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Document E2006X1130(01)

List of marketing authorisations granted by the EEA EFTA States for the second half of 2005

OJ C 291, 30.11.2006, p. 69–77 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)

30.11.2006   

EN

Official Journal of the European Union

C 291/69


List of marketing authorisations granted by the EEA EFTA States for the second half of 2005

(2006/C 291/20)

With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note, at the meeting on 2 June 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 June — 31 December 2005:

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List of withdrawn marketing authorisations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

1.   New Marketing Authorisations:

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 June31 December 2005:

EU-Number

Product

Country

Date of authorisation

EU/1/00/129/001-003

Azopt

Liechtenstein

31.7.2005

EU/1/00/131/001-030

PegIntron

Liechtenstein

30.9.2005

EU/1/00/134/008-011

Lantus

Liechtenstein

30.9.2005

EU/1/00/135/002

DaTSCAN

Liechtenstein

30.9.2005

EU/1/00/142/009-010

NovoMix

Liechtenstein

30.9.2005

EU/1/00/142/011-016

NovoMix

Liechtenstein

30.11.2005

EU/1/00/142/017-022

NovoMix

Liechtenstein

30.11.2005

EU/1/01/198/007-010

Glivec

Liechtenstein

31.7.2005

EU/1/02/215/001/NO-010/NO

Pritor Plus

Norway

7.9.2005

EU/1/02/227/003

Neulasta

Liechtenstein

30.11.2005

EU/1/02/228/003

Neupopeg

Liechtenstein

30.11.2005

EU/1/03/255/001-003

Ventavis

Liechtenstein

30.11.2005

EU/1/03/258/013-014

Avandamet

Liechtenstein

30.9.2005

EU/1/03/263/001-003/IS

Dukoral, Suspension of vaccine and effervescent granules for oral solution

Iceland

6.10.2005

EU/1/03/265/003-004

Bonviva

Liechtenstein

30.9.2005

EU/1/03/266/003-004

Bondenza

Liechtenstein

30.9.2005

EU/1/03/269/001

Faslodex

Liechtenstein

30.11.2005

EU/1/03/270/003

Kentera

Liechtenstein

31.7.2005

EU/1/04/276/021-032

Abilify

Liechtenstein

31.7.2005

EU/1/04/276/033-035

Abilify

Liechtenstein

30.11.2005

EU/1/04/279/030-032

Lyrica

Liechtenstein

30.9.2005

EU/1/04/280/007

Yentreve

Liechtenstein

30.9.2005

EU/1/04/283/007

Ariclaim

Liechtenstein

30.9.2005

EU/1/04/289/002

Angiox

Liechtenstein

31.7.2005

EU/1/04/296/005-006

Cymbalta

Liechtenstein

31.7.2005

EU/1/04/297/005-006

Xeristar

Liechtenstein

31.7.2005

EU/1/05/310/001/NO-005/NO

Fosavance

Norway

6.9.2005

EU/1/05/310/001-005

Fosavance

Liechtenstein

30.9.2005

EU/1/05/310/001-005/IS

Fosavance tablets

Iceland

20.9.2005

EU/1/05/311/001/NO-003/NO

Tarceva

Norway

26.9.2005

EU/1/05/311/001-003

Tarceva

Liechtenstein

30.9.2005

EU/1/05/311/001-003/IS

Tarceva

Iceland

18.10.2005

EU/1/05/312/001/IS

Xyrem

Iceland

18.11.2005

EU/1/05/312/001/NO

Xyrem

Norway

18.11.2005

EU/1/05/313/001/NO-009/NO

Vasovist

Norway

14.10.2005

EU/1/05/313/001-009

Vasovist

Liechtenstein

30.11.2005

EU/1/05/313/001-009/IS

Vasovist

Iceland

2.11.2005

EU/1/05/314/001

Kepivance

Liechtenstein

30.11.2005

EU/1/05/314/001/IS

Kepivance

Iceland

24.11.2005

EU/1/05/314/001/NO

Kepivance

Norway

22.11.2005

EU/1/05/315/001

Aptivus

Liechtenstein

30.11.2005

EU/1/05/315/001/IS

Aptivus

Iceland

25.11.2005

EU/1/05/315/001/NO

Aptivus

Norway

2.11.2005

EU/1/05/316/001/NO-014/NO

Procoralan

Norway

10.11.2005

EU/1/05/316/001-014

Procoralan

Liechtenstein

30.11.2005

EU/1/05/316/001-014/IS

Procoralan

Iceland

24.11.2005

EU/1/05/317/001/NO-014/NO

Corlentor

Norway

10.11.2005

EU/1/05/317/001-014

Corlentor

Liechtenstein

30.11.2005

EU/1/05/317/001-014/IS

Corlentor

Iceland

24.11.2005

EU/1/05/318/001

Revatio

Liechtenstein

30.11.2005

EU/1/05/318/001/IS

Revatio

Iceland

28.11.2005

EU/1/05/318/001/NO

Revatio

Norway

11.11.2005

EU/1/05/319/001/NO-002/NO

Xolair

Norway

7.11.2005

EU/1/05/319/001-002

Xolair

Liechtenstein

30.11.2005

EU/1/05/319/001-002/IS

Xolair

Iceland

25.11.2005

EU/1/05/320/001

Noxafil

Liechtenstein

30.11.2005

EU/1/05/320/001/IS

Noxafil

Iceland

20.11.2005

EU/1/05/320/001/NO

Noxafil

Norway

23.11.2005

EU/1/05/321/001

Posaconazole SP

Liechtenstein

30.11.2005

EU/1/05/321/001/IS

Posaconazole SP

Iceland

24.11.2005

EU/1/05/321/001/NO

Posaconazole SP

Norway

23.11.2005

EU/2/01/030/003-004

Virbagen Omega

Liechtenstein

30.9.2005

EU/2/04/047/001-002/IS

Purevax RCPCh Fel V, powder and solv. for susp. for injection

Iceland

30.6.2005

EU/2/04/048/001-002/IS

Purevax RCP Fel V, powder and solv. for susp. for injection

Iceland

30.6.2005

EU/2/04/049/001-002/IS

Purevax RCCh, powder and solvent for suspension for injection

Iceland

30.6.2005

EU/2/04/050/001-002/IS

Purevax RCPCh, powder and solv. for susp. for injection

Iceland

30.6.2005

EU/2/04/051/001-002/IS

Purevax RC, powder and solvent for suspension for injection

Iceland

30.6.2005

EU/2/04/052/001-002/IS

Purevax RCP, powder and solvent for suspension for injection

Iceland

30.6.2005

EU/2/05/053/001

Naxcel

Liechtenstein

31.7.2005

EU/2/05/053/001/IS

Naxcel, suspension for injection

Iceland

9.6.2005

EU/2/05/053/001/NO

Naxcel

Norway

17.6.2005

EU/2/05/054/001/NO-017/NO

Profender

Norway

30.8.2005

EU/2/05/054/001-017

Profender

Liechtenstein

30.9.2005

EU/2/05/054/001-017/IS

Profender Spot-on solution

Iceland

26.8.2005

EU/2/05/055/001/NO-002/NO

Equilis Te

Norway

12.8.2005

EU/2/05/055/001-002

Equilis Te

Liechtenstein

30.9.2005

EU/2/05/055/001-002/IS

Equilis Te, susp. for injection

Iceland

2.8.2005

EU/2/05/056/001/NO-002/NO

Equilis Prequenza

Norway

12.8.2005

EU/2/05/056/001-002

Equilis Prequenza

Liechtenstein

30.9.2005

EU/2/05/056/001-002/IS

Equilis Prequenza, susp. for injection

Iceland

2.08.2005

EU/2/05/057/001/NO-002/NO

Equilis Prequenza Te

Norway

12.8.2005

EU/2/05/057/001-002

Equilis Prequenza Te

Liechtenstein

30.9.2005

EU/2/05/057/001-002/IS

Equilis Prequenza Te, susp. for injection

Iceland

2.8.2005

EU/2/97/004/011

Metacam

Liechtenstein

31.7.2005

EU/2/97/004/012-013

Metacam

Liechtenstein

30.9.2005


ANNEX II

2.   Renewed Marketing Authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 June31 December 2005:

EU-Number

Product

Country

Date of renewal

EU/1/00/129/001/NO-003/NO

Azopt

Norway

30.6.2005

EU/1/00/129/001-003/IS

Azopt, eye drops, suspension, 1%

Iceland

30.6.2005

EU/1/05/131/001/NO-005/NO

PegIntron

Norway

24.06.2005

EU/1/00/131/001-050/IS

PegIntron

Iceland

28.6.2005

EU/1/00/131/031-050

PegIntron

Liechtenstein

30.9.2005

EU/1/05/132/001/NO-005/NO

ViraferonPeg

Norway

24.6.2005

EU/1/00/132/001-050

ViraferonPeg

Liechtenstein

31.7.2005

EU/1/00/132/001-050/IS

ViraferonPeg

Iceland

28.6.2005

EU/1/00/133/001/NO-008/NO

Optisulin

Norway

27.7.2005

EU/1/00/133/001-008

Optisulin

Liechtenstein

30.9.2005

EU/1/00/133/001-008/IS

Optisulin

Iceland

29.8.2005

EU/1/00/134/001/NO-029/NO

Lantus

Norway

27.7.2005

EU/1/00/134/001-007, 012-029

Lantus

Liechtenstein

30.9.2005

EU/1/00/134/001-029/IS

Lantus

Iceland

29.8.2005

EU/1/00/135/001

DaTSCAN

Liechtenstein

30.9.2005

EU/1/00/135/001/NO-002/NO

DaTSCAN

Norway

20.9.2005

EU/1/00/135/001-002/IS

DaTSCAN

Iceland

11.10.2005

EU/1/00/137/001/NO-012/NO

Avandia

Norway

27.7.2005

EU/1/00/137/001-012

Avandia

Liechtenstein

30.9.2005

EU/1/00/137/001-012/IS

Avandia

Iceland

16.9.2005

EU/1/00/140/001

Visudyne

Liechtenstein

31.7.2005

EU/1/00/140/001/IS

Visudyne 15 mg Powder for solution for injection

Iceland

14.7.2005

EU/1/00/140/001/NO

Visudyne

Norway

27.7.2005

EU/1/00/141/001

Myocet

Liechtenstein

30.9.2005

EU/1/00/141/001/IS

Myocet

Iceland

13.10.2005

EU/1/00/141/001/NO

Myocet

Norway

28.9.2005

EU/1/00/142/004/NO-005/NO

NovoMix Penfill

Norway

13.10.2005

EU/1/00/142/004-005

NovoMix

Liechtenstein

30.9.2005

EU/1/00/142/004-005/IS

NovoMix 30 Penfill

Iceland

21.10.2005

EU/1/00/142/009/NO-010/NO

NovoMix Flexpen

Norway

13.10.2005

EU/1/00/142/009-010/IS

NovoMix 30 FlexPen

Iceland

21.10.2005

EU/1/00/143/001/NO-006/NO

Kogenate Bayer

Norway

7.9.2005

EU/1/00/143/001-006

Kogenate

Liechtenstein

30.9.2005

EU/1/00/143/001-006/IS

Kogenate Bayer

Iceland

7.10.2005

EU/1/00/144/001/NO-003/NO

Helixate NexGen

Norway

7.9.2005

EU/1/00/144/001-003

Helixate

Liechtenstein

30.9.2005

EU/1/00/144/001-003/IS

Helixate NexGen

Iceland

7.10.2005

EU/1/00/145/001

Herceptin

Liechtenstein

30.9.2005

EU/1/00/145/001/IS

Herceptin

Iceland

28.11.2005

EU/1/00/145/001/NO

Herceptin

Norway

23.9.2005

EU/1/00/146/001/NO-029/NO

Keppra

Norway

08.8.2005

EU/1/00/146/001-029

Keppra

Liechtenstein

30.9.2005

EU/1/00/146/001-029/IS

Keppra

Iceland

12.9.2005

EU/1/00/148/001/NO-004/NO

Agenerase

Norway

12.12.2005

EU/1/00/148/001-004

Agenerase

Liechtenstein

30.11.2005

EU/1/00/148/001-004/IS

Agenerase

Iceland

16.12.2005

EU/1/00/149/001

Panretin

Liechtenstein

30.11.2005

EU/1/00/149/001/IS

Panretin

Iceland

16.12.2005

EU/1/00/149/001/NO

Panretin

Norway

9.12.2005

EU/1/00/150/001/NO-015/NO

Actos

Norway

2.11.2005

EU/1/00/150/001-015

Actos

Liechtenstein

30.11.2005

EU/1/00/150/001-015/IS

Actos

Iceland

11.11.2005

EU/1/00/151/001/NO-013/NO

Glustin

Norway

2.11.2005

EU/1/00/151/001-013

Glustin

Liechtenstein

30.11.2005

EU/1/00/151/001-013/IS

Glustin

Iceland

11.11.2005

EU/1/00/152/001-018

Infanrix hexa

Liechtenstein

30.11.2005

EU/1/00/153/001-010

Infanrix penta

Liechtenstein

30.11.2005

EU/1/00/153/001-010/IS

Infanrix penta

Iceland

16.12.2005

EU/1/00/153/001-010/NO

Infanrix penta

Norway

7.12.2005

EU/1/00152/001-018/NO

Infanrix hexa

Norway

7.12.2005

EU/1/95/001/001, 003-005, 009, 012, 021-022, 025-028, 031-035/IS

Gonal-F

Iceland

15.11.2005

EU/1/95/001/001/NO

Gonal-F

Norway

11.11.2005

EU/1/95/001/003/NO-006/NO

Gonal-F

Norway

11.11.2005

EU/1/95/001/009/NO

Gonal-F

Norway

11.11.2005

EU/1/95/001/012/NO

Gonal-F

Norway

11.11.2005

EU/1/95/001/021/NO-022/NO

Gonal-F

Norway

11.11.2005

EU/1/95/001/025/NO-028/NO

Gonal-F

Norway

11.11.2005

EU/1/95/001/031/NO-035/NO

Gonal-F

Norway

11.11.2005

EU/1/98/093/002

Forcaltonin

Liechtenstein

31.7.2005

EU/1/99/127/001/NO-044/NO

IntronA

Norway

20.6.2005

EU/1/99/127/001-044

IntronA

Liechtenstein

31.7.2005

EU/1/99/127/001-044/IS

IntronA

Iceland

27.6.2005

EU/1/99/128/001/NO-037/NO

Viraferon

Norway

20.6.2005

EU/1/99/128/001-037

Viraferon

Liechtenstein

31.7.2005

EU/1/99/128/001-037/IS

Viraferon

Iceland

27.6.2005

EU/2/00/018/001

Incurin

Liechtenstein

31.7.2005

EU/2/00/018/001/NO

Incurin

Norway

16.6.2005

EU/2/00/022//002b-03a

Ibaflin

Liechtenstein

30.9.2005

EU/2/00/022/001/NO-017/NO

Ibaflin

Norway

31.8.2005

EU/2/00/022/001-017/IS

Ibaflin

Iceland

15.07.2005

EU/2/00/022/001a

Ibaflin

Liechtenstein

30.9.2005

EU/2/00/022/001b-02a

Ibaflin

Liechtenstein

30.9.2005

EU/2/00/022/003b-04a

Ibaflin

Liechtenstein

30.9.2005

EU/2/00/022/004b

Ibaflin

Liechtenstein

30.9.2005

EU/2/00/022/005-017

Ibaflin

Liechtenstein

30.9.2005

EU/2/00/024/001/IS

Pruban

Iceland

16.12.2005

EU/2/99/016/001/NO-006/NO

Porcilis Pesti

Norway

18.7.2005

EU/2/99/016/001-006

Porcilis Pesti

Liechtenstein

31.7.2005

EU/2/99/016/001-006/IS

Porcilis Pesti

Iceland

13.7.2005

EU/2/99/017/001/NO-006/NO

Ibraxion

Norway

2.6.2005


ANNEX III

3.   Extended Marketing Authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 June31 December 2005:

EU-Number

Product

Country

Date of extention

EU/1/00/142/011/NO-013/NO

NovoMix Penfill 50

Norway

1.11.2005

EU/1/00/142/001-013/IS

NovoMix 50 Penfill suspension for injection

Iceland

5.10.2005

EU/1/00/142/014/NO-016/NO

NovoMix Flexpen 50

Norway

1.11.2005

EU/1/00/142/014-016/IS

NovoMix 50 FlexPen suspension for injection

Iceland

5.10.2005

EU/1/00/142/017/NO-019/NO

NovoMix Penfill 70

Norway

1.11.2005

EU/1/00/142/017-019/IS

NovoMix 70 Penfill suspension for injection

Iceland

5.10.2005

EU/1/00/142/020/NO-022/NO

NovoMix Flexpen 70

Norway

1.11.2005

EU/1/00/142/020-022/IS

NovoMix 70 FlexPen suspension for injection

Iceland

5.10.2005

EU/1/03/265/003/NO-004/NO

Bonviva, film-coated tablets

Norway

28.9.2005

EU/1/03/265/003-004/IS

Bonviva, film-coated tablets

Iceland

25.10.2005

EU/1/03/266/003/NO-004/NO

Bondenza, film-coated tablets

Norway

28.9.2005

EU/1/03/266/003-004/IS

Bondenza, film-coated tablets

Iceland

21.10.2005

EU/1/04/276/021/NO-023/NO

Abilify, orodispersible tablet 5 mg

Norway

18.7.2005

EU/1/04/276/021-023/IS

Abilify, orodispersible tablet 5 mg

Iceland

14.7.2005

EU/1/04/276/024/NO-026/NO

Abilify, orodispersible tablet 10 mg

Norway

18.7.2005

EU/1/04/276/024-026/IS

Abilify, orodispersible tablet 10 mg

Iceland

14.7.2005

EU/1/04/276/027/NO-029/NO

Abilify, orodispersible tablet 15 mg

Norway

18.7.2005

EU/1/04/276/027-029/IS

Abilify, orodispersible tablet 15 mg

Iceland

14.7.2005

EU/1/04/276/030/NO-032/NO

Abilify, orodispersible tablet 30 mg

Norway

18.7.2005

EU/1/04/276/030-032/IS

Abilify, orodispersible tablet 30 mg

Iceland

14.7.2005

EU/1/04/276/033/NO-035/NO

Abilify 1mg/ml, oral solution

Norway

9.11.2005

EU/1/04/276/033-035/IS

Abilify 1 mg/ml, oral solution

Iceland

1.12.2005

EU/1/96/026/002/IS

Invirase, filmcoated tablet 500 mg

Iceland

19.7.2005

EU/1/96/026/002/NO

Invirase

 Norway

9.6.2005

EU/2/97/004/012/NO-013/NO

Metacam, 0,5 mg/ml oral suspension for dogs

Norway

5.9.2005

EU/2/97/004/012-013/IS

Metacam, 0,5 mg/ml oral suspension for dogs

Iceland

2.9.2005


ANNEX IV

4.   Withdrawn Marketing Authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 June31 December 2005:

EU-Number

Product

Country

Date of withdrawal

EU/1/00/158/001-034/IS

Opulis

Iceland

9.9.2005

EU/1/00/168/001/NO-006/NO

Tenecteplase

Norway

9.8.2005

EU/1/00/168/001-006

Tenecteplase

Liechtenstein

30.9.2005

EU/1/02/208/001-008/IS

Xapit

Iceland

9.9.2005

EU/1/02/210/001/NO-008/NO

Rayzon

Norway

22.7.2005

EU/1/02/210/001-008

Rayzon

Liechtenstein

31.7.2005

EU/1/02/210/001-008/IS

Rayzon

Iceland

5.7.2005

EU/1/02/242/001-024

Valdyn

Liechtenstein

30.9.2005

EU/1/02/242/001-024/IS

Valdyn, filmcoated tablets

Iceland

5.07.2005

EU/1/02/244/001/NO-024/NO

Valdyn

Norway

22.7.2005

EU/1/02/244/001-024/IS

Valdyn

Liechtenstein

31.7.2005

EU/1/96/009/010/NO-017/NO

Zerit

Norway

30.9.2005

EU/1/96/009/010-017/IS

Zerit prolonged-release capsules

Iceland

29.11.2005

EU/1/96/023/001

Cea-Scan

Liechtenstein

30.11.2005

EU/1/96/023/001/IS

CEA-Scan

Iceland

9.11.2005

EU/1/97/048/001-014/IS

Infanrix HepB, suspension for injection

Iceland

15.6.2005

EU/2/00/023/001-003

Pulsaflox

Liechtenstein

30.11.2005


ANNEX V

5.   Suspended Marketing Authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 June31 December 2005:

EU-Number

Product

Country

Date of suspension

EU/1/00/147/001/NO-012/NO

Hexavac

Norway

17.11.2005

EU/1/00/147/001-008

Hexavac

Liechtenstein

30.11.2005

EU/1/00/147/001-008/IS

Hexavac

Iceland

17.11.2005


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