# Official Journal C 237/2010

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2010.237.eng |
| --- | --- |
| Official Journal
  of the European Union | C 237 |
| | |
| English edition | Information and Notices | Volume 532 September 2010 |

ISSN 1725-2423

doi:10.3000/17252423.C_2010.237.eng

Official Journal

of the European Union

C 237

English edition

Information and Notices

Volume 532 September 2010

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2010/C 237/01 | Interest rate applied by the European Central Bank to its main refinancing operations: 1,00 % on 1 September 2010 — Euro exchange rates | 1 |
| | NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA |
| | Standing Committee of the EFTA States |
| 2010/C 237/02 | Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2009 | 2 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2010/C 237/01

Interest rate applied by the European Central Bank to its main refinancing operations: 1,00 % on 1 September 2010 — Euro exchange rates

1

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

2010/C 237/02

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2009

2

| | V   Announcements |
| --- | --- |
| | COURT PROCEEDINGS |
| | EFTA Court |
| 2010/C 237/03 | Action brought on 15 June 2010 by Reassur Aktiengesellschaft against the EFTA Surveillance Authority (Case E-6/10) | 19 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2010/C 237/04 | Prior notification of a concentration (Case COMP/M.5956 — EADS/OPIP/JV) — Candidate case for simplified procedure (
  1
  ) | 20 |
| 2010/C 237/05 | Decision No 297 of 12 May 2010 terminating the procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-5 Devetaki, located in the provinces of Lovech, Pleven and Gabrovo | 21 |
| 2010/C 237/06 | Decision No 300 of 12 May 2010 terminating the procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-10 Botevo, located in the provinces of Vratsa and Montana | 22 |
| 2010/C 237/07 | Decision No 296 of 12 May 2010 terminating the procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-8 Altimir, located in the provinces of Vratsa and Pleven | 23 |

V   Announcements

COURT PROCEEDINGS

EFTA Court

2010/C 237/03

Action brought on 15 June 2010 by Reassur Aktiengesellschaft against the EFTA Surveillance Authority (Case E-6/10)

19

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2010/C 237/04

Prior notification of a concentration (Case COMP/M.5956 — EADS/OPIP/JV) — Candidate case for simplified procedure (
  1
  )

1

20

2010/C 237/05

Decision No 297 of 12 May 2010 terminating the procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-5 Devetaki, located in the provinces of Lovech, Pleven and Gabrovo

21

2010/C 237/06

Decision No 300 of 12 May 2010 terminating the procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-10 Botevo, located in the provinces of Vratsa and Montana

22

2010/C 237/07

Decision No 296 of 12 May 2010 terminating the procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-8 Altimir, located in the provinces of Vratsa and Pleven

23

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

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(1)   Text with EEA relevance

1

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 2.9.2010 | EN | Official Journal of the European Union | C 237/1 |
| --- | --- | --- | --- |

2.9.2010

EN

Official Journal of the European Union

C 237/1

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Interest rate applied by the European Central Bank to its main refinancing operations (1):

1,00 % on 1 September 2010

Euro exchange rates (2)

1 September 2010

2010/C 237/01

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2800 |
| JPY | Japanese yen | 107,54 |
| DKK | Danish krone | 7,4446 |
| GBP | Pound sterling | 0,83105 |
| SEK | Swedish krona | 9,3490 |
| CHF | Swiss franc | 1,2967 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 7,9425 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 24,735 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 286,30 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7091 |
| PLN | Polish zloty | 3,9896 |
| RON | Romanian leu | 4,2648 |
| TRY | Turkish lira | 1,9485 |
| AUD | Australian dollar | 1,4141 |
| CAD | Canadian dollar | 1,3560 |
| HKD | Hong Kong dollar | 9,9542 |
| NZD | New Zealand dollar | 1,8112 |
| SGD | Singapore dollar | 1,7277 |
| KRW | South Korean won | 1 516,73 |
| ZAR | South African rand | 9,4195 |
| CNY | Chinese yuan renminbi | 8,7187 |
| HRK | Croatian kuna | 7,2774 |
| IDR | Indonesian rupiah | 11 511,57 |
| MYR | Malaysian ringgit | 4,0047 |
| PHP | Philippine peso | 57,740 |
| RUB | Russian rouble | 39,3572 |
| THB | Thai baht | 39,903 |
| BRL | Brazilian real | 2,2369 |
| MXN | Mexican peso | 16,8128 |
| INR | Indian rupee | 59,9230 |

Currency

Exchange rate

USD

US dollar

1,2800

JPY

Japanese yen

107,54

DKK

Danish krone

7,4446

GBP

Pound sterling

0,83105

SEK

Swedish krona

9,3490

CHF

Swiss franc

1,2967

ISK

Iceland króna

NOK

Norwegian krone

7,9425

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

24,735

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

286,30

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7091

PLN

Polish zloty

3,9896

RON

Romanian leu

4,2648

TRY

Turkish lira

1,9485

AUD

Australian dollar

1,4141

CAD

Canadian dollar

1,3560

HKD

Hong Kong dollar

9,9542

NZD

New Zealand dollar

1,8112

SGD

Singapore dollar

1,7277

KRW

South Korean won

1 516,73

ZAR

South African rand

9,4195

CNY

Chinese yuan renminbi

8,7187

HRK

Croatian kuna

7,2774

IDR

Indonesian rupiah

11 511,57

MYR

Malaysian ringgit

4,0047

PHP

Philippine peso

57,740

RUB

Russian rouble

39,3572

THB

Thai baht

39,903

BRL

Brazilian real

2,2369

MXN

Mexican peso

16,8128

INR

Indian rupee

59,9230

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(1)  Rate applied to the most recent operation carried out before the indicated day. In the case of a variable rate tender, the interest rate is the marginal rate.

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

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NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

| 2.9.2010 | EN | Official Journal of the European Union | C 237/2 |
| --- | --- | --- | --- |

2.9.2010

EN

Official Journal of the European Union

C 237/2

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Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2009

2010/C 237/02

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 July-31 December 2009, at their meeting on 30 April 2010:

| Annex I | — | List of new marketing authorisations |
| --- | --- | --- |
| Annex II | — | List of renewed marketing authorisations |
| Annex III | — | List of extended marketing authorisations |
| Annex IV | — | List of withdrawn marketing authorisations |
| Annex V | — | List of suspended marketing authorisations |

Annex I

—

List of new marketing authorisations

Annex II

—

List of renewed marketing authorisations

Annex III

—

List of extended marketing authorisations

Annex IV

—

List of withdrawn marketing authorisations

Annex V

—

List of suspended marketing authorisations

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ANNEX I

List of new marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July-31 December 2009:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/06/361/001/NO-002/NO | Luminity | Norway | 20.8.2009 |
| EU/1/07/436/001-002 | Isentress | Liechtenstein | 31.8.2009 |
| EU/1/09/575/001-060 | Copalia HCT | Liechtenstein | 31.12.2009 |
| EU/1/09/511/001-004 | Conbriza | Liechtenstein | 31.10.2009 |
| EU/1/09/515/001-004/IS | Controloc Control | Iceland | 7.9.2009 |
| EU/1/09/516/001/NO | Somac | Norway | 13.7.2009 |
| EU/1/09/516/001-004/IS | Somac Control | Iceland | 7.9.2009 |
| EU/1/09/516/002/NO | Pantoloc | Norway | 13.7.2009 |
| EU/1/09/516/003/NO | Pantecta | Norway | 13.7.2009 |
| EU/1/09/516/004/NO | Controloc | Norway | 13.7.2009 |
| EU/1/09/517/001/NO-002/NO | Pantozol | Norway | 9.7.2009 |
| EU/1/09/517/001-004/IS | Pantozol Control | Iceland | 7.9.2009 |
| EU/1/09/518/001-004/IS | Pantecta Control | Iceland | 7.9.2009 |
| EU/1/09/519/001-004/IS | Pantoloc Control | Iceland | 7.9.2009 |
| EU/1/09/521/001/NO-007/NO | Renvela | Norway | 7.10.2009 |
| EU/1/09/521/001-007/IS | Renvela | Iceland | 4.9.2009 |
| EU/1/09/523/001/NO-002/NO | Modigraf | Norway | 21.10.2009 |
| EU/1/09/523/001-002/IS | Modigraf | Iceland | 23.7.2009 |
| EU/1/09/524/001/NO-002/NO | Qutenza | Norway | 5.8.2009 |
| EU/1/09/524/001-002/IS | Qutenza | Iceland | 21.7.2009 |
| EU/1/09/525/001/NO-046/NO | Nimvastid | Norway | 2.11.2009 |
| EU/1/09/526/001/IS | Iressa | Iceland | 11.9.2009 |
| EU/1/09/526/001/NO | Iressa | Norway | 2.9.2009 |
| EU/1/09/527/001/NO-016/NO | Ribaverin Teva Pharma | Norway | 12.8.2009 |
| EU/1/09/527/001-016 | Ribavirin Teva Pharma BV | Liechtenstein | 31.8.2009 |
| EU/1/09/527/001-016/IS | Ribavirin Teva Pharma BV | Iceland | 17.9.2009 |
| EU/1/09/528/001 | Nymusa | Liechtenstein | 31.8.2009 |
| EU/1/09/528/001/IS | Nymusa | Iceland | 17.9.2009 |
| EU/1/09/528/001/NO | Nymusa | Norway | 12.8.2009 |
| EU/1/09/529/001/NO-005/NO | Victoza | Norway | 4.8.2009 |
| EU/1/09/529/001-005 | Victoza | Liechtenstein | 31.8.2009 |
| EU/1/09/529/001-005/IS | Victoza | Iceland | 15.9.2009 |
| EU/1/09/530/001/NO-015/NO | Repaglinide Teva | Norway | 12.8.2009 |
| EU/1/09/530/001-015 | Repaglinide Teva | Liechtenstein | 31.8.2009 |
| EU/1/09/530/001-015/IS | Repaglinide Teva | Iceland | 11.9.2009 |
| EU/1/09/531/001/NO-009/NO | Instanyl | Norway | 17.8.2009 |
| EU/1/09/531/001-009 | Instanyl | Liechtenstein | 31.8.2009 |
| EU/1/09/531/001-009/IS | Instanyl | Iceland | 24.9.2009 |
| EU/1/09/532/001/NO-007/NO | Clopidogrel Acino | Norway | 25.8.2009 |
| EU/1/09/532/001-007 | Clopidogrel Acino | Liechtenstein | 31.8.2009 |
| EU/1/09/532/001-007/IS | Clopidogrel Acino | Iceland | 24.9.2009 |
| EU/1/09/533/001/NO-003/NO | Vedrop | Norway | 20.8.2009 |
| EU/1/09/533/001-003 | Vedrop | Liechtenstein | 31.8.2009 |
| EU/1/09/533/001-003/IS | Vedrop | Iceland | 5.11.2009 |
| EU/1/09/534/001/NO-007/NO | Clopidogrel Hexal | Norway | 25.8.2009 |
| EU/1/09/534/001-007 | Clopidogrel Hexal | Liechtenstein | 31.8.2009 |
| EU/1/09/534/001-007/IS | Clopidogrel Hexal | Iceland | 28.9.2009 |
| EU/1/09/535/001/NO-014/NO | Grepid | Norway | 20.8.2009 |
| EU/1/09/535/001-014 | Grepid | Liechtenstein | 31.8.2009 |
| EU/1/09/535/001-014/IS | Grepid | Iceland | 9.9.2009 |
| EU/1/09/536/001/NO-002/NO | Topotecan Actavis | Norway | 26.8.2009 |
| EU/1/09/536/001-002 | Topotecan Actavis | Liechtenstein | 31.8.2009 |
| EU/1/09/536/001-002/IS | Topotecan Actavis | Iceland | 29.9.2009 |
| EU/1/09/537/001 | Mozobil | Liechtenstein | 31.8.2009 |
| EU/1/09/537/001/IS | Mozobil | Iceland | 14.10.2009 |
| EU/1/09/537/001/NO | Mozobil | Norway | 10.8.2009 |
| EU/1/09/538/001/NO-006/NO | Afinitor | Norway | 10.8.2009 |
| EU/1/09/538/001-006 | Afinitor | Liechtenstein | 31.8.2009 |
| EU/1/09/538/001-006/IS | Afinitor | Iceland | 15.10.2009 |
| EU/1/09/539/001/NO-004/NO | Samsca | Norway | 21.9.2009 |
| EU/1/09/539/001-004 | Samsca | Liechtenstein | 31.8.2009 |
| EU/1/09/539/001-004/IS | Samsca | Iceland | 22.9.2009 |
| EU/1/09/540/001/NO-009/NO | Clopidogrel Teva | Norway | 20.8.2009 |
| EU/1/09/540/001-009 | Clopidogrel Teva | Liechtenstein | 31.8.2009 |
| EU/1/09/540/001-009/IS | Clopidogrel Teva | Iceland | 29.9.2009 |
| EU/1/09/541/001/NO-007/NO | Clopidogrel ratiopharm GmbH | Norway | 20.8.2009 |
| EU/1/09/541/001-007 | Clopidogrel ratiopharm GmbH | Liechtenstein | 31.8.2009 |
| EU/1/09/541/001-007/IS | Clopidogrel ratiopharm GmbH | Iceland | 24.9.2009 |
| EU/1/09/542/001/NO-007/NO | Clopidogrel 1A Pharma | Norway | 20.8.2009 |
| EU/1/09/542/001-007 | Clopidogrel 1A Pharma | Liechtenstein | 31.8.2009 |
| EU/1/09/542/001-007/IS | Clopidogrel 1A Pharma | Iceland | 28.9.2009 |
| EU/1/09/543/001 | Cayston | Liechtenstein | 31.10.2009 |
| EU/1/09/543/001/IS | Cayston | Iceland | 9.11.2009 |
| EU/1/09/543/001/NO | Cayston | Norway | 30.9.2009 |
| EU/1/09/544/001/NO-002/NO | Cimzia | Norway | 21.10.2009 |
| EU/1/09/544/001-002 | Cimzia | Liechtenstein | 31.10.2009 |
| EU/1/09/544/001-002/IS | Cimzia | Iceland | 24.11.2009 |
| EU/1/09/545/001/NO-010/NO | Onglyza | Norway | 8.10.2009 |
| EU/1/09/545/001-010 | Onglyza | Liechtenstein | 31.10.2009 |
| EU/1/09/545/001-010/IS | Onglyza | Iceland | 12.11.2009 |
| EU/1/09/546/001/NO-004/NO | Simponi | Norway | 16.10.2009 |
| EU/1/09/546/001-004 | Simponi | Liechtenstein | 31.10.2009 |
| EU/1/09/546/001-004/IS | Simponi | Iceland | 2.11.2009 |
| EU/1/09/547/001/NO-007/NO | Clopidogrel Sandoz | Norway | 15.10.2009 |
| EU/1/09/547/001-007 | Clopidogrel Sandoz | Liechtenstein | 31.10.2009 |
| EU/1/09/547/001-007/IS | Clopidogrel Sandoz | Iceland | 25.9.2009 |
| EU/1/09/548/001/NO-007/NO | Clopidogrel Acino Pharma GmbH | Norway | 16.11.2009 |
| EU/1/09/548/001-007 | Clopidogrel Acino Pharma GmbH | Liechtenstein | 31.10.2009 |
| EU/1/09/548/001-007/IS | Clopidogrel Acino Pharma GmbH | Iceland | 24.9.2009 |
| EU/1/09/549/001/NO-007/NO | Clopidogrel Acino Pharma | Norway | 16.11.2009 |
| EU/1/09/549/001-007 | Clopidogrel Acino Pharma | Liechtenstein | 31.10.2009 |
| EU/1/09/549/001-007/IS | Clopidogrel Acino Pharma | Iceland | 30.11.2009 |
| EU/1/09/550/001/NO-012/NO | Javlor | Norway | 21.10.2009 |
| EU/1/09/550/001-012 | Javlor | Liechtenstein | 31.10.2009 |
| EU/1/09/550/001-012/IS | Javlor | Iceland | 10.11.2009 |
| EU/1/09/551/001/NO-012/NO | Vizarsin | Norway | 30.9.2009 |
| EU/1/09/551/001-012 | Vizarsin | Liechtenstein | 31.10.2009 |
| EU/1/09/551/001-012/IS | Vizarsin | Iceland | 6.11.2009 |
| EU/1/09/552/001/NO-004/NO | Topotecan Teva | Norway | 21.10.2009 |
| EU/1/09/552/001-004 | Topotecan Teva | Liechtenstein | 31.10.2009 |
| EU/1/09/552/001-004/IS | Topotecan Teva | Iceland | 10.11.2009 |
| EU/1/09/553/001/NO-010/NO | Zyllt | Norway | 15.10.2009 |
| EU/1/09/553/001-010 | Zyllit | Liechtenstein | 31.10.2009 |
| EU/1/09/553/001-010/IS | Zyllt | Iceland | 5.11.2009 |
| EU/1/09/554/001/NO-007/NO | Clopidogrel ratiopharm | Norway | 28.10.2009 |
| EU/1/09/554/001-007 | Clopidogrel ratiopharm | Liechtenstein | 31.10.2009 |
| EU/1/09/554/001-007/IS | Clopidogrel ratiopharm | Iceland | 27.11.2009 |
| EU/1/09/555/001/NO-009/NO | Clopidogrel TAD | Norway | 15.10.2009 |
| EU/1/09/555/001-009 | Clopidogrel TAD | Liechtenstein | 31.10.2009 |
| EU/1/09/555/001-009/IS | Clopidogrel TAD | Iceland | 2.12.2009 |
| EU/1/09/556/001/NO-009/NO | Clopidogrel Krka | Norway | 15.10.2009 |
| EU/1/09/556/001-009 | Clopidogrel Krka | Liechtenstein | 31.10.2009 |
| EU/1/09/556/001-009/IS | Clopidogrel Krka | Iceland | 17.11.2009 |
| EU/1/09/557/001/NO-009/NO | Clopidogrel Qualimed | Norway | 15.10.2009 |
| EU/1/09/557/001-009 | Clopidogrel Qualimed | Liechtenstein | 31.10.2009 |
| EU/1/09/557/001-009/IS | Clopidogrel Qualimed | Iceland | 3.11.2009 |
| EU/1/09/558/001/NO-010/NO | Zylagren | Norway | 30.9.2009 |
| EU/1/09/558/001-010 | Zylagren | Liechtenstein | 31.10.2009 |
| EU/1/09/558/001-010/IS | Zylagren | Iceland | 5.11.2009 |
| EU/1/09/559/001/NO-009/NO | Clopidogrel Mylan | Norway | 15.10.2009 |
| EU/1/09/559/001-009 | Clopidogrel Mylan | Liechtenstein | 31.10.2009 |
| EU/1/09/559/001-009/IS | Clopidogrel Mylan | Iceland | 29.9.2009 |
| EU/1/09/560/001/NO-009/NO | Clopidogrel Dura | Norway | 15.10.2009 |
| EU/1/09/560/001-009 | Clopidogrel Dura | Liechtenstein | 31.10.2009 |
| EU/1/09/560/001-009/IS | Clopidogrel Dura | Iceland | 2.11.2009 |
| EU/1/09/561/001/NO-009/NO | Clopidogrel HCS | Norway | 15.10.2009 |
| EU/1/09/561/001-009 | Clopidogrel HCS | Liechtenstein | 31.10.2009 |
| EU/1/09/561/001-009/IS | Clopidogrel HCS | Iceland | 3.11.2009 |
| EU/1/09/562/001/NO-009/NO | Zopya | Norway | 30.9.2009 |
| EU/1/09/562/001-009 | Zopya | Liechtenstein | 31.10.2009 |
| EU/1/09/562/001-009/IS | Zopya | Iceland | 3.11.2009 |
| EU/1/09/563/001 | ChondroCelect | Liechtenstein | 31.10.2009 |
| EU/1/09/563/001/IS | ChondroCelect | Iceland | 30.11.2009 |
| EU/1/09/563/001/NO | ChondroCelect | Norway | 22.10.2009 |
| EU/1/09/564/001/NO-002/NO | Ilaris | Norway | 10.11.2009 |
| EU/1/09/564/001-002 | Ilaris | Liechtenstein | 31.10.2009 |
| EU/1/09/564/001-002/IS | Ilaris | Iceland | 20.11.2009 |
| EU/1/09/565/001/NO-028/NO | Biopoin | Norway | 11.11.2009 |
| EU/1/09/565/001-028 | Biopoin | Liechtenstein | 31.10.2009 |
| EU/1/09/565/001-028/IS | Biopoin | Iceland | 20.11.2009 |
| EU/1/09/566/001/NO-005/NO | Lamivudine Teva | Norway | 16.11.2009 |
| EU/1/09/566/001-005 | Lamivudine Teva | Liechtenstein | 31.10.2009 |
| EU/1/09/566/001-005/IS | Lamivudine Teva | Iceland | 20.11.2009 |
| EU/1/09/568/001/NO-018/NO | Klopidogrel Mylan Pharma | Norway | 16.11.2009 |
| EU/1/09/568/001-018 | Clopidogrel Mylan Pharma | Liechtenstein | 31.10.2009 |
| EU/1/09/568/001-018/IS | Clopidogrel Mylan Pharma | Iceland | 27.11.2009 |
| EU/1/09/569/001/NO-060/NO | Exforge HCT | Norway | 2.11.2009 |
| EU/1/09/569/001-060 | Exforge HCT | Liechtenstein | 31.10.2009 |
| EU/1/09/569/001-060/IS | Exforge HCT | Iceland | 18.11.2009 |
| EU/1/09/570/001/NO-060/NO | Imprida HCT | Norway | 24.11.2009 |
| EU/1/09/570/001-060 | Imprida HCT | Liechtenstein | 31.10.2009 |
| EU/1/09/570/001-060/IS | Imprida HCT | Iceland | 18.11.2009 |
| EU/1/09/571/001 | Pandemic Influenza Vaccine H5N1 Baxter | Liechtenstein | 31.12.2009 |
| EU/1/09/571/001/NO | Pandemic Influenza Vaccine H5N1 Baxter | Norway | 2.12.2009 |
| EU/1/09/572/001/NO-009/NO | Alendronate Sodium and Colecalciferol MSD | Norway | 14.12.2009 |
| EU/1/09/572/001-009 | Alendronate Sodium and Colecalciferol MSD | Liechtenstein | 31.10.2009 |
| EU/1/09/572/001-009/IS | Alendronate Sodium and Colecalciferol MSD | Iceland | 26.11.2009 |
| EU/1/09/573/001/NO-028/NO | Eporatio | Norway | 11.11.2009 |
| EU/1/09/573/001-028 | Eporatio | Liechtenstein | 31.12.2009 |
| EU/1/09/573/001-028/IS | Eporatio | Iceland | 20.11.2009 |
| EU/1/09/574/001/NO-060/NO | Dafiro HCT | Norway | 25.11.2009 |
| EU/1/09/574/001-060 | Dafiro HCT | Liechtenstein | 31.12.2009 |
| EU/1/09/574/001-060/IS | Dafiro HCT | Iceland | 25.11.2009 |
| EU/1/09/575/001/NO-060/NO | Copalia | Norway | 25.11.2009 |
| EU/1/09/575/001-060/IS | Copalia HCT | Iceland | 26.11.2009 |
| EU/1/09/576/001/NO-039/NO | Irbesartan Teva | Norway | 11.11.2009 |
| EU/1/09/576/001-039 | Irbesartan Teva | Liechtenstein | 31.12.2009 |
| EU/1/09/576/001-039/IS | Irbesartan Teva | Iceland | 25.11.2009 |
| EU/1/09/577/001-004 | Foclivia | Liechtenstein | 31.12.2009 |
| EU/1/09/578/001 | Pandemic Influenza Vaccine (H5N1) GlaxoSmithKline Biologicals | Liechtenstein | 31.12.2009 |
| EU/1/09/578/001/NO | Pandemivaksine mot influensa | Norway | 1.12.2009 |
| EU/1/09/579/001/NO-018/NO | Repaglinide Krka | Norway | 10.12.2009 |
| EU/1/09/579/001-018 | Repaglinide Krka | Liechtenstein | 31.12.2009 |
| EU/1/09/579/001-018/IS | Repaglinide Krka | Iceland | 17.11.2009 |
| EU/1/09/580/001/NO-018/NO | Enyglid | Norway | 13.11.2009 |
| EU/1/09/580/001-018 | Enyglid | Liechtenstein | 31.10.2009 |
| EU/1/09/580/001-018/IS | Enyglid | Iceland | 17.11.2009 |
| EU/1/09/581/001/NO-002/NO | Resolor | Norway | 14.12.2009 |
| EU/1/09/581/001-002 | Resolor | Liechtenstein | 31.10.2009 |
| EU/1/09/581/001-002/IS | Resolor | Iceland | 18.11.2009 |
| EU/1/09/582/001 | Arcalyst | Liechtenstein | 31.10.2009 |
| EU/1/09/582/001/IS | Arcalyst | Iceland | 20.11.2009 |
| EU/1/09/582/001/NO | Arcalyst | Norway | 11.11.2009 |
| EU/1/09/583/001-072/IS | Irbesartan/Hydrochlorothiazide Teva | Iceland | 17.12.2009 |
| EU/1/09/584/001/NO-018/NO | Sildenafil Teva | Norway | 15.12.2009 |
| EU/1/09/584/001-018/IS | Sildenafil Teva | Iceland | 23.12.2009 |
| EU/1/09/586/001-010/IS | Oslif Breezhaler | Iceland | 22.12.2009 |
| EU/1/09/590/001-006/IS | Prevenar 13 | Iceland | 16.12.2009 |
| EU/1/09/591/001/NO-004/NO | Multaq | Norway | 15.12.2009 |
| EU/1/09/591/001-004/IS | Multaq | Iceland | 21.12.2009 |
| EU/1/09/593/001-010/IS | Onbrez Breezhaler | Iceland | 22.12.2009 |
| EU/1/09/594/001-010/IS | Hirobriz Breezhaler | Iceland | 22.12.2009 |
| EU/1/97/045/001/NO-004/NO | Helicobacter Test INFAI | Norway | 21.9.2009 |
| EU/2/07/076/001-004/IS | Nobilis Influenza H5N6 | Iceland | 7.9.2009 |
| EU/2/08/083/001/IS | Equioxx | Iceland | 21.7.2009 |
| EU/2/08/086/001-003/IS | Duvaxyn WNV | Iceland | 4.11.2009 |
| EU/2/09/095/001-003/IS | Improvac | Iceland | 3.11.2009 |
| EU/2/09/096/001-002/IS | Leucogen | Iceland | 11.9.2009 |
| EU/2/09/097/001/NO-002/NO | Leucofeligen FeLV/RCP | Norway | 13.7.2009 |
| EU/2/09/097/001-002 | Leucofeligen FeLV/RCP | Liechtenstein | 31.8.2009 |
| EU/2/09/097/001-002/IS | Leucofeligen FeLV/RCP | Iceland | 11.9.2009 |
| EU/2/09/098/001 | Melovem | Liechtenstein | 31.8.2009 |
| EU/2/09/098/001/IS | Melovem | Iceland | 22.9.2009 |
| EU/2/09/098/001/NO | Melovem | Norway | 4.9.2009 |
| EU/2/09/099/001/NO-006/NO | Suvaxyn PCV vet | Norway | 18.8.2009 |
| EU/2/09/099/001-006 | Suvaxyn PCV | Liechtenstein | 31.8.2009 |
| EU/2/09/099/001-006/IS | Suvaxyn PCV | Iceland | 28.9.2009 |
| EU/2/09/100/001/NO-003/NO | Palladia | Norway | 29.10.2009 |
| EU/2/09/100/001-003 | Palladia | Liechtenstein | 31.10.2009 |
| EU/2/09/100/001-003/IS | Palladia | Iceland | 11.11.2009 |

EU-Number

Product

Country

Date of authorisation

EU/1/06/361/001/NO-002/NO

Luminity

Norway

20.8.2009

EU/1/07/436/001-002

Isentress

Liechtenstein

31.8.2009

EU/1/09/575/001-060

Copalia HCT

Liechtenstein

31.12.2009

EU/1/09/511/001-004

Conbriza

Liechtenstein

31.10.2009

EU/1/09/515/001-004/IS

Controloc Control

Iceland

7.9.2009

EU/1/09/516/001/NO

Somac

Norway

13.7.2009

EU/1/09/516/001-004/IS

Somac Control

Iceland

7.9.2009

EU/1/09/516/002/NO

Pantoloc

Norway

13.7.2009

EU/1/09/516/003/NO

Pantecta

Norway

13.7.2009

EU/1/09/516/004/NO

Controloc

Norway

13.7.2009

EU/1/09/517/001/NO-002/NO

Pantozol

Norway

9.7.2009

EU/1/09/517/001-004/IS

Pantozol Control

Iceland

7.9.2009

EU/1/09/518/001-004/IS

Pantecta Control

Iceland

7.9.2009

EU/1/09/519/001-004/IS

Pantoloc Control

Iceland

7.9.2009

EU/1/09/521/001/NO-007/NO

Renvela

Norway

7.10.2009

EU/1/09/521/001-007/IS

Renvela

Iceland

4.9.2009

EU/1/09/523/001/NO-002/NO

Modigraf

Norway

21.10.2009

EU/1/09/523/001-002/IS

Modigraf

Iceland

23.7.2009

EU/1/09/524/001/NO-002/NO

Qutenza

Norway

5.8.2009

EU/1/09/524/001-002/IS

Qutenza

Iceland

21.7.2009

EU/1/09/525/001/NO-046/NO

Nimvastid

Norway

2.11.2009

EU/1/09/526/001/IS

Iressa

Iceland

11.9.2009

EU/1/09/526/001/NO

Iressa

Norway

2.9.2009

EU/1/09/527/001/NO-016/NO

Ribaverin Teva Pharma

Norway

12.8.2009

EU/1/09/527/001-016

Ribavirin Teva Pharma BV

Liechtenstein

31.8.2009

EU/1/09/527/001-016/IS

Ribavirin Teva Pharma BV

Iceland

17.9.2009

EU/1/09/528/001

Nymusa

Liechtenstein

31.8.2009

EU/1/09/528/001/IS

Nymusa

Iceland

17.9.2009

EU/1/09/528/001/NO

Nymusa

Norway

12.8.2009

EU/1/09/529/001/NO-005/NO

Victoza

Norway

4.8.2009

EU/1/09/529/001-005

Victoza

Liechtenstein

31.8.2009

EU/1/09/529/001-005/IS

Victoza

Iceland

15.9.2009

EU/1/09/530/001/NO-015/NO

Repaglinide Teva

Norway

12.8.2009

EU/1/09/530/001-015

Repaglinide Teva

Liechtenstein

31.8.2009

EU/1/09/530/001-015/IS

Repaglinide Teva

Iceland

11.9.2009

EU/1/09/531/001/NO-009/NO

Instanyl

Norway

17.8.2009

EU/1/09/531/001-009

Instanyl

Liechtenstein

31.8.2009

EU/1/09/531/001-009/IS

Instanyl

Iceland

24.9.2009

EU/1/09/532/001/NO-007/NO

Clopidogrel Acino

Norway

25.8.2009

EU/1/09/532/001-007

Clopidogrel Acino

Liechtenstein

31.8.2009

EU/1/09/532/001-007/IS

Clopidogrel Acino

Iceland

24.9.2009

EU/1/09/533/001/NO-003/NO

Vedrop

Norway

20.8.2009

EU/1/09/533/001-003

Vedrop

Liechtenstein

31.8.2009

EU/1/09/533/001-003/IS

Vedrop

Iceland

5.11.2009

EU/1/09/534/001/NO-007/NO

Clopidogrel Hexal

Norway

25.8.2009

EU/1/09/534/001-007

Clopidogrel Hexal

Liechtenstein

31.8.2009

EU/1/09/534/001-007/IS

Clopidogrel Hexal

Iceland

28.9.2009

EU/1/09/535/001/NO-014/NO

Grepid

Norway

20.8.2009

EU/1/09/535/001-014

Grepid

Liechtenstein

31.8.2009

EU/1/09/535/001-014/IS

Grepid

Iceland

9.9.2009

EU/1/09/536/001/NO-002/NO

Topotecan Actavis

Norway

26.8.2009

EU/1/09/536/001-002

Topotecan Actavis

Liechtenstein

31.8.2009

EU/1/09/536/001-002/IS

Topotecan Actavis

Iceland

29.9.2009

EU/1/09/537/001

Mozobil

Liechtenstein

31.8.2009

EU/1/09/537/001/IS

Mozobil

Iceland

14.10.2009

EU/1/09/537/001/NO

Mozobil

Norway

10.8.2009

EU/1/09/538/001/NO-006/NO

Afinitor

Norway

10.8.2009

EU/1/09/538/001-006

Afinitor

Liechtenstein

31.8.2009

EU/1/09/538/001-006/IS

Afinitor

Iceland

15.10.2009

EU/1/09/539/001/NO-004/NO

Samsca

Norway

21.9.2009

EU/1/09/539/001-004

Samsca

Liechtenstein

31.8.2009

EU/1/09/539/001-004/IS

Samsca

Iceland

22.9.2009

EU/1/09/540/001/NO-009/NO

Clopidogrel Teva

Norway

20.8.2009

EU/1/09/540/001-009

Clopidogrel Teva

Liechtenstein

31.8.2009

EU/1/09/540/001-009/IS

Clopidogrel Teva

Iceland

29.9.2009

EU/1/09/541/001/NO-007/NO

Clopidogrel ratiopharm GmbH

Norway

20.8.2009

EU/1/09/541/001-007

Clopidogrel ratiopharm GmbH

Liechtenstein

31.8.2009

EU/1/09/541/001-007/IS

Clopidogrel ratiopharm GmbH

Iceland

24.9.2009

EU/1/09/542/001/NO-007/NO

Clopidogrel 1A Pharma

Norway

20.8.2009

EU/1/09/542/001-007

Clopidogrel 1A Pharma

Liechtenstein

31.8.2009

EU/1/09/542/001-007/IS

Clopidogrel 1A Pharma

Iceland

28.9.2009

EU/1/09/543/001

Cayston

Liechtenstein

31.10.2009

EU/1/09/543/001/IS

Cayston

Iceland

9.11.2009

EU/1/09/543/001/NO

Cayston

Norway

30.9.2009

EU/1/09/544/001/NO-002/NO

Cimzia

Norway

21.10.2009

EU/1/09/544/001-002

Cimzia

Liechtenstein

31.10.2009

EU/1/09/544/001-002/IS

Cimzia

Iceland

24.11.2009

EU/1/09/545/001/NO-010/NO

Onglyza

Norway

8.10.2009

EU/1/09/545/001-010

Onglyza

Liechtenstein

31.10.2009

EU/1/09/545/001-010/IS

Onglyza

Iceland

12.11.2009

EU/1/09/546/001/NO-004/NO

Simponi

Norway

16.10.2009

EU/1/09/546/001-004

Simponi

Liechtenstein

31.10.2009

EU/1/09/546/001-004/IS

Simponi

Iceland

2.11.2009

EU/1/09/547/001/NO-007/NO

Clopidogrel Sandoz

Norway

15.10.2009

EU/1/09/547/001-007

Clopidogrel Sandoz

Liechtenstein

31.10.2009

EU/1/09/547/001-007/IS

Clopidogrel Sandoz

Iceland

25.9.2009

EU/1/09/548/001/NO-007/NO

Clopidogrel Acino Pharma GmbH

Norway

16.11.2009

EU/1/09/548/001-007

Clopidogrel Acino Pharma GmbH

Liechtenstein

31.10.2009

EU/1/09/548/001-007/IS

Clopidogrel Acino Pharma GmbH

Iceland

24.9.2009

EU/1/09/549/001/NO-007/NO

Clopidogrel Acino Pharma

Norway

16.11.2009

EU/1/09/549/001-007

Clopidogrel Acino Pharma

Liechtenstein

31.10.2009

EU/1/09/549/001-007/IS

Clopidogrel Acino Pharma

Iceland

30.11.2009

EU/1/09/550/001/NO-012/NO

Javlor

Norway

21.10.2009

EU/1/09/550/001-012

Javlor

Liechtenstein

31.10.2009

EU/1/09/550/001-012/IS

Javlor

Iceland

10.11.2009

EU/1/09/551/001/NO-012/NO

Vizarsin

Norway

30.9.2009

EU/1/09/551/001-012

Vizarsin

Liechtenstein

31.10.2009

EU/1/09/551/001-012/IS

Vizarsin

Iceland

6.11.2009

EU/1/09/552/001/NO-004/NO

Topotecan Teva

Norway

21.10.2009

EU/1/09/552/001-004

Topotecan Teva

Liechtenstein

31.10.2009

EU/1/09/552/001-004/IS

Topotecan Teva

Iceland

10.11.2009

EU/1/09/553/001/NO-010/NO

Zyllt

Norway

15.10.2009

EU/1/09/553/001-010

Zyllit

Liechtenstein

31.10.2009

EU/1/09/553/001-010/IS

Zyllt

Iceland

5.11.2009

EU/1/09/554/001/NO-007/NO

Clopidogrel ratiopharm

Norway

28.10.2009

EU/1/09/554/001-007

Clopidogrel ratiopharm

Liechtenstein

31.10.2009

EU/1/09/554/001-007/IS

Clopidogrel ratiopharm

Iceland

27.11.2009

EU/1/09/555/001/NO-009/NO

Clopidogrel TAD

Norway

15.10.2009

EU/1/09/555/001-009

Clopidogrel TAD

Liechtenstein

31.10.2009

EU/1/09/555/001-009/IS

Clopidogrel TAD

Iceland

2.12.2009

EU/1/09/556/001/NO-009/NO

Clopidogrel Krka

Norway

15.10.2009

EU/1/09/556/001-009

Clopidogrel Krka

Liechtenstein

31.10.2009

EU/1/09/556/001-009/IS

Clopidogrel Krka

Iceland

17.11.2009

EU/1/09/557/001/NO-009/NO

Clopidogrel Qualimed

Norway

15.10.2009

EU/1/09/557/001-009

Clopidogrel Qualimed

Liechtenstein

31.10.2009

EU/1/09/557/001-009/IS

Clopidogrel Qualimed

Iceland

3.11.2009

EU/1/09/558/001/NO-010/NO

Zylagren

Norway

30.9.2009

EU/1/09/558/001-010

Zylagren

Liechtenstein

31.10.2009

EU/1/09/558/001-010/IS

Zylagren

Iceland

5.11.2009

EU/1/09/559/001/NO-009/NO

Clopidogrel Mylan

Norway

15.10.2009

EU/1/09/559/001-009

Clopidogrel Mylan

Liechtenstein

31.10.2009

EU/1/09/559/001-009/IS

Clopidogrel Mylan

Iceland

29.9.2009

EU/1/09/560/001/NO-009/NO

Clopidogrel Dura

Norway

15.10.2009

EU/1/09/560/001-009

Clopidogrel Dura

Liechtenstein

31.10.2009

EU/1/09/560/001-009/IS

Clopidogrel Dura

Iceland

2.11.2009

EU/1/09/561/001/NO-009/NO

Clopidogrel HCS

Norway

15.10.2009

EU/1/09/561/001-009

Clopidogrel HCS

Liechtenstein

31.10.2009

EU/1/09/561/001-009/IS

Clopidogrel HCS

Iceland

3.11.2009

EU/1/09/562/001/NO-009/NO

Zopya

Norway

30.9.2009

EU/1/09/562/001-009

Zopya

Liechtenstein

31.10.2009

EU/1/09/562/001-009/IS

Zopya

Iceland

3.11.2009

EU/1/09/563/001

ChondroCelect

Liechtenstein

31.10.2009

EU/1/09/563/001/IS

ChondroCelect

Iceland

30.11.2009

EU/1/09/563/001/NO

ChondroCelect

Norway

22.10.2009

EU/1/09/564/001/NO-002/NO

Ilaris

Norway

10.11.2009

EU/1/09/564/001-002

Ilaris

Liechtenstein

31.10.2009

EU/1/09/564/001-002/IS

Ilaris

Iceland

20.11.2009

EU/1/09/565/001/NO-028/NO

Biopoin

Norway

11.11.2009

EU/1/09/565/001-028

Biopoin

Liechtenstein

31.10.2009

EU/1/09/565/001-028/IS

Biopoin

Iceland

20.11.2009

EU/1/09/566/001/NO-005/NO

Lamivudine Teva

Norway

16.11.2009

EU/1/09/566/001-005

Lamivudine Teva

Liechtenstein

31.10.2009

EU/1/09/566/001-005/IS

Lamivudine Teva

Iceland

20.11.2009

EU/1/09/568/001/NO-018/NO

Klopidogrel Mylan Pharma

Norway

16.11.2009

EU/1/09/568/001-018

Clopidogrel Mylan Pharma

Liechtenstein

31.10.2009

EU/1/09/568/001-018/IS

Clopidogrel Mylan Pharma

Iceland

27.11.2009

EU/1/09/569/001/NO-060/NO

Exforge HCT

Norway

2.11.2009

EU/1/09/569/001-060

Exforge HCT

Liechtenstein

31.10.2009

EU/1/09/569/001-060/IS

Exforge HCT

Iceland

18.11.2009

EU/1/09/570/001/NO-060/NO

Imprida HCT

Norway

24.11.2009

EU/1/09/570/001-060

Imprida HCT

Liechtenstein

31.10.2009

EU/1/09/570/001-060/IS

Imprida HCT

Iceland

18.11.2009

EU/1/09/571/001

Pandemic Influenza Vaccine H5N1 Baxter

Liechtenstein

31.12.2009

EU/1/09/571/001/NO

Pandemic Influenza Vaccine H5N1 Baxter

Norway

2.12.2009

EU/1/09/572/001/NO-009/NO

Alendronate Sodium and Colecalciferol MSD

Norway

14.12.2009

EU/1/09/572/001-009

Alendronate Sodium and Colecalciferol MSD

Liechtenstein

31.10.2009

EU/1/09/572/001-009/IS

Alendronate Sodium and Colecalciferol MSD

Iceland

26.11.2009

EU/1/09/573/001/NO-028/NO

Eporatio

Norway

11.11.2009

EU/1/09/573/001-028

Eporatio

Liechtenstein

31.12.2009

EU/1/09/573/001-028/IS

Eporatio

Iceland

20.11.2009

EU/1/09/574/001/NO-060/NO

Dafiro HCT

Norway

25.11.2009

EU/1/09/574/001-060

Dafiro HCT

Liechtenstein

31.12.2009

EU/1/09/574/001-060/IS

Dafiro HCT

Iceland

25.11.2009

EU/1/09/575/001/NO-060/NO

Copalia

Norway

25.11.2009

EU/1/09/575/001-060/IS

Copalia HCT

Iceland

26.11.2009

EU/1/09/576/001/NO-039/NO

Irbesartan Teva

Norway

11.11.2009

EU/1/09/576/001-039

Irbesartan Teva

Liechtenstein

31.12.2009

EU/1/09/576/001-039/IS

Irbesartan Teva

Iceland

25.11.2009

EU/1/09/577/001-004

Foclivia

Liechtenstein

31.12.2009

EU/1/09/578/001

Pandemic Influenza Vaccine (H5N1) GlaxoSmithKline Biologicals

Liechtenstein

31.12.2009

EU/1/09/578/001/NO

Pandemivaksine mot influensa

Norway

1.12.2009

EU/1/09/579/001/NO-018/NO

Repaglinide Krka

Norway

10.12.2009

EU/1/09/579/001-018

Repaglinide Krka

Liechtenstein

31.12.2009

EU/1/09/579/001-018/IS

Repaglinide Krka

Iceland

17.11.2009

EU/1/09/580/001/NO-018/NO

Enyglid

Norway

13.11.2009

EU/1/09/580/001-018

Enyglid

Liechtenstein

31.10.2009

EU/1/09/580/001-018/IS

Enyglid

Iceland

17.11.2009

EU/1/09/581/001/NO-002/NO

Resolor

Norway

14.12.2009

EU/1/09/581/001-002

Resolor

Liechtenstein

31.10.2009

EU/1/09/581/001-002/IS

Resolor

Iceland

18.11.2009

EU/1/09/582/001

Arcalyst

Liechtenstein

31.10.2009

EU/1/09/582/001/IS

Arcalyst

Iceland

20.11.2009

EU/1/09/582/001/NO

Arcalyst

Norway

11.11.2009

EU/1/09/583/001-072/IS

Irbesartan/Hydrochlorothiazide Teva

Iceland

17.12.2009

EU/1/09/584/001/NO-018/NO

Sildenafil Teva

Norway

15.12.2009

EU/1/09/584/001-018/IS

Sildenafil Teva

Iceland

23.12.2009

EU/1/09/586/001-010/IS

Oslif Breezhaler

Iceland

22.12.2009

EU/1/09/590/001-006/IS

Prevenar 13

Iceland

16.12.2009

EU/1/09/591/001/NO-004/NO

Multaq

Norway

15.12.2009

EU/1/09/591/001-004/IS

Multaq

Iceland

21.12.2009

EU/1/09/593/001-010/IS

Onbrez Breezhaler

Iceland

22.12.2009

EU/1/09/594/001-010/IS

Hirobriz Breezhaler

Iceland

22.12.2009

EU/1/97/045/001/NO-004/NO

Helicobacter Test INFAI

Norway

21.9.2009

EU/2/07/076/001-004/IS

Nobilis Influenza H5N6

Iceland

7.9.2009

EU/2/08/083/001/IS

Equioxx

Iceland

21.7.2009

EU/2/08/086/001-003/IS

Duvaxyn WNV

Iceland

4.11.2009

EU/2/09/095/001-003/IS

Improvac

Iceland

3.11.2009

EU/2/09/096/001-002/IS

Leucogen

Iceland

11.9.2009

EU/2/09/097/001/NO-002/NO

Leucofeligen FeLV/RCP

Norway

13.7.2009

EU/2/09/097/001-002

Leucofeligen FeLV/RCP

Liechtenstein

31.8.2009

EU/2/09/097/001-002/IS

Leucofeligen FeLV/RCP

Iceland

11.9.2009

EU/2/09/098/001

Melovem

Liechtenstein

31.8.2009

EU/2/09/098/001/IS

Melovem

Iceland

22.9.2009

EU/2/09/098/001/NO

Melovem

Norway

4.9.2009

EU/2/09/099/001/NO-006/NO

Suvaxyn PCV vet

Norway

18.8.2009

EU/2/09/099/001-006

Suvaxyn PCV

Liechtenstein

31.8.2009

EU/2/09/099/001-006/IS

Suvaxyn PCV

Iceland

28.9.2009

EU/2/09/100/001/NO-003/NO

Palladia

Norway

29.10.2009

EU/2/09/100/001-003

Palladia

Liechtenstein

31.10.2009

EU/2/09/100/001-003/IS

Palladia

Iceland

11.11.2009

---

ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July-31 December 2009:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/03/264/001/NO | Zevalin | Norway | 21.8.2009 |
| EU/1/03/270/001/NO-003/NO | Kentera | Norway | 9.7.2009 |
| EU/1/04/275/001/NO-002/NO | Litak | Norway | 1.7.2009 |
| EU/1/04/276/001/NO-036/NO | Abilify | Norway | 13.7.2009 |
| EU/1/04/276/001-020,024-036/IS | Abilify | Iceland | 20.7.2009 |
| EU/1/04/277/001/NO-004/NO | Tachosil | Norway | 24.9.2009 |
| EU/1/04/277/001-004/IS | Tachosil | Iceland | 2.9.2009 |
| EU/1/04/279/001/NO-036/NO | Lyrica | Norway | 29.7.2009 |
| EU/1/04/279/001-025,030-043/IS | Lyrica | Iceland | 21.9.2009 |
| EU/1/04/280/001/NO-008/NO | Yentreve | Norway | 18.8.2009 |
| EU/1/04/280/001-008/IS | Yentreve | Iceland | 14.9.2009 |
| EU/1/04/280/001-008 | Yentreve | Liechtenstein | 31.8.2009 |
| EU/1/04/281/001-005/IS | Erbitux | Iceland | 9.9.2009 |
| EU/1/04/282/001/NO-002/NO | Telzir | Norway | 10.8.2009 |
| EU/1/04/282/001-002/IS | Telzir | Iceland | 21.7.2009 |
| EU/1/04/283/008/NO-012/NO | Ariclaim | Norway | 24.8.2009 |
| EU/1/04/283/008-012/IS | Ariclaim | Iceland | 14.9.2009 |
| EU/1/04/284/001 | Pedea | Liechtenstein | 31.8.2009 |
| EU/1/04/284/001/IS | Pedea | Iceland | 28.9.2009 |
| EU/1/04/284/001/NO | Pedea | Norway | 20.10.2009 |
| EU/1/04/285/001/NO-036/NO | Apidra | Norway | 9.9.2009 |
| EU/1/04/285/001-036 | Apidra | Liechtenstein | 31.8.2009 |
| EU/1/04/285/001-036/IS | Apidra | Iceland | 2.10.2009 |
| EU/1/04/286/001/NO-002/NO | Wilzin | Norway | 26.10.2009 |
| EU/1/04/286/001-002 | Wilzin | Liechtenstein | 31.10.2009 |
| EU/1/04/286/001-002/IS | Wilzin | Iceland | 18.11.2009 |
| EU/1/04/287/001/NO-006/NO | Osseor | Norway | 18.12.2009 |
| EU/1/04/287/001-006 | Osseor | Liechtenstein | 31.12.2009 |
| EU/1/04/287/001-006/IS | Osseor | Iceland | 29.11.2009 |
| EU/1/04/288/001/NO-006/NO | Protelos | Norway | 28.12.2009 |
| EU/1/04/288/001-006/IS | Protelos | Iceland | 29.11.2009 |
| EU/1/04/289/001/NO-002/NO | Angiox | Norway | 9.7.2009 |
| EU/1/04/289/001-002 | Angiox | Liechtenstein | 31.8.2009 |
| EU/1/04/289/001-002/IS | Angiox | Iceland | 9.12.2009 |
| EU/1/04/290/001-002 | Alimta | Liechtenstein | 31.10.2009 |
| EU/1/04/290/001-002/IS | Alimta | Iceland | 24.9.2009 |
| EU/1/04/292/001/NO-012/NO | Mimpara | Norway | 6.10.2009 |
| EU/1/04/292/001-012 | Mimpara | Liechtenstein | 31.10.2009 |
| EU/1/04/292/001-012/IS | Mimpara | Iceland | 12.11.2009 |
| EU/1/04/294/001/NO-028/NO | Emselex | Norway | 21.10.2009 |
| EU/1/04/294/001-028/IS | Emselex | Iceland | 5.11.2009 |
| EU/1/04/295/001 | Xagrid | Liechtenstein | 31.12.2009 |
| EU/1/04/295/001/NO | Xagrid | Norway | 16.12.2009 |
| EU/1/04/295/001/IS | Xagrid | Iceland | 10.12.2009 |
| EU/1/04/296/001/NO-009/NO | Cymbalta | Norway | 24.8.2009 |
| EU/1/04/296/001-009/IS | Cymbalta | Iceland | 14.9.2009 |
| EU/1/04/297/001/NO-006/NO | Xeristar | Norway | 27.10.2009 |
| EU/1/04/297/001-008/IS | Xeristar | Iceland | 14.9.2009 |
| EU/1/04/298/001-003/IS | Kivexa | Iceland | 17.12.2009 |
| EU/1/04/304/001-007 | Azilect | Liechtenstein | 31.10.2009 |
| EU/1/04/304/001-007/IS | Azilect | Iceland | 11.11.2009 |
| EU/1/06/367/001-012/IS | Diacomit | Iceland | 21.12.2009 |
| EU/1/07/423/001/NO-003/NO | Vectibix | Norway | 16.7.2009 |
| EU/1/07/436/001-002/IS | Isentress | Iceland | 27.8.2009 |
| EU/1/08/468/001 | Intelence | Liechtenstein | 31.8.2009 |
| EU/1/08/468/001/IS | Intelence | Iceland | 22.10.2009 |
| EU/1/08/468/001/NO | Intelence | Norway | 20.8.2009 |
| EU/1/09/288/001-006 | Protelos | Liechtenstein | 31.12.2009 |
| EU/1/09/555/002/NO | Alimta | Norway | 23.9.2009 |
| EU/1/97/044/001/NO-008/NO | Simponi | Norway | 20.10.2009 |
| EU/1/97/044/001/NO-008/NO | Tasmar | Norway | 20.10.2009 |
| EU/1/97/044/001-008 | Tasmar | Liechtenstein | 31.10.2009 |
| EU/1/97/044/001-008/IS | Tasmar | Iceland | 15.10.2009 |
| EU/1/99/100/001-003/IS | Cetrotide | Iceland | 30.11.2009 |
| EU/1/99/103/001/NO-004/NO | Refacto AF | Norway | 2.7.2009 |
| EU/1/99/107/001/NO-004/NO | Rebetol | Norway | 30.7.2009 |
| EU/1/99/108/001/NO-003/NO | Ferriprox | Norway | 6.10.2009 |
| EU/1/99/108/001-003 | Ferriprox | Liechtenstein | 31.10.2009 |
| EU/1/99/108/001-003/IS | Ferriprox | Iceland | 11.11.2009 |
| EU/1/99/109/001/NO-002/NO | Integrilin | Norway | 10.8.2009 |
| EU/1/99/109/001-002 | Integrilin | Liechtenstein | 31.8.2009 |
| EU/1/99/109/001-002/IS | Integrilin | Iceland | 30.9.2009 |
| EU/1/99/112/001/NO-002/NO | Ziagen | Norway | 26.8.2009 |
| EU/1/99/112/001-002/IS | Ziagen | Iceland | 12.7.2009 |
| EU/1/99/113/001-004 | Paxene | Liechtenstein | 31.8.2009 |
| EU/1/99/113/001-004/IS | Paxene | Iceland | 27.11.2009 |
| EU/1/99/114/001/NO-003/NO | Zeffix | Norway | 16.9.2009 |
| EU/1/99/114/001-003 | Zeffix | Liechtenstein | 31.10.2009 |
| EU/1/99/114/001-003/IS | Zeffix | Iceland | 15.10.2009 |
| EU/1/99/116/001/NO-005/NO | Remicade | Norway | 2.10.2009 |
| EU/1/99/116/001-005 | Remicade | Liechtenstein | 31.8.2009 |
| EU/1/99/116/001-005/IS | Remicade | Iceland | 8.9.2009 |
| EU/1/99/117/001/NO-002/NO | Synagis | Norway | 28.9.2009 |
| EU/1/99/117/001-002 | Synagis | Liechtenstein | 31.8.2009 |
| EU/1/99/117/001-002/IS | Synagis | Iceland | 22.10.2009 |
| EU/1/99/118/001/NO-009/NO | Arava | Norway | 5.10.2009 |
| EU/1/99/118/001-010 | Arava | Liechtenstein | 31.8.2009 |
| EU/1/99/118/001-010/IS | Arava | Iceland | 15.9.2009 |
| EU/1/99/119/001,003,005-015/IS | NovoRapid | Iceland | 26.8.2009 |
| EU/1/99/120/001/NO-004/NO | Ammonaps | Norway | 22.10.2009 |
| EU/1/99/120/001-004 | Ammonaps | Liechtenstein | 31.10.2009 |
| EU/1/99/120/001-004/IS | Ammonaps | Iceland | 17.11.2009 |
| EU/1/99/126/001-021/IS | Enbrel | Iceland | 21.12.2009 |
| EU/2/04/043/001/NO | Equilis StrepE | Norway | 30.7.2009 |
| EU/2/04/044/001/NO-010/NO | Aivlosin | Norway | 18.9.2009 |
| EU/2/04/044/001-010 | Aivlosin | Liechtenstein | 31.10.2009 |
| EU/2/04/044/001-010/IS | Aivlosin | Iceland | 7.10.2009 |
| EU/2/04/045/001-007/IS | Previcox | Iceland | 21.9.2009 |
| EU/2/04/046/001-003 | Nobivac Piro | Liechtenstein | 31.8.2009 |
| EU/2/04/046/001-003/IS | Nobivac Piro | Iceland | 23.9.2009 |
| EU/2/98/009/001-006/IS | Suvaxyn Aujeszky 783+O/W | Iceland | 5.11.2009 |
| EU/2/98/010/017-18,21-24/NO | Econor | Norway | 24.11.2009 |
| EU/2/99/014//001-012 | Stronghold | Liechtenstein | 31.10.2009 |
| EU/2/99/014/001-012/IS | Stronghold | Iceland | 16.12.2009 |
| EU/2/99/015/001-002 | Oxyglobin | Liechtenstein | 31.10.2009 |
| EU/2/99/015/001-002/IS | Oxyglobin | Iceland | 30.11.2009 |

EU-Number

Product

Country

Date of authorisation

EU/1/03/264/001/NO

Zevalin

Norway

21.8.2009

EU/1/03/270/001/NO-003/NO

Kentera

Norway

9.7.2009

EU/1/04/275/001/NO-002/NO

Litak

Norway

1.7.2009

EU/1/04/276/001/NO-036/NO

Abilify

Norway

13.7.2009

EU/1/04/276/001-020,024-036/IS

Abilify

Iceland

20.7.2009

EU/1/04/277/001/NO-004/NO

Tachosil

Norway

24.9.2009

EU/1/04/277/001-004/IS

Tachosil

Iceland

2.9.2009

EU/1/04/279/001/NO-036/NO

Lyrica

Norway

29.7.2009

EU/1/04/279/001-025,030-043/IS

Lyrica

Iceland

21.9.2009

EU/1/04/280/001/NO-008/NO

Yentreve

Norway

18.8.2009

EU/1/04/280/001-008/IS

Yentreve

Iceland

14.9.2009

EU/1/04/280/001-008

Yentreve

Liechtenstein

31.8.2009

EU/1/04/281/001-005/IS

Erbitux

Iceland

9.9.2009

EU/1/04/282/001/NO-002/NO

Telzir

Norway

10.8.2009

EU/1/04/282/001-002/IS

Telzir

Iceland

21.7.2009

EU/1/04/283/008/NO-012/NO

Ariclaim

Norway

24.8.2009

EU/1/04/283/008-012/IS

Ariclaim

Iceland

14.9.2009

EU/1/04/284/001

Pedea

Liechtenstein

31.8.2009

EU/1/04/284/001/IS

Pedea

Iceland

28.9.2009

EU/1/04/284/001/NO

Pedea

Norway

20.10.2009

EU/1/04/285/001/NO-036/NO

Apidra

Norway

9.9.2009

EU/1/04/285/001-036

Apidra

Liechtenstein

31.8.2009

EU/1/04/285/001-036/IS

Apidra

Iceland

2.10.2009

EU/1/04/286/001/NO-002/NO

Wilzin

Norway

26.10.2009

EU/1/04/286/001-002

Wilzin

Liechtenstein

31.10.2009

EU/1/04/286/001-002/IS

Wilzin

Iceland

18.11.2009

EU/1/04/287/001/NO-006/NO

Osseor

Norway

18.12.2009

EU/1/04/287/001-006

Osseor

Liechtenstein

31.12.2009

EU/1/04/287/001-006/IS

Osseor

Iceland

29.11.2009

EU/1/04/288/001/NO-006/NO

Protelos

Norway

28.12.2009

EU/1/04/288/001-006/IS

Protelos

Iceland

29.11.2009

EU/1/04/289/001/NO-002/NO

Angiox

Norway

9.7.2009

EU/1/04/289/001-002

Angiox

Liechtenstein

31.8.2009

EU/1/04/289/001-002/IS

Angiox

Iceland

9.12.2009

EU/1/04/290/001-002

Alimta

Liechtenstein

31.10.2009

EU/1/04/290/001-002/IS

Alimta

Iceland

24.9.2009

EU/1/04/292/001/NO-012/NO

Mimpara

Norway

6.10.2009

EU/1/04/292/001-012

Mimpara

Liechtenstein

31.10.2009

EU/1/04/292/001-012/IS

Mimpara

Iceland

12.11.2009

EU/1/04/294/001/NO-028/NO

Emselex

Norway

21.10.2009

EU/1/04/294/001-028/IS

Emselex

Iceland

5.11.2009

EU/1/04/295/001

Xagrid

Liechtenstein

31.12.2009

EU/1/04/295/001/NO

Xagrid

Norway

16.12.2009

EU/1/04/295/001/IS

Xagrid

Iceland

10.12.2009

EU/1/04/296/001/NO-009/NO

Cymbalta

Norway

24.8.2009

EU/1/04/296/001-009/IS

Cymbalta

Iceland

14.9.2009

EU/1/04/297/001/NO-006/NO

Xeristar

Norway

27.10.2009

EU/1/04/297/001-008/IS

Xeristar

Iceland

14.9.2009

EU/1/04/298/001-003/IS

Kivexa

Iceland

17.12.2009

EU/1/04/304/001-007

Azilect

Liechtenstein

31.10.2009

EU/1/04/304/001-007/IS

Azilect

Iceland

11.11.2009

EU/1/06/367/001-012/IS

Diacomit

Iceland

21.12.2009

EU/1/07/423/001/NO-003/NO

Vectibix

Norway

16.7.2009

EU/1/07/436/001-002/IS

Isentress

Iceland

27.8.2009

EU/1/08/468/001

Intelence

Liechtenstein

31.8.2009

EU/1/08/468/001/IS

Intelence

Iceland

22.10.2009

EU/1/08/468/001/NO

Intelence

Norway

20.8.2009

EU/1/09/288/001-006

Protelos

Liechtenstein

31.12.2009

EU/1/09/555/002/NO

Alimta

Norway

23.9.2009

EU/1/97/044/001/NO-008/NO

Simponi

Norway

20.10.2009

EU/1/97/044/001/NO-008/NO

Tasmar

Norway

20.10.2009

EU/1/97/044/001-008

Tasmar

Liechtenstein

31.10.2009

EU/1/97/044/001-008/IS

Tasmar

Iceland

15.10.2009

EU/1/99/100/001-003/IS

Cetrotide

Iceland

30.11.2009

EU/1/99/103/001/NO-004/NO

Refacto AF

Norway

2.7.2009

EU/1/99/107/001/NO-004/NO

Rebetol

Norway

30.7.2009

EU/1/99/108/001/NO-003/NO

Ferriprox

Norway

6.10.2009

EU/1/99/108/001-003

Ferriprox

Liechtenstein

31.10.2009

EU/1/99/108/001-003/IS

Ferriprox

Iceland

11.11.2009

EU/1/99/109/001/NO-002/NO

Integrilin

Norway

10.8.2009

EU/1/99/109/001-002

Integrilin

Liechtenstein

31.8.2009

EU/1/99/109/001-002/IS

Integrilin

Iceland

30.9.2009

EU/1/99/112/001/NO-002/NO

Ziagen

Norway

26.8.2009

EU/1/99/112/001-002/IS

Ziagen

Iceland

12.7.2009

EU/1/99/113/001-004

Paxene

Liechtenstein

31.8.2009

EU/1/99/113/001-004/IS

Paxene

Iceland

27.11.2009

EU/1/99/114/001/NO-003/NO

Zeffix

Norway

16.9.2009

EU/1/99/114/001-003

Zeffix

Liechtenstein

31.10.2009

EU/1/99/114/001-003/IS

Zeffix

Iceland

15.10.2009

EU/1/99/116/001/NO-005/NO

Remicade

Norway

2.10.2009

EU/1/99/116/001-005

Remicade

Liechtenstein

31.8.2009

EU/1/99/116/001-005/IS

Remicade

Iceland

8.9.2009

EU/1/99/117/001/NO-002/NO

Synagis

Norway

28.9.2009

EU/1/99/117/001-002

Synagis

Liechtenstein

31.8.2009

EU/1/99/117/001-002/IS

Synagis

Iceland

22.10.2009

EU/1/99/118/001/NO-009/NO

Arava

Norway

5.10.2009

EU/1/99/118/001-010

Arava

Liechtenstein

31.8.2009

EU/1/99/118/001-010/IS

Arava

Iceland

15.9.2009

EU/1/99/119/001,003,005-015/IS

NovoRapid

Iceland

26.8.2009

EU/1/99/120/001/NO-004/NO

Ammonaps

Norway

22.10.2009

EU/1/99/120/001-004

Ammonaps

Liechtenstein

31.10.2009

EU/1/99/120/001-004/IS

Ammonaps

Iceland

17.11.2009

EU/1/99/126/001-021/IS

Enbrel

Iceland

21.12.2009

EU/2/04/043/001/NO

Equilis StrepE

Norway

30.7.2009

EU/2/04/044/001/NO-010/NO

Aivlosin

Norway

18.9.2009

EU/2/04/044/001-010

Aivlosin

Liechtenstein

31.10.2009

EU/2/04/044/001-010/IS

Aivlosin

Iceland

7.10.2009

EU/2/04/045/001-007/IS

Previcox

Iceland

21.9.2009

EU/2/04/046/001-003

Nobivac Piro

Liechtenstein

31.8.2009

EU/2/04/046/001-003/IS

Nobivac Piro

Iceland

23.9.2009

EU/2/98/009/001-006/IS

Suvaxyn Aujeszky 783+O/W

Iceland

5.11.2009

EU/2/98/010/017-18,21-24/NO

Econor

Norway

24.11.2009

EU/2/99/014//001-012

Stronghold

Liechtenstein

31.10.2009

EU/2/99/014/001-012/IS

Stronghold

Iceland

16.12.2009

EU/2/99/015/001-002

Oxyglobin

Liechtenstein

31.10.2009

EU/2/99/015/001-002/IS

Oxyglobin

Iceland

30.11.2009

---

ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July-31 December 2009:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/146/031-032 | Keppra | Liechtenstein | 31.10.2009 |
| EU/1/00/155/007/IS | Luveris | Iceland | 22.7.2009 |
| EU/1/00/155/007/NO | Luveris | Norway | 12.8.2009 |
| EU/1/01/185/074-099 | Aranesp | Liechtenstein | 31.12.2009 |
| EU/1/01/195/022/NO-025/NO | Liprolog Basal | Norway | 13.8.2009 |
| EU/1/01/195/026/NO-027/NO | Liprolog Basal Kwik-Pen | Norway | 13.8.2009 |
| EU/1/02/220/006 | Tracleer | Liechtenstein | 31.8.2009 |
| EU/1/02/220/006/IS | Tracleer | Iceland | 16.9.2009 |
| EU/1/02/227/004 | Neulasta | Liechtenstein | 31.10.2009 |
| EU/1/05/315/002/IS | Aptivus | Iceland | 26.8.2009 |
| EU/1/05/315/002/NO | Aptivus | Norway | 12.8.2009 |
| EU/1/06/347/007/NO-008/NO | Sutent | Norway | 7.9.2009 |
| EU/1/06/347/007-008/IS | Sutent | Iceland | 9.9.2009 |
| EU/1/06/380/004/NO-005/NO | Prezista | Norway | 12.8.2009 |
| EU/1/06/380/004-005/IS | Prezista | Iceland | 10.9.2009 |
| EU/1/07/384/003-004/IS | Docetaxel Winthrop | Iceland | 28.12.2009 |
| EU/1/07/410/021/NO-026/NO | Binocrit | Norway | 27.10.2009 |
| EU/1/07/410/021-026 | Binocrit | Liechtenstein | 31.10.2009 |
| EU/1/07/410/021-026/IS | Binocrit | Iceland | 15.10.2009 |
| EU/1/07/411/021/NO-026/NO | Epoetin alfa Hexal | Norway | 23.10.2009 |
| EU/1/07/411/021-026 | Epoetin alfa Hexal | Liechtenstein | 31.10.2009 |
| EU/1/07/412/021-026/IS | Abseamed | Iceland | 21.12.2009 |
| EU/1/07/416/002 | Ecalta | Liechtenstein | 31.8.2009 |
| EU/1/07/416/002/IS | Ecalta | Iceland | 25.9.2009 |
| EU/1/07/416/002/NO | Ecalta | Norway | 25.8.2009 |
| EU/1/08/446/005-006 | Privigen | Liechtenstein | 31.8.2009 |
| EU/1/08/453/002 | Prepandrix | Liechtenstein | 31.8.2009 |
| EU/1/08/453/002/IS | Prepandrix | Iceland | 9.11.2009 |
| EU/1/08/489/002 | Opgenra | Liechtenstein | 31.10.2009 |
| EU/1/08/497/003-004 | Nplate | Liechtenstein | 31.10.2009 |
| EU/1/95/002/003-004/IS | Taxotere | Iceland | 23.12.2009 |
| EU/1/95/003/009-010 | Betaferon | Liechtenstein | 31.10.2009 |
| EU/1/97/050/013/NO-027/NO | Sifrol | Norway | 20.10.2009 |
| EU/1/97/050/013-027 | Sifrol | Liechtenstein | 31.10.2009 |
| EU/1/97/050/013-027/IS | Sifrol | Iceland | 12.11.2009 |
| EU/1/97/051/013/NO-027/NO | Mirapexin | Norway | 22.10.2009 |
| EU/1/97/051/013-027 | Mirapexin | Liechtenstein | 31.10.2009 |
| EU/1/97/051/013-027/IS | Mirapexin | Iceland | 12.11.2009 |
| EU/1/99/126/019-021 | Enbrel | Liechtenstein | 31.8.2009 |
| EU/2/04/044/009/NO-010/NO | Aivlosin | Norway | 15.7.2009 |
| EU/2/04/044/009-010/IS | Aivlosin | Iceland | 2.9.2009 |
| EU/2/05/053/003 | Naxcel | Liechtenstein | 31.10.2009 |
| EU/2/05/053/003/IS | Naxcel | Iceland | 13.11.2009 |
| EU/2/05/053/003/NO | Naxcel | Norway | 26.10.2009 |
| EU/2/06/070/004 | Meloxidyl | Liechtenstein | 31.10.2009 |
| EU/2/06/070/004/NO | Meloxidyl | Norway | 20.10.2009 |
| EU/2/07/078/004-006 | Zactran | Liechtenstein | 31.8.2009 |
| EU/2/07/078/005/NO-008/NO | Rheumocam | Norway | 26.10.2009 |
| EU/2/07/078/005-008/IS | Rheumocam | Iceland | 13.11.2009 |
| EU/2/078/005-008 | Rheumocam | Liechtenstein | 31.10.2009 |
| EU/2/98/010/004/NO-006/NO | Econor | Norway | 24.11.2009 |

EU-Number

Product

Country

Date of authorisation

EU/1/00/146/031-032

Keppra

Liechtenstein

31.10.2009

EU/1/00/155/007/IS

Luveris

Iceland

22.7.2009

EU/1/00/155/007/NO

Luveris

Norway

12.8.2009

EU/1/01/185/074-099

Aranesp

Liechtenstein

31.12.2009

EU/1/01/195/022/NO-025/NO

Liprolog Basal

Norway

13.8.2009

EU/1/01/195/026/NO-027/NO

Liprolog Basal Kwik-Pen

Norway

13.8.2009

EU/1/02/220/006

Tracleer

Liechtenstein

31.8.2009

EU/1/02/220/006/IS

Tracleer

Iceland

16.9.2009

EU/1/02/227/004

Neulasta

Liechtenstein

31.10.2009

EU/1/05/315/002/IS

Aptivus

Iceland

26.8.2009

EU/1/05/315/002/NO

Aptivus

Norway

12.8.2009

EU/1/06/347/007/NO-008/NO

Sutent

Norway

7.9.2009

EU/1/06/347/007-008/IS

Sutent

Iceland

9.9.2009

EU/1/06/380/004/NO-005/NO

Prezista

Norway

12.8.2009

EU/1/06/380/004-005/IS

Prezista

Iceland

10.9.2009

EU/1/07/384/003-004/IS

Docetaxel Winthrop

Iceland

28.12.2009

EU/1/07/410/021/NO-026/NO

Binocrit

Norway

27.10.2009

EU/1/07/410/021-026

Binocrit

Liechtenstein

31.10.2009

EU/1/07/410/021-026/IS

Binocrit

Iceland

15.10.2009

EU/1/07/411/021/NO-026/NO

Epoetin alfa Hexal

Norway

23.10.2009

EU/1/07/411/021-026

Epoetin alfa Hexal

Liechtenstein

31.10.2009

EU/1/07/412/021-026/IS

Abseamed

Iceland

21.12.2009

EU/1/07/416/002

Ecalta

Liechtenstein

31.8.2009

EU/1/07/416/002/IS

Ecalta

Iceland

25.9.2009

EU/1/07/416/002/NO

Ecalta

Norway

25.8.2009

EU/1/08/446/005-006

Privigen

Liechtenstein

31.8.2009

EU/1/08/453/002

Prepandrix

Liechtenstein

31.8.2009

EU/1/08/453/002/IS

Prepandrix

Iceland

9.11.2009

EU/1/08/489/002

Opgenra

Liechtenstein

31.10.2009

EU/1/08/497/003-004

Nplate

Liechtenstein

31.10.2009

EU/1/95/002/003-004/IS

Taxotere

Iceland

23.12.2009

EU/1/95/003/009-010

Betaferon

Liechtenstein

31.10.2009

EU/1/97/050/013/NO-027/NO

Sifrol

Norway

20.10.2009

EU/1/97/050/013-027

Sifrol

Liechtenstein

31.10.2009

EU/1/97/050/013-027/IS

Sifrol

Iceland

12.11.2009

EU/1/97/051/013/NO-027/NO

Mirapexin

Norway

22.10.2009

EU/1/97/051/013-027

Mirapexin

Liechtenstein

31.10.2009

EU/1/97/051/013-027/IS

Mirapexin

Iceland

12.11.2009

EU/1/99/126/019-021

Enbrel

Liechtenstein

31.8.2009

EU/2/04/044/009/NO-010/NO

Aivlosin

Norway

15.7.2009

EU/2/04/044/009-010/IS

Aivlosin

Iceland

2.9.2009

EU/2/05/053/003

Naxcel

Liechtenstein

31.10.2009

EU/2/05/053/003/IS

Naxcel

Iceland

13.11.2009

EU/2/05/053/003/NO

Naxcel

Norway

26.10.2009

EU/2/06/070/004

Meloxidyl

Liechtenstein

31.10.2009

EU/2/06/070/004/NO

Meloxidyl

Norway

20.10.2009

EU/2/07/078/004-006

Zactran

Liechtenstein

31.8.2009

EU/2/07/078/005/NO-008/NO

Rheumocam

Norway

26.10.2009

EU/2/07/078/005-008/IS

Rheumocam

Iceland

13.11.2009

EU/2/078/005-008

Rheumocam

Liechtenstein

31.10.2009

EU/2/98/010/004/NO-006/NO

Econor

Norway

24.11.2009

---

ANNEX IV

List of withdrawn marketing authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July-31 December 2009:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/01/175/001-021/IS | Trazec | Iceland | 15.12.2009 |
| EU/1/05/321/001/IS | Posaconazole SP | Iceland | 15.12.2009 |
| EU/1/06/369/001/NO-028/NO | Irbesartan BMS | Norway | 1.12.2009 |
| EU/1/06/369/001/NO-028/NO | Irbesartan HCT BMS | Norway | 1.12.2009 |
| EU/1/06/369/001/NO-028/NO | Irbesartan BMS | Norway | 1.12.2009 |
| EU/1/06/369/001/NO-028/NO | Irbesartan HCT BMS | Norway | 1.12.2009 |
| EU/1/06/369/001-028 | Irbesartan HCT BMS | Liechtenstein | 31.12.2009 |
| EU/1/06/369/001-028/IS | Irbesartan HCT BMS | Iceland | 2.12.2009 |
| EU/1/06/375/001-033/IS | Irbesartan BMS | Iceland | 2.12.2009 |
| EU/1/07/385/003/NO | Focetria | Norway | 19.10.2009 |
| EU/1/07/408/001/NO-020/NO | Tekturna | Norway | 17.9.2009 |
| EU/1/07/408/001-020 | Tekturna | Liechtenstein | 31.10.2009 |
| EU/1/07/408/001-020/IS | Tekturna | Iceland | 2.9.2009 |
| EU/1/08/464/001/NO-019/NO | Clopidogrel BMS | Norway | 22.12.2009 |
| EU/1/08/464/001-019/IS | Clopidogrel BMS | Iceland | 2.12.2009 |
| EU/1/08/464/001-019 | Clopidogrel BMS | Liechtenstein | 31.12.2009 |
| EU/1/96/024/006NO,007/NO,009/NO | Crixivan | Norway | 24.9.2009 |
| EU/1/96/024/006NO,007/NO,009/NO | Crixivan | Norway | 24.9.2009 |
| EU/1/99/104/001/IS | Procomvax | Iceland | 15.12.2009 |
| EU/1/99/113/001-004/IS | Paxene | Iceland | 2.12.2009 |

EU-Number

Product

Country

Date of withdrawal

EU/1/01/175/001-021/IS

Trazec

Iceland

15.12.2009

EU/1/05/321/001/IS

Posaconazole SP

Iceland

15.12.2009

EU/1/06/369/001/NO-028/NO

Irbesartan BMS

Norway

1.12.2009

EU/1/06/369/001/NO-028/NO

Irbesartan HCT BMS

Norway

1.12.2009

EU/1/06/369/001/NO-028/NO

Irbesartan BMS

Norway

1.12.2009

EU/1/06/369/001/NO-028/NO

Irbesartan HCT BMS

Norway

1.12.2009

EU/1/06/369/001-028

Irbesartan HCT BMS

Liechtenstein

31.12.2009

EU/1/06/369/001-028/IS

Irbesartan HCT BMS

Iceland

2.12.2009

EU/1/06/375/001-033/IS

Irbesartan BMS

Iceland

2.12.2009

EU/1/07/385/003/NO

Focetria

Norway

19.10.2009

EU/1/07/408/001/NO-020/NO

Tekturna

Norway

17.9.2009

EU/1/07/408/001-020

Tekturna

Liechtenstein

31.10.2009

EU/1/07/408/001-020/IS

Tekturna

Iceland

2.9.2009

EU/1/08/464/001/NO-019/NO

Clopidogrel BMS

Norway

22.12.2009

EU/1/08/464/001-019/IS

Clopidogrel BMS

Iceland

2.12.2009

EU/1/08/464/001-019

Clopidogrel BMS

Liechtenstein

31.12.2009

EU/1/96/024/006NO,007/NO,009/NO

Crixivan

Norway

24.9.2009

EU/1/96/024/006NO,007/NO,009/NO

Crixivan

Norway

24.9.2009

EU/1/99/104/001/IS

Procomvax

Iceland

15.12.2009

EU/1/99/113/001-004/IS

Paxene

Iceland

2.12.2009

---

ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 July-31 December 2009:

| EU-Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| None | None | — | — |

EU-Number

Product

Country

Date of suspension

None

None

—

—

---

V Announcements

COURT PROCEEDINGS

EFTA Court

| 2.9.2010 | EN | Official Journal of the European Union | C 237/19 |
| --- | --- | --- | --- |

2.9.2010

EN

Official Journal of the European Union

C 237/19

---

Action brought on 15 June 2010 by Reassur Aktiengesellschaft against the EFTA Surveillance Authority

(Case E-6/10)

2010/C 237/03

An action against the EFTA Surveillance Authority was brought before the EFTA Court on 15 June 2010 by Reassur Aktiengesellschaft, represented by Ulrich Soltész and Philipp Melcher, acting as agents for Reassur Aktiengesellschaft, Aeulestrasse 5, 9490 Vaduz, LIECHTENSTEIN.

Reassur Aktiengesellschaft requests the EFTA Court to:

| 1. | Annul the EFTA Surveillance Authority’s Decision No 97/10/COL of 24 March 2010 regarding the taxation of captive insurance companies under the Liechtenstein Tax Act, in its entirety; |
| --- | --- |

1.

Annul the EFTA Surveillance Authority’s Decision No 97/10/COL of 24 March 2010 regarding the taxation of captive insurance companies under the Liechtenstein Tax Act, in its entirety;

| 2. | Annul Article 3 of the EFTA Surveillance Authority’s Decision No 97/10/COL of 24 March 2010 regarding the taxation of captive insurance companies under the Liechtenstein Tax Act, at least insofar as it orders recovery for the period prior to 31 March 2009;
  and |
| --- | --- |

2.

Annul Article 3 of the EFTA Surveillance Authority’s Decision No 97/10/COL of 24 March 2010 regarding the taxation of captive insurance companies under the Liechtenstein Tax Act, at least insofar as it orders recovery for the period prior to 31 March 2009;

and

| 3. | Order the EFTA Surveillance Authority to pay the costs of the proceedings. |
| --- | --- |

3.

Order the EFTA Surveillance Authority to pay the costs of the proceedings.

Legal and factual background and pleas in law adduced in support:

| — | The applicant is the reinsurance captive of the Schindler group which has been exclusively engaged in reinsuring certain types of risks of companies belonging to the Schindler group. |
| --- | --- |

—

The applicant is the reinsurance captive of the Schindler group which has been exclusively engaged in reinsuring certain types of risks of companies belonging to the Schindler group.

| — | The applicant contends that since captive (re)insurance companies cover risks, for which insurance coverage is not normally offered by commercial insurance companies, and as their activities are confined to intra-group risk coverage, they are not active in a market where they are in competition with other market players. They are therefore not engaged in an economic activity and do not qualify as undertakings. Consequently, taxation pursuant to the provisions of the Liechtenstein Tax Act concerning taxation of captive (re)insurance companies cannot have distorted competition or intra-EEA trade. The contested tax provisions are not selective and do therefore not constitute State aid. |
| --- | --- |

—

The applicant contends that since captive (re)insurance companies cover risks, for which insurance coverage is not normally offered by commercial insurance companies, and as their activities are confined to intra-group risk coverage, they are not active in a market where they are in competition with other market players. They are therefore not engaged in an economic activity and do not qualify as undertakings. Consequently, taxation pursuant to the provisions of the Liechtenstein Tax Act concerning taxation of captive (re)insurance companies cannot have distorted competition or intra-EEA trade. The contested tax provisions are not selective and do therefore not constitute State aid.

| — | Moreover, the applicant claims that the EFTA Surveillance Authority:






  — | was wrong in choosing the procedure applicable to ‘unlawful aid’ and in adopting a recovery decision, |
| --- | --- | --- |

—

Moreover, the applicant claims that the EFTA Surveillance Authority:

—

was wrong in choosing the procedure applicable to ‘unlawful aid’ and in adopting a recovery decision,

| — | violated the principle of legitimate expectations by ordering recovery for the period from 6 November 2001 through at least 31 March 2009. |
| --- | --- |

—

violated the principle of legitimate expectations by ordering recovery for the period from 6 November 2001 through at least 31 March 2009.

---

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 2.9.2010 | EN | Official Journal of the European Union | C 237/20 |
| --- | --- | --- | --- |

2.9.2010

EN

Official Journal of the European Union

C 237/20

---

Prior notification of a concentration

(Case COMP/M.5956 — EADS/OPIP/JV)

Candidate case for simplified procedure

(Text with EEA relevance)

2010/C 237/04

| 1. | On 26 August 2010, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings EADS Deutschland GmbH (‘EADS DS’, Germany), belonging to the EADS group (The Netherlands), and Odebrecht Plantas Industriais e Participações SA (‘OPIP’, Brazil), controlled by Odebrecht SA (Brazil), acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of a newly created company constituting a joint venture (‘JV’), by way of purchase of shares. |
| --- | --- |

1.

On 26 August 2010, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings EADS Deutschland GmbH (‘EADS DS’, Germany), belonging to the EADS group (The Netherlands), and Odebrecht Plantas Industriais e Participações SA (‘OPIP’, Brazil), controlled by Odebrecht SA (Brazil), acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of a newly created company constituting a joint venture (‘JV’), by way of purchase of shares.

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






  — | EADS DS: integrated defence and security solutions. EADS group is active in aircrafts, telecommunications equipment, defence and security systems and satellites, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

EADS DS: integrated defence and security solutions. EADS group is active in aircrafts, telecommunications equipment, defence and security systems and satellites,

| — | OPIP: engineering, civil construction and industrial assembly services. Odebrecht SA is a business conglomerate active in several areas (engineering, construction, chemical, petrochemical industries, oil and gas, environmental engineering, real-estate developments, infrastructure investments, and bio energy), |
| --- | --- |

—

OPIP: engineering, civil construction and industrial assembly services. Odebrecht SA is a business conglomerate active in several areas (engineering, construction, chemical, petrochemical industries, oil and gas, environmental engineering, real-estate developments, infrastructure investments, and bio energy),

| — | JV: market electronic defence and security systems and products. |
| --- | --- |

—

JV: market electronic defence and security systems and products.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the EC Merger Regulation. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the EC Merger Regulation (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the EC Merger Regulation. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the EC Merger Regulation (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number COMP/M.5956 — EADS/OPIP/JV, to the following address:





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

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number COMP/M.5956 — EADS/OPIP/JV, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  OJ L 24, 29.1.2004, p. 1 (the ‘EC Merger Regulation’).

(2)  OJ C 56, 5.3.2005, p. 32 (‘Notice on a simplified procedure’).

---

| 2.9.2010 | EN | Official Journal of the European Union | C 237/21 |
| --- | --- | --- | --- |

2.9.2010

EN

Official Journal of the European Union

C 237/21

---

DECISION No 297

of 12 May 2010

terminating the procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-5 ‘Devetaki’, located in the provinces of Lovech, Pleven and Gabrovo

2010/C 237/05

REPUBLIC OF BULGARIA

COUNCIL OF MINISTERS

Pursuant to Article 50(2), in conjunction with Articles 23(4) and 46(2)(2), of the Subsurface Resources Act and having regard to an infringement noted in the conduct of the procedure, resulting in a tenderer who does not meet the mandatory requirements laid down in the Subsurface Resources Act and the tender dossier being deemed eligible to take part in the procedure,

THE COUNCIL OF MINISTERS HAS DECIDED THAT:

| 1. | The procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-5 ‘Devetaki’, located in the provinces of Lovech, Pleven and Gabrovo, shall be terminated. |
| --- | --- |

1.

The procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-5 ‘Devetaki’, located in the provinces of Lovech, Pleven and Gabrovo, shall be terminated.

| 2. | The Minister for the Economy, Energy and Tourism shall take the necessary steps to return the deposits to the tenderers after this Decision has entered into force. |
| --- | --- |

2.

The Minister for the Economy, Energy and Tourism shall take the necessary steps to return the deposits to the tenderers after this Decision has entered into force.

| 3. | This Decision shall be subject to appeal before the Supreme Administrative Court within 14 days following its communication to the tenderers. |
| --- | --- |

3.

This Decision shall be subject to appeal before the Supreme Administrative Court within 14 days following its communication to the tenderers.

Prime Minister

Boyko BORISOV

Chief Secretary of the Council of Ministers

Rosen ZHELYAZKOV

---

| 2.9.2010 | EN | Official Journal of the European Union | C 237/22 |
| --- | --- | --- | --- |

2.9.2010

EN

Official Journal of the European Union

C 237/22

---

DECISION No 300

of 12 May 2010

terminating the procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-10 ‘Botevo’, located in the provinces of Vratsa and Montana

2010/C 237/06

REPUBLIC OF BULGARIA

COUNCIL OF MINISTERS

Pursuant to Article 50(2), in conjunction with Articles 23(4) and 46(2)(2), of the Subsurface Resources Act and having regard to an infringement noted in the conduct of the procedure, resulting in a tenderer who does not meet the mandatory requirements laid down in the Subsurface Resources Act and the tender dossier being deemed eligible to take part in the procedure,

THE COUNCIL OF MINISTERS HAS DECIDED THAT:

| 1. | The procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-10 ‘Botevo’, located in the provinces of Vratsa and Montana, shall be terminated. |
| --- | --- |

1.

The procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-10 ‘Botevo’, located in the provinces of Vratsa and Montana, shall be terminated.

| 2. | The Minister for the Economy, Energy and Tourism shall take the necessary steps to return the deposits to the tenderers after this Decision has entered into force. |
| --- | --- |

2.

The Minister for the Economy, Energy and Tourism shall take the necessary steps to return the deposits to the tenderers after this Decision has entered into force.

| 3. | This Decision shall be subject to appeal before the Supreme Administrative Court within 14 days following its communication to the tenderers. |
| --- | --- |

3.

This Decision shall be subject to appeal before the Supreme Administrative Court within 14 days following its communication to the tenderers.

Prime Minister

Boyko BORISOV

Chief Secretary of the Council of Ministers

Rosen ZHELYAZKOV

---

| 2.9.2010 | EN | Official Journal of the European Union | C 237/23 |
| --- | --- | --- | --- |

2.9.2010

EN

Official Journal of the European Union

C 237/23

---

DECISION No 296

of 12 May 2010

terminating the procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-8 ‘Altimir’, located in the provinces of Vratsa and Pleven

2010/C 237/07

REPUBLIC OF BULGARIA

COUNCIL OF MINISTERS

Pursuant to Article 50(2), in conjunction with Articles 23(4) and 46(2)(2), of the Subsurface Resources Act and having regard to an infringement noted in the conduct of the procedure, resulting in a tenderer who does not meet the mandatory requirements laid down in the Subsurface Resources Act and the tender dossier being deemed eligible to take part in the procedure,

THE COUNCIL OF MINISTERS HAS DECIDED THAT:

| 1. | The procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-8 ‘Altimir’, located in the provinces of Vratsa and Pleven, shall be terminated. |
| --- | --- |

1.

The procedure for granting authorisation for the prospection and exploration of oil and natural gas, being subsurface resources as defined in Article 2(1)(3) of the Subsurface Resources Act, in Block 1-8 ‘Altimir’, located in the provinces of Vratsa and Pleven, shall be terminated.

| 2. | The Minister for the Economy, Energy and Tourism shall take the necessary steps to return the deposits to the tenderers after this Decision has entered into force. |
| --- | --- |

2.

The Minister for the Economy, Energy and Tourism shall take the necessary steps to return the deposits to the tenderers after this Decision has entered into force.

| 3. | This Decision shall be subject to appeal before the Supreme Administrative Court within 14 days following its communication to the tenderers. |
| --- | --- |

3.

This Decision shall be subject to appeal before the Supreme Administrative Court within 14 days following its communication to the tenderers.

Prime Minister

Boyko BORISOV

Chief Secretary of the Council of Ministers

Rosen ZHELYAZKOV

---