Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2007
Date: 2008-02-14
Institutions: EFTA Surveillance Authority
Subjects: EFTA countries, European Economic Area, market approval, medicinal product, withdrawal from the market

14.2.2008

EN

Official Journal of the European Union

C 40/5

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the
first half of 2007

(2008/C 40/05)

Subcommittee I — On the free movement of goods

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 2007, at their meeting on 28 September 2007:

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ANNEX IV List of withdrawn marketing authorisations

C 40/6

EN

Official Journal of the European Union

14.2.2008

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
2007:

EU-Number

Product

Country

Date of
authorisation

EU/1/06/001-012/IS

EU/1/06/343/001-005

EU/1/06/360/001-010

EU/1/06/361/001/NO

EU/1/06/363/001-009

EU/1/06/364/001-005

EU/1/06/364/001-005/IS

EU/1/06/364/001-005/NO

EU/1/06/365/001-003

EU/1/06/365/001-003/IS

EU/1/06/365/001-003/NO

EU/1/06/366/001-004

EU/1/06/366/001-004/IS

EU/1/06/366/001-004/NO

EU/1/06/367/001-012

EU/1/06/367/001-012/NO

Diacomit

Baraclude

Champix

Luminity

Sprycel

Adrovance

Adrovance

Adrovance

Elaprase

Elaprase

Elaprase

Tandemact

Tandemact

Tandemact

Diacomit

Diacomit

Iceland

23.1.2007

Liechtenstein

30.4.2007

Liechtenstein

30.4.2007

Norway

7.2.2007

Liechtenstein

30.4.2007

Liechtenstein

28.2.2007

Iceland

Norway

22.1.2007

14.2.2007

Liechtenstein

28.2.2007

Iceland

Norway

6.2.2007

30.1.2007

Liechtenstein

28.2.2007

Iceland

Norway

24.1.2007

30.1.2007

Liechtenstein

28.2.2007

Norway

9.2.2007

15.2.2007

13.2.2007

EU/1/06/368/001-002/IS, 011-019/IS

Insulin Human Winthrop Rapid

Iceland

EU/1/06/368/001-002/NO, 011-019/NO

Insulin Human Winthrop Rapid

Norway

EU/1/06/368/001-057

Insulin Human Winthrop

Liechtenstein

28.2.2007

EU/1/06/368/003-004/IS, 020-028/IS

Insulin Human Winthrop Basal

Iceland

EU/1/06/368/003-004/NO, 020-028/NO

Insulin Human Winthrop Basal

Norway

EU/1/06/368/005-006/IS, 029-037/IS

Insulin Human Winthrop Comb 15

Iceland

EU/1/06/368/005-006/NO, 029-037/NO

Insulin Human Winthrop Comb 15 Norway

EU/1/06/368/007-008/IS, 038-046/IS

Insulin Human Winthrop Comb 25

Iceland

EU/1/06/368/007-008/NO, 038-046/NO

Insulin Human Winthrop Comb 25 Norway

EU/1/06/368/009-010/IS, 047-055/IS

Insulin Human Winthrop Comb 50

Iceland

EU/1/06/368/009-010/NO, 047-055/NO

Insulin Human Winthrop Comb 50 Norway

EU/1/06/368/056-057/IS

Insulin Human Winthrop Infusat

Iceland

EU/1/06/368/056-057/NO

Insulin Human Winthrop Infusat

Norway

15.2.2007

13.2.2007

15.2.2007

13.2.2007

15.2.2007

13.2.2007

15.2.2007

13.2.2007

15.2.2007

13.2.2007

EU/1/06/369/001-028

Irbesartan Hydrochlorothiazide BMS

Liechtenstein

28.2.2007

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

Irbesartan HCT BMS

Iceland

16.2.2007

14.2.2008

EN

Official Journal of the European Union

C 40/7

EU-Number

Product

Country

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

Irbesartan HCT BMS

EU/1/06/370/001-024/IS

EU/1/06/370/001-024/NO

EU/1/06/371/001-024/IS

EU/1/06/371/001-024/NO

EU/1/06/372/001-024/IS

EU/1/06/372/001-024/NO

EU/1/06/373/001-024/IS

EU/1/06/373/001-024/NO

EU/1/06/374/001

EU/1/06/374/001/IS

EU/1/06/374/001/NO

EU/1/06/375/001-033

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

Exforge

Exforge

Dafiro

Dafiro

Copalia

Copalia

Imprida

Imprida

Lucentis

Lucentis

Lucentis

Irbesartan BMS

Irbesartan BMS

EU/1/06/375/001-033/NO

Irbesartan BMS

Date of
authorisation

15.2.2007

14.2.2007

22.2.2007

14.2.2007

5.3.2007

14.2.2007

5.3.2007

14.2.2007

5.3.2007

Norway

Iceland

Norway

Iceland

Norway

Iceland

Norway

Iceland

Norway

Liechtenstein

28.2.2007

Iceland

Norway

12.2.2007

7.2.2007

Liechtenstein

28.2.2007

Iceland

Norway

15.2.2007

15.2.2007

EU/1/06/376/001-033

Irbesartan Winthrop

Liechtenstein

28.2.2007

EU/1/06/376/001-033/IS

Irbesartan Winthrop

EU/1/06/376/001-033/NO

Irbesartan Winthrop

EU/1/06/377/001-028

Irbesartan Hydrochlorothiazide
Winthrop

EU/1/06/377/001-028/IS

Irbesartan HCT Winthrop

EU/1/06/377/001-028/NO

Irbesartan HCT Winthrop

EU/1/06/378/001-016

EU/1/06/378/001-016/IS

EU/1/06/378/001-016/NO

EU/1/06/379/001

EU/1/06/379/001/IS

EU/1/06/379/001/NO

EU/1/06/380/001

EU/1/06/380/001/IS

EU/1/06/380/001/NO

EU/1/06/381/001-008

EU/1/06/381/001-008/IS

EU/1/06/381/001-008/NO

EU/1/07/382/001-018

EU/1/07/382/001-018/IS

Inovelon

Inovelon

Inovelon

Cystadane

Cystadane

Cystadane

Prezista

Prezista

Prezista

Daronrix

Daronrix

Daronrix

Xelevia

Xelevia

Iceland

Norway

16.2.2007

15.2.2007

Liechtenstein

28.2.2007

Iceland

Norway

16.2.2007

15.2.2007

Liechtenstein

28.2.2007

Iceland

Norway

25.2.2007

15.2.2007

Liechtenstein

28.2.2007

Iceland

Norway

23.2.2007

27.2.2007

Liechtenstein

28.2.2007

Iceland

Norway

21.2.2007

26.2.2007

Liechtenstein

30.4.2007

Iceland

Norway

26.3.2007

20.4.2007

Liechtenstein

30.4.2007

Iceland

11.4.2007

C 40/8

EN

Official Journal of the European Union

14.2.2008

EU-Number

Product

Country

Date of
authorisation

EU/1/07/382/001-018/NO

EU/1/07/383/001-018

EU/1/07/383/001-018/IS

EU/1/07/383/001-018/NO

Xelevia

Januvia

Januvia

Januvia

Norway

18.4.2007

Liechtenstein

30.4.2007

Iceland

Norway

10.4.2007

18.4.2007

EU/1/07/384/001-002

Docetaxel Winthrop

Liechtenstein

30.6.2007

EU/1/07/384/001-002/IS

Docetaxel Winthrop

EU/1/07/384/001-002/NO

Docetaxel Winthrop

EU/1/07/385/001-004

EU/1/07/385/001-004/IS

EU/1/07/385/001-004/NO

EU/1/07/386/001-010

EU/1/07/386/001-010/IS

EU/1/07/386/001-010/NO

EU/1/07/387/001-008

EU/1/07/387/001-008/IS

EU/1/07/387/001-008/NO

EU/1/07/388/001

EU/1/07/388/001/IS

EU/1/07/388/001/NO

EU/1/07/389/001-003

EU/1/07/389/001-003/IS

EU/1/07/389/001-003/NO

EU/1/07/390/001-004

EU/1/07/390/001-004/IS

EU/1/07/390/001-004/NO

EU/1/07/391/001-004

EU/1/07/394/001-006

EU/1/07/394/001-006/IS

EU/2/06/064/001-004

EU/2/06/064/001-004/IS

EU/2/06/064/001-004/NO

EU/2/06/065/001-010

EU/2/06/065/001-010/IS

Focetria

Focetria

Focetria

Toviaz

Toviaz

Toviaz

Advagraf

Advagraf

Advagraf

Sebivo

Sebivo

Sebivo

Orencia

Orencia

Orencia

Altargo

Altargo

Altargo

Revlimid

Optaflu

Optaflu

ProMeris

ProMeris

ProMeris

ProMeris Duo

ProMeris Duo

EU/2/06/065/001-010/NO

ProMeris Duo

Iceland

Norway

18.5.2007

10.5.2007

Liechtenstein

30.6.2007

Iceland

Norway

19.6.2007

18.6.2007

Liechtenstein

30.6.2007

Iceland

Norway

24.5.2007

31.5.2007

Liechtenstein

30.6.2007

Iceland

Norway

16.5.2007

18.5.2007

Liechtenstein

30.6.2007

Iceland

Norway

24.5.2007

14.5.2007

Liechtenstein

30.6.2007

Iceland

Norway

18.6.2007

19.6.2007

Liechtenstein

30.6.2007

Iceland

Norway

21.6.2007

21.6.2007

Liechtenstein

30.6.2007

Liechtenstein

30.6.2007

Iceland

21.6.2007

Liechtenstein

28.2.2007

Iceland

Norway

18.1.2007

20.2.2007

Liechtenstein

28.2.2007

Iceland

Norway

18.1.2007

20.2.2007

14.2.2008

EN

Official Journal of the European Union

C 40/9

EU-Number

Product

Country

Date of
authorisation

EU/2/06/066/001-012

EU/2/06/066/001-012/IS

EU/2/06/066/001-012/NO

Prac-Tic

PRAC-TIC

Prac-tic

EU/2/06/067/001-002/IS

Medicinal Oxygen

EU/2/06/068/001-004

EU/2/06/068/001-004/IS

EU/2/06/068/001-004/NO

EU/2/06/069/001

EU/2/06/069/001/IS

EU/2/06/069/001/NO

Ypozane

Ypozane

Ypozane

Cortavance

Cortavance

Cortavance

Liechtenstein

28.2.2007

Iceland

Norway

Iceland

21.1.2007

23.1.2007

16.3.2007

Liechtenstein

28.2.2007

Iceland

Norway

26.1.2007

19.2.2007

Liechtenstein

28.2.2007

Iceland

Norway

23.2.2007

20.2.2007

EU/2/06/070/001-003

Meloxicam CEVA

Liechtenstein

28.2.2007

EU/2/06/070/001-003/NO

Meloxicam Ceva

Norway

20.2.2007

EU/2/07/071/001-003

EU/2/07/071/001-003/IS

EU/2/07/071/001-003/NO

Slentrol

Slentrol

Slentrol

Liechtenstein

30.6.2007

Iceland

Norway

26.4.2007

19.6.2007

EU/2/07/073/001-004

Nobilis Influenza H7N1

Liechtenstein

30.6.2007

EU/2/07/073/001-004/IS

Nobilis Influenza H7N1

Iceland

1.6.2007

EU/2/07/074/001-006

Prilactone

Liechtenstein

30.6.2007

C 40/10

EN

Official Journal of the European Union

14.2.2008

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
2007:

EU-Number

Product

Country

Date of renewal

EU/1/01/200/001

EU/1/01/200/001/IS

EU/1/01/200/001/NO

EU/1/02/201/001-006/IS

EU/1/02/202/001-006/IS

EU/1/02/203/001-004

EU/1/02/203/001-004/IS

EU/1/02/203/001-004/NO

EU/1/02/204/001

EU/1/02/204/001/IS

EU/1/02/204/001/NO

EU/1/02/205/001-002

EU/1/02/205/001-002/IS

EU/1/02/205/001-002/NO

EU/1/02/206/001-020

EU/1/02/206/001-020/IS

EU/1/02/206/001-020/NO

EU/1/02/207/001-020

EU/1/02/207/001-020/IS

EU/1/02/207/001-020/NO

EU/1/02/209/001-008

EU/1/02/209/001-008/IS

EU/1/02/211/001-005

EU/1/02/211/001-005, 010-012/IS

EU/1/02/211/001-005, 010-012/NO

EU/1/02/212/001-026

EU/1/02/212/001-026/IS

EU/1/02/212/001-026/NO

EU/1/02/213/001-016

EU/1/02/213/001-016/IS

EU/1/02/213/001-016/NO

Viread

Viread

Viread

Protopic

Protopy

Kineret

Kineret

Kineret

Trisenox

Trisenox

Trisenox

Lumigan

Lumigan

Lumigan

Arixtra

Arixtra

Arixtra

Quixidar

Quixidar

Quixidar

Dynastat

Dynastat

Dynepo

Dynepo

Dynepo

Vfend

Vfend

Vfend

MicardisPlus

MicardisPlus

MicardisPlus

Liechtenstein

28.2.2007

Iceland

Norway

Iceland

Iceland

22.1.2007

29.1.2007

8.1.2007

8.1.2007

Liechtenstein

30.4.2007

Iceland

Norway

22.3.2007

18.4.2007

Liechtenstein

28.2.2007

Iceland

Norway

14.3.2007

22.3.2007

Liechtenstein

30.4.2007

Iceland

Norway

14.3.2007

29.3.2007

Liechtenstein

30.6.2007

Iceland

Norway

23.4.2007

18.5.2007

Liechtenstein

30.6.2007

Iceland

Norway

23.4.2007

18.5.2007

Liechtenstein

30.6.2007

Iceland

25.4.2007

Liechtenstein

30.6.2007

Iceland

Norway

25.4.2007

18.5.2007

Liechtenstein

30.6.2007

Iceland

Norway

16.5.2007

23.5.2007

Liechtenstein

30.6.2007

Iceland

Norway

23.5.2007

18.6.2007

14.2.2008

EN

Official Journal of the European Union

C 40/11

EU-Number

Product

Country

Date of renewal

EU/1/02/214/001-010

EU/1/02/214/001-010/IS

EU/1/02/214/001-010/NO

EU/1/02/215/001-014

EU/1/02/215/001-014/IS

EU/1/02/215/001-014/NO

EU/1/02/216/001-002

EU/1/02/216/001-002/IS

EU/1/02/217/001-002

EU/1/02/217/001-002/IS

EU/1/02/217/001-002/NO

EU/1/02/219/001-015

EU/1/02/220/001-005

EU/1/02/220/001-005/IS

Kinzalkomb

Kinzalkomb

Kinzalkomb

PritorPlus

PritorPlus

PritorPlus

Invanz

Invanz

Opatanol

Opatanol

Opatanol

Ebixa

Tracleer

Tracleer

EU/1/07/183/001, 004-005, 007-008, 011,
013, 015, 018-029/IS

HBVAXPRO

EU/1/96/014/001-003/IS

Tritanrix HepH

EU/1/96/027/001, 003-005/IS

EU/1/97/030/028-084

Hycamtin

Insuman

EU/1/97/030/033-037, 057-58, 69-72/IS

Insuman Basal

EU/1/97/030/033-037, 057-58, 69-72/NO

Insuman Basal

EU/1/97/030/038-042, 59-60, 73-76/IS

Insuman Comb 15

EU/1/97/030/038-042, 59-60, 73-76/NO

Insuman Comb 15

EU/1/97/030/043-047, 61-62, 77-80/IS

Insuman Comb 25

EU/1/97/030/043-047, 61-62, 77-80/NO

Insuman Comb 25

EU/1/97/030/048-052, 63-64, 81-84/IS

Insuman Comb 50

EU/1/97/030/048-052, 63-64, 81-84/NO

Insuman Comb 50

Liechtenstein

30.6.2007

Iceland

Norway

23.5.2007

18.6.2007

Liechtenstein

30.6.2007

Iceland

Norway

13.6.2007

18.6.2007

Liechtenstein

30.4.2007

Iceland

21.3.2007

Liechtenstein

30.6.2007

Iceland

Norway

19.6.2007

28.6.2007

Liechtenstein

30.6.2007

Liechtenstein

30.6.2007

Iceland

Iceland

Iceland

Iceland

22.6.2007

21.2.2007

21.2.2007

9.1.2007

Liechtenstein

28.2.2007

Iceland

Norway

Iceland

Norway

Iceland

Norway

Iceland

Norway

16.2.2007

13.2.2007

16.2.2007

13.2.2007

16.2.2007

13.2.2007

16.2.2007

13.2.2007

16.2.2007

13.2.2007

16.2.2007

13.2.2007

EU/1/97/030/053-054/IS

Insuman Comb Infusat

Iceland

EU/1/97/030/053-054/NO

Insuman Comb Infusat

Norway

EU/1/97/030/28-32, 55-56, 65-68/IS

Insuman Rapid

EU/1/97/030/28-32, 55-56, 65-68/NO

Insuman Rapid

Iceland

Norway

EU/1/97/032/001

EU/1/97/032/001/IS

EU/1/97/033/001-003

EU/1/97/033/001-003/IS

EU/1/97/033/001-003/NO

Leukoscan

Leukoscan

Avonex

Avonex

Avonex

Liechtenstein

30.6.2007

Iceland

27.6.2007

Liechtenstein

30.4.2007

Iceland

Norway

13.3.2007

20.3.2007

C 40/12

EN

Official Journal of the European Union

14.2.2008

EU-Number

Product

Country

Date of renewal

EU/1/97/035/001-004

EU/1/97/035/001-004/IS

EU/1/97/035/001-004/NO

EU/1/97/037/001

EU/1/97/040/001-002

EU/1/97/040/001-002/IS

Refludan

Refludan

Refludan

Vistide

Teslascan

Teslascan

EU/2/01/030/001-004/NO

Virbagen Omega

Liechtenstein

Iceland

Norway

Liechtenstein

Liechtenstein

Iceland

Norway

EU/2/02/032/001

Vaxxitek HVT+IBD

Liechtenstein

EU/2/96/002/001-003

Fevaxyn Pentofel

Liechtenstein

EU/2/96/002/001-003/IS

Fevaxyn Pentofel

Iceland

30.4.2007

14.3.2007

10.4.2007

30.6.2007

30.6.2007

19.6.2007

14.3.2007

30.6.2007

30.4.2007

14.3.2007

14.2.2008

EN

Official Journal of the European Union

C 40/13

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
2007:

EU-Number

Product

Country

Date of
extention

EU/1/00/134/030-037

EU/1/00/157/035-067

EU/1/00/157/035-067/IS

EU/1/00/157/035-067/NO

EU/1/00/160/037-069

EU/1/00/160/037-069/IS

EU/1/00/160/037-069/NO

EU/1/00/161/035/067/IS

EU/1/00/161/035-067

EU/1/00/161/035-067/NO

EU/1/01/184/069-073

EU/1/01/184/069-073/IS

EU/1/01/185/069-073

EU/1/01/185/069-073/IS

EU/1/02/211/010-012

Lantus

Azomyr

Azomyr

Azomyr

Aerius

Aerius

Aerius

Neoclarityn

Neoclarityn

Neoclarityn

Nespo

Nespo

Aranesp

Aranesp

Dynepo

Liechtenstein

28.2.2007

Liechtenstein

30.6.2007

Iceland

Norway

22.5.2007

5.6.2007

Liechtenstein

30.6.2007

Iceland

Norway

Iceland

22.5.2007

5.6.2007

22.5.2007

Liechtenstein

30.6.2007

Norway

5.6.2007

Liechtenstein

30.6.2007

Iceland

1.6.2007

Liechtenstein

30.6.2007

Iceland

25.5.2007

Liechtenstein

30.4.2007

EU/1/02/213/013-016

MicardisPlus

Liechtenstein

28.2.2007

EU/1/02/215/013-014

EU/1/03/251/002

EU/1/03/266/005-006

EU/1/04/276/036/IS

EU/1/04/280/008

EU/1/04/281/002-005

EU/1/04/281/002-005/IS

EU/1/04/281/002-005/NO

EU/1/04/307/011-013

EU/1/05/327/018

PritorPlus

Hepsera

Bondenza

Abilify

Yentreve

Erbitux

Erbitux

Erbitux

Zonegran

Exubera

Liechtenstein

28.2.2007

Liechtenstein

30.6.2007

Liechtenstein

30.4.2007

Iceland

18.1.2007

Liechtenstein

30.4.2007

Liechtenstein

30.4.2007

Iceland

Norway

21.2.2007

14.3.2007

Liechtenstein

30.4.2007

Liechtenstein

30.4.2007

EU/1/05/331/014-037

Ne juin upro

Liechtenstein

28.2.2007

EU/1/06/332/004-006

EU/1/06/332/004-006/IS

EU/1/06/349/009-010

EU/1/06/360/011

Omnitrope

Omnitrope

Avaglim

Champix

Liechtenstein

30.6.2007

Iceland

18.5.2007

Liechtenstein

30.6.2007

Liechtenstein

30.6.2007

C 40/14

EN

Official Journal of the European Union

14.2.2008

EU-Number

Product

Country

Date of
extention

EU/1/96/016/004

Norvir

Liechtenstein

28.2.2007

EU/1/98/069/005a, 005b, 006a, 006b

Plavix

Liechtenstein

30.6.2007

EU/1/98/070/005a, 005b, 006a, 006b

Iscover

Liechtenstein

30.6.2007

EU/1/98/089/020-022

EU/1/98/090/017-020

EU/1/98/096/009-012

EU/1/98/096/009-012/IS

EU/1/98/096/009-012/NO

EU/1/99/111/010-011/NO

EU/1/99/123/012

EU/2/03/040/002

EU/2/03/040/002/IS

EU/2/03/040/002/NO

EU/2/04/044/006

EU/2/04/045/005-006

EU/2/04/045/007

EU/2/04/045/007/IS

EU/2/97/004/024-025

EU/2/97/004/026-028

Pritor

Micardis

Temodal

Temodal

Temodal

Stocrin

Renagel

Gonazon

Gonazon

Gonazon

Aivlosin

Previcox

Previcox

Previcox

Metacam

Metacam

Liechtenstein

28.2.2007

Liechtenstein

28.2.2007

Liechtenstein

30.6.2007

Iceland

Norway

Norway

22.5.2007

29.5.2007

8.1.2007

Liechtenstein

30.6.2007

Liechtenstein

28.2.2007

Iceland

Norway

29.1.2007

20.2.2007

Liechtenstein

30.4.2007

Liechtenstein

28.2.2007

Liechtenstein

30.4.2007

Iceland

21.3.2007

Liechtenstein

30.4.2007

Liechtenstein

30.6.2007

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
2007:

EU-Number

Product

Country

EU/1/02/236/001-004/IS

EU/1/02/235/001-004/IS

Ultratard

Monotard

Iceland

Iceland

Date of
withdrawal

1.1.2007

1.1.2007