Produkty lecznicze - Wykaz pozwoleń na dopuszczenie do obrotu udzielonych przez państwa EOG-EFTA w drugim półroczu 2022 r. - Podkomitet I ds. swobodnego przepływu towarów - Do wiadomości Wspólnego Komitetu EOG
Produkty lecznicze - Wykaz pozwoleń na dopuszczenie do obrotu udzielonych przez państwa EOG-EFTA w drugim półroczu 2022 r.(2023/C 239/04)
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 17 marca 2023 r. następujące wykazy dotyczące pozwoleń na dopuszczenie do obrotu produktów leczniczych za okres od dnia 1 lipca do dnia 31 grudnia 2022 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
ZAŁĄCZNIKI
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 2022 r. w państwach EOG-EFTA udzielono następujących pozwoleń na dopuszczenie do obrotu:
| Numer UE | Produkt | Państwo | Data udzielenia pozwolenia |
| UE/1/21/1579 | Nexviadyme | Islandia | 13.07.2022 |
| UE/1/21/1579 | Nexviadyme | Norwegia | 4.07.2022 |
| UE/1/21/1580 | VidPrevtyn Beta | Islandia | 7.12.2022 |
| UE/1/21/1580 | VidPrevtyn Beta | Liechtenstein | 30.11.2022 |
| UE/1/21/1580 | VidPrevtyn Beta | Norwegia | 11.11.2022 |
| UE/1/21/1587 | Rayvow | Islandia | 31.08.2022 |
| UE/1/21/1587 | Rayvow | Liechtenstein | 31.08.2022 |
| UE/1/21/1587 | Rayvow | Norwegia | 6.09.2022 |
| UE/1/22/1629 | ZOLSKETIL pegylated liposomal | Norwegia | 11.08.2022 |
| UE/1/22/1646 | Amifampridine SERB | Islandia | 12.08.2022 |
| UE/1/22/1650 | Tabrecta | Islandia | 12.07.2022 |
| UE/1/22/1650 | Tabrecta | Norwegia | 5.07.2022 |
| UE/1/22/1652 | Filsuvez | Islandia | 12.08.2022 |
| UE/1/22/1652 | Filsuvez | Norwegia | 1.08.2022 |
| UE/1/22/1653 | Upstaza | Islandia | 12.08.2022 |
| UE/1/22/1653 | Upstaza | Liechtenstein | 31.07.2022 |
| UE/1/22/1653 | Upstaza | Norwegia | 25.07.2022 |
| UE/1/22/1655 | Pirfenidone AET | Islandia | 12.07.2022 |
| UE/1/22/1655 | Pirfenidone axunio | Liechtenstein | 30.06.2022 |
| UE/1/22/1655 | Pirfenidone AET | Norwegia | 5.07.2022 |
| UE/1/22/1656 | Ertapenem SUN | Islandia | 11.08.2022 |
| UE/1/22/1656 | Ertapenem SUN | Liechtenstein | 31.07.2022 |
| UE/1/22/1656 | Ertapenem SUN | Norwegia | 10.08.2022 |
| UE/1/22/1657 | Kinpeygo | Islandia | 19.07.2022 |
| UE/1/22/1657 | Kinpeygo | Liechtenstein | 31.07.2022 |
| UE/1/22/1657 | Kinpeygo | Norwegia | 21.07.2022 |
| UE/1/22/1658 | Ganirelix Gedeon Richter | Islandia | 21.07.2022 |
| UE/1/22/1658 | Ganirelix Gedeon Richter | Liechtenstein | 31.07.2022 |
| UE/1/22/1658 | Ganirelix Gedeon Richter | Norwegia | 25.07.2022 |
| UE/1/22/1659 | Xenpozyme | Islandia | 13.07.2022 |
| UE/1/22/1659 | Xenpozyme | Norwegia | 4.07.2022 |
| UE/1/22/1660 | Zokinvy | Islandia | 21.07.2022 |
| UE/1/22/1660 | Zokinvy | Liechtenstein | 31.07.2022 |
| UE/1/22/1660 | Zokinvy | Norwegia | 21.07.2022 |
| UE/1/22/1661 | Sitagliptin/Metformin hydrochloride Accord | Islandia | 15.08.2022 |
| UE/1/22/1661 | Sitagliptin/Metformin Hydrochloride Accord | Liechtenstein | 31.07.2022 |
| UE/1/22/1661 | Sitagliptin Metformin Hydrochloride Accord | Norwegia | 1.08.2022 |
| UE/1/22/1662 | Pyrukynd | Islandia | 1.12.2022 |
| UE/1/22/1662 | Pyrukynd | Liechtenstein | 30.11.2022 |
| UE/1/22/1662 | Pyrukynd | Norwegia | 30.11.2022 |
| UE/1/22/1663 | Sugammadex Fresenius Kabi | Islandia | 19.07.2022 |
| UE/1/22/1663 | Sugammadex Fresenius Kabi | Liechtenstein | 31.07.2022 |
| UE/1/22/1663 | Sugammadex Fresenius Kabi | Norwegia | 25.07.2022 |
| UE/1/22/1664 | Cevenfacta | Islandia | 12.08.2022 |
| UE/1/22/1664 | Cevenfacta | Liechtenstein | 31.07.2022 |
| UE/1/22/1664 | Cevenfacta | Norwegia | 22.08.2022 |
| UE/1/22/1666 | Celdoxome pegylated liposomal | Liechtenstein | 30.09.2022 |
| UE/1/22/1666 | Celdoxome pegylated liposomal | Norwegia | 10.10.2022 |
| UE/1/22/1667 | Celdoxome pegylated liposomal | Islandia | 11.10.2022 |
| UE/1/22/1667 | Vegzelma | Islandia | 23.08.2022 |
| UE/1/22/1667 | Vegzelma | Liechtenstein | 31.08.2022 |
| UE/1/22/1667 | Vegzelma | Norwegia | 30.08.2022 |
| UE/1/22/1668 | Roctavian | Islandia | 31.08.2022 |
| UE/1/22/1668 | Roctavian | Liechtenstein | 31.08.2022 |
| UE/1/22/1668 | Roctavian | Norwegia | 30.08.2022 |
| UE/1/22/1669 | Pepaxti | Islandia | 23.08.2022 |
| UE/1/22/1669 | Pepaxti | Liechtenstein | 31.08.2022 |
| UE/1/22/1669 | Pepaxti | Norwegia | 30.08.2022 |
| UE/1/22/1670 | Scemblix | Islandia | 30.08.2022 |
| UE/1/22/1670 | Scemblix | Liechtenstein | 31.08.2022 |
| UE/1/22/1670 | Scemblix | Norwegia | 30.08.2022 |
| UE/1/22/1671 | Sunlenca | Islandia | 23.08.2022 |
| UE/1/22/1671 | Sunlenca | Liechtenstein | 31.08.2022 |
| UE/1/22/1671 | Sunlenca | Norwegia | 30.08.2022 |
| UE/1/22/1672 | Livtencity | Islandia | 1.12.2022 |
| UE/1/22/1672 | Livtencity | Liechtenstein | 30.11.2022 |
| UE/1/22/1672 | Livtencity | Norwegia | 9.11.2022 |
| UE/1/22/1673 | Ranivisio | Islandia | 30.08.2022 |
| UE/1/22/1673 | Ranivisio | Liechtenstein | 31.08.2022 |
| UE/1/22/1673 | Ranivisio | Norwegia | 30.08.2022 |
| UE/1/22/1674 | Vyvgart | Islandia | 17.08.2022 |
| UE/1/22/1674 | Vyvgart | Liechtenstein | 31.08.2022 |
| UE/1/22/1674 | Vyvgart | Norwegia | 15.08.2022 |
| UE/1/22/1675 | Tecvayli | Islandia | 7.09.2022 |
| UE/1/22/1675 | Tecvayli | Liechtenstein | 31.08.2022 |
| UE/1/22/1675 | Tecvayli | Norwegia | 30.08.2022 |
| UE/1/22/1676 | Thalidomide Lipomed | Islandia | 12.10.2022 |
| UE/1/22/1676 | Thalidomide Lipomed | Liechtenstein | 30.09.2022 |
| UE/1/22/1676 | Thalidomide Lipomed | Norwegia | 5.10.2022 |
| UE/1/22/1677 | Tezspire | Islandia | 12.10.2022 |
| UE/1/22/1677 | Tezspire | Liechtenstein | 30.09.2022 |
| UE/1/22/1677 | Tezspire | Norwegia | 26.09.2022 |
| UE/1/22/1678 | Lupkynis | Islandia | 12.10.2022 |
| UE/1/22/1678 | Lupkynis | Liechtenstein | 30.09.2022 |
| UE/1/22/1678 | Lupkynis | Norwegia | 20.09.2022 |
| UE/1/22/1679 | Opdualag | Islandia | 11.10.2022 |
| UE/1/22/1679 | Opdualag | Liechtenstein | 30.09.2022 |
| UE/1/22/1679 | Opdualag | Norwegia | 20.09.2022 |
| UE/1/22/1680 | ilLuzyce | Islandia | 10.10.2022 |
| UE/1/22/1680 | ilLuzyce | Liechtenstein | 30.09.2022 |
| UE/1/22/1680 | ilLuzyce | Norwegia | 20.09.2022 |
| UE/1/22/1681 | Amvuttra | Islandia | 10.10.2022 |
| UE/1/22/1681 | Amvuttra | Liechtenstein | 30.09.2022 |
| UE/1/22/1681 | Amvuttra | Norwegia | 20.09.2022 |
| UE/1/22/1683 | Vabysmo | Islandia | 11.10.2022 |
| UE/1/22/1683 | Vabysmo | Liechtenstein | 30.09.2022 |
| UE/1/22/1683 | Vabysmo | Norwegia | 26.09.2022 |
| UE/1/22/1684 | Nulibry | Liechtenstein | 30.09.2022 |
| UE/1/22/1684 | Nulibry | Norwegia | 26.09.2022 |
| UE/1/22/1685 | Mounjaro | Islandia | 11.10.2022 |
| UE/1/22/1685 | Mounjaro | Liechtenstein | 30.09.2022 |
| UE/1/22/1685 | Mounjaro | Norwegia | 28.10.2022 |
| UE/1/22/1687 | Enjaymo | Islandia | 8.12.2022 |
| UE/1/22/1687 | Enjaymo | Liechtenstein | 30.11.2022 |
| UE/1/22/1688 | Spevigo | Liechtenstein | 31.12.2022 |
| UE/1/22/1688 | Spevigo | Norwegia | 21.12.2022 |
| UE/1/22/1689 | Beyfortus | Islandia | 18.11.2022 |
| UE/1/22/1689 | Beyfortus | Liechtenstein | 31.10.2022 |
| UE/1/22/1689 | Beyfortus | Norwegia | 23.11.2022 |
| UE/1/22/1690 | Mycapssa | Islandia | 14.12.2022 |
| UE/1/22/1690 | Mycapssa | Liechtenstein | 31.12.2022 |
| UE/1/22/1690 | Mycapssa | Norwegia | 2.12.2022 |
| UE/1/22/1691 | Ximluci | Islandia | 1.12.2022 |
| UE/1/22/1691 | Ximluci | Liechtenstein | 30.11.2022 |
| UE/1/22/1691 | Ximluci | Norwegia | 30.11.2022 |
| UE/1/22/1692 | Locametz | Liechtenstein | 31.12.2022 |
| UE/1/22/1693 | Teriflunomide Accord | Islandia | 8.12.2022 |
| UE/1/22/1693 | Teriflunomide Accord | Liechtenstein | 30.11.2022 |
| UE/1/22/1693 | Teriflunomide Accord | Norwegia | 30.11.2022 |
| UE/1/22/1694 | Melatonin Neurim | Islandia | 7.12.2022 |
| UE/1/22/1694 | Melatonin Neurim | Liechtenstein | 30.11.2022 |
| UE/1/22/1694 | Melatonin Neurim | Norwegia | 1.12.2022 |
| UE/1/22/1695 | Zynlonta | Liechtenstein | 31.12.2022 |
| UE/1/22/1696 | Sorafenib Accord | Islandia | 8.12.2022 |
| UE/1/22/1696 | Sorafenib Accord | Liechtenstein | 30.11.2022 |
| UE/1/22/1696 | Sorafenib Accord | Norwegia | 30.11.2022 |
| UE/1/22/1697 | Teriparatide Sun | Islandia | 1.12.2022 |
| UE/1/22/1697 | Teriparatide Sun | Liechtenstein | 30.11.2022 |
| UE/1/22/1697 | Teriparatide Sun | Norwegia | 1.12.2022 |
| UE/1/22/1698 | Teriflunomide Mylan | Islandia | 8.12.2022 |
| UE/1/22/1698 | Teriflunomide Mylan | Liechtenstein | 30.11.2022 |
| UE/1/22/1698 | Teriflunomide Mylan | Norwegia | 1.12.2022 |
| UE/1/22/1699 | Qdenga | Islandia | 15.12.2022 |
| UE/1/22/1699 | Qdenga | Liechtenstein | 31.12.2022 |
| UE/1/22/1699 | Qdenga | Norwegia | 14.12.2022 |
| UE/1/22/1700 | Ebvallo | Liechtenstein | 31.12.2022 |
| UE/1/22/1700 | Ebvallo | Norwegia | 21.12.2022 |
| UE/1/22/1701 | Plerixafor Accord | Liechtenstein | 31.12.2022 |
| UE/1/22/1701 | Plerixafor Accord | Norwegia | 22.12.2022 |
| UE/1/22/1702 | Dimethyl Fumarate Teva | Liechtenstein | 31.12.2022 |
| UE/1/22/1703 | Pluvicto | Liechtenstein | 31.12.2022 |
| UE/1/22/1703 | Pluvicto | Norwegia | 15.12.2022 |
| UE/1/22/1704 | Livmarli | Liechtenstein | 31.12.2022 |
| UE/1/22/1704 | Livmarli | Norwegia | 15.12.2022 |
| UE/1/22/1705 | Pemetrexed Baxter | Islandia | 20.12.2022 |
| UE/1/22/1705 | Pemetrexed Baxter | Liechtenstein | 31.12.2022 |
| UE/1/22/1705 | Pemetrexed Baxter | Norwegia | 21.12.2022 |
| UE/1/22/1706 | Eladynos | Liechtenstein | 31.12.2022 |
| UE/1/22/1706 | Eladynos | Norwegia | 21.12.2022 |
| UE/1/22/1687 | Enjaymo | Norwegia | 1.12.2022 |
| UE/1/22/1687 | Enjaymo | Liechtenstein | 30.11.2022 |
| UE/1/22/1656 | Ertapenem Sun | Norwegia | 10.08.2022 |
| UE/1/22/1656 | Ertapenem Sun | Liechtenstein | 31.07.2022 |
| UE/2/21/281 | CircoMax | Islandia | 12.08.2022 |
| UE/2/22/284 | Evanovo | Islandia | 16.08.2022 |
| UE/2/22/284 | Evanovo | Liechtenstein | 31.07.2022 |
| UE/2/22/284 | Evanovo | Norwegia | 24.08.2022 |
| UE/2/22/286 | Coxatab | Islandia | 31.08.2022 |
| UE/2/22/286 | Coxatab | Liechtenstein | 31.08.2022 |
| UE/2/22/286 | Coxatab | Norwegia | 1.09.2022 |
| UE/2/22/287 | Cortaderm | Islandia | 17.08.2022 |
| UE/2/22/287 | Cortaderm | Liechtenstein | 31.07.2022 |
| UE/2/22/287 | Cortaderm | Norwegia | 24.08.2022 |
| UE/2/22/288 | Lotilaner Elanco | Islandia | 13.10.2022 |
| UE/2/22/288 | Lotilaner Elanco | Liechtenstein | 30.09.2022 |
| UE/2/22/288 | Lotilaner Elanco | Norwegia | 11.10.2022 |
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 2022 r. w państwach EOG-EFTA odnowiono następujące pozwolenia na dopuszczenie do obrotu:
| Numer UE | Produkt | Państwo | Data udzielenia pozwolenia |
| UE/1/11/699 | Fampyra | Islandia | 8.09.2022 |
| UE/1/11/749 | Caprelsa | Islandia | 13.12.2022 |
| UE/1/11/749 | Caprelsa | Liechtenstein | 30.11.2022 |
| UE/1/11/749 | Caprelsa | Norwegia | 9.12.2022 |
| UE/1/12/782 | Kalydeco | Islandia | 8.09.2022 |
| UE/1/12/784 | Cuprymina | Norwegia | 5.07.2022 |
| UE/1/12/794 | Adcetris | Norwegia | 27.09.2022 |
| UE/1/12/794 | Adcetris | Liechtenstein | 31.5.2022 1 |
| UE/1/12/803 | NexoBrid | Islandia | 23.08.2022 |
| UE/1/12/803 | NexoBrid | Liechtenstein | 31.08.2022 |
| UE/1/12/803 | NexoBrid | Norwegia | 30.08.2022 |
| UE/1/13/901 | Sirturo | Liechtenstein | 31.12.2022 |
| UE/1/13/902 | Translarna | Norwegia | 12.07.2022 |
| UE/1/16/1094 | Ninlaro | Islandia | 6.10.2022 |
| UE/1/16/1094 | Ninlaro | Liechtenstein | 30.09.2022 |
| UE/1/16/1094 | Ninlaro | Norwegia | 24.10.2022 |
| UE/1/16/1169 | Alecensa | Islandia | 11.08.2022 |
| UE/1/16/1169 | Alecensa | Liechtenstein | 31.07.2022 |
| UE/1/16/1169 | Alecensa | Norwegia | 17.08.2022 |
| UE/1/17/1192 | Brineura | Islandia | 15.07.2022 |
| UE/1/17/1192 | Brineura | Norwegia | 15.08.2022 |
| UE/1/17/1195 | Erelzi | Norwegia | 16.08.2022 |
| UE/1/17/1199 | Cuprior | Islandia | 30.08.2022 |
| UE/1/17/1199 | Cuprior | Liechtenstein | 31.08.2022 |
| UE/1/17/1199 | Cuprior | Norwegia | 30.08.2022 |
| UE/1/17/1211 | Entecavir Accord | Islandia | 14.07.2022 |
| UE/1/17/1211 | Entecavir Accord | Liechtenstein | 31.07.2022 |
| UE/1/17/1211 | Entecavir Accord | Norwegia | 8.07.2022 |
| UE/1/17/1213 | Maviret | Norwegia | 16.08.2022 |
| UE/1/17/1215 | Fotivda | Islandia | 11.08.2022 |
| UE/1/17/1215 | Fotivda | Liechtenstein | 31.07.2022 |
| UE/1/17/1215 | Fotivda | Norwegia | 17.08.2022 |
| UE/1/17/1217 | Nitisinone MDK | Islandia | 11.08.2022 |
| UE/1/17/1217 | Nitisinone MDK | Liechtenstein | 31.07.2022 |
| UE/1/17/1217 | Nitisinone MDK | Norwegia | 17.08.2022 |
| UE/1/17/1218 | Rydapt | Norwegia | 15.08.2022 |
| UE/1/17/1222 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Norwegia | 12.08.2022 |
| UE/1/17/1223 | Vosevi | Islandia | 22.08.2022 |
| UE/1/17/1224 | Xermelo | Islandia | 12.07.2022 |
| UE/1/17/1224 | Xermelo | Norwegia | 12.7.2022 |
| UE/1/17/1226 | Lutathera | Islandia | 14.07.2022 |
| UE/1/17/1226 | Lutathera | Liechtenstein | 31.07.2022 |
| UE/1/17/1226 | Lutathera | Norwegia | 21.07.2022 |
| UE/1/17/1227 | Entecavir Mylan | Islandia | 12.07.2022 |
| UE/1/17/1227 | Entecavir Mylan | Norwegia | 5.07.2022 |
| UE/1/17/1228 | Tookad | Islandia | 13.10.2022 |
| UE/1/17/1228 | Tookad | Liechtenstein | 30.09.2022 |
| UE/1/17/1228 | Tookad | Norwegia | 27.10.2022 |
| UE/1/17/1229 | Dupixent | Islandia | 8.09.2022 |
| UE/1/17/1229 | Dupixent | Liechtenstein | 30.09.2022 |
| UE/1/17/1229 | Dupixent | Norwegia | 6.09.2022 |
| UE/1/17/1230 | Lacosamide Accord | Islandia | 30.08.2022 |
| UE/1/17/1230 | Lacosamide Accord | Liechtenstein | 31.08.2022 |
| UE/1/17/1230 | Lacosamide Accord | Norwegia | 24.08.2022 |
| UE/1/17/1231 | Ocrevus | Islandia | 12.10.2022 |
| UE/1/17/1231 | Ocrevus | Liechtenstein | 30.09.2022 |
| UE/1/17/1231 | Ocrevus | Norwegia | 27.09.2022 |
| UE/1/17/1232 | Miglustat Gen.Orph | Islandia | 12.10.2022 |
| UE/1/17/1232 | Miglustat Gen.Orph | Liechtenstein | 30.09.2022 |
| UE/1/17/1232 | Miglustat Gen.Orph | Norwegia | 6.10.2022 |
| UE/1/17/1233 | Zubsolv | Islandia | 12.08.2022 |
| UE/1/17/1233 | Zubsolv | Liechtenstein | 31.07.2022 |
| UE/1/17/1233 | Zubsolv | Norwegia | 25.08.2022 |
| UE/1/17/1234 | Tremfya | Islandia | 21.07.2022 |
| UE/1/17/1234 | Tremfya | Liechtenstein | 31.07.2022 |
| UE/1/17/1234 | Tremfya | Norwegia | 21.07.2022 |
| UE/1/17/1235 | Zejula | Islandia | 11.08.2022 |
| UE/1/17/1235 | Zejula | Liechtenstein | 31.07.2022 |
| UE/1/17/1235 | Zejula | Norwegia | 15.08.2022 |
| UE/1/17/1236 | Trelegy Ellipta | Islandia | 19.07.2022 |
| UE/1/17/1236 | Trelegy Ellipta | Liechtenstein | 31.07.2022 |
| UE/1/17/1237 | Elebrato Ellipta | Islandia | 19.07.2022 |
| UE/1/17/1237 | Elebrato Ellipta | Liechtenstein | 31.07.2022 |
| UE/1/17/1237 | Elebrato Ellipta | Norwegia | 21.7.2022 |
| UE/1/17/1238 | Nyxoid | Islandia | 7.10.2022 |
| UE/1/17/1238 | Nyxoid | Liechtenstein | 30.09.2022 |
| UE/1/17/1238 | Nyxoid | Norwegia | 20.09.2022 |
| UE/1/17/1239 | VeraSeal | Islandia | 13.10.2022 |
| UE/1/17/1239 | VeraSeal | Liechtenstein | 30.09.2022 |
| UE/1/17/1239 | VeraSeal | Norwegia | 25.10.2022 |
| UE/1/17/1241 | Ontruzant | Islandia | 17.08.2022 |
| UE/1/17/1241 | Ontruzant | Liechtenstein | 31.07.2022 |
| UE/1/17/1241 | Ontruzant | Norwegia | 18.08.2022 |
| UE/1/17/1242 | Ritonavir Mylan | Islandia | 25.08.2022 |
| UE/1/17/1242 | Ritonavir Mylan | Liechtenstein | 31.08.2022 |
| UE/1/17/1242 | Ritonavir Mylan | Norwegia | 30.08.2022 |
| UE/1/17/1244 | Tacforius | Islandia | 15.08.2022 |
| UE/1/17/1244 | Tacforius | Liechtenstein | 31.08.2022 |
| UE/1/17/1244 | Tacforius | Norwegia | 25.08.2022 |
| UE/1/17/1245 | Prevymis | Liechtenstein | 31.08.2022 |
| UE/1/17/1245 | Prevymis | Norwegia | 13.09.2022 |
| UE/1/17/1246 | Mvasi | Islandia | 18.10.2022 |
| UE/1/17/1246 | Mvasi | Liechtenstein | 30.09.2022 |
| UE/1/17/1246 | Mvasi | Norwegia | 13.10.2022 |
| UE/1/17/1247 | Adynovi | Liechtenstein | 30.11.2022 |
| UE/1/17/1247 | Adynovi | Norwegia | 6.12.2022 |
| UE/1/17/1249 | Darunavir Krka | Liechtenstein | 30.11.2022 |
| UE/1/17/1249 | Darunavir Krka | Norwegia | 8.12.2022 |
| UE/1/17/1251 | Ozempic | Islandia | 12.10.2022 |
| UE/1/17/1251 | Ozempic | Liechtenstein | 30.09.2022 |
| UE/1/17/1251 | Ozempic | Norwegia | 27.09.2022 |
| UE/1/17/1252 | Fasenra | Islandia | 7.10.2022 |
| UE/1/17/1252 | Fasenra | Liechtenstein | 30.09.2022 |
| UE/1/17/1252 | Fasenra | Norwegia | 26.09.2022 |
| UE/1/17/1254 | Jorveza | Islandia | 13.10.2022 |
| UE/1/17/1254 | Jorveza | Liechtenstein | 30.09.2022 |
| UE/1/17/1254 | Jorveza | Norwegia | 27.09.2022 |
| UE/1/17/1255 | Intrarosa | Islandia | 10.10.2022 |
| UE/1/17/1255 | Intrarosa | Liechtenstein | 30.09.2022 |
| UE/1/17/1255 | Intrarosa | Norwegia | 20.09.2022 |
| UE/1/17/1256 | Anagrelide Mylan | Islandia | 12.12.2022 |
| UE/1/17/1256 | Anagrelide Mylan | Liechtenstein | 30.11.2022 |
| UE/1/17/1256 | Anagrelide Mylan | Norwegia | 8.12.2022 |
| UE/1/17/1257 | Herzuma | Liechtenstein | 31.12.2022 |
| UE/1/17/1257 | Herzuma | Norwegia | 9.12.2022 |
| UE/1/17/1260 | Alkindi | Islandia | 5.12.2022 |
| UE/1/17/1260 | Alkindi | Liechtenstein | 30.11.2022 |
| UE/1/17/1260 | Alkindi | Norwegia | 6.12.2022 |
| UE/1/17/1263 | Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | Islandia | 5.12.2022 |
| UE/1/17/1263 | Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | Liechtenstein | 30.11.2022 |
| UE/1/17/1263 | Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | Norwegia | 6.12.2022 |
| UE/1/18/1265 | Segluromet | Islandia | 5.12.2022 |
| UE/1/18/1265 | Segluromet | Liechtenstein | 30.11.2022 |
| UE/1/18/1265 | Segluromet | Norwegia | 6.12.2022 |
| UE/1/18/1266 | Steglujan | Islandia | 14.12.2022 |
| UE/1/18/1266 | Steglujan | Liechtenstein | 31.12.2022 |
| UE/1/18/1266 | Steglujan | Norwegia | 5.12.2022 |
| UE/1/18/1267 | Steglatro | Islandia | 8.12.2022 |
| UE/1/18/1267 | Steglatro | Liechtenstein | 30.11.2022 |
| UE/1/18/1267 | Steglatro | Norwegia | 23.11.2022 |
| UE/1/18/1271 | Hemlibra | Islandia | 7.10.2022 |
| UE/1/18/1271 | Hemlibra | Liechtenstein | 30.09.2022 |
| UE/1/18/1271 | Hemlibra | Norwegia | 20.09.2022 |
| UE/1/18/1272 | Shingrix | Islandia | 14.12.2022 |
| UE/1/18/1272 | Shingrix | Liechtenstein | 31.12.2022 |
| UE/1/18/1272 | Shingrix | Norwegia | 5.12.2022 |
| UE/1/18/1274 | Trydonis | Liechtenstein | 31.12.2022 |
| UE/1/18/1275 | Riarify | Liechtenstein | 31.12.2022 |
| UE/1/18/1275 | Riarify | Norwegia | 9.12.2022 |
| UE/1/18/1277 | Mylotarg | Islandia | 8.12.2022 |
| UE/1/18/1277 | Mylotarg | Liechtenstein | 30.11.2022 |
| UE/1/18/1277 | Mylotarg | Norwegia | 8.12.2022 |
| UE/1/18/1280 | Zessly | Islandia | 14.12.2022 |
| UE/1/18/1280 | Zessly | Liechtenstein | 30.11.2022 |
| UE/1/18/1280 | Zessly | Norwegia | 28.11.2022 |
| UE/1/19/1355 | Lorviqua | Norwegia | 16.08.2022 |
| UE/1/19/1376 | Libtayo | Islandia | 14.07.2022 |
| UE/1/19/1376 | Libtayo | Norwegia | 28.07.2022 |
| UE/1/19/1376 | Libtayo | Liechtenstein | 31.07.2022 |
| UE/1/19/1385 | Vitrakvi | Islandia | 31.08.2022 |
| UE/1/19/1385 | Vitrakvi | Liechtenstein | 31.08.2022 |
| UE/1/19/1385 | Vitrakvi | Norwegia | 12.09.2022 |
| UE/1/20/1437 | Dovprela | Islandia | 12.07.2022 |
| UE/1/20/1437 | Dovprela | Norwegia | 2.08.2022 |
| UE/1/20/1446 | Hepcludex | Islandia | 18.08.2022 |
| UE/1/20/1446 | Hepcludex | Norwegia | 16.08.2022 |
| UE/1/20/1459 | Veklury | Islandia | 17.08.2022 |
| UE/1/20/1459 | Veklury | Norwegia | 15.08.2022 |
| UE/1/20/1460 | Rozlytrek | Islandia | 1.09.2022 |
| UE/1/20/1460 | Rozlytrek | Norwegia | 16.08.2022 |
| UE/1/20/1471 | Idefirix | Islandia | 21.07.2022 |
| UE/1/20/1471 | Idefirix | Liechtenstein | 31.07.2022 |
| UE/1/20/1471 | Idefirix | Norwegia | 3.11.2022 |
| UE/1/20/1473 | Ayvakyt | Islandia | 30.08.2022 |
| UE/1/20/1473 | Ayvakyt | Liechtenstein | 31.07.2022 |
| UE/1/20/1473 | Ayvakyt | Norwegia | 2.08.2022 |
| UE/1/20/1474 | Blenrep | Islandia | 13.07.2022 |
| UE/1/20/1474 | Blenrep | Norwegia | 28.07.2022 |
| UE/1/20/1476 | Adakveo | Liechtenstein | 31.08.2022 |
| UE/1/20/1476 | Adakveo | Norwegia | 10.10.2022 |
| UE/1/20/1492 | Tecartus | Islandia | 8.12.2022 |
| UE/1/20/1492 | Tecartus | Liechtenstein | 30.11.2022 |
| UE/1/20/1507 | Spikevax | Islandia | 13.10.2022 |
| UE/1/20/1507 | Spikevax | Norwegia | 10.10.2022 |
| UE/1/20/1507 | Spikevax | Liechtenstein | 31.10.2022 |
| UE/1/20/1508 | Enhertu | Liechtenstein | 31.10.2022 |
| UE/1/20/1508 | Enhertu | Norwegia | 7.12.2022 |
| UE/1/20/1527 | Retsevmo | Liechtenstein | 31.12.2022 |
| UE/1/20/1528 | Comirnaty | Norwegia | 13.10.2022 |
| UE/1/20/1528 | Comirnaty | Islandia | 9.11.2022 |
| UE/1/20/1528 | Comirnaty | Liechtenstein | 31.10.2022 |
| UE/1/21/1529 | Vaxzevria | Norwegia | 4.11.2022 |
| UE/1/21/1529 | Vaxzevria | Liechtenstein | 31.10.2022 |
| UE/1/21/1537 | NEXPOVIO | Islandia | 25.08.2022 |
| UE/1/21/1539 | Abecma | Islandia | 12.07.2022 |
| UE/1/21/1539 | Abecma | Norwegia | 27.09.2022 |
| UE/1/21/1552 | Koselugo | Islandia | 8.09.2022 |
| UE/1/21/1555 | Gavreto | Islandia | 7.10.2022 |
| UE/1/21/1555 | Gavreto | Liechtenstein | 30.09.2022 |
| UE/1/21/1555 | Gavreto | Norwegia | 26.09.2022 |
| UE/1/21/1570 | Minjuvi | Islandia | 15.07.2022 |
| UE/1/21/1570 | Minjuvi | Liechtenstein | 31.07.2022 |
| UE/1/21/1570 | Minjuvi | Norwegia | 3.08.2022 |
| UE/1/21/1594 | Rybrevant | Islandia | 13.10.2022 |
| UE/1/21/1594 | Rybrevant | Liechtenstein | 30.09.2022 |
| UE/1/21/1594 | Rybrevant | Norwegia | 24.10.2022 |
| UE/1/21/1603 | Lumykras | Liechtenstein | 30.11.2022 |
| UE/1/21/1618 | Nuvaxovid | Liechtenstein | 31.10.2022 |
| UE/1/21/1618 | Nuvaxovid | Norwegia | 11.10.2022 |
| UE/1/22/1625 | Paxlovid | Islandia | 12.12.2022 |
| UE/1/22/1625 | Paxlovid | Liechtenstein | 30.11.2022 |
| UE/1/22/1625 | Paxlovid | Norwegia | 9.12.2022 |
| UE/2/12/143 | Nobivac L4 | Islandia | 16.09.2022 |
| UE/2/12/143 | Nobivac L4 | Liechtenstein | 31.07.2022 |
| UE/2/12/143 | Nobivac L4 | Norwegia | 18.08.2022 |
| UE/2/16/197 | Clynav | Liechtenstein | 30.06.2022 |
| UE/2/16/197 | Clynav | Norwegia | 16.08.2022 |
| UE/2/17/205 | CYTOPOINT | Islandia | 6.10.2022 |
| UE/2/17/206 | Credelio | Islandia | 6.10.2022 |
| UE/2/17/207 | Zulvac BTV | Islandia | 6.10.2022 |
| UE/2/17/209 | RESPIPORC FLUpan H1N1 | Islandia | 6.10.2022 |
| UE/2/17/210 | Zeleris | Islandia | 15.09.2022 |
| UE/2/17/211 | Prevomax | Islandia | 16.09.2022 |
| UE/2/17/211 | Prevomax | Liechtenstein | 31.07.2022 |
| UE/2/17/211 | Prevomax | Norwegia | 18.08.2022 |
| UE/2/17/212 | Exzolt | Islandia | 16.09.2022 |
| UE/2/17/212 | Exzolt | Liechtenstein | 31.07.2022 |
| UE/2/17/212 | Exzolt | Norwegia | 29.09.2022 |
| UE/2/17/214 | Vepured | Liechtenstein | 31.07.2022 |
| UE/2/17/214 | Vepured | Norwegia | 25.08.2022 |
| UE/2/17/215 | Suvaxyn PRRS MLV | Islandia | 16.09.2022 |
| UE/2/17/215 | Suvaxyn PRRS MLV | Liechtenstein | 31.07.2022 |
| UE/2/17/215 | Suvaxyn PRRS MLV | Norwegia | 18.08.2022 |
| UE/2/17/218 | Bovilis Blue-8 | Liechtenstein | 31.10.2022 |
| UE/2/17/218 | Bovilis Blue-8 | Norwegia | 25.10.2022 |
| UE/2/17/223 | Suvaxyn Circo | Norwegia | 22.07.2022 |
| UE/2/19/245 | Gumbohatch | Norwegia | 11.10.2022 |
| UE/2/20/269 | Solensia | Islandia | 16.09.2022 |
| UE/2/20/269 | Solensia | Norwegia | 7.09.2022 |
| UE/2/21/273 | Bonqat | Norwegia | 9.11.2022 |
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 2022 r. w państwach EOG-EFTA przedłużono następujące pozwolenia na dopuszczenie do obrotu:
| Numer UE | Produkt | Państwo | Data udzielenia pozwolenia |
| UE/1/13/861/003-004 | Procysbi | Islandia | 23.08.2022 |
| UE/1/13/861/003-004 | Procysbi | Norwegia | 17.08.2022 |
| UE/1/15/1061 | Genvoya | Norwegia | 3.10.2022 |
| UE/1/15/1061/003-004 | Genvoya | Islandia | 13.10.2022 |
| UE/1/17/1217/004 | Nitisinone MDK | Norwegia | 16.08.2022 |
| UE/1/17/1229 | Dupixent | Norwegia | 13.10.2022 |
| UE/1/17/1229/021-022 | Dupixent | Norwegia | 16.08.2022 |
| UE/1/18/1289/005-006 | Biktavry | Norwegia | 9.12.2022 |
| UE/1/18/1289/005-006 | Biktavry | Islandia | 14.12.2022 |
| UE/1/19/1361/004-005 | Skyrizi | Norwegia | 8.12.2022 |
| UE/1/19/1404/010-011 | Rinvoq | Islandia | 16.08.2022 |
| UE/1/19/1404/010-011 | Rinvoq | Norwegia | 16.08.2022 |
| UE/1/20/1500/003 | Xofluza | Islandia | 6.09.2022 |
| UE/1/20/1507/002-003 | Spikevax | Norwegia | 16.08.2022 |
| UE/1/20/1507/004-005 | Spikevax bivalent Original/Omicron BA.1 | Norwegia | 1.9.2022 |
| UE/1/20/1507/002-003 | Spikevax | Islandia | 1.09.2022 |
| UE/1/20/1507/006 | Spikevax bivalent Original/Omicron bA.4-5 | Norwegia | 20.10.2022 |
| UE/1/20/1507/007-008 | Spikevax bivalent Original/Omicron bA.1 | Norwegia | 20.10.2022 |
| UE/1/20/1507/009-010 | Spikevax bivalent Original/Omicron bA.4-5 | Norwegia | 19.12.2022 |
| UE/1/20/1528/006-007 | Comirnaty Original/Omicron BA.1 | Norwegia | 1.09.2022 |
| UE/1/20/1528/008-009 | Comirnaty Original/Omicron BA.4-5 | Norwegia | 12.09.2022 |
| UE/1/20/1528/010 | Comirnaty | Norwegia | 20.10.2022 |
| UE/1/20/1528/010 | Comirnaty | Islandia | 3.11.2022 |
| UE/1/20/1528/011-012 | Comirnaty Original/Omicron BA.4-5 | Norwegia | 11.11.2022 |
| UE/1/20/1528/011-012 | Comirnaty Original/Omicron BA.4-5 | Islandia | 8.12.2022 |
| UE/1/20/1528/013 | Comirnaty | Norwegia | 22.12.2022 |
| UE/1/20/1528/014 | Comirnaty Original/Omicron BA.4-5 | Norwegia | 22.12.2022 |
| UE/2/10/111/009-017 | Meloxoral | Islandia | 15.12.2022 |
| UE/2/10/111/009-017 | Meloxoral | Norwegia | 30.11.2022 |
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 2022 r. w państwach EOG-EFTA wycofano następujące pozwolenia na dopuszczenie do obrotu:
| Numer UE | Produkt | Państwo | Data wycofania |
| UE/1/00/166 | NeuroBloc | Liechtenstein | 31.12.2022 |
| UE/1/00/166 | NeuroBloc | Norwegia | 31.12.2022 |
| UE/1/01/174 | Starlix | Islandia | 17.08.2022 |
| UE/1/03/251 | Hepsera | Islandia | 12.12.2022 |
| UE/1/03/251 | Hepsera | Liechtenstein | 30.11.2022 |
| UE/1/03/251 | Hepsera | Norwegia | 12.12.2022 |
| UE/1/07/384 | Docetaxel Zentiva | Norwegia | 13.09.2022 |
| UE/1/07/421 | Glubrava | Islandia | 1.09.2022 |
| UE/1/08/498 | Thymanax | Islandia | 13.07.2022 |
| UE/1/08/498 | Thymanax | Liechtenstein | 31.07.2022 |
| UE/1/08/498 | Thymanax | Norwegia | 21.09.2022 |
| UE/1/10/616 | Temozolomide HEXAL | Liechtenstein | 30.09.2022 |
| UE/1/10/617 | Temozolomide Sandoz | Liechtenstein | 30.09.2022 |
| UE/1/10/617 | Temozolomide Sandoz | Norwegia | 27.10.2022 |
| UE/1/13/825 | Imatinib Actavis | Islandia | 1.09.2022 |
| UE/1/13/825 | Imatinib Actavis | Norwegia | 14.07.2022 |
| UE/1/15/1042 | Zalviso | Islandia | 17.08.2022 |
| UE/1/15/1042 | Zalviso | Liechtenstein | 31.08.2022 |
| UE/1/15/1042 | Zalviso | Norwegia | 13.09.2022 |
| UE/1/15/1069 | Episalvan | Norwegia | 21.09.2022 |
| UE/1/19/1359 | Trogarzo | Liechtenstein | 31.12.2022 |
| UE/1/19/1378 | Temybric Ellipta | Liechtenstein | 31.08.2022 |
| UE/1/19/1378 | Temybric Ellipta | Norwegia | 26.10.2022 |
| UE/1/19/1387 | Senstend | Islandia | 25.08.2022 |
| UE/1/19/1387 | Senstend | Norwegia | 21.09.2022 |
| UE/2/02/036 | Nobilis OR inac | Liechtenstein | 30.09.2022 |
| UE/2/02/036 | Nobilis OR inac | Norwegia | 14.10.2022 |
| Numer UE | Produkt | Państwo | Data wycofania |
| UE/2/10/106 | Bovilis BTV8 | Liechtenstein | 31.08.2022 |
| UE/2/10/106 | Bovilis BTV8 | Norwegia | 14.09.2022 |
| UE/2/11/137 | Activyl Tick Plus | Liechtenstein | 30.09.2022 |
| UE/2/11/137 | Activyl Tick Plus | Norwegia | 25.10.2022 |
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 2022 r. w państwach EOG-EFTA zawieszono następujące pozwolenia na dopuszczenie do obrotu:
| Numer UE | Produkt | Państwo | Data zawieszenia |
1 W sposób niezamierzony nie uwzględniono tego pozwolenia w wykazie pozwoleń w pierwszej połowie 2022 r.
Metryka aktu
| Identyfikator: | Dz.U.UE.C.2023.239.58 |
| Rodzaj: | informacja |
| Tytuł: | Produkty lecznicze - Wykaz pozwoleń na dopuszczenie do obrotu udzielonych przez państwa EOG-EFTA w drugim półroczu 2022 r. - Podkomitet I ds. swobodnego przepływu towarów - Do wiadomości Wspólnego Komitetu EOG |
| Data aktu: | 2023-07-06 |
| Data ogłoszenia: | 2023-07-06 |