# Official Journal C 178/2009

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2009.178.eng |
| --- | --- |
| Official Journal
  of the European Union | C 178 |
| | |
| English edition | Information and Notices | Volume 5231 July 2009 |

ISSN 1725-2423

doi:10.3000/17252423.C_2009.178.eng

Official Journal

of the European Union

C 178

English edition

Information and Notices

Volume 5231 July 2009

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 178/01 | Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (
  1
  ) | 1 |
| 2009/C 178/02 | Commission notice concerning the quantity not applied for to be added to the quantity fixed for the subperiod 1 October to 31 December 2009 under certain quotas opened by the Community for pigmeat products | 5 |
| 2009/C 178/03 | Commission notice concerning the quantity not applied for to be added to the quantity fixed for the subperiod 1 October to 31 December 2009 under certain quotas opened by the Community for poultrymeat, eggs and egg albumin | 7 |
| 2009/C 178/04 | Non-opposition to a notified concentration (Case COMP/M.5548 — Barclays/RBS/Hillary) (
  1
  ) | 9 |
| 2009/C 178/05 | Commission communication on the body authorised to issue certificates of authenticity under Regulation (EC) No 620/2009 | 10 |
| 2009/C 178/06 | Commission communication pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council of 24 September 2008 on common rules for the operation of air services in the Community (
  1
  ) | 10 |
| 2009/C 178/07 | List of names of geographical units smaller than the Member State as referred to in Article 51(1) of Council Regulation (EC) No 1493/1999 (table wines with geographical indication) (Published pursuant to Article 28(a) of Commission Regulation (EC) No 753/2002) | 11 |
| 2009/C 178/08 | List of quality wines produced in specified regions (Published pursuant to Article 54 (4) of Council Regulation (EC) No 1493/1999) | 11 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 178/01

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (
  1
  )

1

1

2009/C 178/02

Commission notice concerning the quantity not applied for to be added to the quantity fixed for the subperiod 1 October to 31 December 2009 under certain quotas opened by the Community for pigmeat products

5

2009/C 178/03

Commission notice concerning the quantity not applied for to be added to the quantity fixed for the subperiod 1 October to 31 December 2009 under certain quotas opened by the Community for poultrymeat, eggs and egg albumin

7

2009/C 178/04

Non-opposition to a notified concentration (Case COMP/M.5548 — Barclays/RBS/Hillary) (
  1
  )

1

9

2009/C 178/05

Commission communication on the body authorised to issue certificates of authenticity under Regulation (EC) No 620/2009

10

2009/C 178/06

Commission communication pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council of 24 September 2008 on common rules for the operation of air services in the Community (
  1
  )

1

10

2009/C 178/07

List of names of geographical units smaller than the Member State as referred to in Article 51(1) of Council Regulation (EC) No 1493/1999 (table wines with geographical indication) (Published pursuant to Article 28(a) of Commission Regulation (EC) No 753/2002)

(Published pursuant to Article 28(a) of Commission Regulation (EC) No 753/2002)

11

2009/C 178/08

List of quality wines produced in specified regions (Published pursuant to Article 54 (4) of Council Regulation (EC) No 1493/1999)

(Published pursuant to Article 54 (4) of Council Regulation (EC) No 1493/1999)

11

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Council |
| 2009/C 178/09 | Council Decision of 27 July 2009 appointing one member to the Management Board of the European Chemicals Agency | 12 |
| 2009/C 178/10 | Council Decision of 27 July 2009 appointing one member to the Management Board of the European Chemicals Agency | 13 |
| | Commission |
| 2009/C 178/11 | Euro exchange rates | 14 |
| 2009/C 178/12 | Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 15 |
| 2009/C 178/13 | Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  ) | 24 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Council

2009/C 178/09

Council Decision of 27 July 2009 appointing one member to the Management Board of the European Chemicals Agency

12

2009/C 178/10

Council Decision of 27 July 2009 appointing one member to the Management Board of the European Chemicals Agency

13

Commission

2009/C 178/11

Euro exchange rates

14

2009/C 178/12

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  )

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

)

15

2009/C 178/13

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  )

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

or Article 38 of Directive 2001/82/EC

)

24

| | V   Announcements |
| --- | --- |
| | ADMINISTRATIVE PROCEDURES |
| | Commission |
| 2009/C 178/14 | ESPON 2013 programme — New open calls | 28 |

V   Announcements

ADMINISTRATIVE PROCEDURES

Commission

2009/C 178/14

ESPON 2013 programme — New open calls

28

| | Corrigenda |
| --- | --- |
| 2009/C 178/15 | Corrigendum to Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (OJ C 173, 25.7.2009) | 29 |

Corrigenda

2009/C 178/15

Corrigendum to Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (OJ C 173, 25.7.2009)

(OJ C 173, 25.7.2009)

29

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

---

(1)   Text with EEA relevance

1

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

EN

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 31.7.2009 | EN | Official Journal of the European Union | C 178/1 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/1

---

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty

Cases where the Commission raises no objections

(Text with EEA relevance)

2009/C 178/01

| Date of adoption of the decision | 17.6.2009 |
| --- | --- |
| Reference number of State Aid | N 142/08 |
| Member State | Luxembourg |
| Region | Sud-Ouest: Bascharage, Differdange, Pétange, Sanem; Sud-Est: Dudelange; Est: Echternach, Mertert, Mompach, Rosport; Nord: Clervaux, Eschweiler, Wiltz, Wincrange |
| Title (and/or name of the beneficiary) | Aide aux petites entreprises nouvelles |
| Legal basis | Article 10 du projet de loi ayant pour objet le développement économique de certaines régions du pays et modifiant la loi du 22 décembre 2000 ayant pour objet le développement économique de certaines régions du pays |
| Type of measure | Aid scheme |
| Objective | Regional development, small and medium-sized enterprises |
| Form of aid | Direct grant, interest subsidy |
| Budget | Annual budget: EUR 0,83 million; overall budget: EUR 5 million |
| Intensity | 25 % |
| Duration (period) | until 31.12.2013 |
| Economic sectors | All sectors |
| Name and address of the granting authority | Ministère de l’Économie et du Commerce extérieur |
| 19-21, boulevard Royal |
| 2914 Luxembourg |
| LUXEMBOURG |

Date of adoption of the decision

17.6.2009

Reference number of State Aid

N 142/08

Member State

Luxembourg

Region

Sud-Ouest: Bascharage, Differdange, Pétange, Sanem; Sud-Est: Dudelange; Est: Echternach, Mertert, Mompach, Rosport; Nord: Clervaux, Eschweiler, Wiltz, Wincrange

Title (and/or name of the beneficiary)

Aide aux petites entreprises nouvelles

Legal basis

Article 10 du projet de loi ayant pour objet le développement économique de certaines régions du pays et modifiant la loi du 22 décembre 2000 ayant pour objet le développement économique de certaines régions du pays

Type of measure

Aid scheme

Objective

Regional development, small and medium-sized enterprises

Form of aid

Direct grant, interest subsidy

Budget

Annual budget: EUR 0,83 million; overall budget: EUR 5 million

Intensity

25 %

Duration (period)

until 31.12.2013

Economic sectors

All sectors

Name and address of the granting authority

Ministère de l’Économie et du Commerce extérieur

19-21, boulevard Royal

2914 Luxembourg

LUXEMBOURG

Other information

—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/index.htm

| Date of adoption of the decision | 12.5.2009 |
| --- | --- |
| Reference number of State Aid | N 255/09 |
| Member State | Belgium |
| Region | — |
| Title (and/or name of the beneficiary) | Fortis Bank |
| Legal basis | Avenant no 3 au protocole d'accord du 10 octobre 2008 |
| Type of measure | Individual aid |
| Objective | Aid to remedy serious disturbances in the economy |
| Form of aid | Guarantee, other forms of equity intervention |
| Budget | Overall budget: EUR 2 900 million |
| Intensity | — |
| Duration (period) | — |
| Economic sectors | Financial intermediation |
| Name and address of the granting authority | Etat belge et Société fédérale de participation et d'investissement/Belgische Staat en Federale Participatie- en Investeringsmaatschappij |
| Other information | — |

Date of adoption of the decision

12.5.2009

Reference number of State Aid

N 255/09

Member State

Belgium

Region

—

Title (and/or name of the beneficiary)

Fortis Bank

Legal basis

Avenant no 3 au protocole d'accord du 10 octobre 2008

Type of measure

Individual aid

Objective

Aid to remedy serious disturbances in the economy

Form of aid

Guarantee, other forms of equity intervention

Budget

Overall budget: EUR 2 900 million

Intensity

—

Duration (period)

—

Economic sectors

Financial intermediation

Name and address of the granting authority

Etat belge et Société fédérale de participation et d'investissement/Belgische Staat en Federale Participatie- en Investeringsmaatschappij

Other information

—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/index.htm

| Date of adoption of the decision | 12.5.2009 |
| --- | --- |
| Reference number of State Aid | N 274/09 |
| Member State | Luxembourg |
| Region | — |
| Title (and/or name of the beneficiary) | BGL S.A. |
| Legal basis | Avenant no 3 au protocole d'accord du 10 octobre 2008 |
| Type of measure | Individual aid |
| Objective | Aid to remedy serious disturbances in the economy |
| Form of aid | Other forms of equity intervention |
| Budget | Overall budget: EUR 100 million |
| Intensity | — |
| Duration (period) | — |
| Economic sectors | Financial intermediation |
| Name and address of the granting authority | Trésor — Ministère des Finances |
| Other information | — |

Date of adoption of the decision

12.5.2009

Reference number of State Aid

N 274/09

Member State

Luxembourg

Region

—

Title (and/or name of the beneficiary)

BGL S.A.

Legal basis

Avenant no 3 au protocole d'accord du 10 octobre 2008

Type of measure

Individual aid

Objective

Aid to remedy serious disturbances in the economy

Form of aid

Other forms of equity intervention

Budget

Overall budget: EUR 100 million

Intensity

—

Duration (period)

—

Economic sectors

Financial intermediation

Name and address of the granting authority

Trésor — Ministère des Finances

Other information

—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/index.htm

| Date of adoption of the decision | 8.6.2009 |
| --- | --- |
| Reference number of State Aid | N 278/09 |
| Member State | France |
| Region | — |
| Title (and/or name of the beneficiary) | Modification du régime temporaire relatif aux aides compatibles d’un montant limité (N 188/2009) — Crédit d’impôt en faveur des métiers d’art |
| Legal basis | Article 20 de la constitution du 4 octobre 1958; articles L. 1511-1 à L. 1511-5, L. 2251-1, L2252-1, L 2253-7, L. 3231-1, L 3231-4, L 3231-7, L. 4211-1, L 4211-1 10o, L4253-1, L 4253-3 et L 5111-4 du code général des collectivités territoriales; articles 39octies E, 44 sexies A, 44 sexies, 44 septies, 44 octies I à V, 44 octies VI, 44 octies A, 44 decies, 44 undecies, 44 duodecies, 44 terdecies, 209 C, 217 sexdecies, 220 decies, 223 undecies, 244 quater B II h et i, 244 quater O, 722 bis, 885-0-V bis, 885-0-V bis A, 1383 A, 1383 C, 1383 C bis, 1383 D, 1383 E bis, 1383 F, 1383 H, 1383 I, 1464 B, 1465, 1465 A, 1466 A I ter, 1466 A I quater, 1466 A I quinquies, 1466 A I quinquies A, 14666 A I quinquies B, 1466 A I sexies, 1466 B, 1466 B bis, 1466 D, 1466 E, 1602 A, 1647 C bis, 1647 C sexies, 1647 C septies, du code général des impôts; circulaire du ministre de l’intérieur du 3 juillet 2006 sur la mise en œuvre de la loi du 13 août 2004 relative aux libertés et responsabilités locales en ce qui concerne les interventions économiques des collectivités territoriales et de leurs groupements et ses annexes; circulaire du Premier ministre du 26 janvier 2006 rappelant la réglementation communautaire de la concurrence applicable aux aides publiques aux entreprises; circulaires DIACT du 30 novembre 2007 et du 24 décembre 2008 relatives à l’application de la règlementation des aides publiques aux entreprises. |
| Type of measure | Aid scheme |
| Objective | Aid to remedy serious disturbances in the economy |
| Form of aid | Direct grant, guarantee, soft loan |
| Budget | — |
| Intensity | — |
| Duration (period) | 1.1.2009-31.12.2010 |
| Economic sectors | All sectors |
| Name and address of the granting authority | — |
| Other information | — |

Date of adoption of the decision

8.6.2009

Reference number of State Aid

N 278/09

Member State

France

Region

—

Title (and/or name of the beneficiary)

Modification du régime temporaire relatif aux aides compatibles d’un montant limité (N 188/2009) — Crédit d’impôt en faveur des métiers d’art

Legal basis

Article 20 de la constitution du 4 octobre 1958; articles L. 1511-1 à L. 1511-5, L. 2251-1, L2252-1, L 2253-7, L. 3231-1, L 3231-4, L 3231-7, L. 4211-1, L 4211-1 10o, L4253-1, L 4253-3 et L 5111-4 du code général des collectivités territoriales; articles 39octies E, 44 sexies A, 44 sexies, 44 septies, 44 octies I à V, 44 octies VI, 44 octies A, 44 decies, 44 undecies, 44 duodecies, 44 terdecies, 209 C, 217 sexdecies, 220 decies, 223 undecies, 244 quater B II h et i, 244 quater O, 722 bis, 885-0-V bis, 885-0-V bis A, 1383 A, 1383 C, 1383 C bis, 1383 D, 1383 E bis, 1383 F, 1383 H, 1383 I, 1464 B, 1465, 1465 A, 1466 A I ter, 1466 A I quater, 1466 A I quinquies, 1466 A I quinquies A, 14666 A I quinquies B, 1466 A I sexies, 1466 B, 1466 B bis, 1466 D, 1466 E, 1602 A, 1647 C bis, 1647 C sexies, 1647 C septies, du code général des impôts; circulaire du ministre de l’intérieur du 3 juillet 2006 sur la mise en œuvre de la loi du 13 août 2004 relative aux libertés et responsabilités locales en ce qui concerne les interventions économiques des collectivités territoriales et de leurs groupements et ses annexes; circulaire du Premier ministre du 26 janvier 2006 rappelant la réglementation communautaire de la concurrence applicable aux aides publiques aux entreprises; circulaires DIACT du 30 novembre 2007 et du 24 décembre 2008 relatives à l’application de la règlementation des aides publiques aux entreprises.

Type of measure

Aid scheme

Objective

Aid to remedy serious disturbances in the economy

Form of aid

Direct grant, guarantee, soft loan

Budget

—

Intensity

—

Duration (period)

1.1.2009-31.12.2010

Economic sectors

All sectors

Name and address of the granting authority

—

Other information

—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/index.htm

---

| 31.7.2009 | EN | Official Journal of the European Union | C 178/5 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/5

---

Commission notice concerning the quantity not applied for to be added to the quantity fixed for the subperiod 1 October to 31 December 2009 under certain quotas opened by the Community for pigmeat products

2009/C 178/02

Commission Regulation (EC) No 442/2009 (1) opened tariff quotas for imports of pigmeat products. The applications for import licences lodged during the first seven days of June 2009 for the subperiod 1 July to 30 September 2009 do not, for quotas 09.4038, 09.4170 and 09.4204, cover the quantities available. Pursuant to the second sentence of Article 7(4) of Commission Regulation (EC) No 1301/2006 (2), the quantities that were not applied for are to be added to the quantity fixed for the following quota subperiod, from 1 October to 31 December 2009; they are set out in the Annex to this notice.

---

(1)  OJ L 129, 28.5.2009, p. 13.

(2)  OJ L 238, 1.9.2006, p. 13.

---

ANNEX

| Quota order number | Quantities not applied for, to be added to the quantity fixed for the subperiod 1 October to 31 December 2009
  (kg) |
| --- | --- |
| 09.4038 | 3 396 840 |
| 09.4170 | 1 180 500 |
| 09.4204 | 1 156 000 |

Quota order number

Quantities not applied for, to be added to the quantity fixed for the subperiod 1 October to 31 December 2009

(kg)

09.4038

3 396 840

09.4170

1 180 500

09.4204

1 156 000

---

| 31.7.2009 | EN | Official Journal of the European Union | C 178/7 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/7

---

Commission notice concerning the quantity not applied for to be added to the quantity fixed for the subperiod 1 October to 31 December 2009 under certain quotas opened by the Community for poultrymeat, eggs and egg albumin

2009/C 178/03

Commission Regulations (EC) No 536/2007 (1) and (EC) No 539/2007 (2) opened tariff quotas for imports of poultrymeat, eggs and egg albumin. The applications for import licences lodged during the first seven days of June 2009 for the subperiod 1 July to 30 September 2009 do not, for quotas 09.4169, 09.4015 and 09.4402, cover the quantities available. Pursuant to the second sentence of Article 7(4) of Commission Regulation (EC) No 1301/2006 (3), the quantities that were not applied for are to be added to the quantity fixed for the following quota subperiod, from 1 October to 31 December 2009; they are set out in the Annex to this notice.

---

(1)  OJ L 128, 16.5.2007, p. 6.

(2)  OJ L 128, 16.5.2007, p. 19.

(3)  OJ L 238, 1.9.2006, p. 13.

---

ANNEX

| Quota order number | Quantities not applied for, to be added to the quantity fixed for the subperiod 1 October to 31 December 2009
  (kg) |
| --- | --- |
| 09.4169 | 4 091 250 |
| 09.4015 | 27 000 000 |
| 09.4402 | 1 762 626 |

Quota order number

Quantities not applied for, to be added to the quantity fixed for the subperiod 1 October to 31 December 2009

(kg)

09.4169

4 091 250

09.4015

27 000 000

09.4402

1 762 626

---

| 31.7.2009 | EN | Official Journal of the European Union | C 178/9 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/9

---

Non-opposition to a notified concentration

(Case COMP/M.5548 — Barclays/RBS/Hillary)

(Text with EEA relevance)

2009/C 178/04

On 6 July 2009, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

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

—

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

| — | in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/en/index.htm) under document number 32009M5548. EUR-Lex is the on-line access to the European law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/en/index.htm) under document number 32009M5548. EUR-Lex is the on-line access to the European law.

---

| 31.7.2009 | EN | Official Journal of the European Union | C 178/10 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/10

---

Commission communication on the body authorised to issue certificates of authenticity under Regulation (EC) No 620/2009

2009/C 178/05

By Council Regulation (EC) No 617/2009 of 13 July 2009, published in
  Official Journal of the European Union L 182 of 15 July 2009, an import tariff quota for high-quality beef has been opened.

Under Article 7 of Commission Regulation (EC) No 620/2009 of 13 July 2009, the release for free circulation of the goods imported under that quota is conditional upon presentation of a certificate of authenticity.

The following authority is authorised to issue certificates of authenticity under the Regulation.

Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA)

| United States Mission to the European Union |
| --- |
| Office of Agricultural Affairs |
| Boulevard du Régent 27 |
| 1000 Bruxelles/Brussel |
| BELGIQUE/BELGIE |
| E-mail: aguseubrussels@fas.usda.gov |

United States Mission to the European Union

Office of Agricultural Affairs

Boulevard du Régent 27

1000 Bruxelles/Brussel

BELGIQUE/BELGIE

E-mail: aguseubrussels@fas.usda.gov

---

| 31.7.2009 | EN | Official Journal of the European Union | C 178/10 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/10

---

Commission communication pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council of 24 September 2008 on common rules for the operation of air services in the Community

(Text with EEA relevance)

2009/C 178/06

| Member State | Italy |
| --- | --- |
| Route concerned | Bolzano–Roma Fiumicino and vice versa |
| Period of validity of the contract | From 1 December 2009 to 30 November 2012 |
| Deadline for submission of tenders | Two days after the publication of this notice |
| Address where the text of the invitation to tender and any relevant information and/or documentation related to the pubic tender and the public service obligation is made available free of charge | ENAC Ente nazionale per l’aviazione civile |
| Direzione Trasporto Aereo |
| Viale del Castro Pretorio 118 |
| 00185 Roma RM |
| ITALY |
| http://www.enac-italia.it |
| E-mail: osp@enac.gov.it |

Member State

Italy

Route concerned

Bolzano–Roma Fiumicino and vice versa

Period of validity of the contract

From 1 December 2009 to 30 November 2012

Deadline for submission of tenders

Two days after the publication of this notice

Address where the text of the invitation to tender and any relevant information and/or documentation related to the pubic tender and the public service obligation is made available free of charge

ENAC Ente nazionale per l’aviazione civile

Direzione Trasporto Aereo

Viale del Castro Pretorio 118

00185 Roma RM

ITALY

http://www.enac-italia.it

E-mail: osp@enac.gov.it

---

| 31.7.2009 | EN | Official Journal of the European Union | C 178/11 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/11

---

List of names of geographical units smaller than the Member State as referred to in Article 51(1) of Council Regulation (EC) No 1493/1999 (table wines with geographical indication)

(Published pursuant to Article 28(a) of Commission Regulation (EC) No 753/2002)

2009/C 178/07

Owing to technical reasons, the above mentioned list will be published in OJ C 187 on 8 August 2009.

---

| 31.7.2009 | EN | Official Journal of the European Union | C 178/11 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/11

---

List of quality wines produced in specified regions

(Published pursuant to Article 54 (4) of Council Regulation (EC) No 1493/1999)

2009/C 178/08

Owing to technical reasons, the above mentioned list will be published in OJ C 187 on 8 August 2009.

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Council

| 31.7.2009 | EN | Official Journal of the European Union | C 178/12 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/12

---

COUNCIL DECISION

of 27 July 2009

appointing one member to the Management Board of the European Chemicals Agency

2009/C 178/09

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (1), and in particular Article 79 thereof,

Whereas:

| (1) | Article 79 of Regulation (EC) No 1907/2006 provides that the Council should appoint as Members to the Management Board of the European Chemicals Agency one representative from each Member State. |
| --- | --- |

(1)

Article 79 of Regulation (EC) No 1907/2006 provides that the Council should appoint as Members to the Management Board of the European Chemicals Agency one representative from each Member State.

| (2) | By Decision of 7 June 2007 (2) the Council appointed 27 members to the Management Board of the European Chemicals Agency. |
| --- | --- |

(2)

By Decision of 7 June 2007 (2) the Council appointed 27 members to the Management Board of the European Chemicals Agency.

| (3) | The French government has informed the Council of its intention to replace the French representative on the Management Board and has submitted a nomination for a new representative, who should be appointed for a period which runs until 31 May 2013, |
| --- | --- |

(3)

The French government has informed the Council of its intention to replace the French representative on the Management Board and has submitted a nomination for a new representative, who should be appointed for a period which runs until 31 May 2013,

HAS DECIDED AS FOLLOWS:

Article 1

Ms Catherine MIR of French nationality, born on 20 February 1955, shall be appointed to the Management Board of the European Chemicals Agency in place of Ms Odile GAUTHIER for the period from 1 August 2009 to 31 May 2013.

Article 2

This Decision shall be published in the Official Journal of the European Union.

Done at Brussels, 27 July 2009.

For the Council

The President

C. BILDT

---

(1)  OJ L 396, 30.12.2006, p. 1.

1

(2)  OJ C 134, 16.6.2007, p. 6.

2

---

| 31.7.2009 | EN | Official Journal of the European Union | C 178/13 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/13

---

COUNCIL DECISION

of 27 July 2009

appointing one member to the Management Board of the European Chemicals Agency

2009/C 178/10

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (1), and in particular Article 79 thereof,

Whereas:

| (1) | Article 79 of Regulation (EC) No 1907/2006 provides that the Council should appoint as Members to the Management Board of the European Chemicals Agency one representative from each Member State. |
| --- | --- |

(1)

Article 79 of Regulation (EC) No 1907/2006 provides that the Council should appoint as Members to the Management Board of the European Chemicals Agency one representative from each Member State.

| (2) | By Decision of 7 June 2007 (2) the Council appointed 27 members to the Management Board of the European Chemicals Agency. |
| --- | --- |

(2)

By Decision of 7 June 2007 (2) the Council appointed 27 members to the Management Board of the European Chemicals Agency.

| (3) | The Netherlands government has informed the Council of its intention to replace the Dutch representative on the Management Board and has submitted a nomination for a new representative, who should be appointed for a period which runs until 31 May 2013, |
| --- | --- |

(3)

The Netherlands government has informed the Council of its intention to replace the Dutch representative on the Management Board and has submitted a nomination for a new representative, who should be appointed for a period which runs until 31 May 2013,

HAS DECIDED AS FOLLOWS:

Article 1

Mr Johannes Karel Barend Henri KWISTHOUT of Dutch nationality, born on 6 June 1964, shall be appointed to the Management Board of the European Chemicals Agency in place of Dr Arnoldus Wilhelmus VAN DER WIELEN for the period from 1 August 2009 to 31 May 2013.

Article 2

This Decision shall be published in the Official Journal of the European Union.

Done at Brussels, 27 July 2009.

For the Council

The President

C. BILDT

---

(1)  OJ L 396, 30.12.2006, p. 1.

1

(2)  OJ C 134, 16.6.2007, p. 6.

2

---

Commission

| 31.7.2009 | EN | Official Journal of the European Union | C 178/14 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/14

---

Euro exchange rates (1)

30 July 2009

2009/C 178/11

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,4053 |
| JPY | Japanese yen | 133,89 |
| DKK | Danish krone | 7,4453 |
| GBP | Pound sterling | 0,85240 |
| SEK | Swedish krona | 10,4515 |
| CHF | Swiss franc | 1,5314 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 8,7490 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 25,581 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 268,31 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7014 |
| PLN | Polish zloty | 4,1775 |
| RON | Romanian leu | 4,2070 |
| TRY | Turkish lira | 2,0861 |
| AUD | Australian dollar | 1,7042 |
| CAD | Canadian dollar | 1,5240 |
| HKD | Hong Kong dollar | 10,8911 |
| NZD | New Zealand dollar | 2,1555 |
| SGD | Singapore dollar | 2,0296 |
| KRW | South Korean won | 1 735,50 |
| ZAR | South African rand | 11,0079 |
| CNY | Chinese yuan renminbi | 9,6014 |
| HRK | Croatian kuna | 7,3615 |
| IDR | Indonesian rupiah | 13 989,56 |
| MYR | Malaysian ringgit | 4,9628 |
| PHP | Philippine peso | 67,602 |
| RUB | Russian rouble | 44,5060 |
| THB | Thai baht | 47,857 |
| BRL | Brazilian real | 2,6495 |
| MXN | Mexican peso | 18,6483 |
| INR | Indian rupee | 67,8900 |

Currency

Exchange rate

USD

US dollar

1,4053

JPY

Japanese yen

133,89

DKK

Danish krone

7,4453

GBP

Pound sterling

0,85240

SEK

Swedish krona

10,4515

CHF

Swiss franc

1,5314

ISK

Iceland króna

NOK

Norwegian krone

8,7490

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

25,581

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

268,31

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7014

PLN

Polish zloty

4,1775

RON

Romanian leu

4,2070

TRY

Turkish lira

2,0861

AUD

Australian dollar

1,7042

CAD

Canadian dollar

1,5240

HKD

Hong Kong dollar

10,8911

NZD

New Zealand dollar

2,1555

SGD

Singapore dollar

2,0296

KRW

South Korean won

1 735,50

ZAR

South African rand

11,0079

CNY

Chinese yuan renminbi

9,6014

HRK

Croatian kuna

7,3615

IDR

Indonesian rupiah

13 989,56

MYR

Malaysian ringgit

4,9628

PHP

Philippine peso

67,602

RUB

Russian rouble

44,5060

THB

Thai baht

47,857

BRL

Brazilian real

2,6495

MXN

Mexican peso

18,6483

INR

Indian rupee

67,8900

---

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

---

| 31.7.2009 | EN | Official Journal of the European Union | C 178/15 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/15

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009

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

2009/C 178/12

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code
  (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 10.6.2009 | Renvela | Sevelamer (carbonate) | Genzyme Europe B.V. |
| Gooimeer 10 |
| 1411 DD Naarden |
| NEDERLAND |

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

10.6.2009

Renvela

Sevelamer (carbonate)

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/09/521/001-003

EU/1/09/521/004-007

Film-coated tablet

Powder for oral suspension

V03AE02

12.6.2009

12.6.2009

PANTOLOC Control

Pantoprazole

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2 |
| 78467 Konstanz |
| DEUTSCHLAND |

Nycomed GmbH

Byk-Gulden-Str. 2

78467 Konstanz

DEUTSCHLAND

EU/1/09/519/001-004

Gastro-resistant tablet

A02BC02

16.6.2009

12.6.2009

PANTOZOL Control

Pantoprazole

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2 |
| 78467 Konstanz |
| DEUTSCHLAND |

Nycomed GmbH

Byk-Gulden-Str. 2

78467 Konstanz

DEUTSCHLAND

EU/1/09/517/001-004

Gastro-resistant tablet

A02BC02

16.6.2009

12.6.2009

PANTECTA Control

Pantoprazole

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2 |
| 78467 Konstanz |
| DEUTSCHLAND |

Nycomed GmbH

Byk-Gulden-Str. 2

78467 Konstanz

DEUTSCHLAND

EU/1/09/518/001-004

Gastro-resistant tablet

A02BC02

16.6.2009

12.6.2009

CONTROLOC Control

Pantoprazole

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2 |
| 78467 Konstanz |
| DEUTSCHLAND |

Nycomed GmbH

Byk-Gulden-Str. 2

78467 Konstanz

DEUTSCHLAND

EU/1/09/515/001-004

Gastro-resistant tablet

A02BC02

16.6.2009

12.6.2009

SOMAC Control

Pantoprazole

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2 |
| 78467 Konstanz |
| DEUTSCHLAND |

Nycomed GmbH

Byk-Gulden-Str. 2

78467 Konstanz

DEUTSCHLAND

EU/1/09/516/001-004

Gastro-resistant tablet

A02BC02

16.6.2009

24.6.2009

IRESSA

Gefitinib

| AstraZeneca AB |
| --- |
| SE-151 85 Sodertalje |
| SVERIGE |

AstraZeneca AB

SE-151 85 Sodertalje

SVERIGE

EU/1/09/526/001

Film-coated tablet

L01XE02

26.6.2009

29.6.2009

Repaglinide Teva

Repaglinide

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/530/001-015

Tablet

A10BX02

1.7.2009

30.6.2009

Victoza

Liraglutide

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

Novo Nordisk A/S

Novo Allé

2880 Bagsvaerd

DANMARK

EU/1/09/529/001-005

Solution for injection in pre-filled pen

A10BX07

2.7.2009

—   Modification of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.6.2009 | Avamys | Glaxo Group Ltd |
| Greenford |
| Middlesex |
| UB6 0NN |
| UNITED KINGDOM |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

2.6.2009

Avamys

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/07/434/001-003

5.6.2009

2.6.2009

Alisade

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

Glaxo Group Ltd

Greenford

Middlesex

UB6 ONN

UNITED KINGDOM

EU/1/08/474/001-003

5.6.2009

2.6.2009

Ketek

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

Aventis Pharma S.A.

20 avenue Raymond Aron

92160 Antony

FRANCE

EU/1/01/191/001-005

5.6.2009

2.6.2009

Stocrin

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

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/99/111/001-005

EU/1/99/111/008-011

5.6.2009

2.6.2009

Velmetia

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

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/08/456/001-016

5.6.2009

2.6.2009

Ferriprox

| Apotex Europe B.V. |
| --- |
| Darwingweg 20 |
| 2333 CR Leiden |
| NEDERLAND |

Apotex Europe B.V.

Darwingweg 20

2333 CR Leiden

NEDERLAND

EU/1/99/108/001-003

4.6.2009

2.6.2009

Januvia

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

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/383/001-018

5.6.2009

2.6.2009

Janumet

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

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/08/455/001-016

5.6.2009

2.6.2009

Silgard

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

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/06/358/001-021

4.6.2009

2.6.2009

Sustiva

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/99/110/001-005

EU/1/99/110/008-010

5.6.2009

2.6.2009

Efficib

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

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/08/457/001-016

5.6.2009

4.6.2009

Avandamet

| SmithKline Beecham plc |
| --- |
| 980 Great West Road |
| Brentford |
| Middlesex |
| TW8 9GS |
| UNITED KINGDOM |

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

UNITED KINGDOM

EU/1/03/258/001-022

8.6.2009

4.6.2009

Ovitrelle

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

Serono Europe Limited

56 Marsh Wall

London

E14 9TP

UNITED KINGDOM

EU/1/00/165/001-007

8.6.2009

8.6.2009

Tasigna

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/422/001-004

10.6.2009

8.6.2009

Ziagen

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

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/99/112/001-002

10.6.2009

8.6.2009

Pergoveris

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

Serono Europe Limited

56 Marsh Wall

London

E14 9TP

UNITED KINGDOM

EU/1/07/396/001-003

10.6.2009

8.6.2009

Baraclude

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/06/343/001-007

10.6.2009

8.6.2009

REYATAZ

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/03/267/001-010

10.6.2009

8.6.2009

Abilify

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

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex

UB8 1HU

UNITED KINGDOM

EU/1/04/276/001-020

EU/1/04/276/024-036

10.6.2009

8.6.2009

Kivexa

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

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/04/298/001-003

10.6.2009

9.6.2009

GONAL-f

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

Serono Europe Limited

56 Marsh Wall

London

E14 9TP

UNITED KINGDOM

EU/1/95/001/001

EU/1/95/001/003-005

EU/1/95/001/009

EU/1/95/001/012

EU/1/95/001/021-022

EU/1/95/001/025-028

EU/1/95/001/031-035

11.6.2009

17.6.2009

Erbitux

| Merck KGaA |
| --- |
| Frankfurter Straße 250 |
| 64271 Darmstadt |
| DEUTSCHLAND |

Merck KGaA

Frankfurter Straße 250

64271 Darmstadt

DEUTSCHLAND

EU/1/04/281/001-005

19.6.2009

17.6.2009

Lucentis

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/06/374/001

19.6.2009

18.6.2009

Vivanza

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

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

| Bayer AG |
| --- |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer AG

51368 Leverkusen

DEUTSCHLAND

EU/1/03/249/001-012

22.6.2009

18.6.2009

Vasovist

| TMC Pharma Services Ltd |
| --- |
| Eversley |
| Hampshire |
| RG27 0NT |
| UNITED KINGDOM |

TMC Pharma Services Ltd

Eversley

Hampshire

RG27 0NT

UNITED KINGDOM

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

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/05/313/001-009

22.6.2009

18.6.2009

Angiox

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

The Medicines Company UK Ltd

115 L Milton Park

Abingdon

Oxfordshire

OX14 4SA

UNITED KINGDOM

EU/1/04/289/001-002

22.6.2009

18.6.2009

Emtriva

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

Gilead Sciences International Limited

Cambridge

CB21 6GT

UNITED KINGDOM

EU/1/03/261/001-002

22.6.2009

22.6.2009

Aclasta

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/05/308/001-002

24.6.2009

22.6.2009

Yondelis

| Pharma Mar, S.A. |
| --- |
| Avda. de los Reyes 1 |
| Polígono Industrial La Mina |
| 28770 Colmenar Viejo Madrid |
| ESPAÑA |

Pharma Mar, S.A.

Avda. de los Reyes 1

Polígono Industrial La Mina

28770 Colmenar Viejo Madrid

ESPAÑA

EU/1/07/417/001-002

24.6.2009

22.6.2009

Levitra

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

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

| Bayer AG |
| --- |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer AG

51368 Leverkusen

DEUTSCHLAND

EU/1/03/248/001-012

25.6.2009

23.6.2009

Ebixa

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

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

DANMARK

EU/1/02/219/001-049

25.6.2009

23.6.2009

Prezista

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

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/06/380/004-005

25.6.2009

23.6.2009

Prezista

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

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/06/380/001-002

25.6.2009

23.6.2009

Yondelis

| Pharma Mar, S.A. |
| --- |
| Avda. de los Reyes, 1 |
| Polígono Industrial La Mina |
| 28770 Colmenar Viejo Madrid |
| ESPAÑA |

Pharma Mar, S.A.

Avda. de los Reyes, 1

Polígono Industrial La Mina

28770 Colmenar Viejo Madrid

ESPAÑA

EU/1/07/417/001-002

25.6.2009

23.6.2009

Aptivus

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

Boehringer Ingelheim International GmbH

Binger Straße 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/05/315/002

25.6.2009

23.6.2009

Aptivus

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

Boehringer Ingelheim International GmbH

Binger Straße 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/05/315/001

25.6.2009

24.6.2009

Ariclaim

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| NEDERLAND |

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/04/283/008-012

26.6.2009

24.6.2009

YENTREVE

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| NEDERLAND |

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/04/280/001-008

26.6.2009

24.6.2009

Xeristar

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

Boehringer Ingelheim International GmbH

Binger Straße 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/04/297/001-008

29.6.2009

24.6.2009

Neupro

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

Schwarz Pharma Ltd

Shannon

Industrial Estate

Co. Clare

IRELAND

EU/1/05/331/001-055

26.6.2009

24.6.2009

Cymbalta

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| NEDERLAND |

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/04/296/001-009

26.6.2009

24.6.2009

Axura

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

Merz Pharmaceuticals GmbH

Eckenheimer Landstr. 100-104

60318 Frankfurt/Main

DEUTSCHLAND

EU/1/02/218/001-029

26.6.2009

29.6.2009

RotaTeq

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

Sanofi Pasteur MSD, SNC

8 rue Jonas Salk

69007 Lyon

FRANCE

EU/1/06/348/001-002

2.7.2009

29.6.2009

Yttriga

| Nuclitec GmbH |
| --- |
| Gieselweg 1 |
| 38110 Braunschweig |
| DEUTSCHLAND |

Nuclitec GmbH

Gieselweg 1

38110 Braunschweig

DEUTSCHLAND

EU/1/05/322/001

1.7.2009

29.6.2009

Kepivance

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

Biovitrum AB (publ)

SE-112 76 Stockholm

SVERIGE

EU/1/05/314/001

2.7.2009

29.6.2009

Effentora

| Cephalon Europe |
| --- |
| 5 rue Charles Martigny |
| 94700 Maisons-Alfort |
| FRANCE |

Cephalon Europe

5 rue Charles Martigny

94700 Maisons-Alfort

FRANCE

EU/1/08/441/001-010

1.7.2009

30.6.2009

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

2.7.2009

30.6.2009

Hepsera

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

Gilead Sciences International Limited

Cambridge

CB21 6GT

UNITED KINGDOM

EU/1/03/251/001-002

2.7.2009

30.6.2009

Kineret

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

Biovitrum AB (publ)

SE-112 76 Stockholm

SVERIGE

EU/1/02/203/001-004

2.7.2009

30.6.2009

Ariclaim

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| NEDERLAND |

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/04/283/008-012

2.7.2009

30.6.2009

BeneFIX

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

Wyeth Europa Ltd

Huntercombe Lane South

Taplow

Maidenhead

Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/97/047/001-007

2.7.2009

—   Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 9.6.2009 | Raptiva | Serono Europe Limited |
| 56 Marsh Wall |
| London |
| E14 9TP |
| UNITED KINGDOM |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

9.6.2009

Raptiva

Serono Europe Limited

56 Marsh Wall

London

E14 9TP

UNITED KINGDOM

EU/1/04/291/001-003

11.6.2009

—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (2)
  ): Accepted

| Date of the decision | Name of the medicinal product | INN
  (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code
  (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.6.2009 | Leucogen | | Virbac |
| 1ère avenue |
| 2065 m L.I.D. |
| 06516 Carros Cedex |
| FRANCE |

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

17.6.2009

Leucogen

Virbac

1ère avenue

2065 m L.I.D.

06516 Carros Cedex

FRANCE

EU/2/09/096/001-002

Suspension for injection

QI06AA01

19.6.2009

25.6.2009

Leucofeligen FeLV/RCP

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

Virbac

1ère avenue

2065 m L.I.D.

06516 Carros Cedex

FRANCE

EU/2/09/097/001-002

Lyophilisate and solvent for suspension for injection

QI06AH07

29.6.2009

—   Modification of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.6.2009 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea |
| Co. Galway |
| IRELAND |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

4.6.2009

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea

Co. Galway

IRELAND

EU/2/07/078/001-004

8.6.2009

8.6.2009

Circovac

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

Merial

29 avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/07/075/001-004

10.6.2009

22.6.2009

ProMeris

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

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

NEDERLAND

EU/2/06/064/001-004

25.6.2009

30.6.2009

Posatex

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

| S-P Veterinary |
| --- |
| Shire Park |
| Welwyn Garden City |
| Hertfordshire |
| AL7 1TW |
| UNITED KINGDOM |

S-P Veterinary

Shire Park

Welwyn Garden City

Hertfordshire

AL7 1TW

UNITED KINGDOM

EU/2/08/081/001-003

2.7.2009

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

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

The European Medicines Agency

7 Westferry Circus

Canary Wharf

London

E14 4HB

UNITED KINGDOM

---

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

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

---

| 31.7.2009 | EN | Official Journal of the European Union | C 178/24 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/24

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009

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

2009/C 178/13

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 2.6.2009 | Betavert N | See Annex I | See Annex I | 3.6.2009 |
| 10.6.2009 | Renvela | Genzyme Europe B.V. |
| Gooimeer 10 |
| 1411 DD Naarden |
| NEDERLAND |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

2.6.2009

Betavert N

See Annex I

See Annex I

3.6.2009

10.6.2009

Renvela

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

This Decision is addressed to the Member States

11.6.2009

22.6.2009

Aclasta

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

This Decision is addressed to the Member States

24.6.2009

---

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

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

---

ANNEX I

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

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of Administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | | HENNIG ARZNEIMITTEL |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of Administration

Austria

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertimen 8 mg Tabletten

8 mg

tablet

oral use

Austria

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertimen 16 mg Tabletten

16 mg

tablet

oral use

Bulgaria

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertisan 8 mg Таблетка

8 mg

tablet

oral use

Bulgaria

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertisan 16 mg Таблетка

16 mg

tablet

oral use

Czech Republic

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertisan® 8 mg Tableta

8 mg

tablet

oral use

Czech Republic

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertisan® 16 mg Tableta

16 mg

tablet

oral use

Germany

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Betavert® N 8 mg Tabletten

8 mg

tablet

oral use

Germany

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Betavert® N 16 mg Tabletten

16 mg

tablet

oral use

Hungary

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertisan® N 8 mg Tabletta

8 mg

tablet

oral use

Hungary

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertisan® N 16 mg Tabletta

16 mg

tablet

oral use

Poland

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertisan 8

8 mg

tablet

oral use

Poland

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertisan 16

16 mg

tablet

oral use

Romania

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertisan® 8 mg Comprimate

8 mg

tablet

oral use

Romania

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertisan® 16 mg Comprimate

16 mg

tablet

oral use

Slovak Republic

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertisan® 8 mg Tablety

8 mg

tablet

oral use

Slovak Republic

| HENNIG ARZNEIMITTEL |
| --- |
| GmbH & Co. KG |
| Liebigstraße 1—2 |
| 65439 Flörsheim/Main |
| DEUTSCHLAND |

HENNIG ARZNEIMITTEL

GmbH & Co. KG

Liebigstraße 1—2

65439 Flörsheim/Main

DEUTSCHLAND

Vertisan® 16 mg Tablety

16 mg

tablet

oral use

---

V Announcements

ADMINISTRATIVE PROCEDURES

Commission

| 31.7.2009 | EN | Official Journal of the European Union | C 178/28 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/28

---

ESPON 2013 programme — New open calls

2009/C 178/14

In the framework of the ESPON 2013 programme, calls for proposals and expression of interest will be launched on 16 September 2009.

Please visit www.espon.eu for more detailed information.

---

Corrigenda

| 31.7.2009 | EN | Official Journal of the European Union | C 178/29 |
| --- | --- | --- | --- |

31.7.2009

EN

Official Journal of the European Union

C 178/29

---

Corrigendum to Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections

(
  Official Journal of the European Union C 173 of 25 July 2009
  )

2009/C 178/15

On page 1, ‘Reference number of State Aid’:

for:

‘N 59/03 (ex N 667/02 and N 665/02)’,

read:

‘NN 59/03 (ex N 667/02 and N 665/02)’.

---