28.9.2006   

EN

Official Journal of the European Union

C 233/28


List of marketing authorisations granted by the EEA EFTA States for the second half of 2003

(2006/C 233/09)

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 10 March 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 July — 31 December 2003:

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List of withdrawn marketing authorisations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 I

1.   New Marketing Authorisations:

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July31 December 2003:

EU-Number

Product

Country

Date of authorisation

EU/1/00/141/001/IS

Myocet conc. F. inf. Liposomes

Iceland

31.7.2003

EU/1/00/150/011-015

Actos

Liechtenstein

30.9.2003

EU/1/00/151/009-013

Glustin

Liechtenstein

30.9.2003

EU/1/00/165/007

Ovitrelle

Liechtenstein

30.11.2003

EU/1/02/206/005-008

Arixtra

Liechtenstein

30.11.2003

EU/1/02/207/005-008

Quixidar

Liechtenstein

30.11.2003

EU/1/02/219/010-013

Ebixa

Liechtenstein

30.9.2003

EU/1/02/229/036-037

Actraphane

Liechtenstein

30.9.2003

EU/1/02/230/016-017

Actrapid

Liechtenstein

30.9.2003

EU/1/02/231/036-037

Mixtard

Liechtenstein

30.9.2003

EU/1/02/232/003

Velosulin

Liechtenstein

30.9.2003

EU/1/02/233/016-017

Insulatard

Liechtenstein

30.9.2003

EU/1/02/234/016-017

Protaphane

Liechtenstein

30.9.2003

EU/1/02/240/004

Somavert

Liechtenstein

30.9.2003

EU/1/02/242/001-010/IS

Valdyn tablets 10 mg

Iceland

1.7.2003

EU/1/02/242/011-020/IS

Valdyn tablets 20 mg

Iceland

1.7.2003

EU/1/02/242/021-024/IS

Valdyn tablets 40 mg

Iceland

1.7.2003

EU/1/02/244/001-010/IS

Kudeq tablets 10 mg

Iceland

1.7.2003

EU/1/02/244/011-020/IS

Kudeq tablets 20 mg

Iceland

1.7.2003

EU/1/02/244/021-024/IS

Kudeq tablets 40 mg

Iceland

1.7.2003

EU/1/03/247/001-002

Forsteo

Liechtenstein

31.7.2003

EU/1/03/247/001-002/IS

Forsteo sol for inj. in prefilled pen

Iceland

8.7.2003

EU/1/03/252/001-003

Fuzeon

Liechtenstein

31.7.2003

EU/1/03/253/001-003

Aldurazyme

Liechtenstein

31.7.2003

EU/1/03/253/001-003/IS

Aldurazyme conc. for sol. f. inf. 100 U/ml

Iceland

21.7.2003

EU/1/03/254/001

Busilvex

Liechtenstein

30.9.2003

EU/1/03/254/001/IS

Busilvex 6 mg/ml conc.f. sol. f.inf.

Iceland

22.7.2003

EU/1/03/254/001/NO

Busilvex

Norway

17.7.2003

EU/1/03/255/001/NO-003/NO

Ventavis

Norway

30.10.2003

EU/1/03/255/001-003/IS

Ventavis Nebul. sol.- Inhal. 10 microg/ml

Iceland

15.10.2003

EU/1/03/256/001/NO-006/NO

Humira

Norway

11.9.2003

EU/1/03/256/001-006

Humira

Liechtenstein

30.9.2003

EU/1/03/256/001-006/IS

Humira solution for injection

Iceland

25.9.2003

EU/1/03/257/001/NO-006/NO

Trudexa

Norway

17.9.2003

EU/1/03/257/001-006

Trudexa

Liechtenstein

30.9.2003

EU/1/03/257/001-006/IS

Trudexa solution for injection

Iceland

29.9.2003

EU/1/03/258/001/NO-006/NO

Avandamet

Norway

18.11.2003

EU/1/03/258/001-003/IS

Avandamet tabl. 1mg/500 mg

Iceland

19.11.2003

EU/1/03/258/001-006

Avandamet

Liechtenstein

30.11.2003

EU/1/03/258/004-006/IS

Avandamet tabl. 2mg/500mg

Iceland

19.11.2003

EU/1/03/259/001/NO-006/NO

Onsenal

Norway

5.11.2003

EU/1/03/259/001-004/IS

Onsenal Hard capsules 200 mg

Iceland

16.12.2003

EU/1/03/259/001-006

Onsenal

Liechtenstein

30.11.2003

EU/1/03/259/005-006/IS

Onsenal Hard capsules 400 mg

Iceland

16.12.2003

EU/1/03/260/001/NO-012/NO

Stalevo

Norway

5.11.2003

EU/1/03/260/001-004/IS

Stalevo tabl. 50/12.5/200 mg

Iceland

31.10.2003

EU/1/03/260/001-012

Stalevo

Liechtenstein

30.11.2003

EU/1/03/260/005-008/IS

Stalevo tab. 100/25/200 mg

Iceland

31.10.2003

EU/1/03/260/009-012/IS

Stalevo tabl. 150/37.5/200 mg

Iceland

31.10.2003

EU/1/03/261/001/NO-003/NO

Emtriva

Norway

5.11.2003

EU/1/03/261/001-002/IS

Emtriva hard caps. 200 mg

Iceland

8.11.2003

EU/1/03/261/001-003

Emtriva

Liechtenstein

30.11.2003

EU/1/03/261/003/IS

Emtriva oral sol. 10mg/ml

Iceland

8.11.2003

EU/1/03/262/001/NO-006/NO

Emend

Norway

15.12.2003

EU/1/03/262/001-003/IS

Emend hard caps. 80 mg

Iceland

11.12.2003

EU/1/03/262/004-006/IS

Emend hard caps. 80 mg and 125 mg (comb.)

Iceland

11.12.2003

EU/1/03/262/005/IS

Emend hard caps. 125 mg

Iceland

11.12.2003

EU/1/96/012/001-013

Bondronat

Liechtenstein

30.11.2003

EU/1/96/015/004-005

Epivir

Liechtenstein

30.9.2003

EU/1/97/033/003

Avonex

Liechtenstein

31.7.2003

EU/1/98/064/001/NO

Pylobactell

Norway

1.7.2003

EU/1/98/076/001/NO-002/NO,

004/NO-009/NO

NovoNorm

Norway

15.8.2003

EU/1/98/076/011/NO-016/NO,

018/NO-021/NO

NovoNorm

Norway

15.8.2003

EU/1/99/119/012-014

NovoRapid

Liechtenstein

31.7.2003

EU/2/00/025/001/NO-006/NO

Bayovac CSF E2

Norway

8.9.2003

EU/2/00/027/001/NO-003/NO

Pirsue

Norway

2.9.2003

EU/2/01/030/001/IS

Virbagen Omega powd. & solv. for susp. f. inj. 5 MU

Iceland

10.12.2003

EU/2/01/030/002/IS

Virbagen Omega powd. & solv. for susp. f. inj. 10 MU

Iceland

10.12.2003

EU/2/02/035/001/NO-006/NO

SevoFlo

Norway

2.9.2003

EU/2/02/035/001-006/IS

SevoFlo Inhalation vapour, liquid for dogs

Iceland

1.8.2003

EU/2/03/039/001-004 & 013-014/IS

Advocate spot on sol. for cats

Iceland

25.9.2003

EU/2/03/039/005-012 & 015-018/IS

Advocate spot on sol for dogs

Iceland

25.9.2003

EU/2/03/039/013-018

Advocate

Liechtenstein

31.7.2003

EU/2/03/040/001

Gonazon

Liechtenstein

30.9.2003

EU/2/03/040/001/IS

Gonazon solution injection 1.600 microg/ml

Iceland

30.10.2003

EU/2/03/040/001/NO

Gonazon

Norway

18.8.2003

EU/2/03/041/001/NO-005/NO

Draxxin

Norway

10.12.2003

EU/2/03/041/001-005

Draxxin

Liechtenstein

30.11.2003

EU/2/03/041/001-005/IS

Draxxin sol for injection, cattle and pigs

Iceland

12.12.2003

EU/2/97/003/001-018

Dicural

Liechtenstein

30.9.2003

EU/2/97/004/009

Metacam

Liechtenstein

30.11.2003


ANNEX II

2.   Renewed Marketing Authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July31 December 2003:

EU-Number

Product

Country

Date of authorisation

EU/1/00/162/001-006/IS

Prandin 0.5 mg tablets

Iceland

25.9.2003

EU/1/00/162/001-018

Prandin

Liechtenstein

30.9.2003

EU/1/00/162/001-018/NO

Prandin

Norway

15.8.2003

EU/1/00/162/007-012/IS

Prandin 1 mg tablets

Iceland

25.9.2003

EU/1/00/162/013-018/IS

Prandin 2 mg tablets

Iceland

25.9.2003

EU/1/97/047/001/NO-003/NO

Benefix

Norway

30.12.2003

EU/1/97/048/001/NO-014/NO

InfanrixHep B

Norway

20.11.2003

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

009/NO-012/NO

Mirapexin

Norway

1.9.2003

EU/1/98/058/001-002

Combivir

Liechtenstein

31.7.2003

EU/1/98/058/001-002/IS

Combivir 150/300 mg film coated tablets

Iceland

16.9.2003

EU/1/98/058/001-002/NO

Combivir

Norway

7.7.2003

EU/1/98/063/001-003/IS

Rebif 22 microg/0.5 ml. solution for injection

Iceland

18.9.2003

EU/1/98/063/001-006

Rebif

Liechtenstein

31.7.2003

EU/1/98/063/001-006/NO

Rebif

Norway

19.8.2003

EU/1/98/063/004-006/IS

Rebif 44 microg/0.5 ml. solution for injection

Iceland

18.9.2003

EU/1/98/064/001

Pylobactell

Liechtenstein

31.7.2003

EU/1/98/064/001/IS

Pylobactell 100 mg soluble tablet

Iceland

21.10.2003

EU/1/98/066/001-003/IS

Exelon capsules hard, 1.5 mg

Iceland

26.8.2003

EU/1/98/066/001-013

Exelon

Liechtenstein

31.7.2003

EU/1/98/066/001-013/NO

Exelon

Norway

15.7.2003

EU/1/98/066/004-006/IS

Exelon capsules hard, 3 mg

Iceland

26.8.2003

EU/1/98/066/007-009/IS

Exelon capsules hard, 4.5 mg

Iceland

26.8.2003

EU/1/98/066/010-012/IS

Exelon capsules hard, 6 mg

Iceland

26.8.2003

EU/1/98/066/013/IS

Exelon oral solution 2 mg/ml

Iceland

26.8.2003

EU/1/98/067/001/IS

MabThera Concentrate for solution for infusion 100 mg

Iceland

13.10.2003

EU/1/98/067/001-002

Mabthera

Liechtenstein

30.9.2003

EU/1/98/067/001-002/NO

Mabthera

Norway

6.8.2003

EU/1/98/067/002/IS

MabThera Concentrate for solution for infusion 500 mg

Iceland

13.10.2003

EU/1/98/069/001-004/IS

Plavix tablets 75 mg

Iceland

20.11.2003

EU/1/98/069/001a, 1b, 2a, 2b, 3a, 3b, 4a, 4b

Plavix

Liechtenstein

30.11.2003

EU/1/98/069/001a, 1b, 2a, 2b, 3a, 3b, 4a, 4b/NO

Plavix

Norway

7.11.2003

EU/1/98/070/001-004/IS

Iscover tablets 75 mg

Iceland

20.11.2003

EU/1/98/070/001a, 1b, 2a, 2b, 3a, 3b, 4a, 4b

Iscover

Liechtenstein

30.11.2003

EU/1/98/070/001a, 1b, 2a, 2b, 3a, 3b, 4a, 4b/NO

Iscover

Norway

7.11.2003

EU/1/98/071/001-006

Xenical

Liechtenstein

30.11.2003

EU/1/98/071/001-006/IS

Xenical hard capsules 120 mg

Iceland

1.12.2003

EU/1/98/071/001-006/NO

Xenical

Norway

24.10.2003

EU/1/98/073/001-004

Evista

Liechtenstein

30.9.2003

EU/1/98/073/001-004/IS

Evista film coated tablets 60 mg

Iceland

18.9.2003

EU/1/98/073/001-004/NO

Evista

Norway

1.8.2003

EU/1/98/074/001-004

Optruma

Liechtenstein

30.9.2003

EU/1/98/074/001-004/IS

Optruma film coated tablets 60 mg

Iceland

18.9.2003

EU/1/98/074/001-004/NO

Optruma

Norway

1.8.2003

EU/1/98/075/001-002

Fortovase

Liechtenstein

30.9.2003

EU/1/98/075/001-002/IS

Fortovase soft capsule 200 mg

Iceland

19.11.2003

EU/1/98/075/001-002/NO

Fortovase

Norway

8.10.2003

EU/1/98/076/001-002, 004-007/IS

NovoNorm 0.5 mg tablets

Iceland

25.9.2003

EU/1/98/076/001-002, 004-009

NovoNorm

Liechtenstein

30.9.2003

EU/1/98/076/008-009, 011-014/IS

NovoNorm 1 mg tablets

Iceland

25.9.2003

EU/1/98/076/011-016, 018-021

NovoNorm

Liechtenstein

30.9.2003

EU/1/98/076/015-016, 018-021/IS

NovoNorm 2 mg tablets

Iceland

25.9.2003

EU/1/98/077/001-012

Viagra

Liechtenstein

30.11.2003

EU/1/98/077/001-012/NO

Viagra

Norway

11.12.2003

EU/1/98/080/001

Aldara

Liechtenstein

30.11.2003

EU/1/98/080/001/IS

Aldara cream 5%

Iceland

3.12.2003

EU/1/98/080/001/NO

Aldara

Norway

14.11.2003

EU/1/98/081/001-004

Comtan

Liechtenstein

30.11.2003

EU/1/98/081/001-004/IS

Comtan filmcoated tablets

Iceland

16.12.2003

EU/1/98/081/001-004/NO

Comtan

Norway

3.11.2003

EU/1/98/082/001-004

Comtess

Liechtenstein

30.11.2003

EU/1/98/082/001-004/IS

Comtess filmcoated tablets

Iceland

27.11.2003

EU/1/98/082/001-004/NO

Comtess

Norway

14.11.2003

EU/1/98/084/001-002

Simulect

Liechtenstein

30.11.2003

EU/1/98/084/001-002/NO

Simulect

Norway

18.11.2003

EU/1/98/085/001/NO-010/NO

Karvezide

Norway

18.12.2003

EU/1/98/086/001/NO-010/NO

CoAprovel

Norway

19.12.2003

EU/1/98/092/001-003/IS

Prometax capsules hard 1.5 mg

Iceland

29.8.2003

EU/1/98/092/001-013

Prometax

Liechtenstein

31.7.2003

EU/1/98/092/001-013/NO

Prometax

Norway

15.7.2003

EU/1/98/092/004-006/IS

Prometax capsules hard, 3 mg

Iceland

29.8.2003

EU/1/98/092/007-009/IS

Prometax capsules hard, 4.5 mg

Iceland

29.8.2003

EU/1/98/092/010-012/IS

Prometax capsules hard, 6 mg

Iceland

29.8.2003

EU/1/98/092/013/IS

Prometax oral solution 2mg/ml

Iceland

29.8.2003

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

Fevaxyn Pentofelsol. for inject.

Iceland

15.10.2003

EU/2/97/003/001-003/IS

Dicural 100 mg/ml oral solution

Iceland

12.10.2003

EU/2/97/003/001-018/NO

Dicural

Norway

21.8.2003

EU/2/97/003/004-015/IS

Dicural 15 mg, 50 mg, 100 mg, 150 mg film coated tablets

Iceland

12.10.2003

EU/2/97/003/016-018/IS

Dicural 50 mg/ml solution for inject.

Iceland

12.10.2003

EU/2/97/004/001/IS

Metacam 5 mg/ml solution for injection for cattle

Iceland

8.7.2003

EU/2/97/004/003-005/IS

Metacam 1.5 mg/ml oral suspension for dogs

Iceland

8.7.2003

EU/2/97/004/006/IS

Metacam 5 mg/ml solution for injection for dogs and cats

Iceland

8.7.2003

EU/2/97/004/007-008/IS

Metacam 20 mg/ml solution for injection for cattle

Iceland

8.7.2003

EU/2/97/005/001, 005/IS

Quadrisol oral gel for horses 100 mg/ml

Iceland

27.10.2003

EU/2/97/005/002-003, 006-007/IS

Quadrisol oral gel for dogs 5 mg/ml

Iceland

27.10.2003

EU/2/97/005/004/IS

Quadrisol sol. for injection

Iceland

27.10.2003

EU/2/97/005/008-009/IS

Quadrisol oral gel for dogs 1 mg/ml

Iceland

27.10.2003

EU/2/98/006/001-010

Nobilis IB 4-91

Liechtenstein

30.9.2003

EU/2/98/006/001-010/IS

Nobilis IB 4-91 sol. for injection

Iceland

21.10.2003

EU/2/98/006/001-010/NO

Nobilis IB 4-91

Norway

8.8.2003

EU/2/98/007/00/NO-003/NO

Clomicalm

Norway

1.9.2003

EU/2/98/007/001-003/IS

Clomicalm tablets 5 mg, 20 mg, 80 mg

Iceland

27.10.2003

EU/2/98/008/001-004/IS

Neocolipor suspension for injection

Iceland

22.10.2003


ANNEX III

3.   Extended Marketing Authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July31 December 2003:

EU-Number

Product

Country

Date of extention

EU/1/00/146/027/IS

Keppra oral solution

Iceland

19.8.2003

EU/1/00/150/011/NO-015/NO

Actos

Norway

25.9.2003

EU/1/00/150/011-015/IS

Actos tablets 45 mg

Iceland

27.11.2003

EU/1/00/165/007/IS

Ovitrelle, sol. for inj. 250 microg/0.5 ml

Iceland

16.12.2003

EU/1/00/165/007/NO

Ovitrelle

Norway

7.11.2003

EU/1/02/206/005/NO-008/NO

Arixtra

Norway

21.11.2003

EU/1/02/206/005-008/IS

Arixtra solution for injection, 1.5 mg/0.3 ml.

Iceland

4.12.2003

EU/1/02/207/00/NO-008/NO

Quixidar

Norway

21.11.2003

EU/1/02/207/005-009/IS

Quixidar solution for injection, 1.5 mg/0.3 ml

Iceland

4.12.2003

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

Zerit caps. prolonged release

Iceland

9.10.2003

EU/1/96/012/009/NO-013/NO

Bondronat

Norway

5.11.2003

EU/1/96/015/003/NO,

EU/1/96/015/004/NO-005/NO

Epivir

Norway

29.7.2003

EU/1/97/033/003/IS

Avonex sol. for injection 30 microg/0.5 ml

Iceland

7.11.2003

EU/1/97/033/003/NO

Avonex

Norway

4.7.2003

EU/2/97/004/009/IS

Metacam oral suspention for horses

Iceland

29.10.2003

EU/2/97/004/009/NO

Metacam

Norway

24.10.2003


ANNEX IV

4.   Withdrawn Marketing Authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July31 December 2003:

EU-Number

Product

Country

Date of withdrawal

EU/1/96/021/001-010/IS

Olansek

Iceland

1.7.2003