | EN | Official Journal of the European Union | C 48/s3 |
| --- | --- | --- | --- |

EN

Official Journal of the European Union

C 48/s3

---

NOTICE

On 27 February 2009, in Official Journal of the European Union C 48 A, the ‘Common catalogue of varieties of vegetable species — Second supplement to the 27th complete edition’ and the ‘Common catalogue of varieties of agricultural plant species — Second supplement to the 27th complete edition’ will be published.

Subscribers to the Official Journal may obtain the same number of copies and language versions of this Official Journal as those to which they subscribe free of charge. They are requested to return the attached order form, duly completed and bearing their subscription registration number (code appearing on the left of each label and beginning with: O/...). This Official Journal will remain available free of charge for one year from the date of its publication.

Non-subscribers can order this Official Journal against payment from one of our sales offices (see: http://publications.europa.eu/others/agents/index_en.htm).

This Official Journal — like all Official Journals (L, C, CA, CE) — can be consulted free of charge online at: http://eur-lex.europa.eu

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