Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2007
Date: 2008-06-12
Institutions: EFTA Surveillance Authority
Subjects: Iceland, Liechtenstein, Norway, market approval, medicinal product

12.6.2008

EN

Official Journal of the European Union

C 146/13

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

(2008/C 146/03)

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 2007, at their meeting on 14 March 2008:

Annex I

Annex II

Annex III

Annex IV

Annex V

List of new marketing authorisations

List of renewed marketing authorisations

List of extended marketing authorisations

List of withdrawn marketing authorisations

List of suspended marketing authorisations

C 146/14

EN

Official Journal of the European Union

12.6.2008

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
2007:

EU Number

Product

Country

Date of
authorisation

EU/1/06/361/001

EU/1/07/387/001-008

Luminity

Advagraf

EU/1/07/391/001/NO-004/NO

Revlimid

EU/1/07/391/001-004/IS

EU/1/07/392/001

EU/1/07/392/001/IS

EU/1/07/392/001/NO

EU/1/07/393/001/IS

EU/1/07/393/001/NO

Revlimid

Circadin

Circadin

Circadin

Soliris

Soliris

EU/1/07/394/001/NO-006/NO

Optaflu

EU/1/07/395/001/NO-064/NO

EU/1/07/395/001-064

EU/1/07/395/001-064/IS

Invega

Invega

Invega

EU/1/07/396/001/NO-003/NO

Pergoveris

EU/1/07/396/001-003

EU/1/07/396/001-003/IS

EU/1/07/397/001

EU/1/07/397/001/IS

EU/1/07/397/001/NO

Pergoveris

Pergoveris

Siklos

Siklos

Siklos

EU/1/07/398/001/NO-014/NO

Optimark

EU/1/07/398/001-014

EU/1/07/398/001-014/IS

OptiMark

OptiMark

EU/1/07/399/001/NO-006/NO

Aerinaze

EU/1/07/399/001-006

EU/1/07/399/001-006/IS

Aerinaze

Aerinaze

EU/1/07/400/001/NO-016/NO

Mircera

EU/1/07/400/001-016/IS

Mircera

EU/1/07/401/001/NO-006/NO

Orlistat GSK

EU/1/07/401/001-006

Orlistat GSK

EU/1/07/401/001-006/IS

Orlistat GSK

Liechtenstein

31.12.2007

Liechtenstein

31.12.2007

Norway

Iceland

Liechtenstein

Iceland

Norway

Iceland

Norway

Norway

Norway

Liechtenstein

Iceland

Norway

Liechtenstein

Iceland

Liechtenstein

Iceland

Norway

Norway

Liechtenstein

Iceland

Norway

Liechtenstein

Iceland

Norway

Iceland

Norway

Liechtenstein

Iceland

13.7.2007

11.7.2007

31.8.2007

8.8.2007

15.8.2007

19.7.2007

19.7.2007

20.8.2007

17.7.2007

31.8.2007

20.7.2007

3.7.2007

31.8.2007

20.7.2007

31.8.2007

19.7.2007

22.8.2007

20.8.2007

31.8.2007

20.8.2007

22.8.2007

31.8.2007

30.8.2007

3.9.2007

17.8.2007

20.8.2007

31.8.2007

21.8.2007

12.6.2008

EN

Official Journal of the European Union

C 146/15

EU Number

Product

Country

EU/1/07/402/001

EU/1/07/402/001/IS

EU/1/07/403/001

EU/1/07/403/001/IS

EU/1/07/403/001/NO

Increlex

Increlex

Atriance

Atriance

Atriance

EU/1/07/404/001/NO-005/NO

Flebogammadif

Liechtenstein

Iceland

Date of
authorisation

31.8.2007

31.8.2007

Liechtenstein

31.10.2007

Iceland

Norway

Norway

20.9.2007

4.9.2007

13.9.2007

EU/1/07/404/001-005

Flebogammadif

Liechtenstein

31.10.2007

EU/1/07/404/001-005/IS

Flebogammadif

EU/1/07/405/001/NO-020/NO

Rasilez

EU/1/07/405/001-020

EU/1/07/405/001-020/IS

Rasilez

Rasilez

EU/1/07/406/001/NO-020/NO

Enviage

EU/1/07/406/001-020

EU/1/07/406/001-020/IS

Enviage

Enviage

EU/1/07/407/001/NO-020/NO

Sprimeo

EU/1/07/407/001-020

EU/1/07/407/001-020/IS

Sprimeo

Sprimeo

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

Tekturna

EU/1/07/408/001-020

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

Tekturna

Tekturna

EU/1/07/409/001/NO-020/NO

Riprazo

EU/1/07/409/001-020

EU/1/07/409/001-020/IS

Riprazo

Riprazo

EU/1/07/410/001/NO-016/NO

Binocrit

EU/1/07/410/001-016

EU/1/07/410/001-016/IS

Binocrit

Binocrit

EU/1/07/411/001/NO-016/NO

Epoetin alfa Hexal

Iceland

Norway

13.9.2007

14.9.2007

Liechtenstein

31.10.2007

Iceland

Norway

6.9.2007

14.9.2007

Liechtenstein

31.10.2007

Iceland

Norway

11.9.2007

14.9.2007

Liechtenstein

31.10.2007

Iceland

Norway

11.9.2007

14.9.2007

Liechtenstein

31.10.2007

Iceland

Norway

6.9.2007

14.9.2007

Liechtenstein

31.10.2007

Iceland

Norway

11.9.2007

13.9.2007

Liechtenstein

31.10.2007

Iceland

Norway

18.9.2007

13.9.2007

EU/1/07/411/001-016

Epoetin alfa Hexal

Liechtenstein

31.10.2007

EU/1/07/411/001-016/IS

Epoetin alfa Hexal

EU/1/07/412/001/NO-016/NO

Abseamed

Iceland

Norway

19.9.2007

12.9.2007

EU/1/07/412/001-016

Abseamed

Liechtenstein

31.10.2007

EU/1/07/412/001-016/IS

Abseamed

Iceland

19.9.2007

C 146/16

EN

Official Journal of the European Union

12.6.2008

EU Number

Product

Country

EU/1/07/413/001/NO-003/NO

Gliolan

Norway

Date of
authorisation

28.9.2007

EU/1/07/413/001-003

EU/1/07/413/001-003/IS

Gliolan

Gliolan

EU/1/07/414/001/NO-017/NO

Galvus

EU/1/07/414/001-017

EU/1/07/414/001-017/IS

Galvus

Galvus

EU/1/07/415/001/NO-056/NO

Zalasta

EU/1/07/415/001-056/IS

EU/1/07/415/001-056

EU/1/07/416/001

EU/1/07/416/001/IS

EU/1/07/416/001/NO

Zalasta

Zalasta

Ecalta

Ecalta

Ecalta

EU/1/07/417/001/NO-002/NO

Yondelis

EU/1/07/417/001-002

EU/1/07/417/001-002/IS

Yondelis

Yondelis

EU/1/07/418/001/NO-010/NO

Celsentri

EU/1/07/418/001-010

EU/1/07/418/001-010/IS

Celsentri

Celsentri

EU/1/07/419/001/NO-009/NO

Cervarix

EU/1/07/419/001-009

EU/1/07/419/001-009/IS

EU/1/07/420/001

EU/1/07/420/001/IS

EU/1/07/420/001/NO

Cervarix

Cervarix

Cyanokit

Cyanokit

Cyanokit

Liechtenstein

31.10.2007

Iceland

Norway

21.9.2007

8.10.2007

Liechtenstein

31.10.2007

Iceland

Norway

Iceland

18.10.2007

16.10.2007

26.10.2007

Liechtenstein

31.10.2007

Liechtenstein

31.10.2007

Iceland

Norway

Norway

13.10.2007

28.9.2007

23.10.2007

Liechtenstein

31.10.2007

Iceland

Norway

15.10.2007

25.9.2007

Liechtenstein

31.10.2007

Iceland

Norway

13.10.2007

25.9.2007

Liechtenstein

31.10.2007

Iceland

12.10.2007

Liechtenstein

31.12.2007

Iceland

Norway

17.12.2007

19.12.2007

19.12.2007

EU/1/07/421/001/NO-009/NO

Pioglitazon/metformin Takeda

Norway

EU/1/07/421/001-009

Pioglitazone/Metformin
chloride Takeda

Hydro-

Liechtenstein

31.12.2007

EU/1/07/422/001-004/IS

Tasigna

Iceland

14.12.2007

EU/1/07/424/001

EU/1/07/424/001/IS

EU/1/07/424/001/NO

Torisel

Torisel

Torisel

EU/1/07/425/001/NO-018/NO

Eucreas

Liechtenstein

31.12.2007

Iceland

Norway

Norway

10.12.2007

3.12.2007

5.12.2007

EU/1/07/425/001-018

Eucreas

Liechtenstein

31.12.2007

12.6.2008

EN

Official Journal of the European Union

C 146/17

EU Number

Product

Country

EU/1/07/425/001-018/IS

Eucreas

EU/1/07/426/001/NO-011/NO

Olanzapine Neopharma

EU/1/07/426/001-011/IS

Olanzapine Neopharma

EU/1/07/426/001-011

Olanzapine Neopharma

EU/1/07/433/001

EU/1/07/433/001/NO

Nevanac

Nevanac

EU/107/427/001-037

Olanzapine Teva

Iceland

Norway

Iceland

Liechtenstein

Liechtenstein

Norway

Liechtenstein

EU/2/06/067/001-002

Medicinal Oxygen Air Liquide Santé

Liechtenstein

EU/2/06/070/001-003/IS

Meloxidyl

EU/2/07/072/001/NO-002/NO

Suprelorin

EU/2/07/072/001-002

EU/2/07/072/001-002/IS

Suprelorin

Suprelorin

EU/2/07/074/001/NO-006/NO

Prilactone

EU/2/07/074/001-006/IS

Prilactone

EU/2/07/075/001/NO-004/NO

Circovac

EU/2/07/075/001-004

EU/2/07/075/001-004/IS

EU/2/07/077/001-005

Circovac

Circovac

Meloxivet

Date of
authorisation

6.12.2007

19.12.2007

7.12.2007

31.12.2007

31.12.2007

18.12.2007

31.12.2007

31.12.2007

17.8.2007

24.10.2007

31.8.2007

10.8.2007

20.12.2007

19.7.2007

20.12.2007

31.8.2007

12.7.2007

Iceland

Norway

Liechtenstein

Iceland

Norway

Iceland

Norway

Liechtenstein

Iceland

Liechtenstein

31.12.2007

C 146/18

EN

Official Journal of the European Union

12.6.2008

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
2007:

EU Number

Product

Country

EU/1/02/209/001/NO-008/NO

EU/1/02/216/001/NO-002/NO

EU/1/02/218/001/NO-011/NO

EU/1/02/218/001-011/IS

EU/1/02/219/001/NO-015/NO

EU/1/02/219/001-015/IS

EU/1/02/220/001/NO-005/NO

EU/1/02/221/001/NO-010/NO

EU/1/02/221/001-010/IS

EU/1/02/221/001-010

EU/1/02/222/001/NO-002/NO

EU/1/02/222/001-002

EU/1/02/222/001-004/IS

EU/1/02/223/001/NO-003/NO

EU/1/02/223/001-003

EU/1/02/223/001-003/IS

EU/1/02/224/001/NO-005/NO

EU/1/02/224/001-005

EU/1/02/224/001-005/IS

EU/1/02/225/001/NO-002/NO

EU/1/02/225/001-002

EU/1/02/225/001-002/IS

EU/1/02/226/001

EU/1/02/226/001/IS

EU/1/02/226/001/NO

EU/1/02/227/001/NO-003/NO

EU/1/02/227/001-003

EU/1/02/227/001-003/IS

EU/1/02/228/001-003/IS

EU/1/02/228/001/NO-003/NO

EU/1/02/228/001-003

Dynastat

Invanz

Axura

Axura

Ebixa

Ebixa

Tracleer

Pegasys

Pegasys

Pegasys

Tamiflu

Tamiflu

Tamiflu

Evra

Evra

Evra

Ambirix

Ambirix

Ambirix

Xigris

Xigris

Xigris

InductOs

InductOs

InductOs

Neulasta

Neulasta

Neulasta

Neupopeg

Neupopeg

Neupopeg

Norway

Norway

Norway

Iceland

Norway

Iceland

Norway

Norway

Iceland

Liechtenstein

Norway

Liechtenstein

Iceland

Norway

Date of
authorisation

14.9.2007

4.7.2007

16.7.2007

11.7.2007

11.7.2007

6.7.2007

13.8.2007

18.7.2007

13.7.2007

31.8.2007

31.7.2007

31.8.2007

13.7.2007

17.9.2007

Liechtenstein

31.10.2007

Iceland

Norway

1.10.2007

25.9.2007

Liechtenstein

31.10.2007

Iceland

Norway

Liechtenstein

Iceland

1.10.2007

27.8.2007

31.8.2007

16.8.2007

Liechtenstein

31.10.2007

Iceland

Norway

Norway

Liechtenstein

Iceland

Iceland

Norway

Liechtenstein

17.9.2007

10.9.2007

27.8.2007

31.8.2007

16.8.2007

15.8.2007

27.8.2007

31.8.2007

12.6.2008

EN

Official Journal of the European Union

C 146/19

EU Number

Product

Country

EU/1/02/229/001/NO-037/NO

Actraphane

Norway

Date of
authorisation

9.10.2007

EU/1/02/229/001-037

Actraphane

Liechtenstein

31.10.2007

EU/1/02/229/001-037/IS

Actraphane

EU/1/02/230/001/NO-017/NO

EU/1/02/230/001-017

EU/1/02/230/001-017/IS

EU/1/02/231/001/NO-037/NO

EU/1/02/231/001-037

EU/1/02/231/001-037/IS

EU/1/02/232/001/NO-003/NO

EU/1/02/232/001-003

EU/1/02/232/001-003/IS

EU/1/02/233/001/NO-017/NO

EU/1/02/233/001-017

EU/1/02/233/001-017/IS

Actrapid

Actrapid

Actrapid

Mixtard

Mixtard

Mixtard

Velosulin

Velosulin

Velosulin

Insulatard

Insulatard

Insulatard

EU/1/02/234/001/NO-017/NO

Protaphane

Iceland

Norway

15.10.2007

9.10.2007

Liechtenstein

31.10.2007

Iceland

Norway

15.10.2007

9.10.2007

Liechtenstein

31.10.2007

Iceland

Norway

16.10.2007

9.10.2007

Liechtenstein

31.10.2007

Iceland

Norway

15.10.2007

9.10.2007

Liechtenstein

31.10.2007

Iceland

Norway

16.10.2007

9.10.2007

EU/1/02/234/001-017

Protaphane

Liechtenstein

31.10.2007

EU/1/02/234/001-017/IS

Protaphane

EU/1/02/237/001/NO-008/NO

EU/1/02/237/001-008

EU/1/02/237/001-008/IS

EU/1/02/238/001

EU/1/02/238/001/IS

EU/1/02/238/001/NO

EU/1/02/240/001/NO-004/NO

EU/1/02/240/001-004

EU/1/02/240/001-004/IS

Cialis

Cialis

Cialis

Zavesca

Zavesca

Zavesca

Somavert

Somavert

Somavert

EU/1/97/031/001/NO-003/NO, 019/NO-046/NO

Neorecormon

Iceland

Norway

15.10.2007

15.10.2007

Liechtenstein

31.10.2007

Iceland

15.10.2007

Liechtenstein

31.10.2007

Iceland

Norway

Norway

1.10.2007

17.9.2007

26.9.2007

Liechtenstein

31.10.2007

Iceland

Norway

EU/1/97/031/001-003, 019-046

NeoRecormon

Liechtenstein

EU/1/97/031/001-013, 019-024, 027-046/IS

NeoRecormon

EU/1/97/032/001/NO

EU/1/97/037/001/IS

EU/1/97/037/001/NO

EU/1/97/039/001/NO-004/NO

EU/1/97/039/001-004

LeukoScan

Vistide

Vistide

Cystagon

Cystagon

Iceland

Norway

Iceland

Norway

Norway

Liechtenstein

19.10.2007

17.7.2007

31.8.2007

11.7.2007

4.7.2007

6.7.2007

13.9.2007

31.7.2007

31.8.2007

C 146/20

EN

Official Journal of the European Union

12.6.2008

EU Number

Product

Country

EU/1/97/039/001-004/IS

EU/1/97/040/001/NO-002/NO

EU/1/97/043/001/NO-003/NO

EU/1/97/043/001-003

EU/1/97/043/001-003/IS

EU/1/97/046/001/NO-039/NO

EU/1/97/046/001-033

EU/1/97/046/001-039/IS

EU/1/97/047/001/NO-007/NO

EU/1/97/047/001-007

EU/1/97/047/001-007/IS

EU/1/97/049/001/NO-039/NO

EU/1/97/049/001-033

EU/1/97/049/001-039/IS

Cystagon

Teslascan

Revasc

Revasc

Revasc

Aprovel

Aprovel

Aprovel

BeneFIX

Benefix

BeneFix

Karvea

Karvea

Karvea

EU/1/97/050/001/NO-006/NO, 009/NO-012/NO

Sifrol

EU/1/97/050/001-006, 009-012

EU/1/97/050/001-006, 009-012/IS

Sifrol

Sifrol

EU/1/97/051/001/NO-006/NO, 009/NO-012/NO

Mirapexin

EU/1/97/051/001-006, 009-012

EU/1/97/051/001-006, 009-012/IS

EU/1/97/053/001/NO-005/NO

EU/1/97/053/001-005

EU/1/97/053/001-005/IS

EU/1/97/057/001

EU/2/02/032/001/IS

EU/2/02/033/001/IS

EU/2/02/034/001/IS

EU/2/02/035/001-007

EU/2/02/035/001-007/IS

EU/2/033/001

EU/2/034/001

EU/2/97/001-009/IS

EU/2/97/004/001, EU/2/97/004/003-028

EU/2/97/004/001/NO, 003/NO-030/NO

EU/2/97/005/001-009

Mirapexin

Mirapexin

Cerezyme

Cerezyme

Cerezyme

Quadramet

Liechtenstein

Vaxxitek HVT + IBD

Iceland

Dexdomitor

Nobivac Bb cat

Iceland

Iceland

SevoFlo

SevoFlo

Liechtenstein

Iceland

Dexdomitor

Liechtenstein

Nobivac Bb

Liechtenstein

Quadrisol

Metacam

Metacam

Quadrisol

Iceland

Liechtenstein

Norway

Liechtenstein

EU/2/98/010/004-014, 017-018, 021-024/IS

Econor

Iceland

Liechtenstein

31.10.2007

Iceland

Norway

18.9.2007

11.9.2007

Liechtenstein

31.10.2007

Iceland

Norway

31.8.2007

20.9.2007

Liechtenstein

31.10.2007

Iceland

Norway

Norway

Liechtenstein

Iceland

Norway

Iceland

Norway

Liechtenstein

Iceland

Norway

Liechtenstein

Iceland

Norway

Liechtenstein

Iceland

Date of
authorisation

11.7.2007

20.8.2007

16.7.2007

31.8.2007

11.7.2007

19.9.2007

17.9.2007

16.10.2007

31.10.2007

15.10.2007

15.10.2007

31.10.2007

15.10.2007

9.10.2007

31.10.2007

15.10.2007

31.12.2007

10.7.2007

17.8.2007

19.10.2007

31.12.2007

6.12.2007

31.10.2007

31.10.2007

10.12.2007

31.12.2007

17.12.2007

31.12.2007

8.11.2007

12.6.2008

EN

Official Journal of the European Union

C 146/21

ANNEX III

List of extended marketing authorisations

following marketing authorisations have been extended in the EEA EFTA States during the period

The
1 July-31 December 2007:

EU Number

Product

Country

Date of
extention

EU/1/00/151/023-024

Glustin

Liechtenstein

31.10.2007

EU/1/01/197/003/NO-005/NO

Foscan

Norway

8.11.2007

EU/1/01/197/003-005

EU/1/01/197/003-005/IS

Foscan

Foscan

EU/1/02/222/003/NO-004/NO

Tamiflu

EU/1/02/222/003-004

EU/1/02/222/003-004/IS

EU/1/02/237/006/NO-008/NO

EU/1/02/237/006-008

EU/1/03/254/002

EU/1/03/260/016-018

EU/1/04/290/002

EU/1/04/290/002/IS

Tamiflu

Tamiflu

Cialis

Cialis

Busilvex

Stalevo

Alimta

Alimta

Liechtenstein

31.10.2007

Iceland

Norway

12.11.2007

27.9.2007

Liechtenstein

31.10.2007

Iceland

Norway

Liechtenstein

15.10.2007

3.7.2007

31.8.2007

Liechtenstein

31.12.2007

Liechtenstein

31.10.2007

Liechtenstein

31.12.2007

Iceland

15.11.2007

EU/1/04/296/009

Cymbalta

Liechtenstein

31.10.2007

EU/1/05/310/006/NO-009/NO

Fosavance

Norway

8.11.2007

EU/1/05/310/006-009

EU/1/05/310/006-009/IS

EU/1/05/325/002

Fosavance

Fosavance

Macugen

EU/1/06/332/004/NO-006/NO

Omnitrope

EU/1/06/332/007/NO-009/NO

Omnitrope

Liechtenstein

31.12.2007

Iceland

19.10.2007

Liechtenstein

31.12.2007

Norway

Norway

10.9.2007

8.11.2007

EU/1/06/332/007-009

Omnitrope

Liechtenstein

31.10.2007

EU/1/06/332/007-009/IS

Omnitrope

Iceland

17.10.2007

EU/1/06/344/010-011

EU/1/06/345/010-011

EU/1/06/347/004-006

EU/1/06/361/002

Acomplia

Zimulti

Sutent

Luminity

Liechtenstein

31.10.2007

Liechtenstein

31.10.2007

Liechtenstein

31.12.2007

Liechtenstein

31.12.2007

EU/1/06/364/006/NO-009/NO

Adrovance

Norway

14.11.2007

EU/1/06/364/006-009

EU/1/06/364/006-009/IS

EU/1/06/366/005-016

Adrovance

Adrovance

Tandemact

Liechtenstein

31.10.2007

Iceland

19.10.2007

Liechtenstein

31.12.2007

C 146/22

EN

Official Journal of the European Union

12.6.2008

EU Number

Product

Country

EU/1/95/003/005-006

Betaferon

EU/1/96/022/023-034

EU/1/97/033/004

EU/1/97/046/034-039

Zyprexa

Avonex

Aprovel

EU/1/97/047/004/NO-007/NO

BeneFIX

EU/1/97/047/004-007

EU/1/97/047/007/IS

EU/1/97/049/034-039

EU/1/98/066/019/NO-026/NO

EU/1/98/066/019-026

EU/1/98/066/019-026/IS

EU/1/98/069/007a, 007b

EU/1/98/070/007a, 007b

EU/1/98/085/029-034

EU/1/98/086/029-034

BenFix

Benefix

Karvea

Exelon

Exelon

Exelon

Plavix

Iscover

Karvezide

CoAprovel

EU/1/98/092/019/NO-026/NO

Prometax

EU/1/98/092/019-026

EU/1/98/092/019-026/IS

EU/1/99/108/002-003

Prometax

Prometax

Ferriprox

EU/1/99/108/002/NO-003/NO

Ferriprox

EU/1/99/108/002-003/IS

EU/2/039/019-030

EU/2/97/004/029-030

Ferriprox

Advocate

Metacam

Liechtenstein

Liechtenstein

Liechtenstein

Liechtenstein

Norway

Liechtenstein

Iceland

Liechtenstein

Norway

Liechtenstein

Iceland

Liechtenstein

Liechtenstein

Liechtenstein

Liechtenstein

Norway

Liechtenstein

Iceland

Liechtenstein

Norway

Iceland

Liechtenstein

Liechtenstein

Date of
extention

31.10.2007

31.8.2007

31.8.2007

31.10.2007

4.9.2007

31.8.2007

31.8.2007

31.10.2007

10.10.2007

31.10.2007

17.10.2007

31.8.2007

31.8.2007

31.10.2007

31.10.2007

10.10.2007

31.10.2007

18.10.2007

31.12.2007

5.12.2007

10.12.2007

31.8.2007

31.12.2007

12.6.2008

EN

Official Journal of the European Union

C 146/23

ANNEX IV

List of withdrawn marketing authorisations

following marketing authorisations have been withdrawn in the EEA EFTA States during the period

The
1 July-31 December 2007:

EU Number

Product

Country

Date of
withdrawal

EU/1/01/92/001-005

Levviax

Liechtenstein

31.12.2007

EU/1/03/257/001/NO-010/NO

Trudexa

EU/1/03/257/001-010

EU/1/03/257/001-010/IS

Trudexa

Trudexa

Norway

Liechtenstein

Iceland

29.8.2007

31.8.2007

9.8.2007

ANNEX V

List of suspended marketing authorisations

following marketing authorisations have been suspended in the EEA EFTA States during the period

The
1 July-31 December 2007:

EU Number

Product

Country

Date of suspension

EU/1/97/054/001, 003-005

EU/1/97/054/001-005/IS

Viracept

Viracept

EU/1/97/054/001/NO, 003/NO-005/NO

Viracept

Liechtenstein

Iceland

Norway

31.8.2007 (*)

7.8.2007 (**)

27.8.2007 (***)

(*)
Lifting of the suspension 31 October 2007 — Viracept EU/1/97/054/001, 003-005.
(**) Lifting of the suspension 14 November 2007 — Viracept EU/1/97/054/001, 004-005/IS.
(***) Lifting of the suspension 29 October 2007 — Viracept EU/1/97/054/001/NO, 003/NO-005/NO.