# Official Journal C 56/2008

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 56 |
| | |
| English edition | Information and Notices | Volume 5129 February 2008 |

ISSN 1725-2423

Official Journal

of the European Union

C 56

English edition

Information and Notices

Volume 5129 February 2008

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2008/C 056/01 | Non-opposition to a notified concentration (Case COMP/M.5003 — REWE/UAB Palink) (
  1
  ) | 1 |
| 2008/C 056/02 | Non-opposition to a notified concentration (Case COMP/M.4937 — Bank Sarasin & CIE/AIG Private Bank/JV) (
  1
  ) | 1 |
| 2008/C 056/03 | Non-opposition to a notified concentration (Case COMP/M.4809 — France Telecom/MID Europa Partners/ONE) (
  1
  ) | 2 |
| 2008/C 056/04 | Non-opposition to a notified concentration (Case COMP/M.5019 — Holtzbrinck/SevenOne/JV) (
  1
  ) | 2 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2008/C 056/01

Non-opposition to a notified concentration (Case COMP/M.5003 — REWE/UAB Palink) (
  1
  )

1

1

2008/C 056/02

Non-opposition to a notified concentration (Case COMP/M.4937 — Bank Sarasin & CIE/AIG Private Bank/JV) (
  1
  )

1

1

2008/C 056/03

Non-opposition to a notified concentration (Case COMP/M.4809 — France Telecom/MID Europa Partners/ONE) (
  1
  )

1

2

2008/C 056/04

Non-opposition to a notified concentration (Case COMP/M.5019 — Holtzbrinck/SevenOne/JV) (
  1
  )

1

2

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2008/C 056/05 | Euro exchange rates | 3 |
| 2008/C 056/06 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2007 to 31 December 2007(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 4 |
| 2008/C 056/07 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 5 |
| 2008/C 056/08 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  ) | 14 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2008/C 056/05

Euro exchange rates

3

2008/C 056/06

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2007 to 31 December 2007(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

2008/C 056/07

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008(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

)

5

2008/C 056/08

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  )

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

or Article 38 of Directive 2001/82/EC

)

14

| | V   Announcements |
| --- | --- |
| | ADMINISTRATIVE PROCEDURES |
| | Commission |
| 2008/C 056/09 | Call for applications 2008 — Second Programme of Community action in the field of Health (2008-2013) (
  1
  ) | 30 |

V   Announcements

ADMINISTRATIVE PROCEDURES

Commission

2008/C 056/09

Call for applications 2008 — Second Programme of Community action in the field of Health (2008-2013) (
  1
  )

1

30

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

---

(1)   Text with EEA relevance

1

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

EN

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 29.2.2008 | EN | Official Journal of the European Union | C 56/1 |
| --- | --- | --- | --- |

29.2.2008

EN

Official Journal of the European Union

C 56/1

---

Non-opposition to a notified concentration

(Case COMP/M.5003 — REWE/UAB Palink)

(Text with EEA relevance)

(2008/C 56/01)

On 11 February 2008, 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 32008M5003. 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 32008M5003. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

| 29.2.2008 | EN | Official Journal of the European Union | C 56/1 |
| --- | --- | --- | --- |

29.2.2008

EN

Official Journal of the European Union

C 56/1

---

Non-opposition to a notified concentration

(Case COMP/M.4937 — Bank Sarasin & CIE/AIG Private Bank/JV)

(Text with EEA relevance)

(2008/C 56/02)

On 12 February 2008, 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 32008M4937. 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 32008M4937. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

| 29.2.2008 | EN | Official Journal of the European Union | C 56/2 |
| --- | --- | --- | --- |

29.2.2008

EN

Official Journal of the European Union

C 56/2

---

Non-opposition to a notified concentration

(Case COMP/M.4809 — France Telecom/MID Europa Partners/ONE)

(Text with EEA relevance)

(2008/C 56/03)

On 21 September 2007, 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 32007M4809. 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 32007M4809. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

| 29.2.2008 | EN | Official Journal of the European Union | C 56/2 |
| --- | --- | --- | --- |

29.2.2008

EN

Official Journal of the European Union

C 56/2

---

Non-opposition to a notified concentration

(Case COMP/M.5019 — Holtzbrinck/SevenOne/JV)

(Text with EEA relevance)

(2008/C 56/04)

On 8 February 2008, 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 German 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 32008M5019. 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 32008M5019. 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

| 29.2.2008 | EN | Official Journal of the European Union | C 56/3 |
| --- | --- | --- | --- |

29.2.2008

EN

Official Journal of the European Union

C 56/3

---

Euro exchange rates (1)

28 February 2008

(2008/C 56/05)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,5121 |
| JPY | Japanese yen | 160,57 |
| DKK | Danish krone | 7,4532 |
| GBP | Pound sterling | 0,76135 |
| SEK | Swedish krona | 9,3686 |
| CHF | Swiss franc | 1,6037 |
| ISK | Iceland króna | 99,02 |
| NOK | Norwegian krone | 7,8665 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 25,143 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 260,22 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,6969 |
| PLN | Polish zloty | 3,5234 |
| RON | Romanian leu | 3,6665 |
| SKK | Slovak koruna | 32,790 |
| TRY | Turkish lira | 1,7890 |
| AUD | Australian dollar | 1,6038 |
| CAD | Canadian dollar | 1,4779 |
| HKD | Hong Kong dollar | 11,7726 |
| NZD | New Zealand dollar | 1,8606 |
| SGD | Singapore dollar | 2,1103 |
| KRW | South Korean won | 1 416,31 |
| ZAR | South African rand | 11,3784 |
| CNY | Chinese yuan renminbi | 10,7560 |
| HRK | Croatian kuna | 7,2734 |
| IDR | Indonesian rupiah | 13 722,31 |
| MYR | Malaysian ringgit | 4,8425 |
| PHP | Philippine peso | 61,013 |
| RUB | Russian rouble | 36,3920 |
| THB | Thai baht | 44,910 |
| BRL | Brazilian real | 2,5263 |
| MXN | Mexican peso | 16,1686 |

Currency

Exchange rate

USD

US dollar

1,5121

JPY

Japanese yen

160,57

DKK

Danish krone

7,4532

GBP

Pound sterling

0,76135

SEK

Swedish krona

9,3686

CHF

Swiss franc

1,6037

ISK

Iceland króna

99,02

NOK

Norwegian krone

7,8665

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

25,143

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

260,22

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,6969

PLN

Polish zloty

3,5234

RON

Romanian leu

3,6665

SKK

Slovak koruna

32,790

TRY

Turkish lira

1,7890

AUD

Australian dollar

1,6038

CAD

Canadian dollar

1,4779

HKD

Hong Kong dollar

11,7726

NZD

New Zealand dollar

1,8606

SGD

Singapore dollar

2,1103

KRW

South Korean won

1 416,31

ZAR

South African rand

11,3784

CNY

Chinese yuan renminbi

10,7560

HRK

Croatian kuna

7,2734

IDR

Indonesian rupiah

13 722,31

MYR

Malaysian ringgit

4,8425

PHP

Philippine peso

61,013

RUB

Russian rouble

36,3920

THB

Thai baht

44,910

BRL

Brazilian real

2,5263

MXN

Mexican peso

16,1686

---

(1)

Source: reference exchange rate published by the ECB.

---

| 29.2.2008 | EN | Official Journal of the European Union | C 56/4 |
| --- | --- | --- | --- |

29.2.2008

EN

Official Journal of the European Union

C 56/4

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2007 to 31 December 2007

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

(2008/C 56/06)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.12.2007 | Vectibix | Panitumumab | Amgen Europe B.V. |
| Minervum 7061 |
| 4817 ZK Breda |
| 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

3.12.2007

Vectibix

Panitumumab

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/07/423/001-003

Concentrate for solution for infusion

L01XC08

5.12.2007

—   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 |
| --- | --- | --- | --- | --- |
| 4.12.2007 | Busilvex | Pierre Fabre Médicament |
| 45, Place Abel Gance |
| F-92654 Boulogne Billancourt Cedex |

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

4.12.2007

Busilvex

Pierre Fabre Médicament

45, Place Abel Gance

F-92654 Boulogne Billancourt Cedex

EU/1/03/254/002

6.12.2007

6.12.2007

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

10.12.2007

6.12.2007

Rotarix

| 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/1/05/330/001-004

10.12.2007

—   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 |
| --- | --- | --- | --- | --- |
| 6.12.2007 | METACAM | 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

6.12.2007

METACAM

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein

EU/2/97/004/001

EU/2/97/004/003-030

10.12.2007

---

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

---

| 29.2.2008 | EN | Official Journal of the European Union | C 56/5 |
| --- | --- | --- | --- |

29.2.2008

EN

Official Journal of the European Union

C 56/5

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008

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

(2008/C 56/07)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 10.1.2008 | TESAVEL | Sitagliptin | Merck Sharp & Dohme Ltd |
| Hertford Road |
| Hoddesdon |
| Hertfordshire EN11 9BU |
| 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

10.1.2008

TESAVEL

Sitagliptin

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/07/435/001-018

Film-coated tablet

A10BH01

14.1.2008

11.1.2008

Abraxane

Paclitaxel

| Abraxis BioScience Limited |
| --- |
| West Forest Gate |
| Wellington Road |
| Wokingham |
| Berkshire RG40 2AQ |
| United Kingdom |

Abraxis BioScience Limited

West Forest Gate

Wellington Road

Wokingham

Berkshire RG40 2AQ

United Kingdom

EU/1/07/428/001

Powder for suspension for infusion

L01CD01

15.1.2008

11.1.2008

IVEMEND

Fosaprepitant dimeglumine

| 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/1/07/437/001-002

Powder for solution for infusion

(Non applicable)

16.1.2008

11.1.2008

Avamys

Fluticasone furoate

| Glaxo Group Ltd |
| --- |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/07/434/001-003

Nasal spray suspension

R01AD12

16.1.2008

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 11.1.2008 | Natalizumab | Elan Pharma Ltd |
| Norton Green Road |
| Stevenage |
| Herts SG1 2BA |
| 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

11.1.2008

Natalizumab

Elan Pharma Ltd

Norton Green Road

Stevenage

Herts SG1 2BA

United Kingdom

—

15.1.2008

—   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 |
| --- | --- | --- | --- | --- |
| 8.1.2008 | Puregon | Organon N.V. |
| Kloosterstraat 6 |
| Postbus 20 |
| 5340 BH Oss |
| Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

8.1.2008

Puregon

Organon N.V.

Kloosterstraat 6

Postbus 20

5340 BH Oss

Nederland

EU/1/96/008/001-041

10.1.2008

8.1.2008

DepoCyte

| SkyePharma PLC |
| --- |
| 105 Piccadilly |
| London W1J 7NJ |
| United Kingdom |

SkyePharma PLC

105 Piccadilly

London W1J 7NJ

United Kingdom

| Pacira Limited |
| --- |
| MG House |
| Rumbolds Hill |
| Midhurst |
| West Sussex GU29 9BY |
| United Kingdom |

Pacira Limited

MG House

Rumbolds Hill

Midhurst

West Sussex GU29 9BY

United Kingdom

EU/1/01/187/001

10.1.2008

10.1.2008

Prezista

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

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/06/380/001

14.1.2008

10.1.2008

Velcade

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

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/04/274/001

14.1.2008

10.1.2008

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

14.1.2008

10.1.2008

Viracept

| 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/1/97/054/001

EU/1/97/054/004-005

14.1.2008

10.1.2008

Angiox

| The Medicines Company UK Ltd |
| --- |
| Suite B Park House |
| 11 Milton Park |
| Abingdon |
| Oxfordshire OX14 4RS |
| United Kingdom |

The Medicines Company UK Ltd

Suite B Park House

11 Milton Park

Abingdon

Oxfordshire OX14 4RS

United Kingdom

EU/1/04/289/001-002

14.1.2008

11.1.2008

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

15.1.2008

11.1.2008

Irbesartan HCT BMS

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge UD8 1DH |
| United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/06/369/001-028

15.1.2008

14.1.2008

Optaflu

| Novartis Vaccines and Diagnostics GmbH & Co. KG |
| --- |
| Emil-von-Behring-Straße 76 |
| D-35041 Marburg |

Novartis Vaccines and Diagnostics GmbH & Co. KG

Emil-von-Behring-Straße 76

D-35041 Marburg

EU/1/07/394/001-006

16.1.2008

17.1.2008

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

21.1.2008

17.1.2008

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

21.1.2008

17.1.2008

Neulasta

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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/02/227/001-003

21.1.2008

17.1.2008

Neupopeg

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

Dompé Biotec S.p.A.

Via San Martino, 12

I-20122 Milano

EU/1/02/228/001-003

21.1.2008

17.1.2008

Evoltra

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

Bioenvision Limited

Bassett House

5 Southwell Park Road

Camberley

Surrey GU15 3PU

United Kingdom

EU/1/06/334/001-004

21.1.2008

17.1.2008

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

21.1.2008

17.1.2008

Twinrix Adult

| 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/1/96/020/001-009

21.1.2008

18.1.2008

Telzir

| Glaxo Group Ltd |
| --- |
| Greenford Road |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/282/001-002

22.1.2008

18.1.2008

Dynepo

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

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park

Chineham

Basingstoke

Hampshire RG24 8EP

United Kingdom

EU/1/02/211/001-005

EU/1/02/211/010-012

22.1.2008

18.1.2008

Zerene

| Wyeth Research (UK) Limited |
| --- |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

Wyeth Research (UK) Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

| Meda AB |
| --- |
| Pipers väg 2A |
| S-170 09 Solna |

Meda AB

Pipers väg 2A

S-170 09 Solna

EU/1/99/099/001-006

22.1.2008

18.1.2008

Orgalutran

| N.V. Organon |
| --- |
| P.O. Box 20 |
| Kloosterstraat 6 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

P.O. Box 20

Kloosterstraat 6

5340 BH Oss

Nederland

EU/1/00/130/001-002

22.1.2008

18.1.2008

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

22.1.2008

18.1.2008

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

22.1.2008

22.1.2008

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

25.1.2008

22.1.2008

Twinrix Paediatric

| 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/1/97/029/001-010

24.1.2008

25.1.2008

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

29.1.2008

25.1.2008

Xagrid

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

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park

Chineham

Basingstoke

Hampshire RG24 8EP

United Kingdom

EU/1/04/295/001

29.1.2008

25.1.2008

Osseor

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

Les Laboratoires Servier

22, rue Garnier

F-92200 Neuilly-sur-Seine

EU/1/04/287/001-006

29.1.2008

25.1.2008

Protelos

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

Les Laboratoires Servier

22, rue Garnier

F-92200 Neuilly-sur-Seine

EU/1/04/288/001-006

29.1.2008

25.1.2008

Exubera

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/05/327/001-018

29.1.2008

25.1.2008

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/1/07/414/001-017

29.1.2008

25.1.2008

SUTENT

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/347/001-003

29.1.2008

25.1.2008

Advagraf

| Astellas Pharma GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19 |
| 2353 EW Leiderdorp |
| Nederland |

Astellas Pharma Europe B.V.

Elisabethhof 19

2353 EW Leiderdorp

Nederland

EU/1/07/387/001-010

29.1.2008

25.1.2008

Onsenal

| Pharmacia-Pfizer EEIG |
| --- |
| Ramsgate Road |
| Sandwich CT13 9NJ |
| United Kingdom |

Pharmacia-Pfizer EEIG

Ramsgate Road

Sandwich CT13 9NJ

United Kingdom

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/03/259/001-006

29.1.2008

28.1.2008

Irbesartan Hydrochlorothiazide 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/1/06/377/001-028

30.1.2008

28.1.2008

Macugen

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/05/325/002

30.1.2008

28.1.2008

Vfend

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/02/212/001-026

30.1.2008

28.1.2008

ViraferonPeg

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

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

B-1180 Bruxelles/B-1180 Brussel

EU/1/00/132/001-050

30.1.2008

28.1.2008

PegIntron

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

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

B-1180 Bruxelles/B-1180 Brussel

EU/1/00/131/001-050

30.1.2008

28.1.2008

IntronA

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

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

B-1180 Bruxelles/B-1180 Brussel

EU/1/99/127/001-044

30.1.2008

28.1.2008

Viraferon

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

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

B-1180 Bruxelles/B-1180 Brussel

EU/1/99/128/001-037

30.1.2008

28.1.2008

Agenerase

| Glaxo Group Ltd |
| --- |
| Greenford Road |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/148/001-004

30.1.2008

28.1.2008

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

30.1.2008

29.1.2008

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/1/01/195/001-021

31.1.2008

31.1.2008

Dynastat

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/02/209/001-008

4.2.2008

31.1.2008

Xeloda

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/00/163/001-002

4.2.2008

31.1.2008

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/1/96/007/023-038

4.2.2008

31.1.2008

Naglazyme

| BioMarin Europe Limited |
| --- |
| Axtell House |
| 23-24 Warwick Street |
| London W1B 5NQ |
| United Kingdom |

BioMarin Europe Limited

Axtell House

23-24 Warwick Street

London W1B 5NQ

United Kingdom

EU/1/05/324/001

4.2.2008

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 10.1.2008 | Rheumocam | Meloxicam | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea |
| Co. Galway |
| Ireland |

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

10.1.2008

Rheumocam

Meloxicam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea

Co. Galway

Ireland

EU/2/07/078/001-003

Oral suspension

QM01AC06

15.1.2008

31.1.2008

Nobilis Influenza H5N6

Inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84), inducing an HI titre of ≥ 6,0 log2 as tested according to the potency test

| 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

Emulsion for injection

QI01AA23

4.2.2008

—   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 |
| --- | --- | --- | --- | --- |
| 3.1.2008 | ProMeris | Fort Dodge Animal Health Holland |
| C.J. van Houtenlaan 36 |
| 1381 CP Weesp |
| Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.1.2008

ProMeris

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

Nederland

EU/2/06/064/001-004

7.1.2008

10.1.2008

Nobilis OR Inac

| 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/2/02/036/001-002

14.1.2008

11.1.2008

ProteqFlu Te

| Merial |
| --- |
| 29, Avenue Tony Garnier |
| F-69007 Lyon |

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/03/038/005

15.1.2008

14.1.2008

ProteqFlu

| Merial |
| --- |
| 29, Avenue Tony Garnier |
| F-69007 Lyon |

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/03/037/005

16.1.2008

15.1.2008

Dicural

| Fort Dodge Animal Health Holland |
| --- |
| C.J. van Houtenlaan 36 |
| 1381 CP Weesp |
| Nederland |

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

Nederland

EU/2/97/003/001-018

17.1.2008

17.1.2008

Cerenia

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/2/06/062/001-005

21.1.2008

22.1.2008

Purevax FelV

| Merial |
| --- |
| 29, Avenue Tony Garnier |
| F-69007 Lyon |

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/00/019/005-007

25.1.2008

22.1.2008

Purevax RCP FelV

| Merial |
| --- |
| 29, Avenue Tony Garnier |
| F-69007 Lyon |

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/04/048/001-002

25.1.2008

22.1.2008

Purevax RCCh

| Merial |
| --- |
| 29, Avenue Tony Garnier |
| F-69007 Lyon |

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/04/049/001-002

25.1.2008

22.1.2008

Purevax RCPCH FelV

| Merial |
| --- |
| 29, Avenue Tony Garnier |
| F-69007 Lyon |

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/04/047/001-002

25.1.2008

22.1.2008

Purevax RCPCh

| Merial |
| --- |
| 29, Avenue Tony Garnier |
| F-69007 Lyon |

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/04/050/001-002

25.1.2008

22.1.2008

ProteqFlu

| Merial |
| --- |
| 29, Avenue Tony Garnier |
| F-69007 Lyon |

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/03/037/005

25.1.2008

22.1.2008

ProteqFlu-Te

| Merial |
| --- |
| 29, Avenue Tony Garnier |
| F-69007 Lyon |

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/03/038/005

25.1.2008

22.1.2008

Purevax RC

| Merial |
| --- |
| 29, Avenue Tony Garnier |
| F-69007 Lyon |

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/04/051/001-002

25.1.2008

25.1.2008

Purevax RCP

| Merial |
| --- |
| 29, Avenue Tony Garnier |
| F-69007 Lyon |

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/04/052/001-002

29.1.2008

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.

---

| 29.2.2008 | EN | Official Journal of the European Union | C 56/14 |
| --- | --- | --- | --- |

29.2.2008

EN

Official Journal of the European Union

C 56/14

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008

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

(2008/C 56/08)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 11.1.2008 | Methotaxol-T | See Annex I | See Annex I | 15.1.2008 |
| 17.1.2008 | Ivermectin | See Annex II | See Annex II | 18.1.2008 |
| 18.1.2008 | Ciprofloxacin Nycomed | See Annex III | See Annex III | 21.1.2008 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

11.1.2008

Methotaxol-T

See Annex I

See Annex I

15.1.2008

17.1.2008

Ivermectin

See Annex II

See Annex II

18.1.2008

18.1.2008

Ciprofloxacin Nycomed

See Annex III

See Annex III

21.1.2008

—   Suspension 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 |
| --- | --- | --- | --- | --- |
| 25.1.2008 | Lumiracoxib | See Annex IV | See Annex IV | 29.1.2008 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

25.1.2008

Lumiracoxib

See Annex IV

See Annex IV

29.1.2008

—   Revocation 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 |
| --- | --- | --- | --- | --- |
| 10.1.2008 | Cetirizine dihydrochloride Dermapharm 10 mg | See Annex V | See Annex V | 11.1.2008 |
| 10.1.2008 | Cetirizine dihydrochloride Copypharm 10 mg | See Annex VI | See Annex VI | 11.1.2008 |
| 10.1.2008 | Cetirizine dihydrochloride Apex 10 mg | See Annex VII | See Annex VII | 11.1.2008 |
| 10.1.2008 | Cetirizine dihydrochloride Nordic Drugs 10 mg | See Annex VIII | See Annex VIII | 11.1.2008 |
| 10.1.2008 | Clobutinol | See Annex IX | See Annex IX | 11.1.2008 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

10.1.2008

Cetirizine dihydrochloride Dermapharm 10 mg

See Annex V

See Annex V

11.1.2008

10.1.2008

Cetirizine dihydrochloride Copypharm 10 mg

See Annex VI

See Annex VI

11.1.2008

10.1.2008

Cetirizine dihydrochloride Apex 10 mg

See Annex VII

See Annex VII

11.1.2008

10.1.2008

Cetirizine dihydrochloride Nordic Drugs 10 mg

See Annex VIII

See Annex VIII

11.1.2008

10.1.2008

Clobutinol

See Annex IX

See Annex IX

11.1.2008

---

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

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

---

ANNEX I

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/APPLICANT

| Member State | Applicant or marketing authorisation holder | Product invented name | Pharmaceutical form | Strength | Indication | Recommended dose
  Frequency and route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| The Netherlands | Eurovet Animal Health |
| Handelsweg 25 |
| P.O. Box 179 |
| 5530 AD Bladel |
| Nederland |

Member State

Applicant or marketing authorisation holder

Product invented name

Pharmaceutical form

Strength

Indication

Recommended dose

Frequency and route of administration

The Netherlands

Eurovet Animal Health

Handelsweg 25

P.O. Box 179

5530 AD Bladel

Nederland

Methoxasol-T

Solution for oral administration

Trimethoprim 20 mg/ml

Sulfamethoxazole 100 mg/ml

N-Methyl-2-pyrrolidone

Pigs:

| | Bronchial infections caused by Pasteurella multocida |
| --- | --- |

Bronchial infections caused by Pasteurella multocida

| | Intestinal infections caused by Escherichia coli and Salmonella spp. |
| --- | --- |

Intestinal infections caused by Escherichia coli and Salmonella spp.

| | Urogenital infections caused by Escherichia coli |
| --- | --- |

Urogenital infections caused by Escherichia coli

Non-egg-laying chickens:

| | Bronchial infections caused by Escherichia coli, Salmonella spp. and Pasteurella spp. |
| --- | --- |

Bronchial infections caused by Escherichia coli, Salmonella spp. and Pasteurella spp.

Oral, via the drinking water

Pigs: 2,5-5 mg trimethoprim and 12,5-25 mg sulfamethoxasole per kg body weight per day for 3-5 days

Chickens: 5-12 mg trimethoprim and 25-58 mg sulfamethoxasole per kg body weight per day for 3-5 days

Germany

| Eurovet Animal Health |
| --- |
| Handelsweg 25 |
| P.O. Box 179 |
| 5530 AD Bladel |
| Nederland |

Eurovet Animal Health

Handelsweg 25

P.O. Box 179

5530 AD Bladel

Nederland

Methoxasol-T

As for The Netherlands

As for The Netherlands

Therapeutic treatment of infections caused by trimethoprim and sulfamethoxasole susceptible bacteria

Pigs:

| | Pasteurella multocida, Actinobacillus pleuropneumoniae, Staphylococcus hyicus, E. coli, Haemophilus spp., Pasteurella haemolytica, Salmonella cholerasuis, Salmonella thyphimurium, Streptococcus spp., Staphylococcus aureus, Staphylococcus spp. |
| --- | --- |

Pasteurella multocida, Actinobacillus pleuropneumoniae, Staphylococcus hyicus, E. coli, Haemophilus spp., Pasteurella haemolytica, Salmonella cholerasuis, Salmonella thyphimurium, Streptococcus spp., Staphylococcus aureus, Staphylococcus spp.

Broilers:

| | Staphylococcus aureus, Salmonella enteritidis, E. coli |
| --- | --- |

Staphylococcus aureus, Salmonella enteritidis, E. coli

Oral, via the drinking water

Methoxasol-T should be administered daily in drinking water over a period of 3-4 days

Pigs: 20,8 mg sulfamethoxasole + 4,2 mg trimethoprim per kg body weight per day for 3-4 days

Broilers: 27,5 mg sulfamethoxasole + 5,5 mg trimethoprim per kg body weight per day for 3-4 days

Austria

| Eurovet Animal Health |
| --- |
| Handelsweg 25 |
| P.O. Box 179 |
| 5530 AD Bladel |
| Nederland |

Eurovet Animal Health

Handelsweg 25

P.O. Box 179

5530 AD Bladel

Nederland

Methoxasol — Lösung für Schweine und Hühner

As for The Netherlands

As for The Netherlands

For the treatment of respiratory tract infections, urogenital, gastrointestinal and skin infections caused by pathogens sensitive to trimethoprim and sulfamethoxasole in pigs and poultry (broilers)

As for Germany

Poland

| Eurovet Animal Health |
| --- |
| Handelsweg 25 |
| P.O. Box 179 |
| 5530 AD Bladel |
| Nederland |

Eurovet Animal Health

Handelsweg 25

P.O. Box 179

5530 AD Bladel

Nederland

Methoxasol

As for The Netherlands

As for The Netherlands

For treatment of infections caused by organisms sensitive to combination of trimethoprim and sulfamethoxasole

Pigs:

| | Infections of the respiratory tract caused by Pasteurella multocida, Actinobacillus pleuropneumoniae |
| --- | --- |

Infections of the respiratory tract caused by Pasteurella multocida, Actinobacillus pleuropneumoniae

| | Infections of the digestive system caused by Escherichia coli, Salmonella spp. |
| --- | --- |

Infections of the digestive system caused by Escherichia coli, Salmonella spp.

| | Infections of the urinary system caused by Escherichia coli |
| --- | --- |

Infections of the urinary system caused by Escherichia coli

Hens:

| | Infections of the respiratory tract caused by Escherichia coli, Salmonella spp., Pasteurella multocida |
| --- | --- |

Infections of the respiratory tract caused by Escherichia coli, Salmonella spp., Pasteurella multocida

| | Infections of the digestive system caused by Salmonella spp. |
| --- | --- |

Infections of the digestive system caused by Salmonella spp.

| | Polyarthritis caused by susceptible Escherichia coli |
| --- | --- |

Polyarthritis caused by susceptible Escherichia coli

Oral, via the drinking water

Pigs: 24 mg/kg b.w., equivalent to 1 litre of the drug in 500 l drinking water, for 3-4 days

Hens: 33 mg/kg b.w., equivalent to 1 litre of the drug in 750 l drinking water, for 3-4 days

Hungary and Lithuania

| Eurovet Animal Health |
| --- |
| Handelsweg 25 |
| P.O. Box 179 |
| 5530 AD Bladel |
| Nederland |

Eurovet Animal Health

Handelsweg 25

P.O. Box 179

5530 AD Bladel

Nederland

Methoxasol

As for The Netherlands

As for The Netherlands

For the treatment of pigs and non-egg-laying chickens suffering from infectious diseases of the respiratory system caused by bacteria sensitive to sulfamethoxasole and trimethoprim (e.g. porcine A. pleuropneumoniae and gallinaceous E. coli) and for prophylactic use

Oral, via the drinking water

Pigs: 24 mg of active ingredient compound per kilogram of body weight or 200 ml of the medicine per 1 000 kg of body weight per day

Poultry: 33 mg of active ingredient compound per kilogram of body weight or 275 ml of the medicine per 1 000 kg of body weight per day

---

ANNEX II

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/APPLICANT(S)

| Member State | Marketing authorisation holder/applicant | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Ireland | ECO Animal Health Ltd |
| 78 Coombe Road |
| New Malden |
| Surrey |
| KT3 4QS |
| United Kingdom |

Member State

Marketing authorisation holder/applicant

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Ireland

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey

KT3 4QS

United Kingdom

Ecomectin 18,7 mg/g

Oral paste for horses

Oral paste

A white homogenous paste

Ivermectin 18,7 mg/g

Horses

The paste is given by oral route

One syringe division of paste per 100 kg body weight (based on a recommended dosage of 200 microgram ivermectin per kg body weight)

Belgium

As above

Ivermax 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

Cyprus

As above

Tizoval 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

Czech Republic

As above

Vetimec 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

Denmark

As above

Ecomectin 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

Finland

As above

Ecomectin 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

France

As above

Divamectin 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

Germany

As above

Tizoval 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

Greece

As above

Tizoval 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

Hungary

As above

Ecomectin 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

Italy

As above

Tizoval 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

The Netherlands

As above

Ivermax 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

Norway

As above

Tizoval 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

Portugal

As above

Ecomectin 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

Spain

As above

Ecomectin 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

Sweden

As above

Ecomectin 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

United Kingdom

As above

Animec 18,7 mg/g

Oral paste for horses

As above

As above

As above

As above

As above

---

ANNEX III

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

| Member State | Marketing authorisation holder | Applicant | Invented name
  Name | Strength | Pharmaceutical form | Route of administration | Content
  (Concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| United Kingdom | Nycomed Danmark ApS |
| Langebjerg 1 |
| DK-4000 Roskilde |

Member State

Marketing authorisation holder

Applicant

Invented name

Name

Strength

Pharmaceutical form

Route of administration

Content

(Concentration)

United Kingdom

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Ciprofloxacin

2 mg/ml

Solution for infusion

Intravenous use

50 ml, 100 ml, 200 ml

Denmark

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

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Ciprofloxacin

Nycomed

2 mg/ml

Solution for infusion

Intravenous use

50 ml, 100 ml, 200 ml

Finland

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

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Ciprofloxacin

Nycomed

2 mg/ml

Solution for infusion

Intravenous use

50 ml, 100 ml, 200 ml

Norway

| Nycomed Pharma AS |
| --- |
| Drammernsveien 852 |
| N-1372 Asker |

Nycomed Pharma AS

Drammernsveien 852

N-1372 Asker

Ciprofloxacin

Nycomed

2 mg/ml

Solution for infusion

Intravenous use

50 ml, 100 ml, 200 ml

Sweden

| Nycomed AB |
| --- |
| Tegeluddvägen 17-21 |
| S-102 53 Stockholm |

Nycomed AB

Tegeluddvägen 17-21

S-102 53 Stockholm

Ciprofloxacin

Nycomed

2 mg/ml

Solution for infusion

Intravenous use

50 ml, 100 ml, 200 ml

---

ANNEX IV

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

| Member State | Marketing authorisation holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH |
| Brunner Straße 59 |
| A-1235 Wien |

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Novartis Pharma GmbH

Brunner Straße 59

A-1235 Wien

Prexige

100 mg

Film-coated tablet

Oral use

Austria

| Novartis Pharma GmbH |
| --- |
| Brunner Straße 59 |
| A-1235 Wien |

Novartis Pharma GmbH

Brunner Straße 59

A-1235 Wien

Frexocel

100 mg

Film-coated tablet

Oral use

Belgium

| Novartis Pharma NV |
| --- |
| Medialaan 40 bus 1 |
| B-1800 Vilvoorde |

Novartis Pharma NV

Medialaan 40 bus 1

B-1800 Vilvoorde

Prexigem

100 mg

Film-coated tablet

Oral use

Belgium

| Novartis Pharma NV |
| --- |
| Medialaan 40 bus 1 |
| B-1800 Vilvoorde |

Novartis Pharma NV

Medialaan 40 bus 1

B-1800 Vilvoorde

Stellige

100 mg

Film-coated tablet

Oral use

Czech Republic

| Novartis s.r.o. |
| --- |
| Pharma |
| Nagano III. |
| U Nákladového nádraží 10 |
| CZ-130 00 Prague 3 |

Novartis s.r.o.

Pharma

Nagano III.

U Nákladového nádraží 10

CZ-130 00 Prague 3

Prexige

100 mg

Film-coated tablet

Oral use

Cyprus

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey GU-167-SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey GU-167-SR

United Kingdom

Prexige

100 mg

Film-coated tablet

Oral use

Denmark

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Prexige

100 mg

Film-coated tablet

Oral use

Estonia

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

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Prexige

100 mg

Film-coated tablet

Oral use

Finland

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

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Prexige

100 mg

Film-coated tablet

Oral use

Germany

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

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuernberg

Prexige

100 mg

Film-coated tablet

Oral use

Germany

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

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuernberg

Frexocel

100 mg

Film-coated tablet

Oral use

Germany

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

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuernberg

Hirzia

100 mg

Film-coated tablet

Oral use

Germany

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

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuernberg

Stellige

100 mg

Film-coated tablet

Oral use

Greece

| Novartis Hellas Aebe |
| --- |
| National Road a, 12 th Km |
| Metamorphosi Attikis |
| GR-14451 |

Novartis Hellas Aebe

National Road a, 12 th Km

Metamorphosi Attikis

GR-14451

Prexige

100 mg

Film-coated tablet

Oral use

Greece

| Novartis Hellas Aebe |
| --- |
| National Road a, 12 th Km |
| Metamorphosi Attikis |
| GR-14451 |

Novartis Hellas Aebe

National Road a, 12 th Km

Metamorphosi Attikis

GR-14451

Frexocel

100 mg

Film-coated tablet

Oral use

Hungary

| Novartis Hungária Kft. |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |

Novartis Hungária Kft.

Bartók Béla út 43-47

H-1114 Budapest

Prexige

100 mg

Film-coated tablet

Oral use

Iceland

| Novartis Healthcare A/S, c/o |
| --- |
| Vistor hf. |
| Hörgatúni 2 |
| IS-210 Garðabær |

Novartis Healthcare A/S, c/o

Vistor hf.

Hörgatúni 2

IS-210 Garðabær

Prexige

100 mg

Film-coated tablet

Oral use

Latvia

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

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Prexige

100 mg

Film-coated tablet

Oral use

Lithuania

| Novartis Finland Oy |
| --- |
| Metsanneidonkuja 10 |
| FI-02130 Espoo |

Novartis Finland Oy

Metsanneidonkuja 10

FI-02130 Espoo

Prexige

100 mg

Film-coated tablet

Oral use

Luxembourg

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

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Prexige

100 mg

Film-coated tablet

Oral use

Malta

| Novartis Pharmaceuticals UK Ltd. |
| --- |
| Frimley Business Park |
| Frimley |
| Camberly |
| GU16 7SR Surrey |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd.

Frimley Business Park

Frimley

Camberly

GU16 7SR Surrey

United Kingdom

Prexige

100 mg

Film-coated tablet

Oral use

Netherlands

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| Nederland |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

Nederland

Prexige

100 mg

Film-coated tablet

Oral use

Norway

| Novartis Norge AS |
| --- |
| Brynsalléen 4 |
| N-0667 Oslo |

Novartis Norge AS

Brynsalléen 4

N-0667 Oslo

Prexige

100 mg

Film-coated tablet

Oral use

Poland

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

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nurnberg

Stellige

100 mg

Film-coated tablet

Oral use

Poland

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

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nurnberg

Prexige

100 mg

Film-coated tablet

Oral use

Portugal

| Laboratório Normal |
| --- |
| Produtos Farmacêuticos S.A |
| Rua do Centro Empresarial |
| Edificio 8 — Quinta da Beloura |
| P-2710-444 Sintra |

Laboratório Normal

Produtos Farmacêuticos S.A

Rua do Centro Empresarial

Edificio 8 — Quinta da Beloura

P-2710-444 Sintra

Frexocel

100 mg

Film-coated tablet

Oral use

Portugal

| Sociedade de Produtos Farmacêuticos Wander Lda. |
| --- |
| Rua do Centro Empresarial |
| Edificio 8 — Quinta da Beloura |
| P-2710-444 Sintra |

Sociedade de Produtos Farmacêuticos Wander Lda.

Rua do Centro Empresarial

Edificio 8 — Quinta da Beloura

P-2710-444 Sintra

Hirzia

100 mg

Film-coated tablet

Oral use

Portugal

| Novartis Farma, Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial |
| Edificio 8 — Quinta da Beloura |
| P-2710-444 Sintra |

Novartis Farma, Produtos Farmacêuticos S.A.

Rua do Centro Empresarial

Edificio 8 — Quinta da Beloura

P-2710-444 Sintra

Prexige

100 mg

Film-coated tablet

Oral use

Portugal

| Sanabo-Produtos |
| --- |
| Farmacêuticos Lda. |
| Rua do Centro Empresarial |
| Edificio 8 — Quinta da Beloura |
| P-2710-444 Sintra |

Sanabo-Produtos

Farmacêuticos Lda.

Rua do Centro Empresarial

Edificio 8 — Quinta da Beloura

P-2710-444 Sintra

Stellige

100 mg

Film-coated tablet

Oral use

Slovakia

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

Novartis s.r.o., Nagano III.

U Nákladového nádraží 10

CZ-130 00 Praha 3

Prexige

100 mg

Film-coated tablet

Oral use

Slovenia

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

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Frexocel

100 mg

Film-coated tablet

Oral use

Slovenia

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

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Prexige

100 mg

Film-coated tablet

Oral use

Spain

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes |
| E-764 08013 Barcelona |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes

E-764 08013 Barcelona

Prexige

100 mg

Film-coated tablet

Oral use

Spain

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes |
| E-764 08013 Barcelona |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes

E-764 08013 Barcelona

Stellige

100 mg

Film-coated tablet

Oral use

Sweden

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

Novartis Sverige AB

Box 1150

S-183 11 Täby

Prexige

100 mg

Film-coated tablet

Oral use

United Kingdom

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

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

United Kingdom

Lumiracoxib 100 mg tablets

100 mg

Film-coated tablet

Oral use

United Kingdom

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

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

United Kingdom

Prexige

100 mg

Film-coated tablet

Oral use

United Kingdom

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

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

United Kingdom

Frexocel

100 mg

Film-coated tablet

Oral use

United Kingdom

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

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

United Kingdom

Stellige

100 mg

Film-coated tablet

Oral use

United Kingdom

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

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

United Kingdom

Hirzia

100 mg

Film-coated tablet

Oral use

---

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Cetirizine dihydrochloride Dermapharm 10 mg and associated names

| Member State | Marketing authorisation holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Dermapharm GmbH |
| Türkenstr. 25/12 |
| A-1090 Wien |

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Dermapharm GmbH

Türkenstr. 25/12

A-1090 Wien

Cetiderm 10 mg Filmtabletten

10 mg

Film-coated tablet

Oral

Belgium

| Dermapharm AG |
| --- |
| Luise-Ullrich-Str. 6 |
| D-82031 Grünwald |

Dermapharm AG

Luise-Ullrich-Str. 6

D-82031 Grünwald

Cetirizine dihydrochloride Dermapharm 10 mg filmomhulde tabletten

10 mg

Film-coated tablet

Oral

Germany

| Dermapharm AG |
| --- |
| Luise-Ullrich-Str. 6 |
| D-82031 Grünwald |

Dermapharm AG

Luise-Ullrich-Str. 6

D-82031 Grünwald

Cetiderm 10 mg Filmtabletten

10 mg

Film-coated tablet

Oral

Netherlands

| Dermapharm AG |
| --- |
| Luise-Ullrich-Str. 6 |
| D-82031 Grünwald |

Dermapharm AG

Luise-Ullrich-Str. 6

D-82031 Grünwald

Cetirizine dihydrochloride Dermapharm 10 mg tabletten

10 mg

Film-coated tablet

Oral

---

ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Cetirizine dihydrochloride Copyfarm 10 mg and associated names

| Member State | Marketing authorisation holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Denmark | Copyfarm A/S, |
| Energivej 15, |
| POB 69 |
| DK-5260 Odense S |

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of administration

Denmark

Copyfarm A/S,

Energivej 15,

POB 69

DK-5260 Odense S

Cetirizin ‘Copyfarm’

10 mg

Film-coated tablet

Oral

Netherlands

| Copyfarm A/S |
| --- |
| Energivej 15 |
| POB 69 |
| DK-5260 Odense S |

Copyfarm A/S

Energivej 15

POB 69

DK-5260 Odense S

Cetirizine dihydrochloride Copyfarm 10 mg

10 mg

Film-coated tablet

Oral

Norway

| Copyfarm A/S |
| --- |
| Energivej 15, |
| POB 69, |
| DK-5260 Odense S |

Copyfarm A/S

Energivej 15,

POB 69,

DK-5260 Odense S

Cetirizin Copyfarm

10 mg

Film-coated tablet

Oral

Sweden

| Copyfarm A/S |
| --- |
| Energivej 15, |
| POB 69, |
| DK-5260 Odense S |

Copyfarm A/S

Energivej 15,

POB 69,

DK-5260 Odense S

Cetirizin Copyfarm

10 mg

Film-coated tablet

Oral

---

ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Cetirizine dihydrochloride APEX 10 mg and associated names

| Member State | Marketing authorisation holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Docpharma N.V. |
| Ambachtenlaan 13 H |
| B-3001 Heverlee |

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of administration

Belgium

Docpharma N.V.

Ambachtenlaan 13 H

B-3001 Heverlee

Doccetiri

10 mg

Film-coated tablet

Oral

Luxembourg

| Docpharma N.V. |
| --- |
| Ambachtenlaan 13 H |
| B-3001 Heverlee |

Docpharma N.V.

Ambachtenlaan 13 H

B-3001 Heverlee

Doccetiri —10

10 mg

Film-coated tablet

Oral

Netherlands

| Apex Pharmaceuticals Ltd |
| --- |
| 2nd Floor, Devlin House |
| 36 Saint George Street |
| Mayfair |
| W1S 2FW London |
| United Kingdom |

Apex Pharmaceuticals Ltd

2nd Floor, Devlin House

36 Saint George Street

Mayfair

W1S 2FW London

United Kingdom

Cetirizine dihydrochloride — APEX 10 mg

10 mg

Film-coated tablet

Oral

---

ANNEX VIII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Cetirizine dihydrochloride Nordic Drugs 10 mg and associated names

| Member State | Marketing authorisation holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Denmark | Nordic Drugs AB |
| Box 300 35 |
| S-200 61 Limhamn |

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of administration

Denmark

Nordic Drugs AB

Box 300 35

S-200 61 Limhamn

Gardex

10 mg

Film-coated tablet

Oral

Finland

| Nordic Drugs AB |
| --- |
| Box 300 35 |
| S-200 61 Limhamn |

Nordic Drugs AB

Box 300 35

S-200 61 Limhamn

Gardex

10 mg

Film-coated tablet

Oral

Netherlands

| Nordic Drugs AB |
| --- |
| Box 300 35 |
| S-200 61 Limhamn |

Nordic Drugs AB

Box 300 35

S-200 61 Limhamn

Cetirizine dihydrochloride Nordic Drugs 10 mg

10 mg

Film-coated tablet

Oral

Norway

| Nordic Drugs AB |
| --- |
| Box 30035 |
| S-200 61 Limhamn |

Nordic Drugs AB

Box 30035

S-200 61 Limhamn

Acura

10 mg

Film-coated tablet

Oral

Sweden

| Nordic Drugs AB |
| --- |
| Box 300 35 |
| S-200 61 Limhamn |

Nordic Drugs AB

Box 300 35

S-200 61 Limhamn

Acura

10 mg

Film-coated tablet

Oral

---

ANNEX IX

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

Clobutinol containing medicinal products with marketing authorisation in the European Union

| Member State | Marketing authorisation holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Boehringer Ingelheim Austria GmbH |
| Dr. Boehringer-Gasse 5-11 |
| A-1121 Wien |

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Boehringer Ingelheim Austria GmbH

Dr. Boehringer-Gasse 5-11

A-1121 Wien

Silomat — Dragees

40 mg

Coated tablet

Oral use

Austria

| Boehringer Ingelheim Austria GmbH |
| --- |
| Dr. Boehringer-Gasse 5-11 |
| A-1121 Wien |

Boehringer Ingelheim Austria GmbH

Dr. Boehringer-Gasse 5-11

A-1121 Wien

Silomat — Hustensaft

40 mg/10 ml

Oral solution

Oral use

Austria

| Boehringer Ingelheim Austria GmbH |
| --- |
| Dr. Boehringer-Gasse 5-11 |
| A-1121 Wien |

Boehringer Ingelheim Austria GmbH

Dr. Boehringer-Gasse 5-11

A-1121 Wien

Silomat — Tropfen

60 mg/ml

Oral drops, solution

Oral use

Belgium

| SCS Boehringer Ingelheim Comm.V., |
| --- |
| Avenue Ariane 16 |
| B-1200 Bruxelles |

SCS Boehringer Ingelheim Comm.V.,

Avenue Ariane 16

B-1200 Bruxelles

Silomat

40 mg

Tablets

Oral use

Belgium

| SCS Boehringer Ingelheim Comm.V., |
| --- |
| Avenue Ariane 16 |
| B-1200 Bruxelles |

SCS Boehringer Ingelheim Comm.V.,

Avenue Ariane 16

B-1200 Bruxelles

Silomat

60 mg

Oral solution

Oral use

Belgium

| SCS Boehringer Ingelheim Comm.V., |
| --- |
| Avenue Ariane 16 |
| B-1200 Bruxelles |

SCS Boehringer Ingelheim Comm.V.,

Avenue Ariane 16

B-1200 Bruxelles

Silomat

20 mg/5 ml

Syrup

Oral use

Czech Republic

| SCS Boehringer Ingelheim Comm.V., |
| --- |
| Avenue Ariane 16 |
| B-1200 Bruxelles |

SCS Boehringer Ingelheim Comm.V.,

Avenue Ariane 16

B-1200 Bruxelles

Silomat

20 mg/2 ml

Solution for injection

Intramuscular or intravenous use

Czech Republic

| SCS Boehringer Ingelheim Comm.V., |
| --- |
| Avenue Ariane 16 |
| B-1200 Bruxelles |

SCS Boehringer Ingelheim Comm.V.,

Avenue Ariane 16

B-1200 Bruxelles

Silomat

40 mg/10 ml

Syrup

Oral use

Czech Republic

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

Boehringer Ingelheim GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

Silomat

900 mg /15 ml

Oral drops, solution

Oral use

Germany

| Boehringer Ingelheim Pharma GmbH & Co.KG |
| --- |
| Binger Str. 173 |
| D-55216 Ingelheim |

Boehringer Ingelheim Pharma GmbH & Co.KG

Binger Str. 173

D-55216 Ingelheim

Clobutinol Kapseln 80 mg

80 mg

Capsule, hard

Oral use

Germany

| Boehringer Ingelheim Pharma GmbH & Co.KG |
| --- |
| Binger Str. 173 |
| D-55216 Ingelheim |

Boehringer Ingelheim Pharma GmbH & Co.KG

Binger Str. 173

D-55216 Ingelheim

Clobutinol -Tropfen TH

40 mg/0,67 ml

Oral drops, solution

Oral use

Germany

| Boehringer Ingelheim Pharma GmbH & Co.KG |
| --- |
| Binger Str. 173 |
| D-55216 Ingelheim |

Boehringer Ingelheim Pharma GmbH & Co.KG

Binger Str. 173

D-55216 Ingelheim

Silomat Ampullen gegen Reizhusten

20 mg/2 ml

Solution for injection

Intramuscular or intravenous use

Germany

| Boehringer Ingelheim Pharma GmbH & Co.KG |
| --- |
| Binger Str. 173 |
| D-55216 Ingelheim |

Boehringer Ingelheim Pharma GmbH & Co.KG

Binger Str. 173

D-55216 Ingelheim

Silomat Dragees gegen Reizhusten

40 mg

Coated tablet

Oral use

Germany

| Boehringer Ingelheim Pharma GmbH & Co.KG |
| --- |
| Binger Str. 173 |
| D-55216 Ingelheim |

Boehringer Ingelheim Pharma GmbH & Co.KG

Binger Str. 173

D-55216 Ingelheim

Silomat Saft gegen Reizhusten

40 mg/10 ml

Solution

Oral use

Germany

| Boehringer Ingelheim Pharma GmbH & Co.KG |
| --- |
| Binger Str. 173 |
| D-55216 Ingelheim |

Boehringer Ingelheim Pharma GmbH & Co.KG

Binger Str. 173

D-55216 Ingelheim

Silomat Tropfen gegen Reizhusten

40 mg/0,67 ml

Oral drops, solution

Oral use

Germany

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstr. 50 |
| D-66386 Sankt Ingbert |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Mühlstr. 50

D-66386 Sankt Ingbert

Clobutinol-Chephasaar Kapsel 40 mg

40 mg

Capsule, hard

Oral use

Germany

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstr. 50 |
| D-66386 Sankt Ingbert |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Mühlstr. 50

D-66386 Sankt Ingbert

Clobutinol-Chephasaar Saft 4mg/ml

4 mg/1 ml

Oral solution

Oral use

Germany

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstr. 50 |
| D-66386 Sankt Ingbert |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Mühlstr. 50

D-66386 Sankt Ingbert

Clobutinol-MIP Kapsel 40 mg

40 mg

Capsule, hard

Oral use

Germany

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstr. 50 |
| D-66386 Sankt Ingbert |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Mühlstr. 50

D-66386 Sankt Ingbert

Clobutinol-MIP Tropfen 80 mg/ml

80 mg/1 ml

Oral solution

Oral use

Germany

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstr. 50 |
| D-66386 Sankt Ingbert |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Mühlstr. 50

D-66386 Sankt Ingbert

Rofatuss forte

80 mg

Capsule, hard

Oral use

Germany

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstr. 50 |
| D-66386 Sankt Ingbert |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Mühlstr. 50

D-66386 Sankt Ingbert

Rofatuss N

40 mg

Capsule, hard

Oral use

Germany

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstr. 50 |
| D-66386 Sankt Ingbert |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Mühlstr. 50

D-66386 Sankt Ingbert

Rofatuss Saft

400 mg/100 ml

Oral solution

Oral use

Germany

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstr. 50 |
| D-66386 Sankt Ingbert |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Mühlstr. 50

D-66386 Sankt Ingbert

Rofatuss Tropfen

80 mg/1 ml

Oral drops, solution

Oral use

Germany

| EMRA-MED Arzneimittel GmbH |
| --- |
| Otto Hahn-Str. 11 |
| D-22946 Trittau |

EMRA-MED Arzneimittel GmbH

Otto Hahn-Str. 11

D-22946 Trittau

Silomat Dragees gegen Reizhusten

40 mg

Coated tablet

Oral use

Germany

| EMRA-MED Arzneimittel GmbH |
| --- |
| Otto Hahn-Str. 11 |
| D-22946 Trittau |

EMRA-MED Arzneimittel GmbH

Otto Hahn-Str. 11

D-22946 Trittau

Silomat Saft

40 mg/10 ml

Oral solution

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Clobutinol Tropfen

40 mg/0,67 ml

Oral drops, solution

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Tussed Hustenstiller Dragees

40 mg

Coated tablet

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Tussed Hustenstiller Saft

40 mg/10 ml

Oral solution

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Tussed Hustenstiller Tropfen

40 mg/0,67 ml

Solution

Oral use

Germany

| Hofmann & Sommer GmbH & Co.KG |
| --- |
| Chemisch-pharmazeutische Fabrik |
| Lindenstr. 11 |
| D-07426 Königsee |

Hofmann & Sommer GmbH & Co.KG

Chemisch-pharmazeutische Fabrik

Lindenstr. 11

D-07426 Königsee

Nullatuss Clobutinol Hustentropfen

6 g/100 g

Oral drops, solution

Oral use

Germany

| kohlpharma GmbH |
| --- |
| Im Holzhau 8 |
| D-66663 Merzig |

kohlpharma GmbH

Im Holzhau 8

D-66663 Merzig

Silomat Tropfen gegen Reizhusten

40 mg/0,67 ml

Oral solution

Oral use

Germany

| Pharma Westen GmbH |
| --- |
| Fixheider Str. 4 |
| D-51381 Leverkusen |

Pharma Westen GmbH

Fixheider Str. 4

D-51381 Leverkusen

Silomat Dragees gegen Reizhusten

40 mg

Coated tablet

Oral use

Germany

| Pharma Westen GmbH |
| --- |
| Fixheider Str. 4 |
| D-51381 Leverkusen |

Pharma Westen GmbH

Fixheider Str. 4

D-51381 Leverkusen

Silomat Saft gegen Reizhusten

40 mg/10 ml

Oral solution

Oral use

Germany

| ratiopharm GmbH |
| --- |
| Graf Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf Arco-Str. 3

D-89079 Ulm

Hustenstiller-ratiopharm Clobutinol

20 mg/5 ml

Oral solution

Oral use

Germany

| ratiopharm GmbH |
| --- |
| Graf Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf Arco-Str. 3

D-89079 Ulm

Hustenstiller-ratiopharm Clobutinol Kapseln

80 mg

Capsule, hard

Oral use

Germany

| ratiopharm GmbH |
| --- |
| Graf Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf Arco-Str. 3

D-89079 Ulm

Hustenstiller-ratiopharm Clobutinol Tropfen

80 mg/1 ml

Oral solution

Oral use

Greece

| Boehringer Ingelheim Hellas S.A. |
| --- |
| 2 Ellinikou str. |
| GR-16777 Athens |

Boehringer Ingelheim Hellas S.A.

2 Ellinikou str.

GR-16777 Athens

Silomat Compositum

(Clobutinol HCl + Orciprenaline Sulfate)

20+5 mg/5ml

Syrup

Oral use

Greece

| Boehringer Ingelheim Hellas S.A. |
| --- |
| 2 Ellinikou str. |
| GR-16777 Athens |

Boehringer Ingelheim Hellas S.A.

2 Ellinikou str.

GR-16777 Athens

Silomat

60 mg/ml

Oral solution, drops

Oral use

Greece

| Boehringer Ingelheim Hellas S.A. |
| --- |
| 2 Ellinikou str. |
| GR-16777 Athens |

Boehringer Ingelheim Hellas S.A.

2 Ellinikou str.

GR-16777 Athens

Silomat

20 mg/5ml

Syrup

Oral use

Finland

| Boehringer Ingelheim Finland Oy |
| --- |
| Tammisaarenkatu 5 |
| FI-00180 Helsinki |

Boehringer Ingelheim Finland Oy

Tammisaarenkatu 5

FI-00180 Helsinki

Silomat

4 mg/ml

Oral solution

Oral use

Finland

| Boehringer Ingelheim Finland Oy |
| --- |
| Tammisaarenkatu 5 |
| FI-00180 Helsinki |

Boehringer Ingelheim Finland Oy

Tammisaarenkatu 5

FI-00180 Helsinki

Silomat

40 mg

Coated tablet

Oral use

Finland

| Orion Corporation, ORION PHARMA |
| --- |
| Tengströminkatu 8 |
| P.O. Box 425 |
| FI-20101 Turku |

Orion Corporation, ORION PHARMA

Tengströminkatu 8

P.O. Box 425

FI-20101 Turku

Mixtus

4 mg/ml

Oral solution

Oral use

France

| BOEHRINGER INGELHEIM FRANCE |
| --- |
| 37-39, rue Boissière |
| F-75116 Paris |

BOEHRINGER INGELHEIM FRANCE

37-39, rue Boissière

F-75116 Paris

Silomat

0,40 %

Syrup

Oral use

France

| BOEHRINGER INGELHEIM FRANCE |
| --- |
| 37-39, rue Boissière |
| F-75116 Paris |

BOEHRINGER INGELHEIM FRANCE

37-39, rue Boissière

F-75116 Paris

Silomat

20 mg/2 ml

Solution for injection

Intramuscular or intravenous use

France

| BOEHRINGER INGELHEIM FRANCE |
| --- |
| 37-39, rue Boissière |
| F-75116 Paris |

BOEHRINGER INGELHEIM FRANCE

37-39, rue Boissière

F-75116 Paris

Silomat

40 mg

Coated tablet

Oral use

France

| BOEHRINGER INGELHEIM FRANCE |
| --- |
| 37-39, rue Boissière |
| F-75116 Paris |

BOEHRINGER INGELHEIM FRANCE

37-39, rue Boissière

F-75116 Paris

Silomat

6 %

Oral drops, solution

Oral use

---

V Announcements

ADMINISTRATIVE PROCEDURES

Commission

| 29.2.2008 | EN | Official Journal of the European Union | C 56/30 |
| --- | --- | --- | --- |

29.2.2008

EN

Official Journal of the European Union

C 56/30

---

Call for applications 2008

Second Programme of Community action in the field of Health (2008-2013)

(Text with EEA relevance)

(2008/C 56/09)

A call for applications ‘Health — 2008’ is launched today within the framework of the Second Programme of Community action in the field of Health (2008-2013) (1).

This call for applications consists of the following parts:

| — | a call for proposals for the award of a financial contribution to specific actions in the form of projects, |
| --- | --- |

—

a call for proposals for the award of a financial contribution to specific actions in the form of projects,

| — | a call for proposals for the award of a financial contribution to specific actions in the form of conferences, |
| --- | --- |

—

a call for proposals for the award of a financial contribution to specific actions in the form of conferences,

| — | a call for proposals for the award of a financial contribution to the functioning of non governmental bodies and specialised networks (operating grants), |
| --- | --- |

—

a call for proposals for the award of a financial contribution to the functioning of non governmental bodies and specialised networks (operating grants),

| — | an invitation to Member States and participating countries for submission of joint actions. |
| --- | --- |

—

an invitation to Member States and participating countries for submission of joint actions.

The deadline for submissions of the proposals under each call is 23 May 2008.

All the information, including the Commission Decision 2008/170/EC of 27 February 2008 on the adoption of the work plan for 2008 for the implementation of the second programme of Community action in the field of health (2008-2013), and on the selection, award and other criteria for financial contributions to the actions of this programme, are available on the website of the Public Health Executive Agency at the following address:

http://ec.europa.eu/phea

---

(1)  Decision No 1350/2007/EC of the European Parliament and of the Council of 23 October 2007 establishing a Second Programme of Community action in the field of Health (2008-2013) (OJ L 301, 20.11.2007, p. 3).

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