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Document E2006X1130(01)

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

    JO 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    List of withdrawn marketing authorisations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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