Produkty lecznicze - Wykaz pozwoleń na dopuszczenie do obrotu udzielonych przez państwa EOG-EFTA w drugim półroczu 2023 r.
Produkty lecznicze - Wykaz pozwoleń na dopuszczenie do obrotu udzielonych przez państwa EOG-EFTA w drugim półroczu 2023 r.
(C/2024/4358)
Podkomitet I ds. Swobodnego przepływu towarów (Do wiadomości Wspólnego Komitetu EOG)
(Dz.U.UE C z dnia 4 lipca 2024 r.)
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 15 marca 2024 r. następujące wykazy dotyczące pozwoleń na dopuszczenie do obrotu produktów leczniczych za okres od dnia 1 lipca do dnia 31 grudnia 2023 r.:
Załącznik I Wykaz nowych pozwoleń na dopuszczenie do obrotu
Załącznik II Wykaz odnowionych pozwoleń na dopuszczenie do obrotu
Załącznik III Wykaz przedłużonych pozwoleń na dopuszczenie do obrotu
Załącznik IV Wykaz wycofanych pozwoleń na dopuszczenie do obrotu
Załącznik V Wykaz zawieszonych pozwoleń na dopuszczenie do obrotu
ZAŁĄCZNIK IWykaz nowych pozwoleń na dopuszczenie do obrotu
Wykaz nowych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2023 r. w państwach EOG-EFTA udzielono następujących pozwoleń na dopuszczenie do obrotu:
| Numer EU | Produkt | Państwo | Data udzielenia pozwolenia |
| EU/1/23/1752 | Abrysvo | Islandia | 6.9.2023 |
| EU/1/23/1752 | Abrysvo | Liechtenstein | 31.8.2023 |
| EU/1/23/1752 | Abrysvo | Norwegia | 9.10.2023 |
| EU/1/23/1776 | AGAMREE | Islandia | 28.12.2023 |
| EU/1/23/1776 | AGAMREE | Liechtenstein | 31.12.2023 |
| EU/1/23/1776 | AGAMREE | Norwegia | 19.12.2023 |
| EU/1/23/1722 | AKEEGA | Norwegia | 25.7.2023 |
| EU/1/23/1760 | Apretude | Islandia | 16.10.2023 |
| EU/1/23/1760 | Apretude | Liechtenstein | 30.9.2023 |
| EU/1/23/1760 | Apretude | Norwegia | 9.10.2023 |
| EU/1/23/1750 | AQUIPTA | Islandia | 30.8.2023 |
| EU/1/23/1750 | AQUIPTA | Liechtenstein | 31.8.2023 |
| EU/1/23/1750 | AQUIPTA | Norwegia | 29.8.2023 |
| EU/1/23/1717 | AQUMELDI | Islandia | 4.12.2023 |
| EU/1/23/1717 | AQUMELDI | Liechtenstein | 30.11.2023 |
| EU/1/23/1717 | AQUMELDI | Norwegia | 20.11.2023 |
| EU/2/23/303 | Bovilis Cryptium | Liechtenstein | 30.11.2023 |
| EU/1/23/1716 | Camzyos | Islandia | 9.8.2023 |
| EU/1/23/1716 | Camzyos | Norwegia | 12.7.2023 |
| EU/1/23/1763 | Catiolanze | Islandia | 4.12.2023 |
| EU/1/23/1763 | Catiolanze | Liechtenstein | 30.11.2023 |
| EU/1/23/1763 | Catiolanze | Norwegia | 12.12.2023 |
| EU/1/23/1742 | Columvi | Islandia | 9.8.2023 |
| EU/1/23/1742 | Columvi | Liechtenstein | 31.7.2023 |
| EU/1/23/1742 | Columvi | Norwegia | 13.7.2023 |
| EU/1/23/1753 | Degarelix Accord | Islandia | 23.10.2023 |
| EU/1/23/1753 | Degarelix Accord | Liechtenstein | 30.9.2023 |
| EU/1/23/1753 | Degarelix Accord | Norwegia | 10.10.2023 |
| EU/1/22/1711 | Dimethyl Fumarate Accord | Liechtenstein | 31.12.2023 |
| EU/1/22/1634 | Dimethyl fumarate Mylan | Liechtenstein | 31.12.2023 |
| EU/1/22/1637 | Dimethyl fumarate Neuraxpharm | Liechtenstein | 31.12.2023 |
| EU/1/22/1635 | Dimethyl fumarate Polpharma | Liechtenstein | 31.12.2023 |
| EU/1/22/1702 | Dimethyl Fumarate Teva | Liechtenstein | 31.12.2023 |
| EU/1/23/1765 | Ebglyss | Islandia | 4.12.2023 |
| EU/1/23/1765 | Ebglyss | Liechtenstein | 30.11.2023 |
| EU/1/23/1765 | Ebglyss | Norwegia | 30.11.2023 |
| EU/1/23/1770 | ELREXFIO | Islandia | 18.12.2023 |
| EU/1/23/1770 | ELREXFIO | Liechtenstein | 31.12.2023 |
| EU/1/23/1770 | ELREXFIO | Norwegia | 13.12.2023 |
| EU/1/23/1772 | Elucirem | Islandia | 18.12.2023 |
| EU/1/23/1772 | Elucirem | Liechtenstein | 31.12.2023 |
| EU/1/23/1772 | Elucirem | Norwegia | 18.12.2023 |
| EU/2/23/297 | Eluracat | Islandia | 9.8.2023 |
| EU/2/23/297 | Eluracat | Norwegia | 23.8.2023 |
| EU/1/23/1747 | Enrylaze | Islandia | 19.10.2023 |
| EU/1/23/1747 | Enrylaze | Liechtenstein | 30.9.2023 |
| EU/1/23/1747 | Enrylaze | Norwegia | 10.10.2023 |
| EU/1/23/1767 | Finlee | Islandia | 4.12.2023 |
| EU/1/23/1767 | Finlee | Liechtenstein | 30.11.2023 |
| EU/1/23/1767 | Finlee | Norwegia | 12.12.2023 |
| EU/1/23/1762 | Herwenda | Islandia | 4.12.2023 |
| EU/1/23/1762 | Herwenda | Liechtenstein | 30.11.2023 |
| EU/1/23/1762 | Herwenda | Norwegia | 12.12.2023 |
| EU/1/23/1756 | Inaqovi | Islandia | 13.10.2023 |
| EU/1/23/1756 | Inaqovi | Liechtenstein | 30.9.2023 |
| EU/1/23/1756 | Inaqovi | Norwegia | 28.9.2023 |
| EU/1/23/1738 | Jaypirca | Islandia | 28.11.2023 |
| EU/1/23/1738 | Jaypirca | Liechtenstein | 31.10.2023 |
| EU/1/23/1738 | Jaypirca | Norwegia | 8.11.2023 |
| EU/1/23/1755 | Litfulo | Islandia | 13.10.2023 |
| EU/1/23/1755 | Litfulo | Liechtenstein | 30.9.2023 |
| EU/1/23/1755 | Litfulo | Norwegia | 9.10.2023 |
| EU/1/23/1774 | Loargys | Islandia | 28.12.2023 |
| EU/1/23/1774 | Loargys | Liechtenstein | 31.12.2023 |
| EU/1/23/1774 | Loargys | Norwegia | 19.12.2023 |
| EU/2/23/301 | Loxitab | Islandia | 26.10.2023 |
| EU/2/23/301 | Loxitab | Liechtenstein | 31.10.2023 |
| EU/2/23/301 | Loxitab | Norwegia | 1.11.2023 |
| EU/1/21/1613 | Lyfnua | Islandia | 19.10.2023 |
| EU/1/21/1613 | Lyfnua | Liechtenstein | 30.9.2023 |
| EU/1/21/1613 | Lyfnua | Norwegia | 10.10.2023 |
| EU/1/23/1741 | Lytgobi | Islandia | 9.8.2023 |
| EU/1/23/1741 | Lytgobi | Norwegia | 11.7.2023 |
| EU/1/23/1741 | Lytgobi | Liechtenstein | 31.7.2023 |
| EU/2/23/304 | Nobivac LoVo L4 | Islandia | 11.12.2023 |
| EU/2/23/304 | Nobivac LoVo L4 | Liechtenstein | 30.11.2023 |
| EU/1/23/1737 | Opfolda | Islandia | 9.8.2023 |
| EU/1/23/1737 | Opfolda | Norwegia | 12.7.2023 |
| EU/1/23/1757 | ORSERDU | Islandia | 19.10.2023 |
| EU/1/23/1757 | ORSERDU | Liechtenstein | 30.9.2023 |
| EU/1/23/1757 | ORSERDU | Norwegia | 10.10.2023 |
| EU/2/23/299 | Oxmax | Islandia | 26.10.2023 |
| EU/2/23/299 | Oxmax | Liechtenstein | 31.10.2023 |
| EU/2/23/299 | Oxmax | Norwegia | 26.10.2023 |
| EU/2/23/300 | Poulvac Procerta HVT-IBD | Islandia | 27.11.2023 |
| EU/2/23/300 | Poulvac Procerta HVT-IBD | Liechtenstein | 31.10.2023 |
| EU/2/23/300 | Poulvac Procerta HVT-IBD | Norwegia | 26.10.2023 |
| EU/2/23/302 | Prevexxion RN+HVT | Islandia | 27.11.2023 |
| EU/2/23/302 | Prevexxion RN+HVT | Liechtenstein | 31.10.2023 |
| EU/2/23/302 | Prevexxion RN+HVT | Norwegia | 24.10.2023 |
| EU/1/23/1746 | Pylclari | Islandia | 16.8.2023 |
| EU/1/23/1746 | Pylclari | Liechtenstein | 31.7.2023 |
| EU/1/23/1746 | Pylclari | Norwegia | 15.8.2023 |
| EU/1/23/1775 | Rezzayo | Islandia | 29.12.2023 |
| EU/1/23/1775 | Rezzayo | Liechtenstein | 31.12.2023 |
| EU/1/23/1775 | Rezzayo | Norwegia | 28.12.2023 |
| EU/2/23/305 | Senvelgo | Islandia | 13.12.2023 |
| EU/2/23/305 | Senvelgo | Liechtenstein | 30.11.2023 |
| EU/2/23/305 | Senvelgo | Norwegia | 28.11.2023 |
| EU/1/23/1739 | Sugammadex Piramal | Islandia | 9.8.2023 |
| EU/1/23/1739 | Sugammadex Piramal | Norwegia | 12.7.2023 |
| EU/1/23/1748 | TALVEY | Islandia | 31.8.2023 |
| EU/1/23/1748 | TALVEY | Liechtenstein | 31.8.2023 |
| EU/1/23/1748 | TALVEY | Norwegia | 29.8.2023 |
| EU/1/23/1759 | Tepkinly | Islandia | 20.10.2023 |
| EU/1/23/1759 | Tepkinly | Liechtenstein | 30.9.2023 |
| EU/1/23/1759 | Tepkinly | Norwegia | 10.10.2023 |
| EU/1/23/1758 | Tevimbra | Islandia | 19.10.2023 |
| EU/1/23/1758 | Tevimbra | Liechtenstein | 30.9.2023 |
| EU/1/23/1758 | Tevimbra | Norwegia | 10.10.2023 |
| EU/1/23/1754 | Tyenne | Islandia | 18.10.2023 |
| EU/1/23/1754 | Tyenne | Liechtenstein | 30.9.2023 |
| EU/1/23/1754 | Tyenne | Norwegia | 23.10.2023 |
| EU/1/23/1745 | Tyruko | Islandia | 20.10.2023 |
| EU/1/23/1745 | Tyruko | Liechtenstein | 30.9.2023 |
| EU/1/23/1745 | Tyruko | Norwegia | 5.10.2023 |
| EU/1/23/1768 | VANFLYTA | Islandia | 28.11.2023 |
| EU/1/23/1768 | VANFLYTA | Liechtenstein | 30.11.2023 |
| EU/1/23/1768 | VANFLYTA | Norwegia | 12.12.2023 |
| EU/1/23/1771 | Veoza | Islandia | 18.12.2023 |
| EU/1/23/1771 | Veoza | Liechtenstein | 31.12.2023 |
| EU/1/23/1771 | Veoza | Norwegia | 18.12.2023 |
| EU/1/23/1773 | Vueway | Islandia | 18.12.2023 |
| EU/1/23/1773 | Vueway | Liechtenstein | 31.12.2023 |
| EU/1/23/1773 | Vueway | Norwegia | 15.12.2023 |
| EU/1/23/1751 | Yesafili | Islandia | 19.10.2023 |
| EU/1/23/1751 | Yesafili | Liechtenstein | 30.9.2023 |
| EU/1/23/1751 | Yesafili | Norwegia | 25.10.2023 |
| EU/1/23/1766 | Yorvipath | Islandia | 4.12.2023 |
| EU/1/23/1766 | Yorvipath | Liechtenstein | 30.11.2023 |
| EU/1/23/1766 | Yorvipath | Norwegia | 12.12.2023 |
| EU/2/23/298 | YURVAC RHD | Islandia | 12.10.2023 |
| EU/2/23/298 | YURVAC RHD | Liechtenstein | 30.9.2023 |
| EU/2/23/298 | YURVAC RHD | Norwegia | 11.10.2023 |
| EU/1/23/1764 | Zilbrysq | Islandia | 15.12.2023 |
| EU/1/23/1764 | Zilbrysq | Liechtenstein | 31.12.2023 |
| EU/1/23/1764 | Zilbrysq | Norwegia | 12.12.2023 |
| EU/1/23/1761 | Zoonotic Influenza Vaccine Seqirus | Islandia | 25.10.2023 |
| EU/1/23/1761 | Zoonotic Influenza Vaccine Seqirus | Liechtenstein | 31.10.2023 |
| EU/1/23/1761 | Zoonotic Influenza Vaccine Seqirus | Norwegia | 25.10.2023 |
| EU/1/23/1743 | ZTALMY | Islandia | 16.8.2023 |
| EU/1/23/1743 | ZTALMY | Liechtenstein | 31.7.2023 |
| EU/1/23/1743 | ZTALMY | Norwegia | 15.8.2023 |
ZAŁĄCZNIK IIWykaz odnowionych pozwoleń na dopuszczenie do obrotu
Wykaz odnowionych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2023 r. w państwach EOG-EFTA odnowiono następujące pozwolenia na dopuszczenie do obrotu:
| Numer EU | Produkt | Państwo | Data odnowienia pozwolenia |
| EU/1/21/1539 | Abecma | Norwegia | 15.8.2023 |
| EU/1/19/1358 | AJOVY | Islandia | 28.11.2023 |
| EU/1/19/1358 | AJOVY | Liechtenstein | 30.11.2023 |
| EU/1/19/1358 | AJOVY | Norwegia | 20.11.2023 |
| EU/1/18/1264 | Alunbrig | Islandia | 6.9.2023 |
| EU/1/18/1264 | Alunbrig | Liechtenstein | 31.7.2023 |
| EU/1/18/1292 | Apealea | Islandia | 5.10.2023 |
| EU/1/18/1292 | Apealea | Liechtenstein | 30.9.2023 |
| EU/1/18/1292 | Apealea | Norwegia | 10.10.2023 |
| EU/2/19/249 | Aservo EquiHaler | Norwegia | 22.8.2023 |
| EU/1/19/1353 | Atazanavir Krka | Islandia | 28.12.2023 |
| EU/1/19/1353 | Atazanavir Krka | Liechtenstein | 31.12.2023 |
| EU/1/19/1353 | Atazanavir Krka | Norwegia | 19.12.2023 |
| EU/1/20/1473 | AYVAKYT | Islandia | 14.8.2023 |
| EU/1/20/1473 | AYVAKYT | Liechtenstein | 31.7.2023 |
| EU/1/20/1473 | AYVAKYT | Norwegia | 15.8.2023 |
| EU/1/18/1352 | Besremi | Islandia | 28.12.2023 |
| EU/1/18/1352 | Besremi | Liechtenstein | 31.12.2023 |
| EU/1/18/1352 | Besremi | Norwegia | 19.12.2023 |
| EU/1/18/1339 | Bevespi Aerosphere | Islandia | 20.10.2023 |
| EU/1/18/1339 | Bevespi Aerosphere | Liechtenstein | 30.9.2023 |
| EU/1/18/1339 | Bevespi Aerosphere | Norwegia | 26.10.2023 |
| EU/1/18/1314 | Braftovi | Islandia | 4.7.2023 |
| EU/1/18/1314 | Braftovi | Liechtenstein | 30.6.2023 |
| EU/1/18/1314 | Braftovi | Norwegia | 17.7.2023 |
| EU/1/18/1336 | Buvidal | Islandia | 15.8.2023 |
| EU/1/18/1336 | Buvidal | Liechtenstein | 31.7.2023 |
| EU/1/18/1336 | Buvidal | Norwegia | 15.8.2023 |
| EU/2/15/183 | Canigen L4 | Norwegia | 8.8.2023 |
| EU/2/22/283 | Chanaxin | Norwegia | 22.8.2023 |
| EU/2/17/222 | Clevor | Norwegia | 22.8.2023 |
| EU/2/18/225 | Dany's BienenWohl | Norwegia | 16.8.2023 |
| EU/1/18/1310 | Deferiprone Lipomed | Islandia | 4.7.2023 |
| EU/1/18/1310 | Deferiprone Lipomed | Norwegia | 17.7.2023 |
| EU/1/13/878 | Defitelio | Norwegia | 15.8.2023 |
| EU/1/18/1333 | Delstrigo | Islandia | 10.8.2023 |
| EU/1/18/1333 | Delstrigo | Liechtenstein | 31.7.2023 |
| EU/1/18/1333 | Delstrigo | Norwegia | 17.7.2023 |
| EU/1/18/1338 | Dengvaxia | Islandia | 31.8.2023 |
| EU/1/18/1338 | Dengvaxia | Liechtenstein | 31.8.2023 |
| EU/1/18/1338 | Dengvaxia | Norwegia | 6.9.2023 |
| EU/1/20/1437 | Dovprela | Islandia | 10.8.2023 |
| EU/1/20/1437 | Dovprela | Liechtenstein | 31.7.2023 |
| EU/1/20/1437 | Dovprela | Norwegia | 15.8.2023 |
| EU/1/18/1330 | Emgality | Islandia | 12.9.2023 |
| EU/1/18/1330 | Emgality | Liechtenstein | 30.9.2023 |
| EU/1/18/1330 | Emgality | Norwegia | 6.9.2023 |
| EU/1/20/1508 | Enhertu | Islandia | 2.11.2023 |
| EU/1/20/1508 | Enhertu | Liechtenstein | 31.10.2023 |
| EU/1/20/1508 | Enhertu | Norwegia | 30.10.2023 |
| EU/1/18/1342 | Erleada | Islandia | 20.10.2023 |
| EU/1/18/1342 | Erleada | Liechtenstein | 30.9.2023 |
| EU/1/18/1342 | Erleada | Norwegia | 26.10.2023 |
| EU/2/22/284 | Evanovo | Norwegia | 12.12.2023 |
| EU/1/18/1347 | Febuxostat Krka | Islandia | 28.12.2023 |
| EU/1/18/1347 | Febuxostat Krka | Liechtenstein | 31.12.2023 |
| EU/2/19/238 | Felisecto Plus | Norwegia | 12.12.2023 |
| EU/2/21/277 | Felpreva | Norwegia | 18.9.2023 |
| EU/2/19/235 | Forceris | Liechtenstein | 31.7.2023 |
| EU/1/13/881 | Fortacin | Islandia | 20.10.2023 |
| EU/1/13/881 | Fortacin | Liechtenstein | 30.9.2023 |
| EU/1/13/881 | Fortacin | Norwegia | 25.10.2023 |
| EU/1/18/1329 | Fulphila | Islandia | 18.10.2023 |
| EU/1/18/1329 | Fulphila | Liechtenstein | 30.9.2023 |
| EU/1/18/1329 | Fulphila | Norwegia | 15.9.2023 |
| EU/1/21/1555 | GAVRETO | Islandia | 20.10.2023 |
| EU/1/21/1555 | GAVRETO | Liechtenstein | 30.9.2023 |
| EU/1/21/1555 | GAVRETO | Norwegia | 26.10.2023 |
| EU/1/18/1321 | Gefitinib Mylan | Islandia | 10.8.2023 |
| EU/1/18/1321 | Gefitinib Mylan | Liechtenstein | 30.6.2023 |
| EU/1/18/1321 | Gefitinib Mylan | Norwegia | 17.7.2023 |
| EU/1/22/1715 | Hemgenix | Islandia | 19.12.2023 |
| EU/1/22/1715 | Hemgenix | Liechtenstein | 31.12.2023 |
| EU/1/22/1715 | Hemgenix | Norwegia | 19.12.2023 |
| EU/1/20/1446 | Hepcludex | Islandia | 11.8.2023 |
| EU/1/20/1446 | Hepcludex | Liechtenstein | 31.7.2023 |
| EU/1/20/1446 | Hepcludex | Norwegia | 15.8.2023 |
| EU/1/18/1319 | Hulio | Islandia | 16.8.2023 |
| EU/1/18/1319 | Hulio | Liechtenstein | 31.8.2023 |
| EU/1/18/1319 | Hulio | Norwegia | 21.9.2023 |
| EU/2/18/230 | Hydrocortisone aceponate Ecuphar | Norwegia | 22.8.2023 |
| EU/1/19/1356 | Idacio | Islandia | 27.11.2023 |
| EU/1/19/1356 | Idacio | Liechtenstein | 31.10.2023 |
| EU/1/19/1356 | Idacio | Norwegia | 8.11.2023 |
| EU/1/20/1471 | Idefirix | Islandia | 11.8.2023 |
| EU/1/20/1471 | Idefirix | Liechtenstein | 31.7.2023 |
| EU/1/20/1471 | Idefirix | Norwegia | 16.8.2023 |
| EU/1/18/1323 | Ilumetri | Islandia | 11.8.2023 |
| EU/1/18/1323 | Ilumetri | Liechtenstein | 31.7.2023 |
| EU/1/18/1323 | Ilumetri | Norwegia | 15.8.2023 |
| EU/2/21/280 | Imoxat | Norwegia | 15.8.2023 |
| EU/2/20/256 | Innovax-ND-ILT | Norwegia | 1.11.2023 |
| EU/2/18/232 | Isemid | Islandia | 18.12.2023 |
| EU/2/18/232 | Isemid | Liechtenstein | 30.12.2023 |
| EU/2/18/232 | Isemid | Norwegia | 12.12.2023 |
| EU/1/18/1324 | Jivi | Islandia | 4.7.2023 |
| EU/1/18/1324 | Jivi | Norwegia | 13.7.2023 |
| EU/1/18/1302 | Kigabeq | Islandia | 9.8.2023 |
| EU/1/18/1302 | Kigabeq | Liechtenstein | 31.7.2023 |
| EU/1/18/1302 | Kigabeq | Norwegia | 17.7.2023 |
| EU/1/22/1657 | Kinpeygo | Islandia | 11.8.2023 |
| EU/1/22/1657 | Kinpeygo | Liechtenstein | 31.7.2023 |
| EU/1/22/1657 | Kinpeygo | Norwegia | 16.8.2023 |
| EU/1/21/1552 | Koselugo | Norwegia | 18.7.2023 |
| EU/2/18/234 | Kriptazen | Liechtenstein | 30.12.2023 |
| EU/2/18/234 | Kriptazen | Norwegia | 20.12.2023 |
| EU/1/18/1316 | Lenalidomide Accord | Islandia | 29.8.2023 |
| EU/1/18/1316 | Lenalidomide Accord | Liechtenstein | 31.8.2023 |
| EU/1/18/1316 | Lenalidomide Accord | Norwegia | 24.8.2023 |
| EU/1/21/1603 | Lumykras | Islandia | 29.11.2023 |
| EU/1/21/1603 | Lumykras | Liechtenstein | 30.11.2023 |
| EU/1/21/1603 | Lumykras | Norwegia | 20.11.2023 |
| EU/1/18/1331 | Luxturna | Islandia | 11.8.2023 |
| EU/1/18/1331 | Luxturna | Liechtenstein | 31.7.2023 |
| EU/1/18/1331 | Luxturna | Norwegia | 15.8.2023 |
| EU/1/18/1315 | Mektovi | Islandia | 4.7.2023 |
| EU/1/18/1315 | Mektovi | Norwegia | 13.7.2023 |
| EU/1/18/1301 | Mepsevii | Islandia | 15.8.2023 |
| EU/1/18/1301 | Mepsevii | Liechtenstein | 31.7.2023 |
| EU/1/18/1301 | Mepsevii | Norwegia | 15.8.2023 |
| EU/2/20/259 | MHYOSPHERE PCV ID | Norwegia | 22.8.2023 |
| EU/1/18/1346 | Miglustat Dipharma | Islandia | 29.11.2023 |
| EU/1/18/1346 | Miglustat Dipharma | Liechtenstein | 30.11.2023 |
| EU/1/18/1346 | Miglustat Dipharma | Norwegia | 11.12.2023 |
| EU/1/21/1570 | Minjuvi | Islandia | 11.8.2023 |
| EU/1/21/1570 | Minjuvi | Liechtenstein | 31.7.2023 |
| EU/1/21/1570 | Minjuvi | Norwegia | 16.8.2023 |
| EU/2/17/220 | MiPet Easecto | Norwegia | 22.8.2023 |
| EU/1/18/1325 | Namuscla | Islandia | 30.8.2023 |
| EU/1/18/1325 | Namuscla | Liechtenstein | 31.8.2023 |
| EU/1/18/1325 | Namuscla | Norwegia | 14.8.2023 |
| EU/2/19/241 | NASYM | Norwegia | 15.9.2023 |
| EU/1/15/1078 | Natpar | Norwegia | 25.10.2023 |
| EU/2/20/267 | NexGard Combo | Norwegia | 22.8.2023 |
| EU/1/16/1094 | Ninlaro | Islandia | 12.9.2023 |
| EU/1/16/1094 | Ninlaro | Liechtenstein | 30.9.2023 |
| EU/1/16/1094 | Ninlaro | Norwegia | 6.9.2023 |
| EU/2/20/265 | Nobivac DP Plus | Norwegia | 8.8.2023 |
| EU/1/16/1139 | Ocaliva | Islandia | 29.11.2023 |
| EU/1/16/1139 | Ocaliva | Liechtenstein | 30.11.2023 |
| EU/1/16/1139 | Ocaliva | Norwegia | 12.12.2023 |
| EU/1/18/1341 | Ogivri | Islandia | 23.8.2023 |
| EU/1/18/1341 | Ogivri | Liechtenstein | 31.8.2023 |
| EU/1/18/1341 | Ogivri | Norwegia | 15.8.2023 |
| EU/1/18/1313 | Pelgraz | Norwegia | 13.7.2023 |
| EU/1/18/1328 | Pelmeg | Islandia | 13.12.2023 |
| EU/1/18/1328 | Pelmeg | Liechtenstein | 30.11.2023 |
| EU/1/18/1328 | Pelmeg | Norwegia | 12.12.2023 |
| EU/1/18/1332 | Pifeltro | Islandia | 10.8.2023 |
| EU/1/18/1332 | Pifeltro | Liechtenstein | 31.7.2023 |
| EU/1/18/1332 | Pifeltro | Norwegia | 17.7.2023 |
| EU/1/18/1335 | Poteligeo | Islandia | 4.10.2023 |
| EU/1/18/1335 | Poteligeo | Liechtenstein | 30.9.2023 |
| EU/1/18/1335 | Poteligeo | Norwegia | 10.10.2023 |
| EU/1/18/1291 | Rizmoic | Islandia | 28.11.2023 |
| EU/1/18/1291 | Rizmoic | Liechtenstein | 30.11.2023 |
| EU/1/18/1291 | Rizmoic | Norwegia | 8.11.2023 |
| EU/1/22/1668 | Roctavian | Islandia | 14.8.2023 |
| EU/1/22/1668 | Roctavian | Liechtenstein | 31.7.2023 |
| EU/1/22/1668 | Roctavian | Norwegia | 16.8.2023 |
| EU/1/20/1460 | Rozlytrek | Islandia | 10.8.2023 |
| EU/1/20/1460 | Rozlytrek | Liechtenstein | 31.7.2023 |
| EU/1/20/1460 | Rozlytrek | Norwegia | 8.8.2023 |
| EU/1/18/1294 | RXULTI | Norwegia | 15.8.2023 |
| EU/1/21/1594 | Rybrevant | Islandia | 15.9.2023 |
| EU/1/21/1594 | Rybrevant | Liechtenstein | 30.9.2023 |
| EU/1/21/1594 | Rybrevant | Norwegia | 25.10.2023 |
| EU/1/18/1343 | Silodosin Recordati | Islandia | 29.11.2023 |
| EU/1/18/1343 | Silodosin Recordati | Liechtenstein | 30.11.2023 |
| EU/1/18/1343 | Silodosin Recordati | Norwegia | 12.12.2023 |
| EU/1/13/901 | Sirturo | Liechtenstein | 30.11.2023 |
| EU/1/13/901 | Sirturo | Norwegia | 7.12.2023 |
| EU/1/13/901 | Sirturo | Islandia | 13.12.2023 |
| EU/1/18/1318 | Slenyto | Norwegia | 15.8.2023 |
| EU/1/22/1688 | Spevigo | Islandia | 20.10.2023 |
| EU/1/22/1688 | Spevigo | Liechtenstein | 30.9.2023 |
| EU/1/18/1306 | Symkevi | Islandia | 31.8.2023 |
| EU/1/18/1306 | Symkevi | Liechtenstein | 31.8.2023 |
| EU/1/18/1306 | Symkevi | Norwegia | 29.8.2023 |
| EU/2/18/231 | Syvazul BTV | Norwegia | 22.8.2023 |
| EU/1/18/1340 | TAKHZYRO | Islandia | 30.8.2023 |
| EU/1/18/1340 | TAKHZYRO | Liechtenstein | 31.8.2023 |
| EU/1/18/1340 | TAKHZYRO | Norwegia | 24.8.2023 |
| EU/1/20/1492 | Tecartus | Islandia | 28.12.2023 |
| EU/1/20/1492 | Tecartus | Liechtenstein | 31.12.2023 |
| EU/1/13/837 | Tecfidera | Islandia | 19.10.2023 |
| EU/1/13/837 | Tecfidera | Liechtenstein | 30.9.2023 |
| EU/1/13/837 | Tecfidera | Norwegia | 23.10.2023 |
| EU/1/22/1675 | TECVAYLI | Islandia | 11.8.2023 |
| EU/1/22/1675 | TECVAYLI | Liechtenstein | 31.7.2023 |
| EU/1/22/1675 | TECVAYLI | Norwegia | 16.8.2023 |
| EU/2/20/252 | Tulissin | Norwegia | 22.8.2023 |
| EU/2/18/227 | UBAC | Norwegia | 22.8.2023 |
| EU/1/18/1334 | Vaborem | Islandia | 11.8.2023 |
| EU/1/18/1334 | Vaborem | Liechtenstein | 31.7.2023 |
| EU/1/18/1334 | Vaborem | Norwegia | 15.8.2023 |
| EU/1/18/1350 | Vantobra | Islandia | 20.10.2023 |
| EU/1/18/1350 | Vantobra | Liechtenstein | 30.9.2023 |
| EU/1/18/1350 | Vantobra | Norwegia | 25.10.2023 |
| EU/2/20/266 | Vectormune FP ILT | Norwegia | 18.9.2023 |
| EU/2/20/250 | Vectormune FP ILT+AE | Norwegia | 18.9.2023 |
| EU/1/16/1138 | Venclyxto | Islandia | 30.8.2023 |
| EU/1/16/1138 | Venclyxto | Liechtenstein | 31.8.2023 |
| EU/1/16/1138 | Venclyxto | Norwegia | 24.8.2023 |
| EU/2/14/169 | Versican Plus DHPPi | Norwegia | 19.9.2023 |
| EU/2/14/164 | Versican Plus DHPPi/L4 | Norwegia | 18.9.2023 |
| EU/2/14/163 | Versican Plus DHPPi/L4R | Norwegia | 21.9.2023 |
| EU/2/14/171 | Versican Plus L4 | Norwegia | 18.9.2023 |
| EU/1/18/1307 | Verzenios | Islandia | 10.8.2023 |
| EU/1/18/1307 | Verzenios | Liechtenstein | 30.6.2023 |
| EU/1/18/1307 | Verzenios | Norwegia | 13.7.2023 |
| EU/1/18/1298 | Veyvondi | Islandia | 4.7.2023 |
| EU/1/18/1298 | Veyvondi | Liechtenstein | 30.6.2023 |
| EU/1/18/1298 | Veyvondi | Norwegia | 13.7.2023 |
| EU/1/19/1385 | VITRAKVI | Islandia | 10.8.2023 |
| EU/1/19/1385 | VITRAKVI | Liechtenstein | 31.7.2023 |
| EU/1/19/1385 | VITRAKVI | Norwegia | 15.8.2023 |
| EU/1/19/1354 | Vizimpro | Islandia | 18.12.2023 |
| EU/1/19/1354 | Vizimpro | Liechtenstein | 31.12.2023 |
| EU/1/19/1354 | Vizimpro | Norwegia | 12.12.2023 |
| EU/1/18/1308 | Vyxeos liposomal | Norwegia | 15.8.2023 |
| EU/1/13/873 | Xofigo | Islandia | 27.11.2023 |
| EU/1/13/873 | Xofigo | Liechtenstein | 30.9.2023 |
| EU/1/13/873 | Xofigo | Norwegia | 30.11.2023 |
| EU/1/18/1299 | Yescarta | Islandia | 11.8.2023 |
| EU/1/18/1299 | Yescarta | Liechtenstein | 31.7.2023 |
| EU/1/18/1299 | Yescarta | Norwegia | 15.8.2023 |
| EU/1/18/1327 | Ziextenzo | Islandia | 10.8.2023 |
| EU/1/18/1327 | Ziextenzo | Liechtenstein | 30.6.2023 |
| EU/1/18/1327 | Ziextenzo | Norwegia | 12.7.2023 |
| EU/1/18/1344 | Zirabev | Islandia | 29.11.2023 |
| EU/1/18/1344 | Zirabev | Liechtenstein | 30.11.2023 |
| EU/1/18/1344 | Zirabev | Norwegia | 22.11.2023 |
| EU/1/22/1695 | Zynlonta | Islandia | 29.11.2023 |
| EU/1/22/1695 | Zynlonta | Liechtenstein | 30.11.2023 |
| EU/1/22/1695 | Zynlonta | Norwegia | 12.12.2023 |
ZAŁĄCZNIK IIIWykaz przedłużonych pozwoleń na dopuszczenie do obrotu
Wykaz przedłużonych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2023 r. w państwach EOG-EFTA przedłużono następujące pozwolenia na dopuszczenie do obrotu:
| Numer EU | Produkt | Państwo | Data przedłużenia pozwolenia |
| EU/1/21/1554/004-005 | Adtralza | Islandia | 9.10.2023 |
| EU/1/21/1554/004-005 | Adtralza | Norwegia | 25.10.2023 |
| EU/1/20/1528/018-024 | Comirnaty | Norwegia | 31.8.2023 |
| EU/1/20/1528/015-017 | Comirnaty Original/O- micron BA.4-5 | Islandia | 8.9.2023 |
| EU/1/20/1528/015-017 | Comirnaty Original/O- micron bA.4-5 | Norwegia | 9.8.2023 |
| EU/1/19/1365/002 | Cufence | Islandia | 14.12.2023 |
| EU/1/19/1365/002 | Cufence | Norwegia | 12.12.2023 |
| EU/1/15/1058/023-024 | Entresto | Norwegia | 16.8.2023 |
| EU/1/18/1324/004-006 | Erleada | Norwegia | 30.8.2023 |
| EU/1/18/1324/004-006 | Erleada | Islandia | 5.10.2023 |
| EU/1/19/1374/006-007 | Esperoct | Islandia | 24.10.2023 |
| EU/1/19/1374/006-007 | Esperoct | Norwegia | 10.10.2023 |
| EU/1/18/1323/004 | Ilumetri | Islandia | 16.8.2023 |
| EU/1/18/1323/004 | Ilumetri | Norwegia | 15.8.2023 |
| EU/1/20/1468/003-004 | Kaftrio | Islandia | 14.12.2023 |
| EU/1/20/1468/003-004 | Kaftrio | Norwegia | 12.12.2023 |
| EU/1/12/782/008 | Kalydeco | Islandia | 13.12.2023 |
| EU/1/12/782/008 | Kalydeco | Norwegia | 12.12.2023 |
| EU/1/16/1170/017-019 | OLUMIANT | Islandia | 23.10.2023 |
| EU/1/15/1059/008 | Orkambi | Islandia | 9.8.2023 |
| EU/1/15/1059/008 | Orkambi | Norwegia | 12.7.2023 |
| EU/1/13/822/006 | PHEBURANE | Islandia | 28.12.2023 |
| EU/1/12/822/006 | Pheburane | Norwegia | 12.12.2023 |
| EU/1/20/1501/005-006 | Sogroya | Norwegia | 16.8.2023 |
| EU/1/20/1501/005-006 | Sogroya | Islandia | 16.8.2023 |
| EU/1/18/1340/007-009 | Takhzyro | Islandia | 8.12.2023 |
| EU/1/18/1340/007-009 | Takhzyro | Norwegia | 12.12.2023 |
| EU/1/15/989/002 | Tenkasi | Islandia | 23.10.2023 |
| EU/1/15/989/002 | Tenkasi | Norwegia | 10.10.2023 |
| EU/1/21/1599/003 | Vyepti | Islandia | 18.12.2023 |
| EU/1/21/1599/003 | Vyepti | Norwegia | 18.12.2023 |
| EU/1/22/1674/002 | Vyvgart | Islandia | 1.12.2023 |
| EU/1/22/1674/002 | Vyvgart | Norwegia | 12.12.2023 |
| EU/1/05/319/012-017, | Xolair | Norwegia | 12.12.2023 |
| EU/1/20/1513/017 | Yuflyma | Islandia | 8.12.2023 |
| EU/1/20/1513/017 | Yuflyma | Norwegia | 12.12.2023 |
ZAŁĄCZNIK IVWykaz wycofanych pozwoleń na dopuszczenie do obrotu
Wykaz wycofanych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2023 r. w państwach EOG-EFTA wycofano następujące pozwolenia na dopuszczenie do obrotu:
| Numer EU | Produkt | Państwo | Data wycofania |
| EU/2/10/118 | Activyl | Islandia | 29.11.2023 |
| EU/2/10/118 | Activyl | Liechtenstein | 30.11.2023 |
| EU/1/20/1476 | Adakveo | Islandia | 7.9.2023 |
| EU/1/20/1476 | Adakveo | Liechtenstein | 31.8.2023 |
| EU/1/20/1476 | Adakveo | Norwegia | 21.8.2023 |
| EU/2/13/153 | Aftovaxpur Doe | Norwegia | 14.9.2023 |
| EU/1/03/254 | Busilvex | Islandia | 20.7.2023 |
| EU/2/11/121 | CaniLeish | Islandia | 25.10.2023 |
| EU/2/11/121 | CaniLeish | Liechtenstein | 31.10.2023 |
| EU/2/11/121 | CaniLeish | Norwegia | 22.11.2023 |
| EU/1/15/1055 | Ciambra | Islandia | 25.10.2023 |
| EU/1/15/1055 | Ciambra | Liechtenstein | 31.10.2023 |
| EU/1/15/1055 | Ciambra | Norwegia | 28.11.2023 |
| EU/1/09/558 | Clopidogrel BGR | Liechtenstein | 31.10.2023 |
| EU/1/09/558 | Clopidogrel BGR | Islandia | 6.11.2023 |
| EU/2/10/115 | Comfortis | Islandia | 24.8.2023 |
| EU/2/10/115 | Comfortis | Norwegia | 21.9.2023 |
| EU/1/21/1624 | COVID-19 Vaccine (inactivated, adjuvanted) Valneva | Islandia | 25.10.2023 |
| EU/1/21/1624 | COVID-19 Vaccine (inactivated, adjuvanted) Valneva | Liechtenstein | 31.10.2023 |
| EU/1/21/1624 | COVID-19 Vaccine (inactivated, adjuvanted) Valneva | Norwegia | 22.11.2023 |
| EU/1/17/1248 | Darunavir Krka d.d. | Norwegia | 23.1.2023 (1) |
| EU/1/21/1540 | Dasatinib Accord | Norwegia | 15.9.2023 |
| EU/1/21/1541 | Dasatinib Accordpharma | Norwegia | 15.9.2023 |
| EU/1/21/1568 | Imatinib Koanaa | Islandia | 11.9.2023 |
| EU/1/21/1568 | Imatinib Koanaa | Liechtenstein | 31.8.2023 |
| EU/1/21/1568 | Imatinib Koanaa | Norwegia | 21.9.2023 |
| EU/1/22/1644 | Inpremzia | Norwegia | 14.9.2023 |
| EU/1/96/026 | Invirase | Islandia | 31.8.2023 |
| EU/1/96/026 | Invirase | Liechtenstein | 31.8.2023 |
| EU/1/96/026 | Invirase | Norwegia | 21.9.2023 |
| EU/1/19/1396 | Ivozall | Islandia | 2.11.2023 |
| EU/1/19/1396 | Ivozall | Liechtenstein | 31.10.2023 |
| EU/1/19/1396 | Ivozall | Norwegia | 1.11.2023 |
| EU/1/13/819 | JETREA | Islandia | 11.9.2023 |
| EU/1/13/819 | JETREA | Liechtenstein | 31.8.2023 |
| EU/1/13/819 | JETREA | Norwegia | 11.10.2023 |
| EU/1/10/663 | Lamivudine/Zidovudine Teva | Norwegia | 21.9.2023 |
| EU/1/20/1521 | Lenalidomide Krka d.d. | Norwegia | 21.9.2023 |
| EU/1/20/1519 | Lenalidomide Krka d.d. Novo mesto | Liechtenstein | 30.9.2023 |
| EU/1/09/598 | Nevirapine Teva | Norwegia | 1.11.2023 |
| EU/1/17/1217 | Nitisinone MDK | Norwegia | 26.10.2023 |
| EU/2/11/132 | Nobivac Myxo-RHD | Islandia | 8.9.2023 |
| EU/2/11/132 | Nobivac Myxo-RHD | Liechtenstein | 31.8.2023 |
| EU/2/11/132 | Nobivac Myxo-RHD | Norwegia | 24.8.2023 |
| EU/1/20/1499 | Onbevzi | Islandia | 19.12.2023 |
| EU/1/20/1499 | Onbevzi | Liechtenstein | 31.12.2023 |
| EU/1/09/571 | Pandemic Influenza Vaccine H5N1 BAXTER | Liechtenstein | 30.9.2023 |
| EU/1/09/571 | Pandemic Influenza Vaccine H5N1 BAXTER | Norwegia | 22.11.2023 |
| EU/1/09/571 | Pandemic Influenza Vaccine H5N1 BAXTER | Islandia | 25.10.2023 |
| EU/1/12/757 | Pioglitazone Teva | Norwegia | 21.9.2023 |
| EU/1/15/1012 | Pregabalin Sandoz GmbH | Islandia | 24.10.2023 |
| EU/1/15/1012 | Pregabalin Sandoz GmbH | Liechtenstein | 31.10.2023 |
| EU/1/15/1012 | Pregabalin Sandoz GmbH | Norwegia | 29.11.2023 |
| EU/1/16/1166 | Pregabalin Zentiva k.s., | Norwegia | 14.9.2023 |
| EU/1/99/107 | Rebetol | Islandia | 26.10.2023 |
| EU/1/99/107 | Rebetol | Liechtenstein | 31.10.2023 |
| EU/1/99/107 | Rebetol | Norwegia | 2.11.2023 |
| EU/1/22/1712 | Tremelimumab AstraZeneca | Islandia | 29.11.2023 |
| EU/1/22/1712 | Tremelimumab AstraZeneca | Liechtenstein | 30.11.2023 |
| EU/1/22/1712 | Tremelimumab AstraZeneca | Norwegia | 28.11.2023 |
| EU/1/20/1478 | Zynrelef | Liechtenstein | 31.10.2023 |
| EU/1/20/1478 | Zynrelef | Norwegia | 28.11.2023 |
| EU/1/20/1478 | Zynrelef | Islandia | 25.10.2023 |
| (1) W sposób niezamierzony nie uwzględniono tego wycofania w wykazie pozwoleń w pierwszej połowie 2023 r. | |||
ZAŁĄCZNIK VWykaz zawieszonych pozwoleń na dopuszczenie do obrotu
Wykaz zawieszonych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2023 r. w państwach EOG-EFTA zawieszono następujące pozwolenia na dopuszczenie do obrotu:
| Numer EU | Produkt | Państwo | Data zawieszenia pozwolenia |
Metryka aktu
| Identyfikator: | Dz.U.UE.C.2024.4358 |
| Rodzaj: | informacja |
| Tytuł: | Produkty lecznicze - Wykaz pozwoleń na dopuszczenie do obrotu udzielonych przez państwa EOG-EFTA w drugim półroczu 2023 r. |
| Data aktu: | 2024-07-04 |
| Data ogłoszenia: | 2024-07-04 |