# Official Journal C 260/2009

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2009.260.eng |
| --- | --- |
| Official Journal
  of the European Union | C 260 |
| | |
| English edition | Information and Notices | Volume 5230 October 2009 |

ISSN 1725-2423

doi:10.3000/17252423.C_2009.260.eng

Official Journal

of the European Union

C 260

English edition

Information and Notices

Volume 5230 October 2009

---

| Notice No | Contents | page |
| --- | --- | --- |
| | I   Resolutions, recommendations and opinions |
| | RESOLUTIONS |
| | Council |
| 2009/C 260/01 | Council Resolution of 23 October 2009 on a reinforced strategy for customs cooperation | 1 |

Notice No

Contents

page

I   Resolutions, recommendations and opinions

RESOLUTIONS

Council

2009/C 260/01

Council Resolution of 23 October 2009 on a reinforced strategy for customs cooperation

1

| | II   Information |
| --- | --- |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 260/02 | Non-opposition to a notified concentration (Case COMP/M.5602 — RREEF FUND/BP/EVE/REPSOL/BBG) (
  1
  ) | 4 |

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 260/02

Non-opposition to a notified concentration (Case COMP/M.5602 — RREEF FUND/BP/EVE/REPSOL/BBG) (
  1
  )

1

4

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 260/03 | Euro exchange rates | 5 |
| 2009/C 260/04 | Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 September 2009 to 30 September 2009(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 6 |
| 2009/C 260/05 | Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 May 2009 to 31 May 2009(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  ) | 15 |
| | NOTICES FROM MEMBER STATES |
| 2009/C 260/06 | Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 1857/2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001 | 31 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 260/03

Euro exchange rates

5

2009/C 260/04

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

)

6

2009/C 260/05

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 May 2009 to 31 May 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

)

15

NOTICES FROM MEMBER STATES

2009/C 260/06

Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 1857/2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001

31

| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2009/C 260/07 | Prior notification of a concentration (Case COMP/M.5640 — SCF/AIG Bank/AIG Credit) — Candidate case for simplified procedure (
  1
  ) | 35 |
| 2009/C 260/08 | Prior notification of a concentration (Case COMP/M.5596 — Magna/Sberbank/GM/Opel) (
  1
  ) | 36 |
| 2009/C 260/09 | Prior notification of a concentration (Case COMP/M.5647 — ADVENT/GFKL) — Candidate case for simplified procedure (
  1
  ) | 37 |
| | OTHER ACTS |
| | Commission |
| 2009/C 260/10 | Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs | 38 |
| 2009/C 260/11 | Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs | 43 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2009/C 260/07

Prior notification of a concentration (Case COMP/M.5640 — SCF/AIG Bank/AIG Credit) — Candidate case for simplified procedure (
  1
  )

1

35

2009/C 260/08

Prior notification of a concentration (Case COMP/M.5596 — Magna/Sberbank/GM/Opel) (
  1
  )

1

36

2009/C 260/09

Prior notification of a concentration (Case COMP/M.5647 — ADVENT/GFKL) — Candidate case for simplified procedure (
  1
  )

1

37

OTHER ACTS

Commission

2009/C 260/10

Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs

38

2009/C 260/11

Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs

43

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

---

(1)   Text with EEA relevance

1

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

EN

---

I Resolutions, recommendations and opinions

RESOLUTIONS

Council

| 30.10.2009 | EN | Official Journal of the European Union | C 260/1 |
| --- | --- | --- | --- |

30.10.2009

EN

Official Journal of the European Union

C 260/1

---

COUNCIL RESOLUTION

of 23 October 2009

on a reinforced strategy for customs cooperation

2009/C 260/01

THE COUNCIL OF THE EUROPEAN UNION,

RECALLING:

| 1. | Articles 29 and 30 of the Treaty on European Union; |
| --- | --- |

1.

Articles 29 and 30 of the Treaty on European Union;

| 2. | the Hague Programme (1), adopted by the European Council in November 2004, which sets the objectives to be implemented in the area of freedom, security and justice in the period 2005-2009; |
| --- | --- |

2.

the Hague Programme (1), adopted by the European Council in November 2004, which sets the objectives to be implemented in the area of freedom, security and justice in the period 2005-2009;

| 3. | the Communication of 10 June 2009 from the Commission to the European Parliament and the Council on an area of freedom, security and justice serving the citizen (2); |
| --- | --- |

3.

the Communication of 10 June 2009 from the Commission to the European Parliament and the Council on an area of freedom, security and justice serving the citizen (2);

| 4. | that a new multi-annual programme on an area of freedom, security and justice for the period 2010-2014 is under consideration in Council; |
| --- | --- |

4.

that a new multi-annual programme on an area of freedom, security and justice for the period 2010-2014 is under consideration in Council;

| 5. | the Council Resolution of 2 October 2003 on a Strategy for Customs Cooperation (3); and its implementation ensured by means of consecutive action plans; |
| --- | --- |

5.

the Council Resolution of 2 October 2003 on a Strategy for Customs Cooperation (3); and its implementation ensured by means of consecutive action plans;

| 6. | the Council Conclusions of 14 May 2008 on the Strategy for the Evolution of the Customs Union; |
| --- | --- |

6.

the Council Conclusions of 14 May 2008 on the Strategy for the Evolution of the Customs Union;

| 7. | Council Regulation (EC) No 2007/2004 of 26 October 2004 establishing a European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (4); |
| --- | --- |

7.

Council Regulation (EC) No 2007/2004 of 26 October 2004 establishing a European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (4);

| 8. | Council Decision 2002/187/JHA of 28 February 2002 setting up Eurojust with a view to reinforcing the fight against serious crime (5); |
| --- | --- |

8.

Council Decision 2002/187/JHA of 28 February 2002 setting up Eurojust with a view to reinforcing the fight against serious crime (5);

| 9. | Council Decision 2009/371/JHA of 6 April 2009 establishing the European Police Office (Europol) (6); |
| --- | --- |

9.

Council Decision 2009/371/JHA of 6 April 2009 establishing the European Police Office (Europol) (6);

| 10. | the Council Conclusions of 12 October 2005 on intelligence-led policing and the development of the Organised Crime Threat Assessment (OCTA); |
| --- | --- |

10.

the Council Conclusions of 12 October 2005 on intelligence-led policing and the development of the Organised Crime Threat Assessment (OCTA);

| 11. | the EU Drugs Strategy for the period 2005-2012 and the EU Drugs Action Plan for 2009-2012 (7); |
| --- | --- |

11.

the EU Drugs Strategy for the period 2005-2012 and the EU Drugs Action Plan for 2009-2012 (7);

| 12. | that the European Union has concluded relevant agreements and common strategies with third countries with a particular emphasis on those bordering the Union, |
| --- | --- |

12.

that the European Union has concluded relevant agreements and common strategies with third countries with a particular emphasis on those bordering the Union,

RECOGNISING:

| 1. | that the customs authorities of the Member States play a crucial role in the fight against cross border illicit trafficking in goods, being the first firewall between these illegal activities and the citizens of the Union, and that strong cooperation between the customs authorities and between them and other competent authorities is indispensable for the fulfilment of their tasks; |
| --- | --- |

1.

that the customs authorities of the Member States play a crucial role in the fight against cross border illicit trafficking in goods, being the first firewall between these illegal activities and the citizens of the Union, and that strong cooperation between the customs authorities and between them and other competent authorities is indispensable for the fulfilment of their tasks;

| 2. | that the need for a strategic framework laying down the objectives for the multi-national and multi-agency approach to customs cooperation remains; |
| --- | --- |

2.

that the need for a strategic framework laying down the objectives for the multi-national and multi-agency approach to customs cooperation remains;

| 3. | the changes in the European Union legal framework, including the introduction of new and improved legislation regarding in particular information exchange and cross-border cooperation in order to further enhance the fight against cross-border crime and terrorism, since the adoption of the current Strategy for Customs Cooperation and the consequent need for its revision; |
| --- | --- |

3.

the changes in the European Union legal framework, including the introduction of new and improved legislation regarding in particular information exchange and cross-border cooperation in order to further enhance the fight against cross-border crime and terrorism, since the adoption of the current Strategy for Customs Cooperation and the consequent need for its revision;

| 4. | that cross-border organised crime and terrorism have evolved since 2003 and have become more sophisticated and global, and that the customs authorities, through the use of new forms of cooperation, play an active role in the fight against these threats to the European Union and its citizens; |
| --- | --- |

4.

that cross-border organised crime and terrorism have evolved since 2003 and have become more sophisticated and global, and that the customs authorities, through the use of new forms of cooperation, play an active role in the fight against these threats to the European Union and its citizens;

| 5. | that there is a need to further strengthen the cooperation with relevant European Union and Community agencies and bodies such as Europol, Eurojust, OLAF and FRONTEX; |
| --- | --- |

5.

that there is a need to further strengthen the cooperation with relevant European Union and Community agencies and bodies such as Europol, Eurojust, OLAF and FRONTEX;

| 6. | the need for a closer and more effective cooperation between Member States’ customs authorities and competent authorities in third countries, especially those neighbouring the European Union, and with relevant international organisations, |
| --- | --- |

6.

the need for a closer and more effective cooperation between Member States’ customs authorities and competent authorities in third countries, especially those neighbouring the European Union, and with relevant international organisations,

NOTES WITH SATISFACTION:

| 1. | the progress that has been achieved by the implementation of the 2003 Strategy for Customs Cooperation and the subsequent work carried out in the Council's Customs Cooperation Working Party; |
| --- | --- |

1.

the progress that has been achieved by the implementation of the 2003 Strategy for Customs Cooperation and the subsequent work carried out in the Council's Customs Cooperation Working Party;

| 2. | that customs cooperation continues to evolve through the use of the Naples II Convention and the Customs Information System, including the customs files identification database; |
| --- | --- |

2.

that customs cooperation continues to evolve through the use of the Naples II Convention and the Customs Information System, including the customs files identification database;

| 3. | that the results of Joint Customs Operations and the regional operations carried out by customs authorities and other law enforcement authorities provide a good basis for the development of working methods and ways to share information and intelligence, involving also third countries, and actively contribute to the creation of an area of freedom, security and justice; |
| --- | --- |

3.

that the results of Joint Customs Operations and the regional operations carried out by customs authorities and other law enforcement authorities provide a good basis for the development of working methods and ways to share information and intelligence, involving also third countries, and actively contribute to the creation of an area of freedom, security and justice;

| 4. | the closer cooperation and coordination between the Council's Customs Cooperation Working Party, FRONTEX and the Police Chiefs Task Force in operational matters; |
| --- | --- |

4.

the closer cooperation and coordination between the Council's Customs Cooperation Working Party, FRONTEX and the Police Chiefs Task Force in operational matters;

| 5. | the efforts to develop an EU Information Management Strategy for Justice and Home Affairs, which will make the exchange of information between law enforcement agencies and bodies more effective and secure, |
| --- | --- |

5.

the efforts to develop an EU Information Management Strategy for Justice and Home Affairs, which will make the exchange of information between law enforcement agencies and bodies more effective and secure,

HEREBY RESOLVES:

| 1. | to continue to strengthen and develop the cooperation between the customs authorities and other competent authorities, as well as with European Union and Community agencies and bodies, to ensure that citizens of the Union, society and the economy are better protected against threats from cross-border crime by means of a new and updated strategy. The cooperation should be based on, but not limited to, the following aims:






  (a) | to consider new forms of cooperation and new investigative techniques in order to protect citizens of the European Union and the economy; |
| --- | --- | --- |

1.

to continue to strengthen and develop the cooperation between the customs authorities and other competent authorities, as well as with European Union and Community agencies and bodies, to ensure that citizens of the Union, society and the economy are better protected against threats from cross-border crime by means of a new and updated strategy. The cooperation should be based on, but not limited to, the following aims:

(a)

to consider new forms of cooperation and new investigative techniques in order to protect citizens of the European Union and the economy;

| (b) | to take practical steps towards implementing these new forms of cooperation and to continue to further develop existing forms of cooperation, e.g. by improving operational cooperation, maximising the effectiveness of customs at the external borders of the European Union, adopting an institutional approach based on cooperation between customs, police and other relevant authorities, in order to ensure synergy and to further develop relevant IT systems; and |
| --- | --- |

(b)

to take practical steps towards implementing these new forms of cooperation and to continue to further develop existing forms of cooperation, e.g. by improving operational cooperation, maximising the effectiveness of customs at the external borders of the European Union, adopting an institutional approach based on cooperation between customs, police and other relevant authorities, in order to ensure synergy and to further develop relevant IT systems; and

| (c) | to improve and make more flexible the existing cooperation process with a view to achieving an effective approach to combating cross-border organised crime and the seizure of illicit goods throughout the European Union, |
| --- | --- |

(c)

to improve and make more flexible the existing cooperation process with a view to achieving an effective approach to combating cross-border organised crime and the seizure of illicit goods throughout the European Union,

| 2. | to continue to establish and implement a detailed action plan in order to fulfil the overall aims and objectives of this strategy, taking due account of the priorities of the new multi-annual programme on an area of freedom, security and justice for the period 2010-2014, |
| --- | --- |

2.

to continue to establish and implement a detailed action plan in order to fulfil the overall aims and objectives of this strategy, taking due account of the priorities of the new multi-annual programme on an area of freedom, security and justice for the period 2010-2014,

INVITES:

| 1. | customs authorities, other competent authorities of the Member States and the competent European Union and Community agencies and bodies responsible for the implementation of customs legislation to continue to implement this strategy; |
| --- | --- |

1.

customs authorities, other competent authorities of the Member States and the competent European Union and Community agencies and bodies responsible for the implementation of customs legislation to continue to implement this strategy;

| 2. | customs authorities and other law enforcement authorities of the Member States and the competent European Union and Community agencies and bodies to continue to do their utmost to strengthen and further develop cooperation with each other and with third countries in the fields of prevention, detection, investigation, and prosecution of cross-border criminal activities; |
| --- | --- |

2.

customs authorities and other law enforcement authorities of the Member States and the competent European Union and Community agencies and bodies to continue to do their utmost to strengthen and further develop cooperation with each other and with third countries in the fields of prevention, detection, investigation, and prosecution of cross-border criminal activities;

| 3. | the Commission to make its expertise, technical and logistical assistance, training or communication activity or any other operational support available to the Member States in the performance of their duties in the framework of the implementation of the customs cooperation provided for by Articles 29 and 30 of the Treaty on European Union and to continue to provide, to the maximum possible extent, its financial support for the implementation of this strategy. |
| --- | --- |

3.

the Commission to make its expertise, technical and logistical assistance, training or communication activity or any other operational support available to the Member States in the performance of their duties in the framework of the implementation of the customs cooperation provided for by Articles 29 and 30 of the Treaty on European Union and to continue to provide, to the maximum possible extent, its financial support for the implementation of this strategy.

This Resolution replaces the Resolution of 2 October 2003 on a Strategy for Customs Cooperation.

---

(1)  OJ C 53, 3.3.2005, p. 1.

(2)  COM(2009) 262 final.

(3)  OJ C 247, 15.10.2003, p. 1.

(4)  OJ L 349, 25.11.2004, p. 1.

(5)  OJ L 63, 6.3.2002, p. 1.

(6)  OJ L 121, 15.5.2009, p. 37.

(7)  OJ C 326, 20.12.2008, p. 7.

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 30.10.2009 | EN | Official Journal of the European Union | C 260/4 |
| --- | --- | --- | --- |

30.10.2009

EN

Official Journal of the European Union

C 260/4

---

Non-opposition to a notified concentration

(Case COMP/M.5602 — RREEF FUND/BP/EVE/REPSOL/BBG)

(Text with EEA relevance)

2009/C 260/02

On 9 October 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 32009M5602. 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 32009M5602. EUR-Lex is the on-line access to the European law.

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 30.10.2009 | EN | Official Journal of the European Union | C 260/5 |
| --- | --- | --- | --- |

30.10.2009

EN

Official Journal of the European Union

C 260/5

---

Euro exchange rates (1)

29 October 2009

2009/C 260/03

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,4788 |
| JPY | Japanese yen | 135,13 |
| DKK | Danish krone | 7,4433 |
| GBP | Pound sterling | 0,89750 |
| SEK | Swedish krona | 10,3359 |
| CHF | Swiss franc | 1,5109 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 8,3835 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 26,495 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 272,95 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7090 |
| PLN | Polish zloty | 4,2565 |
| RON | Romanian leu | 4,3090 |
| TRY | Turkish lira | 2,2145 |
| AUD | Australian dollar | 1,6276 |
| CAD | Canadian dollar | 1,5865 |
| HKD | Hong Kong dollar | 11,4609 |
| NZD | New Zealand dollar | 2,0305 |
| SGD | Singapore dollar | 2,0676 |
| KRW | South Korean won | 1 763,31 |
| ZAR | South African rand | 11,5005 |
| CNY | Chinese yuan renminbi | 10,0972 |
| HRK | Croatian kuna | 7,2350 |
| IDR | Indonesian rupiah | 14 188,12 |
| MYR | Malaysian ringgit | 5,0649 |
| PHP | Philippine peso | 70,594 |
| RUB | Russian rouble | 43,1957 |
| THB | Thai baht | 49,499 |
| BRL | Brazilian real | 2,5859 |
| MXN | Mexican peso | 19,5135 |
| INR | Indian rupee | 69,7850 |

Currency

Exchange rate

USD

US dollar

1,4788

JPY

Japanese yen

135,13

DKK

Danish krone

7,4433

GBP

Pound sterling

0,89750

SEK

Swedish krona

10,3359

CHF

Swiss franc

1,5109

ISK

Iceland króna

NOK

Norwegian krone

8,3835

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

26,495

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

272,95

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7090

PLN

Polish zloty

4,2565

RON

Romanian leu

4,3090

TRY

Turkish lira

2,2145

AUD

Australian dollar

1,6276

CAD

Canadian dollar

1,5865

HKD

Hong Kong dollar

11,4609

NZD

New Zealand dollar

2,0305

SGD

Singapore dollar

2,0676

KRW

South Korean won

1 763,31

ZAR

South African rand

11,5005

CNY

Chinese yuan renminbi

10,0972

HRK

Croatian kuna

7,2350

IDR

Indonesian rupiah

14 188,12

MYR

Malaysian ringgit

5,0649

PHP

Philippine peso

70,594

RUB

Russian rouble

43,1957

THB

Thai baht

49,499

BRL

Brazilian real

2,5859

MXN

Mexican peso

19,5135

INR

Indian rupee

69,7850

---

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

---

| 30.10.2009 | EN | Official Journal of the European Union | C 260/6 |
| --- | --- | --- | --- |

30.10.2009

EN

Official Journal of the European Union

C 260/6

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 September 2009 to 30 September 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 260/04

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.9.2009 | Cayston | Aztreonam | Gilead Sciences International Limited |
| Granta Park |
| Abington |
| Cambridge |
| CB21 6GT |
| UNITED KINGDOM |

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

21.9.2009

Cayston

Aztreonam

Gilead Sciences International Limited

Granta Park

Abington

Cambridge

CB21 6GT

UNITED KINGDOM

EU/1/09/543/001

Powder and solvent for nebuliser solution

J01DF01

23.9.2009

21.9.2009

Clopidogrel Sandoz

Clopidogrel

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35 |
| 83714 Miesbach |
| DEUTSCHLAND |

Acino Pharma GmbH

Am Windfeld 35

83714 Miesbach

DEUTSCHLAND

EU/1/09/547/001-007

Film-coated tablet

B01AC-04

23.9.2009

21.9.2009

Vizarsin

Sildenafil

| KRKA, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| SI-8501 Novo mesto |
| SLOVENIJA |

KRKA, d.d.

Novo mesto

Šmarješka cesta 6

SI-8501 Novo mesto

SLOVENIJA

EU/1/09/551/001-012

Film-coated tablet

G04B E03

23.9.2009

21.9.2009

Clopidogrel DURA

Clopidogrel

| Mylan dura GmbH |
| --- |
| Wittichstraße 6 |
| 64295 Darmstadt |
| DEUTSCHLAND |

Mylan dura GmbH

Wittichstraße 6

64295 Darmstadt

DEUTSCHLAND

EU/1/09/560/001-009

Film-coated tablet

B01AC-04

23.9.2009

21.9.2009

Clopidogrel HCS

Clopidogrel

| HCS bvba |
| --- |
| H. Kennisstraat 53 |
| 2650 Edegem |
| BELGÏE |

HCS bvba

H. Kennisstraat 53

2650 Edegem

BELGÏE

EU/1/09/561/001-009

Film-coated tablet

V03AC02

23.9.2009

21.9.2009

Topotecan Teva

Topotecan

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/552/001-004

Concentrate for solution for infusion

L01XX17

23.9.2009

21.9.2009

Zopya

Clopidogrel

| Norpharm Regulatory Services Ltd. |
| --- |
| 26 Laurence Street |
| Drogheda |
| Co. Louth |
| IRELAND |

Norpharm Regulatory Services Ltd.

26 Laurence Street

Drogheda

Co. Louth

IRELAND

EU/1/09/562/001-009

Film-coated tablet

B01AC-04

23.9.2009

21.9.2009

Zylagren

Clopidogrel

| KRKA, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| SI-8501 Novo mesto |
| SLOVENIJA |

KRKA, d.d.

Novo mesto

Šmarješka cesta 6

SI-8501 Novo mesto

SLOVENIJA

EU/1/09/558/001-010

Film-coated tablet

B01AC-04

23.9.2009

21.9.2009

Clopidogrel Mylan

Clopidogrel

| Mylan S.A.S |
| --- |
| 117 Allée des Parcs |
| 69800 Saint Priest |
| FRANCE |

Mylan S.A.S

117 Allée des Parcs

69800 Saint Priest

FRANCE

EU/1/09/559/001-009

Film-coated tablet

B01AC-04

23.9.2009

21.9.2009

Javlor

Vinflunine ditartrate

| Pierre Fabre Médicament |
| --- |
| 45 place Abel Gance |
| 92100 Boulogne |
| FRANCE |

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

FRANCE

EU/1/09/550/001-012

Concentrate for solution for infusion

L01CA05

23.9.2009

21.9.2009

Clopidogrel Acino Pharma GmbH

Clopidogrel

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35 |
| 83714 Miesbach |
| DEUTSCHLAND |

Acino Pharma GmbH

Am Windfeld 35

83714 Miesbach

DEUTSCHLAND

EU/1/09/548/001-007

Film-coated tablet

B01AC-04

23.9.2009

23.9.2009

Clopidogrel TAD

Clopidogrel

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Straße 5 |
| 27472 Cuxhaven |
| DEUTSCHLAND |

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

27472 Cuxhaven

DEUTSCHLAND

EU/1/09/555/001-009

Film-coated tablet

B01AC-04

25.9.2009

23.9.2009

Clopidogrel Krka

Clopidogrel

| KRKA, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| SI-8501 Novo mesto |
| SLOVENIJA |

KRKA, d.d.

Novo mesto

Šmarješka cesta 6

SI-8501 Novo mesto

SLOVENIJA

EU/1/09/556/001-009

Film-coated tablet

B01AC-04

25.9.2009

23.9.2009

Clopidogrel Qualimed

Clopidogrel

| Qualimed |
| --- |
| 117 Allée des Parcs |
| 69800 Saint Priest |
| FRANCE |

Qualimed

117 Allée des Parcs

69800 Saint Priest

FRANCE

EU/1/09/557/001-009

Film-coated tablet

B01AC-04

25.9.2009

23.9.2009

Clopidogrel ratiopharm

Clopidogrel

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35 |
| 83714 Miesbach |
| DEUTSCHLAND |

Acino Pharma GmbH

Am Windfeld 35

83714 Miesbach

DEUTSCHLAND

EU/1/09/554/001-007

Film-coated tablet

B01AC-04

25.9.2009

28.9.2009

Clopidogrel Acino Pharma

Clopidogrel

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35 |
| 83714 Miesbach |
| DEUTSCHLAND |

Acino Pharma GmbH

Am Windfeld 35

83714 Miesbach

DEUTSCHLAND

EU/1/09/549/001-007

Film-coated tablet

B01AC-04

30.9.2009

28.9.2009

Zyllt

Clopidogrel

| KRKA, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| SI-8501 Novo mesto |
| SLOVENIJA |

KRKA, d.d.

Novo mesto

Šmarješka cesta 6

SI-8501 Novo mesto

SLOVENIJA

EU/1/09/553/001-010

Film-coated tablet

B01AC-04

30.9.2009

—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): 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 |
| --- | --- | --- | --- | --- |
| 2.9.2009 | Zomarist | Novartis Europharm Limited |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

2.9.2009

Zomarist

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/08/483/001-018

7.9.2009

2.9.2009

Keppra

| UCB Pharma SA. |
| --- |
| Allée de la Recherche/Researchdreef 60 |
| 1070 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

UCB Pharma SA.

Allée de la Recherche/Researchdreef 60

1070 Bruxelles/Brussel

BELGIQUE/BELGIË

EU/1/00/146/001-032

7.9.2009

2.9.2009

Inovelon

| Eisai Limited |
| --- |
| European Knowledge Centre |
| Mosquito Way |
| Hatfield |
| Herts |
| AL10 9SN |
| UNITED KINGDOM |

Eisai Limited

European Knowledge Centre

Mosquito Way

Hatfield

Herts

AL10 9SN

UNITED KINGDOM

EU/1/06/378/001-016

7.9.2009

2.9.2009

Lumigan

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road |
| Westport |
| Co. Mayo |
| IRELAND |

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

IRELAND

EU/1/02/205/001-002

7.9.2009

2.9.2009

Norvir

| Abbott Laboratories Ltd. |
| --- |
| Queenborough |
| Kent |
| ME11 5EL |
| UNITED KINGDOM |

Abbott Laboratories Ltd.

Queenborough

Kent

ME11 5EL

UNITED KINGDOM

EU/1/96/016/001

EU/1/96/016/003-004

7.9.2009

2.9.2009

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

7.9.2009

4.9.2009

Zevalin

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

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/03/264/001

7.9.2009

4.9.2009

Prialt

| Eisai Limited |
| --- |
| European Knowledge Centre |
| Mosquito Way |
| Hatfield |
| Herts |
| AL10 9SN |
| UNITED KINGDOM |

Eisai Limited

European Knowledge Centre

Mosquito Way

Hatfield

Herts

AL10 9SN

UNITED KINGDOM

EU/1/04/302/001-004

7.9.2009

7.9.2009

Sebivo

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/388/001-003

9.9.2009

9.9.2009

Isentress

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

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/436/001-002

15.9.2009

9.9.2009

Tamiflu

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/02/222/001-004

15.9.2009

14.9.2009

Avaglim

| 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/1/06/349/001-010

15.9.2009

16.9.2009

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

18.9.2009

16.9.2009

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

18.9.2009

16.9.2009

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

18.9.2009

17.9.2009

Ribavirin Teva

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/509/001-004

21.9.2009

17.9.2009

Lantus

| Sanofi-Aventis Deutschland GmbH |
| --- |
| 65926 Frankfurt am Main |
| DEUTSCHLAND |

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/00/134/001-037

21.9.2009

17.9.2009

Actos

| Takeda Global Research and Development Centre (Europe) Ltd. |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| UNITED KINGDOM |

Takeda Global Research and Development Centre (Europe) Ltd.

61 Aldwych

London

WC2B 4AE

UNITED KINGDOM

EU/1/00/150/001-024

21.9.2009

17.9.2009

Glustin

| Takeda Global Research and Development Centre (Europe) Ltd. |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| UNITED KINGDOM |

Takeda Global Research and Development Centre (Europe) Ltd.

61 Aldwych

London

WC2B 4AE

UNITED KINGDOM

EU/1/00/151/001-024

21.9.2009

17.9.2009

Optisulin

| Sanofi-Aventis Deutschland GmbH |
| --- |
| 65926 Frankfurt am Main |
| DEUTSCHLAND |

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/00/133/001-032

21.9.2009

17.9.2009

Doribax

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

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/08/467/001

21.9.2009

17.9.2009

Duloxetine Boehringer Ingelheim

| 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/1/08/471/001-012

21.9.2009

17.9.2009

Glubrava

| Takeda Global Research and Development Centre (Europe) Ltd. |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| UNITED KINGDOM |

Takeda Global Research and Development Centre (Europe) Ltd.

61 Aldwych

London

WC2B 4AE

UNITED KINGDOM

EU/1/07/421/001-009

21.9.2009

21.9.2009

Orfadin

| Swedish Orphan International AB |
| --- |
| Drottninggatan 98 |
| SE-111 60 Stockholm |
| SVERIGE |

Swedish Orphan International AB

Drottninggatan 98

SE-111 60 Stockholm

SVERIGE

EU/1/04/303/001-003

23.9.2009

21.9.2009

Elaprase

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D |
| SE-182 33 Danderyd |
| SVERIGE |

Shire Human Genetic Therapies AB

Svärdvägen 11D

SE-182 33 Danderyd

SVERIGE

EU/1/06/365/001-003

23.9.2009

21.9.2009

Alimta

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

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/04/290/001-002

23.9.2009

21.9.2009

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

23.9.2009

21.9.2009

Azilect

| Teva Pharma GmbH |
| --- |
| Kandelstrasse 10 |
| 79199 Kirchzarten |
| DEUTSCHLAND |

Teva Pharma GmbH

Kandelstrasse 10

79199 Kirchzarten

DEUTSCHLAND

EU/1/04/304/001-007

23.9.2009

21.9.2009

Trisenox

| Cephalon Europe |
| --- |
| 5 Rue Charles Martigny |
| 94700 Maisons Alfort, Cedex |
| FRANCE |

Cephalon Europe

5 Rue Charles Martigny

94700 Maisons Alfort, Cedex

FRANCE

EU/1/02/204/001

23.9.2009

23.9.2009

Mimpara

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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

NEDERLAND

EU/1/04/292/001-012

25.9.2009

24.9.2009

Emselex

| 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/1/04/294/001-028

28.9.2009

25.9.2009

Qutenza

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

Astellas Pharma Europe B.V.

Elisabethhof 19

2353 EW Leiderdorp

NEDERLAND

| NeurogesX UK Limited |
| --- |
| 265 Strand |
| London |
| WC2R 1BH |
| UNITED KINGDOM |

NeurogesX UK Limited

265 Strand

London

WC2R 1BH

UNITED KINGDOM

EU/1/09/524/001-002

29.9.2009

29.9.2009

Focetria

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina 1 |
| Siena SI |
| ITALIA |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina 1

Siena SI

ITALIA

EU/1/07/385/001-004

30.9.2009

29.9.2009

Pandemrix

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l'Institut 89 |
| 1330 Rixensart |
| BELGIQUE |

GlaxoSmithKline Biologicals s.a.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/08/452/001

30.9.2009

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

| 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 |
| --- | --- | --- | --- | --- |
| 14.9.2009 | Lyrica | Pfizer Ltd. |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| 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

14.9.2009

Lyrica

Pfizer Ltd.

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/04/279/001-043

16.9.2009

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

| 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 |
| --- | --- | --- | --- | --- |
| 2.9.2009 | Tekturna | Novartis Europharm Limited |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

2.9.2009

Tekturna

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/408/001-020

7.9.2009

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 23.9.2009 | Palladia | Toceranib | Pfizer Ltd. |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

23.9.2009

Palladia

Toceranib

Pfizer Ltd.

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/2/09/100/001-003

Tablets

QL01XE91

25.9.2009

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004): 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 |
| --- | --- | --- | --- | --- |
| 2.9.2009 | Cerenia | Pfizer Ltd. |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| 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

2.9.2009

Cerenia

Pfizer Ltd.

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/2/06/062/001-003

EU/2/06/062/005

7.9.2009

8.9.2009

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

EU/2/08/081/001-003

10.9.2009

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.

---

| 30.10.2009 | EN | Official Journal of the European Union | C 260/15 |
| --- | --- | --- | --- |

30.10.2009

EN

Official Journal of the European Union

C 260/15

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 May 2009 to 31 May 2009

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

2009/C 260/05

—   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 |
| --- | --- | --- | --- | --- |
| 26.5.2009 | Diovan | See Annex VIII | See Annex VIII | 27.5.2009 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

26.5.2009

Diovan

See Annex VIII

See Annex VIII

27.5.2009

---

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

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

---

ANNEX VIII

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

| Member State EU/EEA | Marketing Authorisation Holder | (Invented) name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH |
| Brunner Strasse 59 |
| 1235 Wien |
| ÖSTERREICH |

Member State EU/EEA

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of administration

Austria

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

ÖSTERREICH

Diovan 40 mg Filmtabletten

40 mg

film-coated tablets

oral

Austria

| Novartis Pharma GmbH |
| --- |
| Brunner Strasse 59 |
| 1235 Wien |
| ÖSTERREICH |

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

ÖSTERREICH

Angiosan 40 mg Filmtabletten

40 mg

film-coated tablets

oral

Austria

| Novartis Pharma GmbH |
| --- |
| Brunner Strasse 59 |
| 1235 Wien |
| ÖSTERREICH |

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

ÖSTERREICH

Diovan 80 mg Filmtabletten

80 mg

film-coated tablets

oral

Austria

| Novartis Pharma GmbH |
| --- |
| Brunner Strasse 59 |
| 1235 Wien |
| ÖSTERREICH |

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

ÖSTERREICH

Angiosan 80 mg Filmtabletten

80 mg

film-coated tablets

oral

Austria

| Novartis Pharma GmbH |
| --- |
| Brunner Strasse 59 |
| 1235 Wien |
| ÖSTERREICH |

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

ÖSTERREICH

Diovan 160 mg Filmtabletten

160 mg

film-coated tablets

oral

Austria

| Novartis Pharma GmbH |
| --- |
| Brunner Strasse 59 |
| 1235 Wien |
| ÖSTERREICH |

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

ÖSTERREICH

Angiosan 160 mg Filmtabletten

160 mg

film-coated tablets

oral

Austria

| Novartis Pharma GmbH |
| --- |
| Brunner Strasse 59 |
| 1235 Wien |
| ÖSTERREICH |

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

ÖSTERREICH

Diovan 320 mg Filmtabletten

320 mg

film-coated tablets

oral

Austria

| Novartis Pharma GmbH |
| --- |
| Brunner Strasse 59 |
| 1235 Wien |
| ÖSTERREICH |

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

ÖSTERREICH

Angiosan 320 mg Filmtabletten

320 mg

film-coated tablets

oral

Belgium

| NV Novartis Pharma SA |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIË |

NV Novartis Pharma SA

Medialaan 40, bus 1

1800 Vilvoorde

BELGIË

Diovane 40 mg

40 mg

film-coated tablets

oral

Belgium

| NV Novartis Pharma SA |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIË |

NV Novartis Pharma SA

Medialaan 40, bus 1

1800 Vilvoorde

BELGIË

Novacard 40 mg

40 mg

film-coated tablets

oral

Belgium

| NV Novartis Pharma SA |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIË |

NV Novartis Pharma SA

Medialaan 40, bus 1

1800 Vilvoorde

BELGIË

Diovane 80 mg

80 mg

film-coated tablets

oral

Belgium

| NV Novartis Pharma SA |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIË |

NV Novartis Pharma SA

Medialaan 40, bus 1

1800 Vilvoorde

BELGIË

Novacard 80 mg

80 mg

film-coated tablets

oral

Belgium

| NV Novartis Pharma SA |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIË |

NV Novartis Pharma SA

Medialaan 40, bus 1

1800 Vilvoorde

BELGIË

Diovane 160 mg

160 mg

film-coated tablets

oral

Belgium

| NV Novartis Pharma SA |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIË |

NV Novartis Pharma SA

Medialaan 40, bus 1

1800 Vilvoorde

BELGIË

Novacard 160 mg

160 mg

film-coated tablets

oral

Belgium

| NV Novartis Pharma SA |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIË |

NV Novartis Pharma SA

Medialaan 40, bus 1

1800 Vilvoorde

BELGIË

Diovane 320 mg

320 mg

film-coated tablets

oral

Belgium

| NV Novartis Pharma SA |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIË |

NV Novartis Pharma SA

Medialaan 40, bus 1

1800 Vilvoorde

BELGIË

Novacard 320 mg

320 mg

film-coated tablets

oral

Bulgaria

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 40 mg

40 mg

film-coated tablets

oral

Bulgaria

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 80 mg

80 mg

film-coated tablets

oral

Bulgaria

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 160 mg

160 mg

film-coated tablets

oral

Cyprus

| Demetriades & Papaellinas Ltd |
| --- |
| Kasou 21 |
| PO Box |
| 23490 Nicosia |
| CYPRUS |

Demetriades & Papaellinas Ltd

Kasou 21

PO Box

23490 Nicosia

CYPRUS

Diovan 40 mg

40 mg

film-coated tablets

oral

Cyprus

| Demetriades & Papaellinas Ltd |
| --- |
| Kasou 21 |
| PO Box |
| 23490 Nicosia |
| CYPRUS |

Demetriades & Papaellinas Ltd

Kasou 21

PO Box

23490 Nicosia

CYPRUS

Diovan 80 mg

80 mg

film-coated tablets

oral

Cyprus

| Demetriades & Papaellinas Ltd |
| --- |
| Kasou 21 |
| PO Box |
| 23490 Nicosia |
| CYPRUS |

Demetriades & Papaellinas Ltd

Kasou 21

PO Box

23490 Nicosia

CYPRUS

Diovan 160 mg

160 mg

film-coated tablets

oral

Cyprus

| Demetriades & Papaellinas Ltd |
| --- |
| Kasou 21 |
| PO Box |
| 23490 Nicosia |
| CYPRUS |

Demetriades & Papaellinas Ltd

Kasou 21

PO Box

23490 Nicosia

CYPRUS

Diovan 320 mg

320 mg

film-coated tablets

oral

Czech Republic

| Novartis s.r.o. Pharma |
| --- |
| Nagano III |
| U Nákladového nádraží 10 |
| 130 00 Praha 3 |
| ČESKÁ REPUBLIKA |

Novartis s.r.o. Pharma

Nagano III

U Nákladového nádraží 10

130 00 Praha 3

ČESKÁ REPUBLIKA

Diovan 40 mg

40 mg

film-coated tablets

oral

Czech Republic

| Novartis s.r.o. Pharma |
| --- |
| Nagano III |
| U Nákladového nádraží 10 |
| 130 00 Praha 3 |
| ČESKÁ REPUBLIKA |

Novartis s.r.o. Pharma

Nagano III

U Nákladového nádraží 10

130 00 Praha 3

ČESKÁ REPUBLIKA

Diovan 160 mg

160 mg

film-coated tablets

oral

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 København K |
| DANMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 København K

DANMARK

Diovan 40 mg

40 mg

film-coated tablets

oral

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 København K |
| DANMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 København K

DANMARK

Diovan 80 mg

80 mg

film-coated tablets

oral

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 København K |
| DANMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 København K

DANMARK

Diovan 160 mg

160 mg

film-coated tablets

oral

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 København K |
| DANMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 København K

DANMARK

Diovan 320 mg

320 mg

film-coated tablets

oral

Estonia

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 40 mg

40 mg

film-coated tablets

oral

Estonia

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 80 mg

80 mg

film-coated tablets

oral

Estonia

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 160 mg

160 mg

film-coated tablets

oral

Estonia

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 320 mg

320 mg

film-coated tablets

oral

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 40 mg

40 mg

film-coated tablets

oral

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 80 mg

80 mg

film-coated tablets

oral

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 160 mg

160 mg

film-coated tablets

oral

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 320 mg

320 mg

film-coated tablets

oral

France

| Novartis Pharma S.A.S. |
| --- |
| 2/4 rue Lionel Terray |
| 92500 Rueil-Malmaison |
| FRANCE |

Novartis Pharma S.A.S.

2/4 rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

Tareg 40 mg

40 mg

film-coated tablets

oral

France

| Novartis Pharma S.A.S. |
| --- |
| 2/4 rue Lionel Terray |
| 92500 Rueil-Malmaison |
| FRANCE |

Novartis Pharma S.A.S.

2/4 rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

Tareg 80 mg

80 mg

film-coated tablets

oral

France

| Novartis Pharma S.A.S. |
| --- |
| 2/4 rue Lionel Terray |
| 92500 Rueil-Malmaison |
| FRANCE |

Novartis Pharma S.A.S.

2/4 rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

Tareg 160 mg

160 mg

film-coated tablets

oral

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 40 mg

40 mg

film-coated tablets

oral

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Cordinate 40 mg

40 mg

film-coated tablets

oral

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Provas 40 mg

40 mg

film-coated tablets

oral

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 80 mg

80 mg

film-coated tablets

oral

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Cordinate 80 mg

80 mg

film-coated tablets

oral

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Provas 80 mg

80 mg

film-coated tablets

oral

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 160 mg

160 mg

film-coated tablets

oral

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Cordinate 160 mg

160 mg

film-coated tablets

oral

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Provas 160 mg

160 mg

film-coated tablets

oral

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 320 mg

320 mg

film-coated tablets

oral

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Cordinate 320 mg

320 mg

film-coated tablets

oral

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Provas 320 mg

320 mg

film-coated tablets

oral

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No 1 (12th km) |
| Metamorphosis |
| 144 51 Athens |
| GREECE |

Novartis (Hellas) S.A.C.I.

National Road No 1 (12th km)

Metamorphosis

144 51 Athens

GREECE

Diovan 40 mg

40 mg

film-coated tablets

oral

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No 1 (12th km) |
| Metamorphosis |
| 144 51 Athens |
| GREECE |

Novartis (Hellas) S.A.C.I.

National Road No 1 (12th km)

Metamorphosis

144 51 Athens

GREECE

Dalzad 40 mg

40 mg

film-coated tablets

oral

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No 1 (12th km) |
| Metamorphosis |
| 144 51 Athens |
| GREECE |

Novartis (Hellas) S.A.C.I.

National Road No 1 (12th km)

Metamorphosis

144 51 Athens

GREECE

Diovan 80 mg

80 mg

film-coated tablets

oral

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No 1 (12th km) |
| Metamorphosis |
| 144 51 Athens |
| GREECE |

Novartis (Hellas) S.A.C.I.

National Road No 1 (12th km)

Metamorphosis

144 51 Athens

GREECE

Dalzad 80 mg

80 mg

film-coated tablets

oral

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No 1 (12th km) |
| Metamorphosis |
| 144 51 Athens |
| GREECE |

Novartis (Hellas) S.A.C.I.

National Road No 1 (12th km)

Metamorphosis

144 51 Athens

GREECE

Diovan 160 mg

160 mg

film-coated tablets

oral

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No 1 (12th km) |
| Metamorphosis |
| 144 51 Athens |
| GREECE |

Novartis (Hellas) S.A.C.I.

National Road No 1 (12th km)

Metamorphosis

144 51 Athens

GREECE

Dalzad 160 mg

160 mg

film-coated tablets

oral

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No 1 (12th km) |
| Metamorphosis |
| 144 51 Athens |
| GREECE |

Novartis (Hellas) S.A.C.I.

National Road No 1 (12th km)

Metamorphosis

144 51 Athens

GREECE

Diovan 320 mg

320 mg

film-coated tablets

oral

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No 1 (12th km) |
| Metamorphosis |
| 144 51 Athens |
| GREECE |

Novartis (Hellas) S.A.C.I.

National Road No 1 (12th km)

Metamorphosis

144 51 Athens

GREECE

Dalzad 320 mg

320 mg

film-coated tablets

oral

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No 1 (12th km) |
| Metamorphosis |
| 144 51 Athens |
| GREECE |

Novartis (Hellas) S.A.C.I.

National Road No 1 (12th km)

Metamorphosis

144 51 Athens

GREECE

Diovan 80 mg

80 mg

Hard gelatine capsules

oral

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No 1 (12th km) |
| Metamorphosis |
| 144 51 Athens |
| GREECE |

Novartis (Hellas) S.A.C.I.

National Road No 1 (12th km)

Metamorphosis

144 51 Athens

GREECE

Dalzad 80 mg

80 mg

Hard gelatine capsules

oral

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No 1 (12th km) |
| Metamorphosis |
| 144 51 Athens |
| GREECE |

Novartis (Hellas) S.A.C.I.

National Road No 1 (12th km)

Metamorphosis

144 51 Athens

GREECE

Diovan 160 mg

160 mg

Hard gelatine capsules

oral

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No 1 (12th km) |
| Metamorphosis |
| 144 51 Athens |
| GREECE |

Novartis (Hellas) S.A.C.I.

National Road No 1 (12th km)

Metamorphosis

144 51 Athens

GREECE

Dalzad 160 mg

160 mg

Hard gelatine capsules

oral

Hungary

| Novartis Hungaria Kft. |
| --- |
| Budapest |
| Bartók Béla út 43–47. |
| 1114 |
| MAGYARORSZÁG/HUNGARY |

Novartis Hungaria Kft.

Budapest

Bartók Béla út 43–47.

1114

MAGYARORSZÁG/HUNGARY

Diovan 40 mg

40 mg

film-coated tablets

oral

Hungary

| Novartis Hungaria Kft. |
| --- |
| Budapest |
| Bartók Béla út 43–47. |
| 1114 |
| MAGYARORSZÁG/HUNGARY |

Novartis Hungaria Kft.

Budapest

Bartók Béla út 43–47.

1114

MAGYARORSZÁG/HUNGARY

Varexan 40 mg

40 mg

film-coated tablets

oral

Hungary

| Novartis Hungaria Kft. |
| --- |
| Budapest |
| Bartók Béla út 43–47. |
| 1114 |
| MAGYARORSZÁG/HUNGARY |

Novartis Hungaria Kft.

Budapest

Bartók Béla út 43–47.

1114

MAGYARORSZÁG/HUNGARY

Diovan 80 mg

80 mg

film-coated tablets

oral

Hungary

| Novartis Hungaria Kft. |
| --- |
| Budapest |
| Bartók Béla út 43–47. |
| 1114 |
| MAGYARORSZÁG/HUNGARY |

Novartis Hungaria Kft.

Budapest

Bartók Béla út 43–47.

1114

MAGYARORSZÁG/HUNGARY

Varexan 80 mg

80 mg

film-coated tablets

oral

Hungary

| Novartis Hungaria Kft. |
| --- |
| Budapest |
| Bartók Béla út 43–47. |
| 1114 |
| MAGYARORSZÁG/HUNGARY |

Novartis Hungaria Kft.

Budapest

Bartók Béla út 43–47.

1114

MAGYARORSZÁG/HUNGARY

Diovan 160 mg

160 mg

film-coated tablets

oral

Hungary

| Novartis Hungaria Kft. |
| --- |
| Budapest |
| Bartók Béla út 43–47. |
| 1114 |
| MAGYARORSZÁG/HUNGARY |

Novartis Hungaria Kft.

Budapest

Bartók Béla út 43–47.

1114

MAGYARORSZÁG/HUNGARY

Varexan 160 mg

160 mg

film-coated tablets

oral

Hungary

| Novartis Hungaria Kft. |
| --- |
| Budapest |
| Bartók Béla út 43–47. |
| 1114 |
| MAGYARORSZÁG/HUNGARY |

Novartis Hungaria Kft.

Budapest

Bartók Béla út 43–47.

1114

MAGYARORSZÁG/HUNGARY

Diovan 320 mg

320 mg

film-coated tablets

oral

Iceland

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 København K |
| DANMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 København K

DANMARK

Diovan 40 mg

40 mg

film-coated tablets

oral

Iceland

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 København K |
| DANMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 København K

DANMARK

Diovan 80 mg

80 mg

film-coated tablets

oral

Iceland

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 København K |
| DANMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 København K

DANMARK

Diovan 160 mg

160 mg

film-coated tablets

oral

Iceland

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 København K |
| DANMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 København K

DANMARK

Diovan 320 mg

320 mg

film-coated tablets

oral

Ireland

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Diovan 40 mg

40 mg

film-coated tablets

oral

Ireland

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Diovan 80 mg

80 mg

film-coated tablets

oral

Ireland

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Diovan 160 mg

160 mg

film-coated tablets

oral

Ireland

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Diovan 320 mg

320 mg

film-coated tablets

oral

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| 21040 Origgio VA |
| ITALIA |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio VA

ITALIA

Tareg 40 mg

40 mg

film-coated tablets

oral

Italy

| LPB Instituto Farmaceutico S.r.l. |
| --- |
| Largo Umberto Boccioni 1 |
| 21040 Origgio VA |
| ITALIA |

LPB Instituto Farmaceutico S.r.l.

Largo Umberto Boccioni 1

21040 Origgio VA

ITALIA

Rixil

40 mg

film-coated tablets

oral

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| 21040 Origgio VA |
| ITALIA |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio VA

ITALIA

Tareg

80 mg

film-coated tablets

oral

Italy

| LPB Instituto Farmaceutico S.r.l. |
| --- |
| Largo Umberto Boccioni 1 |
| 21040 Origgio VA |
| ITALIA |

LPB Instituto Farmaceutico S.r.l.

Largo Umberto Boccioni 1

21040 Origgio VA

ITALIA

Rixil

80 mg

film-coated tablets

oral

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| 21040 Origgio VA |
| ITALIA |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio VA

ITALIA

Tareg

160 mg

film-coated tablets

oral

Italy

| LPB Instituto Farmaceutico S.r.l. |
| --- |
| Largo Umberto Boccioni 1 |
| 21040 Origgio VA |
| ITALIA |

LPB Instituto Farmaceutico S.r.l.

Largo Umberto Boccioni 1

21040 Origgio VA

ITALIA

Rixil

160 mg

film-coated tablets

oral

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| 21040 Origgio VA |
| ITALIA |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio VA

ITALIA

Tareg

80 mg

Hard capsules

oral

Italy

| LPB Instituto Farmaceutico S.r.l. |
| --- |
| Largo Umberto Boccioni 1 |
| 21040 Origgio VA |
| ITALIA |

LPB Instituto Farmaceutico S.r.l.

Largo Umberto Boccioni 1

21040 Origgio VA

ITALIA

Rixil

80 mg

Hard capsules

oral

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| 21040 Origgio VA |
| ITALIA |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio VA

ITALIA

Tareg

160 mg

Hard capsules

oral

Italy

| LPB Instituto Farmaceutico S.r.l. |
| --- |
| Largo Umberto Boccioni 1 |
| 21040 Origgio VA |
| ITALIA |

LPB Instituto Farmaceutico S.r.l.

Largo Umberto Boccioni 1

21040 Origgio VA

ITALIA

Rixil

160 mg

Hard capsules

oral

Latvia

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 40 mg

40 mg

film-coated tablets

oral

Latvia

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 80 mg

80 mg

film-coated tablets

oral

Latvia

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 160 mg

160 mg

film-coated tablets

oral

Latvia

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 320 mg

320 mg

film-coated tablets

oral

Lithuania

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 80 mg

80 mg

film-coated tablets

oral

Lithuania

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 160 mg

160 mg

film-coated tablets

oral

Lithuania

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| SUOMI/FINLAND |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

SUOMI/FINLAND

Diovan 320 mg

320 mg

film-coated tablets

oral

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 40 mg

40 mg

film-coated tablets

oral

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 80 mg

80 mg

film-coated tablets

oral

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 160 mg

160 mg

film-coated tablets

oral

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 320 mg

320 mg

film-coated tablets

oral

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Diovan 40 mg

40 mg

film-coated tablets

oral

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Diovan 80 mg

80 mg

film-coated tablets

oral

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Diovan 160 mg

160 mg

film-coated tablets

oral

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Diovan 320 mg

320 mg

film-coated tablets

oral

Netherlands

| Novartis Pharma B.V. |
| --- |
| Postbus 241 |
| 6824 DP Arnhem |
| NEDERLAND |

Novartis Pharma B.V.

Postbus 241

6824 DP Arnhem

NEDERLAND

Diovan 40 mg

40 mg

film-coated tablets

oral

Netherlands

| Novartis Pharma B.V. |
| --- |
| Postbus 241 |
| 6824 DP Arnhem |
| NEDERLAND |

Novartis Pharma B.V.

Postbus 241

6824 DP Arnhem

NEDERLAND

Diovan 80 mg

80 mg

film-coated tablets

oral

Netherlands

| Novartis Pharma B.V. |
| --- |
| Postbus 241 |
| 6824 DP Arnhem |
| NEDERLAND |

Novartis Pharma B.V.

Postbus 241

6824 DP Arnhem

NEDERLAND

Diovan 160 mg

160 mg

film-coated tablets

oral

Netherlands

| Novartis Pharma B.V. |
| --- |
| Postbus 241 |
| 6824 DP Arnhem |
| NEDERLAND |

Novartis Pharma B.V.

Postbus 241

6824 DP Arnhem

NEDERLAND

Diovan 320 mg

320 mg

film-coated tablets

oral

Norway

| Novartis Norge AS |
| --- |
| Postboks 237 Økern |
| 0510 Oslo |
| NORWAY |

Novartis Norge AS

Postboks 237 Økern

0510 Oslo

NORWAY

Diovan 40 mg

40 mg

film-coated tablets

oral

Norway

| Novartis Norge AS |
| --- |
| Postboks 237 Økern |
| 0510 Oslo |
| NORWAY |

Novartis Norge AS

Postboks 237 Økern

0510 Oslo

NORWAY

Diovan 80 mg

80 mg

film-coated tablets

oral

Norway

| Novartis Norge AS |
| --- |
| Postboks 237 Økern |
| 0510 Oslo |
| NORWAY |

Novartis Norge AS

Postboks 237 Økern

0510 Oslo

NORWAY

Diovan 160 mg

160 mg

film-coated tablets

oral

Norway

| Novartis Norge AS |
| --- |
| Postboks 237 Økern |
| 0510 Oslo |
| NORWAY |

Novartis Norge AS

Postboks 237 Økern

0510 Oslo

NORWAY

Diovan 320 mg

320 mg

film-coated tablets

oral

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan

40 mg

film-coated tablets

oral

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan

80 mg

film-coated tablets

oral

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan

160 mg

film-coated tablets

oral

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan

320 mg

film-coated tablets

oral

Portugal

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

Novartis Farma — Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8.o

Quinta da Beloura

2710-444 Sintra

PORTUGAL

Diovan

40 mg

film-coated tablets

oral

Portugal

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

Novartis Farma — Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8.o

Quinta da Beloura

2710-444 Sintra

PORTUGAL

Diovan

80 mg

film-coated tablets

oral

Portugal

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

Novartis Farma — Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8.o

Quinta da Beloura

2710-444 Sintra

PORTUGAL

Diovan

160 mg

film-coated tablets

oral

Portugal

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

Novartis Farma — Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8.o

Quinta da Beloura

2710-444 Sintra

PORTUGAL

Diovan

320 mg

film-coated tablets

oral

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 40 mg

40 mg

film-coated tablets

oral

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 80 mg

80 mg

film-coated tablets

oral

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 160 mg

160 mg

film-coated tablets

oral

Slovakia

| Novartis s.r.o. |
| --- |
| Praha |
| ČESKÁ REPUBLIKA |

Novartis s.r.o.

Praha

ČESKÁ REPUBLIKA

Diovan 40 mg

40 mg

film-coated tablets

oral

Slovakia

| Novartis s.r.o. |
| --- |
| Praha |
| ČESKÁ REPUBLIKA |

Novartis s.r.o.

Praha

ČESKÁ REPUBLIKA

Diovan 80 mg

80 mg

film-coated tablets

oral

Slovakia

| Novartis s.r.o. |
| --- |
| Praha |
| ČESKÁ REPUBLIKA |

Novartis s.r.o.

Praha

ČESKÁ REPUBLIKA

Diovan 160 mg

160 mg

film-coated tablets

oral

Slovakia

| Novartis s.r.o. |
| --- |
| Praha |
| ČESKÁ REPUBLIKA |

Novartis s.r.o.

Praha

ČESKÁ REPUBLIKA

Diovan 320 mg

320 mg

film-coated tablets

oral

Slovakia

| Novartis s.r.o. |
| --- |
| Praha |
| ČESKÁ REPUBLIKA |

Novartis s.r.o.

Praha

ČESKÁ REPUBLIKA

Diovan 80 mg

80 mg

Hard gelatine capsules

oral

Slovakia

| Novartis s.r.o. |
| --- |
| Praha |
| ČESKÁ REPUBLIKA |

Novartis s.r.o.

Praha

ČESKÁ REPUBLIKA

Diovan 160 mg

160 mg

Hard gelatine capsules

oral

Slovenia

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 40 mg filmsko obložene tablete

40 mg

film-coated tablets

oral

Slovenia

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 80 mg filmsko obložene tablete

80 mg

film-coated tablets

oral

Slovenia

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 160 mg filmsko obložene tablete

160 mg

film-coated tablets

oral

Slovenia

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| DEUTSCHLAND |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

DEUTSCHLAND

Diovan 320 mg filmsko obložene tablete

320 mg

film-coated tablets

oral

Spain

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

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

ESPAÑA

Diovan Cardio 40 mg

40 mg

film-coated tablets

oral

Spain

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

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

ESPAÑA

Kalpress Cardio 40 mg

40 mg

film-coated tablets

oral

Spain

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

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

ESPAÑA

Miten Cardio 40 mg

40 mg

film-coated tablets

oral

Spain

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

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

ESPAÑA

Diovan 80 mg

80 mg

film-coated tablets

oral

Spain

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

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

ESPAÑA

Kalpress 80 mg

80 mg

film-coated tablets

oral

Spain

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

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

ESPAÑA

Miten 80 mg

80 mg

film-coated tablets

oral

Spain

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

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

ESPAÑA

Diovan 160 mg

160 mg

film-coated tablets

oral

Spain

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

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

ESPAÑA

Kalpress 160 mg

160 mg

film-coated tablets

oral

Spain

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

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

ESPAÑA

Miten 160 mg

160 mg

film-coated tablets

oral

Spain

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

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

ESPAÑA

Diovan 320 mg

320 mg

film-coated tablets

oral

Spain

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

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

ESPAÑA

Kalpress 320 mg

320 mg

film-coated tablets

oral

Spain

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

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

ESPAÑA

Miten 320 mg

320 mg

film-coated tablets

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Diovan

40 mg

film-coated tablets

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Angiosan

40 mg

film-coated tablets

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Valsartan Novartis

40 mg

film-coated tablets

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Diovan

80 mg

film-coated tablets

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Angiosan

80 mg

film-coated tablets

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Valsartan Novartis

80 mg

film-coated tablets

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Diovan

160 mg

film-coated tablets

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Angiosan

160 mg

film-coated tablets

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Valsartan Novartis

160 mg

film-coated tablets

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Diovan

320 mg

film-coated tablets

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Angiosan

320 mg

film-coated tablets

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Valsartan Novartis

320 mg

film-coated tablets

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Diovan

80 mg

Hard gelatine capsules

oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

SE-183 11 Täby

SVERIGE

Diovan

160 mg

Hard gelatine capsules

oral

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Diovan 40 mg

40 mg

film-coated tablets

oral

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Diovan 320 mg

320 mg

film-coated tablets

oral

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Diovan 40 mg

40 mg

Hard gelatine capsules

oral

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Diovan 80 mg

80 mg

Hard gelatine capsules

oral

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Diovan 160 mg

160 mg

Hard gelatine capsules

oral

---

NOTICES FROM MEMBER STATES

| 30.10.2009 | EN | Official Journal of the European Union | C 260/31 |
| --- | --- | --- | --- |

30.10.2009

EN

Official Journal of the European Union

C 260/31

---

Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 1857/2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001

2009/C 260/06

Aid No: XA 180/09

Member State: Spain

Region: Castilla y León

Title of aid scheme or name of company receiving an individual aid: Bases reguladoras de la concesión de las ayudas para las Asociaciones de Producción Integrada en Agricultura (APRIAS).

Legal basis: Orden AYG/541/2009, de la Consejería de Agricultura y Ganadería por la que se establecen las Bases Reguladoras para la concesión de las ayudas para las Asociaciones de Producción Integrada en Agricultura (APRIAS).

Orden AYG/1043/2009, de 28 de abril, por la que se modifica la Orden AYG/541/2009, de 3 de marzo, por la que se establecen las bases reguladoras de la concesión de las ayudas para las Asociaciones de Producción Integrada en Agricultura (APRIAS).

This aid scheme is covered by the exemption laid down in Commission Regulation (EC) No 1857/2006 of 15 December 2006 and complies with Articles 14 and 15 of that Regulation

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company: EUR 400 000

Maximum aid intensity: 70 % of costs

Date of implementation: From the date on which the identification number of the exemption request is published on the website of the European Commission’s Directorate-General for Agriculture and Rural Development

Duration of scheme or individual aid award: Until 31 December 2013

Objective of aid: To encourage the production of quality agricultural products (Article 14 of the Regulation (EC) No 1857/2006) and to promote technical assistance in the agricultural sector (Article 15 of the Regulation (EC) No 1857/2006)

Sector(s) concerned: Agriculture and the agri-food sector

Name and address of the granting authority: Dirección General de Producción Agropecuaria

Website: The full text of the aid scheme will be published on the website of the Junta de Castilla y León

Direct link: http://www.jcyl.es/scsiau/Satellite/up/es/EconomiaEmpleo/Page/PlantillaN3/1175259771003/_/_/_?asm=jcyl&paginaNavegacion=&seccion=

Other information: —

Aid No: XA 188/09

Member State: Spain

Region: Navarra

Title of aid scheme or name of company receiving an individual aid: Ayudas a las organizaciones profesionales agrarias para actividades de asistencia técnica a titulares y trabajadores de las explotaciones agrarias, para la formación en el uso de las nuevas tecnologías en el ámbito de la gestión empresarial y comunicación electrónica (TIC’s).

Legal basis: Orden Foral de la Consejera de Desarrollo Rural y Medio Ambiente, por la que se establecen las normas reguladoras que regirán la concesión de ayudas a las organizaciones profesionales agrarias para actividades de asistencia técnica a titulares y trabajadores de las explotaciones agrarias, para la formación en el uso de las nuevas tecnologías en el ámbito de la gestión empresarial y comunicación electrónica (TIC’s).

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company: EUR 136 000

Maximum aid intensity: Up to 75 % of eligible costs

Date of implementation: The aid arrangements will apply from the date on which the identification number of the exemption request provided for in Regulation (EC) No 1857/2006 is published on the website of the European Commission’s Directorate-General for Agriculture and Rural Development

Duration of scheme or individual aid award: From 2009 to 31 December 2013

Objective of aid:

| 1. | The main objective is to promote the adaptation and conversion of agricultural holdings as regards communication and access to information networks and to familiarise agricultural undertakings with electronic communication and management systems. |
| --- | --- |

1.

The main objective is to promote the adaptation and conversion of agricultural holdings as regards communication and access to information networks and to familiarise agricultural undertakings with electronic communication and management systems.

| 2. | The secondary objectives are:






  — | to encourage the use of efficient data transmission communication systems and promote access to information networks for agricultural enterprises, |
| --- | --- | --- |

2.

The secondary objectives are:

—

to encourage the use of efficient data transmission communication systems and promote access to information networks for agricultural enterprises,

| — | to ensure access to coordinated and monitored computerised systems which together form a communal management network, |
| --- | --- |

—

to ensure access to coordinated and monitored computerised systems which together form a communal management network,

| — | to introduce advanced technology systems in the agricultural sector as a foundation for the introduction of the NITCs. |
| --- | --- |

—

to introduce advanced technology systems in the agricultural sector as a foundation for the introduction of the NITCs.

Article 15(2)(b) of Regulation (EC) No 1857/2006: Eligible costs: the costs relating to the organisation of training programmes

Sector(s) concerned: Primary producers in the agriculture and livestock sectors

Name and address of the granting authority:

| Gobierno de Navarra |
| --- |
| Departamento de Desarrollo Rural y Medio Ambiente |
| C/ Tudela, 20 |
| 31003 Pamplona |
| ESPAÑA |

Gobierno de Navarra

Departamento de Desarrollo Rural y Medio Ambiente

C/ Tudela, 20

31003 Pamplona

ESPAÑA

Website: http://www.cfnavarra.es/agricultura/COYUNTURA/AyudasEstado/pdfs/STNO09036%20OF.pdf

Other information:

| Dirección General de Desarrollo Rural |
| --- |
| C/ Tudela, 20 |
| 31003 Pamplona |
| ESPAÑA |
| Tel. +34 848422933 |
| E-mail: izabalv@cfnavarra.es |

Dirección General de Desarrollo Rural

C/ Tudela, 20

31003 Pamplona

ESPAÑA

Tel. +34 848422933

E-mail: izabalv@cfnavarra.es

Aid No: XA 214/09

Member State: France

Region: Département de la Seine-Maritime

Title of aid scheme or name of company receiving an individual aid: Avances remboursables pour l’installation d’exploitants ne bénéficiant pas d’une DJA (dotation jeune agriculteur), Seine-Maritime

Legal basis: articles L 1511-2, L 3231-2 et 3232-1 du Code général des collectivités territoriales; délibération du Conseil général du 31 mars 2009 relative à la politique agricole départementale de la période 2009-2012.

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company: EUR 100 000 per year

Maximum aid intensity: It is proposed that zero-rated loans could cover 40 % of the investment. The equivalent subsidy is calculated on the basis of the financial costs generated by a loan equivalent to 5,5 %.

The ceiling of eligible expenditure is set at EUR 50 000 and that of the loan at 40 % of the costs, or EUR 20 000. For a loan of EUR 20 000, the aid will represent a total of EUR 2 823 in equivalent subsidy

Date of implementation: From when the Commission confirms receipt

Duration of scheme or individual aid award: 2009-2012 period

Objective of aid: Since generational renewal is causing a reduction in the number of farms in the Seine-Maritime, the aim of this arrangement is to help set up agricultural premises away from the family farm or to help candidates coming from other socio-professional sectors. This approach should encourage the agricultural profession to open up to other approaches to the job by introducing into the agricultural sector farmers who have come from other socio-professional sectors.

This aid will facilitate access to the traditional banking system thanks to the leverage effect it will cause.

This aid will be granted in compliance with Article 4 of Regulation (EC) No 1857/2006

Sector(s) concerned: The entire agricultural sector

Name and address of the granting authority:

| Monsieur le Président du Département de Seine-Maritime |
| --- |
| Quai Jean Moulin |
| 76101 Rouen Cedex 1 |
| FRANCE |

Monsieur le Président du Département de Seine-Maritime

Quai Jean Moulin

76101 Rouen Cedex 1

FRANCE

Website: http://www.seinemaritime.net/guidedesaides/medias/File/avance-remboursable-pour-l-installation-non-aidee-t2.pdf

Other information: —

Aid No: XA 217/09

Member State: France

Region: Département de la Seine-Maritime

Title of aid scheme or name of company receiving an individual aid: Aides aux investissements pour la lutte contre l’érosion (Seine-Maritime)

Legal basis: articles L1511-2, L3231-2 et 3232-1 du Code général des collectivités territoriales; délibération du Conseil général du 31 mars 2009 relative à la politique agricole départementale de la période 2009-2012.

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company: EUR 60 000 per year

Maximum aid intensity: 50 % maximum

Date of implementation: From when the Commission confirms receipt

Duration of scheme or individual aid award: 2009-2012 period

Objective of aid: Because of the nature of the soil in the department of Seine-Maritime, mud flows are a regular occurrence following heavy rainfall, particularly in late autumn and in the spring. Moreover, because of the karstic subsoil and the underground nature of the water resources, water abstraction points are regularly confronted with problems of turbidity making the water unfit for consumption.

Many solutions involve adapting cultivation methods, and in particular soil preparation.

The scheme implemented by the department of Seine-Maritime will help farmers to invest in equipment, which will limit the risks of soil sealing, runoff, mud flows and turbidity.

The following equipment is eligible:

localised soil working tools. These allow the soil to be worked solely along the drilling line so that 75 % of the land is not worked, thus improving resistance to erosion,

equipment for sowing a ground cover plant among a crop in the field. This highly specialised equipment allows ground cover to be sown, particularly in a crop of maize. The ground cover plants develop rapidly as soon as the crop has been harvested, thus avoiding bare ground during the winter,

hoeing equipment. This equipment allows soil permeability to be re-established in the spring in root crops (beet and maize),

coarse mulch disc tillers. These allow macroporosity to be created after a harvest, thereby facilitating water infiltration,

seeders for intermediate crops providing ground cover in winter. This equipment is specific to winter cover crops (intermediate crops),

wheel track eradicators. This equipment is fitted to tractors to loosen up the wheel tracks which often cause serious runoff, leading to the creation of gulleys.

This scheme has already been the subject of an exemption procedure for the period 2006-2008 under reference No XA 108/06.

Aid shall be granted in accordance with the provisions of Article 4 of Regulation (EC) No 1857/2006

Sector(s) concerned: The entire agricultural sector

Name and address of the granting authority:

| Monsieur le Président du Département de Seine-Maritime |
| --- |
| Quai Jean Moulin |
| 76101 Rouen Cedex 1 |
| FRANCE |

Monsieur le Président du Département de Seine-Maritime

Quai Jean Moulin

76101 Rouen Cedex 1

FRANCE

Website: http://www.seinemaritime.net/guidedesaides/medias/File/aide-aux-investissements-pour-la-lutte-contre-l-erosion-t2.pdf

Other information: —

Aid No: XA 218/09

Member State: France

Region: Département de la Seine-Maritime

Title of aid scheme or name of company receiving an individual aid: Aides aux investissements pour la récupération des eaux pluviales en vue d’un usage agricole (Seine-Maritime)

Legal basis: articles L 1511-2, L 3231-2 et 3232-1 du Code général des collectivités territoriales; délibération du Conseil général du 31 mars 2009 relative à la politique agricole départementale de la période 2009-2012.

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company: EUR 70 000 per year

Maximum aid intensity: 40 % maximum

Date of implementation: From when the Commission confirms receipt

Duration of scheme or individual aid award: 2009-2012 period

Objective of aid: The objective of the scheme is to help farmers to reduce the impact of their activities on the environment. It involves farms being autonomous in their use of resources. The rainfall in Normandy, which is high and occurs throughout the year, allows water to be recycled for the watering of flocks or filling the sprayer tanks.

Planned aid will be equal to 40 % of the eligible investments, which must amount to between EUR 2 000 and EUR 8 000.

Eligible equipment includes tanks, recycling systems and processing equipment (filters, UV treatment, chlorination).

Aid will be granted in accordance with the provisions of Article 4 of Regulation (EC) No 1857/2006

Sector(s) concerned: The entire agricultural sector

Name and address of the granting authority:

| Monsieur le Président du Département de Seine-Maritime |
| --- |
| Quai Jean Moulin |
| 76101 Rouen Cedex 1 |
| FRANCE |

Monsieur le Président du Département de Seine-Maritime

Quai Jean Moulin

76101 Rouen Cedex 1

FRANCE

Website: http://www.seinemaritime.net/guidedesaides/medias/File/aide-aux-investissements-pour-la-recuperation-des-eaux-pluviales-t2.pdf

Other information: —

---

V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 30.10.2009 | EN | Official Journal of the European Union | C 260/35 |
| --- | --- | --- | --- |

30.10.2009

EN

Official Journal of the European Union

C 260/35

---

Prior notification of a concentration

(Case COMP/M.5640 — SCF/AIG Bank/AIG Credit)

Candidate case for simplified procedure

(Text with EEA relevance)

2009/C 260/07

| 1. | On 16 October 2009 the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Santander Consumer Finance S.A. (‘SCF’, Spain) controlled by Banco Santander S.A. (‘The Santander Group’, Spain) acquires within the meaning of Article 3(1)(b) of the Regulation control of the whole of the undertakings AIG Bank Polska S.A. (‘AIG Bank’, Poland) and AIG Credit S.A. (Poland) by way of share swap. |
| --- | --- |

1.

On 16 October 2009 the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Santander Consumer Finance S.A. (‘SCF’, Spain) controlled by Banco Santander S.A. (‘The Santander Group’, Spain) acquires within the meaning of Article 3(1)(b) of the Regulation control of the whole of the undertakings AIG Bank Polska S.A. (‘AIG Bank’, Poland) and AIG Credit S.A. (Poland) by way of share swap.

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






  — | for undertaking SCF: consumer finance, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for undertaking SCF: consumer finance,

| — | for undertaking Santander Group: retail banking, asset management, corporate and investment banking and treasury, |
| --- | --- |

—

for undertaking Santander Group: retail banking, asset management, corporate and investment banking and treasury,

| — | for undertaking AIG Bank and AIG Credit: retail banking including hire purchase loans, cash loans, credit cards and deposits as well as insurance brokerage in Poland. |
| --- | --- |

—

for undertaking AIG Bank and AIG Credit: retail banking including hire purchase loans, cash loans, credit cards and deposits as well as insurance brokerage 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. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
| --- | --- |

3.

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

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301 or 22967244) or by post, under reference number COMP/M.5640 — SCF/AIG Bank/AIG Credit, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301 or 22967244) or by post, under reference number COMP/M.5640 — SCF/AIG Bank/AIG Credit, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

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

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

---

| 30.10.2009 | EN | Official Journal of the European Union | C 260/36 |
| --- | --- | --- | --- |

30.10.2009

EN

Official Journal of the European Union

C 260/36

---

Prior notification of a concentration

(Case COMP/M.5596 — Magna/Sberbank/GM/Opel)

(Text with EEA relevance)

2009/C 260/08

| 1. | On 22 October 2009, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings Magna International Inc. (‘Magna’, Canada), Sberbank Savings Bank of Russia (‘Sberbank’, Russian Federation) and General Motors Company (‘GM’, USA) acquire within the meaning of Article 3(1)(b) of the Regulation joint control of the undertaking Adam Opel GmbH (‘NewOpel’, Germany) by way of purchase of shares. |
| --- | --- |

1.

On 22 October 2009, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings Magna International Inc. (‘Magna’, Canada), Sberbank Savings Bank of Russia (‘Sberbank’, Russian Federation) and General Motors Company (‘GM’, USA) acquire within the meaning of Article 3(1)(b) of the Regulation joint control of the undertaking Adam Opel GmbH (‘NewOpel’, Germany) by way of purchase of shares.

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






  — | Magna is a diversified automotive supplier. It designs, develops and manufactures automotive systems, assemblies, modules and components, and engineers and assembles complete vehicles. Its products and services are sold primarily to manufacturers of cars and light commercial vehicles, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

Magna is a diversified automotive supplier. It designs, develops and manufactures automotive systems, assemblies, modules and components, and engineers and assembles complete vehicles. Its products and services are sold primarily to manufacturers of cars and light commercial vehicles,

| — | Sberbank, is one of the largest credit institutions in Russia and Eastern Europe. Its principal business activity is corporate and retail banking operations within the Russian Federation, |
| --- | --- |

—

Sberbank, is one of the largest credit institutions in Russia and Eastern Europe. Its principal business activity is corporate and retail banking operations within the Russian Federation,

| — | The principal business of GM is the manufacturer of automotive vehicles. Through its subsidiary Delphi it is also a supplier of automotive components, |
| --- | --- |

—

The principal business of GM is the manufacturer of automotive vehicles. Through its subsidiary Delphi it is also a supplier of automotive components,

| — | NewOpel is a manufacturer of automotive vehicles. |
| --- | --- |

—

NewOpel is a manufacturer of automotive vehicles.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. |
| --- | --- |

3.

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

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301 or 22967244) or by post, under reference number COMP/M.M.5596 — Magna/Sberbank/GM/Opel, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301 or 22967244) or by post, under reference number COMP/M.M.5596 — Magna/Sberbank/GM/Opel, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

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

---

| 30.10.2009 | EN | Official Journal of the European Union | C 260/37 |
| --- | --- | --- | --- |

30.10.2009

EN

Official Journal of the European Union

C 260/37

---

Prior notification of a concentration

(Case COMP/M.5647 — ADVENT/GFKL)

Candidate case for simplified procedure

(Text with EEA relevance)

2009/C 260/09

| 1. | On 23 October 2009, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Advent International Corporation (‘Advent’, USA) acquires, within the meaning of Article 3(1)(b) of the Regulation, control of the whole of the undertaking GFKL Financial Services AG (‘GFKL’, Germany) by way of purchase of shares. |
| --- | --- |

1.

On 23 October 2009, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Advent International Corporation (‘Advent’, USA) acquires, within the meaning of Article 3(1)(b) of the Regulation, control of the whole of the undertaking GFKL Financial Services AG (‘GFKL’, Germany) by way of purchase of shares.

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






  — | for Advent: private equity investor, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Advent: private equity investor,

| — | for GFKL: receivables management and software applications. |
| --- | --- |

—

for GFKL: receivables management and software applications.

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

3.

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

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301 or 22967244) or by post, under reference number COMP/M.5647 — ADVENT/GFKL, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301 or 22967244) or by post, under reference number COMP/M.5647 — ADVENT/GFKL, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

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

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

---

OTHER ACTS

Commission

| 30.10.2009 | EN | Official Journal of the European Union | C 260/38 |
| --- | --- | --- | --- |

30.10.2009

EN

Official Journal of the European Union

C 260/38

---

Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs

2009/C 260/10

This publication confers the right to object to the application pursuant to Article 7 of Council Regulation (EC) No 510/2006. Statements of objection must reach the Commission within six months from the date of this publication.

SINGLE DOCUMENT

COUNCIL REGULATION (EC) No 510/2006

‘MIÓD KURPIOWSKI’

EC No: PL-PGI-0005-0607-30.05.2007

PGI ( X ) PDO ( )

1.   Name:

‘Miód kurpiowski’

2.   Member State or third country:

Poland

3.   Description of the agricultural product or foodstuff:

3.1.   Type of product:

| Class 1.4. | Other products of animal origin, honey |
| --- | --- |

Class 1.4.

Other products of animal origin, honey

3.2.   Description of the product to which the name in (1) applies:

Microscopic characteristics:

‘Miód kurpiowski’ is a nectar honey, with the possible inclusion of honeydew. It is a polyfloral honey; pollen from any one plant species must not account for more than 30 % of the total, and pollen from crop plants may not exceed 10 % of the total.

Organoleptic characteristics:

‘Miód kurpiowski’ is a liquid or crystallised nectar honey, with the possible inclusion of honeydew. Its consistency is thick, liquid and viscous. It forms medium- and fine-grained crystals, and its colour ranges from pale yellow, through straw-coloured to brown with greenish highlights. The greenish highlights indicate the proportion of honeydew in the honey. The honey has an intense aroma, with a distinctive spicy fragrance and a delicate, slightly sweet taste.

Physico-chemical characteristics:

Physico-chemical characteristics of ‘miód kurpiowski’

| — | simple sugar (glucose and fructose) content — not less than 60 g/100 g |
| --- | --- |

—

simple sugar (glucose and fructose) content — not less than 60 g/100 g

| — | sucrose content — not more than 5 g/100 g |
| --- | --- |

—

sucrose content — not more than 5 g/100 g

| — | diastase activity (Schade scale) — not less than 8 |
| --- | --- |

—

diastase activity (Schade scale) — not less than 8

| — | free acids — not more than 50 meq/kg |
| --- | --- |

—

free acids — not more than 50 meq/kg

| — | electrical conductivity — not less than 0,8 mS/cm, |
| --- | --- |

—

electrical conductivity — not less than 0,8 mS/cm,

| — | water-insoluble content — not more than 0,1 g/100 g |
| --- | --- |

—

water-insoluble content — not more than 0,1 g/100 g

| — | water content — not more than 18,5 % |
| --- | --- |

—

water content — not more than 18,5 %

| — | HMF (5-hydroxymethylfurfural) content — not more than 10 mg/kg. |
| --- | --- |

—

HMF (5-hydroxymethylfurfural) content — not more than 10 mg/kg.

‘Miód kurpiowski’ is produced exclusively by bees of the following races: the European dark bee (Apis mellifera mellifera), the Carniolan honeybee (Apis mellifera carnica) and the Caucasian honeybee (Apis mellifera caucasica) and bees resulting from the interbreeding of these races.

3.3.   Raw materials (for processed products only):

—

3.4.   Feed (for products of animal origin only):

The feeding of bees is not permitted during the period in which ‘miód kurpiowski’ is harvested. The bees may be fed after the honey has been extracted, before winter, in quantities necessary to build up reserves to ensure that the colony can survive the winter. Colonies may be fed beet-sugar syrup or glucose-fructose syrups. Beet sugar and glucose-fructose syrups may originate outside the geographical area in which ‘miód kurpiowski’ is obtained. This does not affect the quality of the honey. The winter reserves must not find their way into ‘miód kurpiowski’.

3.5.   Specific steps in production that must take place in the identified geographical area:

All stages in the production of ‘miód kurpiowski’, from the positioning of the apiaries to the final packaging of the honey, must take place in the defined geographical area. ‘Miód kurpiowski’ is cold-spun in a honey extractor using centrifugal force. After being clarified in tanks, the honey is decanted into various kinds of retail packaging. The honey must be decanted into retail packaging before the first crystallisation takes place.

3.6.   Specific rules concerning slicing, grating, packaging, etc.:

The packaging of ‘miód kurpiowski’ must take place in the area identified in 4. This requirement was introduced to ensure that the product is of an appropriate quality and for the purposes of monitoring and checking its origin. The requirement for packaging to take place in the area is aimed at minimising the risk of ‘miód kurpiowski’ being mixed with other types of honey and of other honeys being sold under this protected name.

3.7.   Specific rules concerning labelling:

All beekeepers and entities engaged in the buying-in and further processing of honey under the protected name are required to use one type of label. Labels will be distributed through the Kurpiowsko-Mazowiecki Związek Pszczelarzy (Kurpiowsko-Mazovian Beekeepers' Association) in Ostrołęka. The association forwards detailed rules on the distribution of the labels to the inspection body. The single-label system is intended to guarantee the appropriate quality and facilitate product traceability. These rules may not in any way discriminate against producers who do not belong to the association.

4.   Concise definition of the geographical area:

‘Miód kurpiowski’ is harvested in the area known in a historical and ethnographical context as Kurpie.

This comprises the following area of Mazowieckie Voivodship:

| | the municipalities of Chorzele, Jednorożec and Przasnysz in Przasnysz District; |
| --- | --- |

the municipalities of Chorzele, Jednorożec and Przasnysz in Przasnysz District;

| | the municipalities of Krasnosielc, Płoniawy-Bramura, Sypniewo, Młynarze, Różan, Rzewnie and Maków in Maków District; |
| --- | --- |

the municipalities of Krasnosielc, Płoniawy-Bramura, Sypniewo, Młynarze, Różan, Rzewnie and Maków in Maków District;

| | the municipalities of Obryte and Zatory in Pułtus District; |
| --- | --- |

the municipalities of Obryte and Zatory in Pułtus District;

| | the municipalities of Długosiodło, Brańszczyk and Rząśnik in Wyszków District; |
| --- | --- |

the municipalities of Długosiodło, Brańszczyk and Rząśnik in Wyszków District;

| | the municipalities of Brok, Ostrów, Wąsewo and Małkinia in Ostrów District; |
| --- | --- |

the municipalities of Brok, Ostrów, Wąsewo and Małkinia in Ostrów District;

| | the municipalities of Goworowo, Czerwin, Rzekuń, Olszewo-Borki, Lelis, Troszyn, Baranowo, Kadzidło, Czarnia, Myszyniec and Łyse in Ostrołęka District. |
| --- | --- |

the municipalities of Goworowo, Czerwin, Rzekuń, Olszewo-Borki, Lelis, Troszyn, Baranowo, Kadzidło, Czarnia, Myszyniec and Łyse in Ostrołęka District.

It also comprises the following area of Podlaskie Voivodship:

| | the municipality of Turośl in Kolno District; |
| --- | --- |

the municipality of Turośl in Kolno District;

| | the municipalities of Nowogród and Zbójna in Łomża District. |
| --- | --- |

the municipalities of Nowogród and Zbójna in Łomża District.

5.   Link with the geographical area:

5.1.   Specificity of the geographical area:

‘Miód kurpiowski’ comes from the area known as Kurpie. This area is divided into Kurpie Zielone (Green Kurpie) and Kurpie Białe (White Kurpie). Kurpie Zielone consists of the lands along the right bank of the river Narew and the area around its tributaries, the Pisa, Skwa, Omulew and Rozoga, as far as the left bank of the river Orzyc. Kurpie Białe consists of the lands between the right bank of the lower course of the river Bug and its tributaries, the Tuchełka and the Brok, and the left bank of the lower course of the river Narew and its tributaries, the Wymakracz and the Orz. Kurpie Zielone abounds in rivers and lakes, which is conducive to plant life — hence its name. Kurpie Białe is drier. Its name is derived from its podzolic (white) soils.

Natural factors:

Kurpie is characterised by a very low level of urbanisation. There are no large or medium-sized industrial plants and there are no large-scale commercial farms. Not a single town in the Kurpie region has over 100 000 inhabitants. Thanks in part to its exceptional natural assets, the area has been classed as one of the ‘Green Lungs of Europe’. The exceptional nature of the region is also shown by the number of Natura 2000 sites: Dolina Dolnego Bugu (site code PLB 140001), Puszcza Biała (site code PLB 140007) and Dolina Omulwi i Płodownicy (site code PLB 140005). The region also includes the Nadbużański Landscape Park, and a large number of nature reserves, such as ‘Czarnia’ forest reserve, ‘Surowe’, ‘Czarny Kąt’, ‘Kaniston’, ‘Łokieć’, ‘Tabory’, ‘Minos’, ‘Serafin’, ‘Karaska’, ‘Podgórze’ and ‘Olsy Płoszycie’. The Puszcza Biała site also contains the following nature conservation areas: ‘Dąbrowa’, ‘Nagoszewo’, ‘Brzostowo’, ‘Ochudno’, ‘Czuraj’, ‘Popławy’, ‘Bartnia’, ‘Wielgolas’ and ‘Stawinoga’.

As much as 29 % of the area identified at 4 is covered by forest, whilst other land uses — towns, villages, roads and industry — account for only 1 %. Meadow and scrubland account for 45 % of the area and farmed land 35 %. These habitats do not cover large areas, but form a patchwork (like a mosaic), which means that there is no dominant pollen type in ‘miód kurpiowski’. The area is characterised by poor quality soils (classes V and VI). Class IV soils occur only in the river valleys.

This area also has the lowest average atmospheric precipitation in Poland (not exceeding 500 mm per year).

Human factors:

The area defined at 4 is characterised by great diversity, extensive methods of land use and very low precipitation. This means that the nectar yield of nectar-bearing plants is low, and this, in turn, means that the honey has to be obtained over long periods. In the Kurpie region, it is the beekeeper, rather than the bees, that as a rule has to seek out the nectar, and he positions his hives in good honey-producing locations. ‘Miód kurpiowski’ has been obtained by the traditional method, from grassland and forests, continuously since the 16th century. Grasslands (meadows, pastures and fallow land) are the source of the spring nectar honeys obtained in May and June. Coniferous (spruce and pine) forests are the main source of the summer honeydew and nectar honeys obtained in July and August. Traditionally, the first harvest of honey, produced from spring nectar, takes place in the first half of June. The second harvest of honey, produced from summer nectar, which concludes the honey-collecting season, takes place in the second half of July.

The skills of the local beekeepers are reflected in the selection of sites for apiaries and, in particular, the keeping of apiaries in areas where the nectar yield is low or very low. The times of collecting and (cold) spinning honey and the method of keeping and decanting the honey are determined by centuries-old tradition. Appropriate parameters for ‘miód kurpiowski’, especially those aimed at making sure that it remains of the highest quality, are possible only if very great care is taken in the process of obtaining the honey and if beekeepers comply with the characteristic restrictions that apply to its production. The temperature of the honey must not exceed 30 °C at any stage of production. The filtering (to remove pollen), creaming or pasteurisation and artificial heating of the honey are not permitted. The use of chemicals or other bee repellents, whether in solid, liquid or gaseous form, is forbidden during the process of harvesting the honey. The production of ‘miód kurpiowski’ therefore requires beekeepers to possess great skill and a knowledge of the processes at play in the natural environment. Another feature of beekeeping in Kurpie is the small number of beekeepers — the result of environmental conditions which make it difficult to keep hives. The number of beekeepers working in the area is estimated at no more than 400, with the total number of colonies not exceeding 8 000.

5.2.   Specificity of the product:

‘Miód kurpiowski’ is obtained from the nectar of a number of plant species which flower in succession. The specificity of the product is determined chiefly by two parameters:

| 1. | Pollen composition — the pollen of any one plant species must not account for more than 30 % of the total, and pollen from crop plants may not exceed 10 % of the total. |
| --- | --- |

1.

Pollen composition — the pollen of any one plant species must not account for more than 30 % of the total, and pollen from crop plants may not exceed 10 % of the total.

| 2. | The HMF (5-hydroxymethylfurfural) content must not exceed 10 mg/kg. |
| --- | --- |

2.

The HMF (5-hydroxymethylfurfural) content must not exceed 10 mg/kg.

5.3.   Causal link between the geographical area and the quality or characteristics of the product (for PDO) or a specific quality, the reputation or other characteristic of the product (for PGI):

The exceptional properties of ‘miód kurpiowski’ are due to the specific qualities described at 5.2 and its reputation. Key to the quality of the final product are the very substantial restrictions that apply to its production, e.g. the fact that a temperature of 30 °C must not be exceeded at any stage of production means that all the natural enzymes, essential compounds and other constituents typical of honey are present in the final product. The above mentioned temperature restriction and the requirement that the honey be decanted into retail packaging before the first crystallisation takes place help ensure that the HMF content does not exceed 10 mg/kg. The varied pollen composition of ‘miód kurpiowski’ (in which there is no dominant pollen type) is due to the wealth of diverse plant habitats in the Kurpie region. The product began to earn a good reputation in Kurpie Zielone and Kurpie Białe in the 15th century. Beekeeping in the region dates back to that era. There are many well-documented references to ‘miód kurpiowski’ over the years — from the royal edict on forest beekeeping (regale bartne) of 1401, through the forest beekeeping law of 1559, by which the conversion from customary to beekeeping law was secured, right up to the present day. Kurpie’s links with beekeeping are also reflected in a number of customs related to bees and honey.

In the 20th century, in order to celebrate the status of ‘miód kurpiowski’ as a product inextricably linked with the local forests, the idea of holding a festival in honour of the honey was revived. The first festival after a long break was held in September 1976. It is the biggest event in the region. It is estimated that between 20 000 and 35 000 people attended the Kurpiowskie Miodobranie (Kurpie Honey Harvest) festival every year between 2002 and 2006. Another indication of the popularity of the festival is that, in the course of a single day in 2005, over 60 beekeepers displayed their wares and approximately 12 tonnes of honey was sold. Both the time and the venue of the festivities keep up Kurpie traditions that go back to the 16th century.

Kurpie’s rich beekeeping traditions and the reputation of ‘miód kurpiowski’ also feature in a great number of publications, for instance ‘Zwyczaje Doroczne Kurpiowskiej Puszczy Zielonej’, 2005, by Bernard Kielak, and ‘Bartnictwo Kurpiowskiej Puszczy Zielonej’, published in Łomża in 2004.

The product's reputation can also be gauged from numerous articles and documents indicating that it has become part of the culture and identity of the people who live here. Information on the product and related events is published in the national, regional and local press, e.g. an article entitled ‘miód folklor i konfitura’, which appeared in the Gazeta Współczesna in 2004, and an article entitled ‘Jak to na Kurpiach miód w puszczy podbierają’, which appeared in the Zielony Sztandar weekly.

The honey’s reputation is confirmed by TV films and documentaries about ‘miód kurpiowski’, such as ‘Puszcza Zielona’ (TVP 1) in 1985, ‘Bursztyn i Miód w tradycji kurpiowskiej’ (TVP 1) in 1997, and ‘Kurpiowskie Miodobranie’ (TVP 3), which was broadcast in 2002.

The reputation of ‘miód kurpiowski’ and its role in the region are also evidenced by the fact that the Polish Tourist Organisation in 2004 awarded its Best Tourism Product prize to the Kurpiowskie Miodobranie. ‘Miód kurpiowski’ was also awarded a ‘Perła 2007’ prize in the ‘Nasze Kulinarne Dziedzictwo’ (Our Culinary Heritage) competition.

Kurpie is proud of the quality of the honey produced there. The reputation now enjoyed by ‘miód kurpiowski’ could not have been earned without the climatic conditions that prevail in the area. They contribute to the unique properties of ‘miód kurpiowski’ and to its quality and reputation.

Reference to publication of the specification:

(Article 5(7) of Regulation (EC) No 510/2006)

http://www.bip.minrol.gov.pl/strona/DesktopDefault.aspx?TabOrgId=1620&LangId=0

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| 30.10.2009 | EN | Official Journal of the European Union | C 260/43 |
| --- | --- | --- | --- |

30.10.2009

EN

Official Journal of the European Union

C 260/43

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Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs

2009/C 260/11

This publication confers the right to object to the application pursuant to Article 7 of Council Regulation (EC) No 510/2006. Statements of objection must reach the Commission within six months from the date of this publication.

SINGLE DOCUMENT

COUNCIL REGULATION (EC) No 510/2006

‘RICOTTA DI BUFALA CAMPANA’

EC No: IT-PDO-0005-0559-18.10.2006

PGI ( ) PDO ( X )

1.   Name:

‘Ricotta Di Bufala Campana’

2.   Member State or Third Country:

Italy

3.   Description of the agricultural product or foodstuff:

3.1.   Type of product (Annex II):

| Group 1.4. | Other products of animal origin (eggs, honey, various milk products, not including butter, etc.). |
| --- | --- |

Group 1.4.

Other products of animal origin (eggs, honey, various milk products, not including butter, etc.).

3.2.   Description of the product to which the name in (1) applies:

Ricotta di Bufala Campana PDO is a fresh, i.e. not matured, dairy product that is produced through coagulation by heating of the protein in buffalo milk whey, a raw material which is a by-product of mozzarella di bufala production. Ricotta di Bufala Campana PDO is characterised by a high water content (less than 75 %), and a fat content of not less than 12 % for the whole food. The high fat content in the dry substance (minimum 45 %) is responsible for the product’s specific properties in terms of creaminess and softness. In addition, Ricotta di Bufala Campana PDO is characterised by a sweet and fragrant buffalo milk taste, made possible by a negligible fermentation acid content, not exceeding 0,3 % lactic acid, and enhanced by a limited sodium content, not exceeding 0,3 %. When placed on the market, ‘Ricotta di Bufala Campana’ PDO is presented in a truncated pyramid or truncated cone shape with a maximum weight of 2 000 gr, is porcelain white in colour, has no rind and a soft, grainy but not gritty consistency. The taste is unique, fresh, and delicately sweet and it smells of milk and cream. ‘Ricotta di Bufala Campana’ PDO is sold as ‘fresca’ and ‘fresca omogeneizzata’; for the latter variety, the ricotta, drained of the whey, is heat treated so as to lengthen its shelf-life (a maximum of 21 days from the production date) whereas the ‘fresca’ variety has a maximum shelf-life of 7 days.

3.3.   Raw materials (for processed products only):

The raw material for the production of ‘Ricotta di Bufala Campana’ PDO is the ‘first whey’ (or ‘sweet whey’) which is the by-product of processing buffalo milk, obtained by manually or mechanically milking buffalos of the Italian Mediterranean breed reared in the production area referred to in point 4. The ‘first whey’ (or ‘sweet whey’) must be obtained by draining the curds broken for the production of mozzarella di bufala. The maximum titratable acidity of the whey used for the production of ‘Ricotta di Bufala Campana’ PDO is 3,5oSH/50 ml, which means that the ‘acid whey’ resulting from the complete maturation of the curds cannot be used for the production of ‘Ricotta di Bufala Campana’ PDO. Heat-treated or pasteurised raw buffalo milk from the zone referred to in point 4 may be added up to a maximum proportion of 6 % of the quantity of ‘first whey’ (or ‘sweet whey’). Fresh buffalo milk cream from buffalo milk whey from the area referred to in point 4 may be added up to a maximum proportion of 5 % of the quantity of first whey. Such additions serve to thicken the consistency of the ricotta and facilitate its formation or extraction. Salt (NaCl) may be added up to a maximum proportion of 1 kg per 100 kg of ‘first whey’ (or ‘sweet whey’) or mixture of whey with milk and/or fresh cream.

3.4.   Feed (for products of animal origin only):

Lactating buffalos are fed with fresh and/or dry fodder of which at least half originates from the area referred to in point 4, thus maintaining the vital link between this product and the land. The following indigenous plants provide the principal sources of fodder in the meadows and pastureland of this zone: Sainfoin (Onobrychis viciaefolia); Sulla (Hedysarum coronarium L.); Persian clover (Trifolium resupinatum); Squarrose clover (Trifolium squarrosum L.); Berseem/egyptian clover (Trifolium resupinatum); Vetch (Vicia sativa); Rescue grass (Bromus catharticus) and Birdsfoot. In addition, the use of simple or complex feed concentrates with permitted mineral and vitamin supplement additives is permitted.

3.5.   Specific steps in production that must take place in the identified geographical area:

The production of the milk, whey and fresh cream from the whey as well as of the ricotta must take place within the area referred to in point 4.

3.6.   Specific rules concerning slicing, grating, packaging, etc.:

As an unfermented, rindless product, ‘Ricotta di Bufala Campana’ PDO is 100 % edible and particularly subject, possibly even more than other fresh dairy products, to the risk of contamination after production and therefore deterioration through an increase in the level of environmental micro-organisms that could enter into contact with the product surface during the final draining process of the Ricotta. As a fresh product, Ricotta di Bufala Campana PDO is not matured and therefore all microbial growth must be avoided during the shelf-life period. In order to avoid the risk of deterioration, the product should be packaged inside the same certified production facility. ‘Ricotta di Bufala Campana’ PDO has to be wrapped in paper and packed in closed food grade plastic containers or in other food grade packaging. If the product is sold for use as an ingredient in processed food, packs of up to 40 kg are allowed.

3.7.   Specific rules on labelling:

In addition to the designation and Community logos and the information required by law, the packaging should clearly and legibly state the words ‘fresca’ or ‘fresca omogeneizzata’ that should be listed directly under the designation ‘Ricotta di Bufala Campana’ in letters half the size of those used for the designation ‘Ricotta di Bufala Campana’.

Any other description not expressly allowed is prohibited including the following adjectives: ‘fine, scelto, extra, selezionato, superiore, genuino’ or otherwise praising the product; however, the use of brand names is permitted, provided they have no laudatory purport and are not likely to mislead the consumer, as well as other truthful and documented references that are compatible with the legislation in force. The words ‘Ricotta di Bufala Campana’ must be in Italian.

The product logo has been issued by the inspection body as instructed by the Ministry of Agricultural, Food and Forestry Policy. The product logo is a loop of tri-colour ribbon encircling a buffalo head depicted in profile. Around this device runs the wording RICOTTA DI BUFALA CAMPANA printed in capitals.

Image

4.   Concise definition of the geographical area:

The production area of ‘Ricotta di Bufala Campana’ PDO includes part of the administrative territory of the Regions of Campania, Lazio, Apulia and Molise as detailed below. In Campania, it concerns principally the area around the rivers Garigliano and Volturno and an area on the plain of the river Sele and the area of Cilento, i.e. on the coast and in the valleys; in Lazio, this area is concentrated between the valleys of the river Amaseno and the nearby plain of Pontina; in Apulia, it concerns the stretch of plains and hills of the province of Foggia on the foothills of the Gargano promontory; in Molise, Venafro is the only municipality affected, which has only recently come under the administration of Molise.

5.   Link with the geographical area:

5.1.   Specificity of the geographical area:

The orographic, soil and climatic conditions of the territory listed in point 4 are the principal factors that have been conducive to the spread of buffalo farming in these areas. The morphology of the buffalo makes it ideally suited to cope with any climatic or environmental difficulties and to being farmed in areas with a typically Mediterranean climate. The pedological characteristics of the plains, whose soil is of alluvial origin and/or originally marshy or swampy, and of the hills, among which there is land of volcanic origin, together with the macro-climate typical of this part of the Mediterranean, have dictated which plants grow wild and/or are cultivated in the fields and meadows and the choice of straw of various kinds used to feed the buffalo. Furthermore, for centuries this land has constituted a single territorial, political and administrative unit, as the Kingdom of Naples from 1282 until 1860. One of the factors uniting these land areas is that for centuries they have been used to raise buffalo farmed to produce milk to make cheese and ricotta. The geographical area, even after the draining of the swampy areas and the political and administrative changes, has retained many common features, including the tradition and development of a strong productive district in the form of hundreds of buffalo farmers and cheese makers. According to the data of the National livestock register for Teramo (2008), 92 % of Italy’s Mediterranean breed buffalo are to be found in this area.

5.2.   Specificity of the product:

‘Ricotta di Bufala Campana’ can be distinguished from other products in the same category and, more specifically, from other varieties of Ricotta, on account of the specific structural characteristics of creaminess and softness, for its white porcelain colour, and the unmistakable sensory properties that may be described as the scent of milk and sweetness. This product's uniqueness is attributable to the fact that the composition of buffalo milk whey (in terms of fats and protein) is qualitatively and quantitatively different from the cow’s and sheep’s milk whey used to produce other types of Ricotta. Buffalo milk whey is in fact richer in fat (up to 2,5 %) with regard to cow’s and sheep’s milk on account of the higher fat content (over 8 %) in whole buffalo milk, and contains whey protein levels (0,9-1,0 %) that are higher than that of cow’s milk, but which fluctuate depending on the protein level of the milk from which it was made. The specificity of buffalo whey protein is such that it can be distinguished in laboratory analyses from that of other animals. It even has distinct aromatic characteristics that are attributable to the natural starter whey used for the production of buffalo mozzarella whose characteristics, including aromatics, are transferred proportionally into the sweet whey used for the production of Ricotta di Bufala Campana PDO. The natural whey may thus contain both aromatic ingredients naturally present in the milk, and also ingredients that are not present in the milk as they are produced by native microflora during the production of the natural whey itself. The high fat content in the dry substance and the specific characteristics of the triglycerides of buffalo milk, in which the fatty acids are esterified in a different position compared to cow’s milk fat, contribute to producing the physical and organoleptic characteristics that are absolutely specific, such as the creaminess and softness, as well as to preserving all the aromatic components. The absence of beta-carotene in buffalo milk is one of the causes of the typical white porcelain colour of buffalo milk and cheeses, among which Ricotta, as opposed to cow's milk cheese products. Ricotta di Bufala Campana PDO is different from sheep’s milk Ricotta, as the cheese-making process for many sheep's milk cheeses involves the use of solid rennet, the richness of which in lipase can affect the sensorial qualities of the fat. The absence of lipolysis is therefore a characteristic trait of Ricotta di Bufala Campana PDO which has the effect of heightening the qualities of sweetness and the fragrance of milk. Prohibiting the use of whey during the acidification process and applying specific requirements to the production process regarding the maximum shelf-life are two related safeguards that ensure and maintain this product’s specific characteristics that are unique throughout the whole range of Ricotta-type products. To guarantee the unique sweet and fragrant milk taste characterised by the absence of acid notes, only the ‘first whey’ (or ‘sweet whey’), separated immediately after the curds have been broken and therefore characterised by a maximum titratable acid content of 3,5oSH/50 ml, can be used. The ‘acid whey’, produced by draining the whey after breaking the curds as they are maturing, cannot be used for the production of Ricotta di Bufala Campana PDO, as the high level of lactic acid would not bring out the specific characteristics of the Ricotta or would make it necessary to add alkalis as neutralising agents, which would affect the taste, structure and consistency. ‘Ricotta di Bufala Campana’ PDO is therefore also distinct from a generic buffalo milk ricotta, as the composition of the whey is intrinsically linked to the characteristics of the milk and how it is processed into cheese.

5.3.   Causal link between the geographical area and the quality or characteristics of the product (for PDO) or a specific quality, the reputation or other characteristic of the product (for PGI):

The specificity of ‘Ricotta di Bufala Campana’, described in point 5.2, is intrinsically determined by the quality of the raw materials: whey, fresh cream from buffalo whey and milk that, only if produced in the area of production referred to in point 4, can boost superior characteristics with regard to the same products produced in other areas. The orographic, soil and climatic conditions and macroclimatic characteristics of the area in question are the principal factors that contribute to give the fodder plants that are grow in the meadows and, in consequence, the milk and therefore the whey used to produce ‘Ricotta di Bufala Campana’ PDO, the specific organoleptic characteristics that make this Ricotta unique and recognisable. As compared to other cheeses, the causal link between geographic area, raw material and product is even more complex, as Ricotta is a product whose raw material, whey, is a by-product of processing milk into cheese. The link with the geographic area therefore depends on the producers’ capacity to obtain whey that retains, within the limits of the inevitable difference, the original characteristics of the milk. Choosing to use only sweet whey, that is to say unfermented whey produced when the fresh buffalo milk curd is broken, is the only way of being able to transfer the characteristics of the milk into the Ricotta, and these characteristics are in turn intrinsically linked to the territory of origin. The richness of buffalo milk fat means that the whey has a fat content even higher than that of cow’s milk whey and this enables the aromatic qualities of the milk that are specifically encapsulated in the fat molecules to be retained. The human factor is clearly essential for maintaining this strong link and through it obtaining a unique product.

The centuries-old production practices for Ricotta di Bufala in the territory of the former Kingdom of Naples and subsequently in the current geographic-administrative subdivisions had already understood the need to use only fresh milk and genuinely fresh whey, i.e. separated as soon as the curds are broken. In 1859, Achille Bruni, Professor of the Regia University of Naples, in his monograph ‘On milk and its derivatives’ published in the New Agricultural Encyclopaedia described how Ricotta di Bufala was produced at that time: ‘Take the milk fresh from the buffalo and pour it into the vat, add the goat rennet; once it has set, cut it into large bits with a wooden spatula. Then with a wooden ladle drain off the whey and boil it to extract the ricotta.’

Reference to publication of the specification:

The Government launched the national objection procedure with the publication of the proposal for recognising ‘Ricotta di Bufala Campana’ as a protected designation of origin in Official Gazette of the Italian Republic No 75 of 30 March 2006.

The full text of the product specification is available on the following web site: http://www.politicheagricole.it/DocumentiPubblicazioni/Search_Documenti_Elenco.htm?txtTipoDocumento=Disciplinare%20in%20esame%20UE&txtDocArgomento=Prodotti%20di%20Qualit%E0>Prodotti%20Dop,%20Igp%20e%20Stg

or

by going directly to the home page of the Ministry of Agricultural, Food and Forestry Policy (http://www.politicheagricole.it) and clicking on ‘Prodotti di Qualità’ (on the left of the screen) and finally on ‘Disciplinari di Produzione all’esame dell’UE [regolamento (CE) n. 510/2006]’.

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