# Official Journal C 356/2014

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 356 |
| | |
| English edition | Information and Notices | Volume 579 October 2014 |

ISSN 1977-091X

Official Journal

of the European Union

C 356

English edition

Information and Notices

Volume 579 October 2014

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2014/C 356/01 | Initiation of proceedings (Case M.7265 — Zimmer / Biomet) (
  1
  ) | 1 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2014/C 356/01

Initiation of proceedings (Case M.7265 — Zimmer / Biomet) (
  1
  )

1

1

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | Council |
| 2014/C 356/02 | Notice for the attention of the persons subject to restrictive measures provided for in Council Decision 2011/486/CFSP, as implemented by Council Implementing Decision 2014/701/CFSP, and Council Regulation (EU) No 753/2011, as implemented by Council Implementing Regulation (EU) No 1057/2014 concerning restrictive measures in view of the situation in Afghanistan | 2 |
| 2014/C 356/03 | Notice for the attention of the persons and entities subject to restrictive measures provided for in Council Decision 2013/183/CFSP, as amended by Council Decision 2014/700/CFSP, concerning restrictive measures against the Democratic People’s Republic of Korea | 4 |
| | European Commission |
| 2014/C 356/04 | Euro exchange rates | 5 |
| | Court of Auditors |
| 2014/C 356/05 | Special Report No 15/2014 The External Borders Fund has fostered financial solidarity but requires better measurement of results and needs to provide further EU added value | 6 |
| | NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA |
| | Standing Committee of the EFTA States |
| 2014/C 356/06 | Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2011 | 7 |
| 2014/C 356/07 | Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2012 | 22 |
| 2014/C 356/08 | Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2012 | 37 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

Council

2014/C 356/02

Notice for the attention of the persons subject to restrictive measures provided for in Council Decision 2011/486/CFSP, as implemented by Council Implementing Decision 2014/701/CFSP, and Council Regulation (EU) No 753/2011, as implemented by Council Implementing Regulation (EU) No 1057/2014 concerning restrictive measures in view of the situation in Afghanistan

2

2014/C 356/03

Notice for the attention of the persons and entities subject to restrictive measures provided for in Council Decision 2013/183/CFSP, as amended by Council Decision 2014/700/CFSP, concerning restrictive measures against the Democratic People’s Republic of Korea

4

European Commission

2014/C 356/04

Euro exchange rates

5

Court of Auditors

2014/C 356/05

Special Report No 15/2014 The External Borders Fund has fostered financial solidarity but requires better measurement of results and needs to provide further EU added value

6

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

2014/C 356/06

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2011

7

2014/C 356/07

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2012

22

2014/C 356/08

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2012

37

| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2014/C 356/09 | Prior notification of a concentration (Case M.7359 — PCCR USA/Total's CCP Composite Business) (
  1
  ) | 52 |
| 2014/C 356/10 | Prior notification of a concentration (Case M.7095 — SOCAR/DESFA) (
  1
  ) | 53 |
| | OTHER ACTS |
| | European Commission |
| 2014/C 356/11 | Publication of an amendment application pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs | 54 |
| 2014/C 356/12 | Notice for the attention of Ahmed Abdullah Saleh Al-Khazmari Al-Zahrani, Azzam Abdullah Zureik Al-Maulid Al-Subhi, Anders Cameroon Ostensvig Dale, Ibrahim Suleiman Hamad Al-Hablain, Seifallah Ben Hassine, ‘Abd Al-Rahman Bin ‘Umayr Al-Nu’aymi, ‘Abd Al-Rahman Khalaf ‘Ubayd Juday’ Al-‘Anizi, Anas Hasan Khattab, Maysar Ali Musa Abdallah Al-Juburi, Shafi Sultan Mohammed Al-Ajmi, ‘Abd Al-Rahman Muhammad Mustafa Al-Qaduli, Emilie Konig, Kevin Guiavarch, Oumar Diaby, Ansar Al-Shari’a in Tunisia (ASS-T) and Abdallah Azzam Brigades (AAB) which were added to the list referred to in Articles 2, 3 and 7 of Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network, by virtue of Commission Implementing Regulation (EU) No 1058/2014 | 63 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2014/C 356/09

Prior notification of a concentration (Case M.7359 — PCCR USA/Total's CCP Composite Business) (
  1
  )

1

52

2014/C 356/10

Prior notification of a concentration (Case M.7095 — SOCAR/DESFA) (
  1
  )

1

53

OTHER ACTS

European Commission

2014/C 356/11

Publication of an amendment application pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs

54

2014/C 356/12

Notice for the attention of Ahmed Abdullah Saleh Al-Khazmari Al-Zahrani, Azzam Abdullah Zureik Al-Maulid Al-Subhi, Anders Cameroon Ostensvig Dale, Ibrahim Suleiman Hamad Al-Hablain, Seifallah Ben Hassine, ‘Abd Al-Rahman Bin ‘Umayr Al-Nu’aymi, ‘Abd Al-Rahman Khalaf ‘Ubayd Juday’ Al-‘Anizi, Anas Hasan Khattab, Maysar Ali Musa Abdallah Al-Juburi, Shafi Sultan Mohammed Al-Ajmi, ‘Abd Al-Rahman Muhammad Mustafa Al-Qaduli, Emilie Konig, Kevin Guiavarch, Oumar Diaby, Ansar Al-Shari’a in Tunisia (ASS-T) and Abdallah Azzam Brigades (AAB) which were added to the list referred to in Articles 2, 3 and 7 of Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network, by virtue of Commission Implementing Regulation (EU) No 1058/2014

63

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

---

(1)   Text with EEA relevance

1

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

EN

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II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 9.10.2014 | EN | Official Journal of the European Union | C 356/1 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/1

---

Initiation of proceedings

(Case M.7265 — Zimmer / Biomet)

(Text with EEA relevance)

2014/C 356/01

On 3 October 2014, the Commission decided to initiate proceedings in the abovementioned case after finding that the notified concentration raises serious doubts as to its compatibility with the internal market. The initiation of proceedings opens a second phase investigation with regard to the notified concentration, and is without prejudice to the final decision on the case. The decision is based on Article 6(1)(c) of Council Regulation (EC) No 139/2004 (1).

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

In order to be fully taken into account in the procedure, observations should reach the Commission not later than 15 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301) or by post, under reference M.7265 — Zimmer / Biomet, to the following address:

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

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

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

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

Council

| 9.10.2014 | EN | Official Journal of the European Union | C 356/2 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/2

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Notice for the attention of the persons subject to restrictive measures provided for in Council Decision 2011/486/CFSP, as implemented by Council Implementing Decision 2014/701/CFSP, and Council Regulation (EU) No 753/2011, as implemented by Council Implementing Regulation (EU) No 1057/2014 concerning restrictive measures in view of the situation in Afghanistan

2014/C 356/02

The following information is brought to the attention of the persons that appear in the Annex to Council Decision 2011/486/CFSP (1), as implemented by Council Implementing Decision 2014/701/CFSP (2), and in Annex I to Council Regulation (EU) No 753/2011 (3), as implemented by Council Implementing Regulation (EU) No 1057/2014 (4) concerning restrictive measures in view of the situation in Afghanistan.

The United Nations Security Council adopted Resolution 1988 (2011), imposing restrictive measures with respect to individuals and entities designated, prior to the date of adoption of that Resolution, as the Taliban, and other individuals, groups, undertakings and entities associated with them, as specified in Section A (‘Individuals associated with the Taliban’) and Section B (‘Entities and other groups and undertakings associated with the Taliban’) of the Consolidated List of the Committee established pursuant to Resolutions 1267 (1999) and 1333 (2000), as well as other individuals, groups, undertakings and entities associated with the Taliban.

On 11 February, 18 March, 16 May, 30 July and 20 August 2014, the Committee established pursuant to paragraph 30 of United Nations Security Council Resolution 1988 (2011) amended and updated the list of individuals, groups, undertakings and entities subject to restrictive measures.

The persons concerned may submit at any time a request to the UN Committee established pursuant to paragraph 30 of UNSCR 1988 (2011), together with any supporting documentation, for the decisions to include them in the UN list to be reconsidered. Such request should be sent to the following address:

| United Nations — Focal point for delisting |
| --- |
| Security Council Subsidiary Organs Branch |
| Room TB-08045D |
| United Nations |
| New York, N.Y. 10017 |
| UNITED STATES OF AMERICA |
| Tel. +1 9173679448 |
| Fax +1 2129631300/3778 |
| E-mail: delisting@un.org |
| For more information see: http://www.un.org/sc/committees/1988/index.shtml |

United Nations — Focal point for delisting

Security Council Subsidiary Organs Branch

Room TB-08045D

United Nations

New York, N.Y. 10017

UNITED STATES OF AMERICA

Tel. +1 9173679448

Fax +1 2129631300/3778

E-mail: delisting@un.org

For more information see: http://www.un.org/sc/committees/1988/index.shtml

Further to the UN decision, the Council of the European Union has determined that the persons designated by the UN should be included in the lists of persons, groups, undertakings and entities which are subject to the restrictive measures provided for in Decision 2011/486/CFSP and Regulation (EU) No 753/2011. The grounds for listing of the persons concerned appear in the relevant entries in the Annex to the Decision and in Annex I to the Regulation.

The attention of the persons concerned is drawn to the possibility of making an application to the competent authorities of the relevant Member State(s) as indicated in the websites in Annex II to Regulation (EU) No 753/2011, in order to obtain an authorisation to use frozen funds for basic needs or specific payments (cf. Article 5 of the Regulation).

The persons concerned may submit a request to the Council, together with supporting documentation, that the decision to include them on the abovementioned lists should be reconsidered, to the following address:

| Council of the European Union |
| --- |
| General Secretariat |
| DG C 1C |
| Rue de la Loi/Wetstraat 175 |
| 1048 Bruxelles/Brussel |
| BELGIQUE/BELGIË |
| E-mail: sanctions@consilium.europa.eu |

Council of the European Union

General Secretariat

DG C 1C

Rue de la Loi/Wetstraat 175

1048 Bruxelles/Brussel

BELGIQUE/BELGIË

E-mail: sanctions@consilium.europa.eu

The attention of the persons concerned is also drawn to the possibility of challenging the Council’s decision before the General Court of the European Union, in accordance with the conditions laid down in Article 275, 2nd paragraph, and Article 263, 4th and 6th paragraphs, of the Treaty on the Functioning of the European Union.

---

(1)  OJ L 199, 2.8.2011, p. 57.

(2)  OJ L 293, 9.10.2014, p. 37.

(3)  OJ L 199, 2.8.2011, p. 1.

(4)  OJ L 293, 9.10.2014, p. 1.

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| 9.10.2014 | EN | Official Journal of the European Union | C 356/4 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/4

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Notice for the attention of the persons and entities subject to restrictive measures provided for in Council Decision 2013/183/CFSP, as amended by Council Decision 2014/700/CFSP, concerning restrictive measures against the Democratic People’s Republic of Korea

2014/C 356/03

The following information is brought to the attention of the persons and entities that appear in Annex I to Council Decision 2013/183/CFSP (1), as amended by Council Decision 2014/700/CFSP (2), concerning restrictive measures against the Democratic People’s Republic of Korea.

The United Nations Security Council decided to include those persons on the list of persons and entities subject to the measures imposed by UNSCR 1718 (2006), 1874 (2009), 2087 (2013) and 2094 (2013).

Those concerned may submit at any time a request to the United Nations Security Council Committee established pursuant to resolution 1718 (2006), together with any supporting documentation, for the decisions to include them in the UN list to be reconsidered. Such request should be sent to the following address:

The Focal Point may be contacted at this address:

| Focal Point for De-listing |
| --- |
| Security Council Subsidiary Organs Branch |
| Room DC2 2034 |
| United Nations |
| New York, NY 10017 |
| UNITED STATES OF AMERICA |
| Tel. +1 9173679448 |
| Fax +1 2129631300 |
| E-mail: delisting@un.org |
| For more information see: http://www.un.org/sc/committees/index.shtml |

Focal Point for De-listing

Security Council Subsidiary Organs Branch

Room DC2 2034

United Nations

New York, NY 10017

UNITED STATES OF AMERICA

Tel. +1 9173679448

Fax +1 2129631300

E-mail: delisting@un.org

For more information see: http://www.un.org/sc/committees/index.shtml

Further to the UN decision, the Council of the European Union has decided that those persons and entities should be included in the list of persons and entities subject to restrictive measures in Annex I to Decision 2013/183/CFSP concerning restrictive measures against the Democratic People’s Republic of Korea. The grounds for designations of those persons and entities appear in the relevant entries in that Annex.

The attention of the persons and entities concerned is drawn to the possibility of making an application to the competent authorities of the relevant Member State(s) as indicated in the web-sites in Annex II to Council Regulation (EC) No 329/2007 (3), in order to obtain an authorisation to use frozen funds for basic needs or specific payments (cf. Article 7 of the Regulation).

The persons and entities concerned may submit a request to the Council, together with supporting documentation, that the decision to include them on the above-mentioned list should be reconsidered, to the following address:

| Council of the European Union |
| --- |
| General Secretariat |
| DG C 1C |
| Rue de la Loi/Wetstraat 175 |
| 1048 Bruxelles/Brussel |
| BELGIQUE/BELGIË |
| E-mail: sanctions@consilium.europa.eu |

Council of the European Union

General Secretariat

DG C 1C

Rue de la Loi/Wetstraat 175

1048 Bruxelles/Brussel

BELGIQUE/BELGIË

E-mail: sanctions@consilium.europa.eu

The attention of the persons and entities concerned is also drawn to the possibility of challenging the Council’s decision before the General Court of the European Union, in accordance with the conditions laid down in Article 275, 2nd paragraph, and Article 263, 4th and 6th paragraphs, of the Treaty on the Functioning of the European Union.

---

(1)  OJ L 111, 23.4.2013, p. 52.

(2)  OJ L 293, 9.10.2014, p. 34.

(3)  OJ L 88, 29.3.2007, p. 1.

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European Commission

| 9.10.2014 | EN | Official Journal of the European Union | C 356/5 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/5

---

Euro exchange rates (1)

8 October 2014

2014/C 356/04

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2645 |
| JPY | Japanese yen | 136,97 |
| DKK | Danish krone | 7,4442 |
| GBP | Pound sterling | 0,78700 |
| SEK | Swedish krona | 9,1322 |
| CHF | Swiss franc | 1,2132 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 8,1945 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 27,480 |
| HUF | Hungarian forint | 307,92 |
| LTL | Lithuanian litas | 3,4528 |
| PLN | Polish zloty | 4,1919 |
| RON | Romanian leu | 4,4108 |
| TRY | Turkish lira | 2,8992 |
| AUD | Australian dollar | 1,4416 |
| CAD | Canadian dollar | 1,4131 |
| HKD | Hong Kong dollar | 9,8080 |
| NZD | New Zealand dollar | 1,6210 |
| SGD | Singapore dollar | 1,6173 |
| KRW | South Korean won | 1 360,58 |
| ZAR | South African rand | 14,1770 |
| CNY | Chinese yuan renminbi | 7,7624 |
| HRK | Croatian kuna | 7,6440 |
| IDR | Indonesian rupiah | 15 490,74 |
| MYR | Malaysian ringgit | 4,1388 |
| PHP | Philippine peso | 56,673 |
| RUB | Russian rouble | 50,5925 |
| THB | Thai baht | 41,238 |
| BRL | Brazilian real | 3,0246 |
| MXN | Mexican peso | 17,0353 |
| INR | Indian rupee | 77,6300 |

Currency

Exchange rate

USD

US dollar

1,2645

JPY

Japanese yen

136,97

DKK

Danish krone

7,4442

GBP

Pound sterling

0,78700

SEK

Swedish krona

9,1322

CHF

Swiss franc

1,2132

ISK

Iceland króna

NOK

Norwegian krone

8,1945

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

27,480

HUF

Hungarian forint

307,92

LTL

Lithuanian litas

3,4528

PLN

Polish zloty

4,1919

RON

Romanian leu

4,4108

TRY

Turkish lira

2,8992

AUD

Australian dollar

1,4416

CAD

Canadian dollar

1,4131

HKD

Hong Kong dollar

9,8080

NZD

New Zealand dollar

1,6210

SGD

Singapore dollar

1,6173

KRW

South Korean won

1 360,58

ZAR

South African rand

14,1770

CNY

Chinese yuan renminbi

7,7624

HRK

Croatian kuna

7,6440

IDR

Indonesian rupiah

15 490,74

MYR

Malaysian ringgit

4,1388

PHP

Philippine peso

56,673

RUB

Russian rouble

50,5925

THB

Thai baht

41,238

BRL

Brazilian real

3,0246

MXN

Mexican peso

17,0353

INR

Indian rupee

77,6300

---

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

---

Court of Auditors

| 9.10.2014 | EN | Official Journal of the European Union | C 356/6 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/6

---

Special Report No 15/2014 ‘The External Borders Fund has fostered financial solidarity but requires better measurement of results and needs to provide further EU added value’

2014/C 356/05

The European Court of Auditors hereby informs you that Special Report No 15/2014 ‘The External Borders Fund has fostered financial solidarity but requires better measurement of results and needs to provide further EU added value’ has just been published.

The report can be accessed for consultation or downloading on the European Court of Auditors' website: http://eca.europa.eu

A hard copy version of the report may be obtained free of charge on request to the Court of Auditors:

| European Court of Auditors |
| --- |
| Publications (PUB) |
| 12, rue Alcide De Gasperi |
| 1615 Luxembourg |
| LUXEMBOURG |
| Tel. +352 4398-1 |
| e-mail: eca-info@eca.europa.eu |

European Court of Auditors

Publications (PUB)

12, rue Alcide De Gasperi

1615 Luxembourg

LUXEMBOURG

Tel. +352 4398-1

e-mail: eca-info@eca.europa.eu

or by filling in an electronic order form on EU-Bookshop.

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NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

| 9.10.2014 | EN | Official Journal of the European Union | C 356/7 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/7

---

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2011

2014/C 356/06

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 2011, at their meeting on 15 June 2012:

| 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

---

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 2011:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/09/543/001-002 | Cayston (1) | Liechtenstein | 31.10.2011 |
| EU/1/10/642/001-004 | Ibandronic Acid Teva | Norway | 23.8.2011 |
| EU/1/10/649/001-016 | Clopidogrel Teva Pharma B.V | Norway | 19.7.2011 |
| EU/1/10/649/001-016 | Clopidogrel Teva Pharma B.V. | Liechtenstein | 31.8.2011 |
| EU/1/10/652/001-003 | TOBI Podhaler | Liechtenstein | 31.8.2011 |
| EU/1/10/652/001-003 | TOBI Podhaler | Norway | 17.8.2011 |
| EU/1/10/652/001-003 | TOBI Podhaler | Iceland | 9.8.2011 |
| EU/1/10/654/001-004 | Leflunomide ratiopharm | Norway | 25.8.2011 |
| EU/1/10/660/001-002 | Potactasol | Norway | 24.8.2011 |
| EU/1/10/661/001-002 | Fluenz | Norway | 23.8.2011 |
| EU/1/11/672/001-006 | Xeplion | Liechtenstein | 31.10.2011 |
| EU/1/11/683/001-080 | Sprimeo HCT | Liechtenstein | 31.8.2011 |
| EU/1/11/683/001-080 | Sprimeo HCT | Norway | 22.8.2011 |
| EU/1/11/683/001-080 | Sprimeo HCT | Iceland | 10.8.2011 |
| EU/1/11/685/001-005 | Ibandronic acid Sandoz | Liechtenstein | 31.8.2011 |
| EU/1/11/685/001-005 | Ibandronic acid Sandoz | Iceland | 18.8.2011 |
| EU/1/11/689/001-002 | IOA | Liechtenstein | 31.12.2011 |
| EU/1/11/689/001-002 | IOA | Norway | 6.12.2011 |
| EU/1/11/689/001-002 | Ioa | Iceland | 25.11.2011 |
| EU/1/11/690/001-002 | Zoely | Liechtenstein | 31.8.2011 |
| EU/1/11/690/001-002 | Zoely | Norway | 18.8.2011 |
| EU/1/11/690/001-002 | Zoely | Iceland | 9.8.2011 |
| EU/1/11/691/001-005 | Eliquis | Iceland | 8.8.2011 |
| EU/1/11/693/001-016 | Rivastigmin Actavis | Norway | 19.8.2011 |
| EU/1/11/694/001-002 | Nulojix | Liechtenstein | 31.8.2011 |
| EU/1/11/694/001-002 | Nulojix | Norway | 1.8.2011 |
| EU/1/11/694/001-002 | Nulojix | Iceland | 6.7.2011 |
| EU/1/11/695/001-055 | Leganto | Liechtenstein | 31.8.2011 |
| EU/1/11/695/001-055 | Leganto | Norway | 23.8.2011 |
| EU/1/11/695/001-055 | Leganto | Iceland | 6.7.2011 |
| EU/1/11/696/001-002 | Bydureon | Norway | 5.7.2011 |
| EU/1/11/696/001-002 | Bydureon | Iceland | 6.7.2011 |
| EU/1/11/696/001-002 | Bydureon | Liechtenstein | 31.8.2011 |
| EU/1/11/697/001-012 | Temozolomide Sun | Liechtenstein | 31.8.2011 |
| EU/1/11/697/001-012 | Temozolomide SUN | Norway | 22.8.2011 |
| EU/1/11/697/001-012 | Temozolomide SUN | Iceland | 9.8.2011 |
| EU/1/11/698/001-002 | Yervoy | Liechtenstein | 31.8.2011 |
| EU/1/11/698/001-002 | Yervoy | Norway | 18.8.2011 |
| EU/1/11/698/001-002 | Yervoy | Iceland | 21.7.2011 |
| EU/1/11/699/001-002 | Fampyra | Liechtenstein | 31.8.2011 |
| EU/1/11/699/001-002 | Fampyra | Norway | 23.8.2011 |
| EU/1/11/699/001-002 | Fampyra | Iceland | 9.8.2011 |
| EU/1/11/700/001-002 | Benlysta | Liechtenstein | 31.8.2011 |
| EU/1/11/700/001-002 | Benlysta | Norway | 27.7.2011 |
| EU/1/11/700/001-002 | Benlysta | Iceland | 21.7.2011 |
| EU/1/11/701/001-028 | Levetiracetam Teva | Liechtenstein | 31.10.2011 |
| EU/1/11/701/001-028 | Levetiracetam Teva | Norway | 26.9.2011 |
| EU/1/11/701/001-028 | Levetiracetam Teva | Iceland | 16.9.2011 |
| EU/1/11/702/001-031 | Levetiracetam Ratiopharm | Liechtenstein | 31.10.2011 |
| EU/1/11/702/001-031 | Levetiracetam ratiopharm | Norway | 26.9.2011 |
| EU/1/11/702/001-031 | Levetiracetam ratiopharm | Iceland | 16.9.2011 |
| EU/1/11/703/001-002 | Xgeva | Liechtenstein | 31.8.2011 |
| EU/1/11/703/001-002 | Xgeva | Norway | 15.8.2011 |
| EU/1/11/703/001-002 | XGEVA | Iceland | 21.7.2011 |
| EU/1/11/704/001 | Victrelis | Liechtenstein | 31.8.2011 |
| EU/1/11/704/001 | Victrelis | Norway | 16.8.2011 |
| EU/1/11/704/001 | Victrelis | Iceland | 10.8.2011 |
| EU/1/11/705/001-002 | Vibativ | Liechtenstein | 31.10.2011 |
| EU/1/11/705/001-002 | Vibativ | Norway | 19.9.2011 |
| EU/1/11/705/001-002 | Vibativ | Iceland | 16.9.2011 |
| EU/1/11/706/001-033 | Levodopa/Cardidopa/Entacapone Orion | Liechtenstein | 31.10.2011 |
| EU/1/11/706/001-033 | Levodopa/Carbidopa/Entacapone Orion | Norway | 23.9.2011 |
| EU/1/11/706/001-033 | Levodopa/Carbidopa/Entacapone Orion | Iceland | 14.9.2011 |
| EU/1/11/707/001-011 | Trajenta | Liechtenstein | 31.10.2011 |
| EU/1/11/707/001-011 | Trajenta | Norway | 12.9.2011 |
| EU/1/11/707/001-011 | Trajenta | Iceland | 14.9.2011 |
| EU/1/11/708/001-004 | Entacapone Orion | Liechtenstein | 31.8.2011 |
| EU/1/11/708/001-004 | Entacapone Orion | Norway | 22.9.2011 |
| EU/1/11/708/001-004 | Entacapone Orion | Iceland | 26.8.2011 |
| EU/1/11/709/001-004 | Buccolam | Norway | 27.9.2011 |
| EU/1/11/709/001-03 | Buccolam | Iceland | 1.11.2011 |
| EU/1/11/710/001-007 | Votubia | Liechtenstein | 31.10.2011 |
| EU/1/11/710/001-007 | Votubia | Norway | 15.9.2011 |
| EU/1/11/710/001-007 | Votubia | Iceland | 16.9.2011 |
| EU/1/11/711/001-030 | Matever | Liechtenstein | 31.10.2011 |
| EU/1/11/711/001-030 | Matever | Iceland | 13.10.2011 |
| EU/1/11/712/001-028 | Levetiracetam Accord | Liechtenstein | 31.10.2011 |
| EU/1/11/712/001-028 | Levetiracetam Accord | Iceland | 6.11.2011 |
| EU/1/11/713/001-040 | Levetiracetam Actavis | Liechtenstein | 31.10.2011 |
| EU/1/11/713/001-040 | Levetiracetam Actavis | Iceland | 13.10.2011 |
| EU/1/11/714/001 | Zytiga | Liechtenstein | 31.10.2011 |
| EU/1/11/714/001 | Zytiga | Norway | 26.9.2011 |
| EU/1/11/714/001 | Zytiga 250 mg Tafla | Iceland | 19.9.2011 |
| EU/1/11/715/001-002 | Plenadren | Liechtenstein | 31.12.2011 |
| EU/1/11/715/001-002 | Plenadren | Norway | 25.11.2011 |
| EU/1/11/716/001-005 | Eurartesim | Liechtenstein | 31.12.2011 |
| EU/1/11/716/001-005 | Eurartesim | Norway | 21.12.2011 |
| EU/1/11/716/001-005 | Eurartesim | Iceland | 10.11.2011 |
| EU/1/11/717/001 | Vyndaqel | Liechtenstein | 31.12.2011 |
| EU/1/11/717/001 | Vyndaqel | Norway | 6.12.2011 |
| EU/1/11/717/001 | Vyndaqel | Iceland | 25.11.2011 |
| EU/1/11/718/001-006 | Dexdor | Liechtenstein | 31.10.2011 |
| EU/1/11/718/001-006 | Dexdor | Norway | 11.10.2011 |
| EU/1/11/718/001-006 | Dexdor | Iceland | 30.9.2011 |
| EU/1/11/719/001-060 | Telmisartan Teva Pharma | Norway | 18.10.2011 |
| EU/1/11/719/001-060 | Telmisartan Teva Pharma | Iceland | 6.11.2011 |
| EU/1/11/720/001 | Incivo | Liechtenstein | 31.10.2011 |
| EU/1/11/720/001 | Incivo | Norway | 6.10.2011 |
| EU/1/11/720/001 | Incivo 375 mg Filmuhúðuð tafla | Iceland | 8.10.2011 |
| EU/1/11/728/001-010 | Pramipexole Accord | Liechtenstein | 31.10.2011 |
| EU/1/11/728/001-010 | Pramipexole Accord | Norway | 18.10.2011 |
| EU/1/11/728/001-010 | Pramipexole Accord | Iceland | 10.10.2011 |
| EU/1/11/729/001-006 | Onduarp | Liechtenstein | 31.12.2011 |
| EU/1/11/729/001-006 | Onduarp | Iceland | 14.12.2011 |
| EU/1/11/730/001-060 | Rasitrio | Norway | 7.12.2011 |
| EU/1/11/731/001-012 | Komboglyze | Liechtenstein | 31.12.2011 |
| EU/1/11/731/001-012 | Komboglyze | Norway | 15.12.2011 |
| EU/1/11/731/001-012 | Komboglyze | Iceland | 8.12.2011 |
| EU/1/11/732/001-013 | Desloratadine Teva | Liechtenstein | 31.12.2011 |
| EU/1/11/732/001-013 | Desloratadine Teva | Norway | 20.12.2011 |
| EU/1/11/732/001-013 | Desloratadine Teva | Iceland | 8.12.2011 |
| EU/1/11/733/001-004 | Dificlir | Liechtenstein | 31.12.2011 |
| EU/1/11/733/001-004 | Dificlir | Norway | 20.12.2011 |
| EU/1/11/733/001-004 | Dificlir | Iceland | 14.12.2011 |
| EU/1/11/734/001-011 | Edarbi | Liechtenstein | 31.12.2011 |
| EU/1/11/734/001-011 | Edarbi | Norway | 21.12.2011 |
| EU/1/11/734/001-011 | Edarbi | Iceland | 17.12.2011 |
| EU/1/11/735/001-011 | Ipreziv | Liechtenstein | 31.12.2011 |
| EU/1/11/735/001-011 | Ipreziv | Norway | 21.12.2011 |
| EU/1/11/735/001-011 | Ipreziv | Iceland | 17.12.2011 |
| EU/1/11/736/001 | Edurant | Liechtenstein | 31.12.2011 |
| EU/1/11/736/001 | Edurant | Norway | 6.12.2011 |
| EU/1/11/736/001 | EDURANT | Iceland | 14.12.2011 |
| EU/1/11/737/001-002 | Eviplera | Liechtenstein | 31.12.2011 |
| EU/1/11/737/001-002 | Eviplera | Norway | 6.12.2011 |
| EU/1/11/737/001-002 | Eviplera | Iceland | 14.12.2011 |
| EU/1/11/738/001-003 | Levetiracetam Actavis Group | Liechtenstein | 31.12.2011 |
| EU/1/11/738/001-003 | Levetiracetam Actavis Group | Iceland | 14.12.2011 |
| EU/1/11/739/001-008 | Dasselta | Liechtenstein | 31.12.2011 |
| EU/1/11/739/001-008 | Dasselta | Iceland | 8.12.2011 |
| EU/1/11/740/001 | Ameluz | Liechtenstein | 31.12.2011 |
| EU/2/07/078/011-014 | Rheumocam | Norway | 6.7.2011 |
| EU/2/10/110/001-002 | Coxevac | Norway | 22.8.2011 |
| EU/2/10/112/001-005 | BTVPUR AlSap 1 | Norway | 22.8.2011 |
| EU/2/10/113/001-005 | BTVPUR AlSap 1-8 | Norway | 23.8.2011 |
| EU/2/11/122/001-003 | Bluevac BTV8 | Iceland | 12.7.2011 |
| EU/2/11/124/001-008 | Zuprevo | Norway | 6.7.2011 |
| EU/2/11/125/001-008 | Certifect | Norway | 1.9.2011 |
| EU/2/11/126/001 | MS-H-vaksine – Mycoplasma synoviae | Norway | 5.7.2011 |
| EU/2/11/127/001 | Recuvyra | Norway | 6.12.2011 |
| EU/2/11/127/001 | RECUVYRA | Iceland | 11.11.2011 |
| EU/2/11/128/001-003 | Emdocam | Norway | 14.9.2011 |
| EU/2/11/128/001-003 | Emdocam | Iceland | 8.9.2011 |
| EU/2/11/129/001-004 | Proteq West Nile | Norway | 19.8.2011 |
| EU/2/11/129/001-004 | Proteq West Nile | Iceland | 12.8.2011 |
| EU/2/11/130/001-003 | Zulvac 1 Bovis | Norway | 17.8.2011 |
| EU/2/11/130/001-003 | Zulvac 1 Bovis | Iceland | 18.8.2011 |
| EU/2/11/131/001-006 | Zulvac 1 Ovis | Norway | 17.8.2011 |
| EU/2/11/131/001-006 | Zulvac 1 Ovis | Iceland | 12.8.2011 |
| EU/2/11/132/001-004 | Nobivac Myxo-RHD | Norway | 19.9.2011 |
| EU/2/11/132/001-004 | Nobivac Myxo-RHD | Iceland | 20.9.2011 |
| EU/2/11/133/001-003 | Recocam | Norway | 6.10.2011 |
| EU/2/11/133/001-003 | Recocam 20 mg/ml | Iceland | 23.9.2011 |
| EU/2/11/134/001-014 | Inflacam | Iceland | 19.12.2011 |
| EU/2/11/135/001-003 | Panacur AquaSol | Iceland | 19.12.2011 |

EU-Number

Product

Country

Date of authorisation

EU/1/09/543/001-002

Cayston (1)

Liechtenstein

31.10.2011

EU/1/10/642/001-004

Ibandronic Acid Teva

Norway

23.8.2011

EU/1/10/649/001-016

Clopidogrel Teva Pharma B.V

Norway

19.7.2011

EU/1/10/649/001-016

Clopidogrel Teva Pharma B.V.

Liechtenstein

31.8.2011

EU/1/10/652/001-003

TOBI Podhaler

Liechtenstein

31.8.2011

EU/1/10/652/001-003

TOBI Podhaler

Norway

17.8.2011

EU/1/10/652/001-003

TOBI Podhaler

Iceland

9.8.2011

EU/1/10/654/001-004

Leflunomide ratiopharm

Norway

25.8.2011

EU/1/10/660/001-002

Potactasol

Norway

24.8.2011

EU/1/10/661/001-002

Fluenz

Norway

23.8.2011

EU/1/11/672/001-006

Xeplion

Liechtenstein

31.10.2011

EU/1/11/683/001-080

Sprimeo HCT

Liechtenstein

31.8.2011

EU/1/11/683/001-080

Sprimeo HCT

Norway

22.8.2011

EU/1/11/683/001-080

Sprimeo HCT

Iceland

10.8.2011

EU/1/11/685/001-005

Ibandronic acid Sandoz

Liechtenstein

31.8.2011

EU/1/11/685/001-005

Ibandronic acid Sandoz

Iceland

18.8.2011

EU/1/11/689/001-002

IOA

Liechtenstein

31.12.2011

EU/1/11/689/001-002

IOA

Norway

6.12.2011

EU/1/11/689/001-002

Ioa

Iceland

25.11.2011

EU/1/11/690/001-002

Zoely

Liechtenstein

31.8.2011

EU/1/11/690/001-002

Zoely

Norway

18.8.2011

EU/1/11/690/001-002

Zoely

Iceland

9.8.2011

EU/1/11/691/001-005

Eliquis

Iceland

8.8.2011

EU/1/11/693/001-016

Rivastigmin Actavis

Norway

19.8.2011

EU/1/11/694/001-002

Nulojix

Liechtenstein

31.8.2011

EU/1/11/694/001-002

Nulojix

Norway

1.8.2011

EU/1/11/694/001-002

Nulojix

Iceland

6.7.2011

EU/1/11/695/001-055

Leganto

Liechtenstein

31.8.2011

EU/1/11/695/001-055

Leganto

Norway

23.8.2011

EU/1/11/695/001-055

Leganto

Iceland

6.7.2011

EU/1/11/696/001-002

Bydureon

Norway

5.7.2011

EU/1/11/696/001-002

Bydureon

Iceland

6.7.2011

EU/1/11/696/001-002

Bydureon

Liechtenstein

31.8.2011

EU/1/11/697/001-012

Temozolomide Sun

Liechtenstein

31.8.2011

EU/1/11/697/001-012

Temozolomide SUN

Norway

22.8.2011

EU/1/11/697/001-012

Temozolomide SUN

Iceland

9.8.2011

EU/1/11/698/001-002

Yervoy

Liechtenstein

31.8.2011

EU/1/11/698/001-002

Yervoy

Norway

18.8.2011

EU/1/11/698/001-002

Yervoy

Iceland

21.7.2011

EU/1/11/699/001-002

Fampyra

Liechtenstein

31.8.2011

EU/1/11/699/001-002

Fampyra

Norway

23.8.2011

EU/1/11/699/001-002

Fampyra

Iceland

9.8.2011

EU/1/11/700/001-002

Benlysta

Liechtenstein

31.8.2011

EU/1/11/700/001-002

Benlysta

Norway

27.7.2011

EU/1/11/700/001-002

Benlysta

Iceland

21.7.2011

EU/1/11/701/001-028

Levetiracetam Teva

Liechtenstein

31.10.2011

EU/1/11/701/001-028

Levetiracetam Teva

Norway

26.9.2011

EU/1/11/701/001-028

Levetiracetam Teva

Iceland

16.9.2011

EU/1/11/702/001-031

Levetiracetam Ratiopharm

Liechtenstein

31.10.2011

EU/1/11/702/001-031

Levetiracetam ratiopharm

Norway

26.9.2011

EU/1/11/702/001-031

Levetiracetam ratiopharm

Iceland

16.9.2011

EU/1/11/703/001-002

Xgeva

Liechtenstein

31.8.2011

EU/1/11/703/001-002

Xgeva

Norway

15.8.2011

EU/1/11/703/001-002

XGEVA

Iceland

21.7.2011

EU/1/11/704/001

Victrelis

Liechtenstein

31.8.2011

EU/1/11/704/001

Victrelis

Norway

16.8.2011

EU/1/11/704/001

Victrelis

Iceland

10.8.2011

EU/1/11/705/001-002

Vibativ

Liechtenstein

31.10.2011

EU/1/11/705/001-002

Vibativ

Norway

19.9.2011

EU/1/11/705/001-002

Vibativ

Iceland

16.9.2011

EU/1/11/706/001-033

Levodopa/Cardidopa/Entacapone Orion

Liechtenstein

31.10.2011

EU/1/11/706/001-033

Levodopa/Carbidopa/Entacapone Orion

Norway

23.9.2011

EU/1/11/706/001-033

Levodopa/Carbidopa/Entacapone Orion

Iceland

14.9.2011

EU/1/11/707/001-011

Trajenta

Liechtenstein

31.10.2011

EU/1/11/707/001-011

Trajenta

Norway

12.9.2011

EU/1/11/707/001-011

Trajenta

Iceland

14.9.2011

EU/1/11/708/001-004

Entacapone Orion

Liechtenstein

31.8.2011

EU/1/11/708/001-004

Entacapone Orion

Norway

22.9.2011

EU/1/11/708/001-004

Entacapone Orion

Iceland

26.8.2011

EU/1/11/709/001-004

Buccolam

Norway

27.9.2011

EU/1/11/709/001-03

Buccolam

Iceland

1.11.2011

EU/1/11/710/001-007

Votubia

Liechtenstein

31.10.2011

EU/1/11/710/001-007

Votubia

Norway

15.9.2011

EU/1/11/710/001-007

Votubia

Iceland

16.9.2011

EU/1/11/711/001-030

Matever

Liechtenstein

31.10.2011

EU/1/11/711/001-030

Matever

Iceland

13.10.2011

EU/1/11/712/001-028

Levetiracetam Accord

Liechtenstein

31.10.2011

EU/1/11/712/001-028

Levetiracetam Accord

Iceland

6.11.2011

EU/1/11/713/001-040

Levetiracetam Actavis

Liechtenstein

31.10.2011

EU/1/11/713/001-040

Levetiracetam Actavis

Iceland

13.10.2011

EU/1/11/714/001

Zytiga

Liechtenstein

31.10.2011

EU/1/11/714/001

Zytiga

Norway

26.9.2011

EU/1/11/714/001

Zytiga 250 mg Tafla

Iceland

19.9.2011

EU/1/11/715/001-002

Plenadren

Liechtenstein

31.12.2011

EU/1/11/715/001-002

Plenadren

Norway

25.11.2011

EU/1/11/716/001-005

Eurartesim

Liechtenstein

31.12.2011

EU/1/11/716/001-005

Eurartesim

Norway

21.12.2011

EU/1/11/716/001-005

Eurartesim

Iceland

10.11.2011

EU/1/11/717/001

Vyndaqel

Liechtenstein

31.12.2011

EU/1/11/717/001

Vyndaqel

Norway

6.12.2011

EU/1/11/717/001

Vyndaqel

Iceland

25.11.2011

EU/1/11/718/001-006

Dexdor

Liechtenstein

31.10.2011

EU/1/11/718/001-006

Dexdor

Norway

11.10.2011

EU/1/11/718/001-006

Dexdor

Iceland

30.9.2011

EU/1/11/719/001-060

Telmisartan Teva Pharma

Norway

18.10.2011

EU/1/11/719/001-060

Telmisartan Teva Pharma

Iceland

6.11.2011

EU/1/11/720/001

Incivo

Liechtenstein

31.10.2011

EU/1/11/720/001

Incivo

Norway

6.10.2011

EU/1/11/720/001

Incivo 375 mg Filmuhúðuð tafla

Iceland

8.10.2011

EU/1/11/728/001-010

Pramipexole Accord

Liechtenstein

31.10.2011

EU/1/11/728/001-010

Pramipexole Accord

Norway

18.10.2011

EU/1/11/728/001-010

Pramipexole Accord

Iceland

10.10.2011

EU/1/11/729/001-006

Onduarp

Liechtenstein

31.12.2011

EU/1/11/729/001-006

Onduarp

Iceland

14.12.2011

EU/1/11/730/001-060

Rasitrio

Norway

7.12.2011

EU/1/11/731/001-012

Komboglyze

Liechtenstein

31.12.2011

EU/1/11/731/001-012

Komboglyze

Norway

15.12.2011

EU/1/11/731/001-012

Komboglyze

Iceland

8.12.2011

EU/1/11/732/001-013

Desloratadine Teva

Liechtenstein

31.12.2011

EU/1/11/732/001-013

Desloratadine Teva

Norway

20.12.2011

EU/1/11/732/001-013

Desloratadine Teva

Iceland

8.12.2011

EU/1/11/733/001-004

Dificlir

Liechtenstein

31.12.2011

EU/1/11/733/001-004

Dificlir

Norway

20.12.2011

EU/1/11/733/001-004

Dificlir

Iceland

14.12.2011

EU/1/11/734/001-011

Edarbi

Liechtenstein

31.12.2011

EU/1/11/734/001-011

Edarbi

Norway

21.12.2011

EU/1/11/734/001-011

Edarbi

Iceland

17.12.2011

EU/1/11/735/001-011

Ipreziv

Liechtenstein

31.12.2011

EU/1/11/735/001-011

Ipreziv

Norway

21.12.2011

EU/1/11/735/001-011

Ipreziv

Iceland

17.12.2011

EU/1/11/736/001

Edurant

Liechtenstein

31.12.2011

EU/1/11/736/001

Edurant

Norway

6.12.2011

EU/1/11/736/001

EDURANT

Iceland

14.12.2011

EU/1/11/737/001-002

Eviplera

Liechtenstein

31.12.2011

EU/1/11/737/001-002

Eviplera

Norway

6.12.2011

EU/1/11/737/001-002

Eviplera

Iceland

14.12.2011

EU/1/11/738/001-003

Levetiracetam Actavis Group

Liechtenstein

31.12.2011

EU/1/11/738/001-003

Levetiracetam Actavis Group

Iceland

14.12.2011

EU/1/11/739/001-008

Dasselta

Liechtenstein

31.12.2011

EU/1/11/739/001-008

Dasselta

Iceland

8.12.2011

EU/1/11/740/001

Ameluz

Liechtenstein

31.12.2011

EU/2/07/078/011-014

Rheumocam

Norway

6.7.2011

EU/2/10/110/001-002

Coxevac

Norway

22.8.2011

EU/2/10/112/001-005

BTVPUR AlSap 1

Norway

22.8.2011

EU/2/10/113/001-005

BTVPUR AlSap 1-8

Norway

23.8.2011

EU/2/11/122/001-003

Bluevac BTV8

Iceland

12.7.2011

EU/2/11/124/001-008

Zuprevo

Norway

6.7.2011

EU/2/11/125/001-008

Certifect

Norway

1.9.2011

EU/2/11/126/001

MS-H-vaksine – Mycoplasma synoviae

Norway

5.7.2011

EU/2/11/127/001

Recuvyra

Norway

6.12.2011

EU/2/11/127/001

RECUVYRA

Iceland

11.11.2011

EU/2/11/128/001-003

Emdocam

Norway

14.9.2011

EU/2/11/128/001-003

Emdocam

Iceland

8.9.2011

EU/2/11/129/001-004

Proteq West Nile

Norway

19.8.2011

EU/2/11/129/001-004

Proteq West Nile

Iceland

12.8.2011

EU/2/11/130/001-003

Zulvac 1 Bovis

Norway

17.8.2011

EU/2/11/130/001-003

Zulvac 1 Bovis

Iceland

18.8.2011

EU/2/11/131/001-006

Zulvac 1 Ovis

Norway

17.8.2011

EU/2/11/131/001-006

Zulvac 1 Ovis

Iceland

12.8.2011

EU/2/11/132/001-004

Nobivac Myxo-RHD

Norway

19.9.2011

EU/2/11/132/001-004

Nobivac Myxo-RHD

Iceland

20.9.2011

EU/2/11/133/001-003

Recocam

Norway

6.10.2011

EU/2/11/133/001-003

Recocam 20 mg/ml

Iceland

23.9.2011

EU/2/11/134/001-014

Inflacam

Iceland

19.12.2011

EU/2/11/135/001-003

Panacur AquaSol

Iceland

19.12.2011

---

(1)  From the conditional marketing authorisation with a marketing authorisation not subject to specific obligations.

---

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 2011:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/196/001
  EU/1/01/196/003 | Cancidas | Norway | 20.9.2011 |
| EU/1/01/196/001, 003 | Cancidas | Iceland | 20.9.2011 |
| EU/1/01/196/001, 003 | Cancidas | Liechtenstein | 31.10.2011 |
| EU/1/01/200/001-002 | Viread | Liechtenstein | 31.12.2011 |
| EU/1/06/336/001 | Tygacil | Iceland | 13.7.2011 |
| EU/1/06/340/001-002 | Ganfort | Liechtenstein | 31.8.2011 |
| EU/1/06/340/001-002 | Ganfort | Norway | 1.9.2011 |
| EU/1/06/340/001-002 | Ganfort | Iceland | 8.7.2011 |
| EU/1/06/342/001 | Nexavar | Liechtenstein | 31.8.2011 |
| EU/1/06/342/001 | Nexavar | Norway | 20.9.2011 |
| EU/1/06/342/001 | Nexavar | Iceland | 9.8.2011 |
| EU/1/06/343/001-007 | Baraclude | Norway | 6.7.2011 |
| EU/1/06/346/001 | Tysabri | Liechtenstein | 31.8.2011 |
| EU/1/06/346/001 | Tysabri | Norway | 19.7.2011 |
| EU/1/06/35/001-003 | Livensa | Liechtenstein | 31.8.2011 |
| EU/1/06/350/001 | Savene | Liechtenstein | 31.8.2011 |
| EU/1/06/350/001 | Savene | Norway | 18.8.2011 |
| EU/1/06/350/001 | Savene | Iceland | 9.8.2011 |
| EU/1/06/351/001-003 | Livensa | Norway | 12.8.2011 |
| EU/1/06/351/001-003 | Livensa | Iceland | 9.8.2011 |
| EU/1/06/352/001-003 | Intrinsa | Liechtenstein | 31.8.2011 |
| EU/1/06/352/001-003 | Intrinsa | Norway | 12.8.2011 |
| EU/1/06/352/001-003 | Intrinsa | Iceland | 10.8.2011 |
| EU/1/06/355/001-003 | ATryn | Liechtenstein | 31.8.2011 |
| EU/1/06/355/001-003 | ATryn | Norway | 1.9.2011 |
| EU/1/06/355/001-003 | ATryn | Iceland | 18.8.2011 |
| EU/1/06/356/001-009 | Exjade | Liechtenstein | 31.8.2011 |
| EU/1/06/356/001-009 | Exjade | Norway | 17.8.2011 |
| EU/1/06/356/001-009 | Exjade | Iceland | 9.8.2011 |
| EU/1/06/357/001-008, 018-021 | Gardasil | Iceland | 11.8.2011 |
| EU/1/06/357/001-008
  EU/1/06/357/018-021 | Gardasil | Norway | 19.8.2011 |
| EU/1/06/358/001-008, 018-021 | Silgard | Iceland | 10.8.2011 |
| EU/1/06/358/001-021 | Silgard | Liechtenstein | 31.8.2011 |
| EU/1/06/358/001-021 | Silgard | Norway | 12.8.2011 |
| EU/1/06/359/001-004 | Suboxone | Liechtenstein | 31.10.2011 |
| EU/1/06/359/001-004 | Suboxone | Norway | 14.10.2011 |
| EU/1/06/359/001-004 | Suboxone | Iceland | 4.10.2011 |
| EU/1/06/360/001-013 | Champix | Norway | 3.8.2011 |
| EU/1/06/360/001-013 | Champix | Iceland | 7.7.2011 |
| EU/1/06/361/001-002 | Luminity | Liechtenstein | 31.10.2011 |
| EU/1/06/361/001-002 | Luminity | Norway | 21.9.2011 |
| EU/1/06/361/001-002 | Luminity | Iceland | 21.9.2011 |
| EU/1/06/362/001-004 | Byetta | Liechtenstein | 31.10.2011 |
| EU/1/06/362/001-004 | Byetta | Norway | 6.10.2011 |
| EU/1/06/362/001-004 | Byetta | Iceland | 8.10.2011 |
| EU/1/06/363/001-015 | Sprycel | Liechtenstein | 31.10.2011 |
| EU/1/06/363/001-015 | Sprycel | Norway | 14.10.2011 |
| EU/1/06/363/001-015 | Sprycel | Iceland | 7.11.2011 |
| EU/1/06/364/001-004
  EU/1/06/364/006-008 | Adrovance | Norway | 23.12.2011 |
| EU/1/06/364/001-004, 006-008 | Adrovance | Iceland | 7.12.2011 |
| EU/1/06/364/006-008 | Adrovance | Liechtenstein | 31.12.2011 |
| EU/1/06/365/001-003 | Elaprase | Liechtenstein | 31.10.2011 |
| EU/1/06/365/001-003 | Elaprase | Norway | 14.10.2011 |
| EU/1/06/365/001-003 | Elaprase | Iceland | 6.11.2011 |
| EU/1/06/368/001-015, 020-024, 029-033, 038-042, 047-051, 056-057, 088-102, 113-150, 163-168 | Insulin Human Winthrop | Liechtenstein | 31.12.2011 |
| EU/1/06/368/001-168 | Insulin Human Winthrop | Iceland | 6.12.2011 |
| EU/1/06/370/001-039 | Exforge | Liechtenstein | 31.12.2011 |
| EU/1/06/372/001-039 | Copalia | Liechtenstein | 31.12.2011 |
| EU/1/06/372/001-039 | Copalia | Iceland | 7.12.2011 |
| EU/1/06/373/001-039 | Imprida | Liechtenstein | 31.12.2011 |
| EU/1/07/440/001-006 | Tyverb | Iceland | 22.8.2011 |
| EU/1/08/468/001 | Intelence | Liechtenstein | 31.8.2011 |
| EU/1/08/468/001 | Intelence | Norway | 17.8.2011 |
| EU/1/08/468/001 | INTELENCE | Iceland | 11.8.2011 |
| EU/1/09/543/001-002 | Cayston | Norway | 19.9.2011 |
| EU/1/09/543/001-002 | Cayston | Iceland | 19.9.2011 |
| EU/1/10/628/001-004 | Votrient | Norway | 21.10.2011 |
| EU/1/96/024/001-005 | Crixivan | Liechtenstein | 31.8.2011 |
| EU/1/96/024/001-005
  EU/1/96/024/010 | Crixivan | Norway | 18.8.2011 |
| EU/1/96/024/001-010 | Crixivan | Iceland | 10.8.2011 |
| EU/2/06/059/001 | Convenia | Norway | 6.7.2011 |
| EU/2/06/060/001-002 | Poulvac Flufend H5N3 RG | Iceland | 11.8.2011 |
| EU/2/06/061/001-004 | Nobilis Influenza H5N2 | Norway | 14.9.2011 |
| EU/2/06/061/001-004 | Nobilis Influenza H5N2 | Iceland | 8.9.2011 |
| EU/2/06/062/001-005 | Cerenia | Norway | 18.8.2011 |
| EU/2/06/062/001-005 | Cerenia | Iceland | 12.8.2011 |
| EU/2/06/064/001-004 | ProMeris | Norway | 8.12.2011 |
| EU/2/06/064/001-004 | ProMeris | Iceland | 21.11.2011 |
| EU/2/06/065/001-010 | ProMeris Duo | Iceland | 4.12.2011 |
| EU/2/06/065/001-010 | ProMeris Duo | Norway | 8.12.2011 |
| EU/2/06/066/001-012 | Prac-Tic | Norway | 8.12.2011 |
| EU/2/06/066/001-012 | Prac-tic | Iceland | 25.11.2011 |
| EU/2/06/069/001 | Cortavance | Norway | 27.9.2011 |
| EU/2/06/069/001 | Cortavance | Iceland | 23.9.2011 |
| EU/2/99/016/001-006 | Porcilis Pesti | Norway | 6.10.2011 |
| EU/2/99/016/001-006 | Porcilis Pesti | Iceland | 7.10.2011 |

EU-Number

Product

Country

Date of authorisation

EU/1/01/196/001

EU/1/01/196/003

Cancidas

Norway

20.9.2011

EU/1/01/196/001, 003

Cancidas

Iceland

20.9.2011

EU/1/01/196/001, 003

Cancidas

Liechtenstein

31.10.2011

EU/1/01/200/001-002

Viread

Liechtenstein

31.12.2011

EU/1/06/336/001

Tygacil

Iceland

13.7.2011

EU/1/06/340/001-002

Ganfort

Liechtenstein

31.8.2011

EU/1/06/340/001-002

Ganfort

Norway

1.9.2011

EU/1/06/340/001-002

Ganfort

Iceland

8.7.2011

EU/1/06/342/001

Nexavar

Liechtenstein

31.8.2011

EU/1/06/342/001

Nexavar

Norway

20.9.2011

EU/1/06/342/001

Nexavar

Iceland

9.8.2011

EU/1/06/343/001-007

Baraclude

Norway

6.7.2011

EU/1/06/346/001

Tysabri

Liechtenstein

31.8.2011

EU/1/06/346/001

Tysabri

Norway

19.7.2011

EU/1/06/35/001-003

Livensa

Liechtenstein

31.8.2011

EU/1/06/350/001

Savene

Liechtenstein

31.8.2011

EU/1/06/350/001

Savene

Norway

18.8.2011

EU/1/06/350/001

Savene

Iceland

9.8.2011

EU/1/06/351/001-003

Livensa

Norway

12.8.2011

EU/1/06/351/001-003

Livensa

Iceland

9.8.2011

EU/1/06/352/001-003

Intrinsa

Liechtenstein

31.8.2011

EU/1/06/352/001-003

Intrinsa

Norway

12.8.2011

EU/1/06/352/001-003

Intrinsa

Iceland

10.8.2011

EU/1/06/355/001-003

ATryn

Liechtenstein

31.8.2011

EU/1/06/355/001-003

ATryn

Norway

1.9.2011

EU/1/06/355/001-003

ATryn

Iceland

18.8.2011

EU/1/06/356/001-009

Exjade

Liechtenstein

31.8.2011

EU/1/06/356/001-009

Exjade

Norway

17.8.2011

EU/1/06/356/001-009

Exjade

Iceland

9.8.2011

EU/1/06/357/001-008, 018-021

Gardasil

Iceland

11.8.2011

EU/1/06/357/001-008

EU/1/06/357/018-021

Gardasil

Norway

19.8.2011

EU/1/06/358/001-008, 018-021

Silgard

Iceland

10.8.2011

EU/1/06/358/001-021

Silgard

Liechtenstein

31.8.2011

EU/1/06/358/001-021

Silgard

Norway

12.8.2011

EU/1/06/359/001-004

Suboxone

Liechtenstein

31.10.2011

EU/1/06/359/001-004

Suboxone

Norway

14.10.2011

EU/1/06/359/001-004

Suboxone

Iceland

4.10.2011

EU/1/06/360/001-013

Champix

Norway

3.8.2011

EU/1/06/360/001-013

Champix

Iceland

7.7.2011

EU/1/06/361/001-002

Luminity

Liechtenstein

31.10.2011

EU/1/06/361/001-002

Luminity

Norway

21.9.2011

EU/1/06/361/001-002

Luminity

Iceland

21.9.2011

EU/1/06/362/001-004

Byetta

Liechtenstein

31.10.2011

EU/1/06/362/001-004

Byetta

Norway

6.10.2011

EU/1/06/362/001-004

Byetta

Iceland

8.10.2011

EU/1/06/363/001-015

Sprycel

Liechtenstein

31.10.2011

EU/1/06/363/001-015

Sprycel

Norway

14.10.2011

EU/1/06/363/001-015

Sprycel

Iceland

7.11.2011

EU/1/06/364/001-004

EU/1/06/364/006-008

Adrovance

Norway

23.12.2011

EU/1/06/364/001-004, 006-008

Adrovance

Iceland

7.12.2011

EU/1/06/364/006-008

Adrovance

Liechtenstein

31.12.2011

EU/1/06/365/001-003

Elaprase

Liechtenstein

31.10.2011

EU/1/06/365/001-003

Elaprase

Norway

14.10.2011

EU/1/06/365/001-003

Elaprase

Iceland

6.11.2011

EU/1/06/368/001-015, 020-024, 029-033, 038-042, 047-051, 056-057, 088-102, 113-150, 163-168

Insulin Human Winthrop

Liechtenstein

31.12.2011

EU/1/06/368/001-168

Insulin Human Winthrop

Iceland

6.12.2011

EU/1/06/370/001-039

Exforge

Liechtenstein

31.12.2011

EU/1/06/372/001-039

Copalia

Liechtenstein

31.12.2011

EU/1/06/372/001-039

Copalia

Iceland

7.12.2011

EU/1/06/373/001-039

Imprida

Liechtenstein

31.12.2011

EU/1/07/440/001-006

Tyverb

Iceland

22.8.2011

EU/1/08/468/001

Intelence

Liechtenstein

31.8.2011

EU/1/08/468/001

Intelence

Norway

17.8.2011

EU/1/08/468/001

INTELENCE

Iceland

11.8.2011

EU/1/09/543/001-002

Cayston

Norway

19.9.2011

EU/1/09/543/001-002

Cayston

Iceland

19.9.2011

EU/1/10/628/001-004

Votrient

Norway

21.10.2011

EU/1/96/024/001-005

Crixivan

Liechtenstein

31.8.2011

EU/1/96/024/001-005

EU/1/96/024/010

Crixivan

Norway

18.8.2011

EU/1/96/024/001-010

Crixivan

Iceland

10.8.2011

EU/2/06/059/001

Convenia

Norway

6.7.2011

EU/2/06/060/001-002

Poulvac Flufend H5N3 RG

Iceland

11.8.2011

EU/2/06/061/001-004

Nobilis Influenza H5N2

Norway

14.9.2011

EU/2/06/061/001-004

Nobilis Influenza H5N2

Iceland

8.9.2011

EU/2/06/062/001-005

Cerenia

Norway

18.8.2011

EU/2/06/062/001-005

Cerenia

Iceland

12.8.2011

EU/2/06/064/001-004

ProMeris

Norway

8.12.2011

EU/2/06/064/001-004

ProMeris

Iceland

21.11.2011

EU/2/06/065/001-010

ProMeris Duo

Iceland

4.12.2011

EU/2/06/065/001-010

ProMeris Duo

Norway

8.12.2011

EU/2/06/066/001-012

Prac-Tic

Norway

8.12.2011

EU/2/06/066/001-012

Prac-tic

Iceland

25.11.2011

EU/2/06/069/001

Cortavance

Norway

27.9.2011

EU/2/06/069/001

Cortavance

Iceland

23.9.2011

EU/2/99/016/001-006

Porcilis Pesti

Norway

6.10.2011

EU/2/99/016/001-006

Porcilis Pesti

Iceland

7.10.2011

---

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 2011:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/165/008 | Ovitrelle | Liechtenstein | 31.8.2011 |
| EU/1/00/165/008 | Ovitrelle | Norway | 6.7.2011 |
| EU/1/01/176/007-009 | Zometa | Liechtenstein | 31.10.2011 |
| EU/1/01/176/007-009 | Zometa | Norway | 12.9.2011 |
| EU/1/01/176/007-009 | Zometa | Iceland | 12.11.2011 |
| EU/1/02/221/011-016 | Pegasys | Liechtenstein | 31.8.2011 |
| EU/1/03/248/013-023 | Levitra | Liechtenstein | 31.12.2011 |
| EU/1/03/249/013-015 | Vivanza | Liechtenstein | 31.12.2011 |
| EU/1/03/260/034-038 | Stalevo | Norway | 23.9.2011 |
| EU/1/03/260/034-038 | Stalevo | Liechtenstein | 31.10.2011 |
| EU/1/03/260/034-038 | Stalevo | Iceland | 13.9.2011 |
| EU/1/03/262/009-010 | Emend | Liechtenstein | 31.12.2011 |
| EU/1/03/270/004-005 | Kentera | Liechtenstein | 31.8.2011 |
| EU/1/03/270/004-005 | Kentera | Norway | 7.9.2011 |
| EU/1/03/270/004-005 | Kentera | Iceland | 9.9.2011 |
| EU/1/03/271/007-010 | Advate | Liechtenstein | 31.12.2011 |
| EU/1/05/322/002 | Yttriga | Liechtenstein | 31.8.2011 |
| EU/1/06/332/010-012 | Omnitrope | Norway | 25.8.2011 |
| EU/1/06/378/017 | Inovelon | Liechtenstein | 31.12.2011 |
| EU/1/06/378/017 | Inovelon | Norway | 20.12.2011 |
| EU/1/07/392/003 | Circadin | Liechtenstein | 31.10.2011 |
| EU/1/07/401/016 | Alli | Liechtenstein | 31.8.2011 |
| EU/1/07/422/007-008 | Tasigna | Liechtenstein | 31.8.2011 |
| EU/1/07/422/009-012 | Tasigna | Liechtenstein | 31.12.2011 |
| EU/1/08/442/009-013 | Pradaxa | Iceland | 10.8.2011 |
| EU/1/08/442/009-014 | Pradaxa | Liechtenstein | 31.8.2011 |
| EU/1/08/442/009-014 | Pradaxa | Norway | 17.8.2011 |
| EU/1/08/468/002 | Intelence | Liechtenstein | 31.12.2011 |
| EU/1/08/468/002 | Intelence | Norway | 15.12.2011 |
| EU/1/08/470/014-015 | Vimpat | Iceland | 8.12.2011 |
| EU/1/08/472/011-021 | Xarelto | Liechtenstein | 31.12.2011 |
| EU/1/08/472/011-021 | Xarelto | Iceland | 20.12.2011 |
| EU/1/09/508/011 | Synflorix | Liechtenstein | 31.8.2011 |
| EU/1/09/531/010-021 | Instanyl | Liechtenstein | 31.8.2011 |
| EU/1/09/531/010-021 | Instanyl | Norway | 1.8.2011 |
| EU/1/09/531/010-021 | Instanyl | Iceland | 13.7.2011 |
| EU/1/09/564/003 | Ilaris | Liechtenstein | 31.10.2011 |
| EU/1/09/564/003 | Ilaris | Iceland | 5.10.2011 |
| EU/1/09/564/003 | Ilaris | Norway | 27.9.2011 |
| EU/1/09/610/031-060 | Telmisartan Teva | Liechtenstein | 31.8.2011 |
| EU/1/10/614/003 | Menveo | Liechtenstein | 31.8.2011 |
| EU/1/10/636/004-007 | Daxas | Liechtenstein | 31.12.2011 |
| EU/1/10/646/003-006 | VPRIV | Liechtenstein | 31.8.2011 |
| EU/1/10/647/003-004 | Myclausen | Norway | 27.9.2011 |
| EU/1/10/647/003-004 | Myclausen | Iceland | 3.10.2011 |
| EU/1/95/003/011-012 | Betaferon | Liechtenstein | 31.8.2011 |
| EU/1/97/055/005-009 | Viramune | Norway | 14.10.2011 |
| EU/1/97/055/005-009 | Viramune | Iceland | 5.10.2011 |
| EU/1/98/090/021-022 | Micardis | Liechtenstein | 31.8.2011 |
| EU/1/99/119/019-023 | NovoRapid | Liechtenstein | 31.8.2011 |
| EU/1/99/126/022 | Enbrel | Iceland | 13.7.2011 |
| EU/2/08/090/010-018 | Loxicom | Norway | 15.8.2011 |
| EU/2/08/090/010-026 | Loxicom | Iceland | 22.7.2011 |
| EU/2/08/090/019-026 | Loxicom | Norway | 27.9.2011 |

EU-Number

Product

Country

Date of authorisation

EU/1/00/165/008

Ovitrelle

Liechtenstein

31.8.2011

EU/1/00/165/008

Ovitrelle

Norway

6.7.2011

EU/1/01/176/007-009

Zometa

Liechtenstein

31.10.2011

EU/1/01/176/007-009

Zometa

Norway

12.9.2011

EU/1/01/176/007-009

Zometa

Iceland

12.11.2011

EU/1/02/221/011-016

Pegasys

Liechtenstein

31.8.2011

EU/1/03/248/013-023

Levitra

Liechtenstein

31.12.2011

EU/1/03/249/013-015

Vivanza

Liechtenstein

31.12.2011

EU/1/03/260/034-038

Stalevo

Norway

23.9.2011

EU/1/03/260/034-038

Stalevo

Liechtenstein

31.10.2011

EU/1/03/260/034-038

Stalevo

Iceland

13.9.2011

EU/1/03/262/009-010

Emend

Liechtenstein

31.12.2011

EU/1/03/270/004-005

Kentera

Liechtenstein

31.8.2011

EU/1/03/270/004-005

Kentera

Norway

7.9.2011

EU/1/03/270/004-005

Kentera

Iceland

9.9.2011

EU/1/03/271/007-010

Advate

Liechtenstein

31.12.2011

EU/1/05/322/002

Yttriga

Liechtenstein

31.8.2011

EU/1/06/332/010-012

Omnitrope

Norway

25.8.2011

EU/1/06/378/017

Inovelon

Liechtenstein

31.12.2011

EU/1/06/378/017

Inovelon

Norway

20.12.2011

EU/1/07/392/003

Circadin

Liechtenstein

31.10.2011

EU/1/07/401/016

Alli

Liechtenstein

31.8.2011

EU/1/07/422/007-008

Tasigna

Liechtenstein

31.8.2011

EU/1/07/422/009-012

Tasigna

Liechtenstein

31.12.2011

EU/1/08/442/009-013

Pradaxa

Iceland

10.8.2011

EU/1/08/442/009-014

Pradaxa

Liechtenstein

31.8.2011

EU/1/08/442/009-014

Pradaxa

Norway

17.8.2011

EU/1/08/468/002

Intelence

Liechtenstein

31.12.2011

EU/1/08/468/002

Intelence

Norway

15.12.2011

EU/1/08/470/014-015

Vimpat

Iceland

8.12.2011

EU/1/08/472/011-021

Xarelto

Liechtenstein

31.12.2011

EU/1/08/472/011-021

Xarelto

Iceland

20.12.2011

EU/1/09/508/011

Synflorix

Liechtenstein

31.8.2011

EU/1/09/531/010-021

Instanyl

Liechtenstein

31.8.2011

EU/1/09/531/010-021

Instanyl

Norway

1.8.2011

EU/1/09/531/010-021

Instanyl

Iceland

13.7.2011

EU/1/09/564/003

Ilaris

Liechtenstein

31.10.2011

EU/1/09/564/003

Ilaris

Iceland

5.10.2011

EU/1/09/564/003

Ilaris

Norway

27.9.2011

EU/1/09/610/031-060

Telmisartan Teva

Liechtenstein

31.8.2011

EU/1/10/614/003

Menveo

Liechtenstein

31.8.2011

EU/1/10/636/004-007

Daxas

Liechtenstein

31.12.2011

EU/1/10/646/003-006

VPRIV

Liechtenstein

31.8.2011

EU/1/10/647/003-004

Myclausen

Norway

27.9.2011

EU/1/10/647/003-004

Myclausen

Iceland

3.10.2011

EU/1/95/003/011-012

Betaferon

Liechtenstein

31.8.2011

EU/1/97/055/005-009

Viramune

Norway

14.10.2011

EU/1/97/055/005-009

Viramune

Iceland

5.10.2011

EU/1/98/090/021-022

Micardis

Liechtenstein

31.8.2011

EU/1/99/119/019-023

NovoRapid

Liechtenstein

31.8.2011

EU/1/99/126/022

Enbrel

Iceland

13.7.2011

EU/2/08/090/010-018

Loxicom

Norway

15.8.2011

EU/2/08/090/010-026

Loxicom

Iceland

22.7.2011

EU/2/08/090/019-026

Loxicom

Norway

27.9.2011

---

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 2011:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/02/225/001-002 | Xigris | Liechtenstein | 31.12.2011 |
| EU/1/03/259/001-006 | Onsenal | Norway | 5.8.2011 |
| EU/1/05/313/001-009 | Ablavar | Liechtenstein | 31.10.2011 |
| EU/1/05/313/001-009 | Ablavar | Norway | 29.11.2011 |
| EU/1/05/313/001-009 | Ablavar | Iceland | 6.11.2011 |
| EU/1/08/470/014-015 | Vimpat | Iceland | 8.12.2011 |
| EU/1/08/478/001 | Prepandemic influenza vaccine (H5N1) | Liechtenstein | 31.10.2011 |
| EU/1/08/478/001 | Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals | Iceland | 6.11.2011 |
| EU/1/09/547/001-007 | Clopidogrel Sandoz | Norway | 5.8.2011 |
| EU/1/09/547/001-007 | Clopidogrel Sandoz | Iceland | 23.8.2011 |
| EU/1/10/629/001 | Humenza | Norway | 5.8.2011 |
| EU/2/06/063/001-003 | Yarvitan | Norway | 22.9.2011 |
| EU/2/06/063/001-003 | Yarvitan | Iceland | 26.8.2011 |
| EU/1/06/349/001-010 | Avaglim | Norway | 18.8.2011 |

EU-Number

Product

Country

Date of withdrawal

EU/1/02/225/001-002

Xigris

Liechtenstein

31.12.2011

EU/1/03/259/001-006

Onsenal

Norway

5.8.2011

EU/1/05/313/001-009

Ablavar

Liechtenstein

31.10.2011

EU/1/05/313/001-009

Ablavar

Norway

29.11.2011

EU/1/05/313/001-009

Ablavar

Iceland

6.11.2011

EU/1/08/470/014-015

Vimpat

Iceland

8.12.2011

EU/1/08/478/001

Prepandemic influenza vaccine (H5N1)

Liechtenstein

31.10.2011

EU/1/08/478/001

Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals

Iceland

6.11.2011

EU/1/09/547/001-007

Clopidogrel Sandoz

Norway

5.8.2011

EU/1/09/547/001-007

Clopidogrel Sandoz

Iceland

23.8.2011

EU/1/10/629/001

Humenza

Norway

5.8.2011

EU/2/06/063/001-003

Yarvitan

Norway

22.9.2011

EU/2/06/063/001-003

Yarvitan

Iceland

26.8.2011

EU/1/06/349/001-010

Avaglim

Norway

18.8.2011

---

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 2011:

| EU-Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/06/361/001-002 | Luminity | Liechtenstein | 31.12.2011 |
| EU/2/08/088/001-003 | Acticam | Iceland | 23.8.2011 |

EU-Number

Product

Country

Date of suspension

EU/1/06/361/001-002

Luminity

Liechtenstein

31.12.2011

EU/2/08/088/001-003

Acticam

Iceland

23.8.2011

---

| 9.10.2014 | EN | Official Journal of the European Union | C 356/22 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/22

---

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2012

2014/C 356/07

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 January-30 June 2012, at their meeting on 15 July 2013:

| 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

---

ANNEX I

List of new marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January-30 June 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/11/711/001-030 | Matever | Norway | 1.6.2012 |
| EU/1/11/712/001-028 | Levetiracetam Accord | Norway | 13.4.2012 |
| EU/1/11/713/001-040 | Levetiracetam Actavis | Norway | 16.4.2012 |
| EU/1/11/715/001-002 | Plenadren | Iceland | 23.4.2012 |
| EU/1/11/721/001-021 | Paglitaz | Norway | 13.4.2012 |
| EU/1/11/721/001-021 | Paglitaz | Iceland | 17.4.2012 |
| EU/1/11/722/001-030 | Pioglitazone Accord | Norway | 11.4.2012 |
| EU/1/11/722/001-030 | Pioglitazon Accord | Liechtenstein | 30.4.2012 |
| EU/1/11/722/001-030 | Pioglitazone Accord | Iceland | 20.4.2012 |
| EU/1/11/723/001-021 | Pioglitazone Krka | Norway | 23.5.2012 |
| EU/1/11/723/001-021 | Pioglitazone Krka | Iceland | 20.4.2012 |
| EU/1/11/727/001 | Mercatopurine Nova lab. | Norway | 19.4.2012 |
| EU/1/11/727/001 | Mercaptopurine Nova Laboratories | Iceland | 3.4.2012 |
| EU/1/11/727/001 | Mercatopurine Nova Laboratories | Liechtenstein | 30.4.2012 |
| EU/1/11/729/001-006 | Onduarp | Norway | 8.5.2012 |
| EU/1/11/730/001-060 | Rasitrio | Iceland | 3.2.2012 |
| EU/1/11/738/001-003 | Levetiracetam Actavis Gr. | Norway | 1.3.2012 |
| EU/1/11/739/001-008 | Dasselta | Norway | 16.1.2012 |
| EU/1/11/740/001 | Ameluz | Iceland | 5.1.2012 |
| EU/1/11/740/001 | Ameluz | Norway | 16.1.2012 |
| EU/1/11/741/001 | Levetiracetam SUN | Norway | 27.1.2012 |
| EU/1/11/741/001 | Levetiracetam Sun | Iceland | 9.1.2012 |
| EU/1/11/742/001-010 | Efavirenz Teva | Norway | 13.2.2012 |
| EU/1/11/742/001-010 | Efavirenz Teva | Iceland | 24.1.2012 |
| EU/1/11/742/001-010 | Efavirenz Teva | Liechtenstein | 29.2.2012 |
| EU/1/11/743/001-015 | Repaglinide Accord | Norway | 13.2.2012 |
| EU/1/11/743/001-015 | Repaglinide Accord | Iceland | 19.1.2012 |
| EU/1/11/743/001-015 | Repaglinide Accord | Liechtenstein | 29.2.2012 |
| EU/1/11/744/001-002 | Topotecan Eagle | Iceland | 22.1.2012 |
| EU/1/11/744/001-002 | Topotecan Eagle | Liechtenstein | 29.2.2012 |
| EU/1/11/745/001-009 | Desloratadine Actavis | Iceland | 3.2.2012 |
| EU/1/11/745/001-009 | Desloratadine Actavis | Norway | 13.2.2012 |
| EU/1/11/746/001-012 | Desloratadine ratiopharm | Norway | 13.2.2012 |
| EU/1/11/746/001-012 | Desloratadine ratiopharm | Iceland | 3.2.2012 |
| EU/1/11/746/001-012 | Desloratadine ratiopharm | Liechtenstein | 29.2.2012 |
| EU/1/11/747/001 | Colobreathe | Iceland | 29.2.2012 |
| EU/1/11/747/001 | Colobreathe | Liechtenstein | 29.2.2012 |
| EU/1/11/748/001-006 | Docetaxel Mylan | Iceland | 7.2.2012 |
| EU/1/11/748/001-006 | Docetaxel Mylan | Liechtenstein | 29.2.2012 |
| EU/1/11/749/001-002 | Caprelsa | Liechtenstein | 30.4.2012 |
| EU/1/11/749/001-003 | Caprelsa | Iceland | 9.3.2012 |
| EU/1/11/749/001-002 | Caprelsa | Norway | 13.3.2012 |
| EU/1/12/750/001 | Esmya | Norway | 30.3.2012 |
| EU/1/12/750/001 | Esmya | Iceland | 14.3.2012 |
| EU/1/12/750/001 | Esmya | Liechtenstein | 30.4.2012 |
| EU/1/12/751/001 | Zelboraf | Norway | 14.3.2012 |
| EU/1/12/751/001 | Zelboraf | Iceland | 7.3.2012 |
| EU/1/12/751/001 | Zelboraf | Liechtenstein | 29.2.2012 |
| EU/1/12/752/001 | Vepacel | Norway | 1.3.2012 |
| EU/1/12/752/001 | Vepacel | Iceland | 9.3.2012 |
| EU/1/12/752/001 | Vepacel | Liechtenstein | 29.2.2012 |
| EU/1/12/753/001-012 | Signifor | Norway | 10.5.2012 |
| EU/1/12/753/001-012 | Signifor | Iceland | 24.5.2012 |
| EU/1/12/753/001-012 | Signifor | Liechtenstein | 30.6.2012 |
| EU/1/12/754/001-021 | Sepioglin | Norway | 10.4.2012 |
| EU/1/12/754/001-021 | Sepioglin | Iceland | 3.4.2012 |
| EU/1/12/754/001-021 | Sepioglin | Liechtenstein | 30.4.2012 |
| EU/1/12/755/001-027 | Pioglitazone Actavis | Norway | 13.4.2012 |
| EU/1/12/755/001-027 | Pioglitazone Actavis | Iceland | 30.4.2012 |
| EU/1/12/756/001-027 | Glidipion (ex Ogliton) | Norway | 13.4.2012 |
| EU/1/12/756/001-027 | Pioglitazone Actavis Group | Iceland | 13.4.2012 |
| EU/1/12/756/001-027 | Pioglitazone Actavis Group | Liechtenstein | 30.4.2012 |
| EU/1/12/757/001-030 | Pioglitazone Teva | Norway | 11.4.2012 |
| EU/1/12/757/001-030 | Pioglitazone Teva | Iceland | 23.4.2012 |
| EU/1/12/758/001-030 | Pioglitazone Teva Pharma | Norway | 17.4.2012 |
| EU/1/12/758/001-030 | Pioglitazone Teva Pharma | Iceland | 25.4.2012 |
| EU/1/12/759/001-003 | Zoledronic acid Actavis | Norway | 8.5.2012 |
| EU/1/12/759/001-003 | Zoledronic acid Actavis | Iceland | 16.5.2012 |
| EU/1/12/759/001-003 | Zoledronsäure Actavis | Liechtenstein | 30.4.2012 |
| EU/1/12/760/001-002 | Bronchitol | Norway | 18.5.2012 |
| EU/1/12/760/001-002 | Bronchitol | Iceland | 9.5.2012 |
| EU/1/12/761/001-002 | Capecitabine Teva | Norway | 30.5.2012 |
| EU/1/12/761/001-002 | Capecitabine Teva | Iceland | 20.5.2012 |
| EU/1/12/761/001-002 | Capecitabin Teva | Liechtenstein | 30.4.2012 |
| EU/1/12/762/001-018 | Capecitabine Accord | Iceland | 20.5.2012 |
| EU/1/12/762/001-018 | Capecitabin Accord | Liechtenstein | 30.4.2012 |
| EU/1/12/763/001-018 | Capecitabine Krka | Iceland | 16.5.2012 |
| EU/1/12/763/001-018 | Capecitabin Krka | Liechtenstein | 30.4.2012 |
| EU/1/12/763/001-018 | Capecitabine Krka | Norway | 14.6.2012 |
| EU/1/12/764/001 | Pixuvri | Norway | 14.6.2012 |
| EU/1/12/764/001 | Pixuvri | Iceland | 29.5.2012 |
| EU/1/12/764/001 | Pixuvri | Liechtenstein | 30.6.2012 |
| EU/1/12/765/001-004 | Sabervel | Iceland | 9.5.2012 |
| EU/1/12/765/001-006 | Sabervel | Norway | 8.5.2012 |
| EU/1/12/765/001-006 | Sabervel | Liechtenstein | 30.4.2012 |
| EU/1/12/766/001 | Sancuso | Norway | 10.5.2012 |
| EU/1/12/766/001 | Sancuso | Iceland | 20.5.2012 |
| EU/1/12/766/001 | Sancuso | Liechtenstein | 30.6.2012 |
| EU/1/12/767/001-007 | Nimenrix | Norway | 1.5.2012 |
| EU/1/12/767/001-007 | Nimenrix | Iceland | 16.5.2012 |
| EU/1/12/768/001 | Riluzole Zentiva | Iceland | 25.5.2012 |
| EU/1/12/768/001 | Riluzol Zentiva | Liechtenstein | 30.6.2012 |
| EU/1/12/769/001-003 | Docetaxel Accord | Iceland | 12.6.2012 |
| EU/1/12/769/001-003 | Docetaxel Accord | Liechtenstein | 30.6.2012 |
| EU/1/12/770/001-004 | Docetaxel Kabi | Norway | 19.6.2012 |
| EU/1/12/770/001-004 | Docetaxel Kabi | Iceland | 13.6.2012 |
| EU/1/12/770/001-004 | Docetaxel Kabi | Liechtenstein | 30.6.2012 |
| EU/2/11/134/001-014 | Inflacam | Norway | 6.1.2012 |
| EU/2/11/135/001-003 | Panacur AquaSol | Norway | 10.2.2012 |
| EU/2/11/136/001 | Truscient | Norway | 6.1.2012 |
| EU/2/11/136/001 | TruScient | Iceland | 12.1.2012 |
| EU/2/11/137/001-015 | Activyl Tick Plus | Norway | 13.2.2012 |
| EU/2/11/137/001-015 | Activyl Tick Plus | Iceland | 25.1.2012 |
| EU/2/11/137/001-015 | Activyl Tick Plus | Liechtenstein | 29.2.2012 |
| EU/2/12/138/001-003 | RevitaCAM | Iceland | 14.3.2012 |
| EU/2/12/139/001-003 | Zulvac 1 + 8 Bovis | Norway | 3.4.2012 |
| EU/2/12/139/001-003 | Zulvac 1 + 8 Bovis | Iceland | 4.4.2012 |
| EU/2/12/139/001-003 | Zulvac 1 + 8 Bovis | Liechtenstein | 30.4.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/11/711/001-030

Matever

Norway

1.6.2012

EU/1/11/712/001-028

Levetiracetam Accord

Norway

13.4.2012

EU/1/11/713/001-040

Levetiracetam Actavis

Norway

16.4.2012

EU/1/11/715/001-002

Plenadren

Iceland

23.4.2012

EU/1/11/721/001-021

Paglitaz

Norway

13.4.2012

EU/1/11/721/001-021

Paglitaz

Iceland

17.4.2012

EU/1/11/722/001-030

Pioglitazone Accord

Norway

11.4.2012

EU/1/11/722/001-030

Pioglitazon Accord

Liechtenstein

30.4.2012

EU/1/11/722/001-030

Pioglitazone Accord

Iceland

20.4.2012

EU/1/11/723/001-021

Pioglitazone Krka

Norway

23.5.2012

EU/1/11/723/001-021

Pioglitazone Krka

Iceland

20.4.2012

EU/1/11/727/001

Mercatopurine Nova lab.

Norway

19.4.2012

EU/1/11/727/001

Mercaptopurine Nova Laboratories

Iceland

3.4.2012

EU/1/11/727/001

Mercatopurine Nova Laboratories

Liechtenstein

30.4.2012

EU/1/11/729/001-006

Onduarp

Norway

8.5.2012

EU/1/11/730/001-060

Rasitrio

Iceland

3.2.2012

EU/1/11/738/001-003

Levetiracetam Actavis Gr.

Norway

1.3.2012

EU/1/11/739/001-008

Dasselta

Norway

16.1.2012

EU/1/11/740/001

Ameluz

Iceland

5.1.2012

EU/1/11/740/001

Ameluz

Norway

16.1.2012

EU/1/11/741/001

Levetiracetam SUN

Norway

27.1.2012

EU/1/11/741/001

Levetiracetam Sun

Iceland

9.1.2012

EU/1/11/742/001-010

Efavirenz Teva

Norway

13.2.2012

EU/1/11/742/001-010

Efavirenz Teva

Iceland

24.1.2012

EU/1/11/742/001-010

Efavirenz Teva

Liechtenstein

29.2.2012

EU/1/11/743/001-015

Repaglinide Accord

Norway

13.2.2012

EU/1/11/743/001-015

Repaglinide Accord

Iceland

19.1.2012

EU/1/11/743/001-015

Repaglinide Accord

Liechtenstein

29.2.2012

EU/1/11/744/001-002

Topotecan Eagle

Iceland

22.1.2012

EU/1/11/744/001-002

Topotecan Eagle

Liechtenstein

29.2.2012

EU/1/11/745/001-009

Desloratadine Actavis

Iceland

3.2.2012

EU/1/11/745/001-009

Desloratadine Actavis

Norway

13.2.2012

EU/1/11/746/001-012

Desloratadine ratiopharm

Norway

13.2.2012

EU/1/11/746/001-012

Desloratadine ratiopharm

Iceland

3.2.2012

EU/1/11/746/001-012

Desloratadine ratiopharm

Liechtenstein

29.2.2012

EU/1/11/747/001

Colobreathe

Iceland

29.2.2012

EU/1/11/747/001

Colobreathe

Liechtenstein

29.2.2012

EU/1/11/748/001-006

Docetaxel Mylan

Iceland

7.2.2012

EU/1/11/748/001-006

Docetaxel Mylan

Liechtenstein

29.2.2012

EU/1/11/749/001-002

Caprelsa

Liechtenstein

30.4.2012

EU/1/11/749/001-003

Caprelsa

Iceland

9.3.2012

EU/1/11/749/001-002

Caprelsa

Norway

13.3.2012

EU/1/12/750/001

Esmya

Norway

30.3.2012

EU/1/12/750/001

Esmya

Iceland

14.3.2012

EU/1/12/750/001

Esmya

Liechtenstein

30.4.2012

EU/1/12/751/001

Zelboraf

Norway

14.3.2012

EU/1/12/751/001

Zelboraf

Iceland

7.3.2012

EU/1/12/751/001

Zelboraf

Liechtenstein

29.2.2012

EU/1/12/752/001

Vepacel

Norway

1.3.2012

EU/1/12/752/001

Vepacel

Iceland

9.3.2012

EU/1/12/752/001

Vepacel

Liechtenstein

29.2.2012

EU/1/12/753/001-012

Signifor

Norway

10.5.2012

EU/1/12/753/001-012

Signifor

Iceland

24.5.2012

EU/1/12/753/001-012

Signifor

Liechtenstein

30.6.2012

EU/1/12/754/001-021

Sepioglin

Norway

10.4.2012

EU/1/12/754/001-021

Sepioglin

Iceland

3.4.2012

EU/1/12/754/001-021

Sepioglin

Liechtenstein

30.4.2012

EU/1/12/755/001-027

Pioglitazone Actavis

Norway

13.4.2012

EU/1/12/755/001-027

Pioglitazone Actavis

Iceland

30.4.2012

EU/1/12/756/001-027

Glidipion (ex Ogliton)

Norway

13.4.2012

EU/1/12/756/001-027

Pioglitazone Actavis Group

Iceland

13.4.2012

EU/1/12/756/001-027

Pioglitazone Actavis Group

Liechtenstein

30.4.2012

EU/1/12/757/001-030

Pioglitazone Teva

Norway

11.4.2012

EU/1/12/757/001-030

Pioglitazone Teva

Iceland

23.4.2012

EU/1/12/758/001-030

Pioglitazone Teva Pharma

Norway

17.4.2012

EU/1/12/758/001-030

Pioglitazone Teva Pharma

Iceland

25.4.2012

EU/1/12/759/001-003

Zoledronic acid Actavis

Norway

8.5.2012

EU/1/12/759/001-003

Zoledronic acid Actavis

Iceland

16.5.2012

EU/1/12/759/001-003

Zoledronsäure Actavis

Liechtenstein

30.4.2012

EU/1/12/760/001-002

Bronchitol

Norway

18.5.2012

EU/1/12/760/001-002

Bronchitol

Iceland

9.5.2012

EU/1/12/761/001-002

Capecitabine Teva

Norway

30.5.2012

EU/1/12/761/001-002

Capecitabine Teva

Iceland

20.5.2012

EU/1/12/761/001-002

Capecitabin Teva

Liechtenstein

30.4.2012

EU/1/12/762/001-018

Capecitabine Accord

Iceland

20.5.2012

EU/1/12/762/001-018

Capecitabin Accord

Liechtenstein

30.4.2012

EU/1/12/763/001-018

Capecitabine Krka

Iceland

16.5.2012

EU/1/12/763/001-018

Capecitabin Krka

Liechtenstein

30.4.2012

EU/1/12/763/001-018

Capecitabine Krka

Norway

14.6.2012

EU/1/12/764/001

Pixuvri

Norway

14.6.2012

EU/1/12/764/001

Pixuvri

Iceland

29.5.2012

EU/1/12/764/001

Pixuvri

Liechtenstein

30.6.2012

EU/1/12/765/001-004

Sabervel

Iceland

9.5.2012

EU/1/12/765/001-006

Sabervel

Norway

8.5.2012

EU/1/12/765/001-006

Sabervel

Liechtenstein

30.4.2012

EU/1/12/766/001

Sancuso

Norway

10.5.2012

EU/1/12/766/001

Sancuso

Iceland

20.5.2012

EU/1/12/766/001

Sancuso

Liechtenstein

30.6.2012

EU/1/12/767/001-007

Nimenrix

Norway

1.5.2012

EU/1/12/767/001-007

Nimenrix

Iceland

16.5.2012

EU/1/12/768/001

Riluzole Zentiva

Iceland

25.5.2012

EU/1/12/768/001

Riluzol Zentiva

Liechtenstein

30.6.2012

EU/1/12/769/001-003

Docetaxel Accord

Iceland

12.6.2012

EU/1/12/769/001-003

Docetaxel Accord

Liechtenstein

30.6.2012

EU/1/12/770/001-004

Docetaxel Kabi

Norway

19.6.2012

EU/1/12/770/001-004

Docetaxel Kabi

Iceland

13.6.2012

EU/1/12/770/001-004

Docetaxel Kabi

Liechtenstein

30.6.2012

EU/2/11/134/001-014

Inflacam

Norway

6.1.2012

EU/2/11/135/001-003

Panacur AquaSol

Norway

10.2.2012

EU/2/11/136/001

Truscient

Norway

6.1.2012

EU/2/11/136/001

TruScient

Iceland

12.1.2012

EU/2/11/137/001-015

Activyl Tick Plus

Norway

13.2.2012

EU/2/11/137/001-015

Activyl Tick Plus

Iceland

25.1.2012

EU/2/11/137/001-015

Activyl Tick Plus

Liechtenstein

29.2.2012

EU/2/12/138/001-003

RevitaCAM

Iceland

14.3.2012

EU/2/12/139/001-003

Zulvac 1 + 8 Bovis

Norway

3.4.2012

EU/2/12/139/001-003

Zulvac 1 + 8 Bovis

Iceland

4.4.2012

EU/2/12/139/001-003

Zulvac 1 + 8 Bovis

Liechtenstein

30.4.2012

---

ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January-30 June 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/197/001-005 | Foscan | Iceland | 14.5.2012 |
| EU/1/01/200/001-002 | Viread | Norway | 6.1.2012 |
| EU/1/01/200/001-002 | Viread | Iceland | 5.1.2012 |
| EU/1/02/209/001-008 | Dynastat | Norway | 8.3.2012 |
| EU/1/02/209/001-008 | Dynastat | Iceland | 7.2.2012 |
| EU/1/02/209/001-008 | Dynastat | Liechtenstein | 29.2.2012 |
| EU/1/02/212/001-026 | Vfend | Norway | 6.3.2012 |
| EU/1/02/212/001-026 | Vfend | Iceland | 14.3.2012 |
| EU/1/02/212/001-026 | Vfend | Liechtenstein | 30.4.2012 |
| EU/1/02/216/001-002 | Invanz | Norway | 19.1.2012 |
| EU/1/02/216/001-002 | Invanz | Iceland | 20.1.2012 |
| EU/1/02/216/001-002 | Invanz | Liechtenstein | 29.2.2012 |
| EU/1/02/220/001-006 | Tracleer | Norway | 8.5.2012 |
| EU/1/02/220/001-006 | Tracleer | Iceland | 20.5.2012 |
| EU/1/02/220/001-006 | Tracleer | Liechtenstein | 30.4.2012 |
| EU/1/02/222/001-005 | Tamiflu | Norway | 8.3.2012 |
| EU/1/02/222/001-005 | Tamiflu | Iceland | 19.6.2012 |
| EU/1/02/222/001-005 | Tamiflu | Liechtenstein | 30.6.2012 |
| EU/1/06/334/001-005 | Evoltra | Liechtenstein | 30.4.2012 |
| EU/1/06/347/001-008 | Sutent | Liechtenstein | 29.2.2012 |
| EU/1/06/366/005-022 | Tandemact | Norway | 11.4.2012 |
| EU/1/06/366/005-022 | Tandemact | Iceland | 22.3.2012 |
| EU/1/06/366/005-022 | Tandemact | Liechtenstein | 30.4.2012 |
| EU/1/06/367/001-012 | Diacomit | Norway | 6.3.2012 |
| EU/1/06/367/001-012 | Diacomit | Iceland | 7.2.2012 |
| EU/1/06/367/001-012 | Diacomit | Liechtenstein | 29.2.2012 |
| EU/1/06/370/001-039 | Exforge | Norway | 16.1.2012 |
| EU/1/06/370/001-039 | EXFORGE | Iceland | 3.2.2012 |
| EU/1/06/371/001-039 | Dafiro | Iceland | 8.2.2012 |
| EU/1/06/371/001-039 | Dafiro | Liechtenstein | 29.2.2012 |
| EU/1/06/372/001-039 | Copalia | Norway | 11.1.2012 |
| EU/1/06/373/001-039 | Imprida | Norway | 16.1.2012 |
| EU/1/06/373/001-039 | Imprida | Iceland | 6.2.2012 |
| EU/1/06/374/001 | Lucentis | Norway | 17.1.2012 |
| EU/1/06/374/001 | Lucentis | Iceland | 12.1.2012 |
| EU/1/06/376/001-033 | Irbesartan Zentiva (ex-Winthrop) | Norway | 14.2.2012 |
| EU/1/06/376/001-033 | Irbesartan Zentiva | Iceland | 7.2.2012 |
| EU/1/06/376/001-033 | Irbesartan Winthrop | Liechtenstein | 29.2.2012 |
| EU/1/06/377/001-028 | Irbesartan HCT Zentiva (ex-Winthrop) | Norway | 16.4.2012 |
| EU/1/06/377/001-028 | Irbesartan HCT Zentiva | Iceland | 22.3.2012 |
| EU/1/06/377/001-028 | Irbesartan HCT | Liechtenstein | 30.4.2012 |
| EU/1/06/378/001-017 | Inovelon | Norway | 6.3.2012 |
| EU/1/06/378/001-017 | Inovelon | Iceland | 24.1.2012 |
| EU/1/06/378/001-017 | Inovelon | Liechtenstein | 29.2.2012 |
| EU/1/06/379/001 | Cystadane | Iceland | 9.3.2012 |
| EU/1/06/379/001 | Cystadane | Liechtenstein | 29.2.2012 |
| EU/1/06/386/001-015, 020-024, 029-033, 038-042, 047-051, 056-057, 088102, 113-150, 163-168 | Insulin Human Winthrop | Norway | 6.1.2012 |
| EU/1/07/382/001-018 | Xelevia | Norway | 14.2.2012 |
| EU/1/07/382/001-018 | Xelevia | Iceland | 6.2.2012 |
| EU/1/07/382/001-018 | Xelevia | Liechtenstein | 29.2.2012 |
| EU/1/07/383/001-018 | Januvia | Norway | 26.3.2012 |
| EU/1/07/383/001-018 | Januvia | Iceland | 11.5.2012 |
| EU/1/07/383/001-018 | Januvia | Liechtenstein | 30.4.2012 |
| EU/1/07/384/003-005 | Docetaxel Winthrop | Norway | 10.4.2012 |
| EU/1/07/384/003-005 | Docetaxel Winthrop | Iceland | 23.3.2012 |
| EU/1/07/384/003-005 | Docetaxel Winthrop | Liechtenstein | 30.4.2012 |
| EU/1/07/386/001-018 | Toviaz | Norway | 11.4.2012 |
| EU/1/07/386/001-018 | Toviaz | Iceland | 10.4.2012 |
| EU/1/07/386/001-018 | Toviaz | Liechtenstein | 30.4.2012 |
| EU/1/07/387/001-026 | Advagraf | Norway | 2.5.2012 |
| EU/1/07/387/001-026 | Advagraf | Iceland | 9.5.2012 |
| EU/1/07/387/001-026 | Advagraf | Liechtenstein | 30.4.2012 |
| EU/1/07/388/001-003 | Sebivo | Norway | 8.5.2012 |
| EU/1/07/388/001-003 | Sebivo | Iceland | 16.5.2012 |
| EU/1/07/388/001-003 | Sebivo | Liechtenstein | 30.4.2012 |
| EU/1/07/389/001-003 | Orencia | Norway | 10.4.2012 |
| EU/1/07/389/001-003 | Orencia | Iceland | 10.4.2012 |
| EU/1/07/389/001-003 | Orencia | Liechtenstein | 30.4.2012 |
| EU/1/07/390/001-004 | Altargo | Norway | 8.5.2012 |
| EU/1/07/390/001-004 | Altargo | Iceland | 16.5.2012 |
| EU/1/07/390/001-004 | Altargo | Liechtenstein | 30.4.2012 |
| EU/1/07/391/001-004 | Revlimid | Norway | 3.5.2012 |
| EU/1/07/391/001-004 | Revlimid | Iceland | 9.5.2012 |
| EU/1/07/391/001-004 | Revlimid | Liechtenstein | 30.4.2012 |
| EU/1/07/392/001-003 | Circadin | Norway | 16.5.2012 |
| EU/1/07/392/001-003 | Circadin | Iceland | 10.5.2012 |
| EU/1/07/392/001-003 | Circadin | Liechtenstein | 30.6.2012 |
| EU/1/07/394/001-009 | Optaflu | Norway | 20.6.2012 |
| EU/1/07/395/001-095 | Invega | Liechtenstein | 30.6.2012 |
| EU/1/07/396/001-003 | Pergoveris | Iceland | 20.6.2012 |
| EU/1/07/396/001-003 | Pergoveris | Liechtenstein | 30.6.2012 |
| EU/1/07/398/001-014 | Optimark | Norway | 27.6.2012 |
| EU/1/07/399/001-006 | Aerinaze | Norway | 18.6.2012 |
| EU/1/07/399/001-006 | Aerinaze | Liechtenstein | 30.6.2012 |
| EU/1/07/399/001-006 | Aerinaze | Iceland | 20.6.2012 |
| EU/1/07/400/008-013, 017-024 | Mircera | Iceland | 7.6.2012 |
| EU/1/07/400/008-013, 017-024 | Mircera | Norway | 14.6.2012 |
| EU/1/07/400/017-024 | Mircera | Liechtenstein | 30.6.2012 |
| EU/1/07/401/007-016 | alli | Norway | 29.6.2012 |
| EU/1/07/412/001-052 | Abseamed | Liechtenstein | 30.6.2012 |
| EU/1/07/423/001-003 | Vectibix | Norway | 19.3.2012 |
| EU/1/07/423/001-003 | Vectibix | Iceland | 9.3.2012 |
| EU/1/07/440/001-003 | Tyverb | Liechtenstein | 30.4.2012 |
| EU/1/07/440/001-006 | Tyverb | Norway | 2.5.2012 |
| EU/1/07/440/001-006 | Tyverb | Iceland | 11.5.2012 |
| EU/1/10/625/001&003 | Arzerra | Iceland | 17.2.2012 |
| EU/1/10/625/001&003 | Arzerra | Norway | 18.5.2012 |
| EU/1/10/628/001-004 | Votrient | Norway | 19.6.2012 |
| EU/1/10/628/001-004 | Votrient | Iceland | 13.6.2012 |
| EU/1/11/699/001-004 | Fampyra | Norway | 19.6.2012 |
| EU/1/11/699/001-004 | Fampyra | Iceland | 13.6.2012 |
| EU/1/11/699/001-004 | Fampyra | Liechtenstein | 30.6.2012 |
| EU/2/05/053/001-003 | Naxcel | Norway | 14.2.2012 |
| EU/2/06/068/001-004 | Ypozane | Norway | 13.2.2012 |
| EU/2/06/068/001-004 | Ypozane | Iceland | 18.1.2012 |
| EU/2/06/068/001-004 | Ypozane | Liechtenstein | 30.4.2012 |
| EU/2/06/070/001-008 | Meloxidyl | Iceland | 13.1.2012 |
| EU/2/07/071/001-003 | SLENTROL | Iceland | 7.5.2012 |
| EU/2/07/071/001-003 | Slentrol | Liechtenstein | 30.4.2012 |
| EU/2/07/072/001-004 | Suprelorin | Iceland | 21.6.2012 |
| EU/2/07/074/001-006 | Prilactone | Iceland | 13.6.2012 |
| EU/2/07/075/001-004 | Circovac | Liechtenstein | 30.6.2012 |
| EU/2/07/075/001-004 | Circovac | Iceland | 4.6.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/01/197/001-005

Foscan

Iceland

14.5.2012

EU/1/01/200/001-002

Viread

Norway

6.1.2012

EU/1/01/200/001-002

Viread

Iceland

5.1.2012

EU/1/02/209/001-008

Dynastat

Norway

8.3.2012

EU/1/02/209/001-008

Dynastat

Iceland

7.2.2012

EU/1/02/209/001-008

Dynastat

Liechtenstein

29.2.2012

EU/1/02/212/001-026

Vfend

Norway

6.3.2012

EU/1/02/212/001-026

Vfend

Iceland

14.3.2012

EU/1/02/212/001-026

Vfend

Liechtenstein

30.4.2012

EU/1/02/216/001-002

Invanz

Norway

19.1.2012

EU/1/02/216/001-002

Invanz

Iceland

20.1.2012

EU/1/02/216/001-002

Invanz

Liechtenstein

29.2.2012

EU/1/02/220/001-006

Tracleer

Norway

8.5.2012

EU/1/02/220/001-006

Tracleer

Iceland

20.5.2012

EU/1/02/220/001-006

Tracleer

Liechtenstein

30.4.2012

EU/1/02/222/001-005

Tamiflu

Norway

8.3.2012

EU/1/02/222/001-005

Tamiflu

Iceland

19.6.2012

EU/1/02/222/001-005

Tamiflu

Liechtenstein

30.6.2012

EU/1/06/334/001-005

Evoltra

Liechtenstein

30.4.2012

EU/1/06/347/001-008

Sutent

Liechtenstein

29.2.2012

EU/1/06/366/005-022

Tandemact

Norway

11.4.2012

EU/1/06/366/005-022

Tandemact

Iceland

22.3.2012

EU/1/06/366/005-022

Tandemact

Liechtenstein

30.4.2012

EU/1/06/367/001-012

Diacomit

Norway

6.3.2012

EU/1/06/367/001-012

Diacomit

Iceland

7.2.2012

EU/1/06/367/001-012

Diacomit

Liechtenstein

29.2.2012

EU/1/06/370/001-039

Exforge

Norway

16.1.2012

EU/1/06/370/001-039

EXFORGE

Iceland

3.2.2012

EU/1/06/371/001-039

Dafiro

Iceland

8.2.2012

EU/1/06/371/001-039

Dafiro

Liechtenstein

29.2.2012

EU/1/06/372/001-039

Copalia

Norway

11.1.2012

EU/1/06/373/001-039

Imprida

Norway

16.1.2012

EU/1/06/373/001-039

Imprida

Iceland

6.2.2012

EU/1/06/374/001

Lucentis

Norway

17.1.2012

EU/1/06/374/001

Lucentis

Iceland

12.1.2012

EU/1/06/376/001-033

Irbesartan Zentiva (ex-Winthrop)

Norway

14.2.2012

EU/1/06/376/001-033

Irbesartan Zentiva

Iceland

7.2.2012

EU/1/06/376/001-033

Irbesartan Winthrop

Liechtenstein

29.2.2012

EU/1/06/377/001-028

Irbesartan HCT Zentiva (ex-Winthrop)

Norway

16.4.2012

EU/1/06/377/001-028

Irbesartan HCT Zentiva

Iceland

22.3.2012

EU/1/06/377/001-028

Irbesartan HCT

Liechtenstein

30.4.2012

EU/1/06/378/001-017

Inovelon

Norway

6.3.2012

EU/1/06/378/001-017

Inovelon

Iceland

24.1.2012

EU/1/06/378/001-017

Inovelon

Liechtenstein

29.2.2012

EU/1/06/379/001

Cystadane

Iceland

9.3.2012

EU/1/06/379/001

Cystadane

Liechtenstein

29.2.2012

EU/1/06/386/001-015, 020-024, 029-033, 038-042, 047-051, 056-057, 088102, 113-150, 163-168

Insulin Human Winthrop

Norway

6.1.2012

EU/1/07/382/001-018

Xelevia

Norway

14.2.2012

EU/1/07/382/001-018

Xelevia

Iceland

6.2.2012

EU/1/07/382/001-018

Xelevia

Liechtenstein

29.2.2012

EU/1/07/383/001-018

Januvia

Norway

26.3.2012

EU/1/07/383/001-018

Januvia

Iceland

11.5.2012

EU/1/07/383/001-018

Januvia

Liechtenstein

30.4.2012

EU/1/07/384/003-005

Docetaxel Winthrop

Norway

10.4.2012

EU/1/07/384/003-005

Docetaxel Winthrop

Iceland

23.3.2012

EU/1/07/384/003-005

Docetaxel Winthrop

Liechtenstein

30.4.2012

EU/1/07/386/001-018

Toviaz

Norway

11.4.2012

EU/1/07/386/001-018

Toviaz

Iceland

10.4.2012

EU/1/07/386/001-018

Toviaz

Liechtenstein

30.4.2012

EU/1/07/387/001-026

Advagraf

Norway

2.5.2012

EU/1/07/387/001-026

Advagraf

Iceland

9.5.2012

EU/1/07/387/001-026

Advagraf

Liechtenstein

30.4.2012

EU/1/07/388/001-003

Sebivo

Norway

8.5.2012

EU/1/07/388/001-003

Sebivo

Iceland

16.5.2012

EU/1/07/388/001-003

Sebivo

Liechtenstein

30.4.2012

EU/1/07/389/001-003

Orencia

Norway

10.4.2012

EU/1/07/389/001-003

Orencia

Iceland

10.4.2012

EU/1/07/389/001-003

Orencia

Liechtenstein

30.4.2012

EU/1/07/390/001-004

Altargo

Norway

8.5.2012

EU/1/07/390/001-004

Altargo

Iceland

16.5.2012

EU/1/07/390/001-004

Altargo

Liechtenstein

30.4.2012

EU/1/07/391/001-004

Revlimid

Norway

3.5.2012

EU/1/07/391/001-004

Revlimid

Iceland

9.5.2012

EU/1/07/391/001-004

Revlimid

Liechtenstein

30.4.2012

EU/1/07/392/001-003

Circadin

Norway

16.5.2012

EU/1/07/392/001-003

Circadin

Iceland

10.5.2012

EU/1/07/392/001-003

Circadin

Liechtenstein

30.6.2012

EU/1/07/394/001-009

Optaflu

Norway

20.6.2012

EU/1/07/395/001-095

Invega

Liechtenstein

30.6.2012

EU/1/07/396/001-003

Pergoveris

Iceland

20.6.2012

EU/1/07/396/001-003

Pergoveris

Liechtenstein

30.6.2012

EU/1/07/398/001-014

Optimark

Norway

27.6.2012

EU/1/07/399/001-006

Aerinaze

Norway

18.6.2012

EU/1/07/399/001-006

Aerinaze

Liechtenstein

30.6.2012

EU/1/07/399/001-006

Aerinaze

Iceland

20.6.2012

EU/1/07/400/008-013, 017-024

Mircera

Iceland

7.6.2012

EU/1/07/400/008-013, 017-024

Mircera

Norway

14.6.2012

EU/1/07/400/017-024

Mircera

Liechtenstein

30.6.2012

EU/1/07/401/007-016

alli

Norway

29.6.2012

EU/1/07/412/001-052

Abseamed

Liechtenstein

30.6.2012

EU/1/07/423/001-003

Vectibix

Norway

19.3.2012

EU/1/07/423/001-003

Vectibix

Iceland

9.3.2012

EU/1/07/440/001-003

Tyverb

Liechtenstein

30.4.2012

EU/1/07/440/001-006

Tyverb

Norway

2.5.2012

EU/1/07/440/001-006

Tyverb

Iceland

11.5.2012

EU/1/10/625/001&003

Arzerra

Iceland

17.2.2012

EU/1/10/625/001&003

Arzerra

Norway

18.5.2012

EU/1/10/628/001-004

Votrient

Norway

19.6.2012

EU/1/10/628/001-004

Votrient

Iceland

13.6.2012

EU/1/11/699/001-004

Fampyra

Norway

19.6.2012

EU/1/11/699/001-004

Fampyra

Iceland

13.6.2012

EU/1/11/699/001-004

Fampyra

Liechtenstein

30.6.2012

EU/2/05/053/001-003

Naxcel

Norway

14.2.2012

EU/2/06/068/001-004

Ypozane

Norway

13.2.2012

EU/2/06/068/001-004

Ypozane

Iceland

18.1.2012

EU/2/06/068/001-004

Ypozane

Liechtenstein

30.4.2012

EU/2/06/070/001-008

Meloxidyl

Iceland

13.1.2012

EU/2/07/071/001-003

SLENTROL

Iceland

7.5.2012

EU/2/07/071/001-003

Slentrol

Liechtenstein

30.4.2012

EU/2/07/072/001-004

Suprelorin

Iceland

21.6.2012

EU/2/07/074/001-006

Prilactone

Iceland

13.6.2012

EU/2/07/075/001-004

Circovac

Liechtenstein

30.6.2012

EU/2/07/075/001-004

Circovac

Iceland

4.6.2012

---

ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January-30 June 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/141/002 | Myocet | Liechtenstein | 30.4.2012 |
| EU/1/02/222/05 | Tamiflu | Iceland | 6.2.2012 |
| EU/1/03/262/009-010 | Emend | Norway | 5.1.2012 |
| EU/1/03/262/009-010 | Emend | Iceland | 3.2.2012 |
| EU/1/03/271/007-010 | Advate | Norway | 23.1.2012 |
| EU/1/03/271/007-010 | Advate | Iceland | 17.1.2012 |
| EU/1/05/318/003 | Revatio | Norway | 13.4.2012 |
| EU/1/05/318/003 | Revatio | Iceland | 17.4.2012 |
| EU/1/05/318/003 | Revatio | Liechtenstein | 30.4.2012 |
| EU/1/06/339/003 | Preotact | Liechtenstein | 30.6.2012 |
| EU/1/08/465/021 | Clopidogrel Zentiva | Liechtenstein | 30.6.2012 |
| EU/1/08/468/002 | INTELENCE | Iceland | 3.1.2012 |
| EU/1/08/470/018-019 | Vimpat | Norway | 14.3.2012 |
| EU/1/08/470/018-019 | Vimpat | Iceland | 14.3.2012 |
| EU/1/08/470/018-019 | Vimpat | Liechtenstein | 30.4.2012 |
| EU/1/08/472/011-021 | Xarelto | Norway | 4.1.2012 |
| EU/1/08/475/035-060 | Olanzapin Mylan | Liechtenstein | 29.2.2012 |
| EU/1/09/536/003-004 | Topotecan Actavis | Liechtenstein | 30.4.2012 |
| EU/1/09/551/013-027 | Vizarsin | Iceland | 7.6.2012 |
| EU/1/09/551/013-027 | Vizarsin | Liechtenstein | 30.6.2012 |
| EU/1/09/571/002 | Pandemic influenza vaccine H5N1 Baxter | Liechtenstein | 30.4.2012 |
| EU/1/11/667/004 | Esbriet | Liechtenstein | 30.4.2012 |
| EU/1/11/699/003-004 | Fampyra | Liechtenstein | 30.4.2012 |
| EU/1/11/701/029-032 | Levetiracetam Teva | Liechtenstein | 30.6.2012 |
| EU/1/11/703/003 | Xgeva | Liechtenstein | 29.2.2012 |
| EU/1/11/704/002 | Victrelis | Liechtenstein | 30.4.2012 |
| EU/1/11/720/002 | Incivo | Liechtenstein | 30.6.2012 |
| EU/1/97/044/009 | Tasmar | Liechtenstein | 30.4.2012 |
| EU/2/07/078/015-017 | Rheumocam | Norway | 13.2.2012 |
| EU/2/07/078/015-017 | Rheumocam | Iceland | 7.2.2012 |
| EU/2/07/078/015-017 | Rheumocam | Liechtenstein | 29.2.2012 |
| EU/2/08/085/002-006 | Easotic | Liechtenstein | 30.4.2012 |
| EU/2/08/090/027 | Loxicom | Liechtenstein | 30.6.2012 |
| EU/2/10/114/003 | Hiprabovis IBR Marker Live | Liechtenstein | 29.2.2012 |
| EU/2/97/004/049 | Metacam | Liechtenstein | 29.2.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/00/141/002

Myocet

Liechtenstein

30.4.2012

EU/1/02/222/05

Tamiflu

Iceland

6.2.2012

EU/1/03/262/009-010

Emend

Norway

5.1.2012

EU/1/03/262/009-010

Emend

Iceland

3.2.2012

EU/1/03/271/007-010

Advate

Norway

23.1.2012

EU/1/03/271/007-010

Advate

Iceland

17.1.2012

EU/1/05/318/003

Revatio

Norway

13.4.2012

EU/1/05/318/003

Revatio

Iceland

17.4.2012

EU/1/05/318/003

Revatio

Liechtenstein

30.4.2012

EU/1/06/339/003

Preotact

Liechtenstein

30.6.2012

EU/1/08/465/021

Clopidogrel Zentiva

Liechtenstein

30.6.2012

EU/1/08/468/002

INTELENCE

Iceland

3.1.2012

EU/1/08/470/018-019

Vimpat

Norway

14.3.2012

EU/1/08/470/018-019

Vimpat

Iceland

14.3.2012

EU/1/08/470/018-019

Vimpat

Liechtenstein

30.4.2012

EU/1/08/472/011-021

Xarelto

Norway

4.1.2012

EU/1/08/475/035-060

Olanzapin Mylan

Liechtenstein

29.2.2012

EU/1/09/536/003-004

Topotecan Actavis

Liechtenstein

30.4.2012

EU/1/09/551/013-027

Vizarsin

Iceland

7.6.2012

EU/1/09/551/013-027

Vizarsin

Liechtenstein

30.6.2012

EU/1/09/571/002

Pandemic influenza vaccine H5N1 Baxter

Liechtenstein

30.4.2012

EU/1/11/667/004

Esbriet

Liechtenstein

30.4.2012

EU/1/11/699/003-004

Fampyra

Liechtenstein

30.4.2012

EU/1/11/701/029-032

Levetiracetam Teva

Liechtenstein

30.6.2012

EU/1/11/703/003

Xgeva

Liechtenstein

29.2.2012

EU/1/11/704/002

Victrelis

Liechtenstein

30.4.2012

EU/1/11/720/002

Incivo

Liechtenstein

30.6.2012

EU/1/97/044/009

Tasmar

Liechtenstein

30.4.2012

EU/2/07/078/015-017

Rheumocam

Norway

13.2.2012

EU/2/07/078/015-017

Rheumocam

Iceland

7.2.2012

EU/2/07/078/015-017

Rheumocam

Liechtenstein

29.2.2012

EU/2/08/085/002-006

Easotic

Liechtenstein

30.4.2012

EU/2/08/090/027

Loxicom

Liechtenstein

30.6.2012

EU/2/10/114/003

Hiprabovis IBR Marker Live

Liechtenstein

29.2.2012

EU/2/97/004/049

Metacam

Liechtenstein

29.2.2012

---

ANNEX IV

List of withdrawn marketing authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January-30 June 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/02/255/001-002 | Xigris | Iceland | 25.6.2012 |
| EU/1/04/272/001-002 | PhotoBarr | Norway | 24.5.2012 |
| EU/1/04/272/001-002 | Photobarr | Iceland | 20.5.2012 |
| EU/1/04/272/001-002 | PhotoBarr | Liechtenstein | 30.6.2012 |
| EU/1/06/335/001 | Valtropin | Iceland | 5.6.2012 |
| EU/1/06/335/001 | Valtropin | Liechtenstein | 30.6.2012 |
| EU/1/06/351/001-003 | Livensa | Iceland | 11.4.2012 |
| EU/1/06/351/001-003 | Livensa | Liechtenstein | 30.4.2012 |
| EU/1/06/352/001-003 | Intrinsa | Liechtenstein | 30.6.2012 |
| EU/1/06/352/001-003 | Intrinsa | Iceland | 23.6.2012 |
| EU/1/09/534/001-007 | Clopidogrel Hexal | Iceland | 2.3.2012 |
| EU/1/09/534/001-007 | Clopidgrel Hexal | Liechtenstein | 29.2.2012 |
| EU/1/09/548/001-007 | Clopidogrel Acino Pharma GmbH | Iceland | 2.3.2012 |
| EU/1/09/548/001-007 | Clopidgrel Acino Pharma GmbH | Liechtenstein | 29.2.2012 |
| EU/1/09/549/001-007 | Clopidogrel Acino Pharma | Iceland | 2.3.2012 |
| EU/1/09/549/001-007 | Clopidogrel Acino Pharma | Liechtenstein | 29.2.2012 |
| EU/1/10/630/001-002 | Docefrez | Iceland | 20.6.2012 |
| EU/1/10/630/001-002 | Docefrez | Liechtenstein | 30.6.2012 |
| EU/1/97/035/003-004 | Refludan | Iceland | 24.5.2012 |
| EU/1/97/035/001-004 | Refludan | Norway | 6.6.2012 |
| EU/1/97/035/001-004 | Refludan | Liechtenstein | 30.6.2012 |
| EU/2/00/028/002-008 | Zubrin | Iceland | 17.4.2012 |
| EU/2/00/028/002-008 | Zubrin | Liechtenstein | 30.4.2012 |
| EU/2/03/040/001-002 | Gonazon | Norway | 2.4.2012 |
| EU/2/03/040/001-002 | Gonazon | Iceland | 17.4.2012 |
| EU/2/03/040/001-002 | Gonazon | Liechtenstein | 30.4.2012 |
| EU/2/06/060/001-002 | Poulvac FluFend H5N3 RG | Liechtenstein | 30.6.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/02/255/001-002

Xigris

Iceland

25.6.2012

EU/1/04/272/001-002

PhotoBarr

Norway

24.5.2012

EU/1/04/272/001-002

Photobarr

Iceland

20.5.2012

EU/1/04/272/001-002

PhotoBarr

Liechtenstein

30.6.2012

EU/1/06/335/001

Valtropin

Iceland

5.6.2012

EU/1/06/335/001

Valtropin

Liechtenstein

30.6.2012

EU/1/06/351/001-003

Livensa

Iceland

11.4.2012

EU/1/06/351/001-003

Livensa

Liechtenstein

30.4.2012

EU/1/06/352/001-003

Intrinsa

Liechtenstein

30.6.2012

EU/1/06/352/001-003

Intrinsa

Iceland

23.6.2012

EU/1/09/534/001-007

Clopidogrel Hexal

Iceland

2.3.2012

EU/1/09/534/001-007

Clopidgrel Hexal

Liechtenstein

29.2.2012

EU/1/09/548/001-007

Clopidogrel Acino Pharma GmbH

Iceland

2.3.2012

EU/1/09/548/001-007

Clopidgrel Acino Pharma GmbH

Liechtenstein

29.2.2012

EU/1/09/549/001-007

Clopidogrel Acino Pharma

Iceland

2.3.2012

EU/1/09/549/001-007

Clopidogrel Acino Pharma

Liechtenstein

29.2.2012

EU/1/10/630/001-002

Docefrez

Iceland

20.6.2012

EU/1/10/630/001-002

Docefrez

Liechtenstein

30.6.2012

EU/1/97/035/003-004

Refludan

Iceland

24.5.2012

EU/1/97/035/001-004

Refludan

Norway

6.6.2012

EU/1/97/035/001-004

Refludan

Liechtenstein

30.6.2012

EU/2/00/028/002-008

Zubrin

Iceland

17.4.2012

EU/2/00/028/002-008

Zubrin

Liechtenstein

30.4.2012

EU/2/03/040/001-002

Gonazon

Norway

2.4.2012

EU/2/03/040/001-002

Gonazon

Iceland

17.4.2012

EU/2/03/040/001-002

Gonazon

Liechtenstein

30.4.2012

EU/2/06/060/001-002

Poulvac FluFend H5N3 RG

Liechtenstein

30.6.2012

---

ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 January-30 June 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/06/361/001-002 | Luminity | Iceland | 20.6.2012 |
| EU/1/06/361/001-002 | Luminity | Liechtenstein | 30.6.2012 |
| EU/1/97/037/001 | Vistide | Liechtenstein | 29.2.2012 |
| EU/1/11/705/001 | Vibativ | Iceland | 27.6.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/06/361/001-002

Luminity

Iceland

20.6.2012

EU/1/06/361/001-002

Luminity

Liechtenstein

30.6.2012

EU/1/97/037/001

Vistide

Liechtenstein

29.2.2012

EU/1/11/705/001

Vibativ

Iceland

27.6.2012

---

| 9.10.2014 | EN | Official Journal of the European Union | C 356/37 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/37

---

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2012

2014/C 356/08

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 2012, at their meeting on 8 November 2013:

| 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

---

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 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/11/685/001-005 | Ibandronic acid Sandoz | Norway | 31.7.2012 |
| EU/1/11/719/001-062 | Telmisartan Teva Pharma | Liechtenstein | 31.12.2012 |
| EU/1/11/744/001-002 | Topotecan Eagle | Norway | 30.8.2012 |
| EU/1/11/747/001 | Colobreathe | Norway | 11.7.2012 |
| EU/1/11/748/001-006 | Docetaxel Mylan | Norway | 17.12.2012 |
| EU/1/12/762/001-018 | Capecitabine Accord | Norway | 13.8.2012 |
| EU/1/12/768/001 | Riluzole Zentiva | Norway | 16.8.2012 |
| EU/1/12/769/001-003 | Docetaxel Accord | Norway | 13.8.2012 |
| EU/1/12/771/001-006 | Zoledronic Acid Teva | Iceland | 10.9.2012 |
| EU/1/12/771/001-006 | Zoledronic acid Teva | Norway | 12.10.2012 |
| EU/1/12/772/001-004 | Zoledronic acid Teva Pharma | Iceland | 10.9.2012 |
| EU/1/12/772/001-004 | Zoledronic acid Teva Pharma | Norway | 10.10.2012 |
| EU/1/12/773/001-003 | Jakavi | Liechtenstein | 31.8.2012 |
| EU/1/12/773/001-003 | Jakavi | Norway | 5.9.2012 |
| EU/1/12/773/001-003 | Jakavi | Iceland | 19.9.2012 |
| EU/1/12/774/001-002 | Rienso | Norway | 14.8.2012 |
| EU/1/12/774/001-002 | Rienso | Iceland | 20.7.2012 |
| EU/1/12/774/001-002 | Rienso | Liechtenstein | 31.12.2012 |
| EU/1/12/775/001 | NovoThirteen | Iceland | 17.9.2012 |
| EU/1/12/775/001 | Novo Thirteen | Norway | 19.9.2012 |
| EU/1/12/775/001 | Novo Thirteen | Liechtenstein | 31.10.2012 |
| EU/1/12/776/001-016 | Fycompa | Norway | 27.8.2012 |
| EU/1/12/776/001-016 | Fycompa | Liechtenstein | 31.8.2012 |
| EU/1/12/776/001-016 | Fycompa | Iceland | 11.9.2012 |
| EU/1/12/777/001-006 | Inlyta | Iceland | 14.9.2012 |
| EU/1/12/777/001-006 | Inlyta | Norway | 21.9.2012 |
| EU/1/12/777/001-006 | Inlyta | Liechtenstein | 31.10.2012 |
| EU/1/12/778/001-003 | Eklira Genuair | Iceland | 13.8.2012 |
| EU/1/12/778/001-003 | Eklira Genuair | Norway | 15.8.2012 |
| EU/1/12/778/001-003 | Eklira Genuair | Liechtenstein | 31.8.2012 |
| EU/1/12/779/001-006 | Zoledronic acid medac | Norway | 15.8.2012 |
| EU/1/12/779/001-006 | Zoledronic acid medac | Iceland | 27.8.2012 |
| EU/1/12/779/001-006 | Zoledronic acid medac | Liechtenstein | 31.8.2012 |
| EU/1/12/780/001-028 | Jentadueto | Norway | 31.7.2012 |
| EU/1/12/780/001-028 | Jentadueto | Liechtenstein | 31.8.2012 |
| EU/1/12/780/001-028 | Jentadueto | Iceland | 17.8.2012 |
| EU/1/12/781/001-003 | Bretaris Genuair | Iceland | 13.8.2012 |
| EU/1/12/781/001-003 | Bretaris Genuair | Norway | 15.8.2012 |
| EU/1/12/781/001-003 | Bretaris Genuair | Liechtenstein | 31.8.2012 |
| EU/1/12/782/001-002 | Kalydeco | Norway | 6.8.2012 |
| EU/1/12/782/001-002 | Kalydeco | Iceland | 21.8.2012 |
| EU/1/12/782/001-002 | Kalydeco | Liechtenstein | 31.8.2012 |
| EU/1/12/783/001-003 | Zyclara | Liechtenstein | 31.8.2012 |
| EU/1/12/783/001-003 | Zyclara | Iceland | 12.9.2012 |
| EU/1/12/783/001-003 | Zyclara | Norway | 10.10.2012 |
| EU/1/12/784/001 | Cuprymina | Iceland | 7.9.2012 |
| EU/1/12/784/001 | Cuprymina | Norway | 25.9.2012 |
| EU/1/12/784/001 | Cuprymina | Liechtenstein | 31.10.2012 |
| EU/1/12/785/001 | Zinforo | Liechtenstein | 31.8.2012 |
| EU/1/12/785/001 | Zinforo | Iceland | 6.9.2012 |
| EU/1/12/785/001 | Zinforo | Norway | 17.9.2012 |
| EU/1/12/786/001-003 | Zoledronic acid Mylan | Liechtenstein | 31.8.2012 |
| EU/1/12/786/001-003 | Zoledronic acid Mylan | Iceland | 4.9.2012 |
| EU/1/12/786/001-003 | Zoledronic acid Mylan | Norway | 12.10.2012 |
| EU/1/12/787/001 | Revestive | Iceland | 14.9.2012 |
| EU/1/12/787/001 | Revestive | Norway | 26.9.2012 |
| EU/1/12/787/001 | Revestive | Liechtenstein | 31.10.2012 |
| EU/1/12/788/001-006 | Seebri Breezhaler | Iceland | 16.10.2012 |
| EU/1/12/788/001-006 | Seebri Breezhaler | Norway | 17.10.2012 |
| EU/1/12/789/001-006 | Enurev Breezhaler | Iceland | 17.10.2012 |
| EU/1/12/789/001-006 | Enurev Breezhaler | Norway | 29.10.2012 |
| EU/1/12/790/001-006 | Tovanor Breezhaler | Iceland | 17.10.2012 |
| EU/1/12/790/001-006 | Tovanor Breezhaler | Norway | 29.10.2012 |
| EU/1/12/791/001 | Glybera | Iceland | 15.11.2012 |
| EU/1/12/791/001 | Glybera | Norway | 6.12.2012 |
| EU/1/12/792/001 | Dacogen | Iceland | 15.10.2012 |
| EU/1/12/792/001 | Dacogen | Norway | 17.10.2012 |
| EU/1/12/792/001 | Dacogen | Liechtenstein | 31.10.2012 |
| EU/1/12/793/001-004 | Xalkori | Iceland | 8.11.2012 |
| EU/1/12/793/001-004 | Xalkori | Norway | 14.11.2012 |
| EU/1/12/793/001-004 | Xalkori | Liechtenstein | 31.12.2012 |
| EU/1/12/794/001 | Adcetris | Norway | 10.12.2012 |
| EU/1/12/794/001 | Adectris | Liechtenstein | 31.12.2012 |
| EU/1/12/795/001-010 | Forxiga | Norway | 6.12.2012 |
| EU/1/12/795/001-010 | Forxiga | Iceland | 7.12.2012 |
| EU/1/12/796/001-002 | Picato | Norway | 27.11.2012 |
| EU/1/12/796/001-002 | Picato | Iceland | 7.12.2012 |
| EU/1/12/796/001-002 | Picato | Liechtenstein | 31.12.2012 |
| EU/1/12/797/001-002 | Eylea | Norway | 6.12.2012 |
| EU/1/12/797/001-002 | Eylea | Iceland | 13.12.2012 |
| EU/1/12/798/001-004 | Ibandronic acid Accord | Norway | 12.12.2012 |
| EU/1/12/798/001-004 | Ibandronic acid Accord | Iceland | 10.12.2012 |
| EU/1/12/798/001-004 | Ibandronic acid Accord | Liechtenstein | 31.12.2012 |
| EU/1/12/799/001-029 | Memantine Merz | Iceland | 12.12.2012 |
| EU/1/12/799/001-029 | Memantine Merz | Liechtenstein | 31.12.2012 |
| EU/1/12/800/001-004 | Zoledronic Acid Hospira | Iceland | 7.12.2012 |
| EU/1/12/800/001-004 | Zoledronic acid Hospira | Norway | 17.12.2012 |
| EU/1/12/800/001-004 | Zoledronic acid Hospira | Liechtenstein | 31.12.2012 |
| EU/1/12/801/001-004 | Constella | Iceland | 13.12.2012 |
| EU/1/12/801/001-004 | Constella | Liechtenstein | 31.12.2012 |
| EU/1/12/801/001-004 | Constella | Norway | 17.12.2012 |
| EU/1/12/802/001-042 | Capecitabine medac | Norway | 13.12.2012 |
| EU/1/12/802/001-042 | Capecitabine medac | Iceland | 18.12.2012 |
| EU/1/12/802/001-042 | Capecitabine medac | Liechtenstein | 31.12.2012 |
| EU/2/09/099/001-006 | Suvaxyn PCV | Iceland | 8.11.2012 |
| EU/2/11/122/001-003 | Bluevac BTV8 | Norway | 18.7.2012 |
| EU/2/12/138/001-003 | RevitaCAM | Norway | 19.9.2012 |
| EU/2/12/140/001-008 | Poulvac E. Coli | Iceland | 23.7.2012 |
| EU/2/12/141/001-009 | Porcilis ColiClos | Iceland | 5.7.2012 |
| EU/2/12/141/001-009 | Porcilis ColiClos | Norway | 31.7.2012 |
| EU/2/12/141/001-009 | Porcilis ColiClos | Liechtenstein | 31.8.2012 |
| EU/2/12/142/001-006 | Cardalis 2,5/20 mg | Iceland | 20.8.2012 |
| EU/2/12/143/001-005 | Nobivac L4 | Iceland | 20.8.2012 |
| EU/2/12/143/001-005 | Nobivac L4 | Norway | 28.8.2012 |
| EU/2/12/143/001-005 | Nobivac L4 | Liechtenstein | 31.8.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/11/685/001-005

Ibandronic acid Sandoz

Norway

31.7.2012

EU/1/11/719/001-062

Telmisartan Teva Pharma

Liechtenstein

31.12.2012

EU/1/11/744/001-002

Topotecan Eagle

Norway

30.8.2012

EU/1/11/747/001

Colobreathe

Norway

11.7.2012

EU/1/11/748/001-006

Docetaxel Mylan

Norway

17.12.2012

EU/1/12/762/001-018

Capecitabine Accord

Norway

13.8.2012

EU/1/12/768/001

Riluzole Zentiva

Norway

16.8.2012

EU/1/12/769/001-003

Docetaxel Accord

Norway

13.8.2012

EU/1/12/771/001-006

Zoledronic Acid Teva

Iceland

10.9.2012

EU/1/12/771/001-006

Zoledronic acid Teva

Norway

12.10.2012

EU/1/12/772/001-004

Zoledronic acid Teva Pharma

Iceland

10.9.2012

EU/1/12/772/001-004

Zoledronic acid Teva Pharma

Norway

10.10.2012

EU/1/12/773/001-003

Jakavi

Liechtenstein

31.8.2012

EU/1/12/773/001-003

Jakavi

Norway

5.9.2012

EU/1/12/773/001-003

Jakavi

Iceland

19.9.2012

EU/1/12/774/001-002

Rienso

Norway

14.8.2012

EU/1/12/774/001-002

Rienso

Iceland

20.7.2012

EU/1/12/774/001-002

Rienso

Liechtenstein

31.12.2012

EU/1/12/775/001

NovoThirteen

Iceland

17.9.2012

EU/1/12/775/001

Novo Thirteen

Norway

19.9.2012

EU/1/12/775/001

Novo Thirteen

Liechtenstein

31.10.2012

EU/1/12/776/001-016

Fycompa

Norway

27.8.2012

EU/1/12/776/001-016

Fycompa

Liechtenstein

31.8.2012

EU/1/12/776/001-016

Fycompa

Iceland

11.9.2012

EU/1/12/777/001-006

Inlyta

Iceland

14.9.2012

EU/1/12/777/001-006

Inlyta

Norway

21.9.2012

EU/1/12/777/001-006

Inlyta

Liechtenstein

31.10.2012

EU/1/12/778/001-003

Eklira Genuair

Iceland

13.8.2012

EU/1/12/778/001-003

Eklira Genuair

Norway

15.8.2012

EU/1/12/778/001-003

Eklira Genuair

Liechtenstein

31.8.2012

EU/1/12/779/001-006

Zoledronic acid medac

Norway

15.8.2012

EU/1/12/779/001-006

Zoledronic acid medac

Iceland

27.8.2012

EU/1/12/779/001-006

Zoledronic acid medac

Liechtenstein

31.8.2012

EU/1/12/780/001-028

Jentadueto

Norway

31.7.2012

EU/1/12/780/001-028

Jentadueto

Liechtenstein

31.8.2012

EU/1/12/780/001-028

Jentadueto

Iceland

17.8.2012

EU/1/12/781/001-003

Bretaris Genuair

Iceland

13.8.2012

EU/1/12/781/001-003

Bretaris Genuair

Norway

15.8.2012

EU/1/12/781/001-003

Bretaris Genuair

Liechtenstein

31.8.2012

EU/1/12/782/001-002

Kalydeco

Norway

6.8.2012

EU/1/12/782/001-002

Kalydeco

Iceland

21.8.2012

EU/1/12/782/001-002

Kalydeco

Liechtenstein

31.8.2012

EU/1/12/783/001-003

Zyclara

Liechtenstein

31.8.2012

EU/1/12/783/001-003

Zyclara

Iceland

12.9.2012

EU/1/12/783/001-003

Zyclara

Norway

10.10.2012

EU/1/12/784/001

Cuprymina

Iceland

7.9.2012

EU/1/12/784/001

Cuprymina

Norway

25.9.2012

EU/1/12/784/001

Cuprymina

Liechtenstein

31.10.2012

EU/1/12/785/001

Zinforo

Liechtenstein

31.8.2012

EU/1/12/785/001

Zinforo

Iceland

6.9.2012

EU/1/12/785/001

Zinforo

Norway

17.9.2012

EU/1/12/786/001-003

Zoledronic acid Mylan

Liechtenstein

31.8.2012

EU/1/12/786/001-003

Zoledronic acid Mylan

Iceland

4.9.2012

EU/1/12/786/001-003

Zoledronic acid Mylan

Norway

12.10.2012

EU/1/12/787/001

Revestive

Iceland

14.9.2012

EU/1/12/787/001

Revestive

Norway

26.9.2012

EU/1/12/787/001

Revestive

Liechtenstein

31.10.2012

EU/1/12/788/001-006

Seebri Breezhaler

Iceland

16.10.2012

EU/1/12/788/001-006

Seebri Breezhaler

Norway

17.10.2012

EU/1/12/789/001-006

Enurev Breezhaler

Iceland

17.10.2012

EU/1/12/789/001-006

Enurev Breezhaler

Norway

29.10.2012

EU/1/12/790/001-006

Tovanor Breezhaler

Iceland

17.10.2012

EU/1/12/790/001-006

Tovanor Breezhaler

Norway

29.10.2012

EU/1/12/791/001

Glybera

Iceland

15.11.2012

EU/1/12/791/001

Glybera

Norway

6.12.2012

EU/1/12/792/001

Dacogen

Iceland

15.10.2012

EU/1/12/792/001

Dacogen

Norway

17.10.2012

EU/1/12/792/001

Dacogen

Liechtenstein

31.10.2012

EU/1/12/793/001-004

Xalkori

Iceland

8.11.2012

EU/1/12/793/001-004

Xalkori

Norway

14.11.2012

EU/1/12/793/001-004

Xalkori

Liechtenstein

31.12.2012

EU/1/12/794/001

Adcetris

Norway

10.12.2012

EU/1/12/794/001

Adectris

Liechtenstein

31.12.2012

EU/1/12/795/001-010

Forxiga

Norway

6.12.2012

EU/1/12/795/001-010

Forxiga

Iceland

7.12.2012

EU/1/12/796/001-002

Picato

Norway

27.11.2012

EU/1/12/796/001-002

Picato

Iceland

7.12.2012

EU/1/12/796/001-002

Picato

Liechtenstein

31.12.2012

EU/1/12/797/001-002

Eylea

Norway

6.12.2012

EU/1/12/797/001-002

Eylea

Iceland

13.12.2012

EU/1/12/798/001-004

Ibandronic acid Accord

Norway

12.12.2012

EU/1/12/798/001-004

Ibandronic acid Accord

Iceland

10.12.2012

EU/1/12/798/001-004

Ibandronic acid Accord

Liechtenstein

31.12.2012

EU/1/12/799/001-029

Memantine Merz

Iceland

12.12.2012

EU/1/12/799/001-029

Memantine Merz

Liechtenstein

31.12.2012

EU/1/12/800/001-004

Zoledronic Acid Hospira

Iceland

7.12.2012

EU/1/12/800/001-004

Zoledronic acid Hospira

Norway

17.12.2012

EU/1/12/800/001-004

Zoledronic acid Hospira

Liechtenstein

31.12.2012

EU/1/12/801/001-004

Constella

Iceland

13.12.2012

EU/1/12/801/001-004

Constella

Liechtenstein

31.12.2012

EU/1/12/801/001-004

Constella

Norway

17.12.2012

EU/1/12/802/001-042

Capecitabine medac

Norway

13.12.2012

EU/1/12/802/001-042

Capecitabine medac

Iceland

18.12.2012

EU/1/12/802/001-042

Capecitabine medac

Liechtenstein

31.12.2012

EU/2/09/099/001-006

Suvaxyn PCV

Iceland

8.11.2012

EU/2/11/122/001-003

Bluevac BTV8

Norway

18.7.2012

EU/2/12/138/001-003

RevitaCAM

Norway

19.9.2012

EU/2/12/140/001-008

Poulvac E. Coli

Iceland

23.7.2012

EU/2/12/141/001-009

Porcilis ColiClos

Iceland

5.7.2012

EU/2/12/141/001-009

Porcilis ColiClos

Norway

31.7.2012

EU/2/12/141/001-009

Porcilis ColiClos

Liechtenstein

31.8.2012

EU/2/12/142/001-006

Cardalis 2,5/20 mg

Iceland

20.8.2012

EU/2/12/143/001-005

Nobivac L4

Iceland

20.8.2012

EU/2/12/143/001-005

Nobivac L4

Norway

28.8.2012

EU/2/12/143/001-005

Nobivac L4

Liechtenstein

31.8.2012

---

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 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/187/001 | DepoCyte | Norway | 13.8.2012 |
| EU/1/01/197/001-005 | Foscan | Norway | 7.9.2012 |
| EU/1/02/222/001-005 | Tamiflu | Norway | 21.8.2012 |
| EU/1/02/223/001-003 | Evra | Iceland | 5.7.2012 |
| EU/1/02/223/001-003 | Evra | Norway | 27.8.2012 |
| EU/1/02/223/001-003 | Evra | Liechtenstein | 31.8.2012 |
| EU/1/02/224/001-005 | Ambirix | Iceland | 21.8.2012 |
| EU/1/02/224/001-005 | Ambirix | Norway | 27.8.2012 |
| EU/1/02/224/001-005 | Ambirix | Liechtenstein | 31.8.2012 |
| EU/1/02/226/001 | InductOs | Norway | 2.8.2012 |
| EU/1/02/226/001 | InductOs | Iceland | 14.8.2012 |
| EU/1/02/237/001-009 | Cialis | Norway | 11.10.2012 |
| EU/1/02/237/001-009 | Cialis | Iceland | 17.10.2012 |
| EU/1/02/237/001-009 | Cialis | Liechtenstein | 31.10.2012 |
| EU/1/02/238/001 | Zavesca | Iceland | 22.10.2012 |
| EU/1/02/238/001 | Zavesca | Norway | 29.10.2012 |
| EU/1/02/238/001 | Zavesca | Liechtenstein | 31.10.2012 |
| EU/1/05/314/001 | Kepivance | Norway | 11.9.2012 |
| EU/1/06/339/001-002 | Preotact | Norway | 28.8.2012 |
| EU/1/06/367/001-012 | Diacomit | Norway | 12.12.2012 |
| EU/1/06/367/001-012 | Diacomit | Iceland | 13.12.2012 |
| EU/1/06/367/001-012 | Diacomit | Liechtenstein | 31.12.2012 |
| EU/1/06/371/001-039 | Dafiro | Norway | 26.9.2012 |
| EU/1/06/376/001-039 | Irbesartan Zentiva | Iceland | 28.9.2012 |
| EU/1/07/393/001 | Soliris | Iceland | 5.7.2012 |
| EU/1/07/393/001 | Soliris | Norway | 13.8.2012 |
| EU/1/07/394/001-009 | Optaflu | Iceland | 8.11.2012 |
| EU/1/07/395/001-095 | Invega | Iceland | 31.8.2012 |
| EU/1/07/395/001-095 | Invega | Norway | 11.9.2012 |
| EU/1/07/397/001-004 | Siklos | Iceland | 23.7.2012 |
| EU/1/07/397/001-004 | Siklos | Norway | 9.8.2012 |
| EU/1/07/398/001-014 | Optimark | Iceland | 5.7.2012 |
| EU/1/07/398/001-014 | Optimark | Liechtenstein | 31.8.2012 |
| EU/1/07/401/007-016 | alli | Iceland | 20.7.2012 |
| EU/1/07/401/007-016 | alli | Liechtenstein | 31.8.2012 |
| EU/1/07/402/001 | Increlex | Iceland | 29.8.2012 |
| EU/1/07/402/001 | Increlex | Liechtenstein | 31.8.2012 |
| EU/1/07/402/001 | Increlex | Norway | 3.9.2012 |
| EU/1/07/403/001 | Atriance | Iceland | 20.7.2012 |
| EU/1/07/403/001 | Atriance | Norway | 7.8.2012 |
| EU/1/07/403/001 | Atriance | Liechtenstein | 31.8.2012 |
| EU/1/07/404/001-008 | Flebogamma DIF | Iceland | 11.9.2012 |
| EU/1/07/404/001-008 | Flebogamma DIF | Norway | 12.10.2012 |
| EU/1/07/405/001-040 | Rasilez | Liechtenstein | 31.8.2012 |
| EU/1/07/405/001-040 | Rasilez | Iceland | 19.9.2012 |
| EU/1/07/405/001-040 | Rasilez | Norway | 10.10.2012 |
| EU/1/07/409/001-040 | Riprazo | Iceland | 12.9.2012 |
| EU/1/07/409/001-040 | Riprazo | Norway | 10.10.2012 |
| EU/1/07/409/001-040 | Riprazo | Liechtenstein | 31.8.2012 |
| EU/1/07/410/001-052 | Binocrit | Norway | 27.8.2012 |
| EU/1/07/410/001-052 | Binocrit | Iceland | 20.7.2012 |
| EU/1/07/410/001-052 | Binocrit | Liechtenstein | 31.8.2012 |
| EU/1/07/411/001-052 | Epoetin alfa Hexal | Iceland | 19.7.2012 |
| EU/1/07/411/001-052 | Epoetin alfa Hexal | Norway | 27.8.2012 |
| EU/1/07/411/001-052 | Epoetin alfa Hexal | Liechtenstein | 31.8.2012 |
| EU/1/07/412/001-052 | Abseamed | Iceland | 20.7.2012 |
| EU/1/07/412/001-052 | Abseamed | Norway | 27.8.2012 |
| EU/1/07/413/001-003 | Gliolan | Iceland | 7.9.2012 |
| EU/1/07/413/001-003 | Gliolan | Norway | 15.10.2012 |
| EU/1/07/413/001-003 | Gliolan | Liechtenstein | 31.10.2012 |
| EU/1/07/414/001-010, 018 | Galvus | Iceland | 17.8.2012 |
| EU/1/07/414/001-010, 018 | Galvus | Norway | 31.7.2012 |
| EU/1/07/415/001-056 | Zalasta | Norway | 24.8.2012 |
| EU/1/07/415/001-056 | Zalasta | Iceland | 25.8.2012 |
| EU/1/07/415/001-056 | Zalasta | Liechtenstein | 31.8.2012 |
| EU/1/07/416/002 | Ecalta | Iceland | 3.9.2012 |
| EU/1/07/416/002 | Ecalta | Liechtenstein | 31.8.2012 |
| EU/1/07/416/002 | Ecalta | Norway | 26.9.2012 |
| EU/1/07/417/001-002 | Yondelis | Iceland | 28.8.2012 |
| EU/1/07/417/001-002 | Yondelis | Liechtenstein | 31.8.2012 |
| EU/1/07/417/001-002 | Yondelis | Norway | 17.9.2012 |
| EU/1/07/418/001-010 | Celsentri | Liechtenstein | 31.8.2012 |
| EU/1/07/418/001-010 | Celsentri | Iceland | 12.9.2012 |
| EU/1/07/418/001-010 | Celsentri | Norway | 18.9.2012 |
| EU/1/07/419/001-012 | Cervarix | Iceland | 12.10.2012 |
| EU/1/07/419/001-012 | Cervarix | Norway | 12.10.2012 |
| EU/1/07/419/001-012 | Cervarix | Liechtenstein | 31.10.2012 |
| EU/1/07/420/001-002 | Cyanokit | Iceland | 14.8.2012 |
| EU/1/07/420/001-002 | Cyanokit | Norway | 17.8.2012 |
| EU/1/07/420/001-002 | Cyanokit | Liechtenstein | 31.8.2012 |
| EU/1/07/421/001-009 | Glubrava | Iceland | 12.10.2012 |
| EU/1/07/421/001-009 | Glubrava | Norway | 12.10.2012 |
| EU/1/07/421/001-009 | Glubrava | Liechtenstein | 31.10.2012 |
| EU/1/07/422/001-012 | Tasigna | Norway | 24.10.2012 |
| EU/1/07/422/001-012 | Tasigna | Liechtenstein | 31.10.2012 |
| EU/1/07/422/001-012 | Tasigna | Iceland | 6.12.2012 |
| EU/1/07/424/001 | Torisel | Iceland | 12.10.2012 |
| EU/1/07/424/001 | Torisel | Norway | 22.10.2012 |
| EU/1/07/424/001 | Torisel | Liechtenstein | 31.10.2012 |
| EU/1/07/425/001-018 | Eucreas | Norway | 31.7.2012 |
| EU/1/07/425/001-018 | Eucreas | Iceland | 21.8.2012 |
| EU/1/07/425/001-018 | Eucreas | Liechtenstein | 31.8.2012 |
| EU/1/07/426/001-011 | Olanzapine Neopharma | Iceland | 17.10.2012 |
| EU/1/07/426/001-011 | Olanzapine Neopharma | Norway | 24.10.2012 |
| EU/1/07/426/001-011 | Olanzapine Neopharma | Liechtenstein | 31.10.2012 |
| EU/1/07/427/001-057 | Olanzapine Teva | Norway | 6.12.2012 |
| EU/1/07/427/001-057 | Olanzapine Teva | Iceland | 7.12.2012 |
| EU/1/07/427/001-057 | Olanzapine Teva | Liechtenstein | 31.12.2012 |
| EU/1/07/430/001-002 | Atripla | Norway | 26.9.2012 |
| EU/1/07/430/001-002 | Atripla | Iceland | 12.10.2012 |
| EU/1/07/431/001-025 | Retacrit | Iceland | 7.12.2012 |
| EU/1/07/431/001-025 | Retacrit | Norway | 17.12.2012 |
| EU/1/07/431/001-025 | Retacrit | Liechtenstein | 31.12.2012 |
| EU/1/07/432/001-022 | Silapo | Iceland | 22.8.2012 |
| EU/1/07/432/001-022 | Silapo | Norway | 24.8.2012 |
| EU/1/07/432/001-022 | Silapo | Liechtenstein | 31.8.2012 |
| EU/1/07/433/001 | Nevanac | Norway | 15.10.2012 |
| EU/1/07/433/001 | Nevanac | Liechtenstein | 31.10.2012 |
| EU/1/07/435/001-018 | Tesavel | Iceland | 15.10.2012 |
| EU/1/07/435/001-018 | Tesavel | Norway | 15.10.2012 |
| EU/1/07/437/001-004 | IVEMEND | Iceland | 7.12.2012 |
| EU/1/07/437/003-004 | IVEMEND | Norway | 6.12.2012 |
| EU/1/07/437/003-004 | IVEMEND | Liechtenstein | 31.12.2012 |
| EU/1/07/438/001-006 | Myfenax | Iceland | 12.12.2012 |
| EU/1/07/438/006 | Myfenax | Norway | 13.12.2012 |
| EU/1/07/439/001-006 | Mycophenolate mofetil Teva | Iceland | 12.12.2012 |
| EU/1/07/439/001-006 | Mycophenolate mofetil Teva | Norway | 17.12.2012 |
| EU/1/08/468/001-002 | INTELENCE | Iceland | 16.8.2012 |
| EU/1/08/468/001-002 | INTELENCE | Norway | 27.8.2012 |
| EU/1/08/468/001-002 | INTELENCE | Liechtenstein | 31.8.2012 |
| EU/1/11/710/001-007 | Votubia | Norway | 16.8.2012 |
| EU/1/11/710/001-007 | Votubia | Iceland | 25.8.2012 |
| EU/1/11/710/001-007 | Votubia | Liechtenstein | 31.8.2012 |
| EU/1/97/047/004-007 | BeneFIX | Iceland | 16.8.2012 |
| EU/1/97/047/004-007 | BeneFIX | Norway | 24.8.2012 |
| EU/1/97/047/004-007 | BeneFIX | Liechtenstein | 31.8.2012 |
| EU/2/02/032/001-002 | Vaxxitek HVT + IBD | Iceland | 23.7.2012 |
| EU/2/02/032/001-002 | Vaxxitek HVT + IBD | Liechtenstein | 31.8.2012 |
| EU/2/02/034/001 | Nobivac Bb | Iceland | 18.9.2012 |
| EU/2/02/034/001 | Nobivac Bb | Norway | 23.10.2012 |
| EU/2/02/034/001 | Nobivac Bb | Liechtenstein | 31.10.2012 |
| EU/2/07/072/001-004 | Suprelorin | Norway | 31.7.2012 |
| EU/2/07/072/001-004 | Suprelorin | Liechtenstein | 31.8.2012 |
| EU/2/07/074/001-006 | Prilactone | Liechtenstein | 31.8.2012 |
| EU/2/07/077/001-005 | Meloxivet | Iceland | 6.12.2012 |
| EU/2/07/077/001-005 | Meloxivet | Liechtenstein | 31.10.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/01/187/001

DepoCyte

Norway

13.8.2012

EU/1/01/197/001-005

Foscan

Norway

7.9.2012

EU/1/02/222/001-005

Tamiflu

Norway

21.8.2012

EU/1/02/223/001-003

Evra

Iceland

5.7.2012

EU/1/02/223/001-003

Evra

Norway

27.8.2012

EU/1/02/223/001-003

Evra

Liechtenstein

31.8.2012

EU/1/02/224/001-005

Ambirix

Iceland

21.8.2012

EU/1/02/224/001-005

Ambirix

Norway

27.8.2012

EU/1/02/224/001-005

Ambirix

Liechtenstein

31.8.2012

EU/1/02/226/001

InductOs

Norway

2.8.2012

EU/1/02/226/001

InductOs

Iceland

14.8.2012

EU/1/02/237/001-009

Cialis

Norway

11.10.2012

EU/1/02/237/001-009

Cialis

Iceland

17.10.2012

EU/1/02/237/001-009

Cialis

Liechtenstein

31.10.2012

EU/1/02/238/001

Zavesca

Iceland

22.10.2012

EU/1/02/238/001

Zavesca

Norway

29.10.2012

EU/1/02/238/001

Zavesca

Liechtenstein

31.10.2012

EU/1/05/314/001

Kepivance

Norway

11.9.2012

EU/1/06/339/001-002

Preotact

Norway

28.8.2012

EU/1/06/367/001-012

Diacomit

Norway

12.12.2012

EU/1/06/367/001-012

Diacomit

Iceland

13.12.2012

EU/1/06/367/001-012

Diacomit

Liechtenstein

31.12.2012

EU/1/06/371/001-039

Dafiro

Norway

26.9.2012

EU/1/06/376/001-039

Irbesartan Zentiva

Iceland

28.9.2012

EU/1/07/393/001

Soliris

Iceland

5.7.2012

EU/1/07/393/001

Soliris

Norway

13.8.2012

EU/1/07/394/001-009

Optaflu

Iceland

8.11.2012

EU/1/07/395/001-095

Invega

Iceland

31.8.2012

EU/1/07/395/001-095

Invega

Norway

11.9.2012

EU/1/07/397/001-004

Siklos

Iceland

23.7.2012

EU/1/07/397/001-004

Siklos

Norway

9.8.2012

EU/1/07/398/001-014

Optimark

Iceland

5.7.2012

EU/1/07/398/001-014

Optimark

Liechtenstein

31.8.2012

EU/1/07/401/007-016

alli

Iceland

20.7.2012

EU/1/07/401/007-016

alli

Liechtenstein

31.8.2012

EU/1/07/402/001

Increlex

Iceland

29.8.2012

EU/1/07/402/001

Increlex

Liechtenstein

31.8.2012

EU/1/07/402/001

Increlex

Norway

3.9.2012

EU/1/07/403/001

Atriance

Iceland

20.7.2012

EU/1/07/403/001

Atriance

Norway

7.8.2012

EU/1/07/403/001

Atriance

Liechtenstein

31.8.2012

EU/1/07/404/001-008

Flebogamma DIF

Iceland

11.9.2012

EU/1/07/404/001-008

Flebogamma DIF

Norway

12.10.2012

EU/1/07/405/001-040

Rasilez

Liechtenstein

31.8.2012

EU/1/07/405/001-040

Rasilez

Iceland

19.9.2012

EU/1/07/405/001-040

Rasilez

Norway

10.10.2012

EU/1/07/409/001-040

Riprazo

Iceland

12.9.2012

EU/1/07/409/001-040

Riprazo

Norway

10.10.2012

EU/1/07/409/001-040

Riprazo

Liechtenstein

31.8.2012

EU/1/07/410/001-052

Binocrit

Norway

27.8.2012

EU/1/07/410/001-052

Binocrit

Iceland

20.7.2012

EU/1/07/410/001-052

Binocrit

Liechtenstein

31.8.2012

EU/1/07/411/001-052

Epoetin alfa Hexal

Iceland

19.7.2012

EU/1/07/411/001-052

Epoetin alfa Hexal

Norway

27.8.2012

EU/1/07/411/001-052

Epoetin alfa Hexal

Liechtenstein

31.8.2012

EU/1/07/412/001-052

Abseamed

Iceland

20.7.2012

EU/1/07/412/001-052

Abseamed

Norway

27.8.2012

EU/1/07/413/001-003

Gliolan

Iceland

7.9.2012

EU/1/07/413/001-003

Gliolan

Norway

15.10.2012

EU/1/07/413/001-003

Gliolan

Liechtenstein

31.10.2012

EU/1/07/414/001-010, 018

Galvus

Iceland

17.8.2012

EU/1/07/414/001-010, 018

Galvus

Norway

31.7.2012

EU/1/07/415/001-056

Zalasta

Norway

24.8.2012

EU/1/07/415/001-056

Zalasta

Iceland

25.8.2012

EU/1/07/415/001-056

Zalasta

Liechtenstein

31.8.2012

EU/1/07/416/002

Ecalta

Iceland

3.9.2012

EU/1/07/416/002

Ecalta

Liechtenstein

31.8.2012

EU/1/07/416/002

Ecalta

Norway

26.9.2012

EU/1/07/417/001-002

Yondelis

Iceland

28.8.2012

EU/1/07/417/001-002

Yondelis

Liechtenstein

31.8.2012

EU/1/07/417/001-002

Yondelis

Norway

17.9.2012

EU/1/07/418/001-010

Celsentri

Liechtenstein

31.8.2012

EU/1/07/418/001-010

Celsentri

Iceland

12.9.2012

EU/1/07/418/001-010

Celsentri

Norway

18.9.2012

EU/1/07/419/001-012

Cervarix

Iceland

12.10.2012

EU/1/07/419/001-012

Cervarix

Norway

12.10.2012

EU/1/07/419/001-012

Cervarix

Liechtenstein

31.10.2012

EU/1/07/420/001-002

Cyanokit

Iceland

14.8.2012

EU/1/07/420/001-002

Cyanokit

Norway

17.8.2012

EU/1/07/420/001-002

Cyanokit

Liechtenstein

31.8.2012

EU/1/07/421/001-009

Glubrava

Iceland

12.10.2012

EU/1/07/421/001-009

Glubrava

Norway

12.10.2012

EU/1/07/421/001-009

Glubrava

Liechtenstein

31.10.2012

EU/1/07/422/001-012

Tasigna

Norway

24.10.2012

EU/1/07/422/001-012

Tasigna

Liechtenstein

31.10.2012

EU/1/07/422/001-012

Tasigna

Iceland

6.12.2012

EU/1/07/424/001

Torisel

Iceland

12.10.2012

EU/1/07/424/001

Torisel

Norway

22.10.2012

EU/1/07/424/001

Torisel

Liechtenstein

31.10.2012

EU/1/07/425/001-018

Eucreas

Norway

31.7.2012

EU/1/07/425/001-018

Eucreas

Iceland

21.8.2012

EU/1/07/425/001-018

Eucreas

Liechtenstein

31.8.2012

EU/1/07/426/001-011

Olanzapine Neopharma

Iceland

17.10.2012

EU/1/07/426/001-011

Olanzapine Neopharma

Norway

24.10.2012

EU/1/07/426/001-011

Olanzapine Neopharma

Liechtenstein

31.10.2012

EU/1/07/427/001-057

Olanzapine Teva

Norway

6.12.2012

EU/1/07/427/001-057

Olanzapine Teva

Iceland

7.12.2012

EU/1/07/427/001-057

Olanzapine Teva

Liechtenstein

31.12.2012

EU/1/07/430/001-002

Atripla

Norway

26.9.2012

EU/1/07/430/001-002

Atripla

Iceland

12.10.2012

EU/1/07/431/001-025

Retacrit

Iceland

7.12.2012

EU/1/07/431/001-025

Retacrit

Norway

17.12.2012

EU/1/07/431/001-025

Retacrit

Liechtenstein

31.12.2012

EU/1/07/432/001-022

Silapo

Iceland

22.8.2012

EU/1/07/432/001-022

Silapo

Norway

24.8.2012

EU/1/07/432/001-022

Silapo

Liechtenstein

31.8.2012

EU/1/07/433/001

Nevanac

Norway

15.10.2012

EU/1/07/433/001

Nevanac

Liechtenstein

31.10.2012

EU/1/07/435/001-018

Tesavel

Iceland

15.10.2012

EU/1/07/435/001-018

Tesavel

Norway

15.10.2012

EU/1/07/437/001-004

IVEMEND

Iceland

7.12.2012

EU/1/07/437/003-004

IVEMEND

Norway

6.12.2012

EU/1/07/437/003-004

IVEMEND

Liechtenstein

31.12.2012

EU/1/07/438/001-006

Myfenax

Iceland

12.12.2012

EU/1/07/438/006

Myfenax

Norway

13.12.2012

EU/1/07/439/001-006

Mycophenolate mofetil Teva

Iceland

12.12.2012

EU/1/07/439/001-006

Mycophenolate mofetil Teva

Norway

17.12.2012

EU/1/08/468/001-002

INTELENCE

Iceland

16.8.2012

EU/1/08/468/001-002

INTELENCE

Norway

27.8.2012

EU/1/08/468/001-002

INTELENCE

Liechtenstein

31.8.2012

EU/1/11/710/001-007

Votubia

Norway

16.8.2012

EU/1/11/710/001-007

Votubia

Iceland

25.8.2012

EU/1/11/710/001-007

Votubia

Liechtenstein

31.8.2012

EU/1/97/047/004-007

BeneFIX

Iceland

16.8.2012

EU/1/97/047/004-007

BeneFIX

Norway

24.8.2012

EU/1/97/047/004-007

BeneFIX

Liechtenstein

31.8.2012

EU/2/02/032/001-002

Vaxxitek HVT + IBD

Iceland

23.7.2012

EU/2/02/032/001-002

Vaxxitek HVT + IBD

Liechtenstein

31.8.2012

EU/2/02/034/001

Nobivac Bb

Iceland

18.9.2012

EU/2/02/034/001

Nobivac Bb

Norway

23.10.2012

EU/2/02/034/001

Nobivac Bb

Liechtenstein

31.10.2012

EU/2/07/072/001-004

Suprelorin

Norway

31.7.2012

EU/2/07/072/001-004

Suprelorin

Liechtenstein

31.8.2012

EU/2/07/074/001-006

Prilactone

Liechtenstein

31.8.2012

EU/2/07/077/001-005

Meloxivet

Iceland

6.12.2012

EU/2/07/077/001-005

Meloxivet

Liechtenstein

31.10.2012

---

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 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/200/003-009 | Viread | Iceland | 18.12.2012 |
| EU/1/04/274/001-002 | Velcade | Norway | 18.10.2012 |
| EU/1/04/306/002-003 | Aloxi | Norway | 19.11.2012 |
| EU/1/06/368/169-174 | Insulin Human Winthrop | Liechtenstein | 31.8.2012 |
| EU/1/06/376/034, 036-039 | Irbesartan Zentiva | Liechtenstein | 31.10.2012 |
| EU/1/06/376/034, 036-039 | Irbesartan Zentiva | Norway | 30.8.2012 |
| EU/1/06/377/029-034 | Irbesartan HCT Zentiva | Liechtenstein | 31.8.2012 |
| EU/1/06/377/029-034 | Irbesartan HCT Zentiva | Norway | 12.11.2012 |
| EU/1/06/380/006 | Prezista | Iceland | 14.11.2012 |
| EU/1/06/380/006 | Prezista | Norway | 24.10.2012 |
| EU/1/07/389/004-009 | Orencia | Liechtenstein | 31.10.2012 |
| EU/1/07/389/004-009 | Orencia | Norway | 13.11.2012 |
| EU/1/07/389/004-009 | Orencia | Iceland | 19.10.2012 |
| EU/1/07/391/005-006 | Revlimid | Norway | 25.9.2012 |
| EU/1/07/391/005-006 | Revlimid | Iceland | 11.10.2012 |
| EU/1/07/440/007 | Tyverb | Liechtenstein | 31.8.2012 |
| EU/1/07/440/007 | Tyverb | Norway | 31.7.2012 |
| EU/1/09/514/021-023 | Zebinix | Liechtenstein | 31.8.2012 |
| EU/1/09/514/021-023 | Zebinix | Iceland | 3.9.2012 |
| EU/1/09/514/021-023 | Zebinix | Norway | 25.9.2012 |
| EU/1/10/616/025-036 | Temozolomide HEXAL | Liechtenstein | 31.8.2012 |
| EU/1/10/617/025-036 | Temozolomide Sandoz | Liechtenstein | 31.8.2012 |
| EU/1/11/691/006-013 | Eliquis | Iceland | 11.12.2012 |
| EU/1/11/691/006-013 | Eliquis | Norway | 19.12.2012 |
| EU/1/11/712/029-040 | Levetiracetam Accord | Liechtenstein | 31.10.2012 |
| EU/1/11/731/013-014 | Komboglyze | Liechtenstein | 31.10.2012 |
| EU/1/11/731/013-014 | Komboglyze | Norway | 24.9.2012 |
| EU/1/11/734/012-018 | Edarbi | Liechtenstein | 31.8.2012 |
| EU/1/11/735/012-018 | Ipreziv | Liechtenstein | 31.8.2012 |
| EU/1/12/752/002 | Vepacel | Liechtenstein | 31.10.2012 |
| EU/1/12/765/007-009 | Sabervel | Liechtenstein | 31.12.2012 |
| EU/1/97/030/196-201 | Insuman | Liechtenstein | 31.8.2012 |
| EU/1/97/047/008 | BeneFIX | Liechtenstein | 31.8.2012 |
| EU/1/97/047/008 | BeneFIX | Iceland | 4.9.2012 |
| EU/1/97/047/008 | BeneFIX | Norway | 10.10.2012 |
| EU/2/02/033/003-004 | Dexdomitor | Iceland | 13.9.2012 |
| EU/2/02/033/003-004 | Dexdomitor | Norway | 30.8.2012 |
| EU/2/02/033/003-004 | Dexdomitor | Liechtenstein | 31.10.2012 |
| EU/2/07/074/007-009 | Prilactone | Liechtenstein | 31.12.2012 |
| EU/2/07/078/018-020 | Rheumocam | Norway | 6.12.2012 |
| EU/2/07/078/018-020 | Rheumocam | Liechtenstein | 31.12.2012 |
| EU/2/08/090/028 | Loxicom | Liechtenstein | 31.12.2012 |
| EU/2/10/118/015-021 | Activyl | Liechtenstein | 31.8.2012 |
| EU/2/11/134/015-017 | Inflacam | Iceland | 5.9.2012 |
| EU/2/11/134/015-017 | Inflacam | Norway | 1.11.2012 |
| EU/2/11/134/015-017 | Inflacam | Liechtenstein | 31.8.2012 |
| EU/2/11/134/018-020 | Inflacam | Iceland | 6.12.2012 |
| EU/2/11/134/018-020 | Inflacam | Liechtenstein | 31.12.2012 |
| EU/2/99/015/003-004 | Oxyglobin | Liechtenstein | 31.12.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/01/200/003-009

Viread

Iceland

18.12.2012

EU/1/04/274/001-002

Velcade

Norway

18.10.2012

EU/1/04/306/002-003

Aloxi

Norway

19.11.2012

EU/1/06/368/169-174

Insulin Human Winthrop

Liechtenstein

31.8.2012

EU/1/06/376/034, 036-039

Irbesartan Zentiva

Liechtenstein

31.10.2012

EU/1/06/376/034, 036-039

Irbesartan Zentiva

Norway

30.8.2012

EU/1/06/377/029-034

Irbesartan HCT Zentiva

Liechtenstein

31.8.2012

EU/1/06/377/029-034

Irbesartan HCT Zentiva

Norway

12.11.2012

EU/1/06/380/006

Prezista

Iceland

14.11.2012

EU/1/06/380/006

Prezista

Norway

24.10.2012

EU/1/07/389/004-009

Orencia

Liechtenstein

31.10.2012

EU/1/07/389/004-009

Orencia

Norway

13.11.2012

EU/1/07/389/004-009

Orencia

Iceland

19.10.2012

EU/1/07/391/005-006

Revlimid

Norway

25.9.2012

EU/1/07/391/005-006

Revlimid

Iceland

11.10.2012

EU/1/07/440/007

Tyverb

Liechtenstein

31.8.2012

EU/1/07/440/007

Tyverb

Norway

31.7.2012

EU/1/09/514/021-023

Zebinix

Liechtenstein

31.8.2012

EU/1/09/514/021-023

Zebinix

Iceland

3.9.2012

EU/1/09/514/021-023

Zebinix

Norway

25.9.2012

EU/1/10/616/025-036

Temozolomide HEXAL

Liechtenstein

31.8.2012

EU/1/10/617/025-036

Temozolomide Sandoz

Liechtenstein

31.8.2012

EU/1/11/691/006-013

Eliquis

Iceland

11.12.2012

EU/1/11/691/006-013

Eliquis

Norway

19.12.2012

EU/1/11/712/029-040

Levetiracetam Accord

Liechtenstein

31.10.2012

EU/1/11/731/013-014

Komboglyze

Liechtenstein

31.10.2012

EU/1/11/731/013-014

Komboglyze

Norway

24.9.2012

EU/1/11/734/012-018

Edarbi

Liechtenstein

31.8.2012

EU/1/11/735/012-018

Ipreziv

Liechtenstein

31.8.2012

EU/1/12/752/002

Vepacel

Liechtenstein

31.10.2012

EU/1/12/765/007-009

Sabervel

Liechtenstein

31.12.2012

EU/1/97/030/196-201

Insuman

Liechtenstein

31.8.2012

EU/1/97/047/008

BeneFIX

Liechtenstein

31.8.2012

EU/1/97/047/008

BeneFIX

Iceland

4.9.2012

EU/1/97/047/008

BeneFIX

Norway

10.10.2012

EU/2/02/033/003-004

Dexdomitor

Iceland

13.9.2012

EU/2/02/033/003-004

Dexdomitor

Norway

30.8.2012

EU/2/02/033/003-004

Dexdomitor

Liechtenstein

31.10.2012

EU/2/07/074/007-009

Prilactone

Liechtenstein

31.12.2012

EU/2/07/078/018-020

Rheumocam

Norway

6.12.2012

EU/2/07/078/018-020

Rheumocam

Liechtenstein

31.12.2012

EU/2/08/090/028

Loxicom

Liechtenstein

31.12.2012

EU/2/10/118/015-021

Activyl

Liechtenstein

31.8.2012

EU/2/11/134/015-017

Inflacam

Iceland

5.9.2012

EU/2/11/134/015-017

Inflacam

Norway

1.11.2012

EU/2/11/134/015-017

Inflacam

Liechtenstein

31.8.2012

EU/2/11/134/018-020

Inflacam

Iceland

6.12.2012

EU/2/11/134/018-020

Inflacam

Liechtenstein

31.12.2012

EU/2/99/015/003-004

Oxyglobin

Liechtenstein

31.12.2012

---

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 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/147/001-012 | Hexavac | Iceland | 23.7.2012 |
| EU/1/00/147/001-012 | Hexavac | Liechtenstein | 31.8.2012 |
| EU/1/01/193/001-002 | MabCampath | Norway | 8.8.2012 |
| EU/1/01/193/001-002 | MabCampath | Iceland | 30.8.2012 |
| EU/1/01/193/001-002 | MabCampath | Liechtenstein | 31.8.2012 |
| EU/1/02/205/005-006 | Lumigan | Liechtenstein | 31.12.2012 |
| EU/1/02/209/001-004 | Dynastat | Norway | 18.7.2012 |
| EU/1/04/281/001-002, 004 | Erbitux | Norway | 30.8.2012 |
| EU/1/07/407/001-040 | Sprimeo | Iceland | 23.7.2012 |
| EU/1/07/407/001-040 | Sprimeo | Norway | 4.7.2012 |
| EU/1/07/407/001-040 | Sprimeo | Liechtenstein | 31.8.2012 |
| EU/1/09/513/001-020 | Rivastigmine Teva | Norway | 10.9.2012 |
| EU/1/09/513/001-020 | Rivastigmine Teva | Iceland | 20.9.2012 |
| EU/1/09/513/001-020 | Rivastigmine Teva | Liechtenstein | 31.10.2012 |
| EU/1/09/520/001-020 | Exalief | Iceland | 6.12.2012 |
| EU/1/09/520/001-020 | Exalief | Norway | 30.7.2012 |
| EU/1/09/570/001-060 | Imprida HCT | Iceland | 7.12.2012 |
| EU/1/09/576/040 | Irbesartan Teva | Liechtenstein | 31.12.2012 |
| EU/1/09/582/001 | Rilonacept Regeneron | Iceland | 14.11.2012 |
| EU/1/09/582/001 | Rilonacept Regeneron | Norway | 24.10.2012 |
| EU/1/10/634/005-011 | Ribavirin Mylan | Liechtenstein | 31.12.2012 |
| EU/1/11/638/001-080 | Sprimeo HCT | Liechtenstein | 31.8.2012 |
| EU/1/11/669/005 | Teysuno | Liechtenstein | 31.12.2012 |
| EU/1/11/679/007 | Pravafenix | Liechtenstein | 31.12.2012 |
| EU/1/11/680/001-080 | Riprazo HCT | Norway | 30.8.2012 |
| EU/1/11/680/001-080 | Riprazo HCT | Iceland | 12.9.2012 |
| EU/1/11/683/001-080 | Sprimeo HCT | Norway | 6.7.2012 |
| EU/1/11/683/001-080 | Sprimeo HCT | Iceland | 23.7.2012 |
| EU/1/11/691/006-013 | Eliquis | Liechtenstein | 31.12.2012 |
| EU/1/11/697/013-024 | Temozolomide SUN | Liechtenstein | 31.12.2012 |
| EU/1/12/765/007-009 | Sabervel | Liechtenstein | 31.12.2012 |
| EU/1/12/776/017-023 | Fycompa | Liechtenstein | 31.12.2012 |
| EU/1/12/780/029-034 | Jentadueto | Liechtenstein | 31.12.2012 |
| EU/1/96/006/008-011 | NovoSeven | Liechtenstein | 31.12.2012 |
| EU/1/97/040/001-002 | Teslascan | Iceland | 14.9.2012 |
| EU/1/99/099/001-006 | Zerene | Norway | 23.8.2012 |
| EU/1/99/099/001-006 | Zerene | Iceland | 7.9.2012 |
| EU/1/99/099/001-006 | Zerene | Liechtenstein | 31.10.2012 |
| EU/1/99/101/001 | Regranex | Norway | 16.7.2012 |
| EU/1/99/101/001 | Regranex | Liechtenstein | 31.8.2012 |
| EU/1/99/101/001 | Regranex | Iceland | 14.8.2012 |
| EU/1/99/103/009 | Refacto AF | Liechtenstein | 31.12.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/00/147/001-012

Hexavac

Iceland

23.7.2012

EU/1/00/147/001-012

Hexavac

Liechtenstein

31.8.2012

EU/1/01/193/001-002

MabCampath

Norway

8.8.2012

EU/1/01/193/001-002

MabCampath

Iceland

30.8.2012

EU/1/01/193/001-002

MabCampath

Liechtenstein

31.8.2012

EU/1/02/205/005-006

Lumigan

Liechtenstein

31.12.2012

EU/1/02/209/001-004

Dynastat

Norway

18.7.2012

EU/1/04/281/001-002, 004

Erbitux

Norway

30.8.2012

EU/1/07/407/001-040

Sprimeo

Iceland

23.7.2012

EU/1/07/407/001-040

Sprimeo

Norway

4.7.2012

EU/1/07/407/001-040

Sprimeo

Liechtenstein

31.8.2012

EU/1/09/513/001-020

Rivastigmine Teva

Norway

10.9.2012

EU/1/09/513/001-020

Rivastigmine Teva

Iceland

20.9.2012

EU/1/09/513/001-020

Rivastigmine Teva

Liechtenstein

31.10.2012

EU/1/09/520/001-020

Exalief

Iceland

6.12.2012

EU/1/09/520/001-020

Exalief

Norway

30.7.2012

EU/1/09/570/001-060

Imprida HCT

Iceland

7.12.2012

EU/1/09/576/040

Irbesartan Teva

Liechtenstein

31.12.2012

EU/1/09/582/001

Rilonacept Regeneron

Iceland

14.11.2012

EU/1/09/582/001

Rilonacept Regeneron

Norway

24.10.2012

EU/1/10/634/005-011

Ribavirin Mylan

Liechtenstein

31.12.2012

EU/1/11/638/001-080

Sprimeo HCT

Liechtenstein

31.8.2012

EU/1/11/669/005

Teysuno

Liechtenstein

31.12.2012

EU/1/11/679/007

Pravafenix

Liechtenstein

31.12.2012

EU/1/11/680/001-080

Riprazo HCT

Norway

30.8.2012

EU/1/11/680/001-080

Riprazo HCT

Iceland

12.9.2012

EU/1/11/683/001-080

Sprimeo HCT

Norway

6.7.2012

EU/1/11/683/001-080

Sprimeo HCT

Iceland

23.7.2012

EU/1/11/691/006-013

Eliquis

Liechtenstein

31.12.2012

EU/1/11/697/013-024

Temozolomide SUN

Liechtenstein

31.12.2012

EU/1/12/765/007-009

Sabervel

Liechtenstein

31.12.2012

EU/1/12/776/017-023

Fycompa

Liechtenstein

31.12.2012

EU/1/12/780/029-034

Jentadueto

Liechtenstein

31.12.2012

EU/1/96/006/008-011

NovoSeven

Liechtenstein

31.12.2012

EU/1/97/040/001-002

Teslascan

Iceland

14.9.2012

EU/1/99/099/001-006

Zerene

Norway

23.8.2012

EU/1/99/099/001-006

Zerene

Iceland

7.9.2012

EU/1/99/099/001-006

Zerene

Liechtenstein

31.10.2012

EU/1/99/101/001

Regranex

Norway

16.7.2012

EU/1/99/101/001

Regranex

Liechtenstein

31.8.2012

EU/1/99/101/001

Regranex

Iceland

14.8.2012

EU/1/99/103/009

Refacto AF

Liechtenstein

31.12.2012

---

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 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/09/509/001-004 | Ribavirin Teva | Iceland | 14.12.2012 |
| EU/1/09/509/001-004 | Ribavirin Teva | Norway | 6.12.2012 |
| EU/1/09/527/001-016 | Ribavirin Teva Pharma BV | Iceland | 14.12.2012 |
| EU/1/09/527/001-016 | Ribavirin Teva Pharma BV | Norway | 6.12.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/09/509/001-004

Ribavirin Teva

Iceland

14.12.2012

EU/1/09/509/001-004

Ribavirin Teva

Norway

6.12.2012

EU/1/09/527/001-016

Ribavirin Teva Pharma BV

Iceland

14.12.2012

EU/1/09/527/001-016

Ribavirin Teva Pharma BV

Norway

6.12.2012

---

V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 9.10.2014 | EN | Official Journal of the European Union | C 356/52 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/52

---

Prior notification of a concentration

(Case M.7359 — PCCR USA/Total's CCP Composite Business)

(Text with EEA relevance)

2014/C 356/09

| 1. | On 30 September 2014, the Commission received a notification of a proposed concentration pursuant to Article 4 and following a referral pursuant to Article 4(5) of Council Regulation (EC) No 139/2004 (1) by which the undertaking PCCR USA, Inc (‘PCCR’, the United States), a fully owned subsidiary of Polynt Group SàRL (‘Polynt Group’, Luxembourg) acquires within the meaning of Article 3(1)(b) of the Merger Regulation control of the whole of CCP Composites SA (France), CCP Composites UK Limited (the United Kingdom), CCP Composites Canada, Inc. (Canada), CCP Composites US LLC (the United States), CCP Composites Korea Co., Ltd (South Corea), CCP Composites Resins España, SLU (Spain), CCP Composites e Resinas do Brazil Ltda (Brazil), CCP Australia Pty Ltd (Australia), CCP Composites Resins Malaysia Sdn Bhd (Malaysia), CCP Composites Guangzhou Co., Ltd (China) (altogether referred to as ‘CCP Composite Business’) by way of purchase of shares. |
| --- | --- |

1.

On 30 September 2014, the Commission received a notification of a proposed concentration pursuant to Article 4 and following a referral pursuant to Article 4(5) of Council Regulation (EC) No 139/2004 (1) by which the undertaking PCCR USA, Inc (‘PCCR’, the United States), a fully owned subsidiary of Polynt Group SàRL (‘Polynt Group’, Luxembourg) acquires within the meaning of Article 3(1)(b) of the Merger Regulation control of the whole of CCP Composites SA (France), CCP Composites UK Limited (the United Kingdom), CCP Composites Canada, Inc. (Canada), CCP Composites US LLC (the United States), CCP Composites Korea Co., Ltd (South Corea), CCP Composites Resins España, SLU (Spain), CCP Composites e Resinas do Brazil Ltda (Brazil), CCP Australia Pty Ltd (Australia), CCP Composites Resins Malaysia Sdn Bhd (Malaysia), CCP Composites Guangzhou Co., Ltd (China) (altogether referred to as ‘CCP Composite Business’) by way of purchase of shares.

| 2. | The business activities of the undertakings concerned are:
  —   for PCCR: PCCR is active in the production and the sale of resins for the coating and composite industry in North America (both in the US and Canada),
  —   for CCP Composite Business: is active in the production and the sale of unsaturated polyester resins and gel coats worldwide. |
| --- | --- |

2.

The business activities of the undertakings concerned are:

—   for PCCR: PCCR is active in the production and the sale of resins for the coating and composite industry in North America (both in the US and Canada),

—   for CCP Composite Business: is active in the production and the sale of unsaturated polyester resins and gel coats worldwide.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by e-mail to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number M.7359 — PCCR USA/Total's CCP Composite Business, to the following address:

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

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by e-mail to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number M.7359 — PCCR USA/Total's CCP Composite Business, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

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

---

| 9.10.2014 | EN | Official Journal of the European Union | C 356/53 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/53

---

Prior notification of a concentration

(Case M.7095 — SOCAR/DESFA)

(Text with EEA relevance)

2014/C 356/10

| 1. | On 1 October 2014, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the State Oil Company of the Azerbaijan Republic (‘SOCAR’ of Azerbaijan) acquires within the meaning of Article 3(1)(b) of the Merger Regulation control of the whole of the Hellenic Gas Transmission System Operator (‘DESFA’ of Greece) by way of purchase of shares. |
| --- | --- |

1.

On 1 October 2014, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the State Oil Company of the Azerbaijan Republic (‘SOCAR’ of Azerbaijan) acquires within the meaning of Article 3(1)(b) of the Merger Regulation control of the whole of the Hellenic Gas Transmission System Operator (‘DESFA’ of Greece) by way of purchase of shares.

| 2. | The business activities of the undertakings concerned are:
  —   for SOCAR: wholly-owned by the Republic of Azerbaijan and involved in exploring oil and gas fields, producing, processing, and transporting oil, gas and gas condensate, marketing petroleum and petrochemical products in domestic and international markets, and supplying natural gas to industry and the public in Azerbaijan;
  —   for DESFA: established in 2007 with the objective of operating, maintaining, managing, exploiting and developing the Hellenic Gas Transmission System. The activities of the company, which are governed by a special law, are a public utility and are subject to government supervision. |
| --- | --- |

2.

The business activities of the undertakings concerned are:

—   for SOCAR: wholly-owned by the Republic of Azerbaijan and involved in exploring oil and gas fields, producing, processing, and transporting oil, gas and gas condensate, marketing petroleum and petrochemical products in domestic and international markets, and supplying natural gas to industry and the public in Azerbaijan;

—   for DESFA: established in 2007 with the objective of operating, maintaining, managing, exploiting and developing the Hellenic Gas Transmission System. The activities of the company, which are governed by a special law, are a public utility and are subject to government supervision.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by e-mail to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number M.7095 — SOCAR/DESFA, to the following address:

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

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by e-mail to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number M.7095 — SOCAR/DESFA, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

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

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OTHER ACTS

European Commission

| 9.10.2014 | EN | Official Journal of the European Union | C 356/54 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/54

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Publication of an amendment application pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs

2014/C 356/11

This publication confers the right to oppose the application pursuant to Article 51 of Regulation (EU) No 1151/2012 of the European Parliament and of the Council (1).

AMENDMENT APPLICATION

COUNCIL REGULATION (EC) No 510/2006

on the protection of geographical indications and designations of origin for agricultural products and foodstuffs
   (2)

AMENDMENT APPLICATION ACCORDING TO ARTICLE 9

‘COMTÉ’

EC No: FR-PDO-0217-0116-30.6.2009

PGI ( ) PDO ( X )

1.   Heading in the product specification affected by the amendment

—

—

—

—

—

—

—

—

—

2.   Type of amendments

—

—

—

—

3.   Amendment(s)

3.1.   Amendment to point (2) Description of product

The stage corresponding to the description of the product has been clarified. The term ‘renneted’ has been deleted (the addition of rennet is described under the heading ‘Method of production’), as has the term ‘firm’, which is not very precise.

The maximum fat content has been defined in order to avoid an excess of non-traditional fat.

Stricter criteria have been laid down for the sizes and weights of the cheese in order to better characterise the product.

A new type of packaging (grated) has been included in the specification.

The organoleptic characteristics have been added in order to better describe the product.

The minimum maturing period is reiterated in this chapter.

3.2.   Amendment to point (5) Method of production

5.1.   Milk production

The addition of the breed types (46 and 35) helps facilitate checks. Replacing the former name of the breed, ‘Pie-Rouge de l’Est’, with its new name, ‘Simmental française’, does not change the list of authorised traditional breeds. The authorisation of products obtained by crossing the two breeds (Montbéliarde and Simmental française), which used to be implicit, is now explicit.

Clarifications regarding the seeding of grassland in order to promote a more diverse flora have been added: ‘Grassland that has been seeded with one type of legume, either alone or in combination with one type of grass, for less than five years is authorised on at most 15 % of the forage area of the farm. For the re-seeding of other grassland, it is obligatory to use long-duration mixtures combining at least three types of complementary species: hay grass, pasture grass and legumes.’

Clarifications regarding the fertilisation conditions make it possible to strengthen the link with the region by maintaining a diverse natural flora and avoiding the addition of artificial agents.

‘The amount of nitrogenous mineral manure may not exceed an average of 50 units per hectare of forage area per farm. Any use of the forage area (grazing or mowing) is prohibited for one month after the date of spreading the organic manure and for three weeks after the spreading of any mineral manure. The only organic fertilising substances authorised in the forage areas of the farm come from the geographical area and include compost, manure, slurry and liquid manure. They must meet certain conditions.

3.2.1.

The following are forbidden: organic fertilising substances from animals fed silage, unless the substances have first been composted to destroy any butyric spores, composts of green waste unless they are from the farm, co-composts of green waste except agricultural co-composts of the “manure with green waste” type.

The spreading of organic manure of non-agricultural origin on the farm land is authorised, but it must be ploughed in immediately.

Only co-composts where at least one-third of the co-compost is manure from the farm may be spread on the forage areas of the farm.’

With a view to maintaining the grazing tradition, provisions on feeding (‘Feeding systems with no grazing are forbidden. Supplementary green feed is limited to one meal a day during the growing season, so that grazing provides at least half of the minimum daily ration of roughage.’) have been added, as well as grazing requirement applicable as soon as the soils’ bearing capacity allows and for as long as the weather conditions, the soil’s bearing capacity and the presence of grass allow.

The provisions banning GMOs make it possible to maintain the link to the region.

Provisions on milk productivity per hectare of forage area have been added. Productivity is limited in order to maintain the special characteristics of the region in the cheese. ‘In order to preserve the quality and specificity of “Comté”, milk productivity in forage areas and potential forage areas reserved for the feeding of dairy herds is limited for each farm to the level reached during the best marketing year between 2008/09 and 2012/13, plus 10 %. This productivity may under no circumstances exceed 4 600 litres of milk per year and per hectare of forage area or potential forage area.’ The farm’s stocking density is limited to 1,3 LU/ha in order to preserve the link to the region.

A provision on fermented feed (a farm that switches over to the production of ‘Comté’ must have ceased feeding its dairy herd with fermented feed at least a year earlier) makes it possible to limit the risk of contamination by butyric bacteria. The conditions for the cohabitation of herds (the dairy herd used in the production of ‘Comté’ must be separated from the other herds) are clarified in order to facilitate checks.

By banning the supply of concentrate mixtures with the chopped roughage feed given to the dairy herd, it is possible to limit the risk of contamination by butyric bacteria.

Compliance with the different provisions on feeding means that at least 70 % of the herd’s feed comes from the geographical area. Provisions on the quality of the feed supplied have been added, including a list of forbidden feeds, the conditions applied to supplementary green feed and the conditions for the distribution of beetroot, because of either an adverse effect on the smell or taste of the milk or the risks of contamination by butyric bacteria.

These clarifications make it possible to avoid the use of any supplementary feed that might radically change or alter the characteristics of the milk and consequently of the cheese.

In order to facilitate checks, the conditions for supplying supplementary feed have been clarified: ‘The supply of supplementary feed (grains, flours, oilmeals, dried plants produced outside the farm, etc.) is limited to an average per herd of 1 800 kg/dairy cow/year. The annual consumption of supplementary feed by the heifer herd is calculated on the basis of 500 kg per heifer LU.’ The milking conditions are clarified, as these affect the milk’s flora. ‘Prior to attaching the milking cluster, it is forbidden to use milking grease or to disinfect the teats using impregnated wipes, a spray or any other procedure. The first streams must be eliminated. After calving, the milk may not be used for production for at least eight days.’ A qualified technician must regularly inspect the functioning of the milking installations and of the refrigeration and cooling equipment for the milk. Furthermore, ‘the use of disinfectants for cleaning, disinfection and rinsing is authorised only if necessary’

5.2.   Milk transport

The milk storage conditions are clarified, as they affect the milk’s flora: ‘the milk is stored either at the farm, at the processing plant or at a place to which producers take the milk themselves. There may be no other intermediate storage centres.’ The storage temperatures for milk are laid down in detail. ‘it must be stored at a temperature of 10 °C to 18 °C.,’ Experience shows that by not cooling the milk to less than 10 °C the specific organoleptic qualities of the cheese are brought out more fully.

It is reiterated that ‘Comté’ may only be produced from a mixture of milk from several farms. The aim is to uphold the tradition of a ‘collective product’. The conditions for keeping the milk intended for the production of ‘Comté’ separate from other milk have been clarified.

5.3.   Processing of the milk into cheese

The production plant and its equipment are defined in detail. The time limit for renneting has been redefined in order to facilitate checks. Instead of ‘renneting takes place at the latest within 24 hours of the first milking’ the following wording is proposed: ‘Milking takes place at the latest: — before noon, when the first milking is that of the morning of the previous day; — before midnight, when the first milking is that of the evening of the previous day.’ The provision on heating equipment for milk has been clarified by adding that, in order to facilitate checks, the heating appliance may not have a chambering section.

The authorised leavens and the type of rennet that may be used have been defined in more detail in order to preserve the specificities of the product.

‘Heating and pressing are the only production stages that may be programmed beforehand’ and ‘Production in closed vats is forbidden.’ Indeed, the production method must remain manual, so as to allow cheesemakers to demonstrate their know-how.

‘The maximum capacity of the vats is limited to a maximum of 12 cheeses per vat’ in order to preserve the quality of the cheeses.

‘Over a period of 24 hours not more than three production rounds may be carried out in the same vat. The vat must be scrubbed, washed and rinsed between each production round,’ in order to allow a sufficient release of copper ions, which is indispensable for the selection of the cheese’s microflora. As regards the pressure during pressing, ‘150 g/cm2’ is replaced with ‘100 g/cm2’. This is changed in order to correct a mistake in the previous specification.

2

2

5.4.   Maturation

The provision on the frequency of turning over the cheeses during pre-maturation is removed, because it is not applicable to all lots. The characteristics of the wheels vary greatly, in particular depending on the season. Maturers must be able to demonstrate their know-how by adjusting the frequency of treatment to the drying capacity of the cheese. While this treatment is necessary in most cases, that is not the case for the most moist wheels, especially those on the periphery. In such situations, the treatment may impair the quality (risk of a sticky rind); it is then better to postpone the treatment until the wheel is less moist. The practices of dry salting and brining, both of which are traditional methods, have been defined in detail, as they are essential to revealing the special character of ‘Comté’. ‘Dry salting may be replaced with brining, which must be carried out within 24 hours of removal from the mould, and the cheese must be treated within 48 hours of removal from the brine.’ The use of an international measuring method is specified for the maturity index. ‘Proteolysis measured using a minimum maturity index such as the non-protein nitrogenous content must make up at least 15,5 % of the total nitrogenous content, on the basis of the nitrogen content measured with the Kjeldahl method. For cheeses where the fat content in dry matter exceeds 52 %, this ratio must be 17,5 % or more.’ The addition of provisions on the necessity to measure and register the humidity facilitates checks.

5.5.   Portioning and packaging

The term ‘pre-packaging’ is defined.

The grating conditions are laid down. When packaging small portions of ‘Comté’, especially when it is grated, there is a risk that the quality of the product will be impaired and therefore specific know-how is required. By identifying these operators as packers, it is possible to impose inspection obligations on them and consequently to guarantee good traceability in order to protect consumers. ‘The rind may be removed from portions weighing less than 40 grams each or intended to be grated. If the rind is very moist or if it has deteriorated, it must be removed immediately after the cheese has been cut into portions. If the rind is in good condition, it must be removed within 8 hours of the first cutting. Pieces whose rind has been removed may not be stored in the open air for more than 72 hours; after that, they must be vacuum-packed. Vacuum-packing must take place within 15 days.’

5.6.   Technological innovations

A paragraph on technological innovations has been added.

3.3.   Amendment to point (6) Elements justifying the link with the geographical area

Amendment to point (6) Elements justifying the link with the geographical area

The heading ‘Link to the origin’ has been divided into three parts: ‘specificity of the geographical area’, ‘specificity of the product’ and ‘causal link between the geographical area and the quality or characteristics of the product’ in order to ensure consistency with the single document. This chapter has been rewritten for the sake of clarity.

3.4.   Amendment to point (8) Specific rules on labelling

Amendment to point (8) Specific rules on labelling

| — | Abolition of the INAO logo, which is replaced with the European Union’s AOP (PDO) symbol. |
| --- | --- |

—

Abolition of the INAO logo, which is replaced with the European Union’s AOP (PDO) symbol.

| — | Obligation to affix clearly the name and address of the producer, maturer or prepacker in order to provide consumers with better information. |
| --- | --- |

—

Obligation to affix clearly the name and address of the producer, maturer or prepacker in order to provide consumers with better information.

| — | Size of the name ‘Comté’ (at least two thirds of the other characters), prohibition on the use of additional wording, description of the identification marks, etc. |
| --- | --- |

—

Size of the name ‘Comté’ (at least two thirds of the other characters), prohibition on the use of additional wording, description of the identification marks, etc.

SINGLE DOCUMENT

COUNCIL REGULATION (EC) No 510/2006

COUNCIL REGULATION (EC) No 510/2006

on the protection of geographical indications and designations of origin for agricultural products and foodstuffs
   (3)

on the protection of geographical indications and designations of origin for agricultural products and foodstuffs

3

‘COMTÉ’

‘COMTÉ’

EC No: FR-PDO-0217-0116-30.6.2009

EC No: FR-PDO-0217-0116-30.6.2009

PGI ( ) PDO ( X )

PGI ( ) PDO ( X )

1.   Name

Name

‘Comté’

2.   Member State or Third Country

Member State or Third Country

France

3.   Description of the agricultural product or foodstuff

Description of the agricultural product or foodstuff

3.1.   Type of product

Type of product

Class 1.3. Cheeses

3.2.   Description of the product to which the name in point 1 applies

Description of the product to which the name in point 1 applies

‘Comté’ is made entirely of whole cow’s milk used in raw condition. It is a cheese with pressed, cooked paste that is salted on the surface or in brine. At the time of marketing, which takes place after a minimum maturation period of 120 days, the cheese’s paste has an ivory to yellow colour and an ‘opening’ that may reach the size of a small cherry.

‘Comté’ contains a minimum of 45 g and a maximum of 54 g of fat per 100 g of cheese after total desiccation and the dry matter must not weigh less than 62 g per 100 g of cheese. The salt content is not less than 0,6 g of sodium chloride per 100 g of cheese. The water content of the defatted cheese does not exceed 54 %.

‘Comté’ is presented to consumers in the form of a wheel that weighs 32 to 45 kg and has a diameter of 55 to 75 centimetres and a straight or slightly convex heel 8-13 cm in height. It has a scrubbed, solid and grainy rind that is golden yellow to brown in colour. The cheese must not be more than 1,4 times higher at the centre than at the outer rim.

‘Comté’ may also be presented in packaged portions or grated.

‘Comté’ has a complex taste. While the general sensorial features of all the wheels are the same, no two wheels of Comté are identical. Six main groups of aromas can be distinguished in ‘Comté’ (fruity, milky, roasted, plant-like, animal-like, spicy) and they include more than 90 nuances.

3.3.   Raw materials (for processed products only)

Raw materials (for processed products only)

The milk used to produce ‘Comté’ must come solely from a dairy herd of Montbéliarde cows of breed type 46, or from French Simmental cows of breed type 35, or from crosses of these two breeds of certified descent.

The milk must be collected from within a circular area measuring no more than 25 km in diameter. This rule limits the duration of transport and therefore protects the milk from structural degradation. This ensures that the milk is processed in the conditions laid down in the specification (raw milk). These conditions favour the development of endogenous lactic flora.

In order to maintain the quality and specificity of the product, milk productivity is limited per hectare of potential forage areas.

As regards the use of the milk, the capacity of the vats is limited to a maximum of 12 cheeses per vat in order to guarantee the quality of the product. Over a period of 24 hours not more than three production rounds may be carried out in the same vat.

3.4.   Feed (for products of animal origin only)

Feed (for products of animal origin only)

In order to guarantee a close link between the region and the product by using specific feed from the geographical area, supplementary feed is limited to 1 800 kg per dairy cow per year. On the farm, the grazing area actually used must be at least equal to 1 hectare per dairy cow. Grazing is obligatory for as long as the weather conditions, the soils’ bearing capacity and the presence of grass allow. Compliance with these provisions means that at least 70 % of the herd’s feed comes from the geographical area. The dairy cows’ basic intake comes entirely from the geographical area.

In order to maintain the traditional practice of grazing, farm production systems where all the feed is supplied in troughs during the growing season are forbidden and grazing should remain the main practice.

Fermented fodder, whether silage products or other, are not to be used in the feed of the dairy herd at any time of the year owing to the technological risks related to these practices during the production and maturing of cheeses.

Only raw materials and supplementary feed derived from non-transgenic products are authorised for the dairy herd so as to preserve the traditional nature of the feed.

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

Specific steps in production that must take place in the defined geographical area

The milk is produced and the cheese manufactured and matured in the geographical area.

3.6.   Specific rules on slicing, grating, packaging, etc.

Specific rules on slicing, grating, packaging, etc.

The procedure of cutting and packaging pieces of ‘Comté’ is part of an extended maturation process. It requires particular know-how and has a direct and definite effect on the quality of the product, because it is necessary to sort the wheels to remove those that may not be fit for prepacking. These conditions make it possible to comply fully with the conditions for preserving the cheese after it has been formed into wheels and to guarantee the physical and organoleptic integrity of ‘Comté’ until it reaches the consumer.

If the cheese is prepacked, these are the reasons for cutting or grating it in the geographical area.

If the cheese is prepacked,

| — | the wheels may be cut within not more than 15 days of leaving the maturing cellar. During this time they must be kept at a temperature of 4 °C to 8 °C with a humidity level at least equal to 85 %. |
| --- | --- |

—

the wheels may be cut within not more than 15 days of leaving the maturing cellar. During this time they must be kept at a temperature of 4 °C to 8 °C with a humidity level at least equal to 85 %.

| — | the rind may be removed from portions weighing less than 40 grams each or intended to be grated. If the rind is very moist or if it has deteriorated, it must be removed immediately after the cheese has been cut into portions. If the rind is in good condition, it must be removed within 8 hours of the first cutting. Pieces whose rind has been removed may not be stored in the open air for more than 72 hours; after that, they must be vacuum-packed. Vacuum-packing must take place within 15 days. |
| --- | --- |

—

the rind may be removed from portions weighing less than 40 grams each or intended to be grated. If the rind is very moist or if it has deteriorated, it must be removed immediately after the cheese has been cut into portions. If the rind is in good condition, it must be removed within 8 hours of the first cutting. Pieces whose rind has been removed may not be stored in the open air for more than 72 hours; after that, they must be vacuum-packed. Vacuum-packing must take place within 15 days.

| — | no simultaneous operations involving a product other than ‘Comté’ may take place on the cutting and packaging line. |
| --- | --- |

—

no simultaneous operations involving a product other than ‘Comté’ may take place on the cutting and packaging line.

The cheese may be cut and grated outside the geographical area if this is done in front of the consumer.

3.7.   Specific rules on labelling

Specific rules on labelling

All cheeses with the registered designation of origin ‘Comté’ must bear a label showing the designation in a font at least two thirds as large as the largest font shown on the label.

The labelling must include the European Union’s PDO symbol. It may also include the words ‘appellation d’origine protégée’ [‘protected designation of origin’].

The producer, maturer or prepacker must affix its name and address clearly, and the address must be located in the geographical area.

The use of any term or other reference accompanying the designation is prohibited on the labelling and in advertising, invoices or commercial documents, with the exception of specific trademarks.

Cheeses sold under the designation of origin ‘Comté’ must bear the required identifying marks. Prior to the cheese leaving the maturing cellar, a green or brick-brown band must be affixed to the side of each wheel. Each packaged portion must bear the ‘Comté clochettes vertes’ logo. For consumer portions, it is obligatory to affix the ‘Comté clochettes vertes’ logo and the name ‘Comté’ on the front in a font at least two thirds as large as the largest font using the Pantone 349C green colour code.

If the wheel is sold whole, it must bear on the side under the band an oval-shaped green casein plate bearing the following words printed in black: France, Comté, the number of the production plant and the production month. The production day must be indicated using a casein plate placed near the green casein plate.

4.   Concise definition of the geographical area

Concise definition of the geographical area

Definition of the geographical area

The geographical area extends over the territory of the following municipalities:

The department of Ain:

The cantons of Bellegarde-sur-Valserine, Brénod, Ceyzériat, Champagne-en-Valromey, Hauteville-Lompnes, Izernore, Lhuis, Nantua, Oyonnax, Poncin, Saint-Rambert-en-Bugey, Seyssel and Treffort-Cuisiat: all municipalities;

The cantons of Bellegarde-sur-Valserine, Brénod, Ceyzériat, Champagne-en-Valromey, Hauteville-Lompnes, Izernore, Lhuis, Nantua, Oyonnax, Poncin, Saint-Rambert-en-Bugey, Seyssel and Treffort-Cuisiat

The canton of Ambérieu-en-Bugey: the municipalities of L’Abergement-de-Varey, Ambérieu-en-Bugey, Ambronay, Bettant and Douvres;

The canton of Ambérieu-en-Bugey

The canton of Coligny: the municipalities of Bény, Coligny, Domsure, Pirajoux, Salavre, Verjon and Villemotier;

The canton of Coligny

The canton of Collonges: the municipalities of Chézery-Forens, Collonges, Confort, Farges, Lancrans, Léaz, Péron and Saint-Jean-de-Gonville;

The canton of Collonges

The canton of Ferney-Voltaire: the municipalities of Sergy and Thoiry;

The canton of Ferney-Voltaire

The canton of Gex: the municipalities of Cessy, Crozet, Divonne-les-Bains, Echenevex, Gex, Grilly, Lélex, Mijoux and Vesancy;

The canton of Gex

The canton of Lagnieu: the municipalities of Ambutrix, Lagnieu, Saint-Sorlin-en-Bugey, Sault-Brénaz, Souclin, Vaux-en-Bugey and Villebois;

The canton of Lagnieu

The canton of Pont-d’Ain: the municipalities of Druillat, Journans, Neuville-sur-Ain, Pont-d’Ain, Saint-Martin-du-Mont and Tossiat.

The canton of Pont-d’Ain

The department of Doubs:

The cantons of Amancey, Audeux, Baume-les-Dames, Besançon, Boussières, Clerval, Levier, Maîche, Marchaux, Montbenoît, Morteau, Mouthe, Ornans, Pierrefontaine-les-Varans, Pontarlier, Quingey, Roulans, Le Russey, Saint-Hippolyte and Vercel-Villedieu-le-Camp: all the municipalities;

The cantons of Amancey, Audeux, Baume-les-Dames, Besançon, Boussières, Clerval, Levier, Maîche, Marchaux, Montbenoît, Morteau, Mouthe, Ornans, Pierrefontaine-les-Varans, Pontarlier, Quingey, Roulans, Le Russey, Saint-Hippolyte and Vercel-Villedieu-le-Camp

The canton of Hérimoncourt: the municipalities of Autechaux-Roide, Blamont, Dannemarie, Ecurcey, Glay, Pierrefontaine-lès-Blamont, Roches-lès-Blamont and Villars-lès-Blamont;

The canton of Hérimoncourt

The canton of L’Isle-sur-le-Doubs: the municipalities of Hyémondans and Lanthenans;

The canton of L’Isle-sur-le-Doubs

The canton of Pont-de-Roide: the municipalities of Dambelin, Feule, Goux-lès-Dambelin, Neuchâtel-Urtière, Noirefontaine, Péseux, Pont-de-Roide, Remondans-Vaivre, Rosière-sur-Barbèche, Solemont, Valonne, Villars-sous-Dampjoux and Vernois-lès-Belvoir;

The canton of Pont-de-Roide

The canton of Rougemont: the municipality of Rillans.

The canton of Rougemont

The department of Jura:

All the municipalities, with the exception of the municipalities of the canton of Chemin.

The department of Saône-et-Loire:

The canton of Beaurepaire-en-Bresse: the municipalities of Beaurepaire-en-Bresse, Sagy, Saillenard and Savigny-en-Revermont;

The canton of Beaurepaire-en-Bresse

The canton of Cuiseaux: the municipalities of Champagnat, Cuiseaux, Flacey-en-Bresse and Joudes;

The canton of Cuiseaux

The canton of Pierre-de-Bresse: the municipalities of Beauvernois, Bellevesvre, Fretterans, Mouthiers-en-Bresse and Torpes;

The canton of Pierre-de-Bresse

The department of Haute-Savoie:

The canton of Seyssel: the municipalities of Challonges solely for parcels No 562 (a) and 563 (a) of section A, sixth leaf.

The canton of Seyssel

5.   Link with the geographical area

Link with the geographical area

5.1.   Specificity of the geographical area

Specificity of the geographical area

5.1.1.   Natural factors

Natural factors

The geographical area comprises the arc of the Jura mountains, a set of limestone plateaux, and its extension into a small part of the adjoining plain.

The agricultural areas in question are characterised by their poor soils and significant contours and by the calcareous and molassic nature of the geological substratum.

The climate of the area tends towards both continental and northern with a big difference between winter and summer temperatures and rainfall that, although it is even throughout the year, is heavy in the summer, with a low annual average temperature, despite summer heatwaves, and a large number of days of frost.

It is a very wet mountain or sub-mountain environment with annual rainfall always in excess of 900 mm and generally in excess of 1 000 mm. This rainfall is already considerable at low altitude and increases towards the interior of the mountain range. Seasonal distribution is characterised by the lack of a dry season.

This area is divided between woodland, half of which is composed of spruce, and grassland. The area’s particular geo-climatic conditions (heavy rainfall, no summer drought, limestone substrate) contribute very favourably to high-quality grass production. Indeed, they allow the development of natural grassland that has a very rich flora (especially as regards dicotyledons) and a specific limestone flora.

5.1.2.   Human factors

Human factors

In this area which is well-suited to grazing, dairy cows feed in this manner for as long as the weather conditions, the soils’ bearing capacity and the presence of grass allow. Breeders have selected the Montbéliarde breed, which is well adapted to the conditions in the area and makes up nearly all of the dairy herds in the geographical area. The extensive farming of grassland has been maintained (stocking density, the use of nitrogen and concentrates etc. are limited). In addition, the geographical area has a particular cheese-making tradition. This tradition, based on the pooling of milk for the purpose of making a large cheese, has led to a strong sense of solidarity and common rules.

Since the 11th century farmers in this region have worked together to pool every day the milk produced by their various herds in order to make a large wheel. Still today the great majority of milk producers belong to cooperatives and pool their milk in a processing plant called ‘fruitière’, the local cheese dairy.

The traditional methods of making this cheese live on and are maintained, on the one hand, in the way the animals are bred using a specific system for the management of pastures and the drying of mowed grass and, on the other, in the way the cheese is made by carefully timing the cutting of the curd, its stirring and heating, the extraction and pressing and then the salting, prematuring and maturing.

5.2.   Specificity of the product

Specificity of the product

‘Comté’ is a cheese made from raw cow’s milk. It has a cooked pressed paste and is in the shape of a large wheel 55 to 75 cm in diameter. It is matured for a long time and is therefore a long-keeping cheese.

‘Comté’ has a limited fat content and this distinguishes it from other cheeses with a cooked pressed paste.

It contains at least 62 grams of dry matter per 100 grams of cheese and the water content of the defatted cheese does not exceed 54 %.

The salt content is not less than 0,6 g of sodium chloride per 100 g of cheese.

‘Comté’ has a complex taste. While the general sensorial features of all the wheels are the same, no two wheels of Comté are identical. Six main groups of aromas can be distinguished (fruity, milky, roasted, plant-like, animal-like, spicy) and they include more than 90 nuances.

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

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

It is in this difficult environment, where the landscape is divided between woodland and grassland and where it was impossible to develop other resources, that large hard cheeses became the product of choice. For the people living on this land, a long-keeping cheese was the only preserved food that could be made from the abundant supply of summer milk and that would keep through the long winter. Therefore local breeders selected a cow breed that was particularly well suited to the local conditions and to the making of this particular cheese. The milk was pooled in the ‘fruitières’ for the purpose of producing a large, long-keeping cheese that would allow the breeders to make the best use of the richness of this land outside the geographical area. The choice of a cheese with a cooked paste was based on the abundance of firewood in the area.

The distinctive characteristics of the grassland are expressed in the cheese with the help of specific expertise applied at every production stage.

First of all, the great floral richness of the natural environment of the geographical area contributes strongly to the development of the cheese’s aromatic components. This diversity is preserved through the extensive farming of the grassland. The close link between floral diversity and the rich aroma of ‘Comté’ has been demonstrated by two scientific studies in 1994. By limiting the fat content during cheese-making it is possible to avoid off-tastes due to lipolysis and reinforce the typical aromas of ‘Comté’. By laying down a minimum dry matter content and a maximum water content for the defatted cheese, it is possible to avoid excess water in the cheese and help bring out all the aromas. The aromas are enhanced also by the minimum salt content of the cheese. The obligation to use open vats allows the cheesemakers to maintain their skills, such as the correct timing of the cutting and extraction of the curd. Finally, the maturers use their know-how to carefully adjust the maturing conditions of each lot. The cheese’s aroma, which is the result of natural factors such as the grass and the microbe ecosystem, is fully developed only after a long period of maturation on spruce boards, which are particularly well suited to the maturation of ‘Comté’. The production of ‘Comté’ allows the maintenance of traditional agricultural activities and contributes greatly to achieving a balanced local economy.

Reference to publication of the specification

Reference to publication of the specification

(Article 5(7) of Regulation (EC) No 510/2006 (4))

4

https://www.inao.gouv.fr/fichier/CDCComte.pdf

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(1)  OJ L 343, 14.12.2012, p. 1.

1

(2)  OJ L 93, 31.3.2006, p. 12. Replaced by Regulation (EU) No 1151/2012.

2

(3)  Replaced by Regulation (EU) No 1151/2012.

3

(4)  See footnote 3.

4

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| 9.10.2014 | EN | Official Journal of the European Union | C 356/63 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/63

---

Notice for the attention of Ahmed Abdullah Saleh Al-Khazmari Al-Zahrani, Azzam Abdullah Zureik Al-Maulid Al-Subhi, Anders Cameroon Ostensvig Dale, Ibrahim Suleiman Hamad Al-Hablain, Seifallah Ben Hassine, ‘Abd Al-Rahman Bin ‘Umayr Al-Nu’aymi, ‘Abd Al-Rahman Khalaf ‘Ubayd Juday’ Al-‘Anizi, Anas Hasan Khattab, Maysar Ali Musa Abdallah Al-Juburi, Shafi Sultan Mohammed Al-Ajmi, ‘Abd Al-Rahman Muhammad Mustafa Al-Qaduli, Emilie Konig, Kevin Guiavarch, Oumar Diaby, Ansar Al-Shari’a in Tunisia (ASS-T) and Abdallah Azzam Brigades (AAB) which were added to the list referred to in Articles 2, 3 and 7 of Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network, by virtue of Commission Implementing Regulation (EU) No 1058/2014

2014/C 356/12

| 1. | Common Position 2002/402/CFSP (1) calls upon the Union to freeze the funds and economic resources of the members of the Al-Qaida organisation and other individuals, groups, undertakings and entities associated with them, as referred to in the list drawn up pursuant to UNSCR 1267(1999) and 1333(2000) to be updated regularly by the UN Committee established pursuant to UNSCR 1267(1999).
  The list drawn up by this UN Committee comprises:

  — | Al Qaida, |
| --- | --- | --- |

1.

Common Position 2002/402/CFSP (1) calls upon the Union to freeze the funds and economic resources of the members of the Al-Qaida organisation and other individuals, groups, undertakings and entities associated with them, as referred to in the list drawn up pursuant to UNSCR 1267(1999) and 1333(2000) to be updated regularly by the UN Committee established pursuant to UNSCR 1267(1999).

The list drawn up by this UN Committee comprises:

—

Al Qaida,

| — | natural or legal persons, entities, bodies and groups associated with Al Qaida, and |
| --- | --- |

—

natural or legal persons, entities, bodies and groups associated with Al Qaida, and

| — | legal persons, entities and bodies owned or controlled by, or otherwise supporting, any of these associated persons, entities, bodies and groups. |
| --- | --- |

—

legal persons, entities and bodies owned or controlled by, or otherwise supporting, any of these associated persons, entities, bodies and groups.

Acts or activities indicating that an individual, group, undertaking, or entity is ‘associated with’ Al-Qaida include:

| (a) | participating in the financing, planning, facilitating, preparing, or perpetrating of acts or activities by, in conjunction with, under the name of, on behalf of, or in support of Al Qaida, or any cell, affiliate, splinter group or derivative thereof; |
| --- | --- |

(a)

participating in the financing, planning, facilitating, preparing, or perpetrating of acts or activities by, in conjunction with, under the name of, on behalf of, or in support of Al Qaida, or any cell, affiliate, splinter group or derivative thereof;

| (b) | supplying, selling or transferring arms and related materiel to any of them; |
| --- | --- |

(b)

supplying, selling or transferring arms and related materiel to any of them;

| (c) | recruiting for any of them; or |
| --- | --- |

(c)

recruiting for any of them; or

| (d) | otherwise supporting acts or activities of any of them. |
| --- | --- |

(d)

otherwise supporting acts or activities of any of them.

| 2. | The UN Security Council approved on 23 September 2014 the addition of Ahmed Abdullah Saleh Al-Khazmari Al-Zahrani, Azzam Abdullah Zureik Al-Maulid Al-Subhi, Anders Cameroon Ostensvig Dale, Ibrahim Suleiman Hamad Al-Hablain, Seifallah Ben Hassine, ‘Abd Al-Rahman Bin ‘Umayr Al-Nu’aymi, ‘Abd Al-Rahman Khalaf ‘Ubayd Juday’ Al-‘Anizi, Anas Hasan Khattab, Maysar Ali Musa Abdallah Al-Juburi, Shafi Sultan Mohammed Al-Ajmi, ‘Abd Al-Rahman Muhammad Mustafa Al-Qaduli, Emilie Konig, Kevin Guiavarch, Oumar Diaby, Ansar Al-Shari’a in Tunisia (ASS-T) and Abdallah Azzam Brigades (AAB) to the Al-Qaida Sanctions Committee’s list.
  They may submit at any time a request to the UN Ombudsperson, together with any supporting documentation, for the decision to include them in the UN list referred to above, to be reconsidered. Such request should be sent to the following address:

  United Nations — Office of the Ombudsperson |
| --- | --- |
| Room TB-08041D |
| New York, NY 10017 |
| UNITED STATES OF AMERICA |
| Tel. +1 2129632671 |
| Fax +1 2129631300/3778 |
| E-mail: ombudsperson@un.org |
| See for more information at: http://www.un.org/sc/committees/1267/delisting.shtml |

2.

The UN Security Council approved on 23 September 2014 the addition of Ahmed Abdullah Saleh Al-Khazmari Al-Zahrani, Azzam Abdullah Zureik Al-Maulid Al-Subhi, Anders Cameroon Ostensvig Dale, Ibrahim Suleiman Hamad Al-Hablain, Seifallah Ben Hassine, ‘Abd Al-Rahman Bin ‘Umayr Al-Nu’aymi, ‘Abd Al-Rahman Khalaf ‘Ubayd Juday’ Al-‘Anizi, Anas Hasan Khattab, Maysar Ali Musa Abdallah Al-Juburi, Shafi Sultan Mohammed Al-Ajmi, ‘Abd Al-Rahman Muhammad Mustafa Al-Qaduli, Emilie Konig, Kevin Guiavarch, Oumar Diaby, Ansar Al-Shari’a in Tunisia (ASS-T) and Abdallah Azzam Brigades (AAB) to the Al-Qaida Sanctions Committee’s list.

They may submit at any time a request to the UN Ombudsperson, together with any supporting documentation, for the decision to include them in the UN list referred to above, to be reconsidered. Such request should be sent to the following address:

United Nations — Office of the Ombudsperson

Room TB-08041D

New York, NY 10017

UNITED STATES OF AMERICA

Tel. +1 2129632671

Fax +1 2129631300/3778

E-mail: ombudsperson@un.org

See for more information at: http://www.un.org/sc/committees/1267/delisting.shtml

| 3. | Further to the UN decision referred to in paragraph 2, the Commission has adopted Implementing Regulation (EU) No 1058/2014 (2), which amends Annex I to Council Regulation (EC) No 881/2002 (3) imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network. The amendment, made pursuant to Article 7(1)(a) and 7a(1) of Regulation (EC) No 881/2002, adds Ahmed Abdullah Saleh Al-Khazmari Al-Zahrani, Azzam Abdullah Zureik Al-Maulid Al-Subhi, Anders Cameroon Ostensvig Dale, Ibrahim Suleiman Hamad Al-Hablain, Seifallah Ben Hassine, ‘Abd Al-Rahman Bin ‘Umayr Al-Nu’aymi, ‘Abd Al-Rahman Khalaf ‘Ubayd Juday’ Al-‘Anizi, Anas Hasan Khattab, Maysar Ali Musa Abdallah Al-Juburi, Shafi Sultan Mohammed Al-Ajmi, ‘Abd Al-Rahman Muhammad Mustafa Al-Qaduli, Emilie Konig, Kevin Guiavarch, Oumar Diaby, Ansar Al-Shari’a in Tunisia (ASS-T) and Abdallah Azzam Brigades (AAB) to the list in Annex I of that Regulation (‘Annex I’).
  The following measures of Regulation (EC) No 881/2002 apply to the individuals and entities included in Annex I:

  (1) | the freezing of all funds and economic resources belonging to the individuals and entities concerned, or owned or held by them, and the prohibition (on everyone) on making funds and economic resources available to any of the individuals and entities concerned or for their benefit, whether directly or indirectly (Articles 2 and 2a); and |
| --- | --- | --- |

3.

Further to the UN decision referred to in paragraph 2, the Commission has adopted Implementing Regulation (EU) No 1058/2014 (2), which amends Annex I to Council Regulation (EC) No 881/2002 (3) imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network. The amendment, made pursuant to Article 7(1)(a) and 7a(1) of Regulation (EC) No 881/2002, adds Ahmed Abdullah Saleh Al-Khazmari Al-Zahrani, Azzam Abdullah Zureik Al-Maulid Al-Subhi, Anders Cameroon Ostensvig Dale, Ibrahim Suleiman Hamad Al-Hablain, Seifallah Ben Hassine, ‘Abd Al-Rahman Bin ‘Umayr Al-Nu’aymi, ‘Abd Al-Rahman Khalaf ‘Ubayd Juday’ Al-‘Anizi, Anas Hasan Khattab, Maysar Ali Musa Abdallah Al-Juburi, Shafi Sultan Mohammed Al-Ajmi, ‘Abd Al-Rahman Muhammad Mustafa Al-Qaduli, Emilie Konig, Kevin Guiavarch, Oumar Diaby, Ansar Al-Shari’a in Tunisia (ASS-T) and Abdallah Azzam Brigades (AAB) to the list in Annex I of that Regulation (‘Annex I’).

The following measures of Regulation (EC) No 881/2002 apply to the individuals and entities included in Annex I:

(1)

the freezing of all funds and economic resources belonging to the individuals and entities concerned, or owned or held by them, and the prohibition (on everyone) on making funds and economic resources available to any of the individuals and entities concerned or for their benefit, whether directly or indirectly (Articles 2 and 2a); and

| (2) | the prohibition on granting, selling, supplying or transferring technical advice, assistance or training related to military activities to any of the individuals and entities concerned, whether directly or indirectly (Article 3). |
| --- | --- |

(2)

the prohibition on granting, selling, supplying or transferring technical advice, assistance or training related to military activities to any of the individuals and entities concerned, whether directly or indirectly (Article 3).

| 4. | Article 7a of Regulation (EC) No 881/2002 provides for a review process where observations on the grounds for listing are submitted by those listed. Individuals and entities added to Annex I by Implementing Regulation (EU) No 1058/2014 may make a request for the grounds for their listing to the Commission. This request should be sent to:

  European Commission |
| --- | --- |
| ‘Restrictive measures’ |
| Rue de la Loi/Wetstraat 200 |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

4.

Article 7a of Regulation (EC) No 881/2002 provides for a review process where observations on the grounds for listing are submitted by those listed. Individuals and entities added to Annex I by Implementing Regulation (EU) No 1058/2014 may make a request for the grounds for their listing to the Commission. This request should be sent to:

European Commission

‘Restrictive measures’

Rue de la Loi/Wetstraat 200

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

| 5. | The attention of the individuals and entities concerned is also drawn to the possibility of challenging Implementing Regulation (EU) No 1058/2014 before the General Court of the European Union, in accordance with the conditions laid down in the fourth and sixth paragraphs of Article 263 of the Treaty on the Functioning of the European Union. |
| --- | --- |

5.

The attention of the individuals and entities concerned is also drawn to the possibility of challenging Implementing Regulation (EU) No 1058/2014 before the General Court of the European Union, in accordance with the conditions laid down in the fourth and sixth paragraphs of Article 263 of the Treaty on the Functioning of the European Union.

| 6. | For good order, the attention of the individuals and entities included in Annex I is drawn to the possibility of making an application to the competent authorities in the relevant Member State(s), as listed in Annex II to Regulation (EC) No 881/2002, in order to obtain an authorisation to use frozen funds and economic resources for essential needs or specific payments in accordance with Article 2a of that Regulation. |
| --- | --- |

6.

For good order, the attention of the individuals and entities included in Annex I is drawn to the possibility of making an application to the competent authorities in the relevant Member State(s), as listed in Annex II to Regulation (EC) No 881/2002, in order to obtain an authorisation to use frozen funds and economic resources for essential needs or specific payments in accordance with Article 2a of that Regulation.

---

(1)  OJ L 139, 29.5.2002, p. 4.

1

(2)  OJ L 293, 9.10.2014, p. 12.

2

(3)  OJ L 139, 29.5.2002, p 9.

3

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