# Official Journal C 73/2009

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 73 |
| | |
| English edition | Information and Notices | Volume 5227 March 2009 |

ISSN 1725-2423

Official Journal

of the European Union

C 73

English edition

Information and Notices

Volume 5227 March 2009

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 073/01 | Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (
  1
  ) | 1 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 073/01

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

1

1

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 073/02 | Euro exchange rates | 4 |
| 2009/C 073/03 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2009 to 28 February 2009(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 5 |
| 2009/C 073/04 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2009 to 28 February 2009(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC
  ) | 16 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 073/02

Euro exchange rates

4

2009/C 073/03

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2009 to 28 February 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

)

5

2009/C 073/04

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2009 to 28 February 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

)

16

| | V   Announcements |
| --- | --- |
| | ADMINISTRATIVE PROCEDURES |
| | Commission |
| 2009/C 073/05 | MEDIA 2007 — Development, distribution, promotion and training — Call for proposals — EACEA/03/09 — Support for the transnational distribution of European films — The Automatic Scheme 2009 | 41 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2009/C 073/06 | Notice by the Ministry of the Economy of the Republic of Latvia of a call for tenders for hydrocarbon exploration and production within the exclusive economic zone of the Republic of Latvia | 43 |
| | OTHER ACTS |
| | Commission |
| 2009/C 073/07 | 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 | 45 |

V   Announcements

ADMINISTRATIVE PROCEDURES

Commission

2009/C 073/05

MEDIA 2007 — Development, distribution, promotion and training — Call for proposals — EACEA/03/09 — Support for the transnational distribution of European films — The Automatic Scheme 2009

41

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2009/C 073/06

Notice by the Ministry of the Economy of the Republic of Latvia of a call for tenders for hydrocarbon exploration and production within the exclusive economic zone of the Republic of Latvia

43

OTHER ACTS

Commission

2009/C 073/07

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

45

| | Corrigenda |
| --- | --- |
| 2009/C 073/08 | Corrigendum to authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (OJ C 62, 17.3.2009) | 50 |

Corrigenda

2009/C 073/08

Corrigendum to authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (OJ C 62, 17.3.2009)

(OJ C 62, 17.3.2009)

50

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

---

(1)   Text with EEA relevance

1

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

EN

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 27.3.2009 | EN | Official Journal of the European Union | C 73/1 |
| --- | --- | --- | --- |

27.3.2009

EN

Official Journal of the European Union

C 73/1

---

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

Cases where the Commission raises no objections

(Text with EEA relevance)

(2009/C 73/01)

| Date of adoption of the decision | 23.12.2008 |
| --- | --- |
| Reference number of the aid | N 143/08 |
| Member State | Slovakia |
| Region | Stredné Slovensko |
| Title (and/or name of the beneficiary) | ZSNP, a.s. |
| Legal basis | Zákon č. 587/2004 Z. z. o Environmentálnom fonde a o zmene a doplnení niektorých zákonov v znení neskorších predpisov; Vyhláška Ministerstva životného prostredia Slovenskej republiky č. 157/2005 Z. z., ktorou sa vykonáva zákon č. 587/2004 Z. z. o Environmentálnom fonde a o zmene a doplnení niektorých zákonov; Zákon č. 231/1999 Z. z. o štátnej pomoci v znení neskorších predpisov |
| Type of measure | Individual aid |
| Objective | Environmental protection |
| Form of aid | Soft loan |
| Budget | Overall budget: SKK 65,8 million |
| Intensity | 12 % |
| Duration | — |
| Economic sectors | Manufacturing industry |
| Name and address of the granting authority | Environmentálny fond |
| Bukureštská 4 |
| 813 26 Bratislava |
| SLOVENSKÁ REPUBLIKA |

Date of adoption of the decision

23.12.2008

Reference number of the aid

N 143/08

Member State

Slovakia

Region

Stredné Slovensko

Title (and/or name of the beneficiary)

ZSNP, a.s.

Legal basis

Zákon č. 587/2004 Z. z. o Environmentálnom fonde a o zmene a doplnení niektorých zákonov v znení neskorších predpisov; Vyhláška Ministerstva životného prostredia Slovenskej republiky č. 157/2005 Z. z., ktorou sa vykonáva zákon č. 587/2004 Z. z. o Environmentálnom fonde a o zmene a doplnení niektorých zákonov; Zákon č. 231/1999 Z. z. o štátnej pomoci v znení neskorších predpisov

Type of measure

Individual aid

Objective

Environmental protection

Form of aid

Soft loan

Budget

Overall budget: SKK 65,8 million

Intensity

12 %

Duration

—

Economic sectors

Manufacturing industry

Name and address of the granting authority

Environmentálny fond

Bukureštská 4

813 26 Bratislava

SLOVENSKÁ REPUBLIKA

Other information

—

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

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

| Date of adoption of the decision | 24.2.2009 |
| --- | --- |
| Reference number of the aid | N 77/09 |
| Member State | Hungary |
| Region | — |
| Title (and/or name of the beneficiary) | Limited amounts of compatible aid |
| Legal basis | Art. 23/A, 23/C and 23/D. of the Government Decree 85/2004. (IV. 19.) on the Procedure regarding State Aid defined by Article 87 (1) of the EC Treaty and on the Regional Aid Map |
| Type of measure | Individual aid |
| Objective | Aid to remedy serious disturbances in the economy |
| Form of aid | Ad hoc contracts |
| Budget | — |
| Intensity | — |
| Duration | 22.2.2009-31.12.2010 |
| Economic sectors | All sectors |
| Name and address of the granting authority | All competent aid granting authorities in the Hungary |
| Other information | — |

Date of adoption of the decision

24.2.2009

Reference number of the aid

N 77/09

Member State

Hungary

Region

—

Title (and/or name of the beneficiary)

Limited amounts of compatible aid

Legal basis

Art. 23/A, 23/C and 23/D. of the Government Decree 85/2004. (IV. 19.) on the Procedure regarding State Aid defined by Article 87 (1) of the EC Treaty and on the Regional Aid Map

Type of measure

Individual aid

Objective

Aid to remedy serious disturbances in the economy

Form of aid

Ad hoc contracts

Budget

—

Intensity

—

Duration

22.2.2009-31.12.2010

Economic sectors

All sectors

Name and address of the granting authority

All competent aid granting authorities in the Hungary

Other information

—

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

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

| Date of adoption of the decision | 24.2.2009 |
| --- | --- |
| Reference number of the aid | N 78/09 |
| Member State | Hungary |
| Region | — |
| Title (and/or name of the beneficiary) | Temporary aid scheme for granting aid in the form of loans with subsidised interest rate |
| Legal basis | Art. 23/B, Art. 23/C and Art. 23/D of the Government Decree 85/2004. (IV. 19.) on the Procedure regarding State Aid defined by Article 87 (1) of the EC Treaty and on the Regional Aid Map |
| Type of measure | Individual aid |
| Objective | Aid to remedy serious disturbances in the economy |
| Form of aid | Ad hoc contracts |
| Budget | — |
| Intensity | — |
| Duration | 23.2.2009-31.12.2010 |
| Economic sectors | All sectors |
| Name and address of the granting authority | All competent aid granting authorities in Hungary |
| Other information | — |

Date of adoption of the decision

24.2.2009

Reference number of the aid

N 78/09

Member State

Hungary

Region

—

Title (and/or name of the beneficiary)

Temporary aid scheme for granting aid in the form of loans with subsidised interest rate

Legal basis

Art. 23/B, Art. 23/C and Art. 23/D of the Government Decree 85/2004. (IV. 19.) on the Procedure regarding State Aid defined by Article 87 (1) of the EC Treaty and on the Regional Aid Map

Type of measure

Individual aid

Objective

Aid to remedy serious disturbances in the economy

Form of aid

Ad hoc contracts

Budget

—

Intensity

—

Duration

23.2.2009-31.12.2010

Economic sectors

All sectors

Name and address of the granting authority

All competent aid granting authorities in Hungary

Other information

—

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

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

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 27.3.2009 | EN | Official Journal of the European Union | C 73/4 |
| --- | --- | --- | --- |

27.3.2009

EN

Official Journal of the European Union

C 73/4

---

Euro exchange rates (1)

26 March 2009

(2009/C 73/02)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,3607 |
| JPY | Japanese yen | 133,63 |
| DKK | Danish krone | 7,4488 |
| GBP | Pound sterling | 0,9316 |
| SEK | Swedish krona | 10,8765 |
| CHF | Swiss franc | 1,5266 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 8,8175 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 27,233 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 302 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7095 |
| PLN | Polish zloty | 4,5675 |
| RON | Romanian leu | 4,2655 |
| TRY | Turkish lira | 2,255 |
| AUD | Australian dollar | 1,9349 |
| CAD | Canadian dollar | 1,6707 |
| HKD | Hong Kong dollar | 10,4579 |
| NZD | New Zealand dollar | 2,3497 |
| SGD | Singapore dollar | 2,0349 |
| KRW | South Korean won | 1 810,75 |
| ZAR | South African rand | 12,7498 |
| CNY | Chinese yuan renminbi | 9,2191 |
| HRK | Croatian kuna | 7,4682 |
| IDR | Indonesian rupiah | 15 797,73 |
| MYR | Malaysian ringgit | 4,8909 |
| PHP | Philippine peso | 65,53 |
| RUB | Russian rouble | 45,4005 |
| THB | Thai baht | 47,627 |
| BRL | Brazilian real | 3,0426 |
| MXN | Mexican peso | 19,2525 |
| INR | Indian rupee | 68,246 |

Currency

Exchange rate

USD

US dollar

1,3607

JPY

Japanese yen

133,63

DKK

Danish krone

7,4488

GBP

Pound sterling

0,9316

SEK

Swedish krona

10,8765

CHF

Swiss franc

1,5266

ISK

Iceland króna

NOK

Norwegian krone

8,8175

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

27,233

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

302

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7095

PLN

Polish zloty

4,5675

RON

Romanian leu

4,2655

TRY

Turkish lira

2,255

AUD

Australian dollar

1,9349

CAD

Canadian dollar

1,6707

HKD

Hong Kong dollar

10,4579

NZD

New Zealand dollar

2,3497

SGD

Singapore dollar

2,0349

KRW

South Korean won

1 810,75

ZAR

South African rand

12,7498

CNY

Chinese yuan renminbi

9,2191

HRK

Croatian kuna

7,4682

IDR

Indonesian rupiah

15 797,73

MYR

Malaysian ringgit

4,8909

PHP

Philippine peso

65,53

RUB

Russian rouble

45,4005

THB

Thai baht

47,627

BRL

Brazilian real

3,0426

MXN

Mexican peso

19,2525

INR

Indian rupee

68,246

---

(1)

Source: reference exchange rate published by the ECB.

---

| 27.3.2009 | EN | Official Journal of the European Union | C 73/5 |
| --- | --- | --- | --- |

27.3.2009

EN

Official Journal of the European Union

C 73/5

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2009 to 28 February 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 73/03)

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

| Date of the decision | Name of the medicinal product | INN
  (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
  (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.2.2009 | Nplate | Romiplostim | Amgen Europe B.V. |
| Minervum 7061 |
| 4817 ZK Breda |
| NEDERLAND |

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

4.2.2009

Nplate

Romiplostim

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

NEDERLAND

EU/1/08/497/001-002

Powder for solution for injection

B02BX04

6.2.2009

6.2.2009

Zarzio

Filgrastim

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

Sandoz GmbH

Biochemiestraße 10

6250 Kundl

ÖSTERREICH

EU/1/08/495/001-008

Solution for injection or infusion

L03AA02

10.2.2009

6.2.2009

Filgrastim Hexal

Filgrastim

| HEXAL AG |
| --- |
| Industriestraße 25 |
| 83607 Holzkirchen |
| DEUTSCHLAND |

HEXAL AG

Industriestraße 25

83607 Holzkirchen

DEUTSCHLAND

EU/1/08/496/001-008

Solution for injection or infusion

L03AA02

10.2.2009

17.2.2009

FIRMAGON

Degarelix (as acetate)

| Ferring Pharmaceuticals A/S |
| --- |
| Kay Fiskers Plads 11 |
| Copenhagen S 2300 |
| DANMARK |

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11

Copenhagen S 2300

DANMARK

EU/1/08/504/001-002

Powder and solvent for solution for injection

L02BX02

19.2.2009

19.2.2009

Thymanax

Agomelatine

| Servier (Ireland) Industries Limited |
| --- |
| Gorey Road |
| Arklow |
| Co. Wicklow |
| IRELAND |

Servier (Ireland) Industries Limited

Gorey Road

Arklow

Co. Wicklow

IRELAND

EU/1/08/498/001-008

Film-coated tablet

NO6AX22

23.2.2009

19.2.2009

Opgenra

Eptotermin alfa

| Howmedica International S. de R. L. |
| --- |
| Raheen Business Park |
| Limerick |
| IRELAND |

Howmedica International S. de R. L.

Raheen Business Park

Limerick

IRELAND

EU/1/08/489/001

Powders for suspension for implantation

M05BC02

23.2.2009

19.2.2009

Valdoxan

Agomelatine

| Laboratoires Servier |
| --- |
| 22 rue Garnier |
| 92200 Neuilly-sur-Seine |
| FRANCE |

Laboratoires Servier

22 rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/08/499/001-008

Film-coated tablet

NO6AX22

23.2.2009

24.2.2009

FABLYN

Lasofoxifene

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

EU/1/08/500/001-004

Film-coated tablet

Non applicable

26.2.2009

24.2.2009

INTANZA

Influenza Vaccine (split virion, inactivated)

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

Sanofi Pasteur MSD SNC

8 rue Jonas Salk

69007 Lyon

FRANCE

EU/1/08/505/001-006

Suspension for injection

J07BB02

26.2.2009

24.2.2009

IDflu

Influenza Vaccine (split virion, inactivated)

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

Sanofi Pasteur MSD SNC

8 rue Jonas Salk

69007 Lyon

FRANCE

EU/1/08/507/001-006

Suspension for injection

J07BB02

26.2.2009

25.2.2009

Efient

Prasugrel

| 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/1/08/503/001-014

Film-coated tablet

Non applicable

27.2.2009

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.2.2009 | Vfend | Pfizer Ltd |
| Ramsgate Road |
| Sandwich |
| Kent CT 13 9NJ |
| UNITED KINGDOM |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

2.2.2009

Vfend

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

UNITED KINGDOM

EU/1/02/212/001-026

5.2.2009

2.2.2009

Gardasil

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

Sanofi Pasteur MSD SNC

8 rue Jonas Salk

69007 Lyon

FRANCE

EU/1/06/357/001-021

4.2.2009

2.2.2009

Silgard

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

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

UNITED KINGDOM

EU/1/06/358/001-021

4.2.2009

2.2.2009

Vimpat

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60 |
| 1070 Bruxelles |
| BELGIQUE |

UCB Pharma S.A.

Allée de la Recherche 60

1070 Bruxelles

BELGIQUE

EU/1/08/470/001-016

4.2.2009

2.2.2009

DuoTrav

| Alcon Laboratories (UK) Ltd |
| --- |
| Pentagon Park |
| Boundary Way |
| Hemel Hempstead |
| Herts HP2 7UD |
| UNITED KINGDOM |

Alcon Laboratories (UK) Ltd

Pentagon Park

Boundary Way

Hemel Hempstead

Herts HP2 7UD

UNITED KINGDOM

EU/1/06/338/001-003

4.2.2009

4.2.2009

Elaprase

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

Shire Human Genetic Therapies AB

Svardvagen 11D

182 33 Danderyd

SVERIGE

EU/1/06/365/001-003

6.2.2009

6.2.2009

REYATAZ

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/03/267/001-010

10.2.2009

6.2.2009

Extavia

| 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/1/08/454/001-004

10.2.2009

10.2.2009

Pradaxa

| 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/1/08/442/001-008

12.2.2009

10.2.2009

SUTENT

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT 13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

UNITED KINGDOM

EU/1/06/347/001-006

12.2.2009

10.2.2009

Baraclude

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/06/343/001-007

12.2.2009

10.2.2009

Sprycel

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/06/363/001-011

12.2.2009

10.2.2009

Xolair

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

UNITED KINGDOM

EU/1/05/319/005- 010

12.2.2009

10.2.2009

TachoSil

| Nycomed Austria GmbH |
| --- |
| St.-Peter-Straße 25 |
| 4020 Linz |
| ÖSTERREICH |

Nycomed Austria GmbH

St.-Peter-Straße 25

4020 Linz

ÖSTERREICH

EU/1/04/277/001-004

12.2.2009

10.2.2009

Abraxane

| Abraxis BioSciences Limited |
| --- |
| 2nd floor Titan Court 3 Bishops Sq |
| Hatfield AL 10 9NA |
| UNITED KINGDOM |

Abraxis BioSciences Limited

2nd floor Titan Court 3 Bishops Sq

Hatfield AL 10 9NA

UNITED KINGDOM

EU/1/07/428/001

13.2.2009

10.2.2009

Arava

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

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/99/118/001-010

12.2.2009

10.2.2009

IVEMEND

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

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

UNITED KINGDOM

EU/1/07/437/001-002

12.2.2009

11.2.2009

Zonegran

| Eisai Limited |
| --- |
| 3 Shortlands |
| London W6 8EE |
| UNITED KINGDOM |

Eisai Limited

3 Shortlands

London W6 8EE

UNITED KINGDOM

EU/1/04/307/001-013

13.2.2009

13.2.2009

Clopidogrel Winthrop

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 174 Avenue de France |
| 75013 Paris |
| FRANCE |

Sanofi Pharma Bristol-Myers Squibb SNC

174 Avenue de France

75013 Paris

FRANCE

EU/1/08/465/001

EU/1/08/465/003

EU/1/08/465/005

EU/1/08/465/007

EU/1/08/465/009

EU/1/08/465/011

EU/1/08/465/013

EU/1/08/465/018-019

17.2.2009

13.2.2009

Clopidogrel BMS

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/08/464/001

EU/1/08/464/003

EU/1/08/464/005

EU/1/08/464/007

EU/1/08/464/009

EU/1/08/464/011

EU/1/08/464/013

EU/1/08/464/018-019

17.2.2009

13.2.2009

Dafiro

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

UNITED KINGDOM

EU/1/06/371/001-036

17.2.2009

13.2.2009

Lyrica

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT 13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

UNITED KINGDOM

EU/1/04/279/001-043

17.2.2009

13.2.2009

Copalia

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

UNITED KINGDOM

EU/1/06/372/001-036

17.2.2009

13.2.2009

Exforge

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

UNITED KINGDOM

EU/1/06/370/001-036

17.2.2009

13.2.2009

Tasmar

| Meda Actiebolag |
| --- |
| Pipers väg 2A |
| Box 906 |
| 170 09 Solna |
| SVERIGE |

Meda Actiebolag

Pipers väg 2A

Box 906

170 09 Solna

SVERIGE

EU/1/97/044/001-008

18.2.2009

| Valeant Pharmaceuticals Limited |
| --- |
| Cedarwood |
| Chineham Business Park |
| Crockford Lane |
| Basingstoke RG24 8WD |
| UNITED KINGDOM |

Valeant Pharmaceuticals Limited

Cedarwood

Chineham Business Park

Crockford Lane

Basingstoke RG24 8WD

UNITED KINGDOM

13.2.2009

Imprida

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

UNITED KINGDOM

EU/1/06/373/001-036

17.2.2009

17.2.2009

Temodal

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

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

1180 Bruxelles/1180 Brussel

BELGIQUE/BELGIË

EU/1/98/096/001-022

19.2.2009

19.2.2009

Zerene

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

Meda AB

Pipers väg 2A

170 09 Solna

SVERIGE

EU/1/99/099/001-006

23.2.2009

19.2.2009

Insuman

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

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/97/030/170-189

23.2.2009

19.2.2009

Sonata

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

Meda AB

Pipers väg 2A

170 09 Solna

SVERIGE

EU/1/99/102/001-006

23.2.2009

19.2.2009

Insulin Human Winthrop

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

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/06/368/143-162

23.2.2009

20.2.2009

Myozyme

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/06/333/001-003

24.2.2009

20.2.2009

Evoltra

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/06/334/001-004

24.2.2009

20.2.2009

Luminity

| Bristol-Myers Squibb Pharma Belgium Sprl |
| --- |
| Chaussée de la Hulpe, 185/Terhulpsesteenweg 185 |
| 1170 Bruxelles/1180 Brussel |
| BELGIQUE/BELGIË |

Bristol-Myers Squibb Pharma Belgium Sprl

Chaussée de la Hulpe, 185/Terhulpsesteenweg 185

1170 Bruxelles/1180 Brussel

BELGIQUE/BELGIË

EU/1/06/361/001-002

24.2.2009

20.2.2009

Bondenza

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

UNITED KINGDOM

EU/1/03/266/003-006

24.2.2009

23.2.2009

Myozyme

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/06/333/001-003

25.2.2009

23.2.2009

BeneFIX

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

Wyeth Europa Ltd

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

UNITED KINGDOM

EU/1/97/047/001-007

25.2.2009

23.2.2009

Bonviva

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

UNITED KINGDOM

EU/1/03/265/003-006

25.2.2009

23.2.2009

Mabthera

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

UNITED KINGDOM

EU/1/98/067/001-002

25.2.2009

24.2.2009

Thalidomide Celgene

| Celgene Europe Limited |
| --- |
| Riverside House |
| Riverside Walk |
| Windsor SL4 1NA |
| UNITED KINGDOM |

Celgene Europe Limited

Riverside House

Riverside Walk

Windsor SL4 1NA

UNITED KINGDOM

EU/1/08/443/001

26.2.2009

24.2.2009

Irbesartan HCT BMS

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/06/369/001-028

26.2.2009

24.2.2009

Viracept

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

UNITED KINGDOM

EU/1/97/054/004-005

26.2.2009

24.2.2009

Revlimid

| Celgene Europe Limited |
| --- |
| Riverside House |
| Riverside Walk |
| Windsor |
| Berkshire SL4 1NA |
| UNITED KINGDOM |

Celgene Europe Limited

Riverside House

Riverside Walk

Windsor

Berkshire SL4 1NA

UNITED KINGDOM

EU/1/07/391/001-004

26.2.2009

24.2.2009

Abilify

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

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex UB8 1HU

UNITED KINGDOM

EU/1/04/276/001-020

EU/1/04/276/024-036

26.2.2009

25.2.2009

ORENCIA

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/07/389/001-003

27.2.2009

25.2.2009

Dynastat

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT 13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

UNITED KINGDOM

EU/1/02/209/001-008

27.2.2009

25.2.2009

Levitra

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

Bayer AG

51368 Leverkusen

DEUTSCHLAND

EU/1/03/248/001-012

27.2.2009

25.2.2009

Forsteo

| 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/1/03/247/001-002

27.2.2009

25.2.2009

Zerit

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/96/009/001-009

27.2.2009

25.2.2009

Irbesartan Winthrop

| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC |
| --- |
| 174 avenue de France |
| 75013 Paris |
| FRANCE |

SANOFI PHARMA BRISTOL MYERS SQUIBB SNC

174 avenue de France

75013 Paris

FRANCE

EU/1/06/376/001-033

27.2.2009

25.2.2009

HUMIRA

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

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

UNITED KINGDOM

EU/1/03/256/001-010

27.2.2009

25.2.2009

Vivanza

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

Bayer AG

51368 Leverkusen

DEUTSCHLAND

EU/1/03/249/001-012

27.2.2009

25.2.2009

Advagraf

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

Astellas Pharma Europe B.V.

Elisabethhof 19

2353 EW Leiderdorp

NEDERLAND

EU/1/07/387/001-010

27.2.2009

25.2.2009

Ranexa

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1, Avenue de la Gare |
| L-1611 Luxembourg |
| Luxembourg |

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare

L-1611 Luxembourg

Luxembourg

EU/1/08/462/001-012

27.2.2009

| CV Therapeutics Europe Limited |
| --- |
| 15 Meadway Court |
| Rutherford Close |
| Stevenage |
| Hertfordshire SG1 2EF |
| UNITED KINGDOM |

CV Therapeutics Europe Limited

15 Meadway Court

Rutherford Close

Stevenage

Hertfordshire SG1 2EF

UNITED KINGDOM

26.2.2009

Advate

| Baxter AG |
| --- |
| Industriesstraße 67 |
| 1220 Vienna |
| ÖSTERREICH |

Baxter AG

Industriesstraße 67

1220 Vienna

ÖSTERREICH

EU/1/03/271/001-006

2.3.2009

26.2.2009

ReFacto AF

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

Wyeth Europa Ltd

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

UNITED KINGDOM

EU/1/99/103/001-004

2.3.2009

26.2.2009

Myfenax

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

Teva Pharma B.V.

Computerweg 10

DR Utrecht 3542

NEDERLAND

EU/1/07/438/001-004

2.3.2009

26.2.2009

Fasturtec

| Sanofi-Aventis |
| --- |
| 174 avenue de France |
| 75013 Paris |
| FRANCE |

Sanofi-Aventis

174 avenue de France

75013 Paris

FRANCE

EU/1/00/170/001-002

2.3.2009

26.2.2009

Mycophenolate mofetil Teva

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

Teva Pharma B.V.

Computerweg 10

DR Utrecht 3542

NEDERLAND

EU/1/07/439/001-004

2.3.2009

26.2.2009

Pradaxa

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

Boehringer IngelheimInternational GmbH

Binger Straße 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/08/442/001-008

2.3.2009

26.2.2009

Protopic

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

Astellas Pharma GmbH

Neumarkter Str. 61

81673 München

DEUTSCHLAND

EU/1/02/201/001-006

4.3.2009

26.2.2009

Volibris

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

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

UNITED KINGDOM

EU/1/08/451/001-004

2.3.2009

26.2.2009

Telzir

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

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

UNITED KINGDOM

EU/1/04/282/001-002

2.3.2009

26.2.2009

Xeristar

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

Boehringer Ingelheim International GmbH

Binger Straße 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/04/297/001-008

2.3.2009

26.2.2009

Karvezide

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/98/085/001-034

2.3.2009

26.2.2009

Karvea

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/97/049/001-039

2.3.2009

26.2.2009

CoAprovel

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 174 avenue de France |
| 75013 Paris |
| FRANCE |

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France

75013 Paris

FRANCE

EU/1/98/086/001-034

2.3.2009

26.2.2009

Oprymea

| 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/1/08/469/001-025

2.3.2009

26.2.2009

Aprovel

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 174 avenue de France |
| 75013 Paris |
| FRANCE |

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France

75013 Paris

FRANCE

EU/1/97/046/001-039

2.3.2009

26.2.2009

Tasigna

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

UNITED KINGDOM

EU/1/07/422/001-004

3.3.2009

26.2.2009

Baraclude

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/06/343/001-007

3.3.2009

26.2.2009

REYATAZ

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/03/267/001-010

3.3.2009

26.2.2009

Sprycel

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/06/363/001-011

3.3.2009

26.2.2009

Tyverb

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

UNITED KINGDOM

EU/1/07/440/001-002

3.3.2009

26.2.2009

Xagrid

| Shire Pharmaceutical Contracts Ltd |
| --- |
| Hampshire International Business Park |
| Chineham |
| Basingstoke |
| Hampshire RG24 8EP |
| UNITED KINGDOM |

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park

Chineham

Basingstoke

Hampshire RG24 8EP

UNITED KINGDOM

EU/1/04/295/001

3.3.2009

27.2.2009

Ariclaim

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

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/04/283/001-012

3.3.2009

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

| Date of the decision | Name of the medicinal product | INN
  (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
  (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 10.2.2009 | Loxicom | Meloxicam | Norbrook Laboratories Limited |
| Station Works |
| Newry |
| Co. Down BT35 6JP |
| UNITED KINDGOM |

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

10.2.2009

Loxicom

Meloxicam

Norbrook Laboratories Limited

Station Works

Newry

Co. Down BT35 6JP

UNITED KINDGOM

EU/2/08/090/001-005

Oral Suspension

QM01AC06

12.2.2009

EU/2/08/090/006-008

Solution for Injection

11.2.2009

STARTVAC

Escherichia coli J5: > 50 RED60

Staph. Aureus (CP8): > 50 RED80

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135 |
| 17170 Amer (Girona) |
| ESPAÑA |

Laboratorios Hipra, S.A.

Avda. La Selva, 135

17170 Amer (Girona)

ESPAÑA

EU/2/08/092/001-007

Emulsion for injection

QI02 AB

13.2.2009

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 12.2.2009 | Purevax RCCh | Merial |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

12.2.2009

Purevax RCCh

Merial

29 Avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/049/001-002

16.2.2009

13.2.2009

Purevax RCP FeLV

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

Merial

29 Avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/048/001-002

17.2.2009

13.2.2009

Purevax RCPCh FeLV

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

Merial

29 Avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/047/001-002

17.2.2009

17.2.2009

Purevax RCPCh

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

Merial

29 Avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/050/001-002

19.2.2009

17.2.2009

ProMeris Duo

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

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

NEDERLAND

EU/2/06/065/001-010

19.2.2009

17.2.2009

Purevax RC

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

Merial

29 Avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/051/001-002

20.2.2009

17.2.2009

Purevax RCP

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

Merial

29 Avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/052/001-002

19.2.2009

—   Suspension of a marketing authorization (Article 45 of Regulation (EC) No 726/2004)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 20.2.2009 | Porcilis Pesti | Intervet International B.V. |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| NEDERLAND |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

20.2.2009

Porcilis Pesti

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/99/016/001-006

24.2.2009

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.

---

| 27.3.2009 | EN | Official Journal of the European Union | C 73/16 |
| --- | --- | --- | --- |

27.3.2009

EN

Official Journal of the European Union

C 73/16

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2009 to 28 February 2009

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

(2009/C 73/04)

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 4.2.2009 | Nplate | Amgen Europe B.V. |
| Minervum 7061 |
| 4817 ZK Breda |
| NEDERLAND |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

4.2.2009

Nplate

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

NEDERLAND

This Decision is addressed to the Member States

6.2.2009

6.2.2009

Implanon

See Annex I

See Annex I

9.2.2009

16.2.2009

Diovan

See Annex II

See Annex II

17.2.2009

17.2.2009

FIRMAGON

| Ferring Pharmaceuticals A/S |
| --- |
| Kay Fiskers Plads 11 |
| Copenhagen S 2300 |
| DANMARK |

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11

Copenhagen S 2300

DANMARK

This Decision is addressed to the Member States

18.2.2009

19.2.2009

Valdoxan

| Laboratoires Servier |
| --- |
| 22 rue Garnier |
| 92200 Neuilly-sur-Seine |
| FRANCE |

Laboratoires Servier

22 rue Garnier

92200 Neuilly-sur-Seine

FRANCE

This Decision is addressed to the Member States

23.2.2009

19.2.2009

Opgenra

| Howmedica International S. de R. L. |
| --- |
| Raheen Business Park |
| Limerick |
| IRELAND |

Howmedica International S. de R. L.

Raheen Business Park

Limerick

IRELAND

This Decision is addressed to the Member States

23.2.2009

19.2.2009

Thymanax

| Servier (Ireland) Industries Limited |
| --- |
| Gorey Road |
| Arklow |
| Co. Wicklow |
| IRELAND |

Servier (Ireland) Industries Limited

Gorey Road

Arklow

Co. Wicklow

IRELAND

This Decision is addressed to the Member States

23.2.2009

24.2.2009

FABLYN

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

This Decision is addressed to the Member States

25.2.2009

25.2.2009

Ranexa

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1, Avenue de la Gare |
| L-1611 Luxembourg |
| LUXEMBOURG |
| CV Therapeutics Europe Limited |

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare

L-1611 Luxembourg

LUXEMBOURG

CV Therapeutics Europe Limited

| 15 Meadway Court |
| --- |
| Rutherford Close |
| Stevenage |
| Hertfordshire SG1 2EF |
| UNITED KINGDOM |

15 Meadway Court

Rutherford Close

Stevenage

Hertfordshire SG1 2EF

UNITED KINGDOM

This Decision is addressed to the Member States

26.2.2009

25.2.2009

Efient

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

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

This Decision is addressed to the Member States

27.2.2009

26.2.2009

ReFacto AF

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

Wyeth Europa Ltd

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

UNITED KINGDOM

This Decision is addressed to the Member States

27.2.2009

---

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

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

---

ANNEX I

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

| Member State EU/EEA | Marketing Authorization Holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | N.V. Organon |
| Kloosterstraat 6 |
| PO Box 20 |
| 5349 AB, Oss |
| NEDERLAND |

Member State EU/EEA

Marketing Authorization Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

N.V. Organon

Kloosterstraat 6

PO Box 20

5349 AB, Oss

NEDERLAND

Implanon — Implantat

68 mg

Implant

Subcutaneous use

Belgium

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| PO Box 20 |
| 5340 BH, Oss |
| NEDERLAND |

N.V. Organon

Kloosterstraat 6

PO Box 20

5340 BH, Oss

NEDERLAND

Implanon

68 mg

Implant

Subcutaneous use

Czech Republic

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| PO Box 20 |
| 5340 BH, Oss |
| NEDERLAND |

N.V. Organon

Kloosterstraat 6

PO Box 20

5340 BH, Oss

NEDERLAND

Implanon

68 mg

Implant

Subcutaneous use

Denmark

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| PO Box 20 |
| 5340 BH, Oss |
| NEDERLAND |

N.V. Organon

Kloosterstraat 6

PO Box 20

5340 BH, Oss

NEDERLAND

Implanon

68 mg

Implant

Subcutaneous use

Finland

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| PO Box 20 |
| 5340 BH, Oss |
| NEDERLAND |

N.V. Organon

Kloosterstraat 6

PO Box 20

5340 BH, Oss

NEDERLAND

Implanon

68 mg

Implant

Subcutaneous use

France

| Organon SA |
| --- |
| Immeuble Optima |
| 10 rue Godefroy |
| 92821 Puteaux Cedex |
| FRANCE |

Organon SA

Immeuble Optima

10 rue Godefroy

92821 Puteaux Cedex

FRANCE

Implanon

68 mg

Implant

Subcutaneous use

Germany

| Essex Pharma GmbH |
| --- |
| Thomas-Dehler-Straße, 27 |
| 81737 München |
| DEUTSCHLAND |

Essex Pharma GmbH

Thomas-Dehler-Straße, 27

81737 München

DEUTSCHLAND

Implanon

68 mg

Implant

Subcutaneous use

Hungary

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| PO Box 20 |
| 5340 BH, Oss |
| NEDERLAND |

N.V. Organon

Kloosterstraat 6

PO Box 20

5340 BH, Oss

NEDERLAND

Implanon

68 mg

Implant

Subcutaneous use

Iceland

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| PO Box 20 |
| 5340 BH, Oss |
| NEDERLAND |

N.V. Organon

Kloosterstraat 6

PO Box 20

5340 BH, Oss

NEDERLAND

Implanon

68 mg

Implant

Subcutaneous use

Ireland

| Organon Ireland Ltd |
| --- |
| Drynam Road |
| Swords |
| Co. Dublin |
| IRELAND |

Organon Ireland Ltd

Drynam Road

Swords

Co. Dublin

IRELAND

Implanon 68 mg implant

68 mg

Implant

Subcutaneous use

Italy

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| PO Box 20 |
| 5340 BH, Oss |
| NEDERLAND |

N.V. Organon

Kloosterstraat 6

PO Box 20

5340 BH, Oss

NEDERLAND

Implanon

68 mg

Implant

Subcutaneous use

Luxembourg

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| PO Box 20 |
| 5340 BH, Oss |
| NEDERLAND |

N.V. Organon

Kloosterstraat 6

PO Box 20

5340 BH, Oss

NEDERLAND

Implanon

68 mg

Implant

Subcutaneous use

Malta

| Organon Laboratories Ltd |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0FL |
| UNITED KINGDOM |

Organon Laboratories Ltd

Cambridge Science Park

Milton Road

Cambridge CB4 0FL

UNITED KINGDOM

Implanon

68 mg

Implant

Subcutaneous use

Netherlands

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| PO Box 20 |
| 5340 BH, Oss |
| NEDERLAND |

N.V. Organon

Kloosterstraat 6

PO Box 20

5340 BH, Oss

NEDERLAND

Implanon 68 mg

68 mg

Implant

Subcutaneous use

Norway

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| PO Box 20 |
| 5340 BH, Oss |
| NEDERLAND |

N.V. Organon

Kloosterstraat 6

PO Box 20

5340 BH, Oss

NEDERLAND

Implanon

68 mg

Implant

Subcutaneous use

Portugal

| Organon Portuguesa |
| --- |
| Produtos Químicos e Farmacêuticos, Lda |
| Av. José Malhoa, 16B — 2° |
| 1070-159 Lisboa |
| PORTUGAL |

Organon Portuguesa

Produtos Químicos e Farmacêuticos, Lda

Av. José Malhoa, 16B — 2°

1070-159 Lisboa

PORTUGAL

Implanon

68 mg

Implant

Subcutaneous use

Slovak Republic

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| PO Box 20 |
| 5340 BH, Oss |
| NEDERLAND |

N.V. Organon

Kloosterstraat 6

PO Box 20

5340 BH, Oss

NEDERLAND

Implanon

68 mg

Implant

Subcutaneous use

Spain

| Organon Española, S.A. |
| --- |
| Ctra. de Hospitalet, 147-149 |
| Cityparc Ronda de Dalt |
| Edificio Amsterdam |
| 08940 Cornellá de Llobregat, Barcelona |
| ESPAÑA |

Organon Española, S.A.

Ctra. de Hospitalet, 147-149

Cityparc Ronda de Dalt

Edificio Amsterdam

08940 Cornellá de Llobregat, Barcelona

ESPAÑA

Implanon

68 mg

Implant

Subcutaneous use

Sweden

| N.V. Organon Kloosterstraat 6 |
| --- |
| PO Box 20 |
| 5340 BH, Oss |
| NEDERLAND |

N.V. Organon Kloosterstraat 6

PO Box 20

5340 BH, Oss

NEDERLAND

Implanon

68 mg

Implant

Subcutaneous use

United Kingdom

| Organon Laboratories Ltd |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0FL |
| UNITED KINGDOM |

Organon Laboratories Ltd

Cambridge Science Park

Milton Road

Cambridge CB4 0FL

UNITED KINGDOM

Implanon

68 mg

Implant

Subcutaneous use

---

ANNEX II

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

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

Member State EU/EEA

Marketing Authorization 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

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIQUE |

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

1800 Vilvoorde

BELGIQUE

Diovane 40 mg

40 mg

Film-coated tablets

Oral

Belgium

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIQUE |

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

1800 Vilvoorde

BELGIQUE

Novacard 40 mg

40 mg

Film-coated tablets

Oral

Belgium

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIQUE |

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

1800 Vilvoorde

BELGIQUE

Diovane 80 mg

80 mg

Film-coated tablets

Oral

Belgium

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIQUE |

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

1800 Vilvoorde

BELGIQUE

Novacard 80 mg

80 mg

Film-coated tablets

Oral

Belgium

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIQUE |

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

1800 Vilvoorde

BELGIQUE

Diovane 160 mg

160 mg

Film-coated tablets

Oral

Belgium

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIQUE |

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

1800 Vilvoorde

BELGIQUE

Novacard 160 mg

160 mg

Film-coated tablets

Oral

Belgium

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIQUE |

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

1800 Vilvoorde

BELGIQUE

Diovane 320 mg

320 mg

Film-coated tablets

Oral

Belgium

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, bus 1 |
| 1800 Vilvoorde |
| BELGIQUE |

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

1800 Vilvoorde

BELGIQUE

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 |
| --- |
| 21 Kasou |
| P.O. Box 23490 Nicosia |
| CYPRUS |

Demetriades & Papaellinas ltd

21 Kasou

P.O. Box 23490 Nicosia

CYPRUS

Diovan 40 mg

40 mg

Film-coated tablets

Oral

Cyprus

| Demetriades & Papaellinas ltd |
| --- |
| 21 Kasou |
| P.O. Box 23490 Nicosia |
| CYPRUS |

Demetriades & Papaellinas ltd

21 Kasou

P.O. Box 23490 Nicosia

CYPRUS

Diovan 80 mg

80 mg

Film-coated tablets

Oral

Cyprus

| Demetriades & Papaellinas ltd |
| --- |
| 21 Kasou |
| P.O. Box 23490 Nicosia |
| CYPRUS |

Demetriades & Papaellinas ltd

21 Kasou

P.O. Box 23490 Nicosia

CYPRUS

Diovan 160 mg

160 mg

Film-coated tablets

Oral

Cyprus

| Demetriades & Papaellinas ltd |
| --- |
| 21 Kasou |
| P.O. Box 23490 Nicosia |
| CYPRUS |

Demetriades & Papaellinas ltd

21 Kasou

P.O. 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 Kopenhagen Ø |
| DANEMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

DANEMARK

Diovan 40 mg

40 mg

Film-coated tablets

Oral

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| DANEMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

DANEMARK

Diovan 80 mg

80 mg

Film-coated tablets

Oral

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| DANEMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

DANEMARK

Diovan 160 mg

160 mg

Film-coated tablets

Oral

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| DANEMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

DANEMARK

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 and 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON |
| FRANCE |

Novartis Pharma S.A.S.

2 and 4, rue Lionel Terray

92500 RUEIL-MALMAISON

FRANCE

Tareg 40 mg

40 mg

Film-coated tablets

Oral

France

| Novartis Pharma S.A.S. |
| --- |
| 2 and 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON |
| FRANCE |

Novartis Pharma S.A.S.

2 and 4, rue Lionel Terray

92500 RUEIL-MALMAISON

FRANCE

Tareg 80 mg

80 mg

Film-coated tablets

Oral

France

| Novartis Pharma S.A.S. |
| --- |
| 2 and 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON |
| FRANCE |

Novartis Pharma S.A.S.

2 and 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 |
| ΕΛΛΑΔΑ/GREECE |

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

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

ΕΛΛΑΔΑ/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 |
| ΕΛΛΑΔΑ/GREECE |

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

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

ΕΛΛΑΔΑ/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 |
| ΕΛΛΑΔΑ/GREECE |

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

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

ΕΛΛΑΔΑ/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 |
| ΕΛΛΑΔΑ/GREECE |

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

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

ΕΛΛΑΔΑ/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 |
| ΕΛΛΑΔΑ/GREECE |

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

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

ΕΛΛΑΔΑ/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 |
| ΕΛΛΑΔΑ/GREECE |

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

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

ΕΛΛΑΔΑ/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 |
| ΕΛΛΑΔΑ/GREECE |

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

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

ΕΛΛΑΔΑ/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 |
| ΕΛΛΑΔΑ/GREECE |

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

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

ΕΛΛΑΔΑ/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 |
| ΕΛΛΑΔΑ/GREECE |

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

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

ΕΛΛΑΔΑ/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 |
| ΕΛΛΑΔΑ/GREECE |

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

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

ΕΛΛΑΔΑ/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 |
| ΕΛΛΑΔΑ/GREECE |

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

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

ΕΛΛΑΔΑ/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 |
| ΕΛΛΑΔΑ/GREECE |

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

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

ΕΛΛΑΔΑ/GREECE

Dalzad 160 mg

160 mg

Hard gelatine capsules

Oral

Hungary

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

Novartis Hungaria Kft.

Bartók Béla út 43-47

1114 Budapest

MAGYARORSZÁG/HUNGARY

Diovan 40 mg

40 mg

Film-coated tablets

Oral

Hungary

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

Novartis Hungaria Kft.

Bartók Béla út 43-47

1114 Budapest

MAGYARORSZÁG/HUNGARY

Varexan 40 mg

40 mg

Film-coated tablets

Oral

Hungary

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

Novartis Hungaria Kft.

Bartók Béla út 43-47

1114 Budapest

MAGYARORSZÁG/HUNGARY

Diovan 80 mg

80 mg

Film-coated tablets

Oral

Hungary

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

Novartis Hungaria Kft.

Bartók Béla út 43-47

1114 Budapest

MAGYARORSZÁG/HUNGARY

Varexan 80 mg

80 mg

Film-coated tablets

Oral

Hungary

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

Novartis Hungaria Kft.

Bartók Béla út 43-47

1114 Budapest

MAGYARORSZÁG/HUNGARY

Diovan 160 mg

160 mg

Film-coated tablets

Oral

Hungary

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

Novartis Hungaria Kft.

Bartók Béla út 43-47

1114 Budapest

MAGYARORSZÁG/HUNGARY

Varexan 160 mg

160 mg

Film-coated tablets

Oral

Hungary

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

Novartis Hungaria Kft.

Bartók Béla út 43-47

1114 Budapest

MAGYARORSZÁG/HUNGARY

Diovan 320 mg

320 mg

Film-coated tablets

Oral

Iceland

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| DANMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

DANMARK

Diovan 40 mg

40 mg

Film-coated tablets

Oral

Iceland

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| DANMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

DANMARK

Diovan 80 mg

80 mg

Film-coated tablets

Oral

Iceland

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| DANMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

DANMARK

Diovan 160 mg

160 mg

Film-coated tablets

Oral

Iceland

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| DANMARK |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

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 |
| ITALIA |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio

ITALIA

Tareg 40 mg

40 mg

Film-coated tablets

Oral

Italy

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

LPB Instituto Farmaceutico S.r.l.

Largo Umberto Boccioni 1

21040 Origgio

ITALIA

Rixil

40 mg

Film-coated tablets

Oral

Italy

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

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio

ITALIA

Tareg

80 mg

Film-coated tablets

Oral

Italy

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

LPB Instituto Farmaceutico S.r.l.

Largo Umberto Boccioni 1

21040 Origgio

ITALIA

Rixil

80 mg

Film-coated tablets

Oral

Italy

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

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio

ITALIA

Tareg

160 mg

Film-coated tablets

Oral

Italy

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

LPB Instituto Farmaceutico S.r.l.

Largo Umberto Boccioni 1

21040 Origgio

ITALIA

Rixil

160 mg

Film-coated tablets

Oral

Italy

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

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio

ITALIA

Tareg

80 mg

Hard capsules

Oral

Italy

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

LPB Instituto Farmaceutico S.r.l.

Largo Umberto Boccioni 1

21040 Origgio

ITALIA

Rixil

80 mg

Hard capsules

Oral

Italy

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

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio

ITALIA

Tareg

160 mg

Hard capsules

Oral

Italy

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

LPB Instituto Farmaceutico S.r.l.

Largo Umberto Boccioni 1

21040 Origgio

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

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

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

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

320 mg

Film-coated tablets

Oral

Norway

| Novartis Norge AS |
| --- |
| Postboks 237 Økern |
| NO-0510 Oslo |

Novartis Norge AS

Postboks 237 Økern

NO-0510 Oslo

Diovan 40 mg

40 mg

Film-coated tablets

Oral

Norway

| Novartis Norge AS |
| --- |
| Postboks 237 Økern |
| NO-0510 Oslo |

Novartis Norge AS

Postboks 237 Økern

NO-0510 Oslo

Diovan 80 mg

80 mg

Film-coated tablets

Oral

Norway

| Novartis Norge AS |
| --- |
| Postboks 237 Økern |
| NO-0510 Oslo |

Novartis Norge AS

Postboks 237 Økern

NO-0510 Oslo

Diovan 160 mg

160 mg

Film-coated tablets

Oral

Norway

| Novartis Norge AS |
| --- |
| Postboks 237 Økern |
| NO-0510 Oslo |

Novartis Norge AS

Postboks 237 Økern

NO-0510 Oslo

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 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| PORTUGAL |

Novartis Farma — Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

PORTUGAL

Diovan

40 mg

Film-coated tablets

Oral

Portugal

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

Novartis Farma — Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

PORTUGAL

Diovan

80 mg

Film-coated tablets

Oral

Portugal

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

Novartis Farma — Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

PORTUGAL

Diovan g

160 mg

Film-coated tablets

Oral

Portugal

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

Novartis Farma — Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-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

Slovak Republic

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

Novartis s.r.o.

Praha

ČESKÁ REPUBLIKA

Diovan 40 mg

40 mg

Film-coated tablets

Oral

Slovak Republic

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

Novartis s.r.o.

Praha

ČESKÁ REPUBLIKA

Diovan 80 mg

80 mg

Film-coated tablets

Oral

Slovak Republic

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

Novartis s.r.o.

Praha

ČESKÁ REPUBLIKA

Diovan 160 mg

160 mg

Film-coated tablets

Oral

Slovak Republic

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

Novartis s.r.o.

Praha

ČESKÁ REPUBLIKA

Diovan 320 mg

320 mg

Film-coated tablets

Oral

Slovak Republic

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

Novartis s.r.o.

Praha

ČESKÁ REPUBLIKA

Diovan 80 mg

80 mg

Hard gelatine capsules

Oral

Slovak Republic

| 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 |
| P.O. Box 1150 |
| SE-183 11 Täby |
| SVERIGE |

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

SVERIGE

Diovan

40 mg

Film-coated tablets

Oral

Sweden

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

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

SVERIGE

Angiosan

40 mg

Film-coated tablets

Oral

Sweden

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

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

SVERIGE

Valsartan Novartis

40 mg

Film-coated tablets

Oral

Sweden

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

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

SVERIGE

Diovan

80 mg

Film-coated tablets

Oral

Sweden

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

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

SVERIGE

Angiosan

80 mg

Film-coated tablets

Oral

Sweden

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

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

SVERIGE

Valsartan Novartis

80 mg

Film-coated tablets

Oral

Sweden

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

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

SVERIGE

Diovan

160 mg

Film-coated tablets

Oral

Sweden

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

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

SVERIGE

Angiosan

160 mg

Film-coated tablets

Oral

Sweden

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

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

SVERIGE

Valsartan Novartis

160 mg

Film-coated tablets

Oral

Sweden

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

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

SVERIGE

Diovan

320 mg

Film-coated tablets

Oral

Sweden

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

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

SVERIGE

Angiosan

320 mg

Film-coated tablets

Oral

Sweden

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

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

SVERIGE

Valsartan Novartis

320 mg

Film-coated tablets

Oral

Sweden

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

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

SVERIGE

Diovan

80 mg

Hard gelatine capsules

Oral

Sweden

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

Novartis Sverige AB

Kemistvägen 1B

P.O. 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

---

V Announcements

ADMINISTRATIVE PROCEDURES

Commission

| 27.3.2009 | EN | Official Journal of the European Union | C 73/41 |
| --- | --- | --- | --- |

27.3.2009

EN

Official Journal of the European Union

C 73/41

---

MEDIA 2007 — DEVELOPMENT, DISTRIBUTION, PROMOTION AND TRAINING

Call for proposals — EACEA/03/09

Support for the transnational distribution of European films — The ‘Automatic’ Scheme 2009

(2009/C 73/05)

1.   Objectives and description

This notice of a call for proposals is based on Decision No 1718/2006/EC of the European Parliament and of the Council of 15 November 2006 concerning the implementation of a programme of support for the European audiovisual sector (MEDIA 2007).

One of the objectives of the programme is to encourage and support the wider transnational distribution of recent European films by providing funds to distributors, based upon their performance on the market, for further reinvestment in new non-national European films.

The scheme also aims to encourage the development of links between the production and distribution sectors thus improving the market share of European films and the competitiveness of European companies.

2.   Eligible applicants

This notice is aimed at European companies specialised in the theatrical distribution of European works and whose activities contribute to the attainment of the above objectives of the MEDIA programme as described in the Council Decision.

Applicants must be established in one of the following countries:

| — | the 27 countries of the European Union, |
| --- | --- |

—

the 27 countries of the European Union,

| — | the EFTA countries, |
| --- | --- |

—

the EFTA countries,

| — | Switzerland, |
| --- | --- |

—

Switzerland,

| — | Croatia. |
| --- | --- |

—

Croatia.

3.   Eligible actions

The ‘automatic’ support scheme works in two phases:

| — | generation of a potential Fund, proportional to the number of paying admission tickets sold for non-domestic European films in States participating in the Programme, up to a fixed ceiling per film and adjusted for each country, |
| --- | --- |

—

generation of a potential Fund, proportional to the number of paying admission tickets sold for non-domestic European films in States participating in the Programme, up to a fixed ceiling per film and adjusted for each country,

| — | reinvestment of the potential Fund: thus generated by each company, the Fund must be reinvested in 3 modules (3 types of action) by 1 October 2010:






  1. | the co-production of non-domestic European films; |
| --- | --- | --- |

—

reinvestment of the potential Fund: thus generated by each company, the Fund must be reinvested in 3 modules (3 types of action) by 1 October 2010:

1.

the co-production of non-domestic European films;

| 2. | the acquisition of distribution rights, for example by means of minimum guarantees, of non-domestic European films; and/or in |
| --- | --- |

2.

the acquisition of distribution rights, for example by means of minimum guarantees, of non-domestic European films; and/or in

| 3. | editing costs (prints, dubbing and subtitling), promotion costs and publicity costs for non-domestic European films. |
| --- | --- |

3.

editing costs (prints, dubbing and subtitling), promotion costs and publicity costs for non-domestic European films.

Action type 1 & 2:

| | The maximum duration of the actions is 30 months. |
| --- | --- |

The maximum duration of the actions is 30 months.

| | The actions have to start on 1 August 2009 and finish on 1 February 2012. |
| --- | --- |

The actions have to start on 1 August 2009 and finish on 1 February 2012.

Action type 3:

| | The maximum duration of the actions is 42 months. |
| --- | --- |

The maximum duration of the actions is 42 months.

| | The actions have to start on 1 February 2009 and finish on 1 August 2012. |
| --- | --- |

The actions have to start on 1 February 2009 and finish on 1 August 2012.

4.   Award criteria

A potential Fund will be attributed to eligible European distribution companies on the basis of the admissions achieved by the European non-national films distributed by the applicant in the reference year (2008). Within the limit of the budgetary resources available, the potential Fund will be calculated based upon a fixed amount per eligible entry.

The support will take the form of a potential Fund (the ‘Fund’) available to distributors for further investments in recent non-national European films.

The Fund can be reinvested:

| 1. | in the production of new non-national European films (i.e. films not yet completed at the date of application for reinvestment); |
| --- | --- |

1.

in the production of new non-national European films (i.e. films not yet completed at the date of application for reinvestment);

| 2. | in the meeting of Minimum Distribution Guarantees for recent non-national European films; |
| --- | --- |

2.

in the meeting of Minimum Distribution Guarantees for recent non-national European films;

| 3. | in the meeting of distribution costs i.e. P&A (promotion and advertising) for recent non-national European films. |
| --- | --- |

3.

in the meeting of distribution costs i.e. P&A (promotion and advertising) for recent non-national European films.

5.   Budget

The total budget available is EUR 17 000 000.

There is no maximum amount.

The financial contribution awarded is a subsidy. The financial support from the Commission cannot exceed 40 %, 50 % or 60 % of the total eligible costs.

The Agency reserves the right not to allocate all the funds available.

6.   Deadline for submission of applications

Proposals for the ‘generation’ of a potential Fund must be sent (postmark date) on 29 May 2009 at the latest and at the following address:

| Education, Audiovisual and Culture Executive Agency (EACEA) |
| --- |
| Constantin Daskalakis — BOUR 3/66 |
| Avenue du Bourget, 1 |
| 1140 Brussels |
| BELGIUM |

Education, Audiovisual and Culture Executive Agency (EACEA)

Constantin Daskalakis — BOUR 3/66

Avenue du Bourget, 1

1140 Brussels

BELGIUM

Only applications submitted on the official application form, duly signed by the person entitled to enter into legally binding commitments on behalf of the applicant organisation will be accepted. Envelopes must clearly mention:

MEDIA 2007 — DISTRIBUTION EACEA/03/09 — AUTOMATIC CINEMA

Applications sent by fax or e-mail will be rejected.

7.   Full details

The full detailed guidelines together with the application forms can be found at the following Internet address:

http://ec.europa.eu/information_society/media/distrib/schemes/auto/index_en.htm

Applications must comply with all terms of the guidelines, be submitted on the forms provided and containing all the information and annexes specified in the full text of the call.

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PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 27.3.2009 | EN | Official Journal of the European Union | C 73/43 |
| --- | --- | --- | --- |

27.3.2009

EN

Official Journal of the European Union

C 73/43

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Notice by the Ministry of the Economy of the Republic of Latvia of a call for tenders for hydrocarbon exploration and production within the exclusive economic zone of the Republic of Latvia

(2009/C 73/06)

Pursuant to the Law on Substrata, Cabinet Regulation No 597 of 4 September 2007 on hydrocarbon prospection, exploration and production and the amounts of and procedures for paying Government duties, and Cabinet Order No 594 of 21 September 2007 on establishing licensed hydrocarbon prospection sites within the exclusive economic zone of the Republic of Latvia, the Ministry of the Economy of the Republic of Latvia hereby gives notice of a call for tenders for hydrocarbon exploration and production in the exclusive economic zone of the Republic of Latvia within the following ellipsoidal (geographical) coordinates under the WGS 84 system:

| Corner points | Latitude N | Longitude E |
| --- | --- | --- |
| 1 | 56°10′00′′ | 19°10′14,5′′ |
| 2 | 56°14′59,1′′ | 19°13′22,8′′ |
| 3 | 56°26′59,2′′ | 19°20′52,7′′ |
| 4 | 56°30′00′′ | 19°22′23′′ |
| 5 | 56°30′00′′ | 19°40′00′′ |
| 6 | 56°10′00′′ | 19°40′00′′ |

Corner points

Latitude N

Longitude E

1

56°10′00′′

19°10′14,5′′

2

56°14′59,1′′

19°13′22,8′′

3

56°26′59,2′′

19°20′52,7′′

4

56°30′00′′

19°22′23′′

5

56°30′00′′

19°40′00′′

6

56°10′00′′

19°40′00′′

Pursuant to Article 3(2) of Directive 94/22/EC of the European Parliament and of the Council of 30 May 1994 on the conditions for granting and using authorizations for the prospection, exploration and production of hydrocarbons and paragraph 46 of the aforementioned Cabinet Regulation, the Ministry of the Economy invites all interested entities to obtain a copy of the regulations relating to the call for tenders for hydrocarbon prospection and production within the exclusive economic zone of the Republic of Latvia.

Type of licence: The successful tenderer will be issued with a hydrocarbon prospection and production licence.

Address and office hours for obtaining tender regulations: Ministry of the Economy of the Republic of Latvia, Brīvības iela 55, Riga, LV-1519, every weekday from 9 a.m. to 5 p.m. (GMT +2). The tender regulations may be obtained within 30 days of the date of publication of this notice.

Cost of obtaining the tender regulations: LVL 350. Payment must be made in LVL by transfer of funds to the Ministry of the Economy of the Republic of Latvia, registration no 90000086008, Treasury, code TRELLV22, account no LV10TREL212001C310000, indicating that it is ‘Payment for tender regulations in relation to the call for tenders for hydrocarbon prospection and production within the exclusive economic zone of the Republic of Latvia’. To obtain the regulations, proof of payment must be presented.

Deadline for applications: A tender may be submitted in person at the Customer Service Centre of the Ministry of the Economy of the Republic of Latvia, or may be sent by mail to the Ministry of the Economy of the Republic of Latvia, Brīvības iela 55, Riga, LV-1519 within 90 days of the date of publication of this notice. The deadline for submission of applications is 5 p.m. (GMT +2) on the ninetieth day following the date of publication of this notice.

Contact person: Ilze Ruško, Head of the Licence, Permit and Coordination Division, Department of Energy, Ministry of the Economy of the Republic of Latvia, tel. +371 67013173, e-mail: ilze.rusko@em.gov.lv. Please apply for the tender regulations prior to submitting your application.

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OTHER ACTS

Commission

| 27.3.2009 | EN | Official Journal of the European Union | C 73/45 |
| --- | --- | --- | --- |

27.3.2009

EN

Official Journal of the European Union

C 73/45

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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 73/07)

This publication confers the right to object to the application pursuant to Article 7 of Council Regulation (EC) No 510/2006 (1). Statements of objection must reach the Commission within six months from the date of this publication.

SUMMARY

COUNCIL REGULATION (EC) No 510/2006

‘ČERNÁ HORA’

EC No: CZ-PGI-0005-0409-19.10.2004

PDO ( ) PGI ( X )

This summary sets out the main elements of the product specification for information purposes.

1.   Responsible department in the Member State:

| Name: | Úřad průmyslového vlastnictví |
| --- | --- |
| Address: | Antonína Čermáka 2a |
| 160 68 Praha 6-Bubeneč |
| ČESKÁ REPUBLIKA |

Name:

Úřad průmyslového vlastnictví

Address:

Antonína Čermáka 2a

160 68 Praha 6-Bubeneč

ČESKÁ REPUBLIKA

Tel.

+420 220383111

Fax

+420 224324718

E-mail:

posta@upv.cz

2.   Group:

| Name: | Pivovar Černá Hora, a. s. |
| --- | --- |
| Address: | Černá Hora 3/5 |
| 679 21 Černá Hora |
| ČESKÁ REPUBLIKA |

Name:

Pivovar Černá Hora, a. s.

Address:

Černá Hora 3/5

679 21 Černá Hora

ČESKÁ REPUBLIKA

Tel.

+420 516482411

Fax

+420 516437201

E-mail:

ekonom@pivovarch.cz

Composition:

Producers/processors ( X ) Other ( )

This application derogates from Article 5(1) of Regulation (EC) No 510/2006 on account of the fact that there is only one producer in the area. The requirements laid down in Article 2 of Commission Regulation (EC) No 1898/2006 are fulfilled.

3.   Type of product:

Class 2.1: Beer

4.   Specification:

(Summary of requirements under Article 4(2) of Regulation (EC) No 510/2006)

4.1.   Name:

‘Černá Hora’

4.2.   Description:

The light beer is medium to highly attenuated, golden yellow to golden brown in colour, good head with strong bite, medium to full-favoured, with a clean flavour of malt and hops, and hoppy aroma. The fullness of flavour is mainly due to the presence of unfermented residual extract, characterised by a difference between apparent and real attenuation. A very faint yeasty or fruity (ester) taste and aroma is permitted. The low intensity of the whole aroma is indicative of the relatively low content of unwanted fermentation by-products. The beer is medium to high in bitterness, and has a slight to mild harshness, with longer finish.

The dark beer is medium to highly attenuated, reddish to red-brown in colour with good head, pleasantly hoppy taste and aroma. It has a medium bite and a typically full flavour, owing to the difference between apparent and real attenuation and to the unfermentable compounds in the raw materials. Caramel and treacle are admissible by-flavours.

Varieties of beer and the sensory characteristics thereof:

The Světlý ležák (light lager) is medium to highly attenuated, golden yellow to golden brown in colour, good head with strong bite, medium-favoured, with clean flavour of malt and hops and a hoppy aroma. A very faint yeasty or fruity (ester) taste and aroma is permitted. The beer is of medium bitterness, and has a slight harshness, with longer finish.

The Světlé výčepní pivo (light draught beer) is medium to highly attenuated, golden yellow to golden brown in colour, good head with strong bite, full-favoured, with a clean flavour of malt and a hoppy aroma. A very faint yeasty or fruity (ester) taste and aroma is permitted. The beer is high in bitterness, moderately harsh, with a longer finish.

The Nefiltrované výčepní pivo (unfiltered draught beer) is characterised by a good head, golden yellow to golden brown colour, good bite and fullness of flavour, and by a yeasty flavour and aroma. The beer has a significant, moderately harsh, hoppy bitterness, leaving behind a feeling of pleasant, gradually diminishing bitterness, without any hint of harshness or astringency.

The Tmavý ležák (dark lager) is a beer with the addition of caramel and coloured malt, medium attenuated, garnet to red-brown in colour, caramel to sweetish taste with delicate bitterness.

The Polotmavé výčepní pivo (semi-dark draught beer) is medium to highly attenuated, reddish to garnet colour, strong bite, pleasantly hoppy and with a moderately caramel aroma and flavour with good head.

All types of ‘Černá Hora’ beer are low-fermentation beers characterised by particular sensory qualities, especially unique aroma and flavour with strong bite.

Light beer — quality benchmarks:

| | Pale lager | Pale draught | Unfiltered pale draught |
| --- | --- | --- | --- |
| Original gravity | (% by weight) | 11,00-12,99 | 8,00-10,99 | 8,00-10,99 |
| Alcohol | (% by volume) | 3,8-6,0 | 3,5-4,5 | 3,5-4,5 |
| Colour | EBC units | 8,0-16,0 | 7,0-16,0 | 7,8-16,0 |
| Bitter substances | EBC units | 20,0-45,0 | 16,0-28,0 | 16,0-28,0 |
| pH | | 4,2-4,9 | 4,3-4,7 | 4,3-4,7 |
| Difference between apparent and real attenuation | (% rel.) | 1,0-10,0 | 1,0-10,0 | 1,0-10,0 |
| Polyphenols | (mg/l) | 130,0-230,0 | 130,0-230,0 | 130,0-230,0 |

Pale lager

Pale draught

Unfiltered pale draught

Original gravity

(% by weight)

11,00-12,99

8,00-10,99

8,00-10,99

Alcohol

(% by volume)

3,8-6,0

3,5-4,5

3,5-4,5

Colour

EBC units

8,0-16,0

7,0-16,0

7,8-16,0

Bitter substances

EBC units

20,0-45,0

16,0-28,0

16,0-28,0

pH

4,2-4,9

4,3-4,7

4,3-4,7

Difference between apparent and real attenuation

(% rel.)

1,0-10,0

1,0-10,0

1,0-10,0

Polyphenols

(mg/l)

130,0-230,0

130,0-230,0

130,0-230,0

Dark beer, semi-dark beer — quality benchmarks:

| | Dark lager | Semi-dark draught |
| --- | --- | --- |
| Original gravity | (% by weight) | 11,00-12,99 | 8,00-10,99 |
| Alcohol | (% by volume) | 3,6-5,7 | 3,5-4,5 |
| Colour | EBC units | 50,0-120,0 | 16,0-40,0 |
| Bitter substances | EBC units | 20,0-45,0 | 16,0-28,0 |
| pH | | 4,1-4,8 | 4,3-4,7 |
| Difference between apparent and real attenuation | (% rel.) | 1,0-10,0 | 1,0-10,0 |
| Polyphenols | (mg/l) | 130,0-230,0 | 130,0-230,0 |

Dark lager

Semi-dark draught

Original gravity

(% by weight)

11,00-12,99

8,00-10,99

Alcohol

(% by volume)

3,6-5,7

3,5-4,5

Colour

EBC units

50,0-120,0

16,0-40,0

Bitter substances

EBC units

20,0-45,0

16,0-28,0

pH

4,1-4,8

4,3-4,7

Difference between apparent and real attenuation

(% rel.)

1,0-10,0

1,0-10,0

Polyphenols

(mg/l)

130,0-230,0

130,0-230,0

Raw materials:

Barley malt

This is a light malt, known as ‘Czech malt’, which is produced from two-row spring barley. This barley malt is characterised by low solubility and fermentation.

The following table shows Congress Wort values produced from barley malt:

| Extract in dry malt | (% by weight) | min. | 80 % |
| --- | --- | --- | --- |
| Kolbach index | (%) | | 37-41 % |
| Diastatic power | (WK units) | min. | 220 |
| Actual attenuation | (%) | max. | 82 % |
| Friability | (%) | min. | 75 % |

Extract in dry malt

(% by weight)

min.

80 %

Kolbach index

(%)

37-41 %

Diastatic power

(WK units)

min.

220

Actual attenuation

(%)

max.

82 %

Friability

(%)

min.

75 %

Hops

This is the Žatecký poloraný červeňák variety. These hops are highly specific: they differ primarily from other hop varieties in their ratio of alpha to beta-bitter acids and in their beta-farnesene content. Either dried hops or hop extract is used. (Keep the original wording, where the Žatecký poloraný červeňák variety rather than SKVN Žatecký chmel is used for the preparation of beer).

Water

Water from a variety of sources is used in the production of ‘Černá Hora’ beer. In terms of hardness, this water is considered soft to medium-hard.

Brewer's yeast

Bottom-fermenting yeast strains (Saccharomyces cerevisiae subs. uvarum) are used for producing ‘Černá Hora’ beer as they offer the requisite difference between apparent and real attenuation under this specification.

4.3.   Geographical area:

The municipality of ‘Černá Hora’ in Southern Moravia, Czech Republic.

4.4.   Proof of origin:

The applicant for registration of the geographical designation ‘Černá Hora’ keeps a register of suppliers of raw materials and a register of buyers of the finished product. For each product, compulsory data on products, including addresses, are provided, thereby enabling product traceability.

The entire beer production technology is continuously monitored. The implementation and results of checks are continuously recorded. All raw materials brought in for producing beer are also subject to quality control. Water quality is checked for microbiological suitability and is regularly controlled. A written record of all checks is kept. A record is also kept of the individual batches of raw materials used in the production of individual batches of beer.

Compliance with the specifications is monitored by the Czech Agriculture and Food Inspection Authority.

4.5.   Method of production:

‘Černá Hora’ beer is produced solely by means of the double mash decoction process. Bitter wort is cooked depending on the beer's original gravity. The process of primary fermentation takes place separately from that of the maturing of the beer. This is classic production without intensification processes.

Beer production begins in the brewing house. After mixing the ground malt with the water, just a third of the volume is gradually warmed. This enables the starch and other substances of the malt extract to be transferred into the solution and the starch to be split. The mashing process is repeated twice, and each mash is warmed separately. After the mashing out process, the residue of the malt culms is separated out, giving rise to the first portion of wort. The culm is then drained off with hot water and the digest is mixed with the first portion of wort. The resulting wort is heated for 80 to 120 minutes with separately batched hops or hop products to obtain a hopped wort. Each brew is heated at the original concentration of the wort corresponding to the required gravity of the beer. In other words, during further production, the gravity of the beer is not altered.

The heated wort is then cooled to fermentation temperature, brewer's yeast is added, in particular bottom-fermenting yeast strains, and the first, and indeed main, stage of beer fermentation takes place. This main fermentation stage takes place in classic, open fermenting rooms. The main fermentation temperature must not exceed 9,5 °C. The main fermentation takes 6 to 12 days, depending on the gravity of the original wort.

After the completion of main fermentation comes the lagering stage. This takes place at lower temperatures than the main fermentation stage, as low as around 0 °C and under moderate excess pressure in closed tanks. The lagering process takes 21 to 60 days, depending on the gravity of the beer. During this stage, the beer becomes clear, is saturated with carbon dioxide, and its flavour is rounded off. This gives the beer bite, with a dense, firm head. During the lagering stage, the striking flavour and yeasty smell disappears, the bitterness softens and the aroma typical of certain types of beer emerges. After the completion of the lagering process, the beer is filtered immediately without first altering the original gravity and transferred into barrels, bottles and, where applicable, cans or tanks. Unfiltered beer is also permitted. The end product must satisfy the quality benchmarks set out in the tables in Section 4.2 of this summary.

4.6.   Link:

The beer for which registration of designation of origin of the term ‘Černá Hora’ has been requested has been produced continuously in the municipality of ‘Černá Hora’ since the 13th century. The first written record of the brewery in ‘Černá Hora’ dates back to 1530.

Since then, there has been a rich history of breweries and beer making in ‘Černá Hora’. Many owners have come and gone, but the production and quality of ‘Černá Hora’ beer has steadily increased. In 1949, the brewery was nationalised and gradually incorporated into various national firms. The production of ‘Černá Hora’ nevertheless went on uninterrupted, following traditional production methods and processes. In 1996 the brewery became independent as part of a privatisation drive.

Records of the brewery's rich history and beer production in ‘Černá Hora’ are contained in many documents stored in the Moravian national archive in Brno (for example, the Dominican era in ‘Černá Hora’, the Josefinsky estate for the municipalities of ‘Černá Hora’ and Bořitov and land transfer registry for the municipalities of ‘Černá Hora’ and Bořitov etc) and also in the archives of the Pivovar Černá Hora, a.s. (Černá Hora brewery).

With the development of the brewery, beer production increased and the buildings and production equipment were expanded and modernised accordingly. These changes had only a minor effect on the uniqueness of ‘Černá Hora’ beer, which can ultimately be considered a beverage derived from a centuries-old tradition. All ‘Černá Hora’ brewers have endeavoured to protect the historic uniqueness of ‘Černá Hora’ beer, which has been only minimally affected over time.

Testament to the quality of ‘Černá Hora’ beer and its popularity is the many prizes it has won in domestic and international competitions and fairs (for example, the Táborský palcát (Tabor mace), Cena českých sládků (Czech brewers' prize), Pivo spanilých jízd (Beer of the Hussite campaigns), Zlatý pohár Pivex (Pivex golden cup) and Česká pivní pečeť (Czech beer seal)).

The fame and popularity of ‘Černá Hora’ beer is also evidenced by the fact that in the municipality of ‘Černá Hora’ a wide-ranging cultural and social event to present the beer produced there has been held every spring and autumn for the last ten years. In April, it is the Vítání jara (APRÝLES) (Spring Welcome) and in September the Pivní pouť (Beer fair). These events regularly attract several thousand visitors, who come not just from around Černá Hora but from all over the Czech Republic, and indeed abroad.

Beer from Černá Hora is also mentioned in various encyclopaedias, for example Verhoef, Berry: Large Encyclopaedia of Beer, Čestlice, Rebo Productions, 2002; Jackson, Michael: Great Beer Guide, Prague, Fortuna Print, 2001. Many articles have also been written and published about it in national and local newspapers and magazines. In Černá Hora itself, the periodical ‘Černohorský máz’ is published, which among other things provides information on the successes of ‘Černá Hora’ beer in various competitions and fairs.

In 1995 the Brno historian Leoš Vašek wrote about ‘Černá Hora’ beer in his 1995 book ‘V ČERNÉ HOŘE PIVA MOŘE — z historie černohorského pivovarnictví’ (IN ČERNA HORA A SEA OF BEER — on the history of the Černá Hora brewery).

4.7.   Inspection body:

| Name: | Státní zemědělská a potravinářská inspekce, inspektorát v Brně |
| --- | --- |
| Address: | Běhounská 10 |
| 601 26 Brno |
| ČESKÁ REPUBLIKA |

Name:

Státní zemědělská a potravinářská inspekce, inspektorát v Brně

Address:

Běhounská 10

601 26 Brno

ČESKÁ REPUBLIKA

Tel.

+420 542424011

Fax

+420 542426717

E-mail:

epodatelna@szpi.gov.cz

4.8.   Description:

—

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(1)  OJ L 93, 31.3.2006, p. 12.

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Corrigenda

| 27.3.2009 | EN | Official Journal of the European Union | C 73/50 |
| --- | --- | --- | --- |

27.3.2009

EN

Official Journal of the European Union

C 73/50

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

(
  Official Journal of the European Union C 62 of 17 March 2009
  )

(2009/C 73/08)

On page 11, against ‘Reference number of the aid’:

for:

‘N 23/08’,

read:

‘N 23/09’.

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