# Official Journal C 115/2007

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 115 |
| | |
| English edition | Information and Notices | Volume 5025 May 2007 |

ISSN 1725-2423

Official Journal

of the European Union

C 115

English edition

Information and Notices

Volume 5025 May 2007

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2007/C 115/01 | Non-opposition to a notified concentration (Case COMP/M.4638 — CERP/Sanacorp/Millenium) (
  1
  ) | 1 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2007/C 115/01

Non-opposition to a notified concentration (Case COMP/M.4638 — CERP/Sanacorp/Millenium) (
  1
  )

1

1

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2007/C 115/02 | Euro exchange rates | 2 |
| 2007/C 115/03 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2007 to 30 April 2007(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 3 |
| 2007/C 115/04 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2007 to 30 April 2007(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 10 |
| 2007/C 115/05 | Opinion of the Advisory Committee on Concentrations given at its 137th meeting on 1 March 2006 concerning a draft decision relating to Case COMP/M.3868 — DONG/Elsam/Energy E2 — Rapporteur: Hungary | 31 |
| 2007/C 115/06 | Final report of the Hearing Officer in Case COMP/M.3868 — Dong/Elsam/Energi E2 (pursuant to Article 15 of Commission Decision (2001/462/EC, ECSC) of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21) | 34 |
| | NOTICES FROM MEMBER STATES |
| 2007/C 115/07 | Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 68/2001 on the application of Articles 87 and 88 of the EC Treaty to training aid (
  1
  ) | 36 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2007/C 115/02

Euro exchange rates

2

2007/C 115/03

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2007 to 30 April 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)

3

2007/C 115/04

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2007 to 30 April 2007(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)

10

2007/C 115/05

Opinion of the Advisory Committee on Concentrations given at its 137th meeting on 1 March 2006 concerning a draft decision relating to Case COMP/M.3868 — DONG/Elsam/Energy E2 — Rapporteur: Hungary

31

2007/C 115/06

Final report of the Hearing Officer in Case COMP/M.3868 — Dong/Elsam/Energi E2 (pursuant to Article 15 of Commission Decision (2001/462/EC, ECSC) of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)

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

34

NOTICES FROM MEMBER STATES

2007/C 115/07

Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 68/2001 on the application of Articles 87 and 88 of the EC Treaty to training aid (
  1
  )

1

36

| | V   Announcements |
| --- | --- |
| | ADMINISTRATIVE PROCEDURES |
| | Commission |
| 2007/C 115/08 | Call for Proposals DG EAC/20/07 (Directorate-General for Education and Culture) under the Lifelong Learning Programme — Award of grants for actions to develop and test the European Qualifications Framework (EQF), including national and sectoral qualifications frameworks | 39 |
| 2007/C 115/09 | Call for proposals under the draft annual work programme for grants in the field of the Trans-European Transport Network (TEN-T) for 2007 (Commission Decision C(2007) 2183) | 41 |
| 2007/C 115/10 | Call for proposals under the draft multi-annual work programme for grants in the field of the Trans-European Transport Network (TEN-T) for the period 2007-2013 (Commission Decision C(2007) 2158) | 42 |
| 2007/C 115/11 | Calls for proposals under the work programme for 2007 of the Information and Communication Technologies Policy Support Programme as part of the Competitiveness and Innovation Framework Programme (2007 to 2013) | 43 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2007/C 115/12 | Prior notification of a concentration (Case COMP/M.4689 — Wingas/HydroWingas) — Candidate case for simplified procedure (
  1
  ) | 44 |

V   Announcements

ADMINISTRATIVE PROCEDURES

Commission

2007/C 115/08

Call for Proposals DG EAC/20/07 (Directorate-General for Education and Culture) under the Lifelong Learning Programme — Award of grants for actions to develop and test the European Qualifications Framework (EQF), including national and sectoral qualifications frameworks

39

2007/C 115/09

Call for proposals under the draft annual work programme for grants in the field of the Trans-European Transport Network (TEN-T) for 2007 (Commission Decision C(2007) 2183)

41

2007/C 115/10

Call for proposals under the draft multi-annual work programme for grants in the field of the Trans-European Transport Network (TEN-T) for the period 2007-2013 (Commission Decision C(2007) 2158)

42

2007/C 115/11

Calls for proposals under the work programme for 2007 of the Information and Communication Technologies Policy Support Programme as part of the Competitiveness and Innovation Framework Programme (2007 to 2013)

43

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2007/C 115/12

Prior notification of a concentration (Case COMP/M.4689 — Wingas/HydroWingas) — Candidate case for simplified procedure (
  1
  )

1

44

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

---

(1)   Text with EEA relevance

1

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

EN

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 25.5.2007 | EN | Official Journal of the European Union | C 115/1 |
| --- | --- | --- | --- |

25.5.2007

EN

Official Journal of the European Union

C 115/1

---

Non-opposition to a notified concentration

(Case COMP/M.4638 — CERP/Sanacorp/Millenium)

(Text with EEA relevance)

(2007/C 115/01)

On 4 May 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 32007M4638. 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 32007M4638. 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

| 25.5.2007 | EN | Official Journal of the European Union | C 115/2 |
| --- | --- | --- | --- |

25.5.2007

EN

Official Journal of the European Union

C 115/2

---

Euro exchange rates (1)

24 May 2007

(2007/C 115/02)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,3448 |
| JPY | Japanese yen | 163,20 |
| DKK | Danish krone | 7,4514 |
| GBP | Pound sterling | 0,67670 |
| SEK | Swedish krona | 9,1957 |
| CHF | Swiss franc | 1,6508 |
| ISK | Iceland króna | 83,62 |
| NOK | Norwegian krone | 8,1055 |
| BGN | Bulgarian lev | 1,9558 |
| CYP | Cyprus pound | 0,5832 |
| CZK | Czech koruna | 28,252 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 249,47 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,6962 |
| MTL | Maltese lira | 0,4293 |
| PLN | Polish zloty | 3,8000 |
| RON | Romanian leu | 3,2725 |
| SKK | Slovak koruna | 33,787 |
| TRY | Turkish lira | 1,7915 |
| AUD | Australian dollar | 1,6351 |
| CAD | Canadian dollar | 1,4552 |
| HKD | Hong Kong dollar | 10,5208 |
| NZD | New Zealand dollar | 1,8453 |
| SGD | Singapore dollar | 2,0538 |
| KRW | South Korean won | 1 252,61 |
| ZAR | South African rand | 9,5581 |
| CNY | Chinese yuan renminbi | 10,2903 |
| HRK | Croatian kuna | 7,3160 |
| IDR | Indonesian rupiah | 11 753,55 |
| MYR | Malaysian ringgit | 4,5582 |
| PHP | Philippine peso | 62,143 |
| RUB | Russian rouble | 34,8270 |
| THB | Thai baht | 44,222 |

Currency

Exchange rate

USD

US dollar

1,3448

JPY

Japanese yen

163,20

DKK

Danish krone

7,4514

GBP

Pound sterling

0,67670

SEK

Swedish krona

9,1957

CHF

Swiss franc

1,6508

ISK

Iceland króna

83,62

NOK

Norwegian krone

8,1055

BGN

Bulgarian lev

1,9558

CYP

Cyprus pound

0,5832

CZK

Czech koruna

28,252

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

249,47

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,6962

MTL

Maltese lira

0,4293

PLN

Polish zloty

3,8000

RON

Romanian leu

3,2725

SKK

Slovak koruna

33,787

TRY

Turkish lira

1,7915

AUD

Australian dollar

1,6351

CAD

Canadian dollar

1,4552

HKD

Hong Kong dollar

10,5208

NZD

New Zealand dollar

1,8453

SGD

Singapore dollar

2,0538

KRW

South Korean won

1 252,61

ZAR

South African rand

9,5581

CNY

Chinese yuan renminbi

10,2903

HRK

Croatian kuna

7,3160

IDR

Indonesian rupiah

11 753,55

MYR

Malaysian ringgit

4,5582

PHP

Philippine peso

62,143

RUB

Russian rouble

34,8270

THB

Thai baht

44,222

---

(1)

Source: reference exchange rate published by the ECB.

---

| 25.5.2007 | EN | Official Journal of the European Union | C 115/3 |
| --- | --- | --- | --- |

25.5.2007

EN

Official Journal of the European Union

C 115/3

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2007 to 30 April 2007

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

(2007/C 115/03)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 20.4.2007 | TOVIAZ | fesoterodine | Schwarz Pharma AG |
| Alfred-Nobel Straße 10 |
| D-40789 Monheim |

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

20.4.2007

TOVIAZ

fesoterodine

Schwarz Pharma AG

Alfred-Nobel Straße 10

D-40789 Monheim

EU/1/07/386/001-010

Prolonged-release tablets

G04B D11

24.4.2007

20.4.2007

Docetaxel Winthrop

docetaxel

| Aventis Pharma S.A. |
| --- |
| 20, avenue Raymond Aron |
| F-92165 Antony Cedex |

Aventis Pharma S.A.

20, avenue Raymond Aron

F-92165 Antony Cedex

EU/1/07/384/001-002

Concentrate and solvent for solution for infusion

L01CD02

24.4.2007

23.4.2007

Advagraf

Tacrolimus

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

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

EU/1/07/387/001-008

Prolonged release hard capsules

L04AA05

25.4.2007

24.4.2007

Sebivo

telbivudine

| 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/1/07/388/001

Film-coated tablet

J05AF11

26.4.2007

—   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 |
| --- | --- | --- | --- | --- |
| 2.4.2007 | Dynepo | Shire Pharmaceutical Contracts Ltd |
| Hampshire International Business Park |
| Chineham |
| Basingstoke |
| Hampshire RG24 8EP |
| United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

2.4.2007

Dynepo

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

4.4.2007

2.4.2007

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/1/00/167/001-007

4.4.2007

2.4.2007

Xigris

| 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/1/02/225/001-002

4.4.2007

2.4.2007

AZILECT

| Teva Pharma GmbH |
| --- |
| Kandelstraße 10 |
| D-79199 Kirchzarten |

Teva Pharma GmbH

Kandelstraße 10

D-79199 Kirchzarten

EU/1/04/304/001-007

4.4.2007

2.4.2007

Enbrel

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

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/99/126/013-018

4.4.2007

4.4.2007

Cerezyme

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

Nederland

EU/1/97/053/001-005

11.4.2007

11.4.2007

Panretin

| Ligand Pharmaceuticals UK Ltd |
| --- |
| Innovis House |
| 108 High Street |
| Crawley |
| West Sussex RH10 1BB |
| United Kingdom |

Ligand Pharmaceuticals UK Ltd

Innovis House

108 High Street

Crawley

West Sussex RH10 1BB

United Kingdom

EU/1/00/149/001

13.4.2007

| Eisai Ltd |
| --- |
| 3 Shortlands |
| London W6 8EE |
| United Kingdom |

Eisai Ltd

3 Shortlands

London W6 8EE

United Kingdom

13.4.2007

11.4.2007

TARGRETIN

| Ligand Pharmaceuticals UK Ltd |
| --- |
| Innovis House |
| 108 High Street |
| Crawley |
| West Sussex RH10 1BB |
| United Kingdom |

Ligand Pharmaceuticals UK Ltd

Innovis House

108 High Street

Crawley

West Sussex RH10 1BB

United Kingdom

EU/1/01/178/001

13.4.2007

| Eisai Ltd |
| --- |
| 3 Shortlands |
| London W6 8EE |
| United Kingdom |

Eisai Ltd

3 Shortlands

London W6 8EE

United Kingdom

13.4.2007

13.4.2007

Infanrix Penta

| 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/1/00/153/001-010

17.4.2007

13.4.2007

Infanrix Hexa

| 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/1/00/152/001-018

17.4.2007

13.4.2007

Foscan

| Biolitec pharma Ltd |
| --- |
| United Drug House |
| Magna Drive |
| Dublin 24 |
| Ireland |

Biolitec pharma Ltd

United Drug House

Magna Drive

Dublin 24

Ireland

EU/1/01/197/001-002

18.4.2007

13.4.2007

Revatio

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/05/318/001

17.4.2007

13.4.2007

Glivec

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/01/198/001-013

17.4.2007

17.4.2007

Cystagon

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

Orphan Europe

Immeuble ‘Le Guillaumet’

F-92046 Paris La Défense

EU/1/97/039/001-004

19.4.2007

17.4.2007

Teslascan

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| P.O.Box 4220 Nydalen |
| N-0401 Oslo |

GE Healthcare AS

Nycoveien 1-2

P.O.Box 4220 Nydalen

N-0401 Oslo

EU/1/97/040/001-002

19.4.2007

17.4.2007

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

19.4.2007

20.4.2007

Quixidar

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

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/207/001-020

24.4.2007

20.4.2007

Arixtra

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

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/206/001-020

24.4.2007

20.4.2007

Omnitrope

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

EU/1/06/332/004-006

24.4.2007

23.4.2007

Azomyr

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

Schering Plough Europe

Rue de Stalle 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/00/157/035-067

25.4.2007

23.4.2007

Neoclarityn

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

Schering Plough Europe

Rue de Stalle 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/00/161/035-067

25.4.2007

23.4.2007

Aerius

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

Schering Plough Europe

Rue de Stalle 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/00/160/037-069

25.4.2007

23.4.2007

Temodal

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

Schering Plough Europe

Rue de Stalle 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/98/096/009-012

25.4.2007

23.4.2007

Dynastat

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/02/209/001-008

25.4.2007

23.4.2007

M-M-RVAXPRO

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

Sanofi Pasteur MSD

SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/06/337/001-013

25.4.2007

23.4.2007

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

25.4.2007

23.4.2007

Kinzalkomb

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

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/02/214/001-010

25.4.2007

23.4.2007

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/1/02/213/001-016

25.4.2007

24.4.2007

Macugen

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/05/325/001

26.4.2007

24.4.2007

Kineret

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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/02/203/001-004

26.4.2007

24.4.2007

Truvada

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

Gilead Sciences International Limited

Cambridge CB21 6G

United Kingdom

EU/1/04/305/001

26.4.2007

24.4.2007

Herceptin

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/00/145/001

26.4.2007

24.4.2007

NovoMix

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

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

EU/1/00/142/004-005

EU/1/00/142/009-010

26.4.2007

24.4.2007

Aldara

| Laboratoires 3M Santé |
| --- |
| Boulevard de l'Oise |
| F-95029 Cergy Pontoise Cedex |

Laboratoires 3M Santé

Boulevard de l'Oise

F-95029 Cergy Pontoise Cedex

EU/1/98/080/001

26.4.2007

24.4.2007

DaTSCAN

| GE Healthcare Limited |
| --- |
| Little Chalfont |
| Bucks HP7 9NA |
| United Kingdom |

GE Healthcare Limited

Little Chalfont

Bucks HP7 9NA

United Kingdom

EU/1/00/135/001-002

26.4.2007

25.4.2007

Bondenza

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/03/266/001-006

30.4.2007

25.4.2007

Bonviva

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/03/265/001-006

30.4.2007

25.4.2007

Xigris

| 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/1/02/225/001-002

27.4.2007

25.4.2007

Emtriva

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

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/03/261/001-003

27.4.2007

26.4.2007

Baraclude

| 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/1/06/343/001-005

30.4.2007

26.4.2007

Lysodren

| Laboratoire HRA Pharma |
| --- |
| 15, rue Béranger |
| F-75003 Paris |

Laboratoire HRA Pharma

15, rue Béranger

F-75003 Paris

EU/1/04/273/001

30.4.2007

26.4.2007

Champix

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/360/001-011

30.4.2007

26.4.2007

REYATAZ

| 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/1/03/267/001-007

30.4.2007

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.4.2007 | Slentrol | Dirlotapide | Pfizer Ltd |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| 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

13.4.2007

Slentrol

Dirlotapide

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

EU/2/07/071/001-003

Oral solution

QA08AB91

17.4.2007

—   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 |
| --- | --- | --- | --- | --- |
| 20.4.2007 | 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

20.4.2007

Metacam

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein

EU/2/97/004/012-013

EU/2/97/004/026

24.4.2007

24.4.2007

Oxyglobin

| Biopure Netherlands B.V. |
| --- |
| Drentestraat 24BG |
| 1083HK Amsterdam |
| Nederland |

Biopure Netherlands B.V.

Drentestraat 24BG

1083HK Amsterdam

Nederland

EU/2/99/015/001

26.4.2007

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

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

The European Medicines Agency

7, Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

---

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

---

| 25.5.2007 | EN | Official Journal of the European Union | C 115/10 |
| --- | --- | --- | --- |

25.5.2007

EN

Official Journal of the European Union

C 115/10

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2007 to 30 April 2007

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

(2007/C 115/04)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 13.4.2007 | Alendronate Hexal | See Annex I | See Annex I | 18.4.2007 |
| 13.4.2007 | Gadovist | See Annex II | See Annex II | 19.4.2007 |
| 13.4.2007 | Gadograf | See Annex III | See Annex III | 19.4.2007 |
| 17.4.2007 | Dolovet | See Annex IV | See Annex IV | 20.4.2007 |
| 17.4.2007 | Suvaxyn Parvo E | See Annex V | See Annex V | 20.4.2007 |
| 19.4.2007 | Suvaxyn Ery | See Annex VI | See Annex VI | 20.4.2007 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

13.4.2007

Alendronate Hexal

See Annex I

See Annex I

18.4.2007

13.4.2007

Gadovist

See Annex II

See Annex II

19.4.2007

13.4.2007

Gadograf

See Annex III

See Annex III

19.4.2007

17.4.2007

Dolovet

See Annex IV

See Annex IV

20.4.2007

17.4.2007

Suvaxyn Parvo E

See Annex V

See Annex V

20.4.2007

19.4.2007

Suvaxyn Ery

See Annex VI

See Annex VI

20.4.2007

—   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 |
| --- | --- | --- | --- | --- |
| 2.4.2007 | Equimectin | See Annex VII | See Annex VII | 3.4.2007 |
| 13.4.2007 | Mefecur | See Annex VIII | See Annex VIII | 19.4.2007 |
| 13.4.2007 | Mefecomb | See Annex IX | See Annex IX | 20.4.2007 |
| 13.4.2007 | Mefelor | See Annex X | See Annex X | 19.4.2007 |
| 13.4.2007 | Mefesan | See Annex XI | See Annex XI | 19.4.2007 |
| 13.4.2007 | Metofelosan | See Annex XII | See Annex XII | 20.4.2007 |
| 13.4.2007 | Metoprolol/Felodipin ‘YES’ | See Annex XIII | See Annex XIII | 18.4.2007 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

2.4.2007

Equimectin

See Annex VII

See Annex VII

3.4.2007

13.4.2007

Mefecur

See Annex VIII

See Annex VIII

19.4.2007

13.4.2007

Mefecomb

See Annex IX

See Annex IX

20.4.2007

13.4.2007

Mefelor

See Annex X

See Annex X

19.4.2007

13.4.2007

Mefesan

See Annex XI

See Annex XI

19.4.2007

13.4.2007

Metofelosan

See Annex XII

See Annex XII

20.4.2007

13.4.2007

Metoprolol/Felodipin ‘YES’

See Annex XIII

See Annex XIII

18.4.2007

---

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

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

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE 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) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Sweden | HEXAL A/S |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Name

Strength

Pharmaceutical form

Route of administration

Content (concentration)

Sweden

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Alendronat HEXAL

10 mg

Tablets

Oral use

10 mg per tablet

Belgium

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Alendronate Sandoz

10 mg tabletten

10 mg

Tablets

Oral use

10 mg per tablet

Denmark

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Alendonicht

10 mg

Tablets

Oral use

10 mg per tablet

Greece

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Forosa

10 mg

Tablets

Oral use

10 mg per tablet

---

ANNEX II

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

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Schering Austria GmbH |
| Wienerbergstraße 41 |
| Euro Plaza-Gebäude F/PF45 |
| A-1121 Wien |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Schering Austria GmbH

Wienerbergstraße 41

Euro Plaza-Gebäude F/PF45

A-1121 Wien

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Austria

| Schering Austria GmbH |
| --- |
| Wienerbergstraße 41 |
| Euro Plaza-Gebäude F/PF45 |
| A-1121 Wien |

Schering Austria GmbH

Wienerbergstraße 41

Euro Plaza-Gebäude F/PF45

A-1121 Wien

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Belgium

| NV Schering S.A. |
| --- |
| J.E. Mommaertslaan, 14 |
| B-1831 Machelen (Diegem) |

NV Schering S.A.

J.E. Mommaertslaan, 14

B-1831 Machelen (Diegem)

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Belgium

| NV Schering S.A. |
| --- |
| J.E. Mommaertslaan, 14 |
| B-1831 Machelen (Diegem) |

NV Schering S.A.

J.E. Mommaertslaan, 14

B-1831 Machelen (Diegem)

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Denmark

| Schering AG |
| --- |
| Müllerstr. 178 |
| D-13342 Berlin-Mitte |

Schering AG

Müllerstr. 178

D-13342 Berlin-Mitte

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Denmark

| Schering AG |
| --- |
| Müllerstr. 178 |
| D-13342 Berlin-Mitte |

Schering AG

Müllerstr. 178

D-13342 Berlin-Mitte

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Germany

| Schering Deutschland GmbH |
| --- |
| Max-Dohrn-Strasse 10 |
| D-10589 Berlin |

Schering Deutschland GmbH

Max-Dohrn-Strasse 10

D-10589 Berlin

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Germany

| Schering Deutschland GmbH |
| --- |
| Max-Dohrn-Strasse 10 |
| D-10589 Berlin |

Schering Deutschland GmbH

Max-Dohrn-Strasse 10

D-10589 Berlin

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Greece

| Schering Hellas SA |
| --- |
| 466 Irakliou Ave. & 12-14 Kyprou Str. |
| Neo Iraklio |
| GR-14122 Athens |

Schering Hellas SA

466 Irakliou Ave. & 12-14 Kyprou Str.

Neo Iraklio

GR-14122 Athens

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Greece

| Schering Hellas SA |
| --- |
| 466 Irakliou Ave. &12-14 Kyprou Str. |
| Neo Iraklio |
| GR-14122 Athens |

Schering Hellas SA

466 Irakliou Ave. &12-14 Kyprou Str.

Neo Iraklio

GR-14122 Athens

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Spain

| Schering España, S.A. |
| --- |
| c/ Mendez Alvaro, 55 |
| E-28045 Madrid |

Schering España, S.A.

c/ Mendez Alvaro, 55

E-28045 Madrid

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Spain

| Schering España, S.A. |
| --- |
| c/ Mendez Alvaro, 55 |
| E-28045 Madrid |

Schering España, S.A.

c/ Mendez Alvaro, 55

E-28045 Madrid

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Finland

| Schering Oy |
| --- |
| Pansiontie 47 |
| Post Box 415 |
| FIN-20101 Turku |

Schering Oy

Pansiontie 47

Post Box 415

FIN-20101 Turku

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Finland

| Schering Oy |
| --- |
| Pansiontie 47 |
| Post Box 415 |
| FIN-20101 Turku |

Schering Oy

Pansiontie 47

Post Box 415

FIN-20101 Turku

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

France

| Schering SA |
| --- |
| Z.I. Roubaix-Est |
| rue de Toufflers |
| BP 69 |
| F-59452 Lys-Lez-Lannoy Cedex |

Schering SA

Z.I. Roubaix-Est

rue de Toufflers

BP 69

F-59452 Lys-Lez-Lannoy Cedex

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

France

| Schering SA |
| --- |
| Z.I. Roubaix-Est |
| rue de Toufflers |
| BP 69 |
| F-59452 Lys-Lez-Lannoy Cedex |

Schering SA

Z.I. Roubaix-Est

rue de Toufflers

BP 69

F-59452 Lys-Lez-Lannoy Cedex

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Ireland

| HE Clissmann T/A Schering |
| --- |
| 72 Heather Road |
| Dublin 18 |
| Ireland |

HE Clissmann T/A Schering

72 Heather Road

Dublin 18

Ireland

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Ireland

| HE Clissmann T/A Schering |
| --- |
| 72 Heather Road |
| Dublin 18 |
| Ireland |

HE Clissmann T/A Schering

72 Heather Road

Dublin 18

Ireland

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Italy

| Schering S.p.A. |
| --- |
| Via E. Schering, 21 |
| I-20090 Segrate (MI) |

Schering S.p.A.

Via E. Schering, 21

I-20090 Segrate (MI)

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Italy

| Schering S.p.A. |
| --- |
| Via E. Schering, 21 |
| I-20090 Segrate (MI) |

Schering S.p.A.

Via E. Schering, 21

I-20090 Segrate (MI)

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Luxembourg

| NV Schering S.A. |
| --- |
| J.E. Mommaertslaan, 14 |
| B-1831 Machelen (Diegem) |

NV Schering S.A.

J.E. Mommaertslaan, 14

B-1831 Machelen (Diegem)

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Luxembourg

| NV Schering S.A. |
| --- |
| J.E. Mommaertslaan, 14 |
| B-1831 Machelen (Diegem) |

NV Schering S.A.

J.E. Mommaertslaan, 14

B-1831 Machelen (Diegem)

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Netherlands

| Schering Nederland B.V |
| --- |
| Van Houten Industriepark 1 |
| Postbus 116 |
| 1380 AC Weesp |
| Nederland |

Schering Nederland B.V

Van Houten Industriepark 1

Postbus 116

1380 AC Weesp

Nederland

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Netherlands

| Schering Nederland B.V |
| --- |
| Van Houten Industriepark 1 |
| Postbus 116 |
| 1380 AC Weesp |
| Nederland |

Schering Nederland B.V

Van Houten Industriepark 1

Postbus 116

1380 AC Weesp

Nederland

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Norway

| Schering AG |
| --- |
| Müllerstr. 178 |
| D-13342 Berlin-Mitte |

Schering AG

Müllerstr. 178

D-13342 Berlin-Mitte

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Norway

| Schering AG |
| --- |
| Müllerstr. 178 |
| D-13342 Berlin-Mitte |

Schering AG

Müllerstr. 178

D-13342 Berlin-Mitte

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Portugal

| Schering Lusitana, Lda |
| --- |
| Estrada Nacional 249, km 15 |
| P.O. Box 16 |
| P-2725-397 Mem Martins |

Schering Lusitana, Lda

Estrada Nacional 249, km 15

P.O. Box 16

P-2725-397 Mem Martins

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Sweden

| Schering AG |
| --- |
| Müllerstr. 178 |
| D-13342 Berlin-Mitte |

Schering AG

Müllerstr. 178

D-13342 Berlin-Mitte

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Sweden

| Schering AG |
| --- |
| Müllerstr. 178 |
| D-13342 Berlin-Mitte |
| Allemagne |

Schering AG

Müllerstr. 178

D-13342 Berlin-Mitte

Allemagne

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

United Kingdom

| Schering Health Care Limited |
| --- |
| The Brow |
| Burgess Hill |
| West Sussex RH1F 9NE |
| United Kingdom |

Schering Health Care Limited

The Brow

Burgess Hill

West Sussex RH1F 9NE

United Kingdom

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

United Kingdom

| Schering Health Care Limited |
| --- |
| The Brow |
| Burgess Hill |
| West Sussex RH1F 9NE |
| United Kingdom |

Schering Health Care Limited

The Brow

Burgess Hill

West Sussex RH1F 9NE

United Kingdom

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

---

ANNEX III

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

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Germany | Schering Deutschland GmbH |
| Max-Dohrn-Strasse 10 |
| D-10589 Berlin |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Germany

Schering Deutschland GmbH

Max-Dohrn-Strasse 10

D-10589 Berlin

Gadograf

1 mmol/ml

Solution for injection

Intravenous use

Germany

| Schering Deutschland GmbH |
| --- |
| Max-Dohrn-Strasse 10 |
| D-10589 Berlin |

Schering Deutschland GmbH

Max-Dohrn-Strasse 10

D-10589 Berlin

Gadograf

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Spain

| Schering España, S.A. |
| --- |
| c/ Mendez Alvaro, 55 |
| E-28045 Madrid |

Schering España, S.A.

c/ Mendez Alvaro, 55

E-28045 Madrid

Gadograf

1 mmol/ml

Solution for injection

Intravenous use

Spain

| Schering España, S.A. |
| --- |
| c/ Mendez Alvaro, 55 |
| E-28045 Madrid |

Schering España, S.A.

c/ Mendez Alvaro, 55

E-28045 Madrid

Gadograf

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

---

ANNEX IV

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

| Member State | Applicant or Marketing Authorisation Holder | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Belgium, Czech Republic, Denmark, Spain, Finland, Italy, Luxembourg, The Netherlands, Norway, Poland and Slovakia | Vetcare Ltd. |
| P. O. Box 99 |
| FIN-24101 Salo |

Member State

Applicant or Marketing Authorisation Holder

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Belgium, Czech Republic, Denmark, Spain, Finland, Italy, Luxembourg, The Netherlands, Norway, Poland and Slovakia

Vetcare Ltd.

P. O. Box 99

FIN-24101 Salo

Dolovet vet 2,4 g

Powder

2.4g ketoprofen per sachet of 15g powder

Cattle

(adult animals weighing about 600 kg)

Formula

One bag of 15g once daily for 1 — 3 days. This corresponds to 4mg ketoprofen per kg body weight

Austria and Hungary

As above

Rifen 2,4 g

As above

As above

As above

As above

As above

---

ANNEX V

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

| Member State | Marketing Authorisation Holder | Applicant | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Wyeth Lederle Pharma GmbH, Fort Dodge |
| Waidhausengasse 19/9 |
| A-1140 Vienna |
| Contact: Dr. Attila Romváry |
| Tel: +43 1 912 28 40 |
| Fax: +43 1 911 51 00 |
| Email: romvara@fdah.com |

Member State

Marketing Authorisation Holder

Applicant

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Austria

Wyeth Lederle Pharma GmbH, Fort Dodge

Waidhausengasse 19/9

A-1140 Vienna

Contact: Dr. Attila Romváry

Tel: +43 1 912 28 40

Fax: +43 1 911 51 00

Email: romvara@fdah.com

Wyeth Lederle Pharma GmbH, Fort Dodge

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Belgium

| Fort Dodge Animal Health Holland |
| --- |
| C.J. van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

France

| Fort Dodge Santé Animale S.A. |
| --- |
| 24, Avenue Marcel Dassault |
| BP 440 |
| F-37204 Tours Cedex 3 |
| Contact: Mr. Yves Dehon |
| Tel: +33 2 4774 8979 |
| Fax: +33 2 47748999 |
| Email: dehony@ahp.com |

Fort Dodge Santé Animale S.A.

24, Avenue Marcel Dassault

BP 440

F-37204 Tours Cedex 3

Contact: Mr. Yves Dehon

Tel: +33 2 4774 8979

Fax: +33 2 47748999

Email: dehony@ahp.com

Fort Dodge Santé Animale S.A.

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Germany

| Fort Dodge Veterinär GmbH |
| --- |
| Adenauerstrasse 20 |
| D-52146 Würselen |
| Contact: Dr. Elisabeth Stangl |
| Tel: (49-240) 545 42 16 |
| Fax: (49-240) 545 44 61 |
| Email: stangle@fdah.com |

Fort Dodge Veterinär GmbH

Adenauerstrasse 20

D-52146 Würselen

Contact: Dr. Elisabeth Stangl

Tel: (49-240) 545 42 16

Fax: (49-240) 545 44 61

Email: stangle@fdah.com

Fort Dodge Veterinär GmbH

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Greece

| Wyeth Lederle Pharma GmbH, Fort Dodge |
| --- |
| Waidhausengasse 19/9 |
| A-1140 Vienna |
| Contact: Dr. Eusebio Uruburu |
| Tel: (34-915) 98 13 44 |
| Fax: (34-915) 97 24 34 |
| Email: urubure@fdah.com |

Wyeth Lederle Pharma GmbH, Fort Dodge

Waidhausengasse 19/9

A-1140 Vienna

Contact: Dr. Eusebio Uruburu

Tel: (34-915) 98 13 44

Fax: (34-915) 97 24 34

Email: urubure@fdah.com

Wyeth Lederle Pharma GmbH, Fort Dodge

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Ireland

| Fort Dodge Animal Health Limited |
| --- |
| Flanders Road |
| Hedge End |
| Southampton S030 4QH |
| United Kingdom |
| Contact: Dr. Germán Lastra |
| Tel: (44-14) 89 77 42 21 |
| Fax: (44-14) 89 77 42 51 |
| Email: lastrag@fdah.com |

Fort Dodge Animal Health Limited

Flanders Road

Hedge End

Southampton S030 4QH

United Kingdom

Contact: Dr. Germán Lastra

Tel: (44-14) 89 77 42 21

Fax: (44-14) 89 77 42 51

Email: lastrag@fdah.com

Fort Dodge Animal Health Limited

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Luxembourg

| Fort Dodge Animal Health Holland |
| --- |
| C.J. van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Netherlands

| Fort Dodge Animal Health Holland |
| --- |
| C.J. van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Norway

| Fort Dodge Veterinaria S.A. |
| --- |
| c/ Camprodón s/n ‘La Riba’ |
| Vall de Bianya (Girona), Spain |
| Contact: Dr. Germán Lastra |
| Tel: +44 1489774221 |
| Fax: +44 1489 774 251 |
| Email: lastrag@fdah.com |

Fort Dodge Veterinaria S.A.

c/ Camprodón s/n ‘La Riba’

Vall de Bianya (Girona), Spain

Contact: Dr. Germán Lastra

Tel: +44 1489774221

Fax: +44 1489 774 251

Email: lastrag@fdah.com

Fort Dodge Veterinaria S.A.

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Sweden

| Fort Dodge Animal Health Holland |
| --- |
| C.J. van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Germán Lastra |
| Tel: +44 1489774221 |
| Fax: +44 1489 774 251 |
| Email: lastrag@fdah.com |

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Germán Lastra

Tel: +44 1489774221

Fax: +44 1489 774 251

Email: lastrag@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Parvo/E vet

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

United Kingdom

| Fort Dodge Animal Health Limited |
| --- |
| Flanders Road |
| Hedge End |
| Southampton S030 4QH |
| United Kingdom |
| Tel: (44-14) 89 77 42 21 |
| Fax: (44-14) 89 77 42 51 |
| Email: lastrag@fdah.com |

Fort Dodge Animal Health Limited

Flanders Road

Hedge End

Southampton S030 4QH

United Kingdom

Tel: (44-14) 89 77 42 21

Fax: (44-14) 89 77 42 51

Email: lastrag@fdah.com

Fort Dodge Animal Health Limited

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Spain

| Fort Dodge Veterinaria S.A. Ctra. Camprodón s/n ‘La Riba’ |
| --- |
| E-17813 Vall de Bianya (Girona) |
| Tel: (34) 915 98 13 36 |
| Fax: (34) 915 97 24 34 |
| Email: rodrigv2@fdah.com |

Fort Dodge Veterinaria S.A. Ctra. Camprodón s/n ‘La Riba’

E-17813 Vall de Bianya (Girona)

Tel: (34) 915 98 13 36

Fax: (34) 915 97 24 34

Email: rodrigv2@fdah.com

Fort Dodge Veterinaria S.A.

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

---

ANNEX VI

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

| Member State | Marketing Authorisation Holder | Applicant | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Wyeth Lederle Pharma GmbH, Fort Dodge |
| Waidhausengasse 19/9 |
| A-1140 Vienna |
| Contact: Dr. Attila Romváry |
| Tel: (43-1) 912 28 40 |
| Fax: (43-1) 911 51 00 |
| Email: romvara@fdah.com |

Member State

Marketing Authorisation Holder

Applicant

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Austria

Wyeth Lederle Pharma GmbH, Fort Dodge

Waidhausengasse 19/9

A-1140 Vienna

Contact: Dr. Attila Romváry

Tel: (43-1) 912 28 40

Fax: (43-1) 911 51 00

Email: romvara@fdah.com

Wyeth Lederle Pharma GmbH, Fort Dodge

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Belgium

| Fort Dodge Animal Health Benelux B.V. |
| --- |
| Van Houten Industriepark 25 |
| 1381 MZ Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Benelux B.V.

Van Houten Industriepark 25

1381 MZ Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Benelux B.V.

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Czech Republic

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Estonia

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

France

| Fort Dodge Santé Animale S.A. |
| --- |
| 24, Avenue Marcel Dassault |
| BP 440 |
| F-37204 Tours Cedex 3 |
| Contact: Mr. Yves Dehon |
| Tel: +33 2 47 74 89 79 |
| Fax: +33 2 47 74 89 71 |
| Email: dehonyv@fdah.com |

Fort Dodge Santé Animale S.A.

24, Avenue Marcel Dassault

BP 440

F-37204 Tours Cedex 3

Contact: Mr. Yves Dehon

Tel: +33 2 47 74 89 79

Fax: +33 2 47 74 89 71

Email: dehonyv@fdah.com

Fort Dodge Santé Animale S.A.

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Germany

| Fort Dodge Veterinär GmbH |
| --- |
| Adenauerstrasse 20 |
| D-52146 Würselen |
| Contact: Dr. Elisabeth Stangl |
| Tel: (49-240) 545 42 16 |
| Fax: (49 24) 545 44 61 |
| Email: stangle@fdah.com |

Fort Dodge Veterinär GmbH

Adenauerstrasse 20

D-52146 Würselen

Contact: Dr. Elisabeth Stangl

Tel: (49-240) 545 42 16

Fax: (49 24) 545 44 61

Email: stangle@fdah.com

Fort Dodge Veterinär GmbH

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Greece

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Germán Lastra |
| Tel: (44-14) 89 77 42 21 |
| Fax: (44-14) 89 77 42 51 |
| Email: lastrag@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Germán Lastra

Tel: (44-14) 89 77 42 21

Fax: (44-14) 89 77 42 51

Email: lastrag@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Ireland

| Fort Dodge Animal Health Limited |
| --- |
| Flanders Road |
| Hedge End |
| Southampton S030 4QH |
| United Kingdom |
| Contact: Dr. Germán Lastra |
| Tel: (44-14) 89 77 42 21 |
| Fax: (44-14) 89 77 42 51 |
| Email: lastrag@fdah.com |

Fort Dodge Animal Health Limited

Flanders Road

Hedge End

Southampton S030 4QH

United Kingdom

Contact: Dr. Germán Lastra

Tel: (44-14) 89 77 42 21

Fax: (44-14) 89 77 42 51

Email: lastrag@fdah.com

Fort Dodge Animal Health Limited

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Italy

| Fort Dodge Animal Health SpA |
| --- |
| Via Nettunense 90 |
| I-04011 Aprilia |
| Tel: (39-06) 927 151 |
| Fax: (39-06) 23 32 55 55 |
| Email: bollaa@fdah.com |

Fort Dodge Animal Health SpA

Via Nettunense 90

I-04011 Aprilia

Tel: (39-06) 927 151

Fax: (39-06) 23 32 55 55

Email: bollaa@fdah.com

Fort Dodge Animal Health SpA

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Lithuania

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Luxembourg

| Fort Dodge Animal Health Benelux B.V. |
| --- |
| Van Houten Industriepark 25 |
| 1381 MZ Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Benelux B.V.

Van Houten Industriepark 25

1381 MZ Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Benelux B.V.

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Malta

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Netherlands

| Fort Dodge Animal Health Benelux B.V. |
| --- |
| Van Houten Industriepark 25 |
| 1381 MZ Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Benelux B.V.

Van Houten Industriepark 25

1381 MZ Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Benelux B.V.

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Norway

| Fort Dodge Veterinär GmbH |
| --- |
| Adenauerstrasse 20 |
| D-52146 Würselen |
| Contact: Dr. Germán Lastra |
| Tel: (44-14) 89 77 42 21 |
| Fax: (44-14) 89 77 42 51 |
| Email: lastrag@fdah.com |

Fort Dodge Veterinär GmbH

Adenauerstrasse 20

D-52146 Würselen

Contact: Dr. Germán Lastra

Tel: (44-14) 89 77 42 21

Fax: (44-14) 89 77 42 51

Email: lastrag@fdah.com

Fort Dodge Veterinär GmbH

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Portugal

| Fort Dodge Veterinària Lda. |
| --- |
| Rua Dr. António Loureiro Borges, n.o 2, |
| Arquiparque-Miraflores |
| P-1495-131 Algés |
| Contact: Dr. Virginia Rodríguez |
| Tel: (34-91) 598 13 43 |
| Fax: (34-91) 597 24 34 |
| Email: rodrigv2@fdah.com |

Fort Dodge Veterinària Lda.

Rua Dr. António Loureiro Borges, n.o 2,

Arquiparque-Miraflores

P-1495-131 Algés

Contact: Dr. Virginia Rodríguez

Tel: (34-91) 598 13 43

Fax: (34-91) 597 24 34

Email: rodrigv2@fdah.com

Fort Dodge Veterinària Lda.

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Slovak Republic

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

United Kingdom

| Fort Dodge Animal Health Limited |
| --- |
| Flanders Road |
| Hedge End |
| Southampton S030 4QH |
| United Kingdom |
| Contact: Dr. Germán Lastra |
| Tel: (44-14) 89 77 42 21 |
| Fax: (44-14) 89 77 42 51 |
| Email: lastrag@fdah.com |

Fort Dodge Animal Health Limited

Flanders Road

Hedge End

Southampton S030 4QH

United Kingdom

Contact: Dr. Germán Lastra

Tel: (44-14) 89 77 42 21

Fax: (44-14) 89 77 42 51

Email: lastrag@fdah.com

Fort Dodge Animal Health Limited

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Hungary

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Spain

| Fort Dodge Veterinaria, S.A. |
| --- |
| Ctra. Camprodón s/n ‘La Riba’ |
| E-17813 Vall de Bianya (Girona) |
| Contact: Dra Virginia Rodríguez |
| Tel: (34-91) 598 13 36 |
| Fax: (34-91) 597 24 34 |
| Email: rodrigv2@fdah.com |

Fort Dodge Veterinaria, S.A.

Ctra. Camprodón s/n ‘La Riba’

E-17813 Vall de Bianya (Girona)

Contact: Dra Virginia Rodríguez

Tel: (34-91) 598 13 36

Fax: (34-91) 597 24 34

Email: rodrigv2@fdah.com

Fort Dodge Veterinaria, S.A.

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

---

ANNEX VII

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

| Member State | Applicant or Marketing Authorisation Holder | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Netherlands, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Norway, Poland, Portugal and Spain | Le Vet B.V.
  The Netherlands | Equimectine | Oral gel | 12 mg/g | Horses | Oral use. A single administration of 0.2 mg ivermectin per kg of bodyweight. Retreatment should be done according to the epidemiological situation, but not at less than 30 days interval | A single administration of 0.2 mg ivermectin per kg of bodyweight |

Member State

Applicant or Marketing Authorisation Holder

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Netherlands, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Norway, Poland, Portugal and Spain

Le Vet B.V.

The Netherlands

Equimectine

Oral gel

12 mg/g

Horses

Oral use. A single administration of 0.2 mg ivermectin per kg of bodyweight. Retreatment should be done according to the epidemiological situation, but not at less than 30 days interval

A single administration of 0.2 mg ivermectin per kg of bodyweight

---

ANNEX VIII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | Sandoz Pharmaceuticals GmbH |
| Carl-Zeiss-Ring 3 |
| D-85737 Ismaning |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

Sandoz Pharmaceuticals GmbH

Carl-Zeiss-Ring 3

D-85737 Ismaning

Mefecur

50/5 mg

Prolonged-release tablet

oral

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Carl-Zeiss-Ring 3 |
| D-85737 Ismaning |

Sandoz Pharmaceuticals GmbH

Carl-Zeiss-Ring 3

D-85737 Ismaning

Felodipin Metoprolol Sandoz 5 mg/47,5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

---

ANNEX IX

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | ratiopharm GmbH |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Mefecomb 50 mg/5 mg

50/5 mg

Prolonged-release tablet

oral

Germany

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

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Metoprololtartrat/Felodipin-ratiopharm 50 mg/5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

Finland

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

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Mefecomb 50 mg/5 mg depot-tabletti

50/5 mg

Prolonged-release tablet

oral

Luxembourg

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

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Metoprololtartrat/Felodipin-ratiopharm 50 mg/5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

---

ANNEX X

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | ratiopharm GmbH |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Mefelor

50/5 mg

Prolonged-release tablet

oral

Germany

| AbZ-Pharma GmbH |
| --- |
| Dr.-Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |

AbZ-Pharma GmbH

Dr.-Georg-Spohn-Str. 7

D-89143 Blaubeuren

Metoprololtartrat/Felodipin AbZ 50 mg/5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

---

ANNEX XI

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | CT Arzneimittel GmbH |
| Lengeder Str. 42a |
| D-13407 Berlin |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

CT Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Mefesan

50/5 mg

Prolonged-release tablet

oral

Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42a |
| D-13407 Berlin |

CT Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Metoprololtartrat/Felodipin-CT 50 mg/5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

---

ANNEX XII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | YES Pharmaceutical Development Services GmbH |
| Bahnstraße 42-46 |
| D-61381 Friedrichsdorf |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

YES Pharmaceutical Development Services GmbH

Bahnstraße 42-46

D-61381 Friedrichsdorf

Metofelosan

50/5 mg

Prolonged-release tablet

oral

Germany

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |

ALIUD PHARMA GmbH & Co. KG

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Metocomb AL 50 mg/5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

---

ANNEX XIII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | YES Pharmaceutical Development Services GmbH |
| Bahnstraße 42-46 |
| D-61381 Friedrichsdorf |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

YES Pharmaceutical Development Services GmbH

Bahnstraße 42-46

D-61381 Friedrichsdorf

Metoprolol/Felodipin ‘YES’

50/5 mg

Prolonged-release tablet

oral

Belgium

| Eurogenerics N.V. |
| --- |
| Heizel Esplanade Heysel b22 |
| B-1020 Brussels |

Eurogenerics N.V.

Heizel Esplanade Heysel b22

B-1020 Brussels

Co-Metoprolol EG 50/5 mg tablets (prolonged release)

50/5 mg

Prolonged-release tablet

oral

Germany

| STADApharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

STADApharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Metoplus STADA 50 mg/5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

Finland

| STADA Arzneimittel AG |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

STADA Arzneimittel AG

Stadastr. 2-18

D-61118 Bad Vilbel

Metoprololitartraatti/Felodipiini STADA 50 mg/5 mg depottabletti

50/5 mg

Prolonged-release tablet

oral

Luxembourg

| Eurogenerics N.V. |
| --- |
| Heizel Esplanade Heysel b22 |
| B-1020 Brussels |

Eurogenerics N.V.

Heizel Esplanade Heysel b22

B-1020 Brussels

Co-Metoprolol EG 50/5 mg tablets (prolonged release)

50/5 mg

Prolonged-release tablet

oral

---

| 25.5.2007 | EN | Official Journal of the European Union | C 115/31 |
| --- | --- | --- | --- |

25.5.2007

EN

Official Journal of the European Union

C 115/31

---

Opinion of the Advisory Committee on Concentrations given at its 137th meeting on 1 March 2006 concerning a draft decision relating to Case COMP/M.3868 — DONG/Elsam/Energy E2

Rapporteur: Hungary

(2007/C 115/05)

| 1. | The Advisory Committee agrees with the Commission that the notified operation constitutes a concentration within the meaning of Article 3(1)(b) of Council Regulation (EC) No 139/2004 (1) and that it has a Community dimension. |
| --- | --- |

1.

The Advisory Committee agrees with the Commission that the notified operation constitutes a concentration within the meaning of Article 3(1)(b) of Council Regulation (EC) No 139/2004 (1) and that it has a Community dimension.

| 2. | The Advisory Committee agrees with the Commission that for the purposes of assessing the present operation, the relevant product markets are:
  in the natural gas sector:






  a) | the market for storage or alternatively the market for flexibility of natural gas; |
| --- | --- | --- |

2.

The Advisory Committee agrees with the Commission that for the purposes of assessing the present operation, the relevant product markets are:

in the natural gas sector:

a)

the market for storage or alternatively the market for flexibility of natural gas;

| b) | the wholesale market of natural gas; |
| --- | --- |

b)

the wholesale market of natural gas;

| c) | the market for the supply of natural gas to central combined heat and power plants (CHPs); |
| --- | --- |

c)

the market for the supply of natural gas to central combined heat and power plants (CHPs);

| d) | the market or markets for the supply of natural gas to large industrial customers and to decentralized CHPs; |
| --- | --- |

d)

the market or markets for the supply of natural gas to large industrial customers and to decentralized CHPs;

| e) | the market or markets for the supply of natural gas to non-metered small business customers and to households; |
| --- | --- |

e)

the market or markets for the supply of natural gas to non-metered small business customers and to households;

in the electricity sector:

| f) | the wholesale market of electricity (irrespective of whether it includes or not bilateral wholesales and ancillary services, constituting possibly separate markets), |
| --- | --- |

f)

the wholesale market of electricity (irrespective of whether it includes or not bilateral wholesales and ancillary services, constituting possibly separate markets),

| g) | the market for financial derivatives of electricity (irrespective of whether it includes or not CfDs constituting a possibly separate market), |
| --- | --- |

g)

the market for financial derivatives of electricity (irrespective of whether it includes or not CfDs constituting a possibly separate market),

| h) | the retail market for electricity sales to metered (business) customers, |
| --- | --- |

h)

the retail market for electricity sales to metered (business) customers,

| i) | the retail market for electricity sales to non-metered (predominantly household) customers; |
| --- | --- |

i)

the retail market for electricity sales to non-metered (predominantly household) customers;

for other markets:

| j) | the market for district heating, |
| --- | --- |

j)

the market for district heating,

| k) | the market for fly ash production, |
| --- | --- |

k)

the market for fly ash production,

| l) | the market for trading of CO2 emission rights. |
| --- | --- |

l)

the market for trading of CO2 emission rights.

| 3. | The Advisory Committee agrees with the Commission that for the purposes of assessing the present operation, the relevant geographic markets are:
  in the natural gas sector:






  a) | the market for storage, or alternatively the Danish market for flexibility of natural gas, for Denmark is Danish; |
| --- | --- | --- |

3.

The Advisory Committee agrees with the Commission that for the purposes of assessing the present operation, the relevant geographic markets are:

in the natural gas sector:

a)

the market for storage, or alternatively the Danish market for flexibility of natural gas, for Denmark is Danish;

| b) | the market for storage or alternatively the Swedish market for flexibility of natural gas for Sweden is Swedish or alternatively Swedish-Danish in scope; |
| --- | --- |

b)

the market for storage or alternatively the Swedish market for flexibility of natural gas for Sweden is Swedish or alternatively Swedish-Danish in scope;

| c) | the wholesale market for natural gas for Denmark is Danish in scope; |
| --- | --- |

c)

the wholesale market for natural gas for Denmark is Danish in scope;

| d) | the wholesale market for natural gas for Sweden is Swedish or alternatively Swedish-Danish in scope; |
| --- | --- |

d)

the wholesale market for natural gas for Sweden is Swedish or alternatively Swedish-Danish in scope;

| e) | the market for the supply of natural gas to Danish central CHPs is Danish; |
| --- | --- |

e)

the market for the supply of natural gas to Danish central CHPs is Danish;

| f) | the market for the supply of natural gas to Swedish central CHPs is Swedish or alternatively Swedish-Danish in scope; |
| --- | --- |

f)

the market for the supply of natural gas to Swedish central CHPs is Swedish or alternatively Swedish-Danish in scope;

| g) | the market or markets for the supply of natural gas to large industrial customers and to decentralized CHPs is Danish in scope); |
| --- | --- |

g)

the market or markets for the supply of natural gas to large industrial customers and to decentralized CHPs is Danish in scope);

| h) | the market or markets for the supply of natural gas to small business customers and to households is/are Danish-national or Danish-regional in scope; |
| --- | --- |

h)

the market or markets for the supply of natural gas to small business customers and to households is/are Danish-national or Danish-regional in scope;

in the electricity sector:

| i) | the wholesale market of electricity is East Danish and West Danish or wider; if ancillary services constitute one or more relevant markets then the geographic scope of such market(s) is East Danish and West Danish; |
| --- | --- |

i)

the wholesale market of electricity is East Danish and West Danish or wider; if ancillary services constitute one or more relevant markets then the geographic scope of such market(s) is East Danish and West Danish;

| j) | the market for financial derivatives of electricity encompasses the Nord Pool area if excluding CfDs; if CfDs constitute a separate market then the relevant markets are the individual NordPool areas, i.e. East Danish and West Danish; |
| --- | --- |

j)

the market for financial derivatives of electricity encompasses the Nord Pool area if excluding CfDs; if CfDs constitute a separate market then the relevant markets are the individual NordPool areas, i.e. East Danish and West Danish;

| k) | the retail market for electricity sales to metered (business) customers is Danish in scope; |
| --- | --- |

k)

the retail market for electricity sales to metered (business) customers is Danish in scope;

| l) | the retail market for electricity sales to non-metered (predominantly household) customers is Danish-national or Danish-regional in scope; |
| --- | --- |

l)

the retail market for electricity sales to non-metered (predominantly household) customers is Danish-national or Danish-regional in scope;

for other markets:

| m) | the market for district heating is local; |
| --- | --- |

m)

the market for district heating is local;

| n) | the scope of the geographic market for fly ash production can be left open; |
| --- | --- |

n)

the scope of the geographic market for fly ash production can be left open;

| o) | the market for CO2 trading is EU-wide. |
| --- | --- |

o)

the market for CO2 trading is EU-wide.

| 4. | The Advisory Committee agrees with the Commission that DONG has a dominant position:
  in the natural gas sector:






  a) | on the market for gas storage or gas flexibility for Denmark; |
| --- | --- | --- |

4.

The Advisory Committee agrees with the Commission that DONG has a dominant position:

in the natural gas sector:

a)

on the market for gas storage or gas flexibility for Denmark;

| b) | on the wholesale market of natural gas for Denmark; |
| --- | --- |

b)

on the wholesale market of natural gas for Denmark;

| c) | on the market or markets for the supply of natural gas to large industrial customers and decentralised CHPs in Denmark; |
| --- | --- |

c)

on the market or markets for the supply of natural gas to large industrial customers and decentralised CHPs in Denmark;

| d) | on the market or markets for the supply of natural gas to small business customers and/or households on two of the five Danish regional areas (single dominance) or alternatively on a national market with HNG/MN? (joint dominance), |
| --- | --- |

d)

on the market or markets for the supply of natural gas to small business customers and/or households on two of the five Danish regional areas (single dominance) or alternatively on a national market with HNG/MN? (joint dominance),

| e) | and that the question for the markets for gas storage or gas flexibility and gas wholesale for Sweden can remain open as any commitments which are sufficient to remedy the competition concerns on the respective markets for Denmark also solve such problems on the markets for Sweden. |
| --- | --- |

e)

and that the question for the markets for gas storage or gas flexibility and gas wholesale for Sweden can remain open as any commitments which are sufficient to remedy the competition concerns on the respective markets for Denmark also solve such problems on the markets for Sweden.

| 5. | The Advisory Committee agrees with the Commission that the transaction will give DONG the ability and incentive on the Danish gas storage or gas flexibility market to raise rivals' costs of storage post merger, increase storage tariffs in Denmark and to use the central CHP plants owned by Elsam and Energi E2 for flexibility purposes and that the transaction would thus strengthen DONG's dominant position on the possible Danish market for storage or on the possible Danish market for storage/flexibility and would lead to a significant impediment to effective competition. |
| --- | --- |

5.

The Advisory Committee agrees with the Commission that the transaction will give DONG the ability and incentive on the Danish gas storage or gas flexibility market to raise rivals' costs of storage post merger, increase storage tariffs in Denmark and to use the central CHP plants owned by Elsam and Energi E2 for flexibility purposes and that the transaction would thus strengthen DONG's dominant position on the possible Danish market for storage or on the possible Danish market for storage/flexibility and would lead to a significant impediment to effective competition.

| 6. | The Advisory Committee agrees with the Commission that the transaction will strengthen DONG's dominant position on the Danish wholesale market especially through removing significant actual and potential competitive constraints to DONG and through foreclosure of demand and that this is likely to lead to a significant impediment to effective competition. |
| --- | --- |

6.

The Advisory Committee agrees with the Commission that the transaction will strengthen DONG's dominant position on the Danish wholesale market especially through removing significant actual and potential competitive constraints to DONG and through foreclosure of demand and that this is likely to lead to a significant impediment to effective competition.

| 7. | The Advisory Committee agrees with the Commission that the concentration does not lead to a significant impediment of effective competition on the markets for natural gas supplies to central CHPs either in Denmark or in Sweden. |
| --- | --- |

7.

The Advisory Committee agrees with the Commission that the concentration does not lead to a significant impediment of effective competition on the markets for natural gas supplies to central CHPs either in Denmark or in Sweden.

| 8. | The Advisory Committee agrees with the Commission that the concentration will lead to a significant impediment of effective competition on the market or markets of the supply of natural gas to large industrial customers and decentralised CHPs especially through raising entry barriers and eliminating potential competition. |
| --- | --- |

8.

The Advisory Committee agrees with the Commission that the concentration will lead to a significant impediment of effective competition on the market or markets of the supply of natural gas to large industrial customers and decentralised CHPs especially through raising entry barriers and eliminating potential competition.

| 9. | The Advisory Committee agrees with the Commission that the concentration will significantly impede competition on the market or markets for the supply of natural gas to households and small business customers irrespective of whether these markets are defined as regional or as national in particular through the strengthening of a dominant position. |
| --- | --- |

9.

The Advisory Committee agrees with the Commission that the concentration will significantly impede competition on the market or markets for the supply of natural gas to households and small business customers irrespective of whether these markets are defined as regional or as national in particular through the strengthening of a dominant position.

| 10. | The Advisory Committee agrees with the Commission that the notified concentration does not lead to a significant impediment of effective competition, in particular as a result of the creation or strengthening of a dominant position on either any possible affected market for physical electricity or for financial derivatives of electricity. |
| --- | --- |

10.

The Advisory Committee agrees with the Commission that the notified concentration does not lead to a significant impediment of effective competition, in particular as a result of the creation or strengthening of a dominant position on either any possible affected market for physical electricity or for financial derivatives of electricity.

| 11. | The Advisory Committee agrees with the Commission that in the absence of competition concerns it is not necessary to examine further the effect of the concentration on the markets for district heating, fly ash production and CO2 trading. |
| --- | --- |

11.

The Advisory Committee agrees with the Commission that in the absence of competition concerns it is not necessary to examine further the effect of the concentration on the markets for district heating, fly ash production and CO2 trading.

| 12. | The majority of the Advisory Committee agrees with the Commission that the commitments submitted by the parties concerning storage divestiture and the gas release programme are suitable and in combination with each other sufficient to remove the identified competition problems on the following markets:






  a) | market for gas storage or gas flexibility irrespective of whether only for Denmark or also for Sweden; |
| --- | --- | --- |

12.

The majority of the Advisory Committee agrees with the Commission that the commitments submitted by the parties concerning storage divestiture and the gas release programme are suitable and in combination with each other sufficient to remove the identified competition problems on the following markets:

a)

market for gas storage or gas flexibility irrespective of whether only for Denmark or also for Sweden;

| b) | the wholesale markets of natural gas for Denmark and potentially also for Sweden; |
| --- | --- |

b)

the wholesale markets of natural gas for Denmark and potentially also for Sweden;

| c) | the market or markets for the supply of natural gas to large industrial customers and/or decentralised CHPs in Denmark; |
| --- | --- |

c)

the market or markets for the supply of natural gas to large industrial customers and/or decentralised CHPs in Denmark;

| d) | the market or markets for supply of natural gas to small business customers and/or households in Denmark. |
| --- | --- |

d)

the market or markets for supply of natural gas to small business customers and/or households in Denmark.

A minority disagrees with point b).

| 13. | The Advisory Committee agrees with the Commission that, subject to full compliance with the commitments offered by the parties the proposed concentration does not significantly impede effective competition and as a result the proposed concentration can be declared compatible with the common market and the functioning of the EEA Agreement. |
| --- | --- |

13.

The Advisory Committee agrees with the Commission that, subject to full compliance with the commitments offered by the parties the proposed concentration does not significantly impede effective competition and as a result the proposed concentration can be declared compatible with the common market and the functioning of the EEA Agreement.

| 14. | The Advisory Committee asks the Commission to take into account all the other points raised during the discussion. |
| --- | --- |

14.

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

---

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

---

| 25.5.2007 | EN | Official Journal of the European Union | C 115/34 |
| --- | --- | --- | --- |

25.5.2007

EN

Official Journal of the European Union

C 115/34

---

Final report of the Hearing Officer in Case COMP/M.3868 — Dong/Elsam/Energi E2

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

(2007/C 115/06)

The proposed concentration

On 13 September 2005, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) (‘the Merger Regulation’) whereby the Danish gas incumbent DONG acquires within the meaning of Article 3(1)(b) of the Merger Regulation control of two important Danish power generators (Elsam in the West; Energi E2 in the East) and of two electricity distribution companies, namely København Energi and Frederiksberg Elnet (the latter four companies are hereinafter referred to as ‘other involved parties’).

The initiation of proceedings and provision of key documents

At the end of the first phase of the investigation, the Commission concluded that the concentration raised serious doubts as to its compatibility with the common market and with the EEA Agreement. On 18 October 2005, the Commission therefore initiated proceedings in accordance with Article 6(1)(c) of the Merger Regulation.

On 7 November 2005 DONG was provided with access to the ‘key documents ’in the Commission file in accordance with chapter 7.2. of the ‘Best Practices on the conduct of EC merger control proceedings ’(‘Best Practices’), as determined by the Directorate General for Competition.

The Statement of Objections and the parties' reply

A Statement of Objections was sent to DONG on 19 December 2005. The other involved parties were provided with a non-confidential version of these objections. In the following days, access to the Commission's file was granted. DONG was asked to reply by 9 January 2006. DONG and the other involved parties submitted a joint reply on 5 January 2006.

In their reply of 5 January 2006, DONG considered that ‘their ability to respond to the Commission's concerns in the SO had been undermined by the Commission's approach to the provision on access to file’. More specifically, they stated that ‘the level of redaction of third party submissions was not satisfactory and made it difficult for the parties to properly scrutinise or assess the documents’. By letter of 16 January 2006, I informed DONG that subsequent to Article 8 of Commission Decision 2001/462/EC, ECSC of 23 May 2001 on the terms of reference of hearing officers in certain competition proceedings (2), they were entitled to lodge a reasoned request for access to file with me should they consider that they had not received the information they were entitled to in order to prepare their defence. DONG has not reacted to my letter.

Neither DONG, nor the other involved parties requested to develop their arguments in a formal oral hearing.

The participation of a third party

Upon request, I admitted Naturgas Fyn Group as a third party according to Article 18(4) of Council Regulation 139/2004 on 22 December 2005. They were sent a non-confidential version of the Statement of Objections.

The commitments and the results of the market test

On 30 January 2006, DONG offered commitments. The results of the market test of these commitments conducted as from 1 February 2006 were mixed. Concerns were raised in particular with regard to the effectiveness of the two-step auction process provided for in the envisaged Gas Release Programme. As a result, the commitments were amended. I have not been asked to verify the objectivity of the enquiry.

The draft decision and the respect of the right to be heard

In the light of the commitments proposed and having analysed the results of the market test, the draft decision concludes that the proposed concentration is compatible with the common market and with the EEA Agreement.

In the light of the above, I consider that the rights to be heard of all participants to the present proceeding have been respected.

Brussels, 21 February 2006

Serge DURANDE

---

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

1

(2)  OJ L 162, 19.6.2001, p. 21.

2

---

NOTICES FROM MEMBER STATES

| 25.5.2007 | EN | Official Journal of the European Union | C 115/36 |
| --- | --- | --- | --- |

25.5.2007

EN

Official Journal of the European Union

C 115/36

---

Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 68/2001 on the application of Articles 87 and 88 of the EC Treaty to training aid

(Text with EEA relevance)

(2007/C 115/07)

| Aid No | XT 3/07 |
| --- | --- |
| Member State | Cyprus |
| Region | Κύπρος (Kypros) |
| Title (and/or name of the beneficiary) | Μονοεπιχειρησιακά Προγράμματα Συνεχιζόμενης Κατάρτισης στην Κύπρο [Τίτλος και αριθμός της υφιστάμενης ενίσχυσης: Αρχή Ανάπτυξης Ανθρώπινου Δυναμικού — Μονοεπιχειρησιακά προγράμματα συνεχιζόμενης κατάρτισης — Συνήθη (CY 12/2002)] |
| Legal basis | Ο περί Ανάπτυξης Ανθρωπίνου Δυναμικού Νόμος [Νόμος 125(Ι) του 1999, άρθρο 21)] |
| Annual expenditure planned or overall amount of aid granted to the company | Aid scheme | Annual overall amount | CYP 2,5 million |
| Loans guaranteed | — |
| Individual aid | Overall aid amount | — |
| Loans guaranteed | — |
| Maximum aid intensity | Under Article 4(2)-(7) of the Regulation | Yes
  For general training:






  — | 50 % for large enterprises |

Aid No

XT 3/07

Member State

Cyprus

Region

Κύπρος (Kypros)

Title (and/or name of the beneficiary)

Μονοεπιχειρησιακά Προγράμματα Συνεχιζόμενης Κατάρτισης στην Κύπρο [Τίτλος και αριθμός της υφιστάμενης ενίσχυσης: Αρχή Ανάπτυξης Ανθρώπινου Δυναμικού — Μονοεπιχειρησιακά προγράμματα συνεχιζόμενης κατάρτισης — Συνήθη (CY 12/2002)]

Legal basis

Ο περί Ανάπτυξης Ανθρωπίνου Δυναμικού Νόμος [Νόμος 125(Ι) του 1999, άρθρο 21)]

Annual expenditure planned or overall amount of aid granted to the company

Aid scheme

Annual overall amount

CYP 2,5 million

Loans guaranteed

—

Individual aid

Overall aid amount

—

Loans guaranteed

—

Maximum aid intensity

Under Article 4(2)-(7) of the Regulation

Yes

For general training:

—

50 % for large enterprises

| — | 70 % for micro, small and medium-sized enterprises. |
| --- | --- |

—

70 % for micro, small and medium-sized enterprises.

For specific training:

| — | 25 % for large enterprises |
| --- | --- |

—

25 % for large enterprises

| — | 35 % for micro, small and medium-sized enterprises. |
| --- | --- |

—

35 % for micro, small and medium-sized enterprises.

Date of implementation

1.1.2007

Duration of scheme or individual aid award

Until 30.6.2008

Objective

General training

Yes

Documentary evidence confirming the general nature of the training provided was attached to the notification of the existing scheme.

Specific training

Yes

Economic sectors

All sectors eligible for training aid

Yes

Name and address of the granting authority

Αρχή Ανάπτυξης Ανθρώπινου Δυναμικού Κύπρου

| Αναβύσσου 2 |
| --- |
| Στρόβολος, Τ.Θ. 25431 |
| CY-1392 Λευκωσία |

Αναβύσσου 2

Στρόβολος, Τ.Θ. 25431

CY-1392 Λευκωσία

Large individual aid grants

In conformity with Article 5 of the Regulation

This State aid scheme does not provide for large individual aid grants.

Yes

| Reference number of the aid | XT 4/07 |
| --- | --- |
| Member State | Cyprus |
| Region | Κύπρος (Kypros) |
| Title (and/or name of the beneficiary) | Μονοεπιχειρησιακά Προγράμματα Συνεχιζόμενης Κατάρτισης στο Εξωτερικό [Τίτλος και αριθμός υφιστάμενης ενίσχυσης: Αρχή Ανάπτυξης Ανθρώπινου Δυναμικού — Μονοεπιχειρησιακά προγράμματα συνεχιζόμενης κατάρτισης στο εξωτερικό (CY 11/2002)] |
| Legal basis | Ο περί Ανάπτυξης Ανθρωπίνου Δυναμικού Νόμος [Νόμος 125(Ι) του 1999, άρθρο 21] |
| Type of measure | Aid scheme |
| Budget | Annual budget: CYP 0,6 million; Overall budget: — |
| Maximum aid intensity | In conformity with Article 4(2)-(7) of the Regulation | Yes
  For general training:






  — | 50 % for large enterprises |

Reference number of the aid

XT 4/07

Member State

Cyprus

Region

Κύπρος (Kypros)

Title (and/or name of the beneficiary)

Μονοεπιχειρησιακά Προγράμματα Συνεχιζόμενης Κατάρτισης στο Εξωτερικό [Τίτλος και αριθμός υφιστάμενης ενίσχυσης: Αρχή Ανάπτυξης Ανθρώπινου Δυναμικού — Μονοεπιχειρησιακά προγράμματα συνεχιζόμενης κατάρτισης στο εξωτερικό (CY 11/2002)]

Legal basis

Ο περί Ανάπτυξης Ανθρωπίνου Δυναμικού Νόμος [Νόμος 125(Ι) του 1999, άρθρο 21]

Type of measure

Aid scheme

Budget

Annual budget: CYP 0,6 million; Overall budget: —

Maximum aid intensity

In conformity with Article 4(2)-(7) of the Regulation

Yes

For general training:

—

50 % for large enterprises

| — | 70 % for micro, small and medium-sized enterprises. |
| --- | --- |

—

70 % for micro, small and medium-sized enterprises.

For specific training:

| — | 25 % for large enterprises |
| --- | --- |

—

25 % for large enterprises

| — | 35 % for micro, small and medium-sized enterprises. |
| --- | --- |

—

35 % for micro, small and medium-sized enterprises.

Date of implementation

1.1.2007

Duration

30.6.2008

Objective

General training; Specific training

Yes

Documentary evidence confirming the general nature of the training provided was attached to the notification of the existing scheme.

Economic sectors

All sectors eligible for training aid

Name and address of the granting authority

| Αρχή Ανάπτυξης Ανθρώπινου Δυναμικού Κύπρου |
| --- |
| Αναβύσσου 2 |
| Στρόβολος, Τ.Θ. 25431 |
| CY-1392 Λευκωσία |

Αρχή Ανάπτυξης Ανθρώπινου Δυναμικού Κύπρου

Αναβύσσου 2

Στρόβολος, Τ.Θ. 25431

CY-1392 Λευκωσία

| Reference number of the aid | XT 5/07 |
| --- | --- |
| Member State | Cyprus |
| Region | Κύπρος (Kypros) |
| Title (and/or name of the beneficiary) | Μονοεπιχειρησιακά Προγράμματα Αρχικής Κατάρτισης [Τίτλος και αριθμός υφιστάμενης ενίσχυσης: Αρχή Ανάπτυξης Ανθρώπινου Δυναμικού — Μονοεπιχειρησιακά προγράμματα αρχικής κατάρτισης — Συνήθη (CY 13/2002)] |
| Legal basis | Ο περί Ανάπτυξης Ανθρωπίνου Δυναμικού Νόμος [Νόμος 125(Ι) του 1999, άρθρο 21] |
| Type of measure | Aid scheme |
| Budget | Annual budget: CYP 0,01 million; Overall budget: — |
| Maximum aid intensity | In conformity with Article 4(2)-(7) of the Regulation | Yes
  For general training:






  — | 50 % for large enterprises |

Reference number of the aid

XT 5/07

Member State

Cyprus

Region

Κύπρος (Kypros)

Title (and/or name of the beneficiary)

Μονοεπιχειρησιακά Προγράμματα Αρχικής Κατάρτισης [Τίτλος και αριθμός υφιστάμενης ενίσχυσης: Αρχή Ανάπτυξης Ανθρώπινου Δυναμικού — Μονοεπιχειρησιακά προγράμματα αρχικής κατάρτισης — Συνήθη (CY 13/2002)]

Legal basis

Ο περί Ανάπτυξης Ανθρωπίνου Δυναμικού Νόμος [Νόμος 125(Ι) του 1999, άρθρο 21]

Type of measure

Aid scheme

Budget

Annual budget: CYP 0,01 million; Overall budget: —

Maximum aid intensity

In conformity with Article 4(2)-(7) of the Regulation

Yes

For general training:

—

50 % for large enterprises

| — | 70 % for micro, small and medium-sized enterprises. |
| --- | --- |

—

70 % for micro, small and medium-sized enterprises.

Date of implementation

1.1.2007

Duration

30.6.2008

Objective

General training

Yes

Documentary evidence confirming the general nature of the training provided was attached to the notification of the existing scheme.

Economic sectors

All sectors eligible for training aid

Name and address of the granting authority

| Αρχή Ανάπτυξης Ανθρώπινου Δυναμικού Κύπρου |
| --- |
| Αναβύσσου 2 |
| Στρόβολος, Τ.Θ. 25431 |
| CY-1392 Λευκωσία |

Αρχή Ανάπτυξης Ανθρώπινου Δυναμικού Κύπρου

Αναβύσσου 2

Στρόβολος, Τ.Θ. 25431

CY-1392 Λευκωσία

---

V Announcements

ADMINISTRATIVE PROCEDURES

Commission

| 25.5.2007 | EN | Official Journal of the European Union | C 115/39 |
| --- | --- | --- | --- |

25.5.2007

EN

Official Journal of the European Union

C 115/39

---

CALL FOR PROPOSALS DG EAC/20/07

(DIRECTORATE-GENERAL FOR EDUCATION AND CULTURE)

UNDER THE LIFELONG LEARNING PROGRAMME

Award of grants for actions to develop and test the European Qualifications Framework (EQF), including national and sectoral qualifications frameworks

(2007/C 115/08)

1.   Objectives and description

The objective of this call for proposals is to award grants to approximately 10-15 proposals, with participants from the maximum number of countries and sectors, to organise actions to support consortia:

| — | to develop and test the principles and mechanisms of the future EQF |
| --- | --- |

—

to develop and test the principles and mechanisms of the future EQF

| — | to exchange experiences at national and sectoral level in using the EQF as a common reference point, including the development of qualifications frameworks and, for example, establishing closer links between the European Higher Education Area and the EQF. |
| --- | --- |

—

to exchange experiences at national and sectoral level in using the EQF as a common reference point, including the development of qualifications frameworks and, for example, establishing closer links between the European Higher Education Area and the EQF.

2.   Eligible applicants

The submission of applications for grants under this Call is open especially to consortia of European, national, regional and sectoral organisations, including, for example, ministries, qualifications authorities, sectoral associations, social partners and other key stakeholders with an interest and role in qualifications systems. Applicants should also have representative legitimacy in terms of the sector, labour market or education and training system(s) that their project is intended to benefit.

Applications for funding may only be made by consortia consisting of organisations drawn from 5 or more countries.

Applications may be submitted by organisations established in one of the following countries:

| — | the 27 EU Member States |
| --- | --- |

—

the 27 EU Member States

| — | the three EFTA-EEA countries (Iceland, Liechtenstein, Norway) (1) |
| --- | --- |

—

the three EFTA-EEA countries (Iceland, Liechtenstein, Norway) (1)

| — | Turkey (1) |
| --- | --- |

—

Turkey (1)

3.   Budget and project duration

The total budget earmarked for the cofinancing of projects amounts to EUR 2 million. Financial assistance from the Commission cannot exceed 75 % of the total eligible costs.

Grants are expected to be between EUR 50 000 and EUR 200 000.

Activities must start not later than mid-February 2008. The maximum duration of projects is 24 months.

4.   Deadline

Applications must be despatched, date as postmark, to the Education, Audiovisual and Culture Executive Agency no later than 31 August 2007.

5.   Further information

The full text of the call for proposals and the application forms are available on the following website:

http://ec.europa.eu/dgs/education_culture/calls/grants_en.html

Applications must comply with the requirements set out in the full text and be submitted using the form provided.

---

(1)  Agreements establishing the participation of these countries are currently being finalised and are expected to enter into force by the date of selection. Updated information can be accessed at:

http://eacea.ec.europa.eu/static/en/llp/funding_en.htm#update

---

| 25.5.2007 | EN | Official Journal of the European Union | C 115/41 |
| --- | --- | --- | --- |

25.5.2007

EN

Official Journal of the European Union

C 115/41

---

Call for proposals under the draft annual work programme for grants in the field of the Trans-European Transport Network (TEN-T) for 2007 (Commission Decision C(2007) 2183)

(2007/C 115/09)

The European Commission, Directorate-General for Energy and Transport, is hereby launching a call for proposals in order to award grants to projects in accordance with the priorities and objectives defined in the draft annual work programme for grants in the field of the Trans-European Transport Network for 2007.

The maximum amount available under this call for proposals, for 2007, is EUR 112 607 450.

The call is closing on 20 July 2007.

The complete text of the Call for proposals is available on:

http://ec.europa.eu/dgs/energy_transport/grants/proposal_en.htm

---

| 25.5.2007 | EN | Official Journal of the European Union | C 115/42 |
| --- | --- | --- | --- |

25.5.2007

EN

Official Journal of the European Union

C 115/42

---

Call for proposals under the draft multi-annual work programme for grants in the field of the Trans-European Transport Network (TEN-T) for the period 2007-2013 (Commission Decision C(2007) 2158)

(2007/C 115/10)

The European Commission, Directorate-General for Energy and Transport is hereby launching a call for proposals, under the draft multi-annual work programme for the Trans-European Transport Network (TEN-T) for the period 2007-2013, in order to award grants to:

Field No 1:

TEN-T Priority Projects included in annex III of the Community Guidelines for the development of a trans-European transport network (Decision of the European Parliament and the Council No 1692/96/EC, as last modified by Council Decision (EC) No 1791/2006). The maximum amount available for the selected proposals, for the period 2007-2013, shall range from EUR 4,9004 to 5,30105 billion.

Field No 2:

projects in the field of Intelligent transport systems, sector of Air Traffic Management (ATM)/SESAR. The maximum total amount available for the selected proposals, for the period 2007-2013, is EUR 350 million.

Field No 3:

projects in the field of Intelligent Transport Systems for road traffic (ITS road). The maximum total amount available for the selected proposals, for 2007, is EUR 100 million.

Field No 4:

projects in the field of European Rail Traffic Management System (ERTMS). The maximum total amount available for the selected proposals, for 2007, is EUR 250 million.

The call is closing on 20 July 2007.

The complete text of the Call for proposals is available on:

http://ec.europa.eu/dgs/energy_transport/grants/proposal_en.htm

---

| 25.5.2007 | EN | Official Journal of the European Union | C 115/43 |
| --- | --- | --- | --- |

25.5.2007

EN

Official Journal of the European Union

C 115/43

---

Calls for proposals under the work programme for 2007 of the Information and Communication Technologies Policy Support Programme as part of the Competitiveness and Innovation Framework Programme (2007 to 2013)

(2007/C 115/11)

Notice is hereby given of the launch of the call for proposals under the work programme for 2007 of the Information and Communication Technologies Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Programme — (2007 to 2013).

Proposals are invited for the following call: CIP-ICT PSP-2007-1

Call documentation including content, deadline and budget is given in the call texts which are published on the ICT PSP website:

http://ec.europa.eu/ict_psp

---

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 25.5.2007 | EN | Official Journal of the European Union | C 115/44 |
| --- | --- | --- | --- |

25.5.2007

EN

Official Journal of the European Union

C 115/44

---

Prior notification of a concentration

(Case COMP/M.4689 — Wingas/HydroWingas)

Candidate case for simplified procedure

(Text with EEA relevance)

(2007/C 115/12)

| 1. | On 15 May 2007, 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 Wingas GmbH (‘Wingas’, Germany), controlled by Wintershall Holding AG (‘Wintershall’, Germany) and belonging to the BASF Group, acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of the undertaking HydroWingas Limited (‘HydroWingas’, UK), currently jointly controlled by Wingas and Norsk Hydro (UK) Limited, by way of purchase of shares. |
| --- | --- |

1.

On 15 May 2007, 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 Wingas GmbH (‘Wingas’, Germany), controlled by Wintershall Holding AG (‘Wintershall’, Germany) and belonging to the BASF Group, acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of the undertaking HydroWingas Limited (‘HydroWingas’, UK), currently jointly controlled by Wingas and Norsk Hydro (UK) Limited, by way of purchase of shares.

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






  — | for Wingas: supply, transportation and storage of natural gas; |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Wingas: supply, transportation and storage of natural gas;

| — | for Wintershall: exploration, production and sale of crude oil and natural gas; |
| --- | --- |

—

for Wintershall: exploration, production and sale of crude oil and natural gas;

| — | for HydroWingas: supply and trading of natural gas in the UK. |
| --- | --- |

—

for HydroWingas: supply and trading of natural gas in the UK.

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

3.

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

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4689 — Wingas/HydroWingas, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Bruxelles/Brussel |

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4689 — Wingas/HydroWingas, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

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

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

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