|
12.8.2021 |
PL |
Dziennik Urzędowy Unii Europejskiej |
C 324/16 |
Produkty lecznicze – Wykaz pozwoleń na dopuszczenie do obrotu udzielonych przez państwa EOG–EFTA w drugim półroczu 2020 r.
(2021/C 324/10)
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 19 marca 2021 r. następujące wykazy dotyczące pozwoleń na dopuszczenie do obrotu produktów leczniczych za okres od dnia 1 lipca do dnia 31 grudnia 2020 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 I
Wykaz nowych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2020 r. w państwach EOG–EFTA udzielono następujących pozwoleń na dopuszczenie do obrotu:
|
Numer UE |
Produkt |
Państwo |
Data udzielenia pozwolenia |
|
UE/1/20/1476 |
Adakveo |
Islandia |
6.11.2020 |
|
UE/1/20/1476 |
Adakveo |
Norwegia |
5.11.2020 |
|
UE/1/20/1458 |
Apixaban Accord |
Islandia |
10.08.2020 |
|
UE/1/20/1458 |
Apixaban Accord |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1458 |
Apixaban Accord |
Norwegia |
10.08.2020 |
|
UE/1/20/1469 |
Arikayce liposomal |
Norwegia |
2.11.2020 |
|
UE/1/20/1469 |
Arikayce liposomal |
Islandia |
5.11.2020 |
|
UE/1/20/1475 |
Arsenic trioxide medac |
Islandia |
14.10.2020 |
|
UE/1/20/1475 |
Arsenic trioxide medac |
Norwegia |
29.09.2020 |
|
UE/1/20/1454 |
Aybintio |
Islandia |
25.08.2020 |
|
UE/120/1454 |
Aybintio |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1454 |
Aybintio |
Norwegia |
25.08.2020 |
|
UE/1/20/1473 |
AYVAKYT |
Islandia |
14.10.2020 |
|
UE/1/20/1473 |
Ayvakyt |
Norwegia |
29.09.2020 |
|
UE/1/17/1214 |
Bavencio |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1474 |
Blenrep |
Islandia |
14.09.2020 |
|
UE/1/20/1474 |
Blenrep |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1474 |
Blenrep |
Norwegia |
2.09.2020 |
|
UE/1/19/1403 |
Budesonid/Formoterol Teva Pharma B.V. |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1448 |
Cabazitaxel Accord |
Islandia |
3.09.2020 |
|
UE/1/20/1448 |
Cabazitaxel Accord |
Norwegia |
28.10.2020 |
|
UE/1/20/1479 |
Calquence |
Islandia |
10.11.2020 |
|
UE/1/20/1479 |
Calquence |
Norwegia |
11.11.2020 |
|
UE/2/20/264 |
Circomax Myco |
Norwegia |
16.12.2020 |
|
UE/1/20/1528 |
Comirnaty |
Islandia |
21.12.2020 |
|
UE/1/20/1528 |
Comirnaty |
Norwegia |
21.12.2020 |
|
UE/1/20/1451 |
Daurismo |
Islandia |
20.07.2020 |
|
UE/1/20/1451 |
Daurismo |
Norwegia |
3.07.2020 |
|
UE/1/20/1438 |
Enerzair Breezhaler |
Islandia |
21.07.2020 |
|
UE/1/20/1438 |
Enezair Breezhaler |
Norwegia |
14.07.2020 |
|
UE/2/20/262 |
Enteroporc Coli AC |
Norwegia |
16.12.2020 |
|
UE/1/20/1472 |
Equidacent |
Islandia |
14.10.2020 |
|
UE/1/20/1472 |
Equidacent |
Norwegia |
29.09.2020 |
|
UE/1/20/1489 |
Exparel liposomal |
Islandia |
3.12.2020 |
|
UE/1/20/1489 |
Exparel liposomal |
Norwegia |
24.11.2020 |
|
UE/1/20/1477 |
Fampridine Accord |
Islandia |
15.10.2020 |
|
UE/1/20/1477 |
Fampridine Accord |
Norwegia |
1.10.2020 |
|
UE/1/20/1450 |
Fingolimod Accord |
Islandia |
20.07.2020 |
|
UE/1/20/1450 |
Fingolimod Accord |
Norwegia |
13.07.2020 |
|
UE/1/20/1465 |
Gencebok |
Islandia |
25.08.2020 |
|
UE/1/20/1465 |
Gencebok |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1465 |
Gencebok |
Norwegia |
2.09.2020 |
|
UE/1/20/1446 |
Hepcludex |
Islandia |
12.08.2020 |
|
UE/1/20/1446 |
Hepcludex |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1446 |
Hepcludex |
Norwegia |
10.08.2020 |
|
UE/1/20/1471 |
Idefirix |
Islandia |
2.09.2020 |
|
UE/1/20/1471 |
Idefirix |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1471 |
Idefirix |
Norwegia |
8.09.2020 |
|
UE/2/20/258 |
Increxxa |
Islandia |
21.09.2020 |
|
UE/2/20/256 |
Innovax-ND-ILT |
Islandia |
16.10.2020 |
|
UE/1/20/1447 |
Insulin Aspart Sanofi |
Islandia |
20.07.2020 |
|
UE/1/20/144 |
Insulin aspart Sanofi |
Norwegia |
3.07.2020 |
|
UE/1/20/1480 |
Jyseleca |
Islandia |
14.10.2020 |
|
UE/1/20/1480 |
Jyseleca |
Norwegia |
30.09.2020 |
|
UE/1/20/1468 |
Kaftrio |
Islandia |
25.08.2020 |
|
UE/1/20/1468 |
Kaftrio |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1468 |
Kaftrio |
Norwegia |
3.09.2020 |
|
UE/1/20/1494 |
Leqvio |
Norwegia |
15.12.2020 |
|
UE/2/20/261 |
Librela |
Islandia |
13.11.2020 |
|
UE/1/20/1462 |
Livogiva |
Islandia |
2.09.2020 |
|
UE/1/20/1462 |
Livogiva |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1462 |
Livogiva |
Norwegia |
7.09.2020 |
|
UE/1/20/1483 |
MenQuadfi |
Islandia |
2.12.2020 |
|
UE/1/20/1483 |
MenQuadfi |
Norwegia |
30.11.2020 |
|
UE/1/20/1470 |
Methylthioninium chloride Cosmo |
Islandia |
27.08.2020 |
|
UE/1/20/1470 |
Methylthioninium chloride Cosmo |
Norwegia |
3.09.2020 |
|
UE/2/20/259 |
Mhyosphere PCV ID |
Islandia |
14.10.2020 |
|
UE/2/19/247 |
Mirataz |
Norwegia |
11.08.2020 |
|
UE/1/20/1445 |
Mvabea |
Islandia |
21.07.2020 |
|
UE/1/20/1445 |
Mvabea |
Norwegia |
13.07.2020 |
|
UE/2/20/265 |
Nobivac DP PLUS |
Norwegia |
17.12.2020 |
|
UE/1/20/1424 |
Nustendi |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1486 |
Nyvepria |
Islandia |
3.12.2020 |
|
UE/1/20/1486 |
Nyvepria |
Norwegia |
24.11.2020 |
|
UE/1/20/1485 |
Obiltoxaximab SFL |
Islandia |
8.12.2020 |
|
UE/1/20/1485 |
Obiltoxaximab SFL |
Norwegia |
24.11.2020 |
|
UE/2/20/260 |
OvuGel |
Islandia |
8.12.2020 |
|
UE/1/20/1496 |
Oxlumo |
Islandia |
2.12.2020 |
|
UE/1/20/1496 |
Oxlumo |
Norwegia |
24.11.2020 |
|
UE/1/20/1487 |
PHELINUN |
Islandia |
3.12.2020 |
|
UE/1/20/1487 |
PHELINUN |
Norwegia |
2.12.2020 |
|
UE/1/20/1497 |
Phesgo |
Norwegia |
23.12.2020 |
|
UE/1/20/1455 |
Piqray |
Islandia |
11.08.2020 |
|
UE/1/20/1455 |
Piqray |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1455 |
Piqray |
Norwegia |
10.08.2020 |
|
UE/1/20/1437 |
Pretomanid FGK |
Islandia |
12.08.2020 |
|
UE/1/20/1437 |
Pretomanid FGK |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1437 |
Pretomanid FGK |
Norwegia |
10.08.2020 |
|
UE/2/20/254 |
Prevexxion RN |
Islandia |
10.08.2020 |
|
UE/2/20/254 |
Prevexxion RN |
Norwegia |
10.08.2020 |
|
UE/2/20/255 |
Prevexxion RN+HVT+IBD |
Islandia |
27.07.2020 |
|
UE/2/20/255 |
Prevexxion RN+HVT+IBD |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1463 |
Qutavina |
Islandia |
2.09.2020 |
|
UE/1/20/1463 |
Qutavina |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1463 |
Qutavina |
Norwegia |
7.09.2020 |
|
UE/1/20/1452 |
Reblozyl |
Islandia |
20.07.2020 |
|
UE/1/20/1452 |
Reblozyl |
Norwegia |
3.07.2020 |
|
UE/2/20/263 |
Rexxolide |
Norwegia |
16.12.2020 |
|
UE/1/20/1488 |
Rivaroxaban Accord |
Islandia |
1.12.2020 |
|
UE/1/20/1488 |
Rivaroxaban Accord |
Norwegia |
2.12.2020 |
|
UE/1/20/1460 |
Rozlytrek |
Islandia |
12.08.2020 |
|
UE/1/20/1460 |
Rozlytrek |
Norwegia |
10.08.2020 |
|
UE/1/20/1484 |
Supemtek |
Islandia |
1.12.2020 |
|
UE/1/20/1484 |
Supemtek |
Norwegia |
24.11.2020 |
|
UE/1/20/1492 |
Tecartus |
Norwegia |
30.12.2020 |
|
UE/1/20/1498 |
TRIXEO AEROSPHERE |
Norwegia |
16.12.2020 |
|
UE/2/20/257 |
Tulinovet |
Islandia |
21.09.2020 |
|
UE/2/20/257 |
Tulinovet |
Norwegia |
8.12.2020 |
|
UE/1/20/1459 |
Veklury |
Islandia |
3.07.2020 |
|
EU1/20/1459 |
Veklury |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1459 |
Veklury |
Norwegia |
3.07.2020 |
|
UE/1/20/1481 |
Vocabria |
Norwegia |
30.12.2020 |
|
UE/1/20/1457 |
Xenleta |
Islandia |
11.08.2020 |
|
UE/1/20/1457 |
Xenleta |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1457 |
Xenleta |
Norwegia |
10.08.2020 |
|
UE/1/20/1444 |
Zabdeno |
Islandia |
21.07.2020 |
|
UE/1/20/1444 |
Zabdeno |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1444 |
Zabdeno |
Norwegia |
14.07.2020 |
|
UE/1/20/1456 |
Zercepac |
Islandia |
11.08.2020 |
|
UE/1/20/1456 |
Zercepac |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1456 |
Zercepac |
Norwegia |
10.08.2020 |
|
UE/1/20/1440 |
Zimbus Breezhaler |
Islandia |
21.07.2020 |
|
UE/1/20/1440 |
Zimbus Breezhaler |
Liechtenstein |
31.08.2020 |
|
UE/1/20/1440 |
Zimbus Breezhaler |
Norwegia |
13.07.2020 |
|
UE/1/20/1478 |
ZYNRELEF |
Islandia |
16.10.2020 |
|
UE/1/20/1478 |
Zynrelef |
Norwegia |
1.10.2020 |
ZAŁĄCZNIK II
Wykaz odnowionych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2020 r. w państwach EOG–EFTA odnowiono następujące pozwolenia na dopuszczenie do obrotu:
|
Numer UE |
Produkt |
Państwo |
Data udzielenia pozwolenia |
|
UE/1/12/794 |
ADCETRIS |
Islandia |
2.10.2020 |
|
UE/1/12/794 |
ADCETRIS |
Liechtenstein |
31.08.2020 |
|
UE/1/12/794 |
ADCETRIS |
Norwegia |
14.10.2020 |
|
UE/1/15/1045 |
Aripiprazole Accord |
Islandia |
15.10.2020 |
|
UE/1/15/1045 |
Aripiprazole Accord |
Norwegia |
9.10.2020 |
|
UE/1/15/1029 |
Aripiprazole Sandoz |
Islandia |
20.07.2020 |
|
UE/1/15/1029 |
Aripiprazole Sandoz |
Norwegia |
21.07.2020 |
|
UE/1/15/1063 |
Armisarte |
Islandia |
25.08.2020 |
|
UE/1/15/1063 |
Armisarte |
Liechtenstein |
31.08.2020 |
|
UE/1/15/1063 |
Armisarte |
Norwegia |
28.08.2020 |
|
UE/1/17/1214 |
Bavencio |
Islandia |
10.08.2020 |
|
UE/1/17/1214 |
Bavencio |
Norwegia |
25.08.2020 |
|
UE/1/15/1074 |
Benepali |
Islandia |
7.12.2020 |
|
UE/1/15/1074 |
Benepali |
Norwegia |
26.11.2020 |
|
UE/1/15/1073 |
Briviact |
Islandia |
19.10.2020 |
|
UE/1/15/1073 |
Briviact |
Norwegia |
20.10.2020 |
|
UE/2/15/183 |
Canigen L4 |
Islandia |
26.08.2020 |
|
UE/1/15/1055 |
CIAMBRA |
Islandia |
11.08.2020 |
|
UE/1/15/1055 |
Ciambra |
Norwegia |
10.08.2020 |
|
UE/1/15/1054 |
Cinacalcet Mylan |
Islandia |
13.10.2020 |
|
UE/1/15/1054 |
Cinacalcet Mylan |
Norwegia |
1.10.2020 |
|
UE/1/15/1048 |
Cotellic |
Islandia |
17.07.2020 |
|
UE/1/15/1048 |
Cotellic |
Norwegia |
3.07.2020 |
|
UE/1/15/1036 |
CRESEMBA |
Islandia |
24.08.2020 |
|
UE/1/15/1036 |
Cresemba |
Liechtenstein |
31.08.2020 |
|
UE/1/15/1036 |
Cresemba |
Norwegia |
28.08.2020 |
|
UE/1/15/1028 |
Duloxetine Zentiva |
Islandia |
24.08.2020 |
|
UE/1/15/1028 |
Duloxetine Zentiva |
Liechtenstein |
31.08.2020 |
|
UE/1/15/1028 |
Duloxetine Zentiva |
Norwegia |
2.09.2020 |
|
UE/1/15/1051 |
Ebymect |
Islandia |
3.09.2020 |
|
UE/1/15/1051 |
Ebymect |
Norwegia |
7.09.2020 |
|
UE/1/15/1052 |
Edistride |
Islandia |
15.10.2020 |
|
UE/1/15/1052 |
Edistride |
Norwegia |
1.10.2020 |
|
UE/1/15/1046 |
Elocta |
Islandia |
25.08.2020 |
|
UE/1/15/1046 |
Elocta |
Liechtenstein |
31.08.2020 |
|
UE/1/15/1058 |
Entresto |
Islandia |
20.07.2020 |
|
UE/1/15/1058 |
Entresto |
Norwegia |
3.07.2020 |
|
UE/1/15/1069 |
Episalvan |
Islandia |
13.10.2020 |
|
UE/1/15/1069 |
Episalvan |
Norwegia |
7.10.2020 |
|
UE/1/15/1065 |
Eptifibatide Accord |
Islandia |
15.10.2020 |
|
UE/1/15/1065 |
Eptifibatide Accord |
Norwegia |
8.10.2020 |
|
UE/1/19/1392 |
Ervebo |
Islandia |
21.09.2020 |
|
EU1/19/1392 |
Ervebo |
Liechtenstein |
31.08.2020 |
|
UE/1/19/1392 |
Ervebo |
Norwegia |
21.09.2020 |
|
UE/1/15/1075 |
Feraccru |
Islandia |
10.12.2020 |
|
UE/1/15/1075 |
Feraccru |
Norwegia |
3.12.2020 |
|
UE/2/15/185 |
Fortekor Plus |
Islandia |
10.08.2020 |
|
UE/2/15/185 |
Fortekor Plus |
Liechtenstein |
31.08.2020 |
|
UE/2/15/185 |
Fortekor Plus |
Norwegia |
10.08.2020 |
|
UE/1/15/1061 |
Genvoya |
Islandia |
2.10.2020 |
|
UE/1/15/1061 |
Genvoya |
Norwegia |
29.09.2020 |
|
UE/1/11/677 |
Gilenya |
Islandia |
27.11.2020 |
|
UE/1/11/677 |
Gilenya |
Norwegia |
23.11.2020 |
|
UE/1/15/1008 |
Hetlioz |
Islandia |
20.07.2020 |
|
UE/1/15/1008 |
Hetlioz |
Norwegia |
13.07.2020 |
|
UE/1/15/1064 |
Imlygic |
Islandia |
7.12.2020 |
|
UE/1/15/1064 |
Imlygic |
Norwegia |
23.11.2020 |
|
UE/2/15/193 |
Imrestor |
Islandia |
16.10.2020 |
|
UE/2/15/193 |
Imrestor |
Norwegia |
9.10.2020 |
|
UE/1/15/1040 |
Intuniv |
Islandia |
17.07.2020 |
|
UE/1/15/1040 |
Intuniv |
Norwegia |
3.07.2020 |
|
UE/1/11/676 |
Jevtana |
Norwegia |
22.12.2020 |
|
UE/1/15/1076 |
Kovaltry |
Islandia |
13.10.2020 |
|
UE/1/15/1076 |
Kovaltry |
Norwegia |
7.10.2020 |
|
UE/1/15/1060 |
Kyprolis |
Islandia |
17.07.2020 |
|
UE/1/15/1060 |
Kyprolis |
Norwegia |
3.07.2020 |
|
UE/1/15/1067 |
Lopinavir/Ritonavir Mylan |
Islandia |
27.11.2020 |
|
UE/1/15/1067 |
Lopinavir/Ritonavir Mylan |
Norwegia |
24.11.2020 |
|
UE/1/15/1078 |
Natpar |
Norwegia |
17.08.2020 |
|
UE/1/16/1094 |
Ninlaro |
Islandia |
7.12.2020 |
|
UE/2/15/186 |
Novaquin |
Islandia |
24.07.2020 |
|
UE/2/15/186 |
Novaquin |
Norwegia |
10.08.2020 |
|
UE/1/15/1043 |
Nucala |
Islandia |
24.08.2020 |
|
UE/1/15/1043 |
Nucala |
Liechtenstein |
31.08.2020 |
|
UE/1/15/1043 |
Nucala |
Norwegia |
19.08.2020 |
|
UE/1/15/1035 |
Obizur |
Islandia |
9.12.2020 |
|
UE/1/15/1035 |
Obizur |
Norwegia |
26.11.2020 |
|
UE/1/15/1018 |
Omidria |
Islandia |
10.08.2020 |
|
UE/1/15/1018 |
Omidria |
Liechtenstein |
31.08.2020 |
|
UE/1/15/1018 |
Omidria |
Norwegia |
10.08.2020 |
|
UE/1/15/1070 |
Oncaspar |
Islandia |
7.12.2020 |
|
UE/1/15/1070 |
Oncaspar |
Norwegia |
26.11.2020 |
|
UE/1/18/1345 |
Ondexxya |
Norwegia |
13.08.2020 |
|
UE/1/15/1059 |
Orkambi |
Islandia |
7.12.2020 |
|
UE/1/15/1059 |
Orkambi |
Norwegia |
23.11.2020 |
|
UE/1/15/1071 |
Pemetrexed Accord |
Islandia |
6.11.2020 |
|
EU1/15/1071 |
Pemetrexed Accord |
Norwegia |
9.10.2020 |
|
UE/1/15/1057 |
Pemetrexed Hospira |
Islandia |
14.08.2020 |
|
UE/1/15/1057 |
Pemetrexed Hospira |
Norwegia |
21.08.2020 |
|
UE/1/15/1038 |
Pemetrexed medac |
Islandia |
26.08.2020 |
|
UE/1/15/1038 |
Pemetrexed medac |
Liechtenstein |
31.08.2020 |
|
UE/1/15/1038 |
Pemetrexed medac |
Norwegia |
3.09.2020 |
|
UE/1/15/1037 |
Pemetrexed Sandoz |
Islandia |
31.08.2020 |
|
UE/1/15/1037 |
Pemetrexed Sandoz |
Liechtenstein |
31.08.2020 |
|
UE/1/15/1037 |
Pemetrexed Sandoz |
Norwegia |
3.09.2020 |
|
UE/1/19/1388 |
Polivy |
Norwegia |
17.12.2020 |
|
UE/1/15/1056 |
Praxbind |
Islandia |
11.08.2020 |
|
UE/1/15/1056 |
Praxbind |
Liechtenstein |
31.08.2020 |
|
UE/1/15/1056 |
Praxbind |
Norwegia |
10.08.2020 |
|
UE/1/15/1027 |
Pregabalin Accord |
Islandia |
20.07.2020 |
|
UE/1/15/1027 |
Pregabalin Accord |
Liechtenstein |
31.08.2020 |
|
UE/1/15/1027 |
Pregabalin Accord |
Norwegia |
14.07.2020 |
|
UE/1/15/1011 |
Pregabalin Sandoz |
Islandia |
17.07.2020 |
|
UE/1/15/1011 |
Pregabalin Sandoz |
Norwegia |
13.07.2020 |
|
UE/1/15/1012 |
Pregabalin Sandoz GmbH |
Islandia |
17.07.2020 |
|
UE/1/15/1012 |
Pregabalin Sandoz GmbH |
Norwegia |
13.07.2020 |
|
UE/1/10/618 |
Prolia |
Norwegia |
14.08.2020 |
|
UE/1/16/1090 |
Rasagiline Mylan |
Islandia |
9.12.2020 |
|
UE/1/16/1090 |
Rasagiline Mylan |
Norwegia |
26.11.2020 |
|
UE/1/15/1062 |
Ravicti |
Islandia |
27.08.2020 |
|
UE/1/15/1062 |
Ravicti |
Liechtenstein |
31.08.2020 |
|
UE/1/15/1062 |
Ravicti |
Norwegia |
3.09.2020 |
|
UE/1/15/1020 |
Raxone |
Islandia |
14.08.2020 |
|
UE/1/15/1020 |
Raxone |
Liechtenstein |
31.08.2020 |
|
UE/1/15/1020 |
Raxone |
Norwegia |
19.08.2020 |
|
UE/2/15/191 |
Simparica |
Islandia |
26.08.2020 |
|
UE/2/15/191 |
Simparica |
Liechtenstein |
31.08.2020 |
|
UE/2/15/191 |
Simparica |
Norwegia |
2.09.2020 |
|
UE/1/15/1072 |
Spectrila |
Islandia |
15.10.2020 |
|
UE/1/15/1072 |
Spectrila |
Norwegia |
29.09.2020 |
|
UE/2/15/190 |
Suvaxyn Circo + MH RTU |
Islandia |
21.09.2020 |
|
UE/2/15/190 |
Suvaxyn Circo + MH RTU |
Liechtenstein |
31.08.2020 |
|
UE/2/15/190 |
Suvaxyn Circo + MH RTU |
Norwegia |
29.09.2020 |
|
UE/1/13/902 |
Translarna |
Islandia |
11.08.2020 |
|
UE/1/13/902 |
Translarna |
Norwegia |
20.08.2020 |
|
UE/2/15/184 |
UpCard |
Islandia |
17.07.2020 |
|
UE/2/15/184 |
Upcard |
Norwegia |
3.07.2020 |
|
UE/1/15/1083 |
Uptravi |
Norwegia |
21.12.2020 |
|
UE/1/15/1079 |
VAXELIS |
Islandia |
13.10.2020 |
|
UE/1/15/1079 |
Vaxelis |
Norwegia |
15.10.2020 |
|
UE/2/15/188 |
Vectormune ND |
Liechtenstein |
31.08.2020 |
|
UE/2/15/188 |
Vectormune ND |
Norwegia |
29.07.2020 |
|
UE/1/19/1385 |
VITRAKVI |
Islandia |
28.08.2020 |
|
UE/1/19/1385 |
VITRAKVI |
Liechtenstein |
31.08.2020 |
|
UE/1/19/1385 |
VITRAKVI |
Norwegia |
7.09.2020 |
|
UE/1/11/710 |
Votubia |
Islandia |
10.08.2020 |
|
UE/1/11/710 |
Votubia |
Liechtenstein |
31.08.2020 |
|
UE/1/11/710 |
Votubia |
Norwegia |
10.08.2020 |
|
UE/1/10/646 |
VPRIV |
Islandia |
10.08.2020 |
|
UE/1/10/646 |
VPRIV |
Liechtenstein |
31.08.2020 |
|
UE/1/10/646 |
VPRIV |
Norwegia |
10.08.2020 |
|
UE/1/15/1042 |
Zalviso |
Islandia |
15.10.2020 |
|
UE/1/15/1042 |
Zalviso |
Norwegia |
7.10.2020 |
|
UE/1/16/1093 |
Zonisamide Mylan |
Norwegia |
15.12.2020 |
|
UE/2/15/189 |
Zycortal |
Islandia |
27.08.2020 |
|
UE/2/15/189 |
Zycortal |
Liechtenstein |
31.08.2020 |
|
UE/2//15/189 |
Zycortal |
Norwegia |
3.09.2020 |
ZAŁĄCZNIK III
Wykaz przedłużonych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2020 r. w państwach EOG–EFTA przedłużono następujące pozwolenia na dopuszczenie do obrotu:
|
Numer UE |
Produkt |
Państwo |
Data udzielenia pozwolenia |
|
UE/1/14/980/008-011 |
Cosentyx |
Islandia |
9.12.2020 |
|
UE/1/14/980/008-011 |
Cosentyx |
Norwegia |
30.11.2020 |
|
UE/1/16/1116/002 |
Epclusa |
Islandia |
31.08.2020 |
|
UE/1/16/1116/002 |
Epclusa |
Norwegia |
3.09.2020 |
|
UE/1/14/958/003-005 |
Harvoni |
Islandia |
21.07.2020 |
|
UE/1/14/958 |
Harvoni |
Norwegia |
14.07.2020 |
|
UE/1/16/1095/009 |
IDELVION |
Islandia |
27.08.2020 |
|
UE/1/16/1095/009 |
IDELVION |
Norwegia |
3.09.2020 |
|
UE/1/12/782/007 |
Kalydeco |
Islandia |
9.12.2020 |
|
UE/1/12/782 |
Kalydeco |
Norwegia |
25.11.2020 |
|
UE/1/15/1071/004-007 |
Pemetrexed Accord |
Islandia |
8.12.2020 |
|
UE/1/15/1071 |
Pemetrexed Accord |
Norwegia |
16.11.2020 |
|
UE/1/15/1057/004-006 |
Pemetrexed Hospira |
Islandia |
15.10.2020 |
|
UE/1/15/1057 |
Pemetrexed Hospira |
Norwegia |
30.09.2020 |
|
UE/1/14/934 |
Plegridy |
Norwegia |
14.12.2020 |
|
UE/1/15/1031/019-020 |
Praluent |
Islandia |
24.08.2020 |
|
UE/1/13/894/003-005 |
Sovaldi |
Islandia |
20.07.2020 |
|
UE/1/13/894 |
Sovaldi |
Norwegia |
3.07.2020 |
|
UE/1/06/359/007-018 |
Suboxone |
Islandia |
21.07.2020 |
|
UE/1/06/359/007-018 |
Suboxone |
Norwegia |
17.07.2020 |
|
UE/1/18/1306/002 |
Symkevi |
Islandia |
9.12.2020 |
|
UE/1/18/1306 |
Symkevi |
Norwegia |
25.11.2020 |
|
UE/1/14/956/011-016 |
Trulicity |
Islandia |
9.12.2020 |
|
UE/1/14/956/011-016 |
Trulicity |
Norwegia |
2.12.2020 |
|
UE/1/19/1371/002-003 |
Ultomiris |
Islandia |
3.12.2020 |
|
UE/1/19/1371/002-003 |
Ultomiris |
Norwegia |
25.11.2020 |
|
UE/1/14/943/005 |
Velphoro |
Islandia |
27.11.2020 |
|
UE/1/14/943/005 |
Velphoro |
Norwegia |
23.11.2020 |
ZAŁĄCZNIK IV
Wykaz wycofanych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2020 r. w państwach EOG–EFTA wycofano następujące pozwolenia na dopuszczenie do obrotu:
|
Numer UE |
Produkt |
Państwo |
Data wycofania |
|
UE/1/18/1269 |
Alpivab |
Islandia |
9.12.2020 |
|
UE/1/18/1269 |
Alpivab |
Norwegia |
10.12.2020 |
|
UE/1/10/623 |
Clopidogrel/Acetylsalicylic acid Zentiva |
Islandia |
14.08.2020 |
|
UE/1/18/1300 |
Duzallo |
Islandia |
11.08.2020 |
|
UE/1/18/1300 |
Duzallo |
Norwegia |
10.09.2020 |
|
UE/1/13/895 |
Kolbam |
Islandia |
20.07.2020 |
|
UE/1/13/895 |
Kolbam |
Norwegia |
11.08.2020 |
|
UE/1/00/149 |
Panretin |
Islandia |
13.11.2020 |
|
UE/1/19/1401 |
Qtrilmet |
Islandia |
24.08.2020 |
|
UE/1/19/1401 |
Qtrilmet |
Liechtenstein |
31.08.2020 |
|
UE/1/19/1401 |
Qtrilmet |
Norwegia |
8.10.2020 |
|
UE/1/20/1463 |
Qutavina |
Islandia |
10.12.2020 |
|
UE/1/20/1463 |
Qutavina |
Norwegia |
18.12.2020 |
|
UE/1/10/634 |
Ribavirin Mylan |
Islandia |
5.11.2020 |
|
UE/1/10/634 |
Ribavirin Mylan |
Norwegia |
5.11.2020 |
|
UE/1/07/388 |
Sebivo |
Islandia |
27.11.2020 |
|
UE/1/07/388 |
Sebivo |
Norwegia |
23.11.2020 |
|
UE/2/09/099 |
Suvaxyn PCV |
Islandia |
24.07.2020 |
|
UE/1/12/752 |
Vepacel |
Islandia |
14.10.2020 |
|
UE/1/12/752 |
Vepacel |
Norwegia |
8.10.2020 |
|
UE/1/96/009 |
Zerit |
Islandia |
17.07.2020 |
|
UE/1/96/009 |
Zerit |
Norwegia |
8.07.2020 |
|
UE/2/09/105 |
Zulvac 8 Bovis |
Islandia |
12.11.2020 |
|
UE/2/09/105 |
Zulvac 8 Bovis |
Norwegia |
11.11.2020 |
|
UE/1/15/1080 |
Zurampic |
Islandia |
12.08.2020 |
|
UE/1/15/1080 |
Zurampic |
Liechtenstein |
31.08.2020 |
|
UE/1/15/1080 |
Zurampic |
Norwegia |
10.09.2020 |
ZAŁĄCZNIK V
Wykaz zawieszonych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2020 r. w państwach EOG–EFTA zawieszono następujące pozwolenia na dopuszczenie do obrotu:
|
Numer UE |
Produkt |
Państwo |
Data zawieszenia |
|
UE/1/12/750 |
Esmya |
Islandia |
26.08.2020 |
|
UE/1/18/1309 |
Ulipristal Acetate Gedeon Richter 5 |
Islandia |
26.08.2020 |