# Official Journal C 391/2014

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 391 |
| | |
| English edition | Information and Notices | Volume 576 November 2014 |

ISSN 1977-091X

Official Journal

of the European Union

C 391

English edition

Information and Notices

Volume 576 November 2014

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2014/C 391/01 | Non-opposition to a notified concentration (Case M.7428 — Iridium/DIF/Concession Businesses) (
  1
  ) | 1 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2014/C 391/01

Non-opposition to a notified concentration (Case M.7428 — Iridium/DIF/Concession Businesses) (
  1
  )

1

1

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2014/C 391/02 | Euro exchange rates | 2 |
| | NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA |
| | Standing Committee of the EFTA States |
| 2014/C 391/03 | Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2013 | 3 |
| 2014/C 391/04 | Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2013 | 15 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2014/C 391/02

Euro exchange rates

2

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

2014/C 391/03

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2013

3

2014/C 391/04

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2013

15

| | V   Announcements |
| --- | --- |
| | ADMINISTRATIVE PROCEDURES |
| | European Personnel Selection Office (EPSO) |
| 2014/C 391/05 | Notice of open competition | 30 |

V   Announcements

ADMINISTRATIVE PROCEDURES

European Personnel Selection Office (EPSO)

2014/C 391/05

Notice of open competition

30

| | Corrigenda |
| --- | --- |
| 2014/C 391/06 | Corrigendum to Commission communication concerning Article 4(3) of Directive 2009/22/EC of the European Parliament and of the Council on injunctions for the protection of consumers' interests, which codifies Directive 98/27/EC, concerning the entities qualified to bring an action under Article 2 of this Directive (OJ C 363, 14.10.2014) | 31 |

Corrigenda

2014/C 391/06

Corrigendum to Commission communication concerning Article 4(3) of Directive 2009/22/EC of the European Parliament and of the Council on injunctions for the protection of consumers' interests, which codifies Directive 98/27/EC, concerning the entities qualified to bring an action under Article 2 of this Directive (OJ C 363, 14.10.2014)

31

| | |
| --- | --- |
| | (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

| 6.11.2014 | EN | Official Journal of the European Union | C 391/1 |
| --- | --- | --- | --- |

6.11.2014

EN

Official Journal of the European Union

C 391/1

---

Non-opposition to a notified concentration

(Case M.7428 — Iridium/DIF/Concession Businesses)

(Text with EEA relevance)

2014/C 391/01

On 30 October 2014, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English language and will be made public after it is cleared of any business secrets it may contain. It will be available:

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

—

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

| — | in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32014M7428. EUR-Lex is the online access to the European law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32014M7428. EUR-Lex is the online access to the European law.

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

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 6.11.2014 | EN | Official Journal of the European Union | C 391/2 |
| --- | --- | --- | --- |

6.11.2014

EN

Official Journal of the European Union

C 391/2

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Euro exchange rates (1)

5 November 2014

2014/C 391/02

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2480 |
| JPY | Japanese yen | 143,21 |
| DKK | Danish krone | 7,4426 |
| GBP | Pound sterling | 0,78430 |
| SEK | Swedish krona | 9,2164 |
| CHF | Swiss franc | 1,2043 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 8,5740 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 27,823 |
| HUF | Hungarian forint | 309,05 |
| LTL | Lithuanian litas | 3,4528 |
| PLN | Polish zloty | 4,2336 |
| RON | Romanian leu | 4,4193 |
| TRY | Turkish lira | 2,7919 |
| AUD | Australian dollar | 1,4494 |
| CAD | Canadian dollar | 1,4281 |
| HKD | Hong Kong dollar | 9,6747 |
| NZD | New Zealand dollar | 1,6135 |
| SGD | Singapore dollar | 1,6170 |
| KRW | South Korean won | 1 360,83 |
| ZAR | South African rand | 13,9000 |
| CNY | Chinese yuan renminbi | 7,6310 |
| HRK | Croatian kuna | 7,6628 |
| IDR | Indonesian rupiah | 15 223,74 |
| MYR | Malaysian ringgit | 4,1798 |
| PHP | Philippine peso | 56,288 |
| RUB | Russian rouble | 55,3520 |
| THB | Thai baht | 40,993 |
| BRL | Brazilian real | 3,1428 |
| MXN | Mexican peso | 16,9834 |
| INR | Indian rupee | 76,7511 |

Currency

Exchange rate

USD

US dollar

1,2480

JPY

Japanese yen

143,21

DKK

Danish krone

7,4426

GBP

Pound sterling

0,78430

SEK

Swedish krona

9,2164

CHF

Swiss franc

1,2043

ISK

Iceland króna

NOK

Norwegian krone

8,5740

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

27,823

HUF

Hungarian forint

309,05

LTL

Lithuanian litas

3,4528

PLN

Polish zloty

4,2336

RON

Romanian leu

4,4193

TRY

Turkish lira

2,7919

AUD

Australian dollar

1,4494

CAD

Canadian dollar

1,4281

HKD

Hong Kong dollar

9,6747

NZD

New Zealand dollar

1,6135

SGD

Singapore dollar

1,6170

KRW

South Korean won

1 360,83

ZAR

South African rand

13,9000

CNY

Chinese yuan renminbi

7,6310

HRK

Croatian kuna

7,6628

IDR

Indonesian rupiah

15 223,74

MYR

Malaysian ringgit

4,1798

PHP

Philippine peso

56,288

RUB

Russian rouble

55,3520

THB

Thai baht

40,993

BRL

Brazilian real

3,1428

MXN

Mexican peso

16,9834

INR

Indian rupee

76,7511

---

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

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NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

| 6.11.2014 | EN | Official Journal of the European Union | C 391/3 |
| --- | --- | --- | --- |

6.11.2014

EN

Official Journal of the European Union

C 391/3

---

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2013

2014/C 391/03

Subcommitee 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 2013, at their meeting on 4 April 2014:

| 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 2013:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/12/788/001-006 | Seebri Breezhaler | Liechtenstein | 30.4.2013 |
| EU/1/12/789/001-006 | Enurev Breezhaler | Liechtenstein | 30.4.2013 |
| EU/1/12/790/001-006 | Tovanor Breezhaler | Liechtenstein | 30.4.2013 |
| EU/1/12/791/001 | Glybera | Liechtenstein | 30.4.2013 |
| EU/1/12/795/001-010 | Forxiga | Liechtenstein | 30.4.2013 |
| EU/1/12/797/001-002 | Eylea | Liechtenstein | 30.4.2013 |
| EU/1/12/803/001-002 | NexoBrid | Liechtenstein | 30.4.2013 |
| EU/1/12/803/001-002 | NexoBrid | Iceland | 14.1.2013 |
| EU/1/12/803/001-002 | NexoBrid | Norway | 11.1.2013 |
| EU/1/12/804/001-016 | BindRen | Liechtenstein | 30.4.2013 |
| EU/1/12/804/001-016 | BindRen | Iceland | 8.2.2013 |
| EU/1/12/804/001-016 | BindRen | Norway | 27.2.2013 |
| EU/1/12/805 | Amyvid | Liechtenstein | 28.2.2013 |
| EU/1/12/805/001-004 | AMYViD | Iceland | 6.2.2013 |
| EU/1/12/805/001-004 | AMYViD | Norway | 4.2.2013 |
| EU/1/12/806/001-005 | Ryzodeg | Liechtenstein | 28.2.2013 |
| EU/1/12/806/001-005 | Ryzodeg | Iceland | 20.2.2013 |
| EU/1/12/806/001-005 | Ryzodeg | Norway | 12.2.2013 |
| EU/1/12/807/001-009 | Tresiba | Liechtenstein | 28.2.2013 |
| EU/1/12/807/001-009 | Tresiba | Iceland | 20.2.2013 |
| EU/1/12/807/001-009 | Tresiba | Norway | 12.2.2013 |
| EU/1/12/808/001-040 | Imatinib Teva | Liechtenstein | 28.2.2013 |
| EU/1/12/808/001-040 | Imatinib Teva | Iceland | 5.2.2013 |
| EU/1/12/808/001-040 | Imatinib Teva | Norway | 22.1.2013 |
| EU/1/12/809/001-014 | Betmiga | Liechtenstein | 28.2.2013 |
| EU/1/12/809/001-014 | Betmiga | Iceland | 10.1.2013 |
| EU/1/12/809/001-014 | Betmiga | Norway | 17.1.2013 |
| EU/1/12/810 | Krystexxa | Liechtenstein | 30.4.2013 |
| EU/1/12/810/001 | Krystexxa | Iceland | 14.1.2013 |
| EU/1/12/810/001 | Krystexxa | Norway | 25.1.2013 |
| EU/1/12/811/001-005 | Lyxumia | Iceland | 12.2.2013 |
| EU/1/12/811/001-005 | Lyxumia | Norway | 12.2.2013 |
| EU/1/12/812 | Bexsero | Liechtenstein | 28.2.2013 |
| EU/1/12/812/001-004 | Bexsero | Iceland | 14.2.2013 |
| EU/1/12/812/001-004 | Bexsero | Norway | 4.2.2013 |
| EU/1/12/814 | Zaltrap | Liechtenstein | 28.2.2013 |
| EU/1/12/814/001-003 | Zaltrap | Iceland | 12.2.2013 |
| EU/1/12/814/001-003 | Zaltrap | Norway | 27.2.2013 |
| EU/1/12/815/001-005 | Selincro | Liechtenstein | 30.4.2013 |
| EU/1/12/815/001-005 | Selincro | Iceland | 19.3.2013 |
| EU/1/12/815/001-005 | Selincro | Norway | 11.3.2013 |
| EU/1/13/813/001 | Perjeta | Liechtenstein | 30.4.2013 |
| EU/1/13/813/001 | Perjeta | Iceland | 20.3.2013 |
| EU/1/13/813/001 | Perjeta | Norway | 9.4.2013 |
| EU/1/13/817/001-041 | Actelsar HCT | Iceland | 21.3.2013 |
| EU/1/13/817/001-041 | Actelsar HCT | Norway | 22.4.2013 |
| EU/1/13/818/001-004 | Bosulif | Iceland | 15.4.2013 |
| EU/1/13/818/001-004 | Bosulif | Norway | 30.4.2013 |
| EU/1/13/819/001 | JETREA | Liechtenstein | 30.4.2013 |
| EU/1/13/819/001 | JETREA | Iceland | 11.4.2013 |
| EU/1/13/819/001 | JETREA | Norway | 22.3.2013 |
| EU/1/13/820/001-026 | Maruxa | Liechtenstein | 30.6.2013 |
| EU/1/13/820/001-026 | Maruxa | Norway | 24.5.2013 |
| EU/1/13/821/001-030 | Tolucombi | Liechtenstein | 30.4.2013 |
| EU/1/13/821/001-030 | Tolucombi | Iceland | 21.3.2013 |
| EU/1/13/821/001-030 | Tolucombi | Norway | 22.3.2013 |
| EU/1/13/823/001-002 | Adasuve | Norway | 12.3.2013 |
| EU/1/13/823/001-002 | Adasuve | Liechtenstein | 30.4.2013 |
| EU/1/13/823/001-002 | Adasuve | Iceland | 18.3.2013 |
| EU/1/13/824 | Nemdatine | Liechtenstein | 30.4.2013 |
| EU/1/13/824/001-020 | Nemdatine | Iceland | 21.5.2013 |
| EU/1/13/824/001-020 | Nemdatine | Norway | 3.5.2013 |
| EU/1/13/825 | Imatinib Actavis | Liechtenstein | 30.6.2013 |
| EU/1/13/825/001-018 | Imatinib Actavis | Iceland | 16.5.2013 |
| EU/1/13/825/001-018 | Imatinib Actavis | Norway | 20.6.2013 |
| EU/1/13/826 | Memantine LEK | Liechtenstein | 30.4.2013 |
| EU/1/13/826/001-011 | Memantine LEK | Iceland | 21.5.2013 |
| EU/1/13/826/001-011 | Memantine LEK | Norway | 3.5.2013 |
| EU/1/13/827 | Memantine Mylan | Liechtenstein | 30.4.2013 |
| EU/1/13/827/001-036 | Memantine Mylan | Iceland | 21.5.2013 |
| EU/1/13/827/001-036 | Memantine Mylan | Norway | 3.5.2013 |
| EU/1/13/828 | Hexacima | Liechtenstein | 30.4.2013 |
| EU/1/13/828/001-007 | Hexacima | Iceland | 17.5.2013 |
| EU/1/13/828/001-007 | Hexacima | Norway | 15.5.2013 |
| EU/1/13/829 | Hexyon | Liechtenstein | 30.4.2013 |
| EU/1/13/829/001-007 | Hexyon | Iceland | 17.5.2013 |
| EU/1/13/829/001-007 | Hexyon | Norway | 15.5.2013 |
| EU/1/13/830/001-002 | Stribild | Iceland | 19.6.2013 |
| EU/1/13/830/001-002 | Stribild | Norway | 24.5.2013 |
| EU/1/13/835/001-018 | Voriconazole Accord | Iceland | 31.5.2013 |
| EU/1/13/835/001-018 | Voriconazole Accord | Norway | 31.5.2013 |
| EU/1/13/836 | Memantine ratiopharm | Liechtenstein | 30.6.2013 |
| EU/1/13/836/001-023 | Memantine ratiopharm | Norway | 25.6.2013 |
| EU/1/13/840/001-005 | HyQvia | Iceland | 27.5.2013 |
| EU/1/13/840/001-005 | HyQvia | Norway | 3.6.2013 |
| EU/2/12/142/001-006 | Cardalis | Norway | 20.6.2013 |
| EU/2/12/144/001-004 | Contacera | Liechtenstein | 28.2.2013 |
| EU/2/12/144/001-004 | Contacera | Iceland | 3.1.2013 |
| EU/2/12/144/001-004 | Contacera | Norway | 17.1.2013 |
| EU/2/12/145/001-003 | Kexxtone | Liechtenstein | 30.4.2013 |
| EU/2/12/145/001-003 | Kexxtone | Iceland | 27.2.2013 |
| EU/2/12/145/001-003 | Kexxtone | Norway | 8.3.2013 |
| EU/2/12/146/001 | Semintra | Liechtenstein | 30.4.2013 |
| EU/2/12/146/001 | Semintra | Iceland | 12.3.2013 |
| EU/2/12/146/001 | Semintra | Norway | 5.4.2013 |
| EU/2/12/147/001-004 | Pexion | Liechtenstein | 30.4.2013 |
| EU/2/12/147/001-004 | Pexion | Iceland | 19.3.2013 |
| EU/2/12/147/001-004 | Pexion | Norway | 8.3.2013 |
| EU/2/13/148 | Meloxidolor | Liechtenstein | 30.6.2013 |
| EU/2/13/148/001-007 | Meloxidolor | Iceland | 21.5.2013 |
| EU/2/13/148/001-007 | Meloxidolor | Norway | 22.4.2013 |
| EU/2/13/149 | ECOPORC SHIGA | Liechtenstein | 30.4.2013 |
| EU/2/13/149/001-002 | ECOPORC SHIGA | Iceland | 15.5.2013 |
| EU/2/13/149/001-002 | ECOPORC SHIGA | Norway | 13.5.2013 |
| EU/2/13/150 | Oncept IL-2 | Liechtenstein | 30.6.2013 |
| EU/2/13/151/001-003 | Equilis West Nile | Iceland | 27.6.2013 |

EU-Number

Product

Country

Date of authorisation

EU/1/12/788/001-006

Seebri Breezhaler

Liechtenstein

30.4.2013

EU/1/12/789/001-006

Enurev Breezhaler

Liechtenstein

30.4.2013

EU/1/12/790/001-006

Tovanor Breezhaler

Liechtenstein

30.4.2013

EU/1/12/791/001

Glybera

Liechtenstein

30.4.2013

EU/1/12/795/001-010

Forxiga

Liechtenstein

30.4.2013

EU/1/12/797/001-002

Eylea

Liechtenstein

30.4.2013

EU/1/12/803/001-002

NexoBrid

Liechtenstein

30.4.2013

EU/1/12/803/001-002

NexoBrid

Iceland

14.1.2013

EU/1/12/803/001-002

NexoBrid

Norway

11.1.2013

EU/1/12/804/001-016

BindRen

Liechtenstein

30.4.2013

EU/1/12/804/001-016

BindRen

Iceland

8.2.2013

EU/1/12/804/001-016

BindRen

Norway

27.2.2013

EU/1/12/805

Amyvid

Liechtenstein

28.2.2013

EU/1/12/805/001-004

AMYViD

Iceland

6.2.2013

EU/1/12/805/001-004

AMYViD

Norway

4.2.2013

EU/1/12/806/001-005

Ryzodeg

Liechtenstein

28.2.2013

EU/1/12/806/001-005

Ryzodeg

Iceland

20.2.2013

EU/1/12/806/001-005

Ryzodeg

Norway

12.2.2013

EU/1/12/807/001-009

Tresiba

Liechtenstein

28.2.2013

EU/1/12/807/001-009

Tresiba

Iceland

20.2.2013

EU/1/12/807/001-009

Tresiba

Norway

12.2.2013

EU/1/12/808/001-040

Imatinib Teva

Liechtenstein

28.2.2013

EU/1/12/808/001-040

Imatinib Teva

Iceland

5.2.2013

EU/1/12/808/001-040

Imatinib Teva

Norway

22.1.2013

EU/1/12/809/001-014

Betmiga

Liechtenstein

28.2.2013

EU/1/12/809/001-014

Betmiga

Iceland

10.1.2013

EU/1/12/809/001-014

Betmiga

Norway

17.1.2013

EU/1/12/810

Krystexxa

Liechtenstein

30.4.2013

EU/1/12/810/001

Krystexxa

Iceland

14.1.2013

EU/1/12/810/001

Krystexxa

Norway

25.1.2013

EU/1/12/811/001-005

Lyxumia

Iceland

12.2.2013

EU/1/12/811/001-005

Lyxumia

Norway

12.2.2013

EU/1/12/812

Bexsero

Liechtenstein

28.2.2013

EU/1/12/812/001-004

Bexsero

Iceland

14.2.2013

EU/1/12/812/001-004

Bexsero

Norway

4.2.2013

EU/1/12/814

Zaltrap

Liechtenstein

28.2.2013

EU/1/12/814/001-003

Zaltrap

Iceland

12.2.2013

EU/1/12/814/001-003

Zaltrap

Norway

27.2.2013

EU/1/12/815/001-005

Selincro

Liechtenstein

30.4.2013

EU/1/12/815/001-005

Selincro

Iceland

19.3.2013

EU/1/12/815/001-005

Selincro

Norway

11.3.2013

EU/1/13/813/001

Perjeta

Liechtenstein

30.4.2013

EU/1/13/813/001

Perjeta

Iceland

20.3.2013

EU/1/13/813/001

Perjeta

Norway

9.4.2013

EU/1/13/817/001-041

Actelsar HCT

Iceland

21.3.2013

EU/1/13/817/001-041

Actelsar HCT

Norway

22.4.2013

EU/1/13/818/001-004

Bosulif

Iceland

15.4.2013

EU/1/13/818/001-004

Bosulif

Norway

30.4.2013

EU/1/13/819/001

JETREA

Liechtenstein

30.4.2013

EU/1/13/819/001

JETREA

Iceland

11.4.2013

EU/1/13/819/001

JETREA

Norway

22.3.2013

EU/1/13/820/001-026

Maruxa

Liechtenstein

30.6.2013

EU/1/13/820/001-026

Maruxa

Norway

24.5.2013

EU/1/13/821/001-030

Tolucombi

Liechtenstein

30.4.2013

EU/1/13/821/001-030

Tolucombi

Iceland

21.3.2013

EU/1/13/821/001-030

Tolucombi

Norway

22.3.2013

EU/1/13/823/001-002

Adasuve

Norway

12.3.2013

EU/1/13/823/001-002

Adasuve

Liechtenstein

30.4.2013

EU/1/13/823/001-002

Adasuve

Iceland

18.3.2013

EU/1/13/824

Nemdatine

Liechtenstein

30.4.2013

EU/1/13/824/001-020

Nemdatine

Iceland

21.5.2013

EU/1/13/824/001-020

Nemdatine

Norway

3.5.2013

EU/1/13/825

Imatinib Actavis

Liechtenstein

30.6.2013

EU/1/13/825/001-018

Imatinib Actavis

Iceland

16.5.2013

EU/1/13/825/001-018

Imatinib Actavis

Norway

20.6.2013

EU/1/13/826

Memantine LEK

Liechtenstein

30.4.2013

EU/1/13/826/001-011

Memantine LEK

Iceland

21.5.2013

EU/1/13/826/001-011

Memantine LEK

Norway

3.5.2013

EU/1/13/827

Memantine Mylan

Liechtenstein

30.4.2013

EU/1/13/827/001-036

Memantine Mylan

Iceland

21.5.2013

EU/1/13/827/001-036

Memantine Mylan

Norway

3.5.2013

EU/1/13/828

Hexacima

Liechtenstein

30.4.2013

EU/1/13/828/001-007

Hexacima

Iceland

17.5.2013

EU/1/13/828/001-007

Hexacima

Norway

15.5.2013

EU/1/13/829

Hexyon

Liechtenstein

30.4.2013

EU/1/13/829/001-007

Hexyon

Iceland

17.5.2013

EU/1/13/829/001-007

Hexyon

Norway

15.5.2013

EU/1/13/830/001-002

Stribild

Iceland

19.6.2013

EU/1/13/830/001-002

Stribild

Norway

24.5.2013

EU/1/13/835/001-018

Voriconazole Accord

Iceland

31.5.2013

EU/1/13/835/001-018

Voriconazole Accord

Norway

31.5.2013

EU/1/13/836

Memantine ratiopharm

Liechtenstein

30.6.2013

EU/1/13/836/001-023

Memantine ratiopharm

Norway

25.6.2013

EU/1/13/840/001-005

HyQvia

Iceland

27.5.2013

EU/1/13/840/001-005

HyQvia

Norway

3.6.2013

EU/2/12/142/001-006

Cardalis

Norway

20.6.2013

EU/2/12/144/001-004

Contacera

Liechtenstein

28.2.2013

EU/2/12/144/001-004

Contacera

Iceland

3.1.2013

EU/2/12/144/001-004

Contacera

Norway

17.1.2013

EU/2/12/145/001-003

Kexxtone

Liechtenstein

30.4.2013

EU/2/12/145/001-003

Kexxtone

Iceland

27.2.2013

EU/2/12/145/001-003

Kexxtone

Norway

8.3.2013

EU/2/12/146/001

Semintra

Liechtenstein

30.4.2013

EU/2/12/146/001

Semintra

Iceland

12.3.2013

EU/2/12/146/001

Semintra

Norway

5.4.2013

EU/2/12/147/001-004

Pexion

Liechtenstein

30.4.2013

EU/2/12/147/001-004

Pexion

Iceland

19.3.2013

EU/2/12/147/001-004

Pexion

Norway

8.3.2013

EU/2/13/148

Meloxidolor

Liechtenstein

30.6.2013

EU/2/13/148/001-007

Meloxidolor

Iceland

21.5.2013

EU/2/13/148/001-007

Meloxidolor

Norway

22.4.2013

EU/2/13/149

ECOPORC SHIGA

Liechtenstein

30.4.2013

EU/2/13/149/001-002

ECOPORC SHIGA

Iceland

15.5.2013

EU/2/13/149/001-002

ECOPORC SHIGA

Norway

13.5.2013

EU/2/13/150

Oncept IL-2

Liechtenstein

30.6.2013

EU/2/13/151/001-003

Equilis West Nile

Iceland

27.6.2013

---

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 2013:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/03/247 | Forsteo | Liechtenstein | 30.4.2013 |
| EU/1/03/247/001-002 | Forsteo | Iceland | 19.2.2013 |
| EU/1/03/247/001-002 | Forsteo | Norway | 6.3.2013 |
| EU/1/07/423 | Vectibix | Liechtenstein | 30.4.2013 |
| EU/1/07/423/001-003 | Vectibix | Iceland | 5.2.2013 |
| EU/1/07/423/001-003 | Vectibix | Norway | 12.2.2013 |
| EU/1/07/428/001 | Abraxane | Liechtenstein | 30.4.2013 |
| EU/1/07/428/001 | Abraxane | Iceland | 5.2.2013 |
| EU/1/07/428/001 | Abraxane | Norway | 11.2.2013 |
| EU/1/07/430/001-002 | Atripla | Liechtenstein | 30.4.2013 |
| EU/1/07/433/001 | Nevanac | Iceland | 9.1.2013 |
| EU/1/07/434 | Avamys | Liechtenstein | 28.2.2013 |
| EU/1/07/434/001-003 | Avamys | Iceland | 11.1.2013 |
| EU/1/07/434/001-003 | Avamys | Norway | 14.1.2013 |
| EU/1/07/435/001-018 | Tesavel | Liechtenstein | 30.4.2013 |
| EU/1/07/438/001-006 | Myfenax | Liechtenstein | 30.4.2013 |
| EU/1/07/439/001-006 | Mycophenolate mofetil Teva | Liechtenstein | 30.4.2013 |
| EU/1/07/440 | Tyverb | Liechtenstein | 30.4.2013 |
| EU/1/07/440/001-007 | Tyverb | Norway | 15.5.2013 |
| EU/1/08/441 | Effentora | Liechtenstein | 30.4.2013 |
| EU/1/08/441/001-010 | Effentora | Iceland | 20.3.2013 |
| EU/1/08/441/001-010 | Effentora | Norway | 12.3.2013 |
| EU/1/08/442/001-019 | Pradaxa | Norway | 26.2.2013 |
| EU/1/08/442/001-019 | Pradaxa | Liechtenstein | 30.4.2013 |
| EU/1/08/442/001-019 | Pradaxa | Iceland | 15.2.2013 |
| EU/1/08/443/001 | Thalidomide Celgene | Iceland | 14.1.2013 |
| EU/1/08/443/001 | Thalidomide Celgene | Norway | 16.1.2013 |
| EU/1/08/446/001-006 | Privigen | Iceland | 22.3.2013 |
| EU/1/08/446/001-006 | Privigen | Norway | 21.3.2013 |
| EU/1/08/447/001-012 | Adenuric | Norway | 15.1.2013 |
| EU/1/08/447/001-012 | Adenuric | Liechtenstein | 30.4.2013 |
| EU/1/08/447/001-012 | Adenuric | Iceland | 14.1.2013 |
| EU/1/08/448/001-002 | Mycamine | Liechtenstein | 30.4.2013 |
| EU/1/08/448/001-002 | Mycamine | Iceland | 24.1.2013 |
| EU/1/08/448/001-002 | Mycamine | Norway | 12.2.2013 |
| EU/1/08/451 | Volibris | Liechtenstein | 30.4.2013 |
| EU/1/08/451/001-004 | Volibris | Iceland | 5.2.2013 |
| EU/1/08/451/001-004 | Volibris | Norway | 12.2.2013 |
| EU/1/08/453 | Prepandrix | Liechtenstein | 30.4.2013 |
| EU/1/08/453/002 | Prepandrix | Iceland | 6.2.2013 |
| EU/1/08/453/002 | Prepandrix | Norway | 4.2.2013 |
| EU/1/08/454/001-002, 005-007 | Extavia | Iceland | 9.1.2013 |
| EU/1/08/454/001-002, 005-007 | Extavia | Liechtenstein | 30.4.2013 |
| EU/1/08/454/001-002, 005-007 | Extavia | Norway | 10.1.2013 |
| EU/1/08/455 | Janumet | Liechtenstein | 30.4.2013 |
| EU/1/08/455/001-006 | Janumet | Norway | 10.4.2013 |
| EU/1/08/455/001-016 | Janumet | Iceland | 25.3.2013 |
| EU/1/08/456 | Velmetia | Liechtenstein | 30.4.2013 |
| EU/1/08/456/001-016 | Velmetia | Iceland | 26.3.2013 |
| EU/1/08/457 | Efficib | Liechtenstein | 30.4.2013 |
| EU/1/08/457/001-016 | Efficib | Iceland | 26.3.2013 |
| EU/1/08/461 | Firazyr | Liechtenstein | 30.4.2013 |
| EU/1/08/461/001-002 | Firazyr | Iceland | 11.4.2013 |
| EU/1/08/461/001-002 | Firazyr | Norway | 10.4.2013 |
| EU/1/08/462 | Ranexa | Liechtenstein | 30.4.2013 |
| EU/1/08/462/001-002 | Ranexa | Norway | 9.4.2013 |
| EU/1/08/462/001-012 | Ranexa | Iceland | 20.3.2013 |
| EU/1/08/463 | Relistor | Liechtenstein | 30.6.2013 |
| EU/1/08/463/001-011 | Relistor | Iceland | 21.6.2013 |
| EU/1/08/463/001-011 | Relistor | Norway | 26.6.2013 |
| EU/1/08/465 | Clopidogrel Zentiva | Liechtenstein | 28.2.2013 |
| EU/1/08/465/001-021 | Clopidogrel Zentiva | Iceland | 3.1.2013 |
| EU/1/08/465/001-021 | Clopidogrel Zentiva | Norway | 5.2.2013 |
| EU/1/08/467 | Doribax | Liechtenstein | 30.6.2013 |
| EU/1/08/467/001-002 | Doribax | Iceland | 17.5.2013 |
| EU/1/08/469 | Oprymea | Liechtenstein | 30.4.2013 |
| EU/1/08/469/001-025 | Oprymea | Iceland | 14.5.2013 |
| EU/1/08/469/001-025 | Oprymea | Norway | 24.5.2013 |
| EU/1/08/472 | Xarelto | Liechtenstein | 30.6.2013 |
| EU/1/08/472/001-033 | Xarelto | Norway | 13.6.2013 |
| EU/1/08/472/001-033 | Xarelto | Iceland | 20.6.2013 |
| EU/1/08/475 | Olanzapine Mylan | Liechtenstein | 30.6.2013 |
| EU/1/08/475/001-060 | Olanzapine Mylan | Iceland | 20.6.2013 |
| EU/1/08/475/001-060 | Olanzapine Mylan | Norway | 7.6.2013 |
| EU/1/08/476 | Adcirca | Liechtenstein | 30.6.2013 |
| EU/1/08/476/005-006 | Adcirca | Iceland | 31.5.2013 |
| EU/1/08/476/005-006 | Adcirca | Norway | 4.6.2013 |
| EU/1/10/625 | Arzerra | Liechtenstein | 30.4.2013 |
| EU/1/10/625/001, 003 | Arzerra | Iceland | 15.3.2013 |
| EU/1/10/625/001, 003 | Arzerra | Norway | 9.4.2013 |
| EU/1/11/749 | Caprelsa | Liechtenstein | 30.4.2013 |
| EU/1/11/749/001-002 | Caprelsa | Iceland | 12.3.2013 |
| EU/1/11/749/001-002 | Caprelsa | Norway | 9.4.2013 |
| EU/1/12/764 | Pixuvri | Liechtenstein | 30.4.2013 |
| EU/1/12/764/001 | Pixuvri | Iceland | 12.4.2013 |
| EU/1/12/764/001 | Pixuvri | Norway | 9.4.2013 |
| EU/1/97/055/001-009 | Viramune | Liechtenstein | 30.4.2013 |
| EU/1/97/055/001-009 | Viramune | Iceland | 14.1.2013 |
| EU/1/97/055/001-009 | Viramune | Norway | 22.1.2013 |
| EU/2/02/032/001-002 | Vaxxitec HVT+IBD | Norway | 11.6.2013 |
| EU/2/03/037 | ProteqFlu | Liechtenstein | 30.4.2013 |
| EU/2/03/037/005 | ProteqFlu | Iceland | 21.3.2013 |
| EU/2/03/037/005 | ProteqFlu | Norway | 20.6.2013 |
| EU/2/03/038 | ProteqFlu-Te | Liechtenstein | 30.4.2013 |
| EU/2/03/038/005 | ProteqFlu-Te | Iceland | 21.3.2013 |
| EU/2/03/038/005 | ProteqFlu-Te | Norway | 20.6.2013 |
| EU/2/03/039 | Advocate | Liechtenstein | 28.2.2013 |
| EU/2/03/039/001-054 | Advocate | Iceland | 19.2.2013 |
| EU/2/03/039/001-054 | Advocate | Norway | 5.3.2013 |
| EU/2/07/074/001-006 | Prilactone | Norway | 11.6.2013 |
| EU/2/07/077/001-005 | Meloxivet | Norway | 5.4.2013 |
| EU/2/07/078 | Rheumocam | Liechtenstein | 28.2.2013 |
| EU/2/07/078/001-020 | Rheumocam | Iceland | 11.1.2013 |
| EU/2/07/078/001-020 | Rheumocam | Norway | 21.1.2013 |
| EU/2/07/079 | Ingelvac CircoFLEX | Liechtenstein | 30.4.2013 |
| EU/2/07/079/001-008 | Ingelvac CircoFLEX | Iceland | 7.2.2013 |
| EU/2/07/079/001-008 | Ingelvac CircoFLEX | Norway | 5.3.2013 |
| EU/2/08/081/001-003 | Posatex | Iceland | 14.6.2013 |
| EU/2/08/081/001-003 | Posatex | Norway | 11.6.2013 |
| EU/2/08/083/001-005 | Equioxx | Iceland | 28.6.2013 |
| EU/2/08/083/001-005 | Equioxx | Norway | 20.6.2013 |

EU-Number

Product

Country

Date of authorisation

EU/1/03/247

Forsteo

Liechtenstein

30.4.2013

EU/1/03/247/001-002

Forsteo

Iceland

19.2.2013

EU/1/03/247/001-002

Forsteo

Norway

6.3.2013

EU/1/07/423

Vectibix

Liechtenstein

30.4.2013

EU/1/07/423/001-003

Vectibix

Iceland

5.2.2013

EU/1/07/423/001-003

Vectibix

Norway

12.2.2013

EU/1/07/428/001

Abraxane

Liechtenstein

30.4.2013

EU/1/07/428/001

Abraxane

Iceland

5.2.2013

EU/1/07/428/001

Abraxane

Norway

11.2.2013

EU/1/07/430/001-002

Atripla

Liechtenstein

30.4.2013

EU/1/07/433/001

Nevanac

Iceland

9.1.2013

EU/1/07/434

Avamys

Liechtenstein

28.2.2013

EU/1/07/434/001-003

Avamys

Iceland

11.1.2013

EU/1/07/434/001-003

Avamys

Norway

14.1.2013

EU/1/07/435/001-018

Tesavel

Liechtenstein

30.4.2013

EU/1/07/438/001-006

Myfenax

Liechtenstein

30.4.2013

EU/1/07/439/001-006

Mycophenolate mofetil Teva

Liechtenstein

30.4.2013

EU/1/07/440

Tyverb

Liechtenstein

30.4.2013

EU/1/07/440/001-007

Tyverb

Norway

15.5.2013

EU/1/08/441

Effentora

Liechtenstein

30.4.2013

EU/1/08/441/001-010

Effentora

Iceland

20.3.2013

EU/1/08/441/001-010

Effentora

Norway

12.3.2013

EU/1/08/442/001-019

Pradaxa

Norway

26.2.2013

EU/1/08/442/001-019

Pradaxa

Liechtenstein

30.4.2013

EU/1/08/442/001-019

Pradaxa

Iceland

15.2.2013

EU/1/08/443/001

Thalidomide Celgene

Iceland

14.1.2013

EU/1/08/443/001

Thalidomide Celgene

Norway

16.1.2013

EU/1/08/446/001-006

Privigen

Iceland

22.3.2013

EU/1/08/446/001-006

Privigen

Norway

21.3.2013

EU/1/08/447/001-012

Adenuric

Norway

15.1.2013

EU/1/08/447/001-012

Adenuric

Liechtenstein

30.4.2013

EU/1/08/447/001-012

Adenuric

Iceland

14.1.2013

EU/1/08/448/001-002

Mycamine

Liechtenstein

30.4.2013

EU/1/08/448/001-002

Mycamine

Iceland

24.1.2013

EU/1/08/448/001-002

Mycamine

Norway

12.2.2013

EU/1/08/451

Volibris

Liechtenstein

30.4.2013

EU/1/08/451/001-004

Volibris

Iceland

5.2.2013

EU/1/08/451/001-004

Volibris

Norway

12.2.2013

EU/1/08/453

Prepandrix

Liechtenstein

30.4.2013

EU/1/08/453/002

Prepandrix

Iceland

6.2.2013

EU/1/08/453/002

Prepandrix

Norway

4.2.2013

EU/1/08/454/001-002, 005-007

Extavia

Iceland

9.1.2013

EU/1/08/454/001-002, 005-007

Extavia

Liechtenstein

30.4.2013

EU/1/08/454/001-002, 005-007

Extavia

Norway

10.1.2013

EU/1/08/455

Janumet

Liechtenstein

30.4.2013

EU/1/08/455/001-006

Janumet

Norway

10.4.2013

EU/1/08/455/001-016

Janumet

Iceland

25.3.2013

EU/1/08/456

Velmetia

Liechtenstein

30.4.2013

EU/1/08/456/001-016

Velmetia

Iceland

26.3.2013

EU/1/08/457

Efficib

Liechtenstein

30.4.2013

EU/1/08/457/001-016

Efficib

Iceland

26.3.2013

EU/1/08/461

Firazyr

Liechtenstein

30.4.2013

EU/1/08/461/001-002

Firazyr

Iceland

11.4.2013

EU/1/08/461/001-002

Firazyr

Norway

10.4.2013

EU/1/08/462

Ranexa

Liechtenstein

30.4.2013

EU/1/08/462/001-002

Ranexa

Norway

9.4.2013

EU/1/08/462/001-012

Ranexa

Iceland

20.3.2013

EU/1/08/463

Relistor

Liechtenstein

30.6.2013

EU/1/08/463/001-011

Relistor

Iceland

21.6.2013

EU/1/08/463/001-011

Relistor

Norway

26.6.2013

EU/1/08/465

Clopidogrel Zentiva

Liechtenstein

28.2.2013

EU/1/08/465/001-021

Clopidogrel Zentiva

Iceland

3.1.2013

EU/1/08/465/001-021

Clopidogrel Zentiva

Norway

5.2.2013

EU/1/08/467

Doribax

Liechtenstein

30.6.2013

EU/1/08/467/001-002

Doribax

Iceland

17.5.2013

EU/1/08/469

Oprymea

Liechtenstein

30.4.2013

EU/1/08/469/001-025

Oprymea

Iceland

14.5.2013

EU/1/08/469/001-025

Oprymea

Norway

24.5.2013

EU/1/08/472

Xarelto

Liechtenstein

30.6.2013

EU/1/08/472/001-033

Xarelto

Norway

13.6.2013

EU/1/08/472/001-033

Xarelto

Iceland

20.6.2013

EU/1/08/475

Olanzapine Mylan

Liechtenstein

30.6.2013

EU/1/08/475/001-060

Olanzapine Mylan

Iceland

20.6.2013

EU/1/08/475/001-060

Olanzapine Mylan

Norway

7.6.2013

EU/1/08/476

Adcirca

Liechtenstein

30.6.2013

EU/1/08/476/005-006

Adcirca

Iceland

31.5.2013

EU/1/08/476/005-006

Adcirca

Norway

4.6.2013

EU/1/10/625

Arzerra

Liechtenstein

30.4.2013

EU/1/10/625/001, 003

Arzerra

Iceland

15.3.2013

EU/1/10/625/001, 003

Arzerra

Norway

9.4.2013

EU/1/11/749

Caprelsa

Liechtenstein

30.4.2013

EU/1/11/749/001-002

Caprelsa

Iceland

12.3.2013

EU/1/11/749/001-002

Caprelsa

Norway

9.4.2013

EU/1/12/764

Pixuvri

Liechtenstein

30.4.2013

EU/1/12/764/001

Pixuvri

Iceland

12.4.2013

EU/1/12/764/001

Pixuvri

Norway

9.4.2013

EU/1/97/055/001-009

Viramune

Liechtenstein

30.4.2013

EU/1/97/055/001-009

Viramune

Iceland

14.1.2013

EU/1/97/055/001-009

Viramune

Norway

22.1.2013

EU/2/02/032/001-002

Vaxxitec HVT+IBD

Norway

11.6.2013

EU/2/03/037

ProteqFlu

Liechtenstein

30.4.2013

EU/2/03/037/005

ProteqFlu

Iceland

21.3.2013

EU/2/03/037/005

ProteqFlu

Norway

20.6.2013

EU/2/03/038

ProteqFlu-Te

Liechtenstein

30.4.2013

EU/2/03/038/005

ProteqFlu-Te

Iceland

21.3.2013

EU/2/03/038/005

ProteqFlu-Te

Norway

20.6.2013

EU/2/03/039

Advocate

Liechtenstein

28.2.2013

EU/2/03/039/001-054

Advocate

Iceland

19.2.2013

EU/2/03/039/001-054

Advocate

Norway

5.3.2013

EU/2/07/074/001-006

Prilactone

Norway

11.6.2013

EU/2/07/077/001-005

Meloxivet

Norway

5.4.2013

EU/2/07/078

Rheumocam

Liechtenstein

28.2.2013

EU/2/07/078/001-020

Rheumocam

Iceland

11.1.2013

EU/2/07/078/001-020

Rheumocam

Norway

21.1.2013

EU/2/07/079

Ingelvac CircoFLEX

Liechtenstein

30.4.2013

EU/2/07/079/001-008

Ingelvac CircoFLEX

Iceland

7.2.2013

EU/2/07/079/001-008

Ingelvac CircoFLEX

Norway

5.3.2013

EU/2/08/081/001-003

Posatex

Iceland

14.6.2013

EU/2/08/081/001-003

Posatex

Norway

11.6.2013

EU/2/08/083/001-005

Equioxx

Iceland

28.6.2013

EU/2/08/083/001-005

Equioxx

Norway

20.6.2013

---

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 2013:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/200/003-009 | Viread | Norway | 11.1.2013 |
| EU/1/02/221/017 | Pegasys | Iceland | 26.3.2013 |
| EU/1/02/221/017 | Pegasys | Norway | 26.3.2013 |
| EU/1/06/380/006-007 | Prezista | Liechtenstein | 28.2.2013 |
| EU/1/06/380/007 | Prezista | Iceland | 6.2.2013 |
| EU/1/06/380/007 | Prezista | Norway | 11.2.2013 |
| EU/1/07/433/002 | Nevanac | Norway | 24.5.2013 |
| EU/1/07/436/003-004 | Isentress | Iceland | 19.3.2013 |
| EU/1/07/436/003-004 | Isentress | Norway | 25.2.2013 |
| EU/1/08/468/003 | Intelence | Norway | 17.4.2013 |
| EU/1/09/538/009-010 | Afinitor | Iceland | 5.2.2013 |
| EU/1/09/538/009-010 | Afinitor | Norway | 16.1.2013 |
| EU/1/09/576/041-042 | Irbesartan Teva | Liechtenstein | 28.2.2013 |
| EU/1/11/690/003-004 | Zoely | Liechtenstein | 28.2.2013 |
| EU/1/11/693/017-024 | Rivastigmine Actavis | Iceland | 17.5.2013 |
| EU/1/11/693/017-024 | Rivastigmine Actavis | Norway | 25.6.2013 |
| EU/1/12/750/002 | Esmya | Liechtenstein | 28.2.2013 |
| EU/1/12/770/005 | Docetaxel Kabi | Liechtenstein | 28.2.2013 |
| EU/1/98/066/027-030 | Exelon | Iceland | 7.2.2013 |
| EU/1/98/066/027-030 | Exelon | Norway | 12.2.2013 |
| EU/1/98/077/020-023 | Viagra | Iceland | 17.5.2013 |
| EU/1/98/077/020-023 | Viagra | Norway | 15.5.2013 |
| EU/100/146/033-037 | Keppra | Liechtenstein | 28.2.2013 |
| EU/2/08/090/029-031 | Loxicom | Iceland | 21.3.2013 |
| EU/2/08/090/029-031 | Loxicom | Norway | 6.3.2013 |
| EU/2/10/115/016-019 | Comfortis | Iceland | 8.2.2013 |
| EU/2/10/115/016-019 | Comfortis | Norway | 14.1.2013 |
| EU/2/11/134/018-020 | Inflacam | Norway | 17.1.2013 |

EU-Number

Product

Country

Date of authorisation

EU/1/01/200/003-009

Viread

Norway

11.1.2013

EU/1/02/221/017

Pegasys

Iceland

26.3.2013

EU/1/02/221/017

Pegasys

Norway

26.3.2013

EU/1/06/380/006-007

Prezista

Liechtenstein

28.2.2013

EU/1/06/380/007

Prezista

Iceland

6.2.2013

EU/1/06/380/007

Prezista

Norway

11.2.2013

EU/1/07/433/002

Nevanac

Norway

24.5.2013

EU/1/07/436/003-004

Isentress

Iceland

19.3.2013

EU/1/07/436/003-004

Isentress

Norway

25.2.2013

EU/1/08/468/003

Intelence

Norway

17.4.2013

EU/1/09/538/009-010

Afinitor

Iceland

5.2.2013

EU/1/09/538/009-010

Afinitor

Norway

16.1.2013

EU/1/09/576/041-042

Irbesartan Teva

Liechtenstein

28.2.2013

EU/1/11/690/003-004

Zoely

Liechtenstein

28.2.2013

EU/1/11/693/017-024

Rivastigmine Actavis

Iceland

17.5.2013

EU/1/11/693/017-024

Rivastigmine Actavis

Norway

25.6.2013

EU/1/12/750/002

Esmya

Liechtenstein

28.2.2013

EU/1/12/770/005

Docetaxel Kabi

Liechtenstein

28.2.2013

EU/1/98/066/027-030

Exelon

Iceland

7.2.2013

EU/1/98/066/027-030

Exelon

Norway

12.2.2013

EU/1/98/077/020-023

Viagra

Iceland

17.5.2013

EU/1/98/077/020-023

Viagra

Norway

15.5.2013

EU/100/146/033-037

Keppra

Liechtenstein

28.2.2013

EU/2/08/090/029-031

Loxicom

Iceland

21.3.2013

EU/2/08/090/029-031

Loxicom

Norway

6.3.2013

EU/2/10/115/016-019

Comfortis

Iceland

8.2.2013

EU/2/10/115/016-019

Comfortis

Norway

14.1.2013

EU/2/11/134/018-020

Inflacam

Norway

17.1.2013

---

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 2013:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/03/266 | Bondenza | Liechtenstein | 30.4.2013 |
| EU/1/03/266/001-006 | Bondenza | Norway | 12.6.2013 |
| EU/1/07/409 | Riprazo | Liechtenstein | 30.4.2013 |
| EU/1/07/409/001-040 | Riprazo | Iceland | 27.5.2013 |
| EU/1/07/409/001-040 | Riprazo | Norway | 14.3.2013 |
| EU/1/08/458/001-014 | Trevaclyn | Iceland | 15.5.2013 |
| EU/1/08/458/001-014 | Trevaclyn | Norway | 23.4.2013 |
| EU/1/08/459/001-014 | Tredaptive | Iceland | 15.5.2013 |
| EU/1/08/459/001-014 | Tredaptive | Norway | 23.4.2013 |
| EU/1/08/460/001-014 | Pelzont | Iceland | 15.5.2013 |
| EU/1/08/460/001-014 | Pelzont | Norway | 23.4.2013 |
| EU/1/08/474/001-003 | Alisade | Iceland | 27.6.2013 |
| EU/1/09/582/001 | Rilonacept Regeneron | Liechtenstein | 28.2.2013 |
| EU/1/09/582/001 | Rilonacept Regeneron | Norway | 8.2.2013 |
| EU/1/10/656/001-006 | Possia | Iceland | 15.4.2013 |
| EU/1/10/656/001-006 | Possia | Norway | 12.6.2013 |
| EU/1/11/683/001-080 | Sprimeo HCT | Norway | 21.3.2013 |
| EU/1/12/754/001-021 | Sepioglin | Norway | 20.6.2013 |
| EU/1/97/040/001-002 | Teslascan | Liechtenstein | 28.2.2013 |
| EU/2/04/046 | Nobivac Piro | Liechtenstein | 30.6.2013 |
| EU/2/04/046/001-003 | Nobivac Piro | Iceland | 3.6.2013 |
| EU/2/04/046/001-003 | Nobivac Piro | Norway | 22.5.2013 |

EU-Number

Product

Country

Date of withdrawal

EU/1/03/266

Bondenza

Liechtenstein

30.4.2013

EU/1/03/266/001-006

Bondenza

Norway

12.6.2013

EU/1/07/409

Riprazo

Liechtenstein

30.4.2013

EU/1/07/409/001-040

Riprazo

Iceland

27.5.2013

EU/1/07/409/001-040

Riprazo

Norway

14.3.2013

EU/1/08/458/001-014

Trevaclyn

Iceland

15.5.2013

EU/1/08/458/001-014

Trevaclyn

Norway

23.4.2013

EU/1/08/459/001-014

Tredaptive

Iceland

15.5.2013

EU/1/08/459/001-014

Tredaptive

Norway

23.4.2013

EU/1/08/460/001-014

Pelzont

Iceland

15.5.2013

EU/1/08/460/001-014

Pelzont

Norway

23.4.2013

EU/1/08/474/001-003

Alisade

Iceland

27.6.2013

EU/1/09/582/001

Rilonacept Regeneron

Liechtenstein

28.2.2013

EU/1/09/582/001

Rilonacept Regeneron

Norway

8.2.2013

EU/1/10/656/001-006

Possia

Iceland

15.4.2013

EU/1/10/656/001-006

Possia

Norway

12.6.2013

EU/1/11/683/001-080

Sprimeo HCT

Norway

21.3.2013

EU/1/12/754/001-021

Sepioglin

Norway

20.6.2013

EU/1/97/040/001-002

Teslascan

Liechtenstein

28.2.2013

EU/2/04/046

Nobivac Piro

Liechtenstein

30.6.2013

EU/2/04/046/001-003

Nobivac Piro

Iceland

3.6.2013

EU/2/04/046/001-003

Nobivac Piro

Norway

22.5.2013

---

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 2013:

| EU-Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/09/509/001-004 | Ribavirin Teva | Norway | 3.1.2013 |
| EU/1/09/527/001-006 | Ribavirin Teva Pharma BV | Norway | 3.1.2013 |

EU-Number

Product

Country

Date of suspension

EU/1/09/509/001-004

Ribavirin Teva

Norway

3.1.2013

EU/1/09/527/001-006

Ribavirin Teva Pharma BV

Norway

3.1.2013

---

| 6.11.2014 | EN | Official Journal of the European Union | C 391/15 |
| --- | --- | --- | --- |

6.11.2014

EN

Official Journal of the European Union

C 391/15

---

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2013

2014/C 391/04

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 2013, at their meeting on 16 May 2014:

| 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 2013:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/13/818/001-004 | Bosulif | Liechtenstein | 31.8.2013 |
| EU/1/13/820 | Marixino | Iceland | 22.8.2013 |
| EU/1/13/822 | PHEBURANE | Iceland | 21.8.2013 |
| EU/1/13/822 | PHEBURANE | Norway | 29.8.2013 |
| EU/1/13/830 | Stribild | Norway | 1.7.2013 |
| EU/1/13/831 | Capecitabin SUN | Liechtenstein | 31.8.2013 |
| EU/1/13/831 | Capecitabine SUN | Iceland | 19.7.2013 |
| EU/1/13/831 | Capecitabine SUN | Norway | 26.7.2013 |
| EU/1/13/832 | Stayveer | Liechtenstein | 31.8.2013 |
| EU/1/13/832 | Stayveer | Iceland | 19.7.2013 |
| EU/1/13/832 | Stayveer | Norway | 24.7.2013 |
| EU/1/13/833 | Nuedexta | Liechtenstein | 31.8.2013 |
| EU/1/13/833 | NUEDEXTA | Iceland | 24.7.2013 |
| EU/1/13/833 | Nuedexta | Norway | 3.7.2013 |
| EU/1/13/836 | Memantine ratiopharm | Iceland | 9.8.2013 |
| EU/1/13/838 | AUBAGIO | Liechtenstein | 31.10.2013 |
| EU/1/13/838 | AUBAGIO | Iceland | 9.9.2013 |
| EU/1/13/838 | AUBAGIO | Norway | 18.9.2013 |
| EU/1/13/839 | Iclusig | Liechtenstein | 31.10.2013 |
| EU/1/13/839 | Iclusig | Iceland | 19.7.2013 |
| EU/1/13/839 | Iclusig | Norway | 23.7.2013 |
| EU/1/13/840 | HyQvia | Liechtenstein | 31.10.2013 |
| EU/1/13/841 | Spedra | Liechtenstein | 31.8.2013 |
| EU/1/13/841 | Spedra | Iceland | 19.7.2013 |
| EU/1/13/841 | Spedra | Norway | 19.7.2013 |
| EU/1/13/842 | Incresync | Liechtenstein | 31.10.2013 |
| EU/1/13/842 | Incresync | Iceland | 14.10.2013 |
| EU/1/13/842 | Incresync | Norway | 10.10.2013 |
| EU/1/13/843 | Vipdomet | Liechtenstein | 31.10.2013 |
| EU/1/13/843 | Vipdomet | Iceland | 15.10.2013 |
| EU/1/13/843 | Vipdomet | Norway | 10.10.2013 |
| EU/1/13/844 | Vipidia | Liechtenstein | 31.10.2013 |
| EU/1/13/844 | Vipidia | Iceland | 15.10.2013 |
| EU/1/13/844 | Vipidia | Norway | 10.10.2013 |
| EU/1/13/845 | Imatinib Accord | Iceland | 18.7.2013 |
| EU/1/13/845 | Imatinib Accord | Norway | 18.7.2013 |
| EU/1/13/846 | Xtandi | Iceland | 19.7.2013 |
| EU/1/13/846 | Xtandi | Norway | 17.7.2013 |
| EU/1/13/847 | MACI | Liechtenstein | 31.8.2013 |
| EU/1/13/847 | MACI | Iceland | 24.7.2013 |
| EU/1/13/847 | MACI | Norway | 17.7.2013 |
| EU/1/13/848 | Erivedge | Liechtenstein | 31.8.2013 |
| EU/1/13/848 | Erivedge | Iceland | 8.8.2013 |
| EU/1/13/848 | Erivedge | Norway | 13.8.2013 |
| EU/1/13/849 | Somatropin Biopartners | Liechtenstein | 31.8.2013 |
| EU/1/13/849 | Somatropin Biopartners | Iceland | 22.8.2013 |
| EU/1/13/849 | Somatropin Biopartners | Norway | 10.9.2013 |
| EU/1/13/850 | Pomalidomide Celgene | Iceland | 23.8.2013 |
| EU/1/13/850 | Pomalidomide Celgene | Liechtenstein | 31.10.2013 |
| EU/1/13/850 | Pomalidomide Celgene | Norway | 15.8.2013 |
| EU/1/13/851 | Lojuxta | Liechtenstein | 31.8.2013 |
| EU/1/13/851 | Lojuxta | Iceland | 21.8.2013 |
| EU/1/13/851 | Lojuxta | Norway | 28.8.2013 |
| EU/1/13/852 | Atosiban SUN | Liechtenstein | 31.8.2013 |
| EU/1/13/852 | Atosiban SUN | Iceland | 20.8.2013 |
| EU/1/13/852 | Atosiban SUN | Norway | 29.8.2013 |
| EU/1/13/853 | Remsima | Liechtenstein | 31.10.2013 |
| EU/1/13/853 | Remsima | Iceland | 20.9.2013 |
| EU/1/13/853 | Remsima | Norway | 17.9.2013 |
| EU/1/13/854 | Inflectra | Liechtenstein | 31.10.2013 |
| EU/1/13/854 | Inflectra | Iceland | 20.9.2013 |
| EU/1/13/854 | Inflectra | Norway | 10.10.2013 |
| EU/1/13/855 | Imvanex | Liechtenstein | 31.8.2013 |
| EU/1/13/855 | IMVANEX | Iceland | 23.8.2013 |
| EU/1/13/855 | Imvanex | Norway | 17.9.2013 |
| EU/1/13/856 | Lonquex | Iceland | 20.8.2013 |
| EU/1/13/856 | Lonquex | Norway | 23.8.2013 |
| EU/1/13/857 | Voncento | Liechtenstein | 31.10.2013 |
| EU/1/13/857 | Voncento | Iceland | 11.10.2013 |
| EU/1/13/857 | Voncento | Norway | 16.9.2013 |
| EU/1/13/858 | Stivarga | Liechtenstein | 31.10.2013 |
| EU/1/13/858 | Stivarga | Iceland | 19.9.2013 |
| EU/1/13/858 | Stivarga | Norway | 9.9.2013 |
| EU/1/13/859 | Levodopa/Carbidopa/Entacapone Sandoz | Iceland | 22.11.2013 |
| EU/1/13/859 | Levodopa/Carbidopa/Entacapone Sandoz | Norway | 10.12.2013 |
| EU/1/13/860 | Nexium Control | Liechtenstein | 31.10.2013 |
| EU/1/13/860 | Nexium Control | Iceland | 9.9.2013 |
| EU/1/13/860 | Nexium Control | Norway | 6.9.2013 |
| EU/1/13/861 | Procysbi | Liechtenstein | 31.10.2013 |
| EU/1/13/861 | Procysbi | Iceland | 23.9.2013 |
| EU/1/13/861 | Procysbi | Norway | 24.9.2013 |
| EU/1/13/862 | Ultibro Breezhaler | Liechtenstein | 31.10.2013 |
| EU/1/13/862 | Ultibro Breezhaler | Iceland | 15.10.2013 |
| EU/1/13/862 | Ultibro Breezhaler | Norway | 18.10.2013 |
| EU/1/13/863 | Xoterna Breezhaler | Liechtenstein | 31.10.2013 |
| EU/1/13/863 | Xoterna Breezhaler | Iceland | 14.10.2013 |
| EU/1/13/863 | Xoterna Breezhaler | Norway | 18.10.2013 |
| EU/1/13/865 | Tafinlar | Liechtenstein | 31.10.2013 |
| EU/1/13/865 | Tafinlar | Iceland | 19.9.2013 |
| EU/1/13/865 | Tafinlar | Norway | 18.9.2013 |
| EU/1/13/866 | Cholib | Liechtenstein | 31.10.2013 |
| EU/1/13/866 | Cholib | Iceland | 19.9.2013 |
| EU/1/13/866 | Cholib | Norway | 24.9.2013 |
| EU/1/13/867 | Provenge | Liechtenstein | 31.10.2013 |
| EU/1/13/867 | Provenge | Iceland | 19.9.2013 |
| EU/1/13/867 | Provenge | Norway | 24.9.2013 |
| EU/1/13/868 | EVARREST | Liechtenstein | 31.10.2013 |
| EU/1/13/868 | EVARREST | Iceland | 21.10.2013 |
| EU/1/13/868 | Evarrest | Norway | 18.10.2013 |
| EU/1/13/869 | Lemtrada | Liechtenstein | 31.10.2013 |
| EU/1/13/869 | Lemtrada | Iceland | 23.9.2013 |
| EU/1/13/869 | Lemtrada | Norway | 10.10.2013 |
| EU/1/13/870 | Orphacol | Liechtenstein | 31.10.2013 |
| EU/1/13/870 | Orphacol | Iceland | 10.10.2013 |
| EU/1/13/870 | Orphacol | Norway | 25.9.2013 |
| EU/1/13/871 | Ovaleap | Liechtenstein | 31.10.2013 |
| EU/1/13/871 | Ovaleap | Iceland | 22.10.2013 |
| EU/1/13/871 | Ovaleap | Norway | 17.10.2013 |
| EU/1/13/872 | Tybost | Liechtenstein | 31.10.2013 |
| EU/1/13/872 | Tybost | Iceland | 11.10.2013 |
| EU/1/13/872 | Tybost | Norway | 17.10.2013 |
| EU/1/13/873 | Xofigo | Liechtenstein | 31.12.2013 |
| EU/1/13/873 | Xofigo | Iceland | 11.12.2013 |
| EU/1/13/873 | Xofigo | Norway | 9.12.2013 |
| EU/1/13/876 | Imatinib Medac | Liechtenstein | 31.10.2013 |
| EU/1/13/876 | Imatinib medac | Iceland | 17.10.2013 |
| EU/1/13/876 | Imatinib medac | Norway | 16.10.2013 |
| EU/1/13/877 | Grastofil | Liechtenstein | 31.10.2013 |
| EU/1/13/877 | Grastofil | Iceland | 12.11.2013 |
| EU/1/13/877 | Grastofil | Norway | 18.11.2013 |
| EU/1/13/878 | Defitelio | Liechtenstein | 31.10.2013 |
| EU/1/13/878 | Defitelio | Iceland | 12.11.2013 |
| EU/1/13/878 | Defitelio | Norway | 21.11.2013 |
| EU/1/13/879 | Giotrif | Iceland | 18.10.2013 |
| EU/1/13/879 | Giotrif | Norway | 16.10.2013 |
| EU/1/13/880 | Memantine Accord | Iceland | 16.12.2013 |
| EU/1/13/880 | Memantine Accord | Norway | 17.12.2013 |
| EU/1/13/880 | Memantin Accord | Liechtenstein | 31.12.2013 |
| EU/1/13/881 | Lidocaine/Prilocaine Plethora | Liechtenstein | 31.12.2013 |
| EU/1/13/881 | Lidocaine/Prilocaine Plethora | Iceland | 12.12.2013 |
| EU/1/13/881 | Lidocaine/Prilocaine Plethora | Norway | 16.12.2013 |
| EU/1/13/882 | ABILIFY MAINTENA | Liechtenstein | 31.12.2013 |
| EU/1/13/882 | ABILIFY MAINTENA | Iceland | 12.12.2013 |
| EU/1/13/882 | Abilify Maintena | Norway | 16.12.2013 |
| EU/1/13/883 | Vitekta | Liechtenstein | 31.12.2013 |
| EU/1/13/883 | Vitekta | Iceland | 11.12.2013 |
| EU/1/13/883 | Vitekta | Norway | 16.12.2013 |
| EU/1/13/884 | Invokana | Liechtenstein | 31.12.2013 |
| EU/1/13/884 | Invokana | Iceland | 12.12.2013 |
| EU/1/13/884 | Invokana | Norway | 16.12.2013 |
| EU/1/13/885 | Kadcyla | Liechtenstein | 31.12.2013 |
| EU/1/13/885 | Kadcyla | Iceland | 12.12.2013 |
| EU/1/13/885 | Kadcyla | Norway | 16.12.2013 |
| EU/1/13/886 | Relvar Ellipta | Iceland | 11.12.2013 |
| EU/1/13/886 | Relvar Ellipta | Liechtenstein | 31.12.2013 |
| EU/1/13/886 | Relvar Ellipta | Norway | 25.11.2013 |
| EU/1/13/887 | Fluenz Tetra | Norway | 4.12.2013 |
| EU/1/13/888 | NovoEight | Liechtenstein | 31.12.2013 |
| EU/1/13/888 | NovoEight | Iceland | 11.12.2013 |
| EU/1/13/888 | NovoEight | Norway | 16.12.2013 |
| EU/1/13/893 | Opsumit | Norway | 20.12.2013 |
| EU/2/13/148 | Meloxidolor | Norway | 6.8.2013 |
| EU/2/13/150 | Oncept IL-2 | Iceland | 18.7.2013 |
| EU/2/13/152 | ProZinc | Iceland | 8.8.2013 |
| EU/2/13/152 | ProZinc | Norway | 5.8.2013 |
| EU/2/13/153 | Aftovaxpur Doe | Liechtenstein | 31.8.2013 |
| EU/2/13/153 | Aftovaxpur Doe | Iceland | 9.8.2013 |
| EU/2/13/153 | Aftovaxpur Doe | Norway | 15.7.2013 |
| EU/2/13/154 | Apoquel | Liechtenstein | 31.10.2013 |
| EU/2/13/154 | Apoquel | Iceland | 20.9.2013 |
| EU/2/13/154 | Apoquel | Norway | 12.9.2013 |
| EU/2/13/155 | Trifexis | Liechtenstein | 31.10.2013 |
| EU/2/13/155 | Trifexis | Iceland | 14.10.2013 |
| EU/2/13/156 | Vectra 3D | Liechtenstein | 31.12.2013 |
| EU/2/13/156 | Vectra 3D | Iceland | 23.12.2013 |
| EU/2/13/157 | BROADLINE | Liechtenstein | 31.12.2013 |
| EU/2/13/157 | BROADLINE | Iceland | 23.12.2013 |

EU-Number

Product

Country

Date of authorisation

EU/1/13/818/001-004

Bosulif

Liechtenstein

31.8.2013

EU/1/13/820

Marixino

Iceland

22.8.2013

EU/1/13/822

PHEBURANE

Iceland

21.8.2013

EU/1/13/822

PHEBURANE

Norway

29.8.2013

EU/1/13/830

Stribild

Norway

1.7.2013

EU/1/13/831

Capecitabin SUN

Liechtenstein

31.8.2013

EU/1/13/831

Capecitabine SUN

Iceland

19.7.2013

EU/1/13/831

Capecitabine SUN

Norway

26.7.2013

EU/1/13/832

Stayveer

Liechtenstein

31.8.2013

EU/1/13/832

Stayveer

Iceland

19.7.2013

EU/1/13/832

Stayveer

Norway

24.7.2013

EU/1/13/833

Nuedexta

Liechtenstein

31.8.2013

EU/1/13/833

NUEDEXTA

Iceland

24.7.2013

EU/1/13/833

Nuedexta

Norway

3.7.2013

EU/1/13/836

Memantine ratiopharm

Iceland

9.8.2013

EU/1/13/838

AUBAGIO

Liechtenstein

31.10.2013

EU/1/13/838

AUBAGIO

Iceland

9.9.2013

EU/1/13/838

AUBAGIO

Norway

18.9.2013

EU/1/13/839

Iclusig

Liechtenstein

31.10.2013

EU/1/13/839

Iclusig

Iceland

19.7.2013

EU/1/13/839

Iclusig

Norway

23.7.2013

EU/1/13/840

HyQvia

Liechtenstein

31.10.2013

EU/1/13/841

Spedra

Liechtenstein

31.8.2013

EU/1/13/841

Spedra

Iceland

19.7.2013

EU/1/13/841

Spedra

Norway

19.7.2013

EU/1/13/842

Incresync

Liechtenstein

31.10.2013

EU/1/13/842

Incresync

Iceland

14.10.2013

EU/1/13/842

Incresync

Norway

10.10.2013

EU/1/13/843

Vipdomet

Liechtenstein

31.10.2013

EU/1/13/843

Vipdomet

Iceland

15.10.2013

EU/1/13/843

Vipdomet

Norway

10.10.2013

EU/1/13/844

Vipidia

Liechtenstein

31.10.2013

EU/1/13/844

Vipidia

Iceland

15.10.2013

EU/1/13/844

Vipidia

Norway

10.10.2013

EU/1/13/845

Imatinib Accord

Iceland

18.7.2013

EU/1/13/845

Imatinib Accord

Norway

18.7.2013

EU/1/13/846

Xtandi

Iceland

19.7.2013

EU/1/13/846

Xtandi

Norway

17.7.2013

EU/1/13/847

MACI

Liechtenstein

31.8.2013

EU/1/13/847

MACI

Iceland

24.7.2013

EU/1/13/847

MACI

Norway

17.7.2013

EU/1/13/848

Erivedge

Liechtenstein

31.8.2013

EU/1/13/848

Erivedge

Iceland

8.8.2013

EU/1/13/848

Erivedge

Norway

13.8.2013

EU/1/13/849

Somatropin Biopartners

Liechtenstein

31.8.2013

EU/1/13/849

Somatropin Biopartners

Iceland

22.8.2013

EU/1/13/849

Somatropin Biopartners

Norway

10.9.2013

EU/1/13/850

Pomalidomide Celgene

Iceland

23.8.2013

EU/1/13/850

Pomalidomide Celgene

Liechtenstein

31.10.2013

EU/1/13/850

Pomalidomide Celgene

Norway

15.8.2013

EU/1/13/851

Lojuxta

Liechtenstein

31.8.2013

EU/1/13/851

Lojuxta

Iceland

21.8.2013

EU/1/13/851

Lojuxta

Norway

28.8.2013

EU/1/13/852

Atosiban SUN

Liechtenstein

31.8.2013

EU/1/13/852

Atosiban SUN

Iceland

20.8.2013

EU/1/13/852

Atosiban SUN

Norway

29.8.2013

EU/1/13/853

Remsima

Liechtenstein

31.10.2013

EU/1/13/853

Remsima

Iceland

20.9.2013

EU/1/13/853

Remsima

Norway

17.9.2013

EU/1/13/854

Inflectra

Liechtenstein

31.10.2013

EU/1/13/854

Inflectra

Iceland

20.9.2013

EU/1/13/854

Inflectra

Norway

10.10.2013

EU/1/13/855

Imvanex

Liechtenstein

31.8.2013

EU/1/13/855

IMVANEX

Iceland

23.8.2013

EU/1/13/855

Imvanex

Norway

17.9.2013

EU/1/13/856

Lonquex

Iceland

20.8.2013

EU/1/13/856

Lonquex

Norway

23.8.2013

EU/1/13/857

Voncento

Liechtenstein

31.10.2013

EU/1/13/857

Voncento

Iceland

11.10.2013

EU/1/13/857

Voncento

Norway

16.9.2013

EU/1/13/858

Stivarga

Liechtenstein

31.10.2013

EU/1/13/858

Stivarga

Iceland

19.9.2013

EU/1/13/858

Stivarga

Norway

9.9.2013

EU/1/13/859

Levodopa/Carbidopa/Entacapone Sandoz

Iceland

22.11.2013

EU/1/13/859

Levodopa/Carbidopa/Entacapone Sandoz

Norway

10.12.2013

EU/1/13/860

Nexium Control

Liechtenstein

31.10.2013

EU/1/13/860

Nexium Control

Iceland

9.9.2013

EU/1/13/860

Nexium Control

Norway

6.9.2013

EU/1/13/861

Procysbi

Liechtenstein

31.10.2013

EU/1/13/861

Procysbi

Iceland

23.9.2013

EU/1/13/861

Procysbi

Norway

24.9.2013

EU/1/13/862

Ultibro Breezhaler

Liechtenstein

31.10.2013

EU/1/13/862

Ultibro Breezhaler

Iceland

15.10.2013

EU/1/13/862

Ultibro Breezhaler

Norway

18.10.2013

EU/1/13/863

Xoterna Breezhaler

Liechtenstein

31.10.2013

EU/1/13/863

Xoterna Breezhaler

Iceland

14.10.2013

EU/1/13/863

Xoterna Breezhaler

Norway

18.10.2013

EU/1/13/865

Tafinlar

Liechtenstein

31.10.2013

EU/1/13/865

Tafinlar

Iceland

19.9.2013

EU/1/13/865

Tafinlar

Norway

18.9.2013

EU/1/13/866

Cholib

Liechtenstein

31.10.2013

EU/1/13/866

Cholib

Iceland

19.9.2013

EU/1/13/866

Cholib

Norway

24.9.2013

EU/1/13/867

Provenge

Liechtenstein

31.10.2013

EU/1/13/867

Provenge

Iceland

19.9.2013

EU/1/13/867

Provenge

Norway

24.9.2013

EU/1/13/868

EVARREST

Liechtenstein

31.10.2013

EU/1/13/868

EVARREST

Iceland

21.10.2013

EU/1/13/868

Evarrest

Norway

18.10.2013

EU/1/13/869

Lemtrada

Liechtenstein

31.10.2013

EU/1/13/869

Lemtrada

Iceland

23.9.2013

EU/1/13/869

Lemtrada

Norway

10.10.2013

EU/1/13/870

Orphacol

Liechtenstein

31.10.2013

EU/1/13/870

Orphacol

Iceland

10.10.2013

EU/1/13/870

Orphacol

Norway

25.9.2013

EU/1/13/871

Ovaleap

Liechtenstein

31.10.2013

EU/1/13/871

Ovaleap

Iceland

22.10.2013

EU/1/13/871

Ovaleap

Norway

17.10.2013

EU/1/13/872

Tybost

Liechtenstein

31.10.2013

EU/1/13/872

Tybost

Iceland

11.10.2013

EU/1/13/872

Tybost

Norway

17.10.2013

EU/1/13/873

Xofigo

Liechtenstein

31.12.2013

EU/1/13/873

Xofigo

Iceland

11.12.2013

EU/1/13/873

Xofigo

Norway

9.12.2013

EU/1/13/876

Imatinib Medac

Liechtenstein

31.10.2013

EU/1/13/876

Imatinib medac

Iceland

17.10.2013

EU/1/13/876

Imatinib medac

Norway

16.10.2013

EU/1/13/877

Grastofil

Liechtenstein

31.10.2013

EU/1/13/877

Grastofil

Iceland

12.11.2013

EU/1/13/877

Grastofil

Norway

18.11.2013

EU/1/13/878

Defitelio

Liechtenstein

31.10.2013

EU/1/13/878

Defitelio

Iceland

12.11.2013

EU/1/13/878

Defitelio

Norway

21.11.2013

EU/1/13/879

Giotrif

Iceland

18.10.2013

EU/1/13/879

Giotrif

Norway

16.10.2013

EU/1/13/880

Memantine Accord

Iceland

16.12.2013

EU/1/13/880

Memantine Accord

Norway

17.12.2013

EU/1/13/880

Memantin Accord

Liechtenstein

31.12.2013

EU/1/13/881

Lidocaine/Prilocaine Plethora

Liechtenstein

31.12.2013

EU/1/13/881

Lidocaine/Prilocaine Plethora

Iceland

12.12.2013

EU/1/13/881

Lidocaine/Prilocaine Plethora

Norway

16.12.2013

EU/1/13/882

ABILIFY MAINTENA

Liechtenstein

31.12.2013

EU/1/13/882

ABILIFY MAINTENA

Iceland

12.12.2013

EU/1/13/882

Abilify Maintena

Norway

16.12.2013

EU/1/13/883

Vitekta

Liechtenstein

31.12.2013

EU/1/13/883

Vitekta

Iceland

11.12.2013

EU/1/13/883

Vitekta

Norway

16.12.2013

EU/1/13/884

Invokana

Liechtenstein

31.12.2013

EU/1/13/884

Invokana

Iceland

12.12.2013

EU/1/13/884

Invokana

Norway

16.12.2013

EU/1/13/885

Kadcyla

Liechtenstein

31.12.2013

EU/1/13/885

Kadcyla

Iceland

12.12.2013

EU/1/13/885

Kadcyla

Norway

16.12.2013

EU/1/13/886

Relvar Ellipta

Iceland

11.12.2013

EU/1/13/886

Relvar Ellipta

Liechtenstein

31.12.2013

EU/1/13/886

Relvar Ellipta

Norway

25.11.2013

EU/1/13/887

Fluenz Tetra

Norway

4.12.2013

EU/1/13/888

NovoEight

Liechtenstein

31.12.2013

EU/1/13/888

NovoEight

Iceland

11.12.2013

EU/1/13/888

NovoEight

Norway

16.12.2013

EU/1/13/893

Opsumit

Norway

20.12.2013

EU/2/13/148

Meloxidolor

Norway

6.8.2013

EU/2/13/150

Oncept IL-2

Iceland

18.7.2013

EU/2/13/152

ProZinc

Iceland

8.8.2013

EU/2/13/152

ProZinc

Norway

5.8.2013

EU/2/13/153

Aftovaxpur Doe

Liechtenstein

31.8.2013

EU/2/13/153

Aftovaxpur Doe

Iceland

9.8.2013

EU/2/13/153

Aftovaxpur Doe

Norway

15.7.2013

EU/2/13/154

Apoquel

Liechtenstein

31.10.2013

EU/2/13/154

Apoquel

Iceland

20.9.2013

EU/2/13/154

Apoquel

Norway

12.9.2013

EU/2/13/155

Trifexis

Liechtenstein

31.10.2013

EU/2/13/155

Trifexis

Iceland

14.10.2013

EU/2/13/156

Vectra 3D

Liechtenstein

31.12.2013

EU/2/13/156

Vectra 3D

Iceland

23.12.2013

EU/2/13/157

BROADLINE

Liechtenstein

31.12.2013

EU/2/13/157

BROADLINE

Iceland

23.12.2013

---

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 2013:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/03/255 | Ventavis | Liechtenstein | 31.10.2013 |
| EU/1/03/255 | Ventavis | Iceland | 9.9.2013 |
| EU/1/03/255 | Ventavis | Norway | 18.9.2013 |
| EU/1/06/380 | Prezista | Iceland | 11.10.2013 |
| EU/1/06/380 | Prezista | Norway | 18.10.2013 |
| EU/1/07/440 | Tyverb | Iceland | 26.8.2013 |
| EU/1/08/444 | Ratiograstim | Liechtenstein | 31.8.2013 |
| EU/1/08/444 | Ratiograstim | Iceland | 19.8.2013 |
| EU/1/08/444 | Ratiograstim | Norway | 15.8.2013 |
| EU/1/08/445 | Tevagrastim | Liechtenstein | 31.8.2013 |
| EU/1/08/445 | Tevagrastim | Iceland | 19.8.2013 |
| EU/1/08/445 | Tevagrastim | Norway | 15.8.2013 |
| EU/1/08/450 | Biograstim | Liechtenstein | 31.8.2013 |
| EU/1/08/450 | Biograstim | Iceland | 20.8.2013 |
| EU/1/08/450 | Biograstim | Norway | 27.8.2013 |
| EU/1/08/456 | Velmetia | Norway | 11.9.2013 |
| EU/1/08/457 | Efficib | Norway | 11.9.2013 |
| EU/1/08/466 | Bridion | Liechtenstein | 31.8.2013 |
| EU/1/08/466 | Bridion | Iceland | 17.7.2013 |
| EU/1/08/466 | Bridion | Norway | 19.7.2013 |
| EU/1/08/467 | Doribax | Norway | 29.7.2013 |
| EU/1/08/468 | INTELENCE | Iceland | 17.7.2013 |
| EU/1/08/468 | Intelence | Norway | 24.7.2013 |
| EU/1/08/470 | Vimpat | Liechtenstein | 31.8.2013 |
| EU/1/08/470 | Vimpat | Iceland | 21.8.2013 |
| EU/1/08/470 | Vimpat | Norway | 13.8.2013 |
| EU/1/08/473 | Evicel | Liechtenstein | 31.12.2013 |
| EU/1/08/473 | Evicel | Iceland | 16.12.2013 |
| EU/1/08/473 | Evicel | Norway | 18.12.2013 |
| EU/1/08/477 | Ceplene | Liechtenstein | 31.10.2013 |
| EU/1/08/477 | Ceplene | Iceland | 11.9.2013 |
| EU/1/08/477 | Ceplene | Norway | 18.9.2013 |
| EU/1/08/479 | Zypadhera | Iceland | 9.9.2013 |
| EU/1/08/479 | Zypadhera | Norway | 9.9.2013 |
| EU/1/08/480 | Ifirmasta | Liechtenstein | 31.8.2013 |
| EU/1/08/480 | Ifirmasta | Iceland | 9.9.2013 |
| EU/1/08/480 | Ifirmasta | Norway | 11.9.2013 |
| EU/1/08/481 | Kuvan | Liechtenstein | 31.12.2013 |
| EU/1/08/481 | Kuvan | Iceland | 11.12.2013 |
| EU/1/08/481 | Kuvan | Norway | 10.12.2013 |
| EU/1/08/482 | Azarga | Iceland | 5.9.2013 |
| EU/1/08/482 | Azarga | Norway | 18.9.2013 |
| EU/1/08/483 | Zomarist | Iceland | 21.8.2013 |
| EU/1/08/483 | Zomarist | Norway | 5.9.2013 |
| EU/1/08/484 | Icandra | Iceland | 21.8.2013 |
| EU/1/08/484 | Icandra | Norway | 5.9.2013 |
| EU/1/08/485 | Jalra | Liechtenstein | 31.12.2013 |
| EU/1/08/485 | Jalra | Iceland | 16.12.2013 |
| EU/1/08/485 | Jalra | Norway | 16.12.2013 |
| EU/1/08/486 | Xiliarx | Liechtenstein | 31.12.2013 |
| EU/1/08/486 | Xiliarx | Iceland | 16.12.2013 |
| EU/1/08/486 | Xiliarx | Norway | 16.12.2013 |
| EU/1/08/488 | Vidaza | Liechtenstein | 31.12.2013 |
| EU/1/08/488 | Vidaza | Iceland | 10.12.2013 |
| EU/1/08/488 | Vidaza | Norway | 16.12.2013 |
| EU/1/08/489 | Opgenra | Liechtenstein | 31.12.2013 |
| EU/1/08/489 | Opgenra | Iceland | 16.12.2013 |
| EU/1/08/489 | Opgenra | Norway | 16.12.2013 |
| EU/1/08/490 | Pramipexole Teva | Iceland | 23.9.2013 |
| EU/1/08/490 | Pramipexole Teva | Norway | 20.9.2013 |
| EU/1/08/491 | Rasilez HCT | Liechtenstein | 31.12.2013 |
| EU/1/08/491 | Rasilez HCT | Iceland | 25.11.2013 |
| EU/1/08/491 | Rasilez HCT | Norway | 18.12.2013 |
| EU/1/08/492 | RoActemra | Iceland | 17.10.2013 |
| EU/1/08/492 | RoActemra | Norway | 16.10.2013 |
| EU/1/08/494 | Stelara | Liechtenstein | 31.10.2013 |
| EU/1/08/494 | Stelara | Iceland | 14.10.2013 |
| EU/1/08/494 | Stelara | Norway | 2.10.2013 |
| EU/1/08/495 | Zarzio | Liechtenstein | 31.12.2013 |
| EU/1/08/495 | Zarzio | Iceland | 26.11.2013 |
| EU/1/08/495 | Zarzio | Norway | 16.12.2013 |
| EU/1/08/496 | Filgrastim Hexal | Liechtenstein | 31.12.2013 |
| EU/1/08/496 | Filgrastim Hexal | Iceland | 25.11.2013 |
| EU/1/08/496 | Filgrastim Hexal | Norway | 16.12.2013 |
| EU/1/08/498 | Thymanax | Liechtenstein | 31.12.2013 |
| EU/1/08/498 | Thymanax | Iceland | 25.11.2013 |
| EU/1/08/498 | Thymanax | Norway | 16.12.2013 |
| EU/1/08/499 | Valdoxan | Iceland | 25.11.2013 |
| EU/1/08/499 | Valdoxan | Norway | 17.12.2013 |
| EU/1/08/503 | Efient | Liechtenstein | 31.12.2013 |
| EU/1/08/503 | Efient | Iceland | 10.12.2013 |
| EU/1/08/503 | Efient | Norway | 18.12.2013 |
| EU/1/08/504 | Firmagon | Iceland | 10.12.2013 |
| EU/1/08/504 | Firmagon | Norway | 16.12.2013 |
| EU/1/08/505 | Intanza | Iceland | 17.10.2013 |
| EU/1/08/505 | Intanza | Norway | 22.10.2013 |
| EU/1/08/507 | IDflu | Iceland | 17.10.2013 |
| EU/1/08/507 | IDflu | Norway | 22.10.2013 |
| EU/1/10/628 | Votrient | Iceland | 1.8.2013 |
| EU/1/10/628 | Votrient | Norway | 13.8.2013 |
| EU/1/11/699 | Fampyra | Iceland | 17.7.2013 |
| EU/1/11/699 | Fampyra | Norway | 12.8.2013 |
| EU/1/11/710 | Votubia | Liechtenstein | 31.8.2013 |
| EU/1/11/710 | Votubia | Iceland | 9.8.2013 |
| EU/1/11/710 | Votubia | Norway | 13.8.2013 |
| EU/1/12/793 | Xalkori | Iceland | 10.9.2013 |
| EU/1/12/793 | Xalkori | Norway | 26.8.2013 |
| EU/1/12/794 | Adcetris | Iceland | 9.9.2013 |
| EU/1/12/794 | Adcetris | Norway | 23.9.2013 |
| EU/1/99/103 | ReFacto AF | Liechtenstein | 31.12.2013 |
| EU/1/99/103 | Refacto AF | Norway | 18.12.2013 |
| EU/2/07/075 | Circovac | Norway | 9.8.2013 |
| EU/2/08/080 | Reconcile | Liechtenstein | 31.8.2013 |
| EU/2/08/080 | Reconcile | Iceland | 8.8.2013 |
| EU/2/08/082 | Zactran | Liechtenstein | 31.8.2013 |
| EU/2/08/082 | Zactran | Iceland | 9.8.2013 |
| EU/2/08/082 | Zactran | Norway | 12.8.2013 |
| EU/2/08/084 | Trocoxil | Iceland | 4.9.2013 |
| EU/2/08/086 | Equip WNV | Liechtenstein | 31.10.2013 |
| EU/2/08/086 | Equip WNV | Iceland | 24.9.2013 |
| EU/2/08/087 | Masivet | Liechtenstein | 31.10.2013 |
| EU/2/08/087 | Masivet | Iceland | 17.10.2013 |
| EU/2/08/089 | Onsior | Iceland | 22.11.2013 |
| EU/2/08/091 | Porcilis PCV | Liechtenstein | 31.12.2013 |

EU-Number

Product

Country

Date of authorisation

EU/1/03/255

Ventavis

Liechtenstein

31.10.2013

EU/1/03/255

Ventavis

Iceland

9.9.2013

EU/1/03/255

Ventavis

Norway

18.9.2013

EU/1/06/380

Prezista

Iceland

11.10.2013

EU/1/06/380

Prezista

Norway

18.10.2013

EU/1/07/440

Tyverb

Iceland

26.8.2013

EU/1/08/444

Ratiograstim

Liechtenstein

31.8.2013

EU/1/08/444

Ratiograstim

Iceland

19.8.2013

EU/1/08/444

Ratiograstim

Norway

15.8.2013

EU/1/08/445

Tevagrastim

Liechtenstein

31.8.2013

EU/1/08/445

Tevagrastim

Iceland

19.8.2013

EU/1/08/445

Tevagrastim

Norway

15.8.2013

EU/1/08/450

Biograstim

Liechtenstein

31.8.2013

EU/1/08/450

Biograstim

Iceland

20.8.2013

EU/1/08/450

Biograstim

Norway

27.8.2013

EU/1/08/456

Velmetia

Norway

11.9.2013

EU/1/08/457

Efficib

Norway

11.9.2013

EU/1/08/466

Bridion

Liechtenstein

31.8.2013

EU/1/08/466

Bridion

Iceland

17.7.2013

EU/1/08/466

Bridion

Norway

19.7.2013

EU/1/08/467

Doribax

Norway

29.7.2013

EU/1/08/468

INTELENCE

Iceland

17.7.2013

EU/1/08/468

Intelence

Norway

24.7.2013

EU/1/08/470

Vimpat

Liechtenstein

31.8.2013

EU/1/08/470

Vimpat

Iceland

21.8.2013

EU/1/08/470

Vimpat

Norway

13.8.2013

EU/1/08/473

Evicel

Liechtenstein

31.12.2013

EU/1/08/473

Evicel

Iceland

16.12.2013

EU/1/08/473

Evicel

Norway

18.12.2013

EU/1/08/477

Ceplene

Liechtenstein

31.10.2013

EU/1/08/477

Ceplene

Iceland

11.9.2013

EU/1/08/477

Ceplene

Norway

18.9.2013

EU/1/08/479

Zypadhera

Iceland

9.9.2013

EU/1/08/479

Zypadhera

Norway

9.9.2013

EU/1/08/480

Ifirmasta

Liechtenstein

31.8.2013

EU/1/08/480

Ifirmasta

Iceland

9.9.2013

EU/1/08/480

Ifirmasta

Norway

11.9.2013

EU/1/08/481

Kuvan

Liechtenstein

31.12.2013

EU/1/08/481

Kuvan

Iceland

11.12.2013

EU/1/08/481

Kuvan

Norway

10.12.2013

EU/1/08/482

Azarga

Iceland

5.9.2013

EU/1/08/482

Azarga

Norway

18.9.2013

EU/1/08/483

Zomarist

Iceland

21.8.2013

EU/1/08/483

Zomarist

Norway

5.9.2013

EU/1/08/484

Icandra

Iceland

21.8.2013

EU/1/08/484

Icandra

Norway

5.9.2013

EU/1/08/485

Jalra

Liechtenstein

31.12.2013

EU/1/08/485

Jalra

Iceland

16.12.2013

EU/1/08/485

Jalra

Norway

16.12.2013

EU/1/08/486

Xiliarx

Liechtenstein

31.12.2013

EU/1/08/486

Xiliarx

Iceland

16.12.2013

EU/1/08/486

Xiliarx

Norway

16.12.2013

EU/1/08/488

Vidaza

Liechtenstein

31.12.2013

EU/1/08/488

Vidaza

Iceland

10.12.2013

EU/1/08/488

Vidaza

Norway

16.12.2013

EU/1/08/489

Opgenra

Liechtenstein

31.12.2013

EU/1/08/489

Opgenra

Iceland

16.12.2013

EU/1/08/489

Opgenra

Norway

16.12.2013

EU/1/08/490

Pramipexole Teva

Iceland

23.9.2013

EU/1/08/490

Pramipexole Teva

Norway

20.9.2013

EU/1/08/491

Rasilez HCT

Liechtenstein

31.12.2013

EU/1/08/491

Rasilez HCT

Iceland

25.11.2013

EU/1/08/491

Rasilez HCT

Norway

18.12.2013

EU/1/08/492

RoActemra

Iceland

17.10.2013

EU/1/08/492

RoActemra

Norway

16.10.2013

EU/1/08/494

Stelara

Liechtenstein

31.10.2013

EU/1/08/494

Stelara

Iceland

14.10.2013

EU/1/08/494

Stelara

Norway

2.10.2013

EU/1/08/495

Zarzio

Liechtenstein

31.12.2013

EU/1/08/495

Zarzio

Iceland

26.11.2013

EU/1/08/495

Zarzio

Norway

16.12.2013

EU/1/08/496

Filgrastim Hexal

Liechtenstein

31.12.2013

EU/1/08/496

Filgrastim Hexal

Iceland

25.11.2013

EU/1/08/496

Filgrastim Hexal

Norway

16.12.2013

EU/1/08/498

Thymanax

Liechtenstein

31.12.2013

EU/1/08/498

Thymanax

Iceland

25.11.2013

EU/1/08/498

Thymanax

Norway

16.12.2013

EU/1/08/499

Valdoxan

Iceland

25.11.2013

EU/1/08/499

Valdoxan

Norway

17.12.2013

EU/1/08/503

Efient

Liechtenstein

31.12.2013

EU/1/08/503

Efient

Iceland

10.12.2013

EU/1/08/503

Efient

Norway

18.12.2013

EU/1/08/504

Firmagon

Iceland

10.12.2013

EU/1/08/504

Firmagon

Norway

16.12.2013

EU/1/08/505

Intanza

Iceland

17.10.2013

EU/1/08/505

Intanza

Norway

22.10.2013

EU/1/08/507

IDflu

Iceland

17.10.2013

EU/1/08/507

IDflu

Norway

22.10.2013

EU/1/10/628

Votrient

Iceland

1.8.2013

EU/1/10/628

Votrient

Norway

13.8.2013

EU/1/11/699

Fampyra

Iceland

17.7.2013

EU/1/11/699

Fampyra

Norway

12.8.2013

EU/1/11/710

Votubia

Liechtenstein

31.8.2013

EU/1/11/710

Votubia

Iceland

9.8.2013

EU/1/11/710

Votubia

Norway

13.8.2013

EU/1/12/793

Xalkori

Iceland

10.9.2013

EU/1/12/793

Xalkori

Norway

26.8.2013

EU/1/12/794

Adcetris

Iceland

9.9.2013

EU/1/12/794

Adcetris

Norway

23.9.2013

EU/1/99/103

ReFacto AF

Liechtenstein

31.12.2013

EU/1/99/103

Refacto AF

Norway

18.12.2013

EU/2/07/075

Circovac

Norway

9.8.2013

EU/2/08/080

Reconcile

Liechtenstein

31.8.2013

EU/2/08/080

Reconcile

Iceland

8.8.2013

EU/2/08/082

Zactran

Liechtenstein

31.8.2013

EU/2/08/082

Zactran

Iceland

9.8.2013

EU/2/08/082

Zactran

Norway

12.8.2013

EU/2/08/084

Trocoxil

Iceland

4.9.2013

EU/2/08/086

Equip WNV

Liechtenstein

31.10.2013

EU/2/08/086

Equip WNV

Iceland

24.9.2013

EU/2/08/087

Masivet

Liechtenstein

31.10.2013

EU/2/08/087

Masivet

Iceland

17.10.2013

EU/2/08/089

Onsior

Iceland

22.11.2013

EU/2/08/091

Porcilis PCV

Liechtenstein

31.12.2013

---

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 2013:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/145/002 | Herceptin | Norway | 6.9.2013 |
| EU/1/00/145/002 | Herceptin | Iceland | 9.9.2013 |
| EU/1/02/203/005-007 | Kineret | Norway | 13.12.2013 |
| EU/1/02/203/005-007 | Kineret | Iceland | 13.12.2013 |
| EU/1/03/249/016 | Vivanza | Norway | 5.8.2013 |
| EU/1/03/249/016 | Vivanza | Iceland | 17.7.2013 |
| EU/1/07/436/003-004 | Isentress | Norway | 4.7.2013 |
| EU/1/08/469/026-045 | Oprymea | Norway | 25.11.2013 |
| EU/1/08/469/026-045 | Oprymea | Iceland | 22.11.2013 |
| EU/1/09/546/005-008 | Simponi | Norway | 7.10.2013 |
| EU/1/09/546/005-008 | Simponi | Iceland | 12.9.2013 |
| EU/1/10/612/007-009 | Revolade | Norway | 10.10.2013 |
| EU/1/10/612/007-009 | Revolade | Iceland | 11.10.2013 |
| EU/1/10/637/010-013 | Leflunomide medac | Norway | 27.8.2013 |
| EU/1/10/637/010-013 | Leflunomide medac | Iceland | 19.8.2013 |
| EU/1/11/706/034-038 | Levodopa/Carbidopa/Entacapone Orion | Norway | 18.10.2013 |
| EU/1/11/706/034-038 | Levodopa/Carbidopa/Entacapone Orion | Iceland | 18.7.2013 |
| EU/1/11/710/009-015 | Votubia | Norway | 13.12.2013 |
| EU/1/12/777/007-012 | Inlyta | Norway | 18.9.2013 |
| EU/1/12/777/007-012 | Inlyta | Iceland | 4.9.2013 |
| EU/1/97/030/202-203 | Insuman Implantable | Norway | 18.10.2013 |
| EU/2/04/044/015-016 | Aivlosin | Iceland | 23.12.2013 |
| EU/2/08/090/029-031 | Loxicom | Norway | 26.9.2013 |
| EU/2/09/098/002-007 | Melovem | Iceland | 21.10.2013 |
| EU/2/10/115/011-019 | Comfortis | Norway | 6.8.2013 |
| EU/2/10/115/020-021 | Comfortis | Iceland | 11.12.2013 |

EU-Number

Product

Country

Date of authorisation

EU/1/00/145/002

Herceptin

Norway

6.9.2013

EU/1/00/145/002

Herceptin

Iceland

9.9.2013

EU/1/02/203/005-007

Kineret

Norway

13.12.2013

EU/1/02/203/005-007

Kineret

Iceland

13.12.2013

EU/1/03/249/016

Vivanza

Norway

5.8.2013

EU/1/03/249/016

Vivanza

Iceland

17.7.2013

EU/1/07/436/003-004

Isentress

Norway

4.7.2013

EU/1/08/469/026-045

Oprymea

Norway

25.11.2013

EU/1/08/469/026-045

Oprymea

Iceland

22.11.2013

EU/1/09/546/005-008

Simponi

Norway

7.10.2013

EU/1/09/546/005-008

Simponi

Iceland

12.9.2013

EU/1/10/612/007-009

Revolade

Norway

10.10.2013

EU/1/10/612/007-009

Revolade

Iceland

11.10.2013

EU/1/10/637/010-013

Leflunomide medac

Norway

27.8.2013

EU/1/10/637/010-013

Leflunomide medac

Iceland

19.8.2013

EU/1/11/706/034-038

Levodopa/Carbidopa/Entacapone Orion

Norway

18.10.2013

EU/1/11/706/034-038

Levodopa/Carbidopa/Entacapone Orion

Iceland

18.7.2013

EU/1/11/710/009-015

Votubia

Norway

13.12.2013

EU/1/12/777/007-012

Inlyta

Norway

18.9.2013

EU/1/12/777/007-012

Inlyta

Iceland

4.9.2013

EU/1/97/030/202-203

Insuman Implantable

Norway

18.10.2013

EU/2/04/044/015-016

Aivlosin

Iceland

23.12.2013

EU/2/08/090/029-031

Loxicom

Norway

26.9.2013

EU/2/09/098/002-007

Melovem

Iceland

21.10.2013

EU/2/10/115/011-019

Comfortis

Norway

6.8.2013

EU/2/10/115/020-021

Comfortis

Iceland

11.12.2013

---

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 2013:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/01/189 | Replagal | Norway | 14.8.2013 |
| EU/1/03/266 | Bondenza | Iceland | 12.11.2013 |
| EU/1/09/554 | Clopidogrel ratiopharm | Norway | 25.11.2013 |
| EU/1/10/656 | Possia | Liechtenstein | 31.8.2013 |
| EU/1/11/687 | Hizentra | Norway | 14.8.2013 |
| EU/1/11/730 | Rasitrio | Iceland | 20.9.2013 |
| EU/1/11/730 | Rasitrio | Norway | 3.9.2013 |
| EU/1/12/754 | Sepioglin | Iceland | 12.11.2013 |
| EU/2/00/022 | Ibaflin | Liechtenstein | 31.8.2013 |
| EU/2/09/093 | Netvax | Liechtenstein | 31.10.2013 |
| EU/2/09/093 | Netvax | Iceland | 16.10.2013 |
| EU/2/09/093 | Netvax | Norway | 19.9.2013 |
| EU/2/98/010 | Econor | Norway | 5.8.2013 |

EU-Number

Product

Country

Date of withdrawal

EU/1/01/189

Replagal

Norway

14.8.2013

EU/1/03/266

Bondenza

Iceland

12.11.2013

EU/1/09/554

Clopidogrel ratiopharm

Norway

25.11.2013

EU/1/10/656

Possia

Liechtenstein

31.8.2013

EU/1/11/687

Hizentra

Norway

14.8.2013

EU/1/11/730

Rasitrio

Iceland

20.9.2013

EU/1/11/730

Rasitrio

Norway

3.9.2013

EU/1/12/754

Sepioglin

Iceland

12.11.2013

EU/2/00/022

Ibaflin

Liechtenstein

31.8.2013

EU/2/09/093

Netvax

Liechtenstein

31.10.2013

EU/2/09/093

Netvax

Iceland

16.10.2013

EU/2/09/093

Netvax

Norway

19.9.2013

EU/2/98/010

Econor

Norway

5.8.2013

---

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 2013:

| EU-Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/09/527 | Ribavirin Teva Pharma BV | Liechtenstein | 31.8.2013 |
| EU/1/09/527 | Ribavirin Teva Pharma BV | Iceland | 24.7.2013 |

EU-Number

Product

Country

Date of suspension

EU/1/09/527

Ribavirin Teva Pharma BV

Liechtenstein

31.8.2013

EU/1/09/527

Ribavirin Teva Pharma BV

Iceland

24.7.2013

---

V Announcements

ADMINISTRATIVE PROCEDURES

European Personnel Selection Office (EPSO)

| 6.11.2014 | EN | Official Journal of the European Union | C 391/30 |
| --- | --- | --- | --- |

6.11.2014

EN

Official Journal of the European Union

C 391/30

---

NOTICE OF OPEN COMPETITION

2014/C 391/05

The European Personnel Selection Office (EPSO) is organising the following open competition:

EPSO/AD/294/14 — Administrators (AD 6) in the field of data protection.

The competition notice is published in 24 languages in Official Journal C 391 A of 6 November 2014.

Further information can be found on the EPSO website: http://blogs.ec.europa.eu/eu-careers.info/

---

Corrigenda

| 6.11.2014 | EN | Official Journal of the European Union | C 391/31 |
| --- | --- | --- | --- |

6.11.2014

EN

Official Journal of the European Union

C 391/31

---

Corrigendum to Commission communication concerning Article 4(3) of Directive 2009/22/EC of the European Parliament and of the Council on injunctions for the protection of consumers' interests, which codifies Directive 98/27/EC, concerning the entities qualified to bring an action under Article 2 of this Directive

(
  Official Journal of the European Union C 363 of 14 October 2014
  )

2014/C 391/06

On page 43, part ROMANIA, column Contact details:

for:

| ‘Bd. N. Băalcescu nr. 32-34, et. 4, |
| --- |
| Cam. 16, sector 1, |
| RO-010055, Bucuresti; |
| Tel. 021 311 02 43; |
| Fax 021 315 71 49; |
| E-mail: office@apc-romania.ro; |
| Website: www.apc-romania.ro.’, |

‘Bd. N. Băalcescu nr. 32-34, et. 4,

Cam. 16, sector 1,

RO-010055, Bucuresti;

Tel. 021 311 02 43;

Fax 021 315 71 49;

E-mail: office@apc-romania.ro;

Website: www.apc-romania.ro.’,

read:

read:

| ‘Intr. Licurici 2, bloc 2, ap. 2, sector 3 |
| --- |
| 030894 Bucureşti |
| ROMÂNIA |
| Tel./fax +40 213110243 |
| E-mail: office@apc-romania.ro |
| Internet: www.apc-romania.ro’. |

‘Intr. Licurici 2, bloc 2, ap. 2, sector 3

030894 Bucureşti

ROMÂNIA

Tel./fax +40 213110243

E-mail: office@apc-romania.ro

Internet: www.apc-romania.ro’.

---