# Official Journal C 347/2016

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 347 |
| | |
| English edition | Information and Notices | Volume 5922 September 2016 |

ISSN 1977-091X

Official Journal

of the European Union

C 347

English edition

Information and Notices

Volume 5922 September 2016

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2016/C 347/01 | Communication from the Commission — Automatic increase of an autonomous tariff quota under Council Regulation (EU) 2015/2265 | 1 |
| 2016/C 347/02 | Non-opposition to a notified concentration (Case M.8101 — Siemens/Valeo/JV) (
  1
  ) | 2 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2016/C 347/01

Communication from the Commission — Automatic increase of an autonomous tariff quota under Council Regulation (EU) 2015/2265

1

2016/C 347/02

Non-opposition to a notified concentration (Case M.8101 — Siemens/Valeo/JV) (
  1
  )

1

2

---

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2016/C 347/03 | Euro exchange rates | 3 |
| | NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA |
| | Standing Committee of the EFTA States |
| 2016/C 347/04 | Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2015 | 4 |
| 2016/C 347/05 | Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2015 | 19 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2016/C 347/03

Euro exchange rates

3

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

2016/C 347/04

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2015

4

2016/C 347/05

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2015

19

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| | V   Announcements |
| --- | --- |
| | COURT PROCEEDINGS |
| | EFTA Court |
| 2016/C 347/06 | Action brought on 23 February 2016 by Dr. Gerhard Spitzer against the EFTA Surveillance Authority (Case E-2/16) | 34 |
| 2016/C 347/07 | Action brought on 21 June 2016 by Míla ehf. against the EFTA Surveillance Authority (Case E-7/16) | 35 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2016/C 347/08 | Prior notification of a concentration (Case M.8203 — Blackstone/New Mountain/JDA Software) — Candidate case for simplified procedure (
  1
  ) | 36 |
| 2016/C 347/09 | Prior notification of a concentration (Case M.8192 — Advent International/THL/inVentiv) — Candidate case for simplified procedure (
  1
  ) | 37 |

V   Announcements

COURT PROCEEDINGS

EFTA Court

2016/C 347/06

Action brought on 23 February 2016 by Dr. Gerhard Spitzer against the EFTA Surveillance Authority (Case E-2/16)

34

2016/C 347/07

Action brought on 21 June 2016 by Míla ehf. against the EFTA Surveillance Authority (Case E-7/16)

35

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2016/C 347/08

Prior notification of a concentration (Case M.8203 — Blackstone/New Mountain/JDA Software) — Candidate case for simplified procedure (
  1
  )

1

36

2016/C 347/09

Prior notification of a concentration (Case M.8192 — Advent International/THL/inVentiv) — Candidate case for simplified procedure (
  1
  )

1

37

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

| 22.9.2016 | EN | Official Journal of the European Union | C 347/1 |
| --- | --- | --- | --- |

22.9.2016

EN

Official Journal of the European Union

C 347/1

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COMMUNICATION FROM THE COMMISSION

Automatic increase of an autonomous tariff quota under Council Regulation (EU) 2015/2265

(2016/C 347/01)

Pursuant to Article 4 of Council Regulation (EU) 2015/2265 (1), the volume of the following tariff quota is increased as follows for the 2016 calendar year:

| Order No | CN code | TARIC code | Description | Annual amount of quota
  (tons) | Quota duty | Quota period |
| --- | --- | --- | --- | --- | --- | --- |
| 09.2759 | ex 0302 51 10 | 20 | Cod (Gadus morhua, Gadus ogac, Gadus macrocephalus) and fish of the species Boreogadus saida, excluding livers and roes, fresh, chilled or frozen, for processing (2)
   (3) | 90 000 | 0 % | 1.1.2016-31.12.2016 |
| ex 0302 51 90 | 10 |
| ex 0302 59 10 | 10 |
| ex 0303 63 10 | 10 |
| ex 0303 63 30 | 10 |
| ex 0303 63 90 | 10 |
| ex 0303 69 10 | 10 |

Order No

CN code

TARIC code

Description

Annual amount of quota

(tons)

Quota duty

Quota period

09.2759

ex 0302 51 10

20

Cod (Gadus morhua, Gadus ogac, Gadus macrocephalus) and fish of the species Boreogadus saida, excluding livers and roes, fresh, chilled or frozen, for processing (2)
   (3)

90 000

0 %

1.1.2016-31.12.2016

ex 0302 51 90

10

ex 0302 59 10

10

ex 0303 63 10

10

ex 0303 63 30

10

ex 0303 63 90

10

ex 0303 69 10

10

---

(1)  OJ L 322, 8.12.2015, p. 4.

(2)  The tariff quota is subject to the conditions laid down in Articles 291 to 300 of Regulation (EEC) No 2454/93.

(3)  The tariff quota is not available for products intended solely for one or more of the following operations:

| — | cleaning, gutting, tailing, heading, |
| --- | --- |

—

cleaning, gutting, tailing, heading,

| — | cutting, |
| --- | --- |

—

cutting,

| — | repacking of frozen IQF (individually quick frozen) fillets, |
| --- | --- |

—

repacking of frozen IQF (individually quick frozen) fillets,

| — | sampling, sorting, |
| --- | --- |

—

sampling, sorting,

| — | labelling, |
| --- | --- |

—

labelling,

| — | packing, |
| --- | --- |

—

packing,

| — | chilling, |
| --- | --- |

—

chilling,

| — | freezing, |
| --- | --- |

—

freezing,

| — | deep freezing, |
| --- | --- |

—

deep freezing,

| — | glazing, |
| --- | --- |

—

glazing,

| — | thawing, |
| --- | --- |

—

thawing,

| — | separation. |
| --- | --- |

—

separation.

The tariff quota is not available for products intended, in addition, to undergo treatment or operations which give quota entitlement, where such treatment or operations are carried out at retail or catering level. The reduction of import duties shall apply only for products intended for human consumption.

The tariff quota is, however, available for materials intended for one or more of the following operations:

| — | dicing, |
| --- | --- |

—

dicing,

| — | cutting into rings, cutting into strips for materials under CN codes 0307 49 59, 0307 99 11, 0307 99 17, |
| --- | --- |

—

cutting into rings, cutting into strips for materials under CN codes 0307 49 59, 0307 99 11, 0307 99 17,

| — | filleting, |
| --- | --- |

—

filleting,

| — | production of flaps, |
| --- | --- |

—

production of flaps,

| — | cutting of frozen blocks, |
| --- | --- |

—

cutting of frozen blocks,

| — | splitting of frozen interleaved fillet blocks, |
| --- | --- |

—

splitting of frozen interleaved fillet blocks,

| — | slicing for materials under CN codes ex 0303 66 11, 0303 66 12, 0303 66 13, 0303 66 19, 0303 89 70, 0303 89 90. |
| --- | --- |

—

slicing for materials under CN codes ex 0303 66 11, 0303 66 12, 0303 66 13, 0303 66 19, 0303 89 70, 0303 89 90.

---

| 22.9.2016 | EN | Official Journal of the European Union | C 347/2 |
| --- | --- | --- | --- |

22.9.2016

EN

Official Journal of the European Union

C 347/2

---

Non-opposition to a notified concentration

(Case M.8101 — Siemens/Valeo/JV)

(Text with EEA relevance)

(2016/C 347/02)

On 14 September 2016, 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 32016M8101. 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 32016M8101. EUR-Lex is the online access to the European law.

---

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

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 22.9.2016 | EN | Official Journal of the European Union | C 347/3 |
| --- | --- | --- | --- |

22.9.2016

EN

Official Journal of the European Union

C 347/3

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Euro exchange rates (1)

21 September 2016

(2016/C 347/03)

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,1150 |
| JPY | Japanese yen | 112,49 |
| DKK | Danish krone | 7,4546 |
| GBP | Pound sterling | 0,85693 |
| SEK | Swedish krona | 9,5698 |
| CHF | Swiss franc | 1,0883 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 9,2318 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 27,022 |
| HUF | Hungarian forint | 308,55 |
| PLN | Polish zloty | 4,2915 |
| RON | Romanian leu | 4,4495 |
| TRY | Turkish lira | 3,3168 |
| AUD | Australian dollar | 1,4665 |
| CAD | Canadian dollar | 1,4653 |
| HKD | Hong Kong dollar | 8,6472 |
| NZD | New Zealand dollar | 1,5170 |
| SGD | Singapore dollar | 1,5147 |
| KRW | South Korean won | 1 240,60 |
| ZAR | South African rand | 15,2889 |
| CNY | Chinese yuan renminbi | 7,4384 |
| HRK | Croatian kuna | 7,5080 |
| IDR | Indonesian rupiah | 14 646,08 |
| MYR | Malaysian ringgit | 4,6125 |
| PHP | Philippine peso | 53,301 |
| RUB | Russian rouble | 71,7138 |
| THB | Thai baht | 38,713 |
| BRL | Brazilian real | 3,6137 |
| MXN | Mexican peso | 22,0065 |
| INR | Indian rupee | 74,6800 |

Currency

Exchange rate

USD

US dollar

1,1150

JPY

Japanese yen

112,49

DKK

Danish krone

7,4546

GBP

Pound sterling

0,85693

SEK

Swedish krona

9,5698

CHF

Swiss franc

1,0883

ISK

Iceland króna

NOK

Norwegian krone

9,2318

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

27,022

HUF

Hungarian forint

308,55

PLN

Polish zloty

4,2915

RON

Romanian leu

4,4495

TRY

Turkish lira

3,3168

AUD

Australian dollar

1,4665

CAD

Canadian dollar

1,4653

HKD

Hong Kong dollar

8,6472

NZD

New Zealand dollar

1,5170

SGD

Singapore dollar

1,5147

KRW

South Korean won

1 240,60

ZAR

South African rand

15,2889

CNY

Chinese yuan renminbi

7,4384

HRK

Croatian kuna

7,5080

IDR

Indonesian rupiah

14 646,08

MYR

Malaysian ringgit

4,6125

PHP

Philippine peso

53,301

RUB

Russian rouble

71,7138

THB

Thai baht

38,713

BRL

Brazilian real

3,6137

MXN

Mexican peso

22,0065

INR

Indian rupee

74,6800

---

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

---

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

| 22.9.2016 | EN | Official Journal of the European Union | C 347/4 |
| --- | --- | --- | --- |

22.9.2016

EN

Official Journal of the European Union

C 347/4

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Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2015

(2016/C 347/04)

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 January-30 June 2015, at their meeting on 29 April 2016:

| 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 2015:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/07/423 | Vectibix | Liechtenstein | 28.2.2015 |
| EU/1/11/709 | Buccolam | Liechtenstein | 28.2.2015 |
| EU/1/11/721 | Paglitaz | Liechtenstein | 28.2.2015 |
| EU/1/11/745 | Desloratadine Actavis | Liechtenstein | 28.2.2015 |
| EU/1/12/755 | Pioglitazone Actavis | Liechtenstein | 28.2.2015 |
| EU/1/12/757 | Pioglitazone Teva | Liechtenstein | 28.2.2015 |
| EU/1/12/758 | Pioglitazone Teva Pharma | Liechtenstein | 28.2.2015 |
| EU/1/12/760 | Bronchitol | Liechtenstein | 28.2.2015 |
| EU/1/12/811 | Lyxumia | Liechtenstein | 28.2.2015 |
| EU/1/13/817 | Actelsar HCT | Liechtenstein | 28.2.2015 |
| EU/1/13/822 | Pheburane | Liechtenstein | 28.2.2015 |
| EU/1/13/830 | Stribild | Liechtenstein | 28.2.2015 |
| EU/1/13/835 | Voriconazole Accord | Liechtenstein | 28.2.2015 |
| EU/1/13/845 | Imatinib Accord | Liechtenstein | 28.2.2015 |
| EU/1/13/846 | Xtandi | Liechtenstein | 28.2.2015 |
| EU/1/13/859 | Levodopa-Carbidopa-Entacapone Sandoz | Liechtenstein | 28.2.2015 |
| EU/1/13/879 | Giotrif | Liechtenstein | 28.2.2015 |
| EU/1/13/893 | Opsumit | Liechtenstein | 28.2.2015 |
| EU/1/14/932 | Vantobra | Iceland | 17.4.2015 |
| EU/1/14/932 | Vantobra | Norway | 15.4.2015 |
| EU/1/14/936 | Nuwiq | Liechtenstein | 28.2.2015 |
| EU/1/14/952 | Sevelamer carbonate Zentiva | Iceland | 6.2.2015 |
| EU/1/14/952 | Sevelamer carbonate Zentiva | Liechtenstein | 28.2.2015 |
| EU/1/14/952 | Sevelamer carbonate Zentiva | Norway | 6.2.2015 |
| EU/1/14/953 | Tasermity | Iceland | 12.3.2015 |
| EU/1/14/953 | Tasermity | Liechtenstein | 28.2.2015 |
| EU/1/14/953 | Tasermity | Norway | 12.3.2015 |
| EU/1/14/957 | Cyramza | Iceland | 15.1.2015 |
| EU/1/14/957 | Cyramza | Liechtenstein | 28.2.2015 |
| EU/1/14/957 | Cyramza | Norway | 13.1.2015 |
| EU/1/14/959 | Lynparza | Iceland | 14.1.2015 |
| EU/1/14/959 | Lynparza | Norway | 12.1.2015 |
| EU/1/14/960 | Duavive | Iceland | 14.1.2015 |
| EU/1/14/960 | Duavive | Norway | 12.1.2015 |
| EU/1/14/969 | Scenesse | Iceland | 15.1.2015 |
| EU/1/14/969 | Scenesse | Norway | 15.1.2015 |
| EU/1/14/970 | Rixubis | Iceland | 14.1.2015 |
| EU/1/14/970 | Rixubis | Norway | 13.1.2015 |
| EU/1/14/972 | Duloxetine Lilly | Iceland | 6.1.2015 |
| EU/1/14/973 | Quinsair | Iceland | 19.4.2015 |
| EU/1/14/973 | Quinsair | Liechtenstein | 30.4.2015 |
| EU/1/14/973 | Quinsair | Norway | 15.4.2015 |
| EU/1/14/974 | Cerdelga | Iceland | 5.2.2015 |
| EU/1/14/974 | Cerdelga | Liechtenstein | 28.2.2015 |
| EU/1/14/974 | Cerdelga | Norway | 10.2.2015 |
| EU/1/14/975 | Clopidogrel ratiopharm | Liechtenstein | 28.2.2015 |
| EU/1/14/975 | Clopidogrel ratiopharm | Norway | 5.3.2015 |
| EU/1/14/975 | Clopidogrel ratiopharm | Iceland | 11.3.2015 |
| EU/1/14/976 | Zontivity | Iceland | 5.2.2015 |
| EU/1/14/976 | Zontivity | Liechtenstein | 28.2.2015 |
| EU/1/14/976 | Zontivity | Norway | 16.2.2015 |
| EU/1/14/977 | Rasagilin ratiopharm | Liechtenstein | 28.2.2015 |
| EU/1/14/977 | Rasagiline ratiopharm | Iceland | 22.1.2015 |
| EU/1/14/977 | Rasagiline ratiopharm | Norway | 9.2.2015 |
| EU/1/14/978 | Senshio | Iceland | 30.1.2015 |
| EU/1/14/978 | Senshio | Liechtenstein | 28.2.2015 |
| EU/1/14/978 | Senshio | Norway | 16.2.2015 |
| EU/1/14/979 | Ofev | Iceland | 30.1.2015 |
| EU/1/14/979 | Ofev | Liechtenstein | 28.2.2015 |
| EU/1/14/979 | Ofev | Norway | 29.1.2015 |
| EU/1/14/980 | Cosentyx | Iceland | 4.2.2015 |
| EU/1/14/980 | Cosentyx | Liechtenstein | 28.2.2015 |
| EU/1/14/980 | Cosentyx | Norway | 30.1.2015 |
| EU/1/14/981 | Otezla | Iceland | 5.2.2015 |
| EU/1/14/981 | Otezla | Liechtenstein | 28.2.2015 |
| EU/1/14/981 | Otezla | Norway | 30.1.2015 |
| EU/1/14/982 | Viekirax | Iceland | 29.1.2015 |
| EU/1/14/982 | Viekirax | Liechtenstein | 28.2.2015 |
| EU/1/14/982 | Viekirax | Norway | 20.1.2015 |
| EU/1/14/983 | Exviera | Iceland | 29.1.2015 |
| EU/1/14/983 | Exviera | Liechtenstein | 28.2.2015 |
| EU/1/14/983 | Exviera | Norway | 20.1.2015 |
| EU/1/14/984 | Xadago | Iceland | 11.3.2015 |
| EU/1/14/984 | Xadago | Liechtenstein | 28.2.2015 |
| EU/1/14/984 | Xadago | Norway | 16.3.2015 |
| EU/1/14/985 | Raplixa | Iceland | 17.4.2015 |
| EU/1/14/985 | Raplixa | Liechtenstein | 30.4.2015 |
| EU/1/14/985 | Raplixa | Norway | 10.4.2015 |
| EU/1/14/986 | Xydalba | Iceland | 11.3.2015 |
| EU/1/14/986 | Xydalba | Liechtenstein | 28.2.2015 |
| EU/1/14/986 | Xydalba | Norway | 2.3.2015 |
| EU/1/14/987 | Holoclar | Iceland | 11.3.2015 |
| EU/1/14/987 | Holoclar | Liechtenstein | 28.2.2015 |
| EU/1/14/987 | Holoclar | Norway | 26.2.2015 |
| EU/1/14/988 | Mysimba | Iceland | 19.4.2015 |
| EU/1/14/988 | Mysimba | Liechtenstein | 30.4.2015 |
| EU/1/14/988 | Mysimba | Norway | 15.4.2015 |
| EU/1/15/1000 | Jinarc | Iceland | 4.6.2015 |
| EU/1/15/1000 | Jinarc | Liechtenstein | 30.6.2015 |
| EU/1/15/1000 | Jinarc | Norway | 12.6.2015 |
| EU/1/15/1001 | Akynzeo | Iceland | 4.6.2015 |
| EU/1/15/1001 | Akynzeo | Liechtenstein | 30.6.2015 |
| EU/1/15/1001 | Akynzeo | Norway | 5.6.2015 |
| EU/1/15/1002 | Lenvima | Iceland | 15.6.2015 |
| EU/1/15/1002 | Lenvima | Liechtenstein | 30.6.2015 |
| EU/1/15/1002 | Lenvima | Norway | 15.6.2015 |
| EU/1/15/1003 | Synjardy | Iceland | 9.6.2015 |
| EU/1/15/1003 | Synjardy | Liechtenstein | 30.6.2015 |
| EU/1/15/1003 | Synjardy | Norway | 17.6.2015 |
| EU/1/15/1004 | Voriconazol Hospira | Liechtenstein | 30.6.2015 |
| EU/1/15/1004 | Voriconazole Hospira | Iceland | 4.6.2015 |
| EU/1/15/1004 | Voriconazole Hospira | Norway | 18.6.2015 |
| EU/1/15/1007 | Gardasil 9 | Liechtenstein | 30.6.2015 |
| EU/1/15/1007 | Gardasil 9 | Norway | 18.6.2015 |
| EU/1/15/1009 | Aripiprazole Zentiva | Liechtenstein | 30.6.2015 |
| EU/1/15/1010 | Duloxetine Mylan | Liechtenstein | 30.6.2015 |
| EU/1/15/1011 | Pregabalin Sandoz | Liechtenstein | 30.6.2015 |
| EU/1/15/1012 | Pregabalin Sandoz GmbH | Liechtenstein | 30.6.2015 |
| EU/1/15/1013 | Lumark | Liechtenstein | 30.6.2015 |
| EU/1/15/1014 | Opdivo | Liechtenstein | 30.6.2015 |
| EU/1/15/989 | Orbactiv | Iceland | 17.4.2015 |
| EU/1/15/989 | Orbactiv | Liechtenstein | 30.4.2015 |
| EU/1/15/989 | Orbactiv | Norway | 15.4.2015 |
| EU/1/15/990 | Ikervis | Iceland | 17.4.2015 |
| EU/1/15/990 | Ikervis | Liechtenstein | 30.4.2015 |
| EU/1/15/990 | Ikervis | Norway | 9.4.2015 |
| EU/1/15/991 | Sivextro | Iceland | 19.4.2015 |
| EU/1/15/991 | Sivextro | Liechtenstein | 30.4.2015 |
| EU/1/15/991 | Sivextro | Norway | 15.4.2015 |
| EU/1/15/992 | Saxenda | Iceland | 19.4.2015 |
| EU/1/15/992 | Saxenda | Liechtenstein | 30.4.2015 |
| EU/1/15/992 | Saxenda | Norway | 9.4.2015 |
| EU/1/15/993 | Lixiana | Liechtenstein | 30.6.2015 |
| EU/1/15/994 | Kengrexal | Iceland | 19.4.2015 |
| EU/1/15/994 | Kengrexal | Liechtenstein | 30.4.2015 |
| EU/1/15/994 | Kengrexal | Norway | 10.4.2015 |
| EU/1/15/995 | Dutrebis | Iceland | 19.4.2015 |
| EU/1/15/995 | Dutrebis | Liechtenstein | 30.4.2015 |
| EU/1/15/995 | Dutrebis | Norway | 10.4.2015 |
| EU/1/15/996 | Ristempa | Iceland | 11.5.2015 |
| EU/1/15/996 | Ristempa | Liechtenstein | 30.4.2015 |
| EU/1/15/996 | Ristempa | Norway | 13.4.2015 |
| EU/1/15/999 | Zykadia | Iceland | 4.6.2015 |
| EU/1/15/999 | Zykadia | Liechtenstein | 30.6.2015 |
| EU/1/15/999 | Zykadia | Norway | 27.5.2015 |
| EU/2/11/122 | Bluevac BTV8 | Liechtenstein | 28.2.2015 |
| EU/2/11/131 | Zulvac 1 Ovis | Liechtenstein | 28.2.2015 |
| EU/2/12/140 | Poulvac E. coli | Liechtenstein | 28.2.2015 |
| EU/2/12/142 | Cardalis | Liechtenstein | 28.2.2015 |
| EU/2/13/151 | Equilis West Nile | Liechtenstein | 28.2.2015 |
| EU/2/13/152 | ProZinc | Liechtenstein | 28.2.2015 |
| EU/2/14/162 | Parvoduk | Liechtenstein | 28.2.2015 |
| EU/2/14/176 | Bovela | Iceland | 15.1.2015 |
| EU/2/14/176 | Bovela | Norway | 23.1.2015 |
| EU/2/14/177 | Nexgard Spectra | Iceland | 30.1.2015 |
| EU/2/14/177 | Nexgard Spectra | Liechtenstein | 28.2.2015 |
| EU/2/14/177 | Nexgard Spectra | Norway | 13.2.2015 |
| EU/2/14/178 | Zulvac SBV | Iceland | 24.2.2015 |
| EU/2/14/178 | Zulvac SBV | Liechtenstein | 28.2.2015 |
| EU/2/14/178 | Zulvac SBV | Norway | 11.3.2015 |
| EU/2/14/179 | Suvaxyn CSF Marker | Iceland | 9.4.2015 |
| EU/2/14/179 | Suvaxyn CSF Marker | Liechtenstein | 30.4.2015 |
| EU/2/14/179 | Suvaxyn CSF Marker | Norway | 9.4.2015 |
| EU/2/14/180 | Coliprotec F4 | Iceland | 15.4.2015 |
| EU/2/14/180 | Coliprotec F4 | Liechtenstein | 30.4.2015 |
| EU/2/14/180 | Coliprotec F4 | Norway | 9.4.2015 |
| EU/2/15/181 | Sileo | Liechtenstein | 30.6.2015 |
| EU/2/15/181 | Sileo | Norway | 30.6.2015 |

EU Number

Product

Country

Date of authorisation

EU/1/07/423

Vectibix

Liechtenstein

28.2.2015

EU/1/11/709

Buccolam

Liechtenstein

28.2.2015

EU/1/11/721

Paglitaz

Liechtenstein

28.2.2015

EU/1/11/745

Desloratadine Actavis

Liechtenstein

28.2.2015

EU/1/12/755

Pioglitazone Actavis

Liechtenstein

28.2.2015

EU/1/12/757

Pioglitazone Teva

Liechtenstein

28.2.2015

EU/1/12/758

Pioglitazone Teva Pharma

Liechtenstein

28.2.2015

EU/1/12/760

Bronchitol

Liechtenstein

28.2.2015

EU/1/12/811

Lyxumia

Liechtenstein

28.2.2015

EU/1/13/817

Actelsar HCT

Liechtenstein

28.2.2015

EU/1/13/822

Pheburane

Liechtenstein

28.2.2015

EU/1/13/830

Stribild

Liechtenstein

28.2.2015

EU/1/13/835

Voriconazole Accord

Liechtenstein

28.2.2015

EU/1/13/845

Imatinib Accord

Liechtenstein

28.2.2015

EU/1/13/846

Xtandi

Liechtenstein

28.2.2015

EU/1/13/859

Levodopa-Carbidopa-Entacapone Sandoz

Liechtenstein

28.2.2015

EU/1/13/879

Giotrif

Liechtenstein

28.2.2015

EU/1/13/893

Opsumit

Liechtenstein

28.2.2015

EU/1/14/932

Vantobra

Iceland

17.4.2015

EU/1/14/932

Vantobra

Norway

15.4.2015

EU/1/14/936

Nuwiq

Liechtenstein

28.2.2015

EU/1/14/952

Sevelamer carbonate Zentiva

Iceland

6.2.2015

EU/1/14/952

Sevelamer carbonate Zentiva

Liechtenstein

28.2.2015

EU/1/14/952

Sevelamer carbonate Zentiva

Norway

6.2.2015

EU/1/14/953

Tasermity

Iceland

12.3.2015

EU/1/14/953

Tasermity

Liechtenstein

28.2.2015

EU/1/14/953

Tasermity

Norway

12.3.2015

EU/1/14/957

Cyramza

Iceland

15.1.2015

EU/1/14/957

Cyramza

Liechtenstein

28.2.2015

EU/1/14/957

Cyramza

Norway

13.1.2015

EU/1/14/959

Lynparza

Iceland

14.1.2015

EU/1/14/959

Lynparza

Norway

12.1.2015

EU/1/14/960

Duavive

Iceland

14.1.2015

EU/1/14/960

Duavive

Norway

12.1.2015

EU/1/14/969

Scenesse

Iceland

15.1.2015

EU/1/14/969

Scenesse

Norway

15.1.2015

EU/1/14/970

Rixubis

Iceland

14.1.2015

EU/1/14/970

Rixubis

Norway

13.1.2015

EU/1/14/972

Duloxetine Lilly

Iceland

6.1.2015

EU/1/14/973

Quinsair

Iceland

19.4.2015

EU/1/14/973

Quinsair

Liechtenstein

30.4.2015

EU/1/14/973

Quinsair

Norway

15.4.2015

EU/1/14/974

Cerdelga

Iceland

5.2.2015

EU/1/14/974

Cerdelga

Liechtenstein

28.2.2015

EU/1/14/974

Cerdelga

Norway

10.2.2015

EU/1/14/975

Clopidogrel ratiopharm

Liechtenstein

28.2.2015

EU/1/14/975

Clopidogrel ratiopharm

Norway

5.3.2015

EU/1/14/975

Clopidogrel ratiopharm

Iceland

11.3.2015

EU/1/14/976

Zontivity

Iceland

5.2.2015

EU/1/14/976

Zontivity

Liechtenstein

28.2.2015

EU/1/14/976

Zontivity

Norway

16.2.2015

EU/1/14/977

Rasagilin ratiopharm

Liechtenstein

28.2.2015

EU/1/14/977

Rasagiline ratiopharm

Iceland

22.1.2015

EU/1/14/977

Rasagiline ratiopharm

Norway

9.2.2015

EU/1/14/978

Senshio

Iceland

30.1.2015

EU/1/14/978

Senshio

Liechtenstein

28.2.2015

EU/1/14/978

Senshio

Norway

16.2.2015

EU/1/14/979

Ofev

Iceland

30.1.2015

EU/1/14/979

Ofev

Liechtenstein

28.2.2015

EU/1/14/979

Ofev

Norway

29.1.2015

EU/1/14/980

Cosentyx

Iceland

4.2.2015

EU/1/14/980

Cosentyx

Liechtenstein

28.2.2015

EU/1/14/980

Cosentyx

Norway

30.1.2015

EU/1/14/981

Otezla

Iceland

5.2.2015

EU/1/14/981

Otezla

Liechtenstein

28.2.2015

EU/1/14/981

Otezla

Norway

30.1.2015

EU/1/14/982

Viekirax

Iceland

29.1.2015

EU/1/14/982

Viekirax

Liechtenstein

28.2.2015

EU/1/14/982

Viekirax

Norway

20.1.2015

EU/1/14/983

Exviera

Iceland

29.1.2015

EU/1/14/983

Exviera

Liechtenstein

28.2.2015

EU/1/14/983

Exviera

Norway

20.1.2015

EU/1/14/984

Xadago

Iceland

11.3.2015

EU/1/14/984

Xadago

Liechtenstein

28.2.2015

EU/1/14/984

Xadago

Norway

16.3.2015

EU/1/14/985

Raplixa

Iceland

17.4.2015

EU/1/14/985

Raplixa

Liechtenstein

30.4.2015

EU/1/14/985

Raplixa

Norway

10.4.2015

EU/1/14/986

Xydalba

Iceland

11.3.2015

EU/1/14/986

Xydalba

Liechtenstein

28.2.2015

EU/1/14/986

Xydalba

Norway

2.3.2015

EU/1/14/987

Holoclar

Iceland

11.3.2015

EU/1/14/987

Holoclar

Liechtenstein

28.2.2015

EU/1/14/987

Holoclar

Norway

26.2.2015

EU/1/14/988

Mysimba

Iceland

19.4.2015

EU/1/14/988

Mysimba

Liechtenstein

30.4.2015

EU/1/14/988

Mysimba

Norway

15.4.2015

EU/1/15/1000

Jinarc

Iceland

4.6.2015

EU/1/15/1000

Jinarc

Liechtenstein

30.6.2015

EU/1/15/1000

Jinarc

Norway

12.6.2015

EU/1/15/1001

Akynzeo

Iceland

4.6.2015

EU/1/15/1001

Akynzeo

Liechtenstein

30.6.2015

EU/1/15/1001

Akynzeo

Norway

5.6.2015

EU/1/15/1002

Lenvima

Iceland

15.6.2015

EU/1/15/1002

Lenvima

Liechtenstein

30.6.2015

EU/1/15/1002

Lenvima

Norway

15.6.2015

EU/1/15/1003

Synjardy

Iceland

9.6.2015

EU/1/15/1003

Synjardy

Liechtenstein

30.6.2015

EU/1/15/1003

Synjardy

Norway

17.6.2015

EU/1/15/1004

Voriconazol Hospira

Liechtenstein

30.6.2015

EU/1/15/1004

Voriconazole Hospira

Iceland

4.6.2015

EU/1/15/1004

Voriconazole Hospira

Norway

18.6.2015

EU/1/15/1007

Gardasil 9

Liechtenstein

30.6.2015

EU/1/15/1007

Gardasil 9

Norway

18.6.2015

EU/1/15/1009

Aripiprazole Zentiva

Liechtenstein

30.6.2015

EU/1/15/1010

Duloxetine Mylan

Liechtenstein

30.6.2015

EU/1/15/1011

Pregabalin Sandoz

Liechtenstein

30.6.2015

EU/1/15/1012

Pregabalin Sandoz GmbH

Liechtenstein

30.6.2015

EU/1/15/1013

Lumark

Liechtenstein

30.6.2015

EU/1/15/1014

Opdivo

Liechtenstein

30.6.2015

EU/1/15/989

Orbactiv

Iceland

17.4.2015

EU/1/15/989

Orbactiv

Liechtenstein

30.4.2015

EU/1/15/989

Orbactiv

Norway

15.4.2015

EU/1/15/990

Ikervis

Iceland

17.4.2015

EU/1/15/990

Ikervis

Liechtenstein

30.4.2015

EU/1/15/990

Ikervis

Norway

9.4.2015

EU/1/15/991

Sivextro

Iceland

19.4.2015

EU/1/15/991

Sivextro

Liechtenstein

30.4.2015

EU/1/15/991

Sivextro

Norway

15.4.2015

EU/1/15/992

Saxenda

Iceland

19.4.2015

EU/1/15/992

Saxenda

Liechtenstein

30.4.2015

EU/1/15/992

Saxenda

Norway

9.4.2015

EU/1/15/993

Lixiana

Liechtenstein

30.6.2015

EU/1/15/994

Kengrexal

Iceland

19.4.2015

EU/1/15/994

Kengrexal

Liechtenstein

30.4.2015

EU/1/15/994

Kengrexal

Norway

10.4.2015

EU/1/15/995

Dutrebis

Iceland

19.4.2015

EU/1/15/995

Dutrebis

Liechtenstein

30.4.2015

EU/1/15/995

Dutrebis

Norway

10.4.2015

EU/1/15/996

Ristempa

Iceland

11.5.2015

EU/1/15/996

Ristempa

Liechtenstein

30.4.2015

EU/1/15/996

Ristempa

Norway

13.4.2015

EU/1/15/999

Zykadia

Iceland

4.6.2015

EU/1/15/999

Zykadia

Liechtenstein

30.6.2015

EU/1/15/999

Zykadia

Norway

27.5.2015

EU/2/11/122

Bluevac BTV8

Liechtenstein

28.2.2015

EU/2/11/131

Zulvac 1 Ovis

Liechtenstein

28.2.2015

EU/2/12/140

Poulvac E. coli

Liechtenstein

28.2.2015

EU/2/12/142

Cardalis

Liechtenstein

28.2.2015

EU/2/13/151

Equilis West Nile

Liechtenstein

28.2.2015

EU/2/13/152

ProZinc

Liechtenstein

28.2.2015

EU/2/14/162

Parvoduk

Liechtenstein

28.2.2015

EU/2/14/176

Bovela

Iceland

15.1.2015

EU/2/14/176

Bovela

Norway

23.1.2015

EU/2/14/177

Nexgard Spectra

Iceland

30.1.2015

EU/2/14/177

Nexgard Spectra

Liechtenstein

28.2.2015

EU/2/14/177

Nexgard Spectra

Norway

13.2.2015

EU/2/14/178

Zulvac SBV

Iceland

24.2.2015

EU/2/14/178

Zulvac SBV

Liechtenstein

28.2.2015

EU/2/14/178

Zulvac SBV

Norway

11.3.2015

EU/2/14/179

Suvaxyn CSF Marker

Iceland

9.4.2015

EU/2/14/179

Suvaxyn CSF Marker

Liechtenstein

30.4.2015

EU/2/14/179

Suvaxyn CSF Marker

Norway

9.4.2015

EU/2/14/180

Coliprotec F4

Iceland

15.4.2015

EU/2/14/180

Coliprotec F4

Liechtenstein

30.4.2015

EU/2/14/180

Coliprotec F4

Norway

9.4.2015

EU/2/15/181

Sileo

Liechtenstein

30.6.2015

EU/2/15/181

Sileo

Norway

30.6.2015

---

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 2015:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/133 | Optisulin | Iceland | 18.3.2015 |
| EU/1/00/133 | Optisulin | Liechtenstein | 28.2.2015 |
| EU/1/00/133 | Optisulin | Norway | 27.2.2015 |
| EU/1/00/134 | Lantus | Iceland | 17.3.2015 |
| EU/1/00/134 | Lantus | Liechtenstein | 28.2.2015 |
| EU/1/00/134 | Lantus | Norway | 5.3.2015 |
| EU/1/05/308 | Aclasta | Iceland | 5.2.2015 |
| EU/1/05/308 | Aclasta | Liechtenstein | 28.2.2015 |
| EU/1/05/308 | Aclasta | Norway | 17.2.2015 |
| EU/1/05/310 | Fosavance | Liechtenstein | 30.6.2015 |
| EU/1/05/310 | Fosavance | Norway | 19.5.2015 |
| EU/1/05/315 | Aptivus | Liechtenstein | 30.6.2015 |
| EU/1/05/319 | Xolair | Liechtenstein | 30.6.2015 |
| EU/1/07/423 | Vectibix | Iceland | 15.1.2015 |
| EU/1/07/423 | Vectibix | Norway | 29.1.2015 |
| EU/1/08/506 | Celvapan | Iceland | 3.6.2015 |
| EU/1/08/506 | Celvapan | Liechtenstein | 30.6.2015 |
| EU/1/08/506 | Celvapan | Norway | 27.5.2015 |
| EU/1/09/601 | Firdapse | Iceland | 18.2.2015 |
| EU/1/09/610 | Telmisartan Teva | Iceland | 14.1.2015 |
| EU/1/09/610 | Telmisartan Teva | Liechtenstein | 28.2.2015 |
| EU/1/09/610 | Telmisartan Teva | Norway | 13.1.2015 |
| EU/1/10/612 | Revolade | Iceland | 30.1.2015 |
| EU/1/10/612 | Revolade | Liechtenstein | 28.2.2015 |
| EU/1/10/612 | Revolade | Norway | 29.1.2015 |
| EU/1/10/615 | Temozolomide Hospira | Iceland | 22.1.2015 |
| EU/1/10/615 | Temozolomide Hospira | Liechtenstein | 28.2.2015 |
| EU/1/10/615 | Temozolomide Hospira | Norway | 28.1.2015 |
| EU/1/10/618 | Prolia | Iceland | 4.2.2015 |
| EU/1/10/618 | Prolia | Liechtenstein | 28.2.2015 |
| EU/1/10/618 | Prolia | Norway | 9.2.2015 |
| EU/1/10/620 | Ristfor | Iceland | 14.1.2015 |
| EU/1/10/620 | Ristfor | Norway | 13.1.2015 |
| EU/1/10/621 | Ristaben | Iceland | 14.1.2015 |
| EU/1/10/621 | Ristaben | Norway | 13.1.2015 |
| EU/1/10/625 | Arzerra | Iceland | 2.3.2015 |
| EU/1/10/625 | Arzerra | Liechtenstein | 28.2.2015 |
| EU/1/10/625 | Arzerra | Norway | 26.2.2015 |
| EU/1/10/627 | Raloxifene Teva | Iceland | 20.2.2015 |
| EU/1/10/627 | Raloxifene Teva | Liechtenstein | 28.2.2015 |
| EU/1/10/627 | Raloxifene Teva | Norway | 27.2.2015 |
| EU/1/10/631 | Nivestim | Iceland | 15.6.2015 |
| EU/1/10/631 | Nivestim | Liechtenstein | 30.6.2015 |
| EU/1/10/631 | Nivestim | Norway | 18.6.2015 |
| EU/1/10/632 | Tolura | Iceland | 17.4.2015 |
| EU/1/10/632 | Tolura | Liechtenstein | 30.4.2015 |
| EU/1/10/632 | Tolura | Norway | 9.4.2015 |
| EU/1/10/633 | Topotecan Hospira | Iceland | 15.6.2015 |
| EU/1/10/633 | Topotecan Hospira | Liechtenstein | 30.6.2015 |
| EU/1/10/633 | Topotecan Hospira | Norway | 15.6.2015 |
| EU/1/10/634 | Ribavirin Mylan | Liechtenstein | 28.2.2015 |
| EU/1/10/634 | Ribavirin Mylan | Norway | 27.2.2015 |
| EU/1/10/634 | Ribavirin Mylan | Iceland | 20.2.2015 |
| EU/1/10/635 | Olanzapin Apotex | Liechtenstein | 28.2.2015 |
| EU/1/10/635 | Olanzapin Apotex | Norway | 27.2.2015 |
| EU/1/10/635 | Olanzapine Apotex | Iceland | 20.2.2015 |
| EU/1/10/636 | Daxas | Iceland | 12.5.2015 |
| EU/1/10/636 | Daxas | Norway | 15.5.2015 |
| EU/1/10/637 | Leflunomid medac | Liechtenstein | 30.4.2015 |
| EU/1/10/637 | Leflunomide medac | Iceland | 19.4.2015 |
| EU/1/10/637 | Leflunomide medac | Norway | 9.4.2015 |
| EU/1/10/638 | Ozurdex | Iceland | 19.4.2015 |
| EU/1/10/638 | Ozurdex | Liechtenstein | 30.4.2015 |
| EU/1/10/638 | Ozurdex | Norway | 9.4.2015 |
| EU/1/10/639 | Telmisartan Actavis | Liechtenstein | 30.6.2015 |
| EU/1/10/640 | Sycrest | Iceland | 1.6.2015 |
| EU/1/10/640 | Sycrest | Liechtenstein | 30.6.2015 |
| EU/1/10/640 | Sycrest | Norway | 3.6.2015 |
| EU/1/10/642 | Ibandronsäure Teva | Liechtenstein | 30.6.2015 |
| EU/1/10/643 | Rapiscan | Iceland | 12.5.2015 |
| EU/1/10/643 | Rapiscan | Liechtenstein | 30.6.2015 |
| EU/1/10/643 | Rapiscan | Norway | 15.6.2015 |
| EU/1/10/646 | VPRIV | Liechtenstein | 30.6.2015 |
| EU/1/10/647 | Myclausen | Iceland | 9.6.2015 |
| EU/1/10/647 | Myclausen | Liechtenstein | 30.6.2015 |
| EU/1/10/647 | Myclausen | Norway | 15.6.2015 |
| EU/1/10/651 | Clopidogrel HCS | Liechtenstein | 30.6.2015 |
| EU/1/10/654 | Leflunomid ratiopharm | Liechtenstein | 30.6.2015 |
| EU/1/11/666 | Libertek | Iceland | 12.5.2015 |
| EU/1/11/666 | Libertek | Liechtenstein | 30.6.2015 |
| EU/1/11/666 | Libertek | Norway | 15.5.2015 |
| EU/1/11/668 | Daliresp | Iceland | 12.5.2015 |
| EU/1/11/668 | Daliresp | Liechtenstein | 30.6.2015 |
| EU/1/11/668 | Daliresp | Norway | 15.5.2015 |
| EU/1/11/749 | Caprelsa | Iceland | 30.1.2015 |
| EU/1/11/749 | Caprelsa | Liechtenstein | 28.2.2015 |
| EU/1/11/749 | Caprelsa | Norway | 29.1.2015 |
| EU/1/12/764 | Pixuvri | Iceland | 19.4.2015 |
| EU/1/12/764 | Pixuvri | Norway | 9.4.2015 |
| EU/1/13/818 | Bosulif | Iceland | 11.3.2015 |
| EU/1/13/818 | Bosulif | Liechtenstein | 28.2.2015 |
| EU/1/13/818 | Bosulif | Norway | 6.3.2015 |
| EU/1/13/848 | Erivedge | Iceland | 5.6.2015 |
| EU/1/13/848 | Erivedge | Liechtenstein | 30.6.2015 |
| EU/1/13/848 | Erivedge | Norway | 15.6.2015 |
| EU/1/13/875 | Deltyba | Iceland | 12.5.2015 |
| EU/1/13/875 | Deltyba | Liechtenstein | 30.6.2015 |
| EU/1/13/875 | Deltyba | Norway | 15.5.2015 |
| EU/1/13/890 | Cometriq | Iceland | 5.2.2015 |
| EU/1/13/890 | Cometriq | Liechtenstein | 28.2.2015 |
| EU/1/13/890 | Cometriq | Norway | 13.2.2015 |
| EU/1/13/901 | Sirturo | Iceland | 5.2.2015 |
| EU/1/13/901 | Sirturo | Liechtenstein | 28.2.2015 |
| EU/1/13/901 | Sirturo | Norway | 10.2.2015 |
| EU/2/05/055 | Equilis Te | Liechtenstein | 30.6.2015 |
| EU/2/05/055 | Equilis Te | Norway | 30.6.2015 |
| EU/2/09/103 | Respiporc Flu3 | Norway | 16.1.2015 |
| EU/2/09/104 | Zulvac 8 Ovis | Norway | 14.1.2015 |
| EU/2/10/106 | Bovilis BTV8 | Iceland | 16.6.2015 |
| EU/2/10/106 | Bovilis BTV8 | Liechtenstein | 30.6.2015 |
| EU/2/10/106 | Bovilis BTV8 | Norway | 26.6.2015 |
| EU/2/10/109 | Rhiniseng | Liechtenstein | 30.6.2015 |

EU Number

Product

Country

Date of authorisation

EU/1/00/133

Optisulin

Iceland

18.3.2015

EU/1/00/133

Optisulin

Liechtenstein

28.2.2015

EU/1/00/133

Optisulin

Norway

27.2.2015

EU/1/00/134

Lantus

Iceland

17.3.2015

EU/1/00/134

Lantus

Liechtenstein

28.2.2015

EU/1/00/134

Lantus

Norway

5.3.2015

EU/1/05/308

Aclasta

Iceland

5.2.2015

EU/1/05/308

Aclasta

Liechtenstein

28.2.2015

EU/1/05/308

Aclasta

Norway

17.2.2015

EU/1/05/310

Fosavance

Liechtenstein

30.6.2015

EU/1/05/310

Fosavance

Norway

19.5.2015

EU/1/05/315

Aptivus

Liechtenstein

30.6.2015

EU/1/05/319

Xolair

Liechtenstein

30.6.2015

EU/1/07/423

Vectibix

Iceland

15.1.2015

EU/1/07/423

Vectibix

Norway

29.1.2015

EU/1/08/506

Celvapan

Iceland

3.6.2015

EU/1/08/506

Celvapan

Liechtenstein

30.6.2015

EU/1/08/506

Celvapan

Norway

27.5.2015

EU/1/09/601

Firdapse

Iceland

18.2.2015

EU/1/09/610

Telmisartan Teva

Iceland

14.1.2015

EU/1/09/610

Telmisartan Teva

Liechtenstein

28.2.2015

EU/1/09/610

Telmisartan Teva

Norway

13.1.2015

EU/1/10/612

Revolade

Iceland

30.1.2015

EU/1/10/612

Revolade

Liechtenstein

28.2.2015

EU/1/10/612

Revolade

Norway

29.1.2015

EU/1/10/615

Temozolomide Hospira

Iceland

22.1.2015

EU/1/10/615

Temozolomide Hospira

Liechtenstein

28.2.2015

EU/1/10/615

Temozolomide Hospira

Norway

28.1.2015

EU/1/10/618

Prolia

Iceland

4.2.2015

EU/1/10/618

Prolia

Liechtenstein

28.2.2015

EU/1/10/618

Prolia

Norway

9.2.2015

EU/1/10/620

Ristfor

Iceland

14.1.2015

EU/1/10/620

Ristfor

Norway

13.1.2015

EU/1/10/621

Ristaben

Iceland

14.1.2015

EU/1/10/621

Ristaben

Norway

13.1.2015

EU/1/10/625

Arzerra

Iceland

2.3.2015

EU/1/10/625

Arzerra

Liechtenstein

28.2.2015

EU/1/10/625

Arzerra

Norway

26.2.2015

EU/1/10/627

Raloxifene Teva

Iceland

20.2.2015

EU/1/10/627

Raloxifene Teva

Liechtenstein

28.2.2015

EU/1/10/627

Raloxifene Teva

Norway

27.2.2015

EU/1/10/631

Nivestim

Iceland

15.6.2015

EU/1/10/631

Nivestim

Liechtenstein

30.6.2015

EU/1/10/631

Nivestim

Norway

18.6.2015

EU/1/10/632

Tolura

Iceland

17.4.2015

EU/1/10/632

Tolura

Liechtenstein

30.4.2015

EU/1/10/632

Tolura

Norway

9.4.2015

EU/1/10/633

Topotecan Hospira

Iceland

15.6.2015

EU/1/10/633

Topotecan Hospira

Liechtenstein

30.6.2015

EU/1/10/633

Topotecan Hospira

Norway

15.6.2015

EU/1/10/634

Ribavirin Mylan

Liechtenstein

28.2.2015

EU/1/10/634

Ribavirin Mylan

Norway

27.2.2015

EU/1/10/634

Ribavirin Mylan

Iceland

20.2.2015

EU/1/10/635

Olanzapin Apotex

Liechtenstein

28.2.2015

EU/1/10/635

Olanzapin Apotex

Norway

27.2.2015

EU/1/10/635

Olanzapine Apotex

Iceland

20.2.2015

EU/1/10/636

Daxas

Iceland

12.5.2015

EU/1/10/636

Daxas

Norway

15.5.2015

EU/1/10/637

Leflunomid medac

Liechtenstein

30.4.2015

EU/1/10/637

Leflunomide medac

Iceland

19.4.2015

EU/1/10/637

Leflunomide medac

Norway

9.4.2015

EU/1/10/638

Ozurdex

Iceland

19.4.2015

EU/1/10/638

Ozurdex

Liechtenstein

30.4.2015

EU/1/10/638

Ozurdex

Norway

9.4.2015

EU/1/10/639

Telmisartan Actavis

Liechtenstein

30.6.2015

EU/1/10/640

Sycrest

Iceland

1.6.2015

EU/1/10/640

Sycrest

Liechtenstein

30.6.2015

EU/1/10/640

Sycrest

Norway

3.6.2015

EU/1/10/642

Ibandronsäure Teva

Liechtenstein

30.6.2015

EU/1/10/643

Rapiscan

Iceland

12.5.2015

EU/1/10/643

Rapiscan

Liechtenstein

30.6.2015

EU/1/10/643

Rapiscan

Norway

15.6.2015

EU/1/10/646

VPRIV

Liechtenstein

30.6.2015

EU/1/10/647

Myclausen

Iceland

9.6.2015

EU/1/10/647

Myclausen

Liechtenstein

30.6.2015

EU/1/10/647

Myclausen

Norway

15.6.2015

EU/1/10/651

Clopidogrel HCS

Liechtenstein

30.6.2015

EU/1/10/654

Leflunomid ratiopharm

Liechtenstein

30.6.2015

EU/1/11/666

Libertek

Iceland

12.5.2015

EU/1/11/666

Libertek

Liechtenstein

30.6.2015

EU/1/11/666

Libertek

Norway

15.5.2015

EU/1/11/668

Daliresp

Iceland

12.5.2015

EU/1/11/668

Daliresp

Liechtenstein

30.6.2015

EU/1/11/668

Daliresp

Norway

15.5.2015

EU/1/11/749

Caprelsa

Iceland

30.1.2015

EU/1/11/749

Caprelsa

Liechtenstein

28.2.2015

EU/1/11/749

Caprelsa

Norway

29.1.2015

EU/1/12/764

Pixuvri

Iceland

19.4.2015

EU/1/12/764

Pixuvri

Norway

9.4.2015

EU/1/13/818

Bosulif

Iceland

11.3.2015

EU/1/13/818

Bosulif

Liechtenstein

28.2.2015

EU/1/13/818

Bosulif

Norway

6.3.2015

EU/1/13/848

Erivedge

Iceland

5.6.2015

EU/1/13/848

Erivedge

Liechtenstein

30.6.2015

EU/1/13/848

Erivedge

Norway

15.6.2015

EU/1/13/875

Deltyba

Iceland

12.5.2015

EU/1/13/875

Deltyba

Liechtenstein

30.6.2015

EU/1/13/875

Deltyba

Norway

15.5.2015

EU/1/13/890

Cometriq

Iceland

5.2.2015

EU/1/13/890

Cometriq

Liechtenstein

28.2.2015

EU/1/13/890

Cometriq

Norway

13.2.2015

EU/1/13/901

Sirturo

Iceland

5.2.2015

EU/1/13/901

Sirturo

Liechtenstein

28.2.2015

EU/1/13/901

Sirturo

Norway

10.2.2015

EU/2/05/055

Equilis Te

Liechtenstein

30.6.2015

EU/2/05/055

Equilis Te

Norway

30.6.2015

EU/2/09/103

Respiporc Flu3

Norway

16.1.2015

EU/2/09/104

Zulvac 8 Ovis

Norway

14.1.2015

EU/2/10/106

Bovilis BTV8

Iceland

16.6.2015

EU/2/10/106

Bovilis BTV8

Liechtenstein

30.6.2015

EU/2/10/106

Bovilis BTV8

Norway

26.6.2015

EU/2/10/109

Rhiniseng

Liechtenstein

30.6.2015

---

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 2015:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/133/033-035 | Toujeo | Iceland | 12.5.2015 |
| EU/1/00/133/033-035 | Toujeo | Norway | 19.5.2015 |
| EU/1/01/195/028-029 | Liprolog KwikPen | Iceland | 19.2.2015 |
| EU/1/04/303/004 | Orfadin | Iceland | 3.6.2015 |
| EU/1/04/303/004 | Orfadin | Norway | 28.5.2015 |
| EU/1/07/319/009 | Revlimid | Norway | 2.3.2015 |
| EU/1/07/391/009 | Revlimid | Iceland | 10.3.2015 |
| EU/1/08/469/046-049 | Oprymea | Iceland | 2.3.2015 |
| EU/1/08/469/050-053 | Oprymea | Iceland | 2.3.2015 |
| EU/1/08/469/046-049 | Oprymea | Norway | 25.2.2015 |
| EU/1/08/469/050-053 | Oprymea | Norway | 25.2.2015 |
| EU/1/12/771/007-009 | Zoledronic Acid Teva | Iceland | 15.1.2015 |
| EU/1/12/798/005-006 | Ibandronic acid Accord | Iceland | 19.4.2015 |
| EU/1/12/798/005-006 | Ibandronic acid Accord | Norway | 10.4.2015 |
| EU/1/13/819/002 | Jetrea | Iceland | 13.5.2015 |
| EU/1/13/819/002 | Jetrea | Norway | 13.5.2015 |
| EU/1/96/007/039-042 | Humalog KwikPen | Iceland | 19.2.2015 |
| EU/2/06/062/005 | Cerenia | Norway | 29.6.2015 |
| EU/2/07/078/021 | Rheumocam | Iceland | 4.6.2015 |
| EU/2/07/078/021 | Rheumocam | Norway | 2.6.2015 |
| EU/2/97/004/050-053 | Metacam | Norway | 6.5.2015 |
| EU/2/97/004/050-053 | Metacam | Iceland | 6.5.2015 |
| EU/2/99/014/013-016 | Stronghold | Norway | 10.4.2015 |

EU Number

Product

Country

Date of authorisation

EU/1/00/133/033-035

Toujeo

Iceland

12.5.2015

EU/1/00/133/033-035

Toujeo

Norway

19.5.2015

EU/1/01/195/028-029

Liprolog KwikPen

Iceland

19.2.2015

EU/1/04/303/004

Orfadin

Iceland

3.6.2015

EU/1/04/303/004

Orfadin

Norway

28.5.2015

EU/1/07/319/009

Revlimid

Norway

2.3.2015

EU/1/07/391/009

Revlimid

Iceland

10.3.2015

EU/1/08/469/046-049

Oprymea

Iceland

2.3.2015

EU/1/08/469/050-053

Oprymea

Iceland

2.3.2015

EU/1/08/469/046-049

Oprymea

Norway

25.2.2015

EU/1/08/469/050-053

Oprymea

Norway

25.2.2015

EU/1/12/771/007-009

Zoledronic Acid Teva

Iceland

15.1.2015

EU/1/12/798/005-006

Ibandronic acid Accord

Iceland

19.4.2015

EU/1/12/798/005-006

Ibandronic acid Accord

Norway

10.4.2015

EU/1/13/819/002

Jetrea

Iceland

13.5.2015

EU/1/13/819/002

Jetrea

Norway

13.5.2015

EU/1/96/007/039-042

Humalog KwikPen

Iceland

19.2.2015

EU/2/06/062/005

Cerenia

Norway

29.6.2015

EU/2/07/078/021

Rheumocam

Iceland

4.6.2015

EU/2/07/078/021

Rheumocam

Norway

2.6.2015

EU/2/97/004/050-053

Metacam

Norway

6.5.2015

EU/2/97/004/050-053

Metacam

Iceland

6.5.2015

EU/2/99/014/013-016

Stronghold

Norway

10.4.2015

---

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 2015:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/07/426 | Olanzapine Cipla | Norway | 21.1.2015 |
| EU/1/08/458 | Trevaclyn | Liechtenstein | 28.2.2015 |
| EU/1/08/459 | Tredaptive | Liechtenstein | 28.2.2015 |
| EU/1/08/460 | Pelzont | Liechtenstein | 28.2.2015 |
| EU/1/09/554 | Clopidogrel ratiopharm | Liechtenstein | 28.2.2015 |
| EU/1/09/560 | Clopidogrel Dura | Liechtenstein | 30.6.2015 |
| EU/1/09/560 | Clopidogrel Dura | Norway | 30.6.2015 |
| EU/1/10/649 | Clopidogrel Teva Pharma B.V. | Norway | 21.1.2015 |
| EU/1/10/650 | Clopidogrel Teva Generics B.V. | Iceland | 5.2.2015 |
| EU/1/10/664 | Pumarix | Iceland | 20.2.2015 |
| EU/1/10/664 | Pumarix | Liechtenstein | 28.2.2015 |
| EU/1/10/664 | Pumarix | Norway | 31.1.2015 |
| EU/1/11/686 | Rasilamlo | Liechtenstein | 30.6.2015 |
| EU/1/11/723 | Pioglitazone Krka | Norway | 21.1.2015 |
| EU/1/11/748 | Docetaxel Mylan (Sunset clause) | Norway | 3.2.2015 |
| EU/1/12/754 | Sepioglin | Liechtenstein | 28.2.2015 |
| EU/1/12/774 | Rienso | Iceland | 12.5.2015 |
| EU/1/12/774 | Rienso | Liechtenstein | 30.4.2015 |
| EU/1/12/774 | Rienso | Norway | 19.5.2015 |
| EU/1/12/804 | BindRen | Iceland | 13.3.2015 |
| EU/1/12/804 | BindRen | Liechtenstein | 30.4.2015 |
| EU/1/12/804 | BindRen | Norway | 14.4.2015 |
| EU/1/13/867 | Provenge | Liechtenstein | 30.6.2015 |
| EU/1/13/867 | Provenge | Norway | 15.6.2015 |
| EU/1/97/037 | Vistide | Norway | 4.2.2015 |
| EU/2/04/049 | Purevax RCCh | Iceland | 10.2.2015 |
| EU/2/07/071 | Slentrol | Iceland | 5.2.2015 |
| EU/2/07/071 | Slentrol | Liechtenstein | 28.2.2015 |
| EU/2/07/071 | Slentrol | Norway | 30.3.2015 |
| EU/2/11/136 | TruScient | Iceland | 5.2.2015 |
| EU/2/11/136 | TruScient | Liechtenstein | 28.2.2015 |
| EU/2/11/136 | TruScient | Norway | 22.4.2015 |

EU Number

Product

Country

Date of authorisation

EU/1/07/426

Olanzapine Cipla

Norway

21.1.2015

EU/1/08/458

Trevaclyn

Liechtenstein

28.2.2015

EU/1/08/459

Tredaptive

Liechtenstein

28.2.2015

EU/1/08/460

Pelzont

Liechtenstein

28.2.2015

EU/1/09/554

Clopidogrel ratiopharm

Liechtenstein

28.2.2015

EU/1/09/560

Clopidogrel Dura

Liechtenstein

30.6.2015

EU/1/09/560

Clopidogrel Dura

Norway

30.6.2015

EU/1/10/649

Clopidogrel Teva Pharma B.V.

Norway

21.1.2015

EU/1/10/650

Clopidogrel Teva Generics B.V.

Iceland

5.2.2015

EU/1/10/664

Pumarix

Iceland

20.2.2015

EU/1/10/664

Pumarix

Liechtenstein

28.2.2015

EU/1/10/664

Pumarix

Norway

31.1.2015

EU/1/11/686

Rasilamlo

Liechtenstein

30.6.2015

EU/1/11/723

Pioglitazone Krka

Norway

21.1.2015

EU/1/11/748

Docetaxel Mylan (Sunset clause)

Norway

3.2.2015

EU/1/12/754

Sepioglin

Liechtenstein

28.2.2015

EU/1/12/774

Rienso

Iceland

12.5.2015

EU/1/12/774

Rienso

Liechtenstein

30.4.2015

EU/1/12/774

Rienso

Norway

19.5.2015

EU/1/12/804

BindRen

Iceland

13.3.2015

EU/1/12/804

BindRen

Liechtenstein

30.4.2015

EU/1/12/804

BindRen

Norway

14.4.2015

EU/1/13/867

Provenge

Liechtenstein

30.6.2015

EU/1/13/867

Provenge

Norway

15.6.2015

EU/1/97/037

Vistide

Norway

4.2.2015

EU/2/04/049

Purevax RCCh

Iceland

10.2.2015

EU/2/07/071

Slentrol

Iceland

5.2.2015

EU/2/07/071

Slentrol

Liechtenstein

28.2.2015

EU/2/07/071

Slentrol

Norway

30.3.2015

EU/2/11/136

TruScient

Iceland

5.2.2015

EU/2/11/136

TruScient

Liechtenstein

28.2.2015

EU/2/11/136

TruScient

Norway

22.4.2015

---

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 2015:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/13/847/001 | MACI | Norway | 22.1.2015 |

EU Number

Product

Country

Date of authorisation

EU/1/13/847/001

MACI

Norway

22.1.2015

---

| 22.9.2016 | EN | Official Journal of the European Union | C 347/19 |
| --- | --- | --- | --- |

22.9.2016

EN

Official Journal of the European Union

C 347/19

---

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2015

(2016/C 347/05)

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 2015, at their meeting on 18 March 2016:

| 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 2015:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/11/710 | Votubia (switch to non-conditional) | Liechtenstein | 31.12.2015 |
| EU/1/13/895 | Kolbam | Iceland | 14.12.2015 |
| EU/1/13/895 | Kolbam | Norway | 15.12.2015 |
| EU/1/13/895 | Kolbam | Liechtenstein | 31.12.2015 |
| EU/1/15/1005 | Aripiprazole Pharmathen | Iceland | 23.7.2015 |
| EU/1/15/1005 | Aripiprazole Pharmathen | Liechtenstein | 31.8.2015 |
| EU/1/15/1005 | Aripiprazole Pharmathen | Norway | 16.7.2015 |
| EU/1/15/1006 | Respreeza | Iceland | 31.8.2015 |
| EU/1/15/1006 | Respreeza | Liechtenstein | 31.8.2015 |
| EU/1/15/1006 | Respreeza | Norway | 28.8.2015 |
| EU/1/15/1007 | Gardasil 9 | Iceland | 8.7.2015 |
| EU/1/15/1008 | Hetlioz | Iceland | 4.8.2015 |
| EU/1/15/1008 | Hetlioz | Liechtenstein | 31.8.2015 |
| EU/1/15/1008 | Hetlioz | Norway | 16.7.2015 |
| EU/1/15/1009 | Aripiprazole Zentiva | Iceland | 23.7.2015 |
| EU/1/15/1009 | Aripiprazole Zentiva | Norway | 16.7.2015 |
| EU/1/15/1010 | Duloxetine Mylan | Iceland | 9.7.2015 |
| EU/1/15/1010 | Duloxetine Mylan | Norway | 9.7.2015 |
| EU/1/15/1011 | Pregabalin Sandoz | Iceland | 10.7.2015 |
| EU/1/15/1011 | Pregabalin Sandoz | Norway | 17.7.2015 |
| EU/1/15/1012 | Pregabalin Sandoz GmbH | Iceland | 10.7.2015 |
| EU/1/15/1012 | Pregabalin Sandoz GmbH | Norway | 17.7.2015 |
| EU/1/15/1013 | Lumark | Norway | 13.7.2015 |
| EU/1/15/1013 | Lumark | Iceland | 10.7.2015 |
| EU/1/15/1014 | OPDIVO | Iceland | 10.7.2015 |
| EU/1/15/1014 | Opdivo | Norway | 2.7.2015 |
| EU/1/15/1015 | Strensiq | Iceland | 10.9.2015 |
| EU/1/15/1015 | Strensiq | Liechtenstein | 31.10.2015 |
| EU/1/15/1015 | Strensiq | Norway | 14.9.2015 |
| EU/1/15/1016 | Repatha | Iceland | 14.8.2015 |
| EU/1/15/1016 | Repatha | Liechtenstein | 31.8.2015 |
| EU/1/15/1016 | Repatha | Norway | 5.8.2015 |
| EU/1/15/1017 | Docetaxel Hospira UK Limited | Iceland | 4.9.2015 |
| EU/1/15/1017 | Docetaxel Hospira UK limited | Liechtenstein | 31.10.2015 |
| EU/1/15/1017 | Docetaxel Hospira UK Limited | Norway | 7.9.2015 |
| EU/1/15/1018 | Omidria | Iceland | 19.8.2015 |
| EU/1/15/1018 | Omidria | Liechtenstein | 31.8.2015 |
| EU/1/15/1018 | Omidria | Norway | 26.8.2015 |
| EU/1/15/1019 | Bortezomib Accord | Iceland | 19.8.2015 |
| EU/1/15/1019 | Bortezomib Accord | Liechtenstein | 31.8.2015 |
| EU/1/15/1019 | Bortezomib Accord | Norway | 11.8.2015 |
| EU/1/15/1020 | Raxone | Iceland | 15.9.2015 |
| EU/1/15/1020 | Raxone | Liechtenstein | 31.10.2015 |
| EU/1/15/1020 | Raxone | Norway | 30.9.2015 |
| EU/1/15/1021 | Pregabalin Zentiva | Iceland | 14.8.2015 |
| EU/1/15/1021 | Pregabalin Zentiva | Liechtenstein | 31.8.2015 |
| EU/1/15/1021 | Pregabalin Zentiva | Norway | 10.8.2015 |
| EU/1/15/1022 | Unituxin | Iceland | 21.8.2015 |
| EU/1/15/1022 | Unituxin | Liechtenstein | 31.8.2015 |
| EU/1/15/1022 | Unituxin | Norway | 25.8.2015 |
| EU/1/15/1023 | Farydak | Iceland | 4.9.2015 |
| EU/1/15/1023 | Farydak | Liechtenstein | 31.10.2015 |
| EU/1/15/1023 | Farydak | Norway | 7.9.2015 |
| EU/1/15/1024 | Keytruda | Iceland | 13.8.2015 |
| EU/1/15/1024 | Keytruda | Liechtenstein | 31.8.2015 |
| EU/1/15/1024 | Keytruda | Norway | 11.8.2015 |
| EU/1/15/1025 | Evotaz | Iceland | 12.8.2015 |
| EU/1/15/1025 | Evotaz | Liechtenstein | 31.8.2015 |
| EU/1/15/1025 | Evotaz | Norway | 10.8.2015 |
| EU/1/15/1026 | Nivolumab BMS | Iceland | 28.12.2015 |
| EU/1/15/1026 | Nivolumab BMS | Liechtenstein | 31.8.2015 |
| EU/1/15/1026 | Nivolumab BMS | Norway | 11.8.2015 |
| EU/1/15/1027 | Pregabalin Accord | Iceland | 2.9.2015 |
| EU/1/15/1027 | Pregabalin Accord | Liechtenstein | 31.10.2015 |
| EU/1/15/1027 | Pregabalin Accord | Norway | 7.9.2015 |
| EU/1/15/1028 | Duloxetine Zentiva | Iceland | 31.8.2015 |
| EU/1/15/1028 | Duloxetine Zentiva | Liechtenstein | 31.8.2015 |
| EU/1/15/1028 | Duloxetine Zentiva | Norway | 23.9.2015 |
| EU/1/15/1029 | Aripiprazole Sandoz | Iceland | 31.8.2015 |
| EU/1/15/1029 | Aripiprazole Sandoz | Liechtenstein | 31.8.2015 |
| EU/1/15/1029 | Aripiprazole Sandoz | Norway | 25.8.2015 |
| EU/1/15/1030 | Odomzo | Iceland | 1.9.2015 |
| EU/1/15/1030 | Odomzo | Liechtenstein | 31.8.2015 |
| EU/1/15/1030 | Odomzo | Norway | 4.9.2015 |
| EU/1/15/1031 | Praluent | Iceland | 16.10.2015 |
| EU/1/15/1031 | Praluent | Liechtenstein | 31.10.2015 |
| EU/1/15/1031 | Praluent | Norway | 1.10.2015 |
| EU/1/15/1032 | Zerbaxa | Iceland | 23.9.2015 |
| EU/1/15/1032 | Zerbaxa | Liechtenstein | 31.10.2015 |
| EU/1/15/1032 | Zerbaxa | Norway | 13.10.2015 |
| EU/1/15/1033 | Kanuma | Iceland | 2.9.2015 |
| EU/1/15/1033 | Kanuma | Liechtenstein | 31.8.2015 |
| EU/1/15/1033 | Kanuma | Norway | 10.9.2015 |
| EU/1/15/1034 | Pemetrexed Lilly | Iceland | 21.9.2015 |
| EU/1/15/1034 | Pemetrexed Lilly | Liechtenstein | 31.10.2015 |
| EU/1/15/1034 | Pemetrexed Lilly | Norway | 21.9.2015 |
| EU/1/15/1035 | Obizur | Iceland | 18.11.2015 |
| EU/1/15/1035 | Obizur | Norway | 30.11.2015 |
| EU/1/15/1035 | Obizur | Liechtenstein | 31.12.2015 |
| EU/1/15/1036 | Cresemba | Iceland | 23.10.2015 |
| EU/1/15/1036 | Cresemba | Liechtenstein | 31.10.2015 |
| EU/1/15/1036 | Cresemba | Norway | 11.11.2015 |
| EU/1/15/1037 | Pemetrexed Sandoz | Iceland | 15.10.2015 |
| EU/1/15/1037 | Pemetrexed Sandoz | Liechtenstein | 31.10.2015 |
| EU/1/15/1037 | Pemetrexed Sandoz | Norway | 24.9.2015 |
| EU/1/15/1038 | Pemetrexed medac | Iceland | 11.12.2015 |
| EU/1/15/1038 | Pemetrexed medac | Norway | 14.12.2015 |
| EU/1/15/1038 | Pemetrexed medac | Liechtenstein | 31.12.2015 |
| EU/1/15/1039 | Fexeric | Iceland | 16.10.2015 |
| EU/1/15/1039 | Fexeric | Liechtenstein | 31.10.2015 |
| EU/1/15/1039 | Fexeric | Norway | 13.10.2015 |
| EU/1/15/1040 | Intuniv | Iceland | 21.9.2015 |
| EU/1/15/1040 | Intuniv | Liechtenstein | 31.10.2015 |
| EU/1/15/1040 | Intuniv | Norway | 23.9.2015 |
| EU/1/15/1041 | Ivabradine Anpharm | Iceland | 15.10.2015 |
| EU/1/15/1041 | Ivabradine Anpharm | Liechtenstein | 31.10.2015 |
| EU/1/15/1041 | Ivabradine Anpharm | Norway | 1.10.2015 |
| EU/1/15/1042 | Zalviso | Liechtenstein | 31.10.2015 |
| EU/1/15/1042 | Zalviso | Iceland | 16.10.2015 |
| EU/1/15/1042 | Zalviso | Norway | 13.10.2015 |
| EU/1/15/1043 | Nucala | Iceland | 29.12.2015 |
| EU/1/15/1043 | Nucala | Norway | 10.12.2015 |
| EU/1/15/1043 | Nucala | Liechtenstein | 31.12.2015 |
| EU/1/15/1044 | Numient | Iceland | 14.12.2015 |
| EU/1/15/1044 | Numient | Norway | 22.12.2015 |
| EU/1/15/1044 | Numient | Liechtenstein | 31.12.2015 |
| EU/1/15/1045 | Aripiprazole Accord | Iceland | 20.11.2015 |
| EU/1/15/1045 | Aripiprazole Accord | Norway | 3.12.2015 |
| EU/1/15/1045 | Aripiprazole Accord | Liechtenstein | 31.12.2015 |
| EU/1/15/1046 | Elocta | Iceland | 11.12.2015 |
| EU/1/15/1046 | Elocta | Norway | 17.12.2015 |
| EU/1/15/1046 | Elocta | Liechtenstein | 31.12.2015 |
| EU/1/15/1047 | Blincyto | Iceland | 23.12.2015 |
| EU/1/15/1047 | Blincyto | Norway | 1.12.2015 |
| EU/1/15/1047 | Blincyto | Liechtenstein | 31.12.2015 |
| EU/1/15/1048 | Cotellic | Iceland | 11.12.2015 |
| EU/1/15/1048 | Cotellic | Norway | 30.11.2015 |
| EU/1/15/1048 | Cotellic | Liechtenstein | 31.12.2015 |
| EU/1/15/1050 | Ionsys | Iceland | 24.11.2015 |
| EU/1/15/1050 | Ionsys | Norway | 10.12.2015 |
| EU/1/15/1050 | Ionsys | Liechtenstein | 31.12.2015 |
| EU/1/15/1051 | Ebymect | Iceland | 23.11.2015 |
| EU/1/15/1051 | Ebymect | Norway | 10.12.2015 |
| EU/1/15/1051 | Ebymect | Liechtenstein | 31.12.2015 |
| EU/1/15/1052 | Edistride | Iceland | 17.11.2015 |
| EU/1/15/1052 | Edistride | Norway | 3.12.2015 |
| EU/1/15/1052 | Edistride | Liechtenstein | 31.12.2015 |
| EU/1/15/1054 | Cinacalcet Mylan | Iceland | 24.11.2015 |
| EU/1/15/1054 | Cinacalcet Mylan | Norway | 30.11.2015 |
| EU/1/15/1054 | Cinacalcet Mylan | Liechtenstein | 31.12.2015 |
| EU/1/15/1055 | Ciambra | Iceland | 29.12.2015 |
| EU/1/15/1055 | Ciambra | Norway | 10.12.2015 |
| EU/1/15/1055 | Ciambra | Liechtenstein | 31.12.2015 |
| EU/1/15/1056 | Praxbind | Iceland | 11.12.2015 |
| EU/1/15/1056 | Praxbind | Norway | 10.12.2015 |
| EU/1/15/1056 | Praxbind | Liechtenstein | 31.12.2015 |
| EU/1/15/1057 | Pemetrexed Hospira | Iceland | 11.12.2015 |
| EU/1/15/1057 | Pemetrexed Hospira | Norway | 1.12.2015 |
| EU/1/15/1057 | Pemetrexed Hospira | Liechtenstein | 31.12.2015 |
| EU/1/15/1058 | Entresto | Iceland | 11.12.2015 |
| EU/1/15/1058 | Entresto | Norway | 26.11.2015 |
| EU/1/15/1058 | Entresto | Liechtenstein | 31.12.2015 |
| EU/1/15/1059 | Orkambi | Iceland | 8.12.2015 |
| EU/1/15/1059 | Orkambi | Norway | 10.12.2015 |
| EU/1/15/1059 | Orkambi | Liechtenstein | 31.12.2015 |
| EU/1/15/1060 | Kyprolis | Iceland | 24.11.2015 |
| EU/1/15/1060 | Kyprolis | Norway | 1.12.2015 |
| EU/1/15/1060 | Kyprolis | Liechtenstein | 31.12.2015 |
| EU/1/15/1061 | Genvoya | Iceland | 9.12.2015 |
| EU/1/15/1061 | Genvoya | Norway | 10.12.2015 |
| EU/1/15/1061 | Genvoya | Liechtenstein | 31.12.2015 |
| EU/1/15/1062 | Ravicti | Iceland | 15.12.2015 |
| EU/1/15/1062 | Ravicti | Norway | 10.12.2015 |
| EU/1/15/1062 | Ravicti | Liechtenstein | 31.12.2015 |
| EU/1/15/993 | Lixiana | Iceland | 10.7.2015 |
| EU/1/15/993 | Lixiana | Norway | 6.7.2015 |
| EU/1/15/997 | Pregabalin Mylan | Iceland | 13.7.2015 |
| EU/1/15/997 | Pregabalin Mylan | Liechtenstein | 31.8.2015 |
| EU/1/15/997 | Pregabalin Mylan | Norway | 16.7.2015 |
| EU/1/15/998 | Pregabalin Mylan Pharma | Iceland | 13.7.2015 |
| EU/1/15/998 | Pregabalin Mylan Pharma | Liechtenstein | 31.8.2015 |
| EU/1/15/998 | Pregabalin Mylan Pharma | Norway | 16.7.2015 |
| EU/2/15/181 | Sileo | Iceland | 8.7.2015 |
| EU/2/15/182 | Innovax ILT | Liechtenstein | 31.8.2015 |
| EU/2/15/182 | Innovax-ILT | Iceland | 24.7.2015 |
| EU/2/15/182 | Innovax-ILT | Norway | 30.7.2015 |
| EU/2/15/183 | Canigen L4 | Iceland | 6.8.2015 |
| EU/2/15/183 | Canigen L4 | Liechtenstein | 31.8.2015 |
| EU/2/15/183 | Canigen L4 | Norway | 30.7.2015 |
| EU/2/15/184 | UpCard | Iceland | 20.8.2015 |
| EU/2/15/184 | UpCard | Liechtenstein | 31.10.2015 |
| EU/2/15/184 | UpCard | Norway | 10.8.2015 |
| EU/2/15/185 | Fortekor Plus | Iceland | 21.9.2015 |
| EU/2/15/185 | Fortekor Plus | Liechtenstein | 31.10.2015 |
| EU/2/15/185 | Fortekor Plus | Norway | 6.10.2015 |
| EU/2/15/186 | Novaquin | Iceland | 15.9.2015 |
| EU/2/15/186 | Novaquin | Liechtenstein | 31.10.2015 |
| EU/2/15/186 | Novaquin | Norway | 6.10.2015 |
| EU/2/15/187 | Porcilis PCV ID | Iceland | 2.9.2015 |
| EU/2/15/187 | Porcilis PCV ID | Liechtenstein | 31.10.2015 |
| EU/2/15/187 | Porcilis PCV ID | Norway | 9.9.2015 |
| EU/2/15/188 | Vectormune ND | Iceland | 21.9.2015 |
| EU/2/15/188 | Vectormune ND | Liechtenstein | 31.10.2015 |
| EU/2/15/188 | Vectormune ND | Norway | 6.10.2015 |
| EU/2/15/189 | Zycortal | Iceland | 20.11.2015 |
| EU/2/15/189 | Zycortal | Norway | 3.12.2015 |
| EU/2/15/189 | Zycortal | Liechtenstein | 31.12.2015 |
| EU/2/15/190 | Suvaxyn Circo + MH RTU | Norway | 4.12.2015 |
| EU/2/15/190 | Suvaxyn Circo + MH RTU | Liechtenstein | 31.12.2015 |
| EU/2/15/190 | Suvaxyn Circo + MH RTU | Iceland | 16.11.2015 |
| EU/2/15/191 | Simparica | Iceland | 20.11.2015 |
| EU/2/15/191 | Simparica | Norway | 4.12.2015 |
| EU/2/15/191 | Simparica | Liechtenstein | 31.12.2015 |
| EU/2/15/192 | Velactis | Iceland | 30.12.2015 |
| EU/2/15/192 | Velactis | Liechtenstein | 31.12.2015 |
| EU/2/15/193 | Imrestor | Liechtenstein | 31.12.2015 |

EU Number

Product

Country

Date of authorisation

EU/1/11/710

Votubia (switch to non-conditional)

Liechtenstein

31.12.2015

EU/1/13/895

Kolbam

Iceland

14.12.2015

EU/1/13/895

Kolbam

Norway

15.12.2015

EU/1/13/895

Kolbam

Liechtenstein

31.12.2015

EU/1/15/1005

Aripiprazole Pharmathen

Iceland

23.7.2015

EU/1/15/1005

Aripiprazole Pharmathen

Liechtenstein

31.8.2015

EU/1/15/1005

Aripiprazole Pharmathen

Norway

16.7.2015

EU/1/15/1006

Respreeza

Iceland

31.8.2015

EU/1/15/1006

Respreeza

Liechtenstein

31.8.2015

EU/1/15/1006

Respreeza

Norway

28.8.2015

EU/1/15/1007

Gardasil 9

Iceland

8.7.2015

EU/1/15/1008

Hetlioz

Iceland

4.8.2015

EU/1/15/1008

Hetlioz

Liechtenstein

31.8.2015

EU/1/15/1008

Hetlioz

Norway

16.7.2015

EU/1/15/1009

Aripiprazole Zentiva

Iceland

23.7.2015

EU/1/15/1009

Aripiprazole Zentiva

Norway

16.7.2015

EU/1/15/1010

Duloxetine Mylan

Iceland

9.7.2015

EU/1/15/1010

Duloxetine Mylan

Norway

9.7.2015

EU/1/15/1011

Pregabalin Sandoz

Iceland

10.7.2015

EU/1/15/1011

Pregabalin Sandoz

Norway

17.7.2015

EU/1/15/1012

Pregabalin Sandoz GmbH

Iceland

10.7.2015

EU/1/15/1012

Pregabalin Sandoz GmbH

Norway

17.7.2015

EU/1/15/1013

Lumark

Norway

13.7.2015

EU/1/15/1013

Lumark

Iceland

10.7.2015

EU/1/15/1014

OPDIVO

Iceland

10.7.2015

EU/1/15/1014

Opdivo

Norway

2.7.2015

EU/1/15/1015

Strensiq

Iceland

10.9.2015

EU/1/15/1015

Strensiq

Liechtenstein

31.10.2015

EU/1/15/1015

Strensiq

Norway

14.9.2015

EU/1/15/1016

Repatha

Iceland

14.8.2015

EU/1/15/1016

Repatha

Liechtenstein

31.8.2015

EU/1/15/1016

Repatha

Norway

5.8.2015

EU/1/15/1017

Docetaxel Hospira UK Limited

Iceland

4.9.2015

EU/1/15/1017

Docetaxel Hospira UK limited

Liechtenstein

31.10.2015

EU/1/15/1017

Docetaxel Hospira UK Limited

Norway

7.9.2015

EU/1/15/1018

Omidria

Iceland

19.8.2015

EU/1/15/1018

Omidria

Liechtenstein

31.8.2015

EU/1/15/1018

Omidria

Norway

26.8.2015

EU/1/15/1019

Bortezomib Accord

Iceland

19.8.2015

EU/1/15/1019

Bortezomib Accord

Liechtenstein

31.8.2015

EU/1/15/1019

Bortezomib Accord

Norway

11.8.2015

EU/1/15/1020

Raxone

Iceland

15.9.2015

EU/1/15/1020

Raxone

Liechtenstein

31.10.2015

EU/1/15/1020

Raxone

Norway

30.9.2015

EU/1/15/1021

Pregabalin Zentiva

Iceland

14.8.2015

EU/1/15/1021

Pregabalin Zentiva

Liechtenstein

31.8.2015

EU/1/15/1021

Pregabalin Zentiva

Norway

10.8.2015

EU/1/15/1022

Unituxin

Iceland

21.8.2015

EU/1/15/1022

Unituxin

Liechtenstein

31.8.2015

EU/1/15/1022

Unituxin

Norway

25.8.2015

EU/1/15/1023

Farydak

Iceland

4.9.2015

EU/1/15/1023

Farydak

Liechtenstein

31.10.2015

EU/1/15/1023

Farydak

Norway

7.9.2015

EU/1/15/1024

Keytruda

Iceland

13.8.2015

EU/1/15/1024

Keytruda

Liechtenstein

31.8.2015

EU/1/15/1024

Keytruda

Norway

11.8.2015

EU/1/15/1025

Evotaz

Iceland

12.8.2015

EU/1/15/1025

Evotaz

Liechtenstein

31.8.2015

EU/1/15/1025

Evotaz

Norway

10.8.2015

EU/1/15/1026

Nivolumab BMS

Iceland

28.12.2015

EU/1/15/1026

Nivolumab BMS

Liechtenstein

31.8.2015

EU/1/15/1026

Nivolumab BMS

Norway

11.8.2015

EU/1/15/1027

Pregabalin Accord

Iceland

2.9.2015

EU/1/15/1027

Pregabalin Accord

Liechtenstein

31.10.2015

EU/1/15/1027

Pregabalin Accord

Norway

7.9.2015

EU/1/15/1028

Duloxetine Zentiva

Iceland

31.8.2015

EU/1/15/1028

Duloxetine Zentiva

Liechtenstein

31.8.2015

EU/1/15/1028

Duloxetine Zentiva

Norway

23.9.2015

EU/1/15/1029

Aripiprazole Sandoz

Iceland

31.8.2015

EU/1/15/1029

Aripiprazole Sandoz

Liechtenstein

31.8.2015

EU/1/15/1029

Aripiprazole Sandoz

Norway

25.8.2015

EU/1/15/1030

Odomzo

Iceland

1.9.2015

EU/1/15/1030

Odomzo

Liechtenstein

31.8.2015

EU/1/15/1030

Odomzo

Norway

4.9.2015

EU/1/15/1031

Praluent

Iceland

16.10.2015

EU/1/15/1031

Praluent

Liechtenstein

31.10.2015

EU/1/15/1031

Praluent

Norway

1.10.2015

EU/1/15/1032

Zerbaxa

Iceland

23.9.2015

EU/1/15/1032

Zerbaxa

Liechtenstein

31.10.2015

EU/1/15/1032

Zerbaxa

Norway

13.10.2015

EU/1/15/1033

Kanuma

Iceland

2.9.2015

EU/1/15/1033

Kanuma

Liechtenstein

31.8.2015

EU/1/15/1033

Kanuma

Norway

10.9.2015

EU/1/15/1034

Pemetrexed Lilly

Iceland

21.9.2015

EU/1/15/1034

Pemetrexed Lilly

Liechtenstein

31.10.2015

EU/1/15/1034

Pemetrexed Lilly

Norway

21.9.2015

EU/1/15/1035

Obizur

Iceland

18.11.2015

EU/1/15/1035

Obizur

Norway

30.11.2015

EU/1/15/1035

Obizur

Liechtenstein

31.12.2015

EU/1/15/1036

Cresemba

Iceland

23.10.2015

EU/1/15/1036

Cresemba

Liechtenstein

31.10.2015

EU/1/15/1036

Cresemba

Norway

11.11.2015

EU/1/15/1037

Pemetrexed Sandoz

Iceland

15.10.2015

EU/1/15/1037

Pemetrexed Sandoz

Liechtenstein

31.10.2015

EU/1/15/1037

Pemetrexed Sandoz

Norway

24.9.2015

EU/1/15/1038

Pemetrexed medac

Iceland

11.12.2015

EU/1/15/1038

Pemetrexed medac

Norway

14.12.2015

EU/1/15/1038

Pemetrexed medac

Liechtenstein

31.12.2015

EU/1/15/1039

Fexeric

Iceland

16.10.2015

EU/1/15/1039

Fexeric

Liechtenstein

31.10.2015

EU/1/15/1039

Fexeric

Norway

13.10.2015

EU/1/15/1040

Intuniv

Iceland

21.9.2015

EU/1/15/1040

Intuniv

Liechtenstein

31.10.2015

EU/1/15/1040

Intuniv

Norway

23.9.2015

EU/1/15/1041

Ivabradine Anpharm

Iceland

15.10.2015

EU/1/15/1041

Ivabradine Anpharm

Liechtenstein

31.10.2015

EU/1/15/1041

Ivabradine Anpharm

Norway

1.10.2015

EU/1/15/1042

Zalviso

Liechtenstein

31.10.2015

EU/1/15/1042

Zalviso

Iceland

16.10.2015

EU/1/15/1042

Zalviso

Norway

13.10.2015

EU/1/15/1043

Nucala

Iceland

29.12.2015

EU/1/15/1043

Nucala

Norway

10.12.2015

EU/1/15/1043

Nucala

Liechtenstein

31.12.2015

EU/1/15/1044

Numient

Iceland

14.12.2015

EU/1/15/1044

Numient

Norway

22.12.2015

EU/1/15/1044

Numient

Liechtenstein

31.12.2015

EU/1/15/1045

Aripiprazole Accord

Iceland

20.11.2015

EU/1/15/1045

Aripiprazole Accord

Norway

3.12.2015

EU/1/15/1045

Aripiprazole Accord

Liechtenstein

31.12.2015

EU/1/15/1046

Elocta

Iceland

11.12.2015

EU/1/15/1046

Elocta

Norway

17.12.2015

EU/1/15/1046

Elocta

Liechtenstein

31.12.2015

EU/1/15/1047

Blincyto

Iceland

23.12.2015

EU/1/15/1047

Blincyto

Norway

1.12.2015

EU/1/15/1047

Blincyto

Liechtenstein

31.12.2015

EU/1/15/1048

Cotellic

Iceland

11.12.2015

EU/1/15/1048

Cotellic

Norway

30.11.2015

EU/1/15/1048

Cotellic

Liechtenstein

31.12.2015

EU/1/15/1050

Ionsys

Iceland

24.11.2015

EU/1/15/1050

Ionsys

Norway

10.12.2015

EU/1/15/1050

Ionsys

Liechtenstein

31.12.2015

EU/1/15/1051

Ebymect

Iceland

23.11.2015

EU/1/15/1051

Ebymect

Norway

10.12.2015

EU/1/15/1051

Ebymect

Liechtenstein

31.12.2015

EU/1/15/1052

Edistride

Iceland

17.11.2015

EU/1/15/1052

Edistride

Norway

3.12.2015

EU/1/15/1052

Edistride

Liechtenstein

31.12.2015

EU/1/15/1054

Cinacalcet Mylan

Iceland

24.11.2015

EU/1/15/1054

Cinacalcet Mylan

Norway

30.11.2015

EU/1/15/1054

Cinacalcet Mylan

Liechtenstein

31.12.2015

EU/1/15/1055

Ciambra

Iceland

29.12.2015

EU/1/15/1055

Ciambra

Norway

10.12.2015

EU/1/15/1055

Ciambra

Liechtenstein

31.12.2015

EU/1/15/1056

Praxbind

Iceland

11.12.2015

EU/1/15/1056

Praxbind

Norway

10.12.2015

EU/1/15/1056

Praxbind

Liechtenstein

31.12.2015

EU/1/15/1057

Pemetrexed Hospira

Iceland

11.12.2015

EU/1/15/1057

Pemetrexed Hospira

Norway

1.12.2015

EU/1/15/1057

Pemetrexed Hospira

Liechtenstein

31.12.2015

EU/1/15/1058

Entresto

Iceland

11.12.2015

EU/1/15/1058

Entresto

Norway

26.11.2015

EU/1/15/1058

Entresto

Liechtenstein

31.12.2015

EU/1/15/1059

Orkambi

Iceland

8.12.2015

EU/1/15/1059

Orkambi

Norway

10.12.2015

EU/1/15/1059

Orkambi

Liechtenstein

31.12.2015

EU/1/15/1060

Kyprolis

Iceland

24.11.2015

EU/1/15/1060

Kyprolis

Norway

1.12.2015

EU/1/15/1060

Kyprolis

Liechtenstein

31.12.2015

EU/1/15/1061

Genvoya

Iceland

9.12.2015

EU/1/15/1061

Genvoya

Norway

10.12.2015

EU/1/15/1061

Genvoya

Liechtenstein

31.12.2015

EU/1/15/1062

Ravicti

Iceland

15.12.2015

EU/1/15/1062

Ravicti

Norway

10.12.2015

EU/1/15/1062

Ravicti

Liechtenstein

31.12.2015

EU/1/15/993

Lixiana

Iceland

10.7.2015

EU/1/15/993

Lixiana

Norway

6.7.2015

EU/1/15/997

Pregabalin Mylan

Iceland

13.7.2015

EU/1/15/997

Pregabalin Mylan

Liechtenstein

31.8.2015

EU/1/15/997

Pregabalin Mylan

Norway

16.7.2015

EU/1/15/998

Pregabalin Mylan Pharma

Iceland

13.7.2015

EU/1/15/998

Pregabalin Mylan Pharma

Liechtenstein

31.8.2015

EU/1/15/998

Pregabalin Mylan Pharma

Norway

16.7.2015

EU/2/15/181

Sileo

Iceland

8.7.2015

EU/2/15/182

Innovax ILT

Liechtenstein

31.8.2015

EU/2/15/182

Innovax-ILT

Iceland

24.7.2015

EU/2/15/182

Innovax-ILT

Norway

30.7.2015

EU/2/15/183

Canigen L4

Iceland

6.8.2015

EU/2/15/183

Canigen L4

Liechtenstein

31.8.2015

EU/2/15/183

Canigen L4

Norway

30.7.2015

EU/2/15/184

UpCard

Iceland

20.8.2015

EU/2/15/184

UpCard

Liechtenstein

31.10.2015

EU/2/15/184

UpCard

Norway

10.8.2015

EU/2/15/185

Fortekor Plus

Iceland

21.9.2015

EU/2/15/185

Fortekor Plus

Liechtenstein

31.10.2015

EU/2/15/185

Fortekor Plus

Norway

6.10.2015

EU/2/15/186

Novaquin

Iceland

15.9.2015

EU/2/15/186

Novaquin

Liechtenstein

31.10.2015

EU/2/15/186

Novaquin

Norway

6.10.2015

EU/2/15/187

Porcilis PCV ID

Iceland

2.9.2015

EU/2/15/187

Porcilis PCV ID

Liechtenstein

31.10.2015

EU/2/15/187

Porcilis PCV ID

Norway

9.9.2015

EU/2/15/188

Vectormune ND

Iceland

21.9.2015

EU/2/15/188

Vectormune ND

Liechtenstein

31.10.2015

EU/2/15/188

Vectormune ND

Norway

6.10.2015

EU/2/15/189

Zycortal

Iceland

20.11.2015

EU/2/15/189

Zycortal

Norway

3.12.2015

EU/2/15/189

Zycortal

Liechtenstein

31.12.2015

EU/2/15/190

Suvaxyn Circo + MH RTU

Norway

4.12.2015

EU/2/15/190

Suvaxyn Circo + MH RTU

Liechtenstein

31.12.2015

EU/2/15/190

Suvaxyn Circo + MH RTU

Iceland

16.11.2015

EU/2/15/191

Simparica

Iceland

20.11.2015

EU/2/15/191

Simparica

Norway

4.12.2015

EU/2/15/191

Simparica

Liechtenstein

31.12.2015

EU/2/15/192

Velactis

Iceland

30.12.2015

EU/2/15/192

Velactis

Liechtenstein

31.12.2015

EU/2/15/193

Imrestor

Liechtenstein

31.12.2015

---

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 2015:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/146 | Keppra | Iceland | 31.8.2015 |
| EU/1/00/146 | Keppra | Liechtenstein | 31.10.2015 |
| EU/1/00/146 | Keppra | Norway | 8.9.2015 |
| EU/1/05/310 | Fosavance | Iceland | 24.8.2015 |
| EU/1/05/312 | Xyrem | Iceland | 15.10.2015 |
| EU/1/05/312 | Xyrem | Liechtenstein | 31.10.2015 |
| EU/1/05/312 | Xyrem | Norway | 14.10.2015 |
| EU/1/05/315 | Aptivus | Iceland | 10.7.2015 |
| EU/1/05/315 | Aptivus | Norway | 2.7.2015 |
| EU/1/05/319 | Xolair | Iceland | 9.7.2015 |
| EU/1/05/319 | Xolair | Norway | 7.7.2015 |
| EU/1/05/323 | ProQuad | Liechtenstein | 31.12.2015 |
| EU/1/05/325 | Macugen | Iceland | 9.12.2015 |
| EU/1/05/325 | Macugen | Norway | 30.11.2015 |
| EU/1/05/325 | Macugen | Liechtenstein | 31.12.2015 |
| EU/1/10/639 | Telmisartan Actavis | Iceland | 9.7.2015 |
| EU/1/10/639 | Telmisartan Actavis | Norway | 8.7.2015 |
| EU/1/10/641 | Ruconest | Iceland | 16.10.2015 |
| EU/1/10/641 | Ruconest | Norway | 14.10.2015 |
| EU/1/10/641 | Ruconest | Liechtenstein | 31.12.2015 |
| EU/1/10/642 | Ibandronic Acid Teva | Iceland | 9.7.2015 |
| EU/1/10/642 | Ibandronic Acid Teva | Norway | 16.7.2015 |
| EU/1/10/644 | PecFent | Iceland | 27.8.2015 |
| EU/1/10/644 | PecFent | Norway | 10.8.2015 |
| EU/1/10/645 | Brinavess | Iceland | 19.8.2015 |
| EU/1/10/645 | Brinavess | Liechtenstein | 31.8.2015 |
| EU/1/10/645 | Brinavess | Norway | 26.8.2015 |
| EU/1/10/646 | VPRIV | Iceland | 9.7.2015 |
| EU/1/10/646 | VPRIV | Norway | 7.7.2015 |
| EU/1/10/648 | Twynsta | Iceland | 1.9.2015 |
| EU/1/10/648 | Twynsta | Liechtenstein | 31.10.2015 |
| EU/1/10/648 | Twynsta | Norway | 8.9.2015 |
| EU/1/10/651 | Clopidogrel HCS | Iceland | 9.7.2015 |
| EU/1/10/651 | Clopidogrel HCS | Norway | 1.7.2015 |
| EU/1/10/654 | Leflunomide ratiopharm | Iceland | 10.7.2015 |
| EU/1/10/654 | Leflunomide ratiopharm | Norway | 2.7.2015 |
| EU/1/10/655 | Brilique | Iceland | 13.8.2015 |
| EU/1/10/655 | Brilique | Liechtenstein | 31.8.2015 |
| EU/1/10/655 | Brilique | Norway | 26.8.2015 |
| EU/1/10/658 | Aflunov | Iceland | 13.8.2015 |
| EU/1/10/658 | Aflunov | Liechtenstein | 31.8.2015 |
| EU/1/10/658 | Aflunov | Norway | 14.8.2015 |
| EU/1/10/659 | Iasibon | Norway | 20.10.2015 |
| EU/1/10/659 | Iasibon | Iceland | 14.10.2015 |
| EU/1/10/659 | Iasibon | Liechtenstein | 31.10.2015 |
| EU/1/10/660 | Potactasol | Iceland | 22.10.2015 |
| EU/1/10/660 | Potactasol | Liechtenstein | 31.10.2015 |
| EU/1/10/660 | Potactasol | Norway | 16.10.2015 |
| EU/1/10/663 | Lamivudine/Zidovudine Teva | Norway | 10.12.2015 |
| EU/1/10/663 | Lamivudine/Zidovudine Teva | Iceland | 9.12.2015 |
| EU/1/10/663 | Lamivudine/Zidovudine Teva | Liechtenstein | 31.12.2015 |
| EU/1/10/665 | Entacapone Teva | Iceland | 10.12.2015 |
| EU/1/10/665 | Entacapone Teva | Norway | 10.12.2015 |
| EU/1/10/665 | Entacapone Teva | Liechtenstein | 31.12.2015 |
| EU/1/11/667 | Esbriet | Iceland | 15.9.2015 |
| EU/1/11/667 | Esbriet | Liechtenstein | 31.10.2015 |
| EU/1/11/667 | Esbriet | Norway | 16.9.2015 |
| EU/1/11/669 | Teysuno | Iceland | 8.12.2015 |
| EU/1/11/669 | Teysuno | Norway | 1.12.2015 |
| EU/1/11/669 | Teysuno | Liechtenstein | 31.12.2015 |
| EU/1/11/672 | Xeplion | Liechtenstein | 31.12.2015 |
| EU/1/11/673 | Ifirmacombi | Iceland | 10.12.2015 |
| EU/1/11/673 | Ifirmacombi | Norway | 30.11.2015 |
| EU/1/11/673 | Ifirmacombi | Liechtenstein | 31.12.2015 |
| EU/1/11/676 | Jevtana | Iceland | 10.12.2015 |
| EU/1/11/676 | Jevtana | Norway | 27.11.2015 |
| EU/1/11/676 | Jevtana | Liechtenstein | 31.12.2015 |
| EU/1/11/677 | Gilenya | Iceland | 8.12.2015 |
| EU/1/11/677 | Gilenya | Norway | 27.11.2015 |
| EU/1/11/678 | Halaven | Iceland | 9.12.2015 |
| EU/1/11/678 | Halaven | Norway | 27.11.2015 |
| EU/1/11/678 | Halaven | Liechtenstein | 31.12.2015 |
| EU/1/11/699 | Fampyra | Iceland | 25.8.2015 |
| EU/1/11/699 | Fampyra | Liechtenstein | 31.8.2015 |
| EU/1/11/699 | Fampyra | Norway | 3.8.2015 |
| EU/1/11/710 | Votubia | Iceland | 19.8.2015 |
| EU/1/11/710 | Votubia | Liechtenstein | 31.8.2015 |
| EU/1/11/710 | Votubia | Norway | 14.8.2015 |
| EU/1/12/793 | Xalkori | Iceland | 13.8.2015 |
| EU/1/12/793 | Xalkori | Liechtenstein | 31.8.2015 |
| EU/1/12/793 | Xalkori | Norway | 17.8.2015 |
| EU/1/12/794 | Adcetris | Iceland | 15.10.2015 |
| EU/1/12/794 | Adcetris | Norway | 30.9.2015 |
| EU/1/12/794 | Adcetris | Liechtenstein | 31.12.2015 |
| EU/1/13/902 | Translarna | Iceland | 19.8.2015 |
| EU/1/13/902 | Translarna | Liechtenstein | 31.8.2015 |
| EU/1/13/902 | Translarna | Norway | 26.8.2016 |
| EU/1/14/987 | Holoclar | Norway | 17.12.2015 |
| EU/1/14/987 | Holoclar | Liechtenstein | 31.12.2015 |
| EU/2/05/055 | Equilis Te | Iceland | 9.7.2015 |
| EU/2/10/108 | BTVPUR AlSap 2-4 | Iceland | 20.8.2015 |
| EU/2/10/108 | BTVPUR AlSap 2-4 | Liechtenstein | 31.8.2015 |
| EU/2/10/108 | BTVPUR AlSap 2-4 | Norway | 10.8.2015 |
| EU/2/10/109 | Rhiniseng | Iceland | 23.7.2015 |
| EU/2/10/109 | Rhiniseng | Norway | 29.7.2015 |
| EU/2/10/110 | Coxevac | Iceland | 20.8.2015 |
| EU/2/10/110 | Coxevac | Liechtenstein | 31.8.2015 |
| EU/2/10/110 | Coxevac | Norway | 13.8.2015 |
| EU/2/10/111 | Meloxoral | Iceland | 15.9.2015 |
| EU/2/10/111 | Meloxoral | Liechtenstein | 31.10.2015 |
| EU/2/10/111 | Meloxoral | Norway | 6.10.2015 |
| EU/2/10/112 | BTVPUR ALSap 1 | Iceland | 15.9.2015 |
| EU/2/10/112 | BTVPUR AlSap 1 | Liechtenstein | 31.10.2015 |
| EU/2/10/112 | BTVPUR AlSap 1 | Norway | 6.10.2015 |
| EU/2/10/113 | BTVPUR ALSap 1-8 | Iceland | 15.9.2015 |
| EU/2/10/113 | BTVPUR AlSap 1-8 | Norway | 6.10.2015 |
| EU/2/10/114 | Hiprabovis IBR Marker Live | Iceland | 20.11.2015 |
| EU/2/10/114 | Hiprabovis IBR Marker Live | Norway | 3.12.2015 |
| EU/2/10/114 | Hiprabovis IBR Marker Live | Liechtenstein | 31.12.2015 |
| EU/2/10/117 | Purevax Rabies | Iceland | 30.12.2015 |
| EU/2/10/117 | Purevax Rabies | Norway | 18.12.2015 |
| EU/2/10/117 | Purevax Rabies | Liechtenstein | 31.12.2015 |

EU Number

Product

Country

Date of authorisation

EU/1/00/146

Keppra

Iceland

31.8.2015

EU/1/00/146

Keppra

Liechtenstein

31.10.2015

EU/1/00/146

Keppra

Norway

8.9.2015

EU/1/05/310

Fosavance

Iceland

24.8.2015

EU/1/05/312

Xyrem

Iceland

15.10.2015

EU/1/05/312

Xyrem

Liechtenstein

31.10.2015

EU/1/05/312

Xyrem

Norway

14.10.2015

EU/1/05/315

Aptivus

Iceland

10.7.2015

EU/1/05/315

Aptivus

Norway

2.7.2015

EU/1/05/319

Xolair

Iceland

9.7.2015

EU/1/05/319

Xolair

Norway

7.7.2015

EU/1/05/323

ProQuad

Liechtenstein

31.12.2015

EU/1/05/325

Macugen

Iceland

9.12.2015

EU/1/05/325

Macugen

Norway

30.11.2015

EU/1/05/325

Macugen

Liechtenstein

31.12.2015

EU/1/10/639

Telmisartan Actavis

Iceland

9.7.2015

EU/1/10/639

Telmisartan Actavis

Norway

8.7.2015

EU/1/10/641

Ruconest

Iceland

16.10.2015

EU/1/10/641

Ruconest

Norway

14.10.2015

EU/1/10/641

Ruconest

Liechtenstein

31.12.2015

EU/1/10/642

Ibandronic Acid Teva

Iceland

9.7.2015

EU/1/10/642

Ibandronic Acid Teva

Norway

16.7.2015

EU/1/10/644

PecFent

Iceland

27.8.2015

EU/1/10/644

PecFent

Norway

10.8.2015

EU/1/10/645

Brinavess

Iceland

19.8.2015

EU/1/10/645

Brinavess

Liechtenstein

31.8.2015

EU/1/10/645

Brinavess

Norway

26.8.2015

EU/1/10/646

VPRIV

Iceland

9.7.2015

EU/1/10/646

VPRIV

Norway

7.7.2015

EU/1/10/648

Twynsta

Iceland

1.9.2015

EU/1/10/648

Twynsta

Liechtenstein

31.10.2015

EU/1/10/648

Twynsta

Norway

8.9.2015

EU/1/10/651

Clopidogrel HCS

Iceland

9.7.2015

EU/1/10/651

Clopidogrel HCS

Norway

1.7.2015

EU/1/10/654

Leflunomide ratiopharm

Iceland

10.7.2015

EU/1/10/654

Leflunomide ratiopharm

Norway

2.7.2015

EU/1/10/655

Brilique

Iceland

13.8.2015

EU/1/10/655

Brilique

Liechtenstein

31.8.2015

EU/1/10/655

Brilique

Norway

26.8.2015

EU/1/10/658

Aflunov

Iceland

13.8.2015

EU/1/10/658

Aflunov

Liechtenstein

31.8.2015

EU/1/10/658

Aflunov

Norway

14.8.2015

EU/1/10/659

Iasibon

Norway

20.10.2015

EU/1/10/659

Iasibon

Iceland

14.10.2015

EU/1/10/659

Iasibon

Liechtenstein

31.10.2015

EU/1/10/660

Potactasol

Iceland

22.10.2015

EU/1/10/660

Potactasol

Liechtenstein

31.10.2015

EU/1/10/660

Potactasol

Norway

16.10.2015

EU/1/10/663

Lamivudine/Zidovudine Teva

Norway

10.12.2015

EU/1/10/663

Lamivudine/Zidovudine Teva

Iceland

9.12.2015

EU/1/10/663

Lamivudine/Zidovudine Teva

Liechtenstein

31.12.2015

EU/1/10/665

Entacapone Teva

Iceland

10.12.2015

EU/1/10/665

Entacapone Teva

Norway

10.12.2015

EU/1/10/665

Entacapone Teva

Liechtenstein

31.12.2015

EU/1/11/667

Esbriet

Iceland

15.9.2015

EU/1/11/667

Esbriet

Liechtenstein

31.10.2015

EU/1/11/667

Esbriet

Norway

16.9.2015

EU/1/11/669

Teysuno

Iceland

8.12.2015

EU/1/11/669

Teysuno

Norway

1.12.2015

EU/1/11/669

Teysuno

Liechtenstein

31.12.2015

EU/1/11/672

Xeplion

Liechtenstein

31.12.2015

EU/1/11/673

Ifirmacombi

Iceland

10.12.2015

EU/1/11/673

Ifirmacombi

Norway

30.11.2015

EU/1/11/673

Ifirmacombi

Liechtenstein

31.12.2015

EU/1/11/676

Jevtana

Iceland

10.12.2015

EU/1/11/676

Jevtana

Norway

27.11.2015

EU/1/11/676

Jevtana

Liechtenstein

31.12.2015

EU/1/11/677

Gilenya

Iceland

8.12.2015

EU/1/11/677

Gilenya

Norway

27.11.2015

EU/1/11/678

Halaven

Iceland

9.12.2015

EU/1/11/678

Halaven

Norway

27.11.2015

EU/1/11/678

Halaven

Liechtenstein

31.12.2015

EU/1/11/699

Fampyra

Iceland

25.8.2015

EU/1/11/699

Fampyra

Liechtenstein

31.8.2015

EU/1/11/699

Fampyra

Norway

3.8.2015

EU/1/11/710

Votubia

Iceland

19.8.2015

EU/1/11/710

Votubia

Liechtenstein

31.8.2015

EU/1/11/710

Votubia

Norway

14.8.2015

EU/1/12/793

Xalkori

Iceland

13.8.2015

EU/1/12/793

Xalkori

Liechtenstein

31.8.2015

EU/1/12/793

Xalkori

Norway

17.8.2015

EU/1/12/794

Adcetris

Iceland

15.10.2015

EU/1/12/794

Adcetris

Norway

30.9.2015

EU/1/12/794

Adcetris

Liechtenstein

31.12.2015

EU/1/13/902

Translarna

Iceland

19.8.2015

EU/1/13/902

Translarna

Liechtenstein

31.8.2015

EU/1/13/902

Translarna

Norway

26.8.2016

EU/1/14/987

Holoclar

Norway

17.12.2015

EU/1/14/987

Holoclar

Liechtenstein

31.12.2015

EU/2/05/055

Equilis Te

Iceland

9.7.2015

EU/2/10/108

BTVPUR AlSap 2-4

Iceland

20.8.2015

EU/2/10/108

BTVPUR AlSap 2-4

Liechtenstein

31.8.2015

EU/2/10/108

BTVPUR AlSap 2-4

Norway

10.8.2015

EU/2/10/109

Rhiniseng

Iceland

23.7.2015

EU/2/10/109

Rhiniseng

Norway

29.7.2015

EU/2/10/110

Coxevac

Iceland

20.8.2015

EU/2/10/110

Coxevac

Liechtenstein

31.8.2015

EU/2/10/110

Coxevac

Norway

13.8.2015

EU/2/10/111

Meloxoral

Iceland

15.9.2015

EU/2/10/111

Meloxoral

Liechtenstein

31.10.2015

EU/2/10/111

Meloxoral

Norway

6.10.2015

EU/2/10/112

BTVPUR ALSap 1

Iceland

15.9.2015

EU/2/10/112

BTVPUR AlSap 1

Liechtenstein

31.10.2015

EU/2/10/112

BTVPUR AlSap 1

Norway

6.10.2015

EU/2/10/113

BTVPUR ALSap 1-8

Iceland

15.9.2015

EU/2/10/113

BTVPUR AlSap 1-8

Norway

6.10.2015

EU/2/10/114

Hiprabovis IBR Marker Live

Iceland

20.11.2015

EU/2/10/114

Hiprabovis IBR Marker Live

Norway

3.12.2015

EU/2/10/114

Hiprabovis IBR Marker Live

Liechtenstein

31.12.2015

EU/2/10/117

Purevax Rabies

Iceland

30.12.2015

EU/2/10/117

Purevax Rabies

Norway

18.12.2015

EU/2/10/117

Purevax Rabies

Liechtenstein

31.12.2015

---

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 2015:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/02/240/009-012 | Somavert | Iceland | 13.8.2015 |
| EU/1/02/240/009-012 | Somavert | Norway | 6.8.2015 |
| EU/1/04/303/005 | Orfadin | Iceland | 10.7.2015 |
| EU/1/04/303/005 | Orfadin | Norway | 13.7.2015 |
| EU/1/06/359/005-006 | Suboxone | Iceland | 20.11.2015 |
| EU/1/06/359/005-006 | Suboxone | Norway | 3.12.2015 |
| EU/1/12/782/003-004 | Kalydeco | Iceland | 8.12.2015 |
| EU/1/12/782/003-004 | Kalydeco | Norway | 10.12.2015 |
| EU/1/12/782/006 | Iclusig | Norway | 14.12.2015 |
| EU/1/13/839/006 | Iclusig | Iceland | 23.12.2015 |
| EU/1/96/016/009 | Norvir | Iceland | 2.9.2015 |
| EU/1/96/016/009 | Norvir | Norway | 8.9.2015 |
| EU/2/11/134/021 | Inflacam | Iceland | 30.12.2015 |
| EU/2/11/134/021 | Inflacam | Norway | 30.12.2015 |

EU Number

Product

Country

Date of authorisation

EU/1/02/240/009-012

Somavert

Iceland

13.8.2015

EU/1/02/240/009-012

Somavert

Norway

6.8.2015

EU/1/04/303/005

Orfadin

Iceland

10.7.2015

EU/1/04/303/005

Orfadin

Norway

13.7.2015

EU/1/06/359/005-006

Suboxone

Iceland

20.11.2015

EU/1/06/359/005-006

Suboxone

Norway

3.12.2015

EU/1/12/782/003-004

Kalydeco

Iceland

8.12.2015

EU/1/12/782/003-004

Kalydeco

Norway

10.12.2015

EU/1/12/782/006

Iclusig

Norway

14.12.2015

EU/1/13/839/006

Iclusig

Iceland

23.12.2015

EU/1/96/016/009

Norvir

Iceland

2.9.2015

EU/1/96/016/009

Norvir

Norway

8.9.2015

EU/2/11/134/021

Inflacam

Iceland

30.12.2015

EU/2/11/134/021

Inflacam

Norway

30.12.2015

---

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 2015:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/179 | Osigraft | Liechtenstein | 31.12.2015 |
| EU/1/08/450 | Biograstim | Iceland | 22.10.2015 |
| EU/1/08/450 | Biograstim | Liechtenstein | 31.10.2015 |
| EU/1/08/450 | Biograstim | Norway | 7.10.2015 |
| EU/1/08/452 | Pandemrix | Iceland | 17.11.2015 |
| EU/1/11/686 | Rasilamlo | Iceland | 23.7.2015 |
| EU/1/11/686 | Rasilamlo | Norway | 18.8.2015 |
| EU/1/14/912 | Zoledronic acid Teva Generics | Iceland | 12.8.2015 |
| EU/1/14/912 | Zoledronic acid Teva Generics | Norway | 25.9.2015 |
| EU/1/15/1026 | Nivolumab BMS | Iceland | 28.12.2015 |
| EU/1/15/1026 | Nivolumab BMS | Norway | 9.12.2015 |
| EU/1/15/1026 | Nivolumab BMS | Liechtenstein | 31.12.2015 |
| EU/1/99/102 | Sonata | Iceland | 6.8.2015 |
| EU/1/99/102 | Sonata | Liechtenstein | 31.8.2015 |
| EU/1/99/102 | Sonata | Norway | 18.8.2015 |
| EU/2/06/064 | ProMeris | Iceland | 7.8.2015 |
| EU/2/06/064 | ProMeris | Liechtenstein | 31.8.2015 |
| EU/2/06/064 | ProMeris | Norway | 18.8.2015 |
| EU/2/06/065 | ProMeris Duo | Iceland | 7.8.2015 |
| EU/2/06/065 | ProMeris Duo | Liechtenstein | 31.8.2015 |
| EU/2/06/065 | ProMeris Duo | Norway | 26.8.2015 |
| EU/2/97/003 | Dicural | Iceland | 6.11.2015 |
| EU/2/97/003 | Dicural | Liechtenstein | 31.10.2015 |
| EU/2/97/003 | Dicural | Norway | 1.12.2015 |

EU Number

Product

Country

Date of authorisation

EU/1/01/179

Osigraft

Liechtenstein

31.12.2015

EU/1/08/450

Biograstim

Iceland

22.10.2015

EU/1/08/450

Biograstim

Liechtenstein

31.10.2015

EU/1/08/450

Biograstim

Norway

7.10.2015

EU/1/08/452

Pandemrix

Iceland

17.11.2015

EU/1/11/686

Rasilamlo

Iceland

23.7.2015

EU/1/11/686

Rasilamlo

Norway

18.8.2015

EU/1/14/912

Zoledronic acid Teva Generics

Iceland

12.8.2015

EU/1/14/912

Zoledronic acid Teva Generics

Norway

25.9.2015

EU/1/15/1026

Nivolumab BMS

Iceland

28.12.2015

EU/1/15/1026

Nivolumab BMS

Norway

9.12.2015

EU/1/15/1026

Nivolumab BMS

Liechtenstein

31.12.2015

EU/1/99/102

Sonata

Iceland

6.8.2015

EU/1/99/102

Sonata

Liechtenstein

31.8.2015

EU/1/99/102

Sonata

Norway

18.8.2015

EU/2/06/064

ProMeris

Iceland

7.8.2015

EU/2/06/064

ProMeris

Liechtenstein

31.8.2015

EU/2/06/064

ProMeris

Norway

18.8.2015

EU/2/06/065

ProMeris Duo

Iceland

7.8.2015

EU/2/06/065

ProMeris Duo

Liechtenstein

31.8.2015

EU/2/06/065

ProMeris Duo

Norway

26.8.2015

EU/2/97/003

Dicural

Iceland

6.11.2015

EU/2/97/003

Dicural

Liechtenstein

31.10.2015

EU/2/97/003

Dicural

Norway

1.12.2015

---

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 2015:

| EU Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/02/226 | InductOs | Iceland | 17.12.2015 |
| EU/1/02/226 | InductOs | Norway | 1.12.2015 |
| EU/1/02/226 | InductOs | Liechtenstein | 31.12.2015 |

EU Number

Product

Country

Date of suspension

EU/1/02/226

InductOs

Iceland

17.12.2015

EU/1/02/226

InductOs

Norway

1.12.2015

EU/1/02/226

InductOs

Liechtenstein

31.12.2015

---

V Announcements

COURT PROCEEDINGS

EFTA Court

| 22.9.2016 | EN | Official Journal of the European Union | C 347/34 |
| --- | --- | --- | --- |

22.9.2016

EN

Official Journal of the European Union

C 347/34

---

Action brought on 23 February 2016 by Dr. Gerhard Spitzer against the EFTA Surveillance Authority

(Case E-2/16)

(2016/C 347/06)

An action against the EFTA Surveillance Authority was brought before the EFTA Court on 23 February 2016 by Dr. Gerhard Spitzer, represented by Antonius Falkner, Attorney-at-law, Lettstrasse 18, FL-9490 Vaduz.

The applicant claims that the EFTA Court should:

| 1. | Annul EFTA Surveillance Authority Decision 425/15/COL of 25 November 2015, and |
| --- | --- |

1.

Annul EFTA Surveillance Authority Decision 425/15/COL of 25 November 2015, and

| 2. | Order the EFTA Surveillance Authority to bear the costs of the proceedings. |
| --- | --- |

2.

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

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

| — | The applicant, Dr Gerhard Spitzer, is an Austrian citizen, domiciled in South Africa, which has been a customer of LLB AG, a company under majority ownership of the Principality of Liechtenstein, since the early 1990s. |
| --- | --- |

—

The applicant, Dr Gerhard Spitzer, is an Austrian citizen, domiciled in South Africa, which has been a customer of LLB AG, a company under majority ownership of the Principality of Liechtenstein, since the early 1990s.

| — | The case concerns an application for annulment of a decision by the EFTA Surveillance Authority to close a case regarding a complaint against Liechtenstein concerning a failure to observe and correctly apply Directive 2002/47/EC. |
| --- | --- |

—

The case concerns an application for annulment of a decision by the EFTA Surveillance Authority to close a case regarding a complaint against Liechtenstein concerning a failure to observe and correctly apply Directive 2002/47/EC.

| — | The applicant claims that the EFTA Surveillance Authority was under the duty to initiate a formal investigation procedure concerning a failure by Liechtenstein to observe and correctly apply Directive 2002/47/EC, and by failing to do so, the EFTA Surveillance Authority has infringed the rights of the applicant. |
| --- | --- |

—

The applicant claims that the EFTA Surveillance Authority was under the duty to initiate a formal investigation procedure concerning a failure by Liechtenstein to observe and correctly apply Directive 2002/47/EC, and by failing to do so, the EFTA Surveillance Authority has infringed the rights of the applicant.

---

| 22.9.2016 | EN | Official Journal of the European Union | C 347/35 |
| --- | --- | --- | --- |

22.9.2016

EN

Official Journal of the European Union

C 347/35

---

Action brought on 21 June 2016 by Míla ehf. against the EFTA Surveillance Authority

(Case E-7/16)

(2016/C 347/07)

An action against the EFTA Surveillance Authority was brought before the EFTA Court on 21 June 2016 by Míla ehf., represented by Espen Bakken, attorney at law and Atle Erling Lunder, attorney at law, Arntzen de Besche Advokatfirma AS, Bygdøy allé 2, 0204 Oslo, Norway.

The Applicant requests the EFTA Court to:

| 1. | Declare void Articles 1 and 2 of ESA Decision 061/16/COL; |
| --- | --- |

1.

Declare void Articles 1 and 2 of ESA Decision 061/16/COL;

| 2. | Order the Authority to pay the costs of the present proceedings. |
| --- | --- |

2.

Order the Authority to pay the costs of the present proceedings.

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

| — | The Applicant seeks the annulment of the EFTA Surveillance Authority’s Decision No 061/16/COL of 16 March 2016. |
| --- | --- |

—

The Applicant seeks the annulment of the EFTA Surveillance Authority’s Decision No 061/16/COL of 16 March 2016.

| — | As a consequence of the EFTA Court's judgment in Case E-1/13, the EFTA Surveillance Authority initiated a formal investigation procedure to look into the lease by the Defence Agency of the Ministry for Foreign Affairs of Iceland with Og fjarskipti of 1 February 2010, for the use and operation of an optical fibre. The investigation was concluded with Decision No 061/16/COL where the EFTA Surveillance Authority found that the lease did not involve State aid within the meaning of Article 61(1) of the EEA Agreement. |
| --- | --- |

—

As a consequence of the EFTA Court's judgment in Case E-1/13, the EFTA Surveillance Authority initiated a formal investigation procedure to look into the lease by the Defence Agency of the Ministry for Foreign Affairs of Iceland with Og fjarskipti of 1 February 2010, for the use and operation of an optical fibre. The investigation was concluded with Decision No 061/16/COL where the EFTA Surveillance Authority found that the lease did not involve State aid within the meaning of Article 61(1) of the EEA Agreement.

| — | The Applicant claims that the contested Decision rests upon a misapplication of Article 61(1) of the EEA Agreement. |
| --- | --- |

—

The Applicant claims that the contested Decision rests upon a misapplication of Article 61(1) of the EEA Agreement.

---

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 22.9.2016 | EN | Official Journal of the European Union | C 347/36 |
| --- | --- | --- | --- |

22.9.2016

EN

Official Journal of the European Union

C 347/36

---

Prior notification of a concentration

(Case M.8203 — Blackstone/New Mountain/JDA Software)

Candidate case for simplified procedure

(Text with EEA relevance)

(2016/C 347/08)

| 1. | On 15 September 2016, the Commission received notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings The Blackstone Group, L.P. (‘Blackstone’, United States) and New Mountain Capital, L.L.C. (‘New Mountain Capital’, United States) acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of the whole of the undertaking RedPrairie Holding, Inc. (‘RedPrairie’, United States), which owns JDA Software Group, Inc. (‘JDA Software Group’), by way of purchase of shares. |
| --- | --- |

1.

On 15 September 2016, the Commission received notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings The Blackstone Group, L.P. (‘Blackstone’, United States) and New Mountain Capital, L.L.C. (‘New Mountain Capital’, United States) acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of the whole of the undertaking RedPrairie Holding, Inc. (‘RedPrairie’, United States), which owns JDA Software Group, Inc. (‘JDA Software Group’), by way of purchase of shares.

| 2. | The business activities of the undertakings concerned are:
  —   Blackstone: global alternative asset manager that controls the following providers of application software: RGIS; Ipreo; CMS Info Systems Ltd; and Change Healthcare;
  —   New Mountain Capital: private equity firm;
  —   JDA Software Group: global provider of end-to-end, integrated retail, omni-channel, and supply chain planning and execution enterprise application software solutions. |
| --- | --- |

2.

The business activities of the undertakings concerned are:

—   Blackstone: global alternative asset manager that controls the following providers of application software: RGIS; Ipreo; CMS Info Systems Ltd; and Change Healthcare;

—   New Mountain Capital: private equity firm;

—   JDA Software Group: global provider of end-to-end, integrated retail, omni-channel, and supply chain planning and execution enterprise application software solutions.

| 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. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in this Notice. |
| --- | --- |

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. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in this Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number M.8203 — Blackstone/New Mountain/JDA Software, 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 email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number M.8203 — Blackstone/New Mountain/JDA Software, 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’).

(2)  OJ C 366, 14.12.2013, p. 5.

---

| 22.9.2016 | EN | Official Journal of the European Union | C 347/37 |
| --- | --- | --- | --- |

22.9.2016

EN

Official Journal of the European Union

C 347/37

---

Prior notification of a concentration

(Case M.8192 — Advent International/THL/inVentiv)

Candidate case for simplified procedure

(Text with EEA relevance)

(2016/C 347/09)

| 1. | On 15 September 2016, the Commission received notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which Advent International (US) and Thomas H. Lee Partners (US) acquire within the meaning of Article 3(1)(b) of the Merger Regulation control of part of inVentiv (US) by way of purchase of shares. |
| --- | --- |

1.

On 15 September 2016, the Commission received notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which Advent International (US) and Thomas H. Lee Partners (US) acquire within the meaning of Article 3(1)(b) of the Merger Regulation control of part of inVentiv (US) by way of purchase of shares.

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






  — | Advent International is a private equity investor. It acquires equity stakes (both controlling and non-controlling) in companies in the following sectors: business and financial services; healthcare; industrial; retail, consumer and leisure; and technology, media and telecoms. |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

Advent International is a private equity investor. It acquires equity stakes (both controlling and non-controlling) in companies in the following sectors: business and financial services; healthcare; industrial; retail, consumer and leisure; and technology, media and telecoms.

| — | THL is a private equity firm that invests in global businesses in the following broad sectors: consumer and healthcare; media and information services; and business and financial services. |
| --- | --- |

—

THL is a private equity firm that invests in global businesses in the following broad sectors: consumer and healthcare; media and information services; and business and financial services.

| — | inVentiv is a global provider of clinical development and commercialisation services. Its main clients are pharmaceutical, biotechnology, generic drug and medical device companies. |
| --- | --- |

—

inVentiv is a global provider of clinical development and commercialisation services. Its main clients are pharmaceutical, biotechnology, generic drug and medical device companies.

| 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. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in this Notice. |
| --- | --- |

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. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in this Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number M.8192 — Advent International/THL/inVentiv, 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 email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number M.8192 — Advent International/THL/inVentiv, 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’).

(2)  OJ C 366, 14.12.2013, p. 5.

---