Produkty lecznicze - Wykaz pozwoleń na dopuszczenie do obrotu udzielonych przez państwa EOG należące do EOG w drugim półroczu 2021 r. - Podkomitet I ds. swobodnego przepływu towarów
Dzienniki UE
Dz.U.UE.C.2022.306.22
Akt nienormatywny Wersja od: 11 sierpnia 2022 r.
Produkty lecznicze - Wykaz pozwoleń na dopuszczenie do obrotu udzielonych przez państwa EOG należące do EOG w drugim półroczu 2021 r.
Podkomitet I ds. swobodnego przepływu towarów
(Tekst mający znaczenie dla EOG)
(2022/C 306/05)
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 18 marca 2022 r. następujące wykazy dotyczące pozwoleń na dopuszczenie do obrotu produktów leczniczych za okres od dnia 1 lipca do dnia 31 grudnia 2021 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 I
Wykaz nowych pozwoleń na dopuszczenie do obrotu
Wykaz nowych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2021 r. udzielono następujących pozwoleń na dopuszczenie do obrotu w państwach EFTA należących do EOG:
Numer UE | Produkt | Państwo | Data udzielenia pozwolenia |
UE/1/21/1539 | Abecma | Norwegia | 23.08.2021 |
UE/1/21/1539 | Abecma | Liechtenstein | 31.08.2021 |
UE/1/21/1539 | Abecma | Islandia | 30.08.2021 |
UE/1/21/1553 | Abiraterone Krka | Islandia | 13.07.2021 |
UE/1/21/1571 | Abiraterone Mylan | Norwegia | 7.09.2021 |
UE/1/21/1571 | Abiraterone Mylan | Liechtenstein | 31.08.2021 |
UE/1/21/1571 | Abiraterone Mylan | Islandia | 2.09.2021 |
UE/1/21/1554 | Adtralza | Islandia | 12.07.2021 |
UE/1/21/1582 | Artesunate Amivas | Norwegia | 17.12.2021 |
UE/1/21/1582 | Artesunate Amivas | Liechtenstein | 31.12.2021 |
UE/1/21/1582 | Artesunate Amivas | Islandia | 15.12.2021 |
UE/1/21/1595 | Aspaveli | Norwegia | 16.12.2021 |
UE/1/21/1595 | Aspaveli | Liechtenstein | 31.12.2021 |
UE/1/21/1595 | ASPAVELI | Islandia | 30.12.2021 |
UE/1/21/1575 | Bimzelx | Norwegia | 30.08.2021 |
UE/1/21/1575 | Bimzelx | Liechtenstein | 31.08.2021 |
UE/1/21/1575 | Bimzelx | Islandia | 1.09.2021 |
UE/2/21/273 | Bonqat | Norwegia | 5.08.2021 |
UE/2/21/273 | Bonqat | Liechtenstein | 31.08.2021 |
UE/2/21/273 | Bonqat | Islandia | 23.08.2021 |
UE/1/21/1576 | Brukinsa | Norwegia | 29.11.2021 |
UE/1/21/1576 | Brukinsa | Liechtenstein | 31.12.2021 |
UE/1/21/1576 | Brukinsa | Islandia | 14.12.2021 |
UE/1/21/1566 | Bylvay | Norwegia | 5.08.2021 |
UE/1/21/1566 | Bylvay | Liechtenstein | 31.08.2021 |
UE/1/21/1566 | Bylvay | Islandia | 24.08.2021 |
UE/1/21/1572 | Byooviz | Norwegia | 7.09.2021 |
UE/1/21/1572 | Byooviz | Liechtenstein | 31.08.2021 |
UE/1/21/1572 | Byooviz | Islandia | 3.09.2021 |
UE/1/21/1560 | Celsunax | Liechtenstein | 31.08.2021 |
UE/1/21/1560 | Celsunax | Islandia | 9.07.2021 |
UE/1/21/1593 | Cibingo | Norwegia | 15.12.2021 |
UE/2/21/1593 | Cibinqo | Liechtenstein | 31.12.2021 |
UE/1/21/1593 | Cibinqo | Islandia | 30.12.2021 |
UE/1/21/1559 | Enspryng | Norwegia | 6.07.2021 |
UE/1/21/1559 | Enspryng | Islandia | 15.07.2021 |
UE/1/21/1551 | Evkeeza | Islandia | 20.07.2021 |
UE/1/21/1574 | Evrenzo | Norwegia | 23.08.2021 |
UE/1/21/1574 | Evrenzo | Liechtenstein | 31.08.2021 |
UE/1/21/1574 | Evrenzo | Islandia | 30.08.2021 |
UE/2/21/275 | FATROVAX RHD | Norwegia | 23.08.2021 |
UE/2/21/275 | FATROVAX RHD | Liechtenstein | 31.08.2021 |
UE/2/21/275 | FATROVAX RHD | Islandia | 20.10.2021 |
UE/2/21/277 | Felpreva | Norwegia | 16.11.2021 |
UE/2/21/277 | Felpreva | Liechtenstein | 31.12.2021 |
UE/2/21/277 | Felpreva | Islandia | 1.12.2021 |
UE/1/21/1573 | Fingolid Mylan | Liechtenstein | 31.08.2021 |
UE/1/21/1573 | Fingolimod Mylan | Norwegia | 7.09.2021 |
UE/1/21/1573 | Fingolimod Mylan | Islandia | 2.09.2021 |
UE/1/21/1555 | Gavreto | Norwegia | 22.12.2021 |
UE/1/21/1555 | Gavreto | Liechtenstein | 31.12.2021 |
UE/1/21/1555 | GAVRETO | Islandia | 14.12.2021 |
UE/1/21/1589 | Hukyndra | Norwegia | 18.11.2021 |
UE/1/21/1589 | Hukyndra | Liechtenstein | 31.12.2021 |
UE/1/21/1589 | Hukyndra | Islandia | 10.12.2021 |
UE/1/21/1567 | Icatibant Accord | Norwegia | 5.08.2021 |
UE/1/21/1567 | Icatibant Accord | Liechtenstein | 31.08.2021 |
UE/1/21/1567 | Icatibant Accord | Islandia | 23.08.2021 |
UE/1/21/1568 | Imatinib Koanaa | Norwegia | 27.09.2021 |
UE/1/21/1568 | Imatinib Koanaa | Liechtenstein | 31.10.2021 |
UE/1/21/1568 | Imatinib Koanaa | Islandia | 15.10.2021 |
UE/1/21/1564 | Imcivree | Norwegia | 5.08.2021 |
UE/1/21/1564 | Imcivree | Liechtenstein | 31.08.2021 |
UE/1/21/1564 | IMCIVREE | Islandia | 21.07.2021 |
UE/2/21/280 | Imoxat | Liechtenstein | 31.12.2021 |
UE/2/21/280 | Imoxat | Islandia | 21.12.2021 |
UE/1/21/1557 | Jayempi | Islandia | 20.07.2021 |
UE/1/21/1558 | Klisyri | Norwegia | 5.08.2021 |
UE/1/21/1558 | Klisyri | Liechtenstein | 31.08.2021 |
UE/1/21/1558 | Klisyri | Islandia | 21.07.2021 |
UE/1/21/1552 | Koselugo | Islandia | 20.07.2021 |
UE/1/21/1590 | Libmyris | Norwegia | 18.11.2021 |
UE/1/21/1590 | Libmyris | Liechtenstein | 31.12.2021 |
UE/1/21/1590 | Libmyris | Islandia | 8.12.2021 |
UE/1/21/1570 | Minjuvi | Norwegia | 7.09.2021 |
UE/1/21/1570 | Minjuvi | Liechtenstein | 31.08.2021 |
UE/1/21/1570 | Minjuvi | Islandia | 6.09.2021 |
UE/1/21/1581 | Nuvaxovid | Norwegia | 20.12.2021 |
UE/1/21/1581 | Nuvaxovid | Liechtenstein | 31.12.2021 |
UE/1/21/1618 | Nuvaxovid | Islandia | 31.12.2021 |
UE/1/21/1556 | Onureg | Liechtenstein | 31.08.2021 |
UE/1/21/1556 | Onureg | Islandia | 20.07.2021 |
UE/1/21/1546 | Ozawade | Norwegia | 8.09.2021 |
UE/1/21/1546 | Ozawade | Liechtenstein | 31.08.2021 |
UE/1/21/1546 | Ozawade | Islandia | 6.09.2021 |
UE/1/21/1569 | Qinlock | Liechtenstein | 31.12.2021 |
UE/1/21/1569 | Qinlock | Islandia | 14.12.2021 |
UE/1/21/1597 | Regkirona | Norwegia | 12.11.2021 |
UE/1/21/1597 | Regkirona | Liechtenstein | 31.12.2021 |
UE/1/21/1597 | Regkirona | Islandia | 26.11.2021 |
UE/1/21/1588 | Rivaroxaban Mylan | Norwegia | 9.12.2021 |
UE/1/21/1588 | Rivaroxaban Mylan | Liechtenstein | 31.12.2021 |
UE/1/21/1588 | Rivaroxaban Mylan | Islandia | 8.12.2021 |
UE/1/21/1601 | Ronapreve | Norwegia | 12.11.2021 |
UE/1/21/1601 | Ronapreve | Liechtenstein | 31.12.2021 |
UE/1/21/1601 | Ronapreve | Islandia | 26.11.2021 |
UE/1/21/1594 | Rybrevant | Norwegia | 15.12.2021 |
UE/1/21/1594 | Rybrevant | Liechtenstein | 31.12.2021 |
UE/1/21/1594 | Rybrevant | Islandia | 30.12.2021 |
UE/1/21/1565 | Ryeqo | Norwegia | 5.08.2021 |
UE/1/21/1565 | Ryeqo | Liechtenstein | 31.08.2021 |
UE/1/21/1565 | Ryeqo | Islandia | 31.08.2021 |
UE/1/21/1598 | Sitagiptin SUN | Liechtenstein | 31.12.2021 |
UE/1/21/1598 | Sitagliptin SUN | Islandia | 30.12.2021 |
UE/1/21/1563 | Skysona | Norwegia | 5.08.2021 |
UE/1/21/1563 | Skysona | Liechtenstein | 31.08.2021 |
UE/1/21/1563 | Skysona | Islandia | 25.08.2021 |
UE/2/20/269 | Solensia | Islandia | 25.08.2021 |
UE/2/21/274 | Strangvac | Norwegia | 23.08.2021 |
UE/2/21/274 | Strangvac | Liechtenstein | 31.08.2021 |
UE/2/21/274 | Strangvac | Islandia | 30.08.2021 |
UE/1/21/1583 | Sugammadex Mylan | Liechtenstein | 31.12.2021 |
UE/1/21/1583 | Sugammadex Mylan | Islandia | 10.12.2021 |
UE/1/21/1583 | Sugammadex Mylan | Norwegia | 14.12.2021 |
UE/2/21/278 | Suiseng Diff/A | Norwegia | 16.12.2021 |
UE/2/21/278 | Suiseng Diff/A | Liechtenstein | 31.12.2021 |
UE/2/21/278 | Suiseng Diff/A | Islandia | 17.12.2021 |
UE/2/21/276 | Tessie | Norwegia | 23.08.2021 |
UE/2/21/276 | Tessie | Liechtenstein | 31.08.2021 |
UE/2/21/276 | Tessie | Islandia | 27.08.2021 |
UE/1/21/1592 | Trodelvy | Norwegia | 29.11.2021 |
UE/1/21/1592 | Trodelvy | Liechtenstein | 31.12.2021 |
UE/1/21/1592 | Trodelvy | Islandia | 7.12.2021 |
UE/1/21/1591 | Vaxneuvance | Norwegia | 16.12.2021 |
UE/1/21/1591 | Vaxneuvance | Liechtenstein | 31.12.2021 |
UE/1/21/1591 | Vaxneuvance | Islandia | 31.12.2021 |
UE/1/21/1561 | Verquvo | Norwegia | 5.08.2021 |
UE/1/21/1561 | Verquvo | Liechtenstein | 31.08.2021 |
UE/1/21/1561 | Verquvo | Islandia | 24.08.2021 |
UE/1/21/1577 | Voxzogo | Norwegia | 7.09.2021 |
UE/1/21/1577 | Voxzogo | Liechtenstein | 31.08.2021 |
UE/1/21/1577 | Voxzogo | Islandia | 2.09.2021 |
UE/1/21/1585 | Vumerity | Norwegia | 23.11.2021 |
UE/1/21/1585 | Vumerity | Liechtenstein | 31.12.2021 |
UE/1/21/1585 | Vumerity | Islandia | 1.12.2021 |
UE/1/21/1562 | Xevudy | Norwegia | 17.12.2021 |
UE/1/21/1562 | Xevudy | Liechtenstein | 31.12.2021 |
UE/1/21/1562 | Xevudy | Islandia | 31.12.2021 |
UE/2/21/279 | Zenalpha | Liechtenstein | 31.12.2021 |
UE/2/21/279 | Zenalpha | Islandia | 31.12.2021 |
ZAŁĄCZNIK II
Wykaz odnowionych pozwoleń na dopuszczenie do obrotu
Wykaz odnowionych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2021 r. udzielono następujących pozwoleń na dopuszczenie do obrotu w państwach EFTA należących do EOG:
Numer UE | Produkt | Państwo | Data udzielenia pozwolenia |
UE/1/20/1476 | Adakveo | Liechtenstein | 31.10.2021 |
UE/1/20/1476 | Adakveo | Islandia | 18.10.2021 |
UE/1/20/1476 | Adakveo | Norwegia | 6.10.2021 |
UE/1/12/794 | Adcetris | Liechtenstein | 31.10.2021 |
UE/1/12/794 | ADCETRIS | Islandia | 15.10.2021 |
UE/1/12/794 | Adcetris | Norwegia | 24.11.2021 |
UE/1/16/1158 | Afstyla | Liechtenstein | 31.08.2021 |
UE/1/16/1158 | Afstyla | Islandia | 3.09.2021 |
UE/1/16/1158 | Afstyla | Norwegia | 27.08.2021 |
UE/1/16/1164 | Amgevita | Liechtenstein | 31.12.2021 |
UE/1/16/1164 | Amgevita | Islandia | 30.12.2021 |
UE/1/16/1164 | Amgevita | Norwegia | 15.12.2021 |
UE/1/16/1092 | Amlodipine/Valsartan Mylan | Norwegia | 18.08.2021 |
UE/1/20/1473 | Ayvakyt | Liechtenstein | 31.08.2021 |
UE/1/20/1473 | AYVAKYT | Islandia | 26.08.2021 |
UE/1/20/1473 | Ayvakyt | Norwegia | 31.08.2021 |
UE/1/20/1474 | Blenprep | Norwegia | 6.07.2021 |
UE/1/20/1474 | Blenrep | Islandia | 12.07.2021 |
UE/1/16/1102 | Bortezomib SUN | Islandia | 13.07.2021 |
UE/2/16/200 | Cepedex | Liechtenstein | 31.12.2021 |
UE/2/16/200 | Cepedex | Islandia | 3.12.2021 |
UE/2/16/200 | Cepedex | Norwegia | 6.12.2021 |
UE/1/16/1110 | Chenodeoxycholic acid Leadiant | Liechtenstein | 31.12.2021 |
UE/1/16/1110 | Chenodeoxycholic acid Leadiant | Islandia | 30.12.2021 |
UE/1/16/1110 | Chenodeoxycholic acid Leadiant | Norwegia | 15.12.2021 |
UE/2/16/202 | Coliprotec F4/F18 | Liechtenstein | 31.12.2021 |
UE/2/16/202 | Coliprotec F4/F18 | Islandia | 8.12.2021 |
UE/2/16/202 | Coliprotec F4/F18 | Norwegia | 22.12.2021 |
UE/1/13/890 | Cometriq | Liechtenstein | 31.10.2021 |
UE/1/13/890 | Cometriq | Islandia | 19.10.2021 |
UE/1/13/890 | Cometriq | Norwegia | 18.08.2021 |
UE/1/13/890 | Cometriq | Norwegia | 16.11.2021 |
UE/1/20/1528 | Comirnaty | Liechtenstein | 31.12.2021 |
UE/1/20/1528 | Comirnaty | Islandia | 5.11.2021 |
UE/1/20/1528 | Comirnaty | Norwegia | 20.12.2021 |
UE/1/17/1262 | Crysvita | Norwegia | 30.08.2021 |
UE/1/15/1049 | Cystadrops | Liechtenstein | 31.10.2021 |
UE/1/15/1049 | CYSTADROPS | Islandia | 14.10.2021 |
UE/1/15/1049 | Cystadrops | Norwegia | 15.09.2021 |
UE/1/17/1175 | Daptomycin Hospira | Liechtenstein | 31.12.2021 |
UE/1/16/1140 | Darunavir Mylan | Liechtenstein | 31.10.2021 |
UE/1/16/1140 | Darunavir Mylan | Islandia | 15.10.2021 |
UE/1/16/1140 | Darunavir Mylan | Norwegia | 30.09.2021 |
UE/1/13/875 | Deltyba | Norwegia | 18.08.2021 |
UE/1/20/1437 | Dovprela | Liechtenstein | 31.08.2021 |
UE/1/20/1437 | Dovprela | Islandia | 21.07.2021 |
UE/1/20/1437 | Dovprela | Norwegia | 5.08.2021 |
UE/1/16/1133 | Emitricitabine/Tenofovir disoproxil Mylan | Norwegia | 6.10.2021 |
UE/1/16/1088 | Empliciti | Norwegia | 18.08.2021 |
UE/1/16/1151 | Emtricitabine/Tenofovir disoproxil Krka | Islandia | 12.10.2021 |
UE/1/16/1151 | Emtricitabine/Tenofovir disoproxil Krka | Norwegia | 27.09.2021 |
UE/1/16/1133 | Emtricitabine/Tenofovir disoproxil Mylan | Islandia | 18.10.2021 |
UE/1/16/1148 | Emtricitabine/Tenofovir disoproxil Zentiva | Liechtenstein | 31.08.2021 |
UE/1/16/1148 | Emtricitabine/Tenofovir disoproxil Zentiva | Islandia | 25.08.2021 |
UE/1/16/1148 | Emtricitabine/Tenofovir disoproxil Zentiva | Norwegia | 5.08.2021 |
UE/1/16/1151 | Emtricitabine/Tenofovir disproxil Krka | Liechtenstein | 31.10.2021 |
UE/1/16/1133 | Emtricitabine/Tenofovir disproxil Mylan | Liechtenstein | 31.10.2021 |
UE/1/20/1508 | Enhertu | Liechtenstein | 31.12.2021 |
UE/1/20/1508 | Enhertu | Islandia | 8.12.2021 |
UE/1/20/1508 | Enhertu | Norwegia | 14.12.2021 |
UE/2/16/199 | Eravac | Liechtenstein | 31.08.2021 |
UE/2/16/199 | Eravac | Islandia | 27.08.2021 |
UE/2/16/199 | Eravac | Norwegia | 30.08.2021 |
UE/1/13/848 | Erivedge | Liechtenstein | 31.08.2021 |
UE/1/13/848 | Erivedge | Islandia | 15.07.2021 |
UE/1/13/848 | Erivedge | Norwegia | 7.07.2021 |
UE/1/16/1160 | Fiasp | Liechtenstein | 31.08.2021 |
UE/1/16/1160 | Fiasp | Islandia | 31.08.2021 |
UE/1/16/1160 | Fiasp | Norwegia | 25.08.2021 |
UE/1/16/1146 | Glyxambi | Liechtenstein | 31.08.2021 |
UE/1/16/1146 | Glyxambi | Islandia | 6.09.2021 |
UE/1/16/1146 | Glyxambi | Norwegia | 6.09.2021 |
UE/1/16/1137 | Granpidam | Liechtenstein | 31.08.2021 |
UE/1/16/1137 | Granpidam | Islandia | 2.09.2021 |
UE/16/1137 | Granpidam | Norwegia | 8.09.2021 |
UE/2/16/201 | Halagon | Liechtenstein | 31.10.2021 |
UE/2/16/201 | Halagon | Islandia | 13.10.2021 |
UE/2/16/201 | Halagon | Norwegia | 16.12.2021 |
UE/1/20/1446 | Hepcludex | Liechtenstein | 31.08.2021 |
UE/1/20/1446 | Hepcludex | Islandia | 27.08.2021 |
UE/1/20/1446 | Hepcludex | Norwegia | 23.08.2021 |
UE/1/14/987 | Holoclar | Norwegia | 18.08.2021 |
UE/1/16/1147 | Ibrance | Liechtenstein | 31.08.2021 |
UE/1/16/1147 | Ibrance | Islandia | 24.08.2021 |
UE/1/16/1147 | Ibrance | Norwegia | 5.08.2021 |
UE/1/20/1471 | Idefirix | Liechtenstein | 31.08.2021 |
UE/1/20/1471 | Idefirix | Islandia | 24.08.2021 |
UE/1/20/1471 | Idefirix | Norwegia | 6.09.2021 |
UE/1/21/1564 | Imcivree | Liechtenstein | 31.08.2021 |
UE/1/16/1132 | Inhixa | Liechtenstein | 31.08.2021 |
UE/1/16/1132 | Inhixa | Islandia | 2.09.2021 |
UE/1/16/1132 | Inhixa | Norwegia | 6.09.2021 |
UE/1/16/1144 | Ivabradine Zentiva | Liechtenstein | 31.10.2021 |
UE/1/16/1144 | Ivabradine Zentiva | Islandia | 18.10.2021 |
UE/1/16/1144 | Ivabradine Zentiva | Norwegia | 7.10.2021 |
UE/1/16/1128 | Kisplyx | Islandia | 12.07.2021 |
UE/1/16/1161 | Movymia | Liechtenstein | 31.10.2021 |
UE/1/16/1161 | Movymia | Islandia | 15.10.2021 |
UE/1/16/1161 | Movymia | Norwegia | 28.09.2021 |
UE/1/16/1134 | Mysildecard | Liechtenstein | 31.10.2021 |
UE/1/16/1134 | Mysildecard | Islandia | 15.09.2021 |
UE/1/16/1134 | Mysildecard | Norwegia | 27.09.2021 |
UE/1/16/1094 | Ninlaro | Liechtenstein | 31.12.2021 |
UE/1/16/1094 | Ninlaro | Islandia | 17.12.2021 |
UE/1/16/1094 | Ninlaro | Norwegia | 15.12.2021 |
UE/1/16/1124 | Nordimet | Islandia | 13.07.2021 |
UE/1/16/1170 | Olumiant | Liechtenstein | 31.12.2021 |
UE/1/16/1170 | OLUMIANT | Islandia | 8.12.2021 |
UE/1/16/1170 | Olumiant | Norwegia | 19.11.2021 |
UE/1/16/1130 | Onivyde pegylated liposomal | Liechtenstein | 31.08.2021 |
UE/1/16/1130 | Onivyde pegylated liposomal | Islandia | 25.08.2021 |
UE/1/16/1130 | Onivyde pegylated liposomal | Norwegia | 17.08.2021 |
UE/1/16/1142 | Parsabiv | Liechtenstein | 31.10.2021 |
UE/1/16/1142 | Parsabiv | Islandia | 13.10.2021 |
UE/1/16/1142 | Parsabiv | Norwegia | 27.09.2021 |
UE/1/19/1388 | Polivy | Liechtenstein | 31.12.2021 |
UE/1/19/1388 | Polivy | Islandia | 17.12.2021 |
UE/1/19/1388 | Polivy | Norwegia | 22.12.2021 |
UE/1/16/1166 | Pregabalin Zentiva k.s | Liechtenstein | 31.12.2021 |
UE/1/16/1166 | Pregabalin Zentiva k.s. | Islandia | 15.12.2021 |
UE/1/16/1166 | Pregabalin Zentiva k.s. | Norwegia | 29.11.2021 |
UE/1/16/1150 | Rekovelle | Liechtenstein | 31.08.2021 |
UE/1/16/1150 | REKOVELLE | Islandia | 24.08.2021 |
UE/1/16/1150 | Rekovelle | Norwegia | 5.08.2021 |
UE/1/20/1527 | Retsevmo | Liechtenstein | 31.12.2021 |
UE/1/20/1460 | Rozlytrek | Islandia | 13.07.2021 |
UE/1/20/1460 | Rozlytrek | Norwegia | 6.07.2021 |
UE/2/16/198 | Sedadex | Liechtenstein | 31.08.2021 |
UE/2/16/198 | Sedadex | Islandia | 3.09.2021 |
UE/2/16/198 | Sedadex | Norwegia | 6.09.2021 |
UE/1/16/1135 | Sialanar | Islandia | 13.07.2021 |
UE/1/16/1141 | SomaKit TOC | Liechtenstein | 31.12.2021 |
UE/1/16/1141 | SomaKit TOC | Islandia | 8.12.2021 |
UE/1/16/1141 | SomaKit TOC | Norwegia | 23.11.2021 |
UE/1/20/1507 | Spikevax | Liechtenstein | 31.10.2021 |
UE/1/20/1507 | Spikevax | Islandia | 27.10.2021 |
UE/1/20/1507 | Spikevax | Norwegia | 5.10.2021 |
UE/2/16/204 | Stronghold Plus | Liechtenstein | 31.12.2021 |
UE/2/16/204 | Stronghold Plus | Islandia | 21.12.2021 |
UE/2/16/204 | Stronghold Plus | Norwegia | 17.12.2021 |
UE/1/16/1157 | Suliqua | Liechtenstein | 31.12.2021 |
UE/1/16/1157 | Suliqua | Islandia | 14.12.2021 |
UE/1/16/1157 | Suliqua | Norwegia | 22.12.2021 |
UE/17/1177 | Tadalafil Lilly | Liechtenstein | 31.12.2021 |
UE/1/17/1177 | Tadalafil Lilly | Islandia | 3.12.2021 |
UE/1/17/1177 | Tadalafil Lilly | Norwegia | 19.11.2021 |
UE/1/16/1153 | Talmanco | Liechtenstein | 31.12.2021 |
UE/1/16/1153 | Talmanco | Islandia | 7.12.2021 |
UE/1/16/1153 | Talmanco | Norwegia | 6.12.2021 |
UE/1/20/1492 | Tecartus | Islandia | 15.12.2021 |
UE/1/20/1492 | Tecartus | Liechtenstein | 31.12.2021 |
UE/1/20/1492 | Tecartus | Norwegia | 16.12.2021 |
UE/1/16/1129 | Tenofovir disoproxil Mylan | Liechtenstein | 31.08.2021 |
UE/1/16/1129 | Tenofovir disoproxil Mylan | Islandia | 1.09.2021 |
UE/1/16/1129 | Tenofovir disoproxil Mylan | Norwegia | 6.09.2021 |
UE/1/16/1127 | Tenofovir disoproxil Zentiva | Liechtenstein | 31.08.2021 |
UE/1/16/1127 | Tenofovir disoproxil Zentiva | Islandia | 25.08.2021 |
UE/1/16/1127 | Tenofovir disoproxil Zentiva | Norwegia | 5.08.2021 |
UE/1/16/1159 | Terrosa | Liechtenstein | 31.10.2021 |
UE/1/16/1159 | Terrosa | Islandia | 14.10.2021 |
UE/1/16/1159 | Terrosa | Norwegia | 5.10.2021 |
UE/1/13/902 | Translarna | Islandia | 13.07.2021 |
UE/1/13/902 | Translarna | Norwegia | 6.07.2021 |
UE/1/16/1167 | Truxima | Liechtenstein | 31.12.2021 |
UE/1/16/1167 | Truxima | Islandia | 1.12.2021 |
UE/1/16/1167 | Truxima | Norwegia | 19.11.2021 |
UE/1/21/1529 | Vaxzevria | Liechtenstein | 31.12.2021 |
UE/1/21/1529 | Vaxzevria | Islandia | 8.12.2021 |
UE/1/21/1529 | Vaxzevria | Norwegia | 15.11.2021 |
UE/1/20/1459 | Veklury | Islandia | 13.07.2021 |
UE/1/20/1459 | Veklury | Norwegia | 5.07.2021 |
UE/1/16/1168 | Vihuma | Liechtenstein | 31.10.2021 |
UE/1/16/1168 | Vihuma | Islandia | 18.10.2021 |
UE/1/16/1168 | Vihuma | Norwegia | 30.09.2021 |
UE/1/19/1385 | Vitrakvi | Liechtenstein | 31.08.2021 |
UE/1/19/1385 | VITRAKVI | Islandia | 31.08.2021 |
UE/1/19/1385 | Vitrakvi | Norwegia | 23.08.2021 |
UE/1/15/1068 | Wakix | Norwegia | 18.08.2021 |
UE/1/12/793 | Xalkori | Liechtenstein | 31.08.2021 |
UE/1/12/793 | XALKORI | Islandia | 24.08.2021 |
UE/1/12/793 | Xalkori | Norwegia | 5.08.2021 |
UE/1/16/1156 | Zinplava | Liechtenstein | 31.10.2021 |
UE/1/16/1156 | Zinplava | Islandia | 16.09.2021 |
UE/1/16/1156 | Zinplava | Norwegia | 8.09.2021 |
UE/1/19/1367 | Zynteglo | Liechtenstein | 31.10.2021 |
UE/1/19/1367 | Zynteglo | Islandia | 19.10.2021 |
UE/1/19/1367 | Zynteglo | Norwegia | 29.09.2021 |
ZAŁĄCZNIK III
Wykaz przedłużonych pozwoleń na dopuszczenie do obrotu
Wykaz przedłużonych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2021 r. udzielono następujących pozwoleń na dopuszczenie do obrotu w państwach EFTA należących do EOG:
Numer UE | Produkt | Państwo | Data udzielenia pozwolenia |
UE/1/15/1001/004 | Akynzeo | Islandia | 8.12.2021 |
UE/1/15/1001/004 | Akynzeo | Norwegia | 23.11.2021 |
UE/2/13/154/028-033 | Apoquel | Islandia | 30.12.2021 |
UE/1/13/838/006 | AUBAGIO | Islandia | 26.08.2021 |
UE/1/15/1019/003-006 | Bortezomib Accord | Islandia | 31.08.2021 |
UE/1/15/1019/003-006 | Bortezomib Accord | Norwegia | 9.08.2021 |
UE/1/20/1453/007-008 | BYANNLI | Islandia | 22.12.2021 |
UE/1/20/1453/007-008 | Byannli | Norwegia | 21.12.2021 |
UE/1/20/1528/002-003 | Comirnaty | Islandia | 5.11.2021 |
UE/1/20/1528/004-005 | Comirnaty | Islandia | 29.11.2021 |
UE/1/14/980/012-013 | Cosentyx | Islandia | 25.08.2021 |
UE/1/14/980/008-011 | Cosentyx | Norwegia | 9.08.2021 |
UE/1/13/875/005 | Deltyba | Islandia | 15.10.2021 |
UE/1/13/875/005 | Deltyba | Norwegia | 27.09.2021 |
UE/2/11/128/004-010 | Emdocam | Norwegia | 2.07.2021 |
UE/1/01/188 | Fabrazyme | Norwegia | 1.07.2021 |
UE/1/17/1230/026-027 | Lacosamide Accord | Islandia | 14.12.2021 |
UE/1/17/1230/026-027 | Lacosamide Accord | Norwegia | 22.12.2021 |
UE/1/17/1213/002 | Maviret | Islandia | 13.07.2021 |
UE/1/19/1404/006-009 | Rinvoq | Islandia | 31.08.2021 |
UE/1/19/1404/006-009 | Rinvoq | Norwegia | 27.08.2021 |
UE/1/08/451/005 | Volibris | Islandia | 18.10.2021 |
UE/1/08/451/005 | Volibris | Norwegia | 28.09.2021 |
UE/1/17/1223/002 | Vosevi | Islandia | 11.10.2021 |
UE/1/17/1223/002 | Vosevi | Norwegia | 27.09.2021 |
UE/1/17/1178/015 | XELJANZ | Islandia | 31.08.2021 |
UE/1/17/1178/015 | Xeljanz | Norwegia | 18.08.2021 |
ZAŁĄCZNIK IV
Wykaz wycofanych pozwoleń na dopuszczenie do obrotu
Wykaz wycofanych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2021 r. w państwach EFTA należących do EOG wycofano następujące pozwolenia na dopuszczenie do obrotu:
Numer UE | Produkt | Państwo | Data wycofania |
UE/1/07/430 | Atripla | Islandia | 10.12.2021 |
UE/1/07/430 | Atripla | Liechtenstein | 31.12.2021 |
UE/1/07/430 | Atripla | Norwegia | 15.12.2021 |
UE/1/15/1081 | Caspofungin Accord | Norwegia | 15.02.2021 |
UE/2/14/180 | Coliprotec F4 | Liechtenstein | 31.12.2021 |
UE/2/14/180 | Coliprotec F4 | Islandia | 10.12.2021 |
UE/1/09/611 | Docetaxel Teva | Islandia | 26.10.2021 |
UE/1/09/611 | Docetaxel Teva | Liechtenstein | 31.10.2021 |
UE/1/09/611 | Docetaxel Teva | Norwegia | 16.12.2021 |
UE/1/20/1472 | Equidacent | Islandia | 17.11.2021 |
UE/1/20/1472 | Equidacent | Liechtenstein | 31.10.2021 |
UE/1/20/1472 | Equidacent | Norwegia | 15.11.2021 |
UE/1/12/756 | Glidipion | Islandia | 26.08.2021 |
UE/1/12/756 | Glidipion | Liechtenstein | 31.08.2021 |
UE/1/00/151 | Glustin | Islandia | 15.12.2021 |
UE/1/00/151 | Glustin | Liechtenstein | 31.12.2021 |
UE/1/00/151 | Glustin | Norwegia | 21.12.2021 |
UE/1/99/127 | IntronA | Islandia | 17.12.2021 |
UE/1/99/127 | IntronA | Liechtenstein | 31.12.2021 |
UE/1/99/127 | IntronA | Norwegia | 21.12.2021 |
UE/1/20/1516 | Lextemy | Islandia | 13.07.2021 |
UE/1/20/1516 | Lextemy | Norwegia | 1.07.2021 |
UE/1/20/1522 | Lumoxiti | Islandia | 26.08.2021 |
UE/1/29/1522 | Lumoxiti | Liechtenstein | 31.08.2021 |
UE/1/20/1522 | Lumoxiti | Norwegia | 23.08.2021 |
UE/1/04/297 | Nodetrip | Islandia | 12.07.2021 |
UE/1/00/149 | Panretin | Liechtenstein | 31.12.2021 |
UE/1/00/149/001 | Panretin | Norwegia | 6.01.2021 |
UE/1/09/519 | Pantoloc Control | Liechtenstein | 31.12.2021 |
UE/1/12/758 | Pioglitazone Teva Pharma | Islandia | 12.07.2021 |
UE/1/12/758 | Pioglitazone Teva Pharma | Liechtenstein | 31.08.2021 |
UE/1/12/758 | Pioglitazone Teva Pharma | Norwegia | 16.07.2021 |
UE/2/99/016 | Porcilis Pesti | Islandia | 30.08.2021 |
UE/2/99/016 | Porcilis Pesti | Liechtenstein | 31.08.2021 |
UE/2/99/016 | Porcilis Pesti | Norwegia | 24.08.2021 |
UE/1/15/1084 | Portrazza | Norwegia | 18.02.2021 |
UE/1/15/998 | Pregabalin Mylan Pharma | Islandia | 1.12.2021 |
UE/1/15/998 | Pregabalin Mylan Pharma | Liechtenstein | 31.12.2021 |
UE/1/15/998 | Pregabalin Mylan Pharma | Norwegia | 15.11.2021 |
UE/1/08/491 | Rasilez HCT | Liechtenstein | 31.12.2021 |
UE/1/09/509 | Ribavirin Teva | Islandia | 12.07.2021 |
UE/1/09/509 | Ribavirin Teva | Liechtenstein | 31.08.2021 |
UE/1/09/509 | Ribavirin Teva | Norwegia | 16.07.2021 |
UE/1/09/527 | Ribavirin Teva Pharma B.V. | Islandia | 12.07.2021 |
UE/1/09/527 | Ribavirin Teva Pharma BV | Liechtenstein | 31.08.2021 |
UE/1/09/527 | Ribavirin Teva Pharma BV | Norwegia | 16.07.2021 |
UE/1/17/1207 | Ritemvia | Islandia | 12.07.2021 |
UE/1/17/1207 | Ritemvia | Liechtenstein | 31.08.2021 |
UE/1/17/1207 | Ritemvia | Norwegia | 16.07.2021 |
UE/1/21/1563 | Skysona | Islandia | 25.08.2021 |
UE/1/21/1563 | Skysona | Liechtenstein | 31.12.2021 |
UE/1/21/1563 | Skysona | Norwegia | 21.12.2021 |
UE/2/07/074 | Spironolactone Ceva | Islandia | 26.08.2021 |
UE/2/07/074 | Spironolactone Ceva | Liechtenstein | 31.08.2021 |
UE/1/18/1309 | Ulipristal Acetate Gedeon Richter | Islandia | 26.08.2021 |
UE/1/18/1309 | Ulipristal Acetate Gedeon Richter | Liechtenstein | 31.08.2021 |
UE/1/18/1309 | Ulipristal Acetate Gedeon Richter | Norwegia | 16.07.2021 |
UE/1/03/250 | Ytracis | Liechtenstein | 31.12.2021 |
ZAŁĄCZNIK V
Wykaz zawieszonych pozwoleń na dopuszczenie do obrotu
Wykaz zawieszonych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2021 r. zawieszono następujące pozwolenia na dopuszczenie do obrotu w państwach EFTA należących do EOG:
Numer UE | Produkt | Państwo | Data zawieszenia |
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