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Document C:2007:039:FULL

Official Journal of the European Union, C 39, 23 February 2007


Display all documents published in this Official Journal
 

ISSN 1725-2423

Official Journal

of the European Union

C 39

European flag  

English edition

Information and Notices

Volume 50
23 February 2007


Notice No

Contents

page

 

I   Resolutions, recommendations, guidelines and opinions

 

OPINIONS

 

European Central Bank

2007/C 039/01

Opinion of the European Central Bank of 15 February 2007 at the request of the Council of the European Union on eight proposals amending Directives 2006/49/EC, 2006/48/EC, 2005/60/EC, 2004/109/EC, 2004/39/EC, 2003/71/EC, 2003/6/EC and 2002/87/EC, as regards the implementing powers conferred on the Commission (CON/2007/4)

1

 

II   Information

 

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

 

Commission

2007/C 039/02

Non-opposition to a notified concentration (Case COMP/M.4445 — voestalpine/Stamptec) ( 1 )

3

2007/C 039/03

Non-opposition to a notified concentration (Case COMP/M.4431 — BG Group/Serene) ( 1 )

3

2007/C 039/04

Non-opposition to a notified concentration (Case COMP/M.4510 — L Capital 2/Calligaris) ( 1 )

4

2007/C 039/05

Non-opposition to a notified concentration (Case COMP/M.4319 — Mondi/Schleipen & Erkens) ( 1 )

4

2007/C 039/06

Non-opposition to a notified concentration (Case COMP/M.4314 — Johnson & Johnson/Pfizer Consumer Healthcare) ( 1 )

5

2007/C 039/07

Non-opposition to a notified concentration (Case COMP/M.4526 — PAI/Lafarge) ( 1 )

5

 

IV   Notices

 

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

 

Commission

2007/C 039/08

Euro exchange rates

6

2007/C 039/09

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2007 to 31 January 2007(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )

7

2007/C 039/10

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2007 to 31 January 2007(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

18

 

NOTICES FROM MEMBER STATES

2007/C 039/11

Publication of decisions by Member States to grant or revoke operating licenses pursuant to Article 13(4) of Council Regulation (EEC) No 2407/92 on licensing of air carriers ( 1 )

25

 

V   Announcements

 

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

 

Commission

2007/C 039/12

Notice of initiation of a partial interim review of the antidumping measures applicable to imports of grain oriented flat-rolled products of silicon-electrical steel (GOES) originating in Russia

26

 

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

 

Commission

2007/C 039/13

Prior notification of a concentration (Case COMP/M.4469 — Scholz/voestalpine/Scholz Austria) ( 1 )

28

2007/C 039/14

Prior notification of a concentration (Case COMP/M.4522 — Carrefour/Ahold Polska) ( 1 )

29

 

2007/C 039/15

Notice

s3

 


 

(1)   Text with EEA relevance

EN

 


I Resolutions, recommendations, guidelines and opinions

OPINIONS

European Central Bank

23.2.2007   

EN

Official Journal of the European Union

C 39/1


OPINION OF THE EUROPEAN CENTRAL BANK

of 15 February 2007

at the request of the Council of the European Union on eight proposals amending Directives 2006/49/EC, 2006/48/EC, 2005/60/EC, 2004/109/EC, 2004/39/EC, 2003/71/EC, 2003/6/EC and 2002/87/EC, as regards the implementing powers conferred on the Commission

(CON/2007/4)

(2007/C 39/01)

Introduction and legal basis

On 29 and 31 January 2007 the European Central Bank (ECB) received requests from the Council of the European Union for an opinion on eight proposals for directives (1) in the financial field (hereinafter ‘the proposals’) whose main objectives are to amend the comitology provisions of eight existing directives to incorporate provisions on a new comitology procedure (the ‘regulatory procedure with scrutiny’), following the adoption of Council Decision 2006/512/EC of 17 July 2006 amending Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission (2), and to repeal the provisions of the eight existing directives that provide for a time limit for the delegation of implementing powers to the Commission (the so-called ‘sunset clauses’). The ECB's competence to deliver an opinion is based on Article 105(4) of the Treaty establishing the European Community. In accordance with the first sentence of Article 17(5) of the Rules of Procedure of the European Central Bank, the Governing Council has adopted this opinion.

1.   Observations

1.1

The ECB welcomes the new agreement on comitology reached between the European Parliament, the Council and the Commission, which is of great importance for the continued functioning of the Lamfalussy process.

1.2

The ECB has no specific comments on the proposals which are in line with the joint statement of the European Parliament, the Council and the Commission on the introduction of the new ‘regulatory procedure with scrutiny’ into the comitology framework (3).

1.3

Having regard to the importance of the role played by implementing measures in EU legislation in the financial services field, the ECB takes this opportunity to underline the importance of its advisory role under Article 105(4) of the Treaty, which requires the ECB to be consulted ‘on any proposed Community act in its fields of competence’. As recently noted (4), ‘the ECB considers that proposed Level 2 acts constitute “proposed Community acts” within the meaning of Article 105(4) of the Treaty’ (5). Therefore the Treaty provision which requires the ECB to be consulted on any proposed Community act in its field of competence includes an obligation for it to be consulted on these implementing acts (6).

Done at Frankfurt am Main, 15 February 2007.

The President of the ECB

Jean-Claude TRICHET


(1)  (1) Proposal for a Directive of the European Parliament and of the Council amending Directive 2006/49/EC on the capital adequacy of investment firms and credit institutions, as regards the implementing powers conferred on the Commission (COM(2006) 90l final); (2) Proposal for a Directive of the European Parliament and of the Council amending Directive 2006/48/EC relating to the taking up and pursuit of the business of credit institutions, as regards the implementing powers conferred to the Commission (COM(2006) 902 final); (3) Proposal for a Directive of the European Parliament and of the Council amending Directive 2005/60/EC on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing, as regards the implementing powers conferred on the Commission (COM(2006) 906 final); (4) Proposal for a Directive of the European Parliament and of the Council amending Directive 2004/109/EC relating to the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market as regards the implementing powers conferred on the Commission (COM(2006) 909 final); (5) Proposal for a Directive of the European Parliament and of the Council amending Directive 2004/39/EC relating to markets in financial instruments as regards the implementing powers conferred on the Commission (COM(2006) 910 final); (6) Proposal for a Directive of the European Parliament and of the Council amending Directive 2003/71/EC relating to the prospectus to be published when securities are offered to the public or admitted to trading, as regards the implementing powers conferred on the Commission (COM(2006) 911 final); (7) Proposal for a Directive of the European Parliament and of the Council amending Directive 2003/6/EC on insider dealing and market manipulation (market abuse), as regards the implementing powers conferred on the Commission (COM(2006) 913 final); (8) Proposal for a Directive of the European Parliament and of the Council amending Directive 2002/87/EC relating to the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate as regards the implementing powers conferred on the Commission (COM(2006) 916 final).

(2)  OJ L 200, 22.7.2006, p. 11.

(3)  Statement by the European Parliament, the Council and the Commission concerning the Council Decision of 17 July 2006 amending Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission (2006/512/EC), (OJ C 255, 21.10.2006, p. 1).

(4)  ECB Opinion CON/2006/57 of 12 December 2006 on a draft Commission Directive implementing Council Directive 85/611/EEC on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) as regards the clarification of certain definitions.

(5)  Under the Lamfalussy framework the implementing acts are referred as ‘Level 2 acts’.

(6)  The lack of consultation between Community institutions has been the subject of several judgments by the Court of Justice. On the obligation to consult the European Parliament, see Case 138/79 Roquette Frères [1980] ECR 3333 and Case C-21/94 Parliament v Council [1995] ECR I-1827, paragraph 17. On the obligation of the High Authority to consult the Council and the Consultative Committee under the ECSC Treaty, see Case 1/54 France v High Authority [1954-56] ECR 1, at p 15 and Case 2/54 Italy v High Authority [1954-56] ECR 37, at p 52, which was confirmed by Case 6/54 Netherlands v High Authority [1954-56] ECR 103, at p 112. As far as Article 105(4) of the Treaty is concerned, in Case C-11/00 Commission v European Central Bank [2003] ECR I-7147, Advocate General Jacobs emphasised that: ‘Consultation of the ECB on proposed measures in its field of competence is a procedural step, required by a provision of the Treaty, which is clearly capable of affecting the content of the measures adopted. Failure to comply with such requirement must, in my view, be capable of leading to the annulment of the measures adopted’, Opinion of Advocate General Jacobs given on 3 October 2002, paragraph 131.


II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

23.2.2007   

EN

Official Journal of the European Union

C 39/3


Non-opposition to a notified concentration

(Case COMP/M.4445 — voestalpine/Stamptec)

(Text with EEA relevance)

(2007/C 39/02)

On 6 February 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,

in electronic form on the EUR-Lex website under document number 32007M4445. EUR-Lex is the on-line access to European law. (http://eur-lex.europa.eu)


23.2.2007   

EN

Official Journal of the European Union

C 39/3


Non-opposition to a notified concentration

(Case COMP/M.4431 — BG Group/Serene)

(Text with EEA relevance)

(2007/C 39/03)

On 1 February 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,

in electronic form on the EUR-Lex website under document number 32007M4431. EUR-Lex is the on-line access to European law. (http://eur-lex.europa.eu)


23.2.2007   

EN

Official Journal of the European Union

C 39/4


Non-opposition to a notified concentration

(Case COMP/M.4510 — L Capital 2/Calligaris)

(Text with EEA relevance)

(2007/C 39/04)

On 12 February 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,

in electronic form on the EUR-Lex website under document number 32007M4510. EUR-Lex is the on-line access to European law. (http://eur-lex.europa.eu)


23.2.2007   

EN

Official Journal of the European Union

C 39/4


Non-opposition to a notified concentration

(Case COMP/M.4319 — Mondi/Schleipen & Erkens)

(Text with EEA relevance)

(2007/C 39/05)

On 24 October 2006, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

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

in electronic form on the EUR-Lex website under document number 32006M4319. EUR-Lex is the on-line access to European law. (http://eur-lex.europa.eu)


23.2.2007   

EN

Official Journal of the European Union

C 39/5


Non-opposition to a notified concentration

(Case COMP/M.4314 — Johnson & Johnson/Pfizer Consumer Healthcare)

(Text with EEA relevance)

(2007/C 39/06)

On 11 December 2006, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(2) 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,

in electronic form on the EUR-Lex website under document number 32006M4314. EUR-Lex is the on-line access to European law. (http://eur-lex.europa.eu)


23.2.2007   

EN

Official Journal of the European Union

C 39/5


Non-opposition to a notified concentration

(Case COMP/M.4526 — PAI/Lafarge)

(Text with EEA relevance)

(2007/C 39/07)

On 15 February 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,

in electronic form on the EUR-Lex website under document number 32007M4526. 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

23.2.2007   

EN

Official Journal of the European Union

C 39/6


Euro exchange rates (1)

22 February 2007

(2007/C 39/08)

1 euro=

 

Currency

Exchange rate

USD

US dollar

1,3106

JPY

Japanese yen

159,00

DKK

Danish krone

7,4555

GBP

Pound sterling

0,67190

SEK

Swedish krona

9,3155

CHF

Swiss franc

1,6281

ISK

Iceland króna

87,15

NOK

Norwegian krone

8,0635

BGN

Bulgarian lev

1,9558

CYP

Cyprus pound

0,5792

CZK

Czech koruna

28,237

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

251,67

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7057

MTL

Maltese lira

0,4293

PLN

Polish zloty

3,8762

RON

Romanian leu

3,3815

SKK

Slovak koruna

34,286

TRY

Turkish lira

1,8110

AUD

Australian dollar

1,6610

CAD

Canadian dollar

1,5214

HKD

Hong Kong dollar

10,2376

NZD

New Zealand dollar

1,8560

SGD

Singapore dollar

2,0108

KRW

South Korean won

1 230,52

ZAR

South African rand

9,2551

CNY

Chinese yuan renminbi

10,1475

HRK

Croatian kuna

7,3433

IDR

Indonesian rupiah

11 900,90

MYR

Malaysian ringgit

4,5805

PHP

Philippine peso

63,302

RUB

Russian rouble

34,3900

THB

Thai baht

44,460


(1)  

Source: reference exchange rate published by the ECB.


23.2.2007   

EN

Official Journal of the European Union

C 39/7


Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2007 to 31 January 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 39/09)

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

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

4.1.2007

ADROVANCE

Alendronate sodium/Colecalciferol

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/06/364/001-005

Tablet

(Non applicable)

9.1.2007

4.1.2007

Diacomit

Stiripentol

Biocodex

7, avenue Gallieni

F-94250 Gentilly

EU/1/06/367/001-006

Capsule

N03AX17

9.1.2007

EU/1/06/367/007-012

Powder for oral suspension

8.1.2007

Elaprase

Idursulfase

Shire Human Genetic Therapies AB

Rinkebyvägen 11B

SE-182 36 Danderyd

EU/1/06/365/001-003

Concentrate for solution for infusion

A16AB09

10.1.2007

8.1.2007

Tandemact

Pioglitazone/Glimepiride

Takeda Global Research and Development Centre (Europe) Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/06/366/001-004

Tablet

(Non applicable)

10.1.2007

16.1.2007

Inovelon

rufinamide

Eisai Limited

3, Shortlands

London W6 8EE

United Kingdom

EU/1/06/378/001-016

Film-coated tablet

N03AF03

18.1.2007

16.1.2007

Dafiro

amlodipine/valsartan

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/371/001-024

Film-coated tablet

C09DB01

18.1.2007

16.1.2007

Copalia

amlodipine/valsartan

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/372/001-024

Film-coated tablet

C09DB01

18.1.2007

17.1.2007

Exforge

amlodipine/valsartan

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/370/001-024

Film-coated tablet

C09DB01

19.1.2007

17.1.2007

Imprida

amlodipine/valsartan

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/373/001-024

Film-coated tablet

C09DB01

19.1.2007

17.1.2007

Insulin Human Winthrop

insulin human

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/06/368/001-002

EU/1/06/368/011-015

EU/1/06/368/056-057

Solution for injection

A10AB01

2.2.2007

EU/1/06/368/003-010

EU/1/06/368/020-024

EU/1/06/368/029-033

EU/1/06/368/038-042

EU/1/06/368/047-051

Suspension for injection

EU/1/06/368/016-019

EU/1/06/368/025-028

EU/1/06/368/034-037

EU/1/06/368/043-046

EU/1/06/368/052-055

OptiSet, solution for injection

19.1.2007

Irbesartan BMS

irbesartan

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/06/375/001-015

Tablet

C09CA04

23.1.2007

EU/1/06/375/016-033

Film-coated tablets

19.1.2007

Irbesartan Hydrochlorothiazide BMS

irbesartan/hydrochlorothiazide

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/06/369/001-010

Tablet

C09DA04

23.1.2007

EU/1/06/369/011-028

Film-coated tablets

19.1.2007

Irbesartan Winthrop

Irbesartan

SANOFI PHARMA BRISTOL MYERS SQUIBB SNC

174, avenue de France

F-75013 Paris

EU/1/06/376/001-015

Tablet

C09CA04

23.1.2007

EU/1/06/376/016-033

Film-coated tablets

19.1.2007

Irbesartan Hydrochlorothiazide Winthrop

irbesartan/hydrochlorothiazide

SANOFI PHARMA BRISTOL MYERS SQUIBB SNC

174, avenue de France

F-75013 Paris

EU/1/06/377/001-010

Tablet

C09DA04

23.1.2007

EU/1/06/377/011-028

Film-coated tablets

22.1.2007

Lucentis

ranibizumab

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/374/001

Solution for injection

S01LA04

24.1.2007

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

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

16.1.2007

Thymanax

Les Laboratoires Servier

22, rue Garnier

F-92200 Neuilly-sur-Seine

18.1.2007

16.1.2007

Valdoxan

Les Laboratoires Servier

22, rue Garnier

F-92200 Neuilly-sur-Seine

18.1.2007

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

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.1.2007

MicardisPlus

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/02/213/001-016

9.1.2007

3.1.2007

Neulasta

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/02/227/001-003

9.1.2007

3.1.2007

Neupopeg

Dompé Biotec S.p.A.

Via San Martino 12

I-20122 Milano

EU/1/02/228/001-003

9.1.2007

3.1.2007

Invirase

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/96/026/001-002

9.1.2007

3.1.2007

Ceprotin

Baxter AG

Industriesstrasse 67

A-1220 Vienna

EU/1/01/190/001-002

9.1.2007

3.1.2007

Ambirix

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/02/224/ 001-005

9.1.2007

3.1.2007

Velcade

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

EU/1/04/274/001

9.1.2007

3.1.2007

Zostavax

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/06/341/001-013

9.1.2007

3.1.2007

Nexavar

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/06/342/001

9.1.2007

3.1.2007

Telzir

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/282/001-002

9.1.2007

4.1.2007

Twinrix Paediatric

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/97/029/001-010

9.1.2007

4.1.2007

NovoSeven

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/96/006/001-003

9.1.2007

4.1.2007

PEGASYS

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/02/221/001-010

9.1.2007

4.1.2007

Kinzalmono

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/98/091/001-014

9.1.2007

4.1.2007

Twinrix Adult

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/96/020/001-009

9.1.2007

4.1.2007

NeoRecormon

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/97/031/001-003 EU/1/97/031/019-046

9.1.2007

4.1.2007

Micardis

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/98/090/001-020

9.1.2007

4.1.2007

Rebetol

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/99/107/001-005

9.1.2007

4.1.2007

Competact

Takeda Global Research and Development Centre (Europe) Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/06/354/001-009

9.1.2007

4.1.2007

Remicade

Centocor B.V.

Einsteinweg 101

2333 CB Leiden

Nederland

EU/1/99/116/001-003

9.1.2007

4.1.2007

Ketek

Aventis Pharma S.A.

20, Avenue Raymond Aron

F-92160 Antony

EU/1/01/191/001-005

9.1.2007

4.1.2007

Levviax

Aventis Pharma S.A.

20, Avenue Raymond Aron

F-92160 Antony

EU/1/01/192/001-005

9.1.2007

4.1.2007

Temodal

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/98/096/001-008

9.1.2007

4.1.2007

Keppra

UCB S.A.

Allée de la recherche, 60

B-1070 Bruxelles

Researchdreef 60

B-1070 Brussel

EU/1/00/146/001-030

10.1.2007

4.1.2007

Kinzalkomb

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/02/214/001-010

9.1.2007

8.1.2007

PritorPlus

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/02/215/001-014

10.1.2007

8.1.2007

Pritor

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/98/089/001-022

10.1.2007

8.1.2007

DepoCyte

SkyePharma PLC

105 Piccadilly

London W1J 7NJ

United Kindgom

EU/1/01/187/001

10.1.2007

8.1.2007

Agenerase

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/148/001-004

10.1.2007

8.1.2007

IntronA

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/99/127/001-044

10.1.2007

8.1.2007

Viread

Gilead Sciences International Limited

Cambridge CB1 6GT

United Kingdom

EU/1/01/200/001

10.1.2007

9.1.2007

Puregon

Organon N.V.

P.O. Box 20

5340 BH Oss

Nederland

EU/1/96/008/001-041

11.1.2007

9.1.2007

Neupro

Schwarz Pharma Ltd

Shannon, Industrial Estate

Co.Clare

Ireland

EU/1/05/331/001-037

11.1.2007

9.1.2007

Viraferon

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/99/128/001-037

11.1.2007

9.1.2007

Thyrogen

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

Nederland

EU/1/99/122/001-002

11.1.2007

11.1.2007

Karvezide

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/98/085/001-028

15.1.2007

11.1.2007

CoAprovel

Sanofi Pharma Bristol-Myers Squibb SNC

174, avenue de France

F-75013 Paris

EU/1/98/086/001-028

15.1.2007

11.1.2007

Sutent

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/347/001-003

15.1.2007

11.1.2007

Viracept

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/97/054/001

EU/1/97/054/003-005

15.1.2007

11.1.2007

Invirase

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/96/026/001-002

15.1.2007

11.1.2007

Karvezide

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/98/085/001-028

15.1.2007

12.1.2007

MabThera

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/98/067/001-002

16.1.2007

12.1.2007

Truvada

Gilead Sciences International Limited

Granta Park Abington

Cambridge CB1 6GT

United Kingdom

EU/1/04/305/001

16.1.2007

12.1.2007

Emtriva

Gilead Sciences International Limited

Granta Park Abington

Cambridge CB1 6GT

United Kingdom

EU/1/03/261/001-003

16.1.2007

12.1.2007

Norvir

Abbott laboratories Ltd

Queenborough

Kent ME11 5EL

United-Kingdom

EU/1/96/016/001

EU/1/96/016/003-004

16.1.2007

15.1.2007

Stocrin

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/99/111/001-011

18.1.2007

15.1.2007

Viramune

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/97/055/001-003

18.1.2007

15.1.2007

Sustiva

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/99/110/001-009

18.1.2007

15.1.2007

Viread

Gilead Sciences International Limited

Cambridge CB1 6GT

United Kingdom

EU/1/01/200/001

18.1.2007

16.1.2007

Insuman

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/97/030/028-084

2.2.2007

16.1.2007

Kaletra

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/01/172/001-005

18.1.2007

17.1.2007

REYATAZ

Bristol-Myers Squibb Pharma EEIG

141-149 Staines Road

Hounslow TW3 3JA

United Kingdom

EU/1/03/267/001-007

19.1.2007

17.1.2007

Revatio

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom.

EU/1/05/318/001

19.1.2007

17.1.2007

SUTENT

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/347/001-003

19.1.2007

17.1.2007

Kivexa

Glaxo Group Ltd

Berkeley Avenue

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/298/001-002

19.1.2007

17.1.2007

Lyrica

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/04/279/001-035

19.1.2007

17.1.2007

Advate

Baxter AG

Industriestraße 67

A-1221 Wien

EU/1/03/271/001-004

19.1.2007

17.1.2007

Ziagen

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/99/112/001-002

19.1.2007

18.1.2007

Telzir

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/282/001-002

22.1.2007

18.1.2007

Avaglim

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/06/349/001-008

22.1.2007

18.1.2007

Enbrel

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/99/126/001-018

22.1.2007

19.1.2007

Zerit

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/96/009/001-009

23.1.2007

24.1.2007

Stalevo

Orion Corporation

Orionintie 1

FIN-02200 Espoo

EU/1/03/260/001-015

26.1.2007

24.1.2007

Paxene

Norton Healthcare Limited

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

EU/1/99/113/001-004

26.1.2007

24.1.2007

Comtess

Orion Corporation

Orionintie 1

FIN-02200 Espoo

EU/1/98/082/001-003 EU/1/98/082/005

26.1.2007

24.1.2007

Fuzeon

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/03/252/001-003

26.1.2007

24.1.2007

TRIZIVIR

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/156/002-003

26.1.2007

24.1.2007

Agenerase

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/148/001-004

26.1.2007

24.1.2007

Fabrazyme

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

Nederland

EU/1/01/188/001-006

26.1.2007

24.1.2007

Tarceva

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/05/311/001-003

26.1.2007

24.1.2007

Avandamet

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/03/258/001-022

26.1.2007

24.1.2007

Aptivus

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/05/315/001

26.1.2007

24.1.2007

Nexavar

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/06/342/001

26.1.2007

24.1.2007

Crixivan

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United-Kingdom

EU/1/96/024/001-005 EU/1/96/024/007-008 EU/1/96/024/010

26.1.2007

25.1.2007

Evra

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

EU/1/02/223/001-003

29.1.2007

25.1.2007

Epivir

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/96/015/001-005

29.1.2007

26.1.2007

Alimta

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/290/001

30.1.2007

26.1.2007

Actos

Takeda Global Research and Development Centre (Europe) Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/00/150/001-024

30.1.2007

26.1.2007

Combivir

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/98/058/001-002

30.1.2007

26.1.2007

Helixate NexGen

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/00/144/001-003

30.1.2007

26.1.2007

TARGRETIN

Ligand Pharmaceuticals UK Ltd

Innovis House

108 High Street

Crawley

West Sussex RH10 1BB

United Kingdom

EU/1/01/178/001

30.1.2007

29.1.2007

KOGENATE Bayer

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/00/143/001-009

31.1.2007

31.1.2007

Avonex

Biogen Idec Ltd

5 Roxborough Way

Foundation Park

Maidenhead

Berkshire SL6 3UD

United Kindgom

EU/1/97/033/001-003

2.2.2007

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

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

9.1.2007

Cortavance

Hydrocortisone aceponate

VIRBAC S.A.

1ère Avenue 2065 m L.I.D

F-06516 Carros

EU/2/06/069/001

Cutaneous spray, solution

QD07AC

11.1.2007

11.1.2007

Yposane

Osaterone acetate

VIRBAC S.A.

1ère Avenue 2065 m L.I.D

F-06516 Carros

EU/2/06/068/001-004

Tablets

QG04CX

15.1.2007

15.1.2007

Meloxicam CEVA

Meloxicam

CEVA SANTE ANIMALE

Z.I. la Ballastière

F-33500 Libourne

EU/2/06/070/001-003

oral suspension

QM01AC06

18.1.2007

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

4.1.2007

Previcox

Merial

29, avenue Tony Garnier

F-69007 Lyon

EU/2/04/045/001-006

9.1.2007

16.1.2007

Equilis StrepE

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/04/043/001

18.1.2007

11.1.2007

Gonazon

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/03/040/002

15.1.2007

16.1.2007

Profender

Bayer HealthCare AG

D-51368 Leverkusen

EU/2/05/054/001-017

18.1.2007

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


(1)  OJ L 136, 30.4.2004, p. 1.


23.2.2007   

EN

Official Journal of the European Union

C 39/18


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

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

(2007/C 39/10)

—   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

22.1.2007

Lucentis

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

This Decision is addressed to the Member States

24.1.2007

24.1.2007

Ciprofloxacin Kabi

See Annex I

See Annex I

25.1.2007


(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, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State

Marketing

Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Netherlands

Fresenius Kabi Nederland B.V.

Postbus 2379

5202 CJ 's-Hertogenbosch

Nederland

Tel.: (31) 0800 022 1905

Fax: (31) 0800 022 8295

 

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Netherlands

Fresenius Kabi Nederland B.V.

Postbus 2379

5202 CJ 's-Hertogenbosch

Nederland

Tel.: (31) 0800 022 1905

Fax: (31) 0800 022 8295

 

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Netherlands

Fresenius Kabi Nederland B.V.

Postbus 2379

5202 CJ 's-Hertogenbosch

Nederland

Tel.: (31) 0800 022 1905

Fax: (31) 0800 022 8295

 

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Austria

 

Fresenius Kabi Austria GmbH

Hafnerstraße 36

A-8055 Graz

Tel.: (43) 316 24 95 24

Fax: (43) 316 24 92 70

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Austria

 

Fresenius Kabi Austria GmbH

Hafnerstraße 36

A-8055 Graz

Tel.: (43) 316 24 95 24

Fax: (43) 316 24 92 70

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Austria

 

Fresenius Kabi Austria GmbH

Hafnerstraße 36

A-8055 Graz

Tel.: (43) 316 24 95 24

Fax: (43) 316 24 92 70

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Belgium

 

Fresenius Kabi N.V.

Molenberglei 7

B-2627 Schelle

Tel.: (32-3) 880 50 24

Fax: (32-3) 880 28 88

Ciprofloxacin Fresenius Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Belgium

 

Fresenius Kabi N.V.

Molenberglei 7

B-2627 Schelle

Tel.: (32-3) 880 50 24

Fax: (32-3) 880 28 88

Ciprofloxacin Fresenius Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Cyprus

 

Fresenius Kabi Hellas A.E.

354 Messogion Avenue

GR-15341 Agia Paraskevi Attica

Tel.: (30) 21 06 54 29 09

Fax: (30) 21 06 54 89 09

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Cyprus

 

Fresenius Kabi Hellas A.E.

354 Messogion Avenue

GR-15341 Agia Paraskevi Attica

Tel.: (30) 21 06 54 29 09

Fax: (30) 21 06 54 89 09

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Cyprus

 

Fresenius Kabi Hellas A.E.

354 Messogion Avenue

GR-15341 Agia Paraskevi Attica

Tel.: (30) 21 06 54 29 09

Fax: (30) 21 06 54 89 09

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Czech Republic

 

Fresenius Kabi Nederland B.V.

Postbus 2379

5202 CJ 's-Hertogenbosch

Nederland

Tel.: (31) 800 022 1905

Fax: (31) 0800 022 8295

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Czech Republic

 

Fresenius Kabi Nederland B.V.

Postbus 2379

5202 CJ 's-Hertogenbosch

Nederland

Tel.: (31) 800 022 1905

Fax: (31) 0800 022 8295

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Czech Republic

 

Fresenius Kabi Nederland B.V.

Postbus 2379

5202 CJ 's-Hertogenbosch

Nederland

Tel.: (31) 800 022 1905

Fax: (31) 0800 022 8295

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Germany

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Germany

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Germany

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Denmark

 

Fresenius Kabi AB

S-75174 Uppsala

Tlf. nr (46) 18 644 000

Fax nr (46) 18 644 013

Ciprofloxacin Fresenius Kabi 2 mg/ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml,

400 mg/200 ml

Greece

 

Fresenius Kabi Hellas A.E.

354 Messogion Avenue

GR-15341 Agia Paraskevi Attica

Tel.: (30) 21 06 54 29 09

Fax: (30) 21 06 54 89 09

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Greece

 

Fresenius Kabi Hellas A.E.

354 Messogion Avenue

GR-15341 Agia Paraskevi Attica

Tel.: (30) 21 06 54 29 09

Fax: (30) 21 06 54 89 09

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Greece

 

Fresenius Kabi Hellas A.E.

354 Messogion Avenue

GR-15341 Agia Paraskevi Attica

Tel.: (30) 21 06 54 29 09

Fax: (30) 21 06 54 89 09

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Spain

 

Fresenius Kabi España S.A.

c./ Marina 16-18, planta 17

E-08005 Barcelona

Tel.: (0034-93) 225 65 80

Fax: (0034-93) 225 65 73

Ciprofloxacin Kabi 2 mg/ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml,

400 mg/200 ml

Finland

 

Fresenius Kabi AB

S-75174 Uppsala

Tlf nr: 0046 18 644 000

Fax nr: 0046 18 644 013

Ciprofloxacin Fresenius Kabi 2 mg/ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml,

400 mg/200 ml

Hungary

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Hungary

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Italy

 

Fresenius Kabi Italia S.r.L.

via Camagre 41

I-37063 Isola della Scala (VR)

Tel.: 0039 0456 64 93 11

Fax: 0039 0456 64 94 04

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Italy

 

Fresenius Kabi Italia S.r.L.

via Camagre 41

I-37063 Isola della Scala (VR)

Tel.: 0039 0456 64 93 11

Fax: 0039 0456 64 94 04

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Italy

 

Fresenius Kabi Italia S.r.L.

via Camagre 41

I-37063 Isola della Scala (VR)

Tel.: 0039 0456 64 93 11

Fax: 0039 0456 64 94 04

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Poland

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Poland

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Poland

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Portugal

 

Fresenius Kabi Pharma Portugal Lda.

Avenida do Forte 3

Edifício Suécia IV

Piso 3

P-94-039 Carnaxide

Tel.: (00351) 214 24 12 84

Fax: (00351) 214 24 12 90

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Portugal

 

Fresenius Kabi Pharma Portugal Lda.

Avenida do Forte 3

Edifício Suécia IV

Piso 3

P-794-039 Carnaxide

Tel.: (00351) 214 24 12 84

Fax: (00351) 214 24 12 90

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Portugal

 

Fresenius Kabi Pharma Portugal Lda.

Avenida do Forte 3

Edifício Suécia IV

Piso 3

P-94-039 Carnaxide

Tel.: (00351) 214 24 12 84

Fax: (00351) 214 24 12 90

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Sweden

 

Fresenius Kabi AB

S-75174 Uppsala

Tfn nr (46) 18 644 000

Fax nr (46) 18 644 013

Ciprofloxacin Fresenius Kabi 2 mg/ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml,

400 mg/200 ml

Slovak Republic

 

Fresenius Kabi Deutschland GmbH,

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Slovak Republic

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Slovak Republic

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

United Kingdom

 

Fresenius Kabi Limited Cestrian Court

Eastgate Way Manor Park

Runcorn Cheshire WA7 1NT

United Kingdom

Tel.: (44-19) 28 59 42 21

Fax: (44-19) 28 59 43 14

Ciprofloxacine Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

United Kingdom

 

Fresenius Kabi Limited Cestrian Court

Eastgate Way Manor Park

Runcorn Cheshire WA7 1NT

United Kingdom

Tel.: (44-19) 28 59 42 21

Fax: (44-19) 28 59 43 14

Ciprofloxacine Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

United Kingdom

 

Fresenius Kabi Limited Cestrian Court

Eastgate Way Manor Park

Runcorn Cheshire WA7 1NT

United Kingdom

Tel.: (44-19) 28 59 42 21

Fax: (44-19) 28 59 43 14

Ciprofloxacine Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml


NOTICES FROM MEMBER STATES

23.2.2007   

EN

Official Journal of the European Union

C 39/25


Publication of decisions by Member States to grant or revoke operating licenses pursuant to Article 13(4) of Council Regulation (EEC) No 2407/92 on licensing of air carriers (1)  (2)

(Text with EEA relevance)

(2007/C 39/11)

GERMANY

Operating licences granted

Category B:   Operating licences including the restriction of Article 5(7)(a) of Regulation (EEC) No 2407/92

Name of air carrier

Address of air carrier

Permitted to carry

Decision effective since

Air Hamburg Luftverkehrsgesellschaft mbH

Kleine Bahnstr. 8

D-22525 Hamburg

passengers, mail, cargo

13.12.2006

DVS Deutsche Verkehrsfliegerschule GmbH

Flugplatz

D-63329 Egelsbach

passengers, mail, cargo

31.1.2007

Operating licences revoked

Category A:   Operating licences without the restriction of Article 5(7)(a) of Regulation (EEC) No 2407/92

Name of air carrier

Address of air carrier

Permitted to carry

Decision effective since

Lufthansa Flight Training GmbH

Airporting Tor 24

D-60549 Frankfurt/Main

passengers, mail, cargo

22.12.2006

Antares Airtransport Maintenance und Service AG

Friedenstr. 113

D-02929 Rothenburg/Oberlausitz

passengers, mail, cargo

31.1.2007

Category B:   Operating licences including the restriction of Article 5(7)(a) of Regulation (EEC) No 2407/92

Name of air carrier

Address of air carrier

Permitted to carry

Decision effective since

Helicopter Medical Services

Flugplatz

D-63329 Egelsbach

passengers, mail, cargo

21.12.2006


(1)  OJ L 240, 24.8.1992, p.1.

(2)  Communicated to the European Commission before 31.8.2005.


V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

Commission

23.2.2007   

EN

Official Journal of the European Union

C 39/26


Notice of initiation of a partial interim review of the antidumping measures applicable to imports of grain oriented flat-rolled products of silicon-electrical steel (GOES) originating in Russia

(2007/C 39/12)

The Commission has decided on its own initiative to initiate a partial interim review pursuant to Article 11(3) of Council Regulation (EC) No 384/96 on protection against dumped imports from countries not members of the European Community (‘the basic Regulation’) (1). The review is limited to the examination of the level of dumping for two Russian exporting producers, Novolipetsk Iron & Steel Corporation (NLMK) and Viz Stal.

1.   Product

The product under review is grain oriented flat-rolled products of silicon-electrical steel originating in Russia (‘the product concerned’), currently classifiable within CN codes 7225 11 00 and 7226 11 00. These CN codes are given only for information.

2.   Existing measures

The measures currently in force are a definitive anti-dumping duty imposed by Council Regulation (EC) No 1371/2005 (2) on imports of grain oriented flat-rolled products of silicon-electrical steel originating in Russia. By Decision No 2005/622/EC of 5 August 2005 (3), the Commission accepted an undertaking offered by Novolipetsk Iron & Steel Corporation. As a result, imports of the product concerned from this company are not subject to the definitive anti-dumping duty in accordance with Article 2 of Regulation (EC) No 1371/2005.

3.   Grounds for the review

The Commission has been notified that NLMK has acquired 100 % of Viz Stal. In addition, evidence has been provided regarding production, sales and distribution of the product concerned under the new corporate structure. In view of this evidence, the circumstances on the basis of which measures were established appear to have changed in a lasting way.

The evidence at hand also shows that the dumping margin under the new corporate structure would change significantly as compared to the level of the current measures.

On the basis of the foregoing, it appears that the individual duties in force for NLMK (although duties are currently not collected for imports from this company for the reason set out in point 2 above) and Viz Stal are no longer appropriate, and that a review should be initiated ex officio in order to calculate one single measure for the new joint company.

4.   Procedure for the determination of dumping

(a)   General

Having determined, after consulting the Advisory Committee, that sufficient evidence exists to justify the initiation of a partial interim review, the Commission hereby initiates a review in accordance with Article 11 (3) of the basic Regulation.

The investigation will assess the need for the continuation, removal or amendment of the existing measures in respect of NLMK and Viz Stal under the new corporate structure. This assessment will be made on the basis of data collected during the investigation that lead to the imposition of the existing measures.

If it is determined that measures should be removed or amended for the companies concerned by this review under the new corporate structure, it may be necessary to amend the rate of duty currently applicable to imports from other exporting producers of the product concerned as set out in Article 1(2) of Council Regulation (EC) No 1371/2005.

(b)   Collection of information and holding of hearings

All interested parties are hereby invited to make their views known, submit information and to provide supporting evidence. This information and supporting evidence must reach the Commission within the time limit set in point 6(a).

Furthermore, the Commission may hear interested parties, provided that they make a request showing that there are particular reasons why they should be heard. This request must be made within the time limit set in point 6(b).

5.   Time limits

(a)   For parties to make themselves known and to submit any other information

All interested parties, if their representations are to be taken into account during the investigation, must make themselves known by contacting the Commission, present their views and submit any other information within 40 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified. Attention is drawn to the fact that the exercise of most procedural rights set out in the basic Regulation depends on the party's making itself known within the aforementioned period.

(b)   Hearings

All interested parties may also apply to be heard by the Commission within the same 40-day time limit.

6.   Written submissions and correspondence

All submissions and requests made by interested parties must be made in writing (not in electronic format, unless otherwise specified) and must indicate the name, address, e-mail address, telephone and fax numbers of the interested party. All written submissions, including the information requested in this notice and correspondence provided by interested parties on a confidential basis shall be labelled as ‘Limited  (4)’ and, in accordance with Article 19(2) of the basic Regulation, shall be accompanied by a non-confidential version, which will be labelled ‘FOR INSPECTION BY INTERESTED PARTIES’.

Commission address for correspondence:

European Commission

Directorate General for Trade

Directorate B

Office: J-79 5/16

B-1049 Brussels

Fax: (32-2) 295 65 05

7.   Non-co-operation

In cases in which any interested party refuses access to or does not provide the necessary information within the time limits, or significantly impedes the investigation, findings, affirmative or negative, may be made in accordance with Article 18 of the basic Regulation, on the basis of the facts available.

Where it is found that any interested party has supplied false or misleading information, the information shall be disregarded and use may be made, in accordance with Article 18 of the basic Regulation, of the facts available. If an interested party does not cooperate or cooperates only partially, and use of facts available is made, the result may be less favourable to that party than if it had cooperated.

8.   Schedule of the investigation

The investigation will be concluded, according to Article 6(9) of the basic Regulation within 15 months of the date of the publication of this notice in the Official Journal of the European Union.


(1)  OJ L 56, 6.3.1996, p. 1. Regulation as last amended by Regulation (EC) No 2117/2005 (OJ L 340, 23.12.2005, p. 17.).

(2)  OJ L 223, 27.8.2005, p. 1.

(3)  OJ L 223, 27.8.2005, p. 42.

(4)  This means that the document is for internal use only. It is protected pursuant to Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). It is a confidential document pursuant to Article 19 of the basic Regulation and Article 6 of the WTO Agreement on Implementation of Article VI of the GATT 1994 (Anti-dumping Agreement).


PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

23.2.2007   

EN

Official Journal of the European Union

C 39/28


Prior notification of a concentration

(Case COMP/M.4469 — Scholz/voestalpine/Scholz Austria)

(Text with EEA relevance)

(2007/C 39/13)

1.

On 15 February 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 undertakings Scholz AG (‘Scholz’, Germany) and voestalpine AG (‘voestalpine’, Austria) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of Scholz Austria GmbH (‘Scholz Austria’, Austria) by means of purchase of shares in a newly created company constituting a joint venture.

2.

The business activities of the undertakings concerned are:

for Scholz: collection and processing of and trade in metal scrap;

for voestalpine: production and processing of steel products;

for Scholz Austria: collection and processing of and trade in metal scrap.

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved.

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (fax No (32-2) 296 43 01 or 296 72 44) or by post, under reference number Case COMP/M.4469 — Scholz/voestalpine/Scholz Austria, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel


(1)  OJ L 24, 29.1.2004, p. 1.


23.2.2007   

EN

Official Journal of the European Union

C 39/29


Prior notification of a concentration

(Case COMP/M.4522 — Carrefour/Ahold Polska)

(Text with EEA relevance)

(2007/C 39/14)

1.

On 16 February 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 Carrefour Nederland BV (‘Carrefour Nederland’, Netherlands), belonging to the group Carrefour (‘Carrefour’, France), acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of the undertaking Ahold Polska Sp. z o.o (‘Ahold Polska’, Poland) by way of purchase of shares.

2.

The business activities of the undertakings concerned are:

for Carrefour: international group active in food and non-food retailing;

for Ahold Polska: part of the Ahold group, active in food and non-food retailing in Poland.

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved.

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (fax No (32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4522 — Carrefour/Ahold Polska, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel


(1)  OJ L 24, 29.1.2004, p. 1.


23.2.2007   

EN

Official Journal of the European Union

C 39/s3


NOTICE

On 23 February 2007, in Official Journal of the European Union C 39 A, the ‘Common catalogue of agricultural plant species —25th complete edition’ will be published.

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

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

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

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