|
12.8.2021 |
HR |
Službeni list Europske unije |
C 324/16 |
Lijekovi – Popis odobrenja za stavljanje u promet izdanih u državama EFTA-e koje su članice EGP-a u drugoj polovini 2020.
(2021/C 324/10)
Pododbor I. za slobodno kretanje robe
Na znanje Zajedničkom odboru EGP-a
S obzirom na Odluku Zajedničkog odbora EGP-a br. 74/1999 od 28. svibnja 1999. Zajednički odbor EGP-a poziva se da na svojem sastanku 19. ožujka 2021. primi na znanje sljedeće popise odobrenja za stavljanje u promet lijekova za razdoblje od 1. srpnja do 31. prosinca 2020.:
|
Prilog I. |
Popis novih odobrenja za stavljanje u promet |
|
Prilog II. |
Popis obnovljenih odobrenja za stavljanje u promet |
|
Prilog III. |
Popis proširenih odobrenja za stavljanje u promet |
|
Prilog IV. |
Popis oduzetih odobrenja za stavljanje u promet |
|
Prilog V. |
Popis privremeno oduzetih odobrenja za stavljanje u promet |
PRILOG I.
Popis novih odobrenja za stavljanje u promet
U razdoblju od 1. srpnja do 31. prosinca 2020. u državama EFTA-e koje su članice EGP-a izdana su sljedeća odobrenja za stavljanje u promet:
|
Broj EU |
Proizvod |
Država |
Datum odobrenja |
|
EU/1/20/1476 |
Adakveo |
Island |
6.11.2020. |
|
EU/1/20/1476 |
Adakveo |
Norveška |
5.11.2020. |
|
EU/1/20/1458 |
Apixaban Accord |
Island |
10.8.2020. |
|
EU/1/20/1458 |
Apixaban Accord |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1458 |
Apixaban Accord |
Norveška |
10.8.2020. |
|
EU/1/20/1469 |
Arikayce liposomal |
Norveška |
2.11.2020. |
|
EU/1/20/1469 |
Arikayce liposomal |
Island |
5.11.2020. |
|
EU/1/20/1475 |
Arsenic trioxide medac |
Island |
14.10.2020. |
|
EU/1/20/1475 |
Arsenic trioxide medac |
Norveška |
29.9.2020. |
|
EU/1/20/1454 |
Aybintio |
Island |
25.8.2020. |
|
EU/120/1454 |
Aybintio |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1454 |
Aybintio |
Norveška |
25.8.2020. |
|
EU/1/20/1473 |
AYVAKYT |
Island |
14.10.2020. |
|
EU/1/20/1473 |
Ayvakyt |
Norveška |
29.9.2020. |
|
EU/1/17/1214 |
Bavencio |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1474 |
Blenrep |
Island |
14.9.2020. |
|
EU/1/20/1474 |
Blenrep |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1474 |
Blenrep |
Norveška |
2.9.2020. |
|
EU/1/19/1403 |
Budesonid/Formoterol Teva Pharma B.V. |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1448 |
Cabazitaxel Accord |
Island |
3.9.2020. |
|
EU/1/20/1448 |
Cabazitaxel Accord |
Norveška |
28.10.2020. |
|
EU/1/20/1479 |
Calquence |
Island |
10.11.2020. |
|
EU/1/20/1479 |
Calquence |
Norveška |
11.11.2020. |
|
EU/2/20/264 |
Circomax Myco |
Norveška |
16.12.2020. |
|
EU/1/20/1528 |
Comirnaty |
Island |
21.12.2020. |
|
EU/1/20/1528 |
Comirnaty |
Norveška |
21.12.2020. |
|
EU/1/20/1451 |
Daurismo |
Island |
20.7.2020. |
|
EU/1/20/1451 |
Daurismo |
Norveška |
3.7.2020. |
|
EU/1/20/1438 |
Enerzair Breezhaler |
Island |
21.7.2020. |
|
EU/1/20/1438 |
Enezair Breezhaler |
Norveška |
14.7.2020. |
|
EU/2/20/262 |
Enteroporc Coli AC |
Norveška |
16.12.2020. |
|
EU/1/20/1472 |
Equidacent |
Island |
14.10.2020. |
|
EU/1/20/1472 |
Equidacent |
Norveška |
29.9.2020. |
|
EU/1/20/1489 |
Exparel liposomal |
Island |
3.12.2020. |
|
EU/1/20/1489 |
Exparel liposomal |
Norveška |
24.11.2020. |
|
EU/1/20/1477 |
Fampridine Accord |
Island |
15.10.2020. |
|
EU/1/20/1477 |
Fampridine Accord |
Norveška |
1.10.2020. |
|
EU/1/20/1450 |
Fingolimod Accord |
Island |
20.7.2020. |
|
EU/1/20/1450 |
Fingolimod Accord |
Norveška |
13.7.2020. |
|
EU/1/20/1465 |
Gencebok |
Island |
25.8.2020. |
|
EU/1/20/1465 |
Gencebok |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1465 |
Gencebok |
Norveška |
2.9.2020. |
|
EU/1/20/1446 |
Hepcludex |
Island |
12.8.2020. |
|
EU/1/20/1446 |
Hepcludex |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1446 |
Hepcludex |
Norveška |
10.8.2020. |
|
EU/1/20/1471 |
Idefirix |
Island |
2.9.2020. |
|
EU/1/20/1471 |
Idefirix |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1471 |
Idefirix |
Norveška |
8.9.2020. |
|
EU/2/20/258 |
Increxxa |
Island |
21.9.2020. |
|
EU/2/20/256 |
Innovax-ND-ILT |
Island |
16.10.2020. |
|
EU/1/20/1447 |
Insulin Aspart Sanofi |
Island |
20.7.2020. |
|
EU/1/20/144 |
Insulin aspart Sanofi |
Norveška |
3.7.2020. |
|
EU/1/20/1480 |
Jyseleca |
Island |
14.10.2020. |
|
EU/1/20/1480 |
Jyseleca |
Norveška |
30.9.2020. |
|
EU/1/20/1468 |
Kaftrio |
Island |
25.8.2020. |
|
EU/1/20/1468 |
Kaftrio |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1468 |
Kaftrio |
Norveška |
3.9.2020. |
|
EU/1/20/1494 |
Leqvio |
Norveška |
15.12.2020. |
|
EU/2/20/261 |
Librela |
Island |
13.11.2020. |
|
EU/1/20/1462 |
Livogiva |
Island |
2.9.2020. |
|
EU/1/20/1462 |
Livogiva |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1462 |
Livogiva |
Norveška |
7.9.2020. |
|
EU/1/20/1483 |
MenQuadfi |
Island |
2.12.2020. |
|
EU/1/20/1483 |
MenQuadfi |
Norveška |
30.11.2020. |
|
EU/1/20/1470 |
Methylthioninium chloride Cosmo |
Island |
27.8.2020. |
|
EU/1/20/1470 |
Methylthioninium chloride Cosmo |
Norveška |
3.9.2020. |
|
EU/2/20/259 |
Mhyosphere PCV ID |
Island |
14.10.2020. |
|
EU/2/19/247 |
Mirataz |
Norveška |
11.8.2020. |
|
EU/1/20/1445 |
Mvabea |
Island |
21.7.2020. |
|
EU/1/20/1445 |
Mvabea |
Norveška |
13.7.2020. |
|
EU/2/20/265 |
Nobivac DP PLUS |
Norveška |
17.12.2020. |
|
EU/1/20/1424 |
Nustendi |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1486 |
Nyvepria |
Island |
3.12.2020. |
|
EU/1/20/1486 |
Nyvepria |
Norveška |
24.11.2020. |
|
EU/1/20/1485 |
Obiltoxaximab SFL |
Island |
8.12.2020. |
|
EU/1/20/1485 |
Obiltoxaximab SFL |
Norveška |
24.11.2020. |
|
EU/2/20/260 |
OvuGel |
Island |
8.12.2020. |
|
EU/1/20/1496 |
Oxlumo |
Island |
2.12.2020. |
|
EU/1/20/1496 |
Oxlumo |
Norveška |
24.11.2020. |
|
EU/1/20/1487 |
PHELINUN |
Island |
3.12.2020. |
|
EU/1/20/1487 |
PHELINUN |
Norveška |
2.12.2020. |
|
EU/1/20/1497 |
Phesgo |
Norveška |
23.12.2020. |
|
EU/1/20/1455 |
Piqray |
Island |
11.8.2020. |
|
EU/1/20/1455 |
Piqray |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1455 |
Piqray |
Norveška |
10.8.2020. |
|
EU/1/20/1437 |
Pretomanid FGK |
Island |
12.8.2020. |
|
EU/1/20/1437 |
Pretomanid FGK |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1437 |
Pretomanid FGK |
Norveška |
10.8.2020. |
|
EU/2/20/254 |
Prevexxion RN |
Island |
10.8.2020. |
|
EU/2/20/254 |
Prevexxion RN |
Norveška |
10.8.2020. |
|
EU/2/20/255 |
Prevexxion RN+HVT+IBD |
Island |
27.7.2020. |
|
EU/2/20/255 |
Prevexxion RN+HVT+IBD |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1463 |
Qutavina |
Island |
2.9.2020. |
|
EU/1/20/1463 |
Qutavina |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1463 |
Qutavina |
Norveška |
7.9.2020. |
|
EU/1/20/1452 |
Reblozyl |
Island |
20.7.2020. |
|
EU/1/20/1452 |
Reblozyl |
Norveška |
3.7.2020. |
|
EU/2/20/263 |
Rexxolide |
Norveška |
16.12.2020. |
|
EU/1/20/1488 |
Rivaroxaban Accord |
Island |
1.12.2020. |
|
EU/1/20/1488 |
Rivaroxaban Accord |
Norveška |
2.12.2020. |
|
EU/1/20/1460 |
Rozlytrek |
Island |
12.8.2020. |
|
EU/1/20/1460 |
Rozlytrek |
Norveška |
10.8.2020. |
|
EU/1/20/1484 |
Supemtek |
Island |
1.12.2020. |
|
EU/1/20/1484 |
Supemtek |
Norveška |
24.11.2020. |
|
EU/1/20/1492 |
Tecartus |
Norveška |
30.12.2020. |
|
EU/1/20/1498 |
TRIXEO AEROSPHERE |
Norveška |
16.12.2020. |
|
EU/2/20/257 |
Tulinovet |
Island |
21.9.2020. |
|
EU/2/20/257 |
Tulinovet |
Norveška |
8.12.2020. |
|
EU/1/20/1459 |
Veklury |
Island |
3.7.2020. |
|
EU/1/20/1459 |
Veklury |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1459 |
Veklury |
Norveška |
3.7.2020. |
|
EU/1/20/1481 |
Vocabria |
Norveška |
30.12.2020. |
|
EU/1/20/1457 |
Xenleta |
Island |
11.8.2020. |
|
EU/1/20/1457 |
Xenleta |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1457 |
Xenleta |
Norveška |
10.8.2020. |
|
EU/1/20/1444 |
Zabdeno |
Island |
21.7.2020. |
|
EU/1/20/1444 |
Zabdeno |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1444 |
Zabdeno |
Norveška |
14.7.2020. |
|
EU/1/20/1456 |
Zercepac |
Island |
11.8.2020. |
|
EU/1/20/1456 |
Zercepac |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1456 |
Zercepac |
Norveška |
10.8.2020. |
|
EU/1/20/1440 |
Zimbus Breezhaler |
Island |
21.7.2020. |
|
EU/1/20/1440 |
Zimbus Breezhaler |
Lihtenštajn |
31.8.2020. |
|
EU/1/20/1440 |
Zimbus Breezhaler |
Norveška |
13.7.2020. |
|
EU/1/20/1478 |
ZYNRELEF |
Island |
16.10.2020. |
|
EU/1/20/1478 |
Zynrelef |
Norveška |
1.10.2020. |
PRILOG II.
Popis obnovljenih odobrenja za stavljanje u promet
U razdoblju od 1. srpnja do 31. prosinca 2020. u državama EFTA-e koje su članice EGP-a obnovljena su sljedeća odobrenja za stavljanje u promet:
|
Broj EU |
Proizvod |
Država |
Datum odobrenja |
|
EU/1/12/794 |
ADCETRIS |
Island |
2.10.2020. |
|
EU/1/12/794 |
ADCETRIS |
Lihtenštajn |
31.8.2020. |
|
EU/1/12/794 |
ADCETRIS |
Norveška |
14.10.2020. |
|
EU/1/15/1045 |
Aripiprazole Accord |
Island |
15.10.2020. |
|
EU/1/15/1045 |
Aripiprazole Accord |
Norveška |
9.10.2020. |
|
EU/1/15/1029 |
Aripiprazole Sandoz |
Island |
20.7.2020. |
|
EU/1/15/1029 |
Aripiprazole Sandoz |
Norveška |
21.7.2020. |
|
EU/1/15/1063 |
Armisarte |
Island |
25.8.2020. |
|
EU/1/15/1063 |
Armisarte |
Lihtenštajn |
31.8.2020. |
|
EU/1/15/1063 |
Armisarte |
Norveška |
28.8.2020. |
|
EU/1/17/1214 |
Bavencio |
Island |
10.8.2020. |
|
EU/1/17/1214 |
Bavencio |
Norveška |
25.8.2020. |
|
EU/1/15/1074 |
Benepali |
Island |
7.12.2020. |
|
EU/1/15/1074 |
Benepali |
Norveška |
26.11.2020. |
|
EU/1/15/1073 |
Briviact |
Island |
19.10.2020. |
|
EU/1/15/1073 |
Briviact |
Norveška |
20.10.2020. |
|
EU/2/15/183 |
Canigen L4 |
Island |
26.8.2020. |
|
EU/1/15/1055 |
CIAMBRA |
Island |
11.8.2020. |
|
EU/1/15/1055 |
Ciambra |
Norveška |
10.8.2020. |
|
EU/1/15/1054 |
Cinacalcet Mylan |
Island |
13.10.2020. |
|
EU/1/15/1054 |
Cinacalcet Mylan |
Norveška |
1.10.2020. |
|
EU/1/15/1048 |
Cotellic |
Island |
17.7.2020. |
|
EU/1/15/1048 |
Cotellic |
Norveška |
3.7.2020. |
|
EU/1/15/1036 |
CRESEMBA |
Island |
24.8.2020. |
|
EU/1/15/1036 |
Cresemba |
Lihtenštajn |
31.8.2020. |
|
EU/1/15/1036 |
Cresemba |
Norveška |
28.8.2020. |
|
EU/1/15/1028 |
Duloxetine Zentiva |
Island |
24.8.2020. |
|
EU/1/15/1028 |
Duloxetine Zentiva |
Lihtenštajn |
31.8.2020. |
|
EU/1/15/1028 |
Duloxetine Zentiva |
Norveška |
2.9.2020. |
|
EU/1/15/1051 |
Ebymect |
Island |
3.9.2020. |
|
EU/1/15/1051 |
Ebymect |
Norveška |
7.9.2020. |
|
EU/1/15/1052 |
Edistride |
Island |
15.10.2020. |
|
EU/1/15/1052 |
Edistride |
Norveška |
1.10.2020. |
|
EU/1/15/1046 |
Elocta |
Island |
25.8.2020. |
|
EU/1/15/1046 |
Elocta |
Lihtenštajn |
31.8.2020. |
|
EU/1/15/1058 |
Entresto |
Island |
20.7.2020. |
|
EU/1/15/1058 |
Entresto |
Norveška |
3.7.2020. |
|
EU/1/15/1069 |
Episalvan |
Island |
13.10.2020. |
|
EU/1/15/1069 |
Episalvan |
Norveška |
7.10.2020. |
|
EU/1/15/1065 |
Eptifibatide Accord |
Island |
15.10.2020. |
|
EU/1/15/1065 |
Eptifibatide Accord |
Norveška |
8.10.2020. |
|
EU/1/19/1392 |
Ervebo |
Island |
21.9.2020. |
|
EU1/19/1392 |
Ervebo |
Lihtenštajn |
31.8.2020. |
|
EU/1/19/1392 |
Ervebo |
Norveška |
21.9.2020. |
|
EU/1/15/1075 |
Feraccru |
Island |
10.12.2020. |
|
EU/1/15/1075 |
Feraccru |
Norveška |
3.12.2020. |
|
EU/2/15/185 |
Fortekor Plus |
Island |
10.8.2020. |
|
EU/2/15/185 |
Fortekor Plus |
Lihtenštajn |
31.8.2020. |
|
EU/2/15/185 |
Fortekor Plus |
Norveška |
10.8.2020. |
|
EU/1/15/1061 |
Genvoya |
Island |
2.10.2020. |
|
EU/1/15/1061 |
Genvoya |
Norveška |
29.9.2020. |
|
EU/1/11/677 |
Gilenya |
Island |
27.11.2020. |
|
EU/1/11/677 |
Gilenya |
Norveška |
23.11.2020. |
|
EU/1/15/1008 |
Hetlioz |
Island |
20.7.2020. |
|
EU/1/15/1008 |
Hetlioz |
Norveška |
13.7.2020. |
|
EU/1/15/1064 |
Imlygic |
Island |
7.12.2020. |
|
EU/1/15/1064 |
Imlygic |
Norveška |
23.11.2020. |
|
EU/2/15/193 |
Imrestor |
Island |
16.10.2020. |
|
EU/2/15/193 |
Imrestor |
Norveška |
9.10.2020. |
|
EU/1/15/1040 |
Intuniv |
Island |
17.7.2020. |
|
EU/1/15/1040 |
Intuniv |
Norveška |
3.7.2020. |
|
EU/1/11/676 |
Jevtana |
Norveška |
22.12.2020. |
|
EU/1/15/1076 |
Kovaltry |
Island |
13.10.2020. |
|
EU/1/15/1076 |
Kovaltry |
Norveška |
7.10.2020. |
|
EU/1/15/1060 |
Kyprolis |
Island |
17.7.2020. |
|
EU/1/15/1060 |
Kyprolis |
Norveška |
3.7.2020. |
|
EU/1/15/1067 |
Lopinavir/Ritonavir Mylan |
Island |
27.11.2020. |
|
EU/1/15/1067 |
Lopinavir/Ritonavir Mylan |
Norveška |
24.11.2020. |
|
EU/1/15/1078 |
Natpar |
Norveška |
17.8.2020. |
|
EU/1/16/1094 |
Ninlaro |
Island |
7.12.2020. |
|
EU/2/15/186 |
Novaquin |
Island |
24.7.2020. |
|
EU/2/15/186 |
Novaquin |
Norveška |
10.8.2020. |
|
EU/1/15/1043 |
Nucala |
Island |
24.8.2020. |
|
EU/1/15/1043 |
Nucala |
Lihtenštajn |
31.8.2020. |
|
EU/1/15/1043 |
Nucala |
Norveška |
19.8.2020. |
|
EU/1/15/1035 |
Obizur |
Island |
9.12.2020. |
|
EU/1/15/1035 |
Obizur |
Norveška |
26.11.2020. |
|
EU/1/15/1018 |
Omidria |
Island |
10.8.2020. |
|
EU/1/15/1018 |
Omidria |
Lihtenštajn |
31.8.2020. |
|
EU/1/15/1018 |
Omidria |
Norveška |
10.8.2020. |
|
EU/1/15/1070 |
Oncaspar |
Island |
7.12.2020. |
|
EU/1/15/1070 |
Oncaspar |
Norveška |
26.11.2020. |
|
EU/1/18/1345 |
Ondexxya |
Norveška |
13.8.2020. |
|
EU/1/15/1059 |
Orkambi |
Island |
7.12.2020. |
|
EU/1/15/1059 |
Orkambi |
Norveška |
23.11.2020. |
|
EU/1/15/1071 |
Pemetrexed Accord |
Island |
6.11.2020. |
|
EU1/15/1071 |
Pemetrexed Accord |
Norveška |
9.10.2020. |
|
EU/1/15/1057 |
Pemetrexed Hospira |
Island |
14.8.2020. |
|
EU/1/15/1057 |
Pemetrexed Hospira |
Norveška |
21.8.2020. |
|
EU/1/15/1038 |
Pemetrexed medac |
Island |
26.8.2020. |
|
EU/1/15/1038 |
Pemetrexed medac |
Lihtenštajn |
31.8.2020. |
|
EU/1/15/1038 |
Pemetrexed medac |
Norveška |
3.9.2020. |
|
EU/1/15/1037 |
Pemetrexed Sandoz |
Island |
31.8.2020. |
|
EU/1/15/1037 |
Pemetrexed Sandoz |
Lihtenštajn |
31.8.2020. |
|
EU/1/15/1037 |
Pemetrexed Sandoz |
Norveška |
3.9.2020. |
|
EU/1/19/1388 |
Polivy |
Norveška |
17.12.2020. |
|
EU/1/15/1056 |
Praxbind |
Island |
11.8.2020. |
|
EU/1/15/1056 |
Praxbind |
Lihtenštajn |
31.8.2020. |
|
EU/1/15/1056 |
Praxbind |
Norveška |
10.8.2020. |
|
EU/1/15/1027 |
Pregabalin Accord |
Island |
20.7.2020. |
|
EU/1/15/1027 |
Pregabalin Accord |
Lihtenštajn |
31.8.2020. |
|
EU/1/15/1027 |
Pregabalin Accord |
Norveška |
14.7.2020. |
|
EU/1/15/1011 |
Pregabalin Sandoz |
Island |
17.7.2020. |
|
EU/1/15/1011 |
Pregabalin Sandoz |
Norveška |
13.7.2020. |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Island |
17.7.2020. |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Norveška |
13.7.2020. |
|
EU/1/10/618 |
Prolia |
Norveška |
14.8.2020. |
|
EU/1/16/1090 |
Rasagiline Mylan |
Island |
9.12.2020. |
|
EU/1/16/1090 |
Rasagiline Mylan |
Norveška |
26.11.2020. |
|
EU/1/15/1062 |
Ravicti |
Island |
27.8.2020. |
|
EU/1/15/1062 |
Ravicti |
Lihtenštajn |
31.8.2020. |
|
EU/1/15/1062 |
Ravicti |
Norveška |
3.9.2020. |
|
EU/1/15/1020 |
Raxone |
Island |
14.8.2020. |
|
EU/1/15/1020 |
Raxone |
Lihtenštajn |
31.8.2020. |
|
EU/1/15/1020 |
Raxone |
Norveška |
19.8.2020. |
|
EU/2/15/191 |
Simparica |
Island |
26.8.2020. |
|
EU/2/15/191 |
Simparica |
Lihtenštajn |
31.8.2020. |
|
EU/2/15/191 |
Simparica |
Norveška |
2.9.2020. |
|
EU/1/15/1072 |
Spectrila |
Island |
15.10.2020. |
|
EU/1/15/1072 |
Spectrila |
Norveška |
29.9.2020. |
|
EU/2/15/190 |
Suvaxyn Circo + MH RTU |
Island |
21.9.2020. |
|
EU/2/15/190 |
Suvaxyn Circo + MH RTU |
Lihtenštajn |
31.8.2020. |
|
EU/2/15/190 |
Suvaxyn Circo + MH RTU |
Norveška |
29.9.2020. |
|
EU/1/13/902 |
Translarna |
Island |
11.8.2020. |
|
EU/1/13/902 |
Translarna |
Norveška |
20.8.2020. |
|
EU/2/15/184 |
UpCard |
Island |
17.7.2020. |
|
EU/2/15/184 |
Upcard |
Norveška |
3.7.2020. |
|
EU/1/15/1083 |
Uptravi |
Norveška |
21.12.2020. |
|
EU/1/15/1079 |
VAXELIS |
Island |
13.10.2020. |
|
EU/1/15/1079 |
Vaxelis |
Norveška |
15.10.2020. |
|
EU/2/15/188 |
Vectormune ND |
Lihtenštajn |
31.8.2020. |
|
EU/2/15/188 |
Vectormune ND |
Norveška |
29.7.2020. |
|
EU/1/19/1385 |
VITRAKVI |
Island |
28.8.2020. |
|
EU/1/19/1385 |
VITRAKVI |
Lihtenštajn |
31.8.2020. |
|
EU/1/19/1385 |
VITRAKVI |
Norveška |
7.9.2020. |
|
EU/1/11/710 |
Votubia |
Island |
10.8.2020. |
|
EU/1/11/710 |
Votubia |
Lihtenštajn |
31.8.2020. |
|
EU/1/11/710 |
Votubia |
Norveška |
10.8.2020. |
|
EU/1/10/646 |
VPRIV |
Island |
10.8.2020. |
|
EU/1/10/646 |
VPRIV |
Lihtenštajn |
31.8.2020. |
|
EU/1/10/646 |
VPRIV |
Norveška |
10.8.2020. |
|
EU/1/15/1042 |
Zalviso |
Island |
15.10.2020. |
|
EU/1/15/1042 |
Zalviso |
Norveška |
7.10.2020. |
|
EU/1/16/1093 |
Zonisamide Mylan |
Norveška |
15.12.2020. |
|
EU/2/15/189 |
Zycortal |
Island |
27.8.2020. |
|
EU/2/15/189 |
Zycortal |
Lihtenštajn |
31.8.2020. |
|
EU/2/15/189 |
Zycortal |
Norveška |
3.9.2020. |
PRILOG III.
Popis proširenih odobrenja za stavljanje u promet
U razdoblju od 1. srpnja do 31. prosinca 2020. u državama EFTA-e koje su članice EGP-a proširena su sljedeća odobrenja za stavljanje u promet:
|
Broj EU |
Proizvod |
Država |
Datum odobrenja |
|
EU/1/14/980/008-011 |
Cosentyx |
Island |
9.12.2020. |
|
EU/1/14/980/008-011 |
Cosentyx |
Norveška |
30.11.2020. |
|
EU/1/16/1116/002 |
Epclusa |
Island |
31.8.2020. |
|
EU/1/16/1116/002 |
Epclusa |
Norveška |
3.9.2020. |
|
EU/1/14/958/003-005 |
Harvoni |
Island |
21.7.2020. |
|
EU/1/14/958 |
Harvoni |
Norveška |
14.7.2020. |
|
EU/1/16/1095/009 |
IDELVION |
Island |
27.8.2020. |
|
EU/1/16/1095/009 |
IDELVION |
Norveška |
3.9.2020. |
|
EU/1/12/782/007 |
Kalydeco |
Island |
9.12.2020. |
|
EU/1/12/782 |
Kalydeco |
Norveška |
25.11.2020. |
|
EU/1/15/1071/004-007 |
Pemetrexed Accord |
Island |
8.12.2020. |
|
EU/1/15/1071 |
Pemetrexed Accord |
Norveška |
16.11.2020. |
|
EU/1/15/1057/004-006 |
Pemetrexed Hospira |
Island |
15.10.2020. |
|
EU/1/15/1057 |
Pemetrexed Hospira |
Norveška |
30.9.2020. |
|
EU/1/14/934 |
Plegridy |
Norveška |
14.12.2020. |
|
EU/1/15/1031/019-020 |
Praluent |
Island |
24.8.2020. |
|
EU/1/13/894/003-005 |
Sovaldi |
Island |
20.7.2020. |
|
EU/1/13/894 |
Sovaldi |
Norveška |
3.7.2020. |
|
EU/1/06/359/007-018 |
Suboxone |
Island |
21.7.2020. |
|
EU/1/06/359/007-018 |
Suboxone |
Norveška |
17.7.2020. |
|
EU/1/18/1306/002 |
Symkevi |
Island |
9.12.2020. |
|
EU/1/18/1306 |
Symkevi |
Norveška |
25.11.2020. |
|
EU/1/14/956/011-016 |
Trulicity |
Island |
9.12.2020. |
|
EU/1/14/956/011-016 |
Trulicity |
Norveška |
2.12.2020. |
|
EU/1/19/1371/002-003 |
Ultomiris |
Island |
3.12.2020. |
|
EU/1/19/1371/002-003 |
Ultomiris |
Norveška |
25.11.2020. |
|
EU/1/14/943/005 |
Velphoro |
Island |
27.11.2020. |
|
EU/1/14/943/005 |
Velphoro |
Norveška |
23.11.2020. |
PRILOG IV.
Popis oduzetih odobrenja za stavljanje u promet
U razdoblju od 1. srpnja do 31. prosinca 2020. u državama EFTA-e koje su članice EGP-a oduzeta su sljedeća odobrenja za stavljanje u promet:
|
Broj EU |
Proizvod |
Država |
Datum oduzimanja |
|
EU/1/18/1269 |
Alpivab |
Island |
9.12.2020. |
|
EU/1/18/1269 |
Alpivab |
Norveška |
10.12.2020. |
|
EU/1/10/623 |
Clopidogrel/Acetylsalicylic acid Zentiva |
Island |
14.8.2020. |
|
EU/1/18/1300 |
Duzallo |
Island |
11.8.2020. |
|
EU/1/18/1300 |
Duzallo |
Norveška |
10.9.2020. |
|
EU/1/13/895 |
Kolbam |
Island |
20.7.2020. |
|
EU/1/13/895 |
Kolbam |
Norveška |
11.8.2020. |
|
EU/1/00/149 |
Panretin |
Island |
13.11.2020. |
|
EU/1/19/1401 |
Qtrilmet |
Island |
24.8.2020. |
|
EU/1/19/1401 |
Qtrilmet |
Lihtenštajn |
31.8.2020. |
|
EU/1/19/1401 |
Qtrilmet |
Norveška |
8.10.2020. |
|
EU/1/20/1463 |
Qutavina |
Island |
10.12.2020. |
|
EU/1/20/1463 |
Qutavina |
Norveška |
18.12.2020. |
|
EU/1/10/634 |
Ribavirin Mylan |
Island |
5.11.2020. |
|
EU/1/10/634 |
Ribavirin Mylan |
Norveška |
5.11.2020. |
|
EU/1/07/388 |
Sebivo |
Island |
27.11.2020. |
|
EU/1/07/388 |
Sebivo |
Norveška |
23.11.2020. |
|
EU/2/09/099 |
Suvaxyn PCV |
Island |
24.7.2020. |
|
EU/1/12/752 |
Vepacel |
Island |
14.10.2020. |
|
EU/1/12/752 |
Vepacel |
Norveška |
8.10.2020. |
|
EU/1/96/009 |
Zerit |
Island |
17.7.2020. |
|
EU/1/96/009 |
Zerit |
Norveška |
8.7.2020. |
|
EU/2/09/105 |
Zulvac 8 Bovis |
Island |
12.11.2020. |
|
EU/2/09/105 |
Zulvac 8 Bovis |
Norveška |
11.11.2020. |
|
EU/1/15/1080 |
Zurampic |
Island |
12.8.2020. |
|
EU/1/15/1080 |
Zurampic |
Lihtenštajn |
31.8.2020. |
|
EU/1/15/1080 |
Zurampic |
Norveška |
10.9.2020. |
PRILOG V.
Popis privremeno oduzetih odobrenja za stavljanje u promet
U razdoblju od 1. srpnja do 31. prosinca 2020. u državama EFTA-e koje su članice EGP-a privremeno su oduzeta sljedeća odobrenja za stavljanje u promet:
|
Broj EU |
Proizvod |
Država |
Datum privremenog oduzimanja |
|
EU/1/12/750 |
Esmya |
Island |
26.8.2020. |
|
EU/1/18/1309 |
Ulipristal Acetate Gedeon Richter 5 |
Island |
26.8.2020. |