Produkty lecznicze - Wykaz pozwoleń na dopuszczenie do obrotu udzielonych w drugim półroczu 2009 r. przez państwa EFTA należące do EOG.
Dz.U.UE.C.2010.237.2
Akt nienormatywny(2010/C 237/02)
(Dz.U.UE C z dnia 2 września 2010 r.)
Podkomitet I ds. swobodnego przepływu towarów
Do wiadomości Wspólnego Komitetu EOG
W nawiązaniu do decyzji Wspólnego Komitetu EOG nr 74/1999 z dnia 28 maja 1999 r. Wspólnemu Komitetowi EOG przekazuje się celem przyjęcia do wiadomości na posiedzeniu w dniu 30 kwietnia 2010 r. następujące wykazy dotyczące pozwoleń na dopuszczenie do obrotu produktów leczniczych za okres od dnia 1 lipca do dnia 31 grudnia 2009 r.:
ZAŁĄCZNIKI
ZAŁĄCZNIK I
Wykaz nowych pozwoleń na dopuszczenie do obrotu
Wykaz nowych pozwoleń na dopuszczenie do obrotu
Numer UE | Produkt | Państwo | Data wydania pozwolenia |
EU/1/06/361/001/NO-002/NO | Luminity | Norwegia | 20.8.2009 |
EU/1/07/436/001-002 | Isentress | Liechtenstein | 31.8.2009 |
EU/1/09//575/001-060 | Copalia HCT | Liechtenstein | 31.12.2009 |
EU/1/09/511/001-004 | Conbriza | Liechtenstein | 31.10.2009 |
EU/1/09/515/001-004/IS | Controloc Control | Islandia | 7.9.2009 |
EU/1/09/516/001/NO | Somac | Norwegia | 13.7.2009 |
EU/1/09/516/001-004/IS | Somac Control | Islandia | 7.9.2009 |
EU/1/09/516/002/NO | Pantoloc | Norwegia | 13.7.2009 |
EU/1/09/516/003/NO | Pantecta | Norwegia | 13.7.2009 |
EU/1/09/516/004/NO | Controloc | Norwegia | 13.7.2009 |
EU/1/09/517/001/NO-002/NO | Pantozol | Norwegia | 9.7.2009 |
EU/1/09/517/001-004/IS | Pantozol Control | Islandia | 7.9.2009 |
EU/1/09/518/001-004/IS | Pantecta Control | Islandia | 7.9.2009 |
EU/1/09/519/001-004/IS | Pantoloc Control | Islandia | 7.9.2009 |
EU/1/09/521/001/NO-007/NO | Renvela | Norwegia | 7.10.2009 |
EU/1/09/521/001-007/IS | Renvela | Islandia | 4.9.2009 |
EU/1/09/523/001/NO-002/NO | Modigraf | Norwegia | 21.10.2009 |
EU/1/09/523/001-002/IS | Modigraf | Islandia | 23.7.2009 |
EU/1/09/524/001/NO-002/NO | Qutenza | Norwegia | 5.8.2009 |
EU/1/09/524/001-002/IS | Qutenza | Islandia | 21.7.2009 |
EU/1/09/525/001/NO-046/NO | Nimvastid | Norwegia | 2.11.2009 |
EU/1/09/526/001/IS | Iressa | Islandia | 11.9.2009 |
EU/1/09/526/001/NO | Iressa | Norwegia | 2.9.2009 |
EU/1/09/527/001/NO-016/NO | Ribaverin Teva Pharma | Norwegia | 12.8.2009 |
EU/1/09/527/001-016 | Ribavirin Teva Pharma BV | Liechtenstein | 31.8.2009 |
EU/1/09/527/001-016/IS | Ribavirin Teva Pharma BV | Islandia | 17.9.2009 |
EU/1/09/528/001 | Nymusa | Liechtenstein | 31.8.2009 |
EU/1/09/528/001/IS | Nymusa | Islandia | 17.9.2009 |
EU/1/09/528/001/NO | Nymusa | Norwegia | 12.8.2009 |
EU/1/09/529/001/NO-005/NO | Victoza | Norwegia | 4.8.2009 |
EU/1/09/529/001-005 | Victoza | Liechtenstein | 31.8.2009 |
EU/1/09/529/001-005/IS | Victoza | Islandia | 15.9.2009 |
EU/1/09/530/001/NO-015/NO | Repaglinide Teva | Norwegia | 12.8.2009 |
EU/1/09/530/001-015 | Repaglinide Teva | Liechtenstein | 31.8.2009 |
EU/1/09/530/001-015/IS | Repaglinide Teva | Islandia | 11.9.2009 |
EU/1/09/531/001/NO-009/NO | Instanyl | Norwegia | 17.8.2009 |
EU/1/09/531/001-009 | Instanyl | Liechtenstein | 31.8.2009 |
EU/1/09/531/001-009/IS | Instanyl | Islandia | 24.9.2009 |
EU/1/09/532/001/NO-007/NO | Clopidogrel Acino | Norwegia | 25.8.2009 |
EU/1/09/532/001-007 | Clopidogrel Acino | Liechtenstein | 31.8.2009 |
EU/1/09/532/001-007/IS | Clopidogrel Acino | Islandia | 24.9.2009 |
EU/1/09/533/001/NO-003/NO | Vedrop | Norwegia | 20.8.2009 |
EU/1/09/533/001-003 | Vedrop | Liechtenstein | 31.8.2009 |
EU/1/09/533/001-003/IS | Vedrop | Islandia | 5.11.2009 |
EU/1/09/534/001/NO-007/NO | Clopidogrel Hexal | Norwegia | 25.8.2009 |
EU/1/09/534/001-007 | Clopidogrel Hexal | Liechtenstein | 31.8.2009 |
EU/1/09/534/001-007/IS | Clopidogrel Hexal | Islandia | 28.9.2009 |
EU/1/09/535/001/NO-014/NO | Grepid | Norwegia | 20.8.2009 |
EU/1/09/535/001-014 | Grepid | Liechtenstein | 31.8.2009 |
EU/1/09/535/001-014/IS | Grepid | Islandia | 9.9.2009 |
EU/1/09/536/001/NO-002/NO | Topotecan Actavis | Norwegia | 26.8.2009 |
EU/1/09/536/001-002 | Topotecan Actavis | Liechtenstein | 31.8.2009 |
EU/1/09/536/001-002/IS | Topotecan Actavis | Islandia | 29.9.2009 |
EU/1/09/537/001 | Mozobil | Liechtenstein | 31.8.2009 |
EU/1/09/537/001/IS | Mozobil | Islandia | 14.10.2009 |
EU/1/09/537/001/NO | Mozobil | Norwegia | 10.8.2009 |
EU/1/09/538/001/NO-006/NO | Afinitor | Norwegia | 10.8.2009 |
EU/1/09/538/001-006 | Afinitor | Liechtenstein | 31.8.2009 |
EU/1/09/538/001-006/IS | Afinitor | Islandia | 15.10.2009 |
EU/1/09/539/001/NO-004/NO | Samsca | Norwegia | 21.9.2009 |
EU/1/09/539/001-004 | Samsca | Liechtenstein | 31.8.2009 |
EU/1/09/539/001-004/IS | Samsca | Islandia | 22.9.2009 |
EU/1/09/540/001/NO-009/NO | Clopidogrel Teva | Norwegia | 20.8.2009 |
EU/1/09/540/001-009 | Clopidogrel Teva | Liechtenstein | 31.8.2009 |
EU/1/09/540/001-009/IS | Clopidogrel Teva | Islandia | 29.9.2009 |
EU/1/09/541/001/NO-007/NO | Clopifogrel ratiopharm GmbH | Norwegia | 20.8.2009 |
EU/1/09/541/001-007 | Clopidogrel ratiopharm GmbH | Liechtenstein | 31.8.2009 |
EU/1/09/541/001-007/IS | Clopidogrel ratiopharm GmbH | Islandia | 24.9.2009 |
EU/1/09/542/001/NO-007/NO | Clopidogrel 1A Pharma | Norwegia | 20.8.2009 |
EU/1/09/542/001-007 | Clopidogrel 1A Pharma | Liechtenstein | 31.8.2009 |
EU/1/09/542/001-007/IS | Clopidogrel 1A Pharma | Islandia | 28.9.2009 |
EU/1/09/543/001 | Cayston | Liechtenstein | 31.10.2009 |
EU/1/09/543/001/IS | Cayston | Islandia | 9.11.2009 |
EU/1/09/543/001/NO | Cayston | Norwegia | 30.9.2009 |
EU/1/09/544/001/NO-002/NO | Cimzia | Norwegia | 21.10.2009 |
EU/1/09/544/001-002 | Cimzia | Liechtenstein | 31.10.2009 |
EU/1/09/544/001-002/IS | Cimzia | Islandia | 24.11.2009 |
EU/1/09/545/001/NO-010/NO | Onglyza | Norwegia | 8.10.2009 |
EU/1/09/545/001-010 | Onglyza | Liechtenstein | 31.10.2009 |
EU/1/09/545/001-010/IS | Onglyza | Islandia | 12.11.2009 |
EU/1/09/546/001/NO-004/NO | Simponi | Norwegia | 16.10.2009 |
EU/1/09/546/001-004 | Simponi | Liechtenstein | 31.10.2009 |
EU/1/09/546/001-004/IS | Simponi | Islandia | 2.11.2009 |
EU/1/09/547/001/NO-007/NO | Clopidogrel Sandoz | Norwegia | 15.10.2009 |
EU/1/09/547/001-007 | Clopidogrel Sandoz | Liechtenstein | 31.10.2009 |
EU/1/09/547/001-007/IS | Clopidogrel Sandoz | Islandia | 25.9.2009 |
EU/1/09/548/001/NO-007/NO | Clopidogrel Acino Pharma GmbH | Norwegia | 16.11.2009 |
EU/1/09/548/001-007 | Clopidogrel Acino Pharma GmbH | Liechtenstein | 31.10.2009 |
EU/1/09/548/001-007/IS | Clopidogrel Acino Pharma GmbH | Islandia | 24.9.2009 |
EU/1/09/549/001/NO-007/NO | Clopidogrel Acino Pharma | Norwegia | 16.11.2009 |
EU/1/09/549/001-007 | Clopidogrel Acino Pharma | Liechtenstein | 31.10.2009 |
EU/1/09/549/001-007/IS | Clopidogrel Acino Pharma | Islandia | 30.11.2009 |
EU/1/09/550/001/NO-012/NO | Javlor | Norwegia | 21.10.2009 |
EU/1/09/550/001-012 | Javlor | Liechtenstein | 31.10.2009 |
EU/1/09/550/001-012/IS | Javlor | Islandia | 10.11.2009 |
EU/1/09/551/001/NO-012/NO | Vizarsin | Norwegia | 30.9.2009 |
EU/1/09/551/001-012 | Vizarsin | Liechtenstein | 31.10.2009 |
EU/1/09/551/001-012/IS | Vizarsin | Islandia | 6.11.2009 |
EU/1/09/552/001/NO-004/NO | Topotecan Teva | Norwegia | 21.10.2009 |
EU/1/09/552/001-004 | Topotecan Teva | Liechtenstein | 31.10.2009 |
EU/1/09/552/001-004/IS | Topotecan Teva | Islandia | 10.11.2009 |
EU/1/09/553/001/NO-010/NO | Zyllt | Norwegia | 15.10.2009 |
EU/1/09/553/001-010 | Zyllit | Liechtenstein | 31.10.2009 |
EU/1/09/553/001-010/IS | Zyllt | Islandia | 5.11.2009 |
EU/1/09/554/001/NO-007/NO | Clopidogrel ratiopharm | Norwegia | 28.10.2009 |
EU/1/09/554/001-007 | Clopidogrel ratiopharm | Liechtenstein | 31.10.2009 |
EU/1/09/554/001-007/IS | Clopidogrel ratiopharm | Islandia | 27.11.2009 |
EU/1/09/555/001/NO-009/NO | Clopidogrel TAD | Norwegia | 15.10.2009 |
EU/1/09/555/001-009 | Clopidogrel TAD | Liechtenstein | 31.10.2009 |
EU/1/09/555/001-009/IS | Clopidogrel TAD | Islandia | 2.12.2009 |
EU/1/09/556/001/NO-009/NO | Clopidogrel Krka | Norwegia | 15.10.2009 |
EU/1/09/556/001-009 | Clopidogrel Krka | Liechtenstein | 31.10.2009 |
EU/1/09/556/001-009/IS | Clopidogrel Krka | Islandia | 17.11.2009 |
EU/1/09/557/001/NO-009/NO | Clopidogrel Qualimed | Norwegia | 15.10.2009 |
EU/1/09/557/001-009 | Clopidogrel Qualimed | Liechtenstein | 31.10.2009 |
EU/1/09/557/001-009/IS | Clopidogrel Qualimed | Islandia | 3.11.2009 |
EU/1/09/558/001/NO-010/NO | Zylagren | Norwegia | 30.9.2009 |
EU/1/09/558/001-010 | Zylagren | Liechtenstein | 31.10.2009 |
EU/1/09/558/001-010/IS | Zylagren | Islandia | 5.11.2009 |
EU/1/09/559/001/NO-009/NO | Clopidogrel Mylan | Norwegia | 15.10.2009 |
EU/1/09/559/001-009 | Clopidogrel Mylan | Liechtenstein | 31.10.2009 |
EU/1/09/559/001-009/IS | Clopidogrel Mylan | Islandia | 29.9.2009 |
EU/1/09/560/001/NO-009/NO | Clopidogrel Dura | Norwegia | 15.10.2009 |
EU/1/09/560/001-009 | Clopidogrel Dura | Liechtenstein | 31.10.2009 |
EU/1/09/560/001-009/IS | Clopidogrel Dura | Islandia | 2.11.2009 |
EU/1/09/561/001/NO-009/NO | Clopidogrel HCS | Norwegia | 15.10.2009 |
EU/1/09/561/001-009 | Clopidogrel HCS | Liechtenstein | 31.10.2009 |
EU/1/09/561/001-009/IS | Clopidogrel HCS | Islandia | 3.11.2009 |
EU/1/09/562/001/NO-009/NO | Zopya | Norwegia | 30.9.2009 |
EU/1/09/562/001-009 | Zopya | Liechtenstein | 31.10.2009 |
EU/1/09/562/001-009/IS | Zopya | Islandia | 3.11.2009 |
EU/1/09/563/001 | ChondroCelect | Liechtenstein | 31.10.2009 |
EU/1/09/563/001/IS | ChondroCelect | Islandia | 30.11.2009 |
EU/1/09/563/001/NO | ChondroCelect | Norwegia | 22.10.2009 |
EU/1/09/564/001/NO-002/NO | Ilaris | Norwegia | 10.11.2009 |
EU/1/09/564/001-002 | Ilaris | Liechtenstein | 31.10.2009 |
EU/1/09/564/001-002/IS | Ilaris | Islandia | 20.11.2009 |
EU/1/09/565/001/NO-028/NO | Biopoin | Norwegia | 11.11.2009 |
EU/1/09/565/001-028 | Biopoin | Liechtenstein | 31.10.2009 |
EU/1/09/565/001-028/IS | Biopoin | Islandia | 20.11.2009 |
EU/1/09/566/001/NO-005/NO | Lamivudine Teva | Norwegia | 16.11.2009 |
EU/1/09/566/001-005 | Lamivudine Teva | Liechtenstein | 31.10.2009 |
EU/1/09/566/001-005/IS | Lamivudine Teva | Islandia | 20.11.2009 |
EU/1/09/568/001/NO-018/NO | Klopidogrel Mylan Pharma | Norwegia | 16.11.2009 |
EU/1/09/568/001-018 | Clopidogrel Mylan Pharma | Liechtenstein | 31.10.2009 |
EU/1/09/568/001-018/IS | Clopidogrel Mylan Pharma | Islandia | 27.11.2009 |
EU/1/09/569/001/NO-060/NO | Exforge HCT | Norwegia | 2.11.2009 |
EU/1/09/569/001-060 | Exforge HCT | Liechtenstein | 31.10.2009 |
EU/1/09/569/001-060/IS | Exforge HCT | Islandia | 18.11.2009 |
EU/1/09/570/001/NO-060/NO | Imprida HCT | Norwegia | 24.11.2009 |
EU/1/09/570/001-060 | Imprida HCT | Liechtenstein | 31.10.2009 |
EU/1/09/570/001-060/IS | Imprida HCT | Islandia | 18.11.2009 |
EU/1/09/571/001 | Prepandemiczna szczepionka przeciw grypie H5N1 Baxter | Liechtenstein | 31.12.2009 |
EU/1/09/571/001/NO | Prepandemiczna szczepionka przeciw grypie H5N1 Baxter | Norwegia | 2.12.2009 |
EU/1/09/572/001/NO-009/NO | Alendronian sodu i kolekalcyferol MSD | Norwegia | 14.12.2009 |
EU/1/09/572/001-009 | Alendronian sodu i kolekalcyferol MSD | Liechtenstein | 31.10.2009 |
EU/1/09/572/001-009/IS | Alendronian sodu i kolekalcyferol MSD | Islandia | 26.11.2009 |
EU/1/09/573/001/NO-028/NO | Eporatio | Norwegia | 11.11.2009 |
EU/1/09/573/001-028 | Eporatio | Liechtenstein | 31.12.2009 |
EU/1/09/573/001-028/IS | Eporatio | Islandia | 20.11.2009 |
EU/1/09/574/001/NO-060/NO | Dafiro HCT | Norwegia | 25.11.2009 |
EU/1/09/574/001-060 | Dafiro HCT | Liechtenstein | 31.12.2009 |
EU/1/09/574/001-060/IS | Dafiro HCT | Islandia | 25.11.2009 |
EU/1/09/575/001/NO-060/NO | Copalia | Norwegia | 25.11.2009 |
EU/1/09/575/001-060/IS | Copalia HCT | Islandia | 26.11.2009 |
EU/1/09/576/001/NO-039/NO | Irbesartan Teva | Norwegia | 11.11.2009 |
EU/1/09/576/001-039 | Irbesartan Teva | Liechtenstein | 31.12.2009 |
EU/1/09/576/001-039/IS | Irbesartan Teva | Islandia | 25.11.2009 |
EU/1/09/577/001-004 | Foclivia | Liechtenstein | 31.12.2009 |
EU/1/09/578/001 | Prepandemiczna szczepionka przeciw grypie (H5N1) GlaxoSmith-Kline Biologicals | Liechtenstein | 31.12.2009 |
EU/1/09/578/001/NO | Pandemivaksine mot influensa | Norwegia | 1.12.2009 |
EU/1/09/579/001/NO-018/NO | Repaglinide Krka | Norwegia | 10.12.2009 |
EU/1/09/579/001-018 | Repaglinide Krka | Liechtenstein | 31.12.2009 |
EU/1/09/579/001-018/IS | Repaglinide Krka | Islandia | 17.11.2009 |
EU/1/09/580/001/NO-018/NO | Enyglid | Norwegia | 13.11.2009 |
EU/1/09/580/001-018 | Enyglid | Liechtenstein | 31.10.2009 |
EU/1/09/580/001-018/IS | Enyglid | Islandia | 17.11.2009 |
EU/1/09/581/001/NO-002/NO | Resolor | Norwegia | 14.12.2009 |
EU/1/09/581/001-002 | Resolor | Liechtenstein | 31.10.2009 |
EU/1/09/581/001-002/IS | Resolor | Islandia | 18.11.2009 |
EU/1/09/582/001 | Arcalyst | Liechtenstein | 31.10.2009 |
EU/1/09/582/001/IS | Arcalyst | Islandia | 20.11.2009 |
EU/1/09/582/001/NO | Arcalyst | Norwegia | 11.11.2009 |
EU/1/09/583/001-072/IS | Irbesartan hydrochlorotiazyd Teva | Islandia | 17.12.2009 |
EU/1/09/584/001/NO-018/NO | Sildenafil Teva | Norwegia | 15.12.2009 |
EU/1/09/584/001-018/IS | Sildenafil Teva | Islandia | 23.12.2009 |
EU/1/09/586/001-010/IS | Oslif Breezhaler | Islandia | 22.12.2009 |
EU/1/09/590/001-006/IS | Prevenar 13 | Islandia | 16.12.2009 |
EU/1/09/591/001/NO-004/NO | Multaq | Norwegia | 15.12.2009 |
EU/1/09/591/001-004/IS | Multaq | Islandia | 21.12.2009 |
EU/1/09/593/001-010/IS | Onbrez Breezhaler | Islandia | 22.12.2009 |
EU/1/09/594/001-010/IS | Hirobriz Breezhaler | Islandia | 22.12.2009 |
EU/1/97/045/001/NO-004/NO | Helicobacter Test INFAI | Norwegia | 21.9.2009 |
EU/2/07/076/001-004/IS | Nobilis Influenza H5N6 | Islandia | 7.9.2009 |
EU/2/08/083/001/IS | Equioxx | Islandia | 21.7.2009 |
EU/2/08/086/001-003/IS | Duvaxyn WNV | Islandia | 4.11.2009 |
EU/2/09/095/001-003/IS | Improvac | Islandia | 3.11.2009 |
EU/2/09/096/001-002/IS | Leucogen | Islandia | 11.9.2009 |
EU/2/09/097/001/NO-002/NO | Leucofeligen FeLV/RCP | Norwegia | 13.7.2009 |
EU/2/09/097/001-002 | Leucofeligen FeLV/RCP | Liechtenstein | 31.8.2009 |
EU/2/09/097/001-002/IS | Leucofeligen FeLV/RCP | Islandia | 11.9.2009 |
EU/2/09/098/001 | Melovem | Liechtenstein | 31.8.2009 |
EU/2/09/098/001/IS | Melovem | Islandia | 22.9.2009 |
EU/2/09/098/001/NO | Melovem | Norwegia | 4.9.2009 |
EU/2/09/099/001/NO-006/NO | Suvaxyn PCV vet | Norwegia | 18.8.2009 |
EU/2/09/099/001-006 | Suvaxyn PCV | Liechtenstein | 31.8.2009 |
EU/2/09/099/001-006/IS | Suvaxyn PCV | Islandia | 28.9.2009 |
EU/2/09/100/001/NO-003/NO | Palladia | Norwegia | 29.10.2009 |
EU/2/09/100/001-003 | Palladia | Liechtenstein | 31.10.2009 |
EU/2/09/100/001-003/IS | Palladia | Islandia | 11.11.2009 |
ZAŁĄCZNIK II
Wykaz odnowionych pozwoleń na dopuszczenie do obrotu
Wykaz odnowionych pozwoleń na dopuszczenie do obrotu
Numer UE | Produkt | Państwo | Data wydania pozwolenia |
EU/1/03/264/001/NO | Zevalin | Norwegia | 21.8.2009 |
EU/1/03/270/001/NO-003/NO | Kentera | Norwegia | 9.7.2009 |
EU/1/04/275/001/NO-002/NO | Litak | Norwegia | 1.7.2009 |
EU/1/04/276/001/NO-036/NO | Abilify | Norwegia | 13.7.2009 |
EU/1/04/276/001-020,024-036/IS | Abilify | Islandia | 20.7.2009 |
EU/1/04/277/001/NO-004/NO | Tachosil | Norwegia | 24.9.2009 |
EU/1/04/277/001-004/IS | Tachosil | Islandia | 2.9.2009 |
EU/1/04/279/001/NO-036/NO | Lyrica | Norwegia | 29.7.2009 |
EU/1/04/279/001-025,030-043/IS | Lyrica | Islandia | 21.9.2009 |
EU/1/04/280/001/NO-008/NO | Yentreve | Norwegia | 18.8.2009 |
EU/1/04/280/001-008/IS | Yentreve | Islandia | 14.9.2009 |
EU/1/04/280/001-008 | Yentreve | Liechtenstein | 31.8.2009 |
EU/1/04/281/001-005/IS | Erbitux | Islandia | 9.9.2009 |
EU/1/04/282/001/NO-002/NO | Telzir | Norwegia | 10.8.2009 |
EU/1/04/282/001-002/IS | Telzir | Islandia | 21.7.2009 |
EU/1/04/283/008/NO-012/NO | Ariclaim | Norwegia | 24.8.2009 |
EU/1/04/283/008-012/IS | Ariclaim | Islandia | 14.9.2009 |
EU/1/04/284/001 | Pedea | Liechtenstein | 31.8.2009 |
EU/1/04/284/001/IS | Pedea | Islandia | 28.9.2009 |
EU/1/04/284/001/NO | Pedea | Norwegia | 20.10.2009 |
EU/1/04/285/001/NO-036/NO | Apidra | Norwegia | 9.9.2009 |
EU/1/04/285/001-036 | Apidra | Liechtenstein | 31.8.2009 |
EU/1/04/285/001-036/IS | Apidra | Islandia | 2.10.2009 |
EU/1/04/286/001/NO-002/NO | Wilzin | Norwegia | 26.10.2009 |
EU/1/04/286/001-002 | Wilzin | Liechtenstein | 31.10.2009 |
EU/1/04/286/001-002/IS | Wilzin | Islandia | 18.11.2009 |
EU/1/04/287/001/NO-006/NO | Osseor | Norwegia | 18.12.2009 |
EU/1/04/287/001-006 | Osseor | Liechtenstein | 31.12.2009 |
EU/1/04/287/001-006/IS | Osseor | Islandia | 29.11.2009 |
EU/1/04/288/001/NO-006/NO | Protelos | Norwegia | 28.12.2009 |
EU/1/04/288/001-006/IS | Protelos | Islandia | 29.11.2009 |
EU/1/04/289/001/NO-002/NO | Angiox | Norwegia | 9.7.2009 |
EU/1/04/289/001-002 | Angiox | Liechtenstein | 31.8.2009 |
EU/1/04/289/001-002/IS | Angiox | Islandia | 9.12.2009 |
EU/1/04/290/001-002 | Alimta | Liechtenstein | 31.10.2009 |
EU/1/04/290/001-002/IS | Alimta | Islandia | 24.9.2009 |
EU/1/04/292/001/NO-012/NO | Mimpara | Norwegia | 6.10.2009 |
EU/1/04/292/001-012 | Mimpara | Liechtenstein | 31.10.2009 |
EU/1/04/292/001-012/IS | Mimpara | Islandia | 12.11.2009 |
EU/1/04/294/001/NO-028/NO | Emselex | Norwegia | 21.10.2009 |
EU/1/04/294/001-028/IS | Emselex | Islandia | 5.11.2009 |
EU/1/04/295/001 | Xagrid | Liechtenstein | 31.12.2009 |
EU/1/04/295/001/NO | Xagrid | Norwegia | 16.12.2009 |
EU/1/04/295/001/IS | Xagrid | Islandia | 10.12.2009 |
EU/1/04/296/001/NO-009/NO | Cymbalta | Norwegia | 24.8.2009 |
EU/1/04/296/001-009/IS | Cymbalta | Islandia | 14.9.2009 |
EU/1/04/297/001/NO-006/NO | Xeristar | Norwegia | 27.10.2009 |
EU/1/04/297/001-008/IS | Xeristar | Islandia | 14.9.2009 |
EU/1/04/298/001-003/IS | Kivexa | Islandia | 17.12.2009 |
EU/1/04/304/001-007 | Azilect | Liechtenstein | 31.10.2009 |
EU/1/04/304/001-007/IS | Azilect | Islandia | 11.11.2009 |
EU/1/06/367/001-012/IS | Diacomit | Islandia | 21.12.2009 |
EU/1/07/423/001/NO-003/NO | Vectibix | Norwegia | 16.7.2009 |
EU/1/07/436/001-002/IS | Isentress | Islandia | 27.8.2009 |
EU/1/08/468/001 | Intelence | Liechtenstein | 31.8.2009 |
EU/1/08/468/001/IS | Intelence | Islandia | 22.10.2009 |
EU/1/08/468/001/NO | Intelence | Norwegia | 20.8.2009 |
EU/1/09/288/001-006 | Protelos | Liechtenstein | 31.12.2009 |
EU/1/09/555/002/NO | Alimta | Norwegia | 23.9.2009 |
EU/1/97/044/001/NO-008/NO | Simponi | Norwegia | 20.10.2009 |
EU/1/97/044/001/NO-008/NO | Tasmar | Norwegia | 20.10.2009 |
EU/1/97/044/001-008 | Tasmar | Liechtenstein | 31.10.2009 |
EU/1/97/044/001-008/IS | Tasmar | Islandia | 15.10.2009 |
EU/1/99/100/001-003/IS | Cetrotide | Islandia | 30.11.2009 |
EU/1/99/103/001/NO-004/NO | Refacto AF | Norwegia | 2.7.2009 |
EU/1/99/107/001/NO-004/NO | Rebetol | Norwegia | 30.7.2009 |
EU/1/99/108/001/NO-003/NO | Ferriprox | Norwegia | 6.10.2009 |
EU/1/99/108/001-003 | Ferriprox | Liechtenstein | 31.10.2009 |
EU/1/99/108/001-003/IS | Ferriprox | Islandia | 11.11.2009 |
EU/1/99/109/001/NO-002/NO | Integrilin | Norwegia | 10.8.2009 |
EU/1/99/109/001-002 | Integrilin | Liechtenstein | 31.8.2009 |
EU/1/99/109/001-002/IS | Integrilin | Islandia | 30.9.2009 |
EU/1/99/112/001/NO-002/NO | Ziagen | Norwegia | 26.8.2009 |
EU/1/99/112/001-002/IS | Ziagen | Islandia | 12.7.2009 |
EU/1/99/113/001-004 | Paxene | Liechtenstein | 31.8.2009 |
EU/1/99/113/001-004/IS | Paxene | Islandia | 27.11.2009 |
EU/1/99/114/001/NO-003/NO | Zeffix | Norwegia | 16.9.2009 |
EU/1/99/114/001-003 | Zeffix | Liechtenstein | 31.10.2009 |
EU/1/99/114/001-003/IS | Zeffix | Islandia | 15.10.2009 |
EU/1/99/116/001/NO-005/NO | Remicade | Norwegia | 2.10.2009 |
EU/1/99/116/001-005 | Remicade | Liechtenstein | 31.8.2009 |
EU/1/99/116/001-005/IS | Remicade | Islandia | 8.9.2009 |
EU/1/99/117/001/NO-002/NO | Synagis | Norwegia | 28.9.2009 |
EU/1/99/117/001-002 | Synagis | Liechtenstein | 31.8.2009 |
EU/1/99/117/001-002/IS | Synagis | Islandia | 22.10.2009 |
EU/1/99/118/001/NO-009/NO | Arava | Norwegia | 5.10.2009 |
EU/1/99/118/001-010 | Arava | Liechtenstein | 31.8.2009 |
EU/1/99/118/001-010/IS | Arava | Islandia | 15.9.2009 |
EU/1/99/119/001,003,005-015/IS | NovoRapid | Islandia | 26.8.2009 |
EU/1/99/120/001/NO-004/NO | Ammonaps | Norwegia | 22.10.2009 |
EU/1/99/120/001-004 | Ammonaps | Liechtenstein | 31.10.2009 |
EU/1/99/120/001-004/IS | Ammonaps | Islandia | 17.11.2009 |
EU/1/99/126/001-021/IS | Enbrel | Islandia | 21.12.2009 |
EU/2/04/043/001/NO | Equilis StrepE | Norwegia | 30.7.2009 |
EU/2/04/044/001/NO-010/NO | Aivlosin | Norwegia | 18.9.2009 |
EU/2/04/044/001-010 | Aivlosin | Liechtenstein | 31.10.2009 |
EU/2/04/044/001-010/IS | Aivlosin | Islandia | 7.10.2009 |
EU/2/04/045/001-007/IS | Previcox | Islandia | 21.9.2009 |
EU/2/04/046/001-003 | Nobivac Piro | Liechtenstein | 31.8.2009 |
EU/2/04/046/001-003/IS | Nobivac Piro | Islandia | 23.9.2009 |
EU/2/98/009/001-006/IS | Suvaxyn Aujeszky 783+O/W | Islandia | 5.11.2009 |
EU/2/98/010/017-18,21-24/NO | Econor | Norwegia | 24.11.2009 |
EU/2/99/014//001-012 | Stronghold | Liechtenstein | 31.10.2009 |
EU/2/99/014/001-012/IS | Stronghold | Islandia | 16.12.2009 |
EU/2/99/015/001-002 | Oxyglobin | Liechtenstein | 31.10.2009 |
EU/2/99/015/001-002/IS | Oxyglobin | Islandia | 30.11.2009 |
ZAŁĄCZNIK III
Wykaz przedłużonych pozwoleń na dopuszczenie do obrotu
Wykaz przedłużonych pozwoleń na dopuszczenie do obrotu
Numer UE | Produkt | Państwo | Data wydania pozwolenia |
EU/1/00/146/031-032 | Keppra | Liechtenstein | 31.10.2009 |
EU/1/00/155/007/IS | Luveris | Islandia | 22.7.2009 |
EU/1/00/155/007/NO | Luveris | Norwegia | 12.8.2009 |
EU/1/01/185/074-099 | Aranesp | Liechtenstein | 31.12.2009 |
EU/1/01/195/022/NO-025/NO | Liprolog Basal | Norwegia | 13.8.2009 |
EU/1/01/195/026/NO-027/NO | Liprolog Basal Kwik-Pen | Norwegia | 13.8.2009 |
EU/1/02/220/006 | Tracleer | Liechtenstein | 31.8.2009 |
EU/1/02/220/006/IS | Tracleer | Islandia | 16.9.2009 |
EU/1/02/227/004 | Neulasta | Liechtenstein | 31.10.2009 |
EU/1/05/315/002/IS | Aptivus | Islandia | 26.8.2009 |
EU/1/05/315/002/NO | Aptivus | Norwegia | 12.8.2009 |
EU/1/06/347/007/NO-008/NO | Sutent | Norwegia | 7.9.2009 |
EU/1/06/347/007-008/IS | Sutent | Islandia | 9.9.2009 |
EU/1/06/380/004/NO-005/NO | Prezista | Norwegia | 12.8.2009 |
EU/1/06/380/004-005/IS | Prezista | Islandia | 10.9.2009 |
EU/1/07/384/003-004/IS | Docetaxel Winthrop | Islandia | 28.12.2009 |
EU/1/07/410/021/NO-026/NO | Binocrit | Norwegia | 27.10.2009 |
EU/1/07/410/021-026 | Binocrit | Liechtenstein | 31.10.2009 |
EU/1/07/410/021-026/IS | Binocrit | Islandia | 15.10.2009 |
EU/1/07/411/021/NO-026/NO | Epoetin alfa Hexal | Norwegia | 23.10.2009 |
EU/1/07/411/021-026 | Epoetin alfa Hexal | Liechtenstein | 31.10.2009 |
EU/1/07/412/021-026/IS | Abseamed | Islandia | 21.12.2009 |
EU/1/07/416/002 | Ecalta | Liechtenstein | 31.8.2009 |
EU/1/07/416/002/IS | Ecalta | Islandia | 25.9.2009 |
EU/1/07/416/002/NO | Ecalta | Norwegia | 25.8.2009 |
EU/1/08/446/005-006 | Privigen | Liechtenstein | 31.8.2009 |
EU/1/08/453/002 | Prepandrix | Liechtenstein | 31.8.2009 |
EU/1/08/453/002/IS | Prepandrix | Islandia | 9.11.2009 |
EU/1/08/489/002 | Opgenra | Liechtenstein | 31.10.2009 |
EU/1/08/497/003-004 | Nplate | Liechtenstein | 31.10.2009 |
EU/1/95/002/003-004/IS | Taxotere | Islandia | 23.12.2009 |
EU/1/95/003/009-010 | Betaferon | Liechtenstein | 31.10.2009 |
EU/1/97/050/013/NO-027/NO | Sifrol | Norwegia | 20.10.2009 |
EU/1/97/050/013-027 | Sifrol | Liechtenstein | 31.10.2009 |
EU/1/97/050/013-027/IS | Sifrol | Islandia | 12.11.2009 |
EU/1/97/051/013/NO-027/NO | Mirapexin | Norwegia | 22.10.2009 |
EU/1/97/051/013-027 | Mirapexin | Liechtenstein | 31.10.2009 |
EU/1/97/051/013-027/IS | Mirapexin | Islandia | 12.11.2009 |
EU/1/99/126/019-021 | Enbrel | Liechtenstein | 31.8.2009 |
EU/2/04/044/009/NO-010/NO | Aivlosin | Norwegia | 15.7.2009 |
EU/2/04/044/009-010/IS | Aivlosin | Islandia | 2.9.2009 |
EU/2/05/053/003 | Naxcel | Liechtenstein | 31.10.2009 |
EU/2/05/053/003/IS | Naxcel | Islandia | 13.11.2009 |
EU/2/05/053/003/NO | Naxcel | Norwegia | 26.10.2009 |
EU/2/06/070/004 | Meloxidyl | Liechtenstein | 31.10.2009 |
EU/2/06/070/004/NO | Meloxidyl | Norwegia | 20.10.2009 |
EU/2/07/078/004-006 | Zactran | Liechtenstein | 31.8.2009 |
EU/2/07/078/005/NO-008/NO | Rheumocam | Norwegia | 26.10.2009 |
EU/2/07/078/005-008/IS | Rheumocam | Islandia | 13.11.2009 |
EU/2/078/005-008 | Rheumocam | Liechtenstein | 31.10.2009 |
EU/2/98/010/004/NO-006/NO | Econor | Norwegia | 24.11.2009 |
ZAŁĄCZNIK IV
Wykaz wycofanych pozwoleń na dopuszczenie do obrotu
Wykaz wycofanych pozwoleń na dopuszczenie do obrotu
Numer UE | Produkt | Państwo | Data wycofania pozwolenia |
EU/1/01/175/001-021/IS | Trazec | Islandia | 15.12.2009 |
EU/1/05/321/001/IS | Posakonazol SP | Islandia | 15.12.2009 |
EU/1/06/369/001/NO-028/NO | Irbesartan BMS | Norwegia | 1.12.2009 |
EU/1/06/369/001/NO-028/NO | Irbesartan HCT BMS | Norwegia | 1.12.2009 |
EU/1/06/369/001/NO-028/NO | Irbesartan BMS | Norwegia | 1.12.2009 |
EU/1/06/369/001/NO-028/NO | Irbesartan HCT BMS | Norwegia | 1.12.2009 |
EU/1/06/369/001-028 | Irbesartan HCT BMS | Liechtenstein | 31.12.2009 |
EU/1/06/369/001-028/IS | Irbesartan HCT BMS | Islandia | 2.12.2009 |
EU/1/06/375/001-033/IS | Irbesartan BMS | Islandia | 2.12.2009 |
EU/1/07/385/003/NO | Focetria | Norwegia | 19.10.2009 |
EU/1/07/408/001/NO-020/NO | Tekturna | Norwegia | 17.9.2009 |
EU/1/07/408/001-020 | Tekturna | Liechtenstein | 31.10.2009 |
EU/1/07/408/001-020/IS | Tekturna | Islandia | 2.9.2009 |
EU/1/08/464/001/NO-019/NO | Clopidogrel BMS | Norwegia | 22.12.2009 |
EU/1/08/464/001-019/IS | Clopidogrel BMS | Islandia | 2.12.2009 |
EU/1/08/464/001-019 | Clopidogrel BMS | Liechtenstein | 31.12.2009 |
EU/1/96/024/006NO,007/NO,009/NO | Crixivan | Norwegia | 24.9.2009 |
EU/1/96/024/006NO,007/NO,009/NO | Crixivan | Norwegia | 24.9.2009 |
EU/1/99/104/001/IS | Procomvax | Islandia | 15.12.2009 |
EU/1/99/113/001-004/IS | Paxene | Islandia | 2.12.2009 |
ZAŁĄCZNIK V
Wykaz zawieszonych pozwoleń na dopuszczenie do obrotu
Wykaz zawieszonych pozwoleń na dopuszczenie do obrotu
Numer UE | Produkt | Państwo | Data zawieszenia |
Nie dotyczy | Nie dotyczy | - | - |
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