|
12.8.2021 |
CS |
Úřední věstník Evropské unie |
C 324/16 |
Léčivé přípravky – Seznam registrací udělených státy ESVO EHP v druhé polovině roku 2020
(2021/C 324/10)
Podvýbor i pro volný pohyb zboží
Na vědomí Smíšenému výboru EHP
S ohledem na rozhodnutí Smíšeného výboru EHP č. 74/1999 ze dne 28. května 1999 se Smíšený výbor EHP vyzývá, aby na svém zasedání konaném dne 19. března 2021 vzal na vědomí tyto seznamy registrací léčivých přípravků za období od 1. července do 31. prosince 2020:
|
Příloha I |
Seznam nových registrací |
|
Příloha II |
Seznam obnovených registrací |
|
Příloha III |
Seznam prodloužených registrací |
|
Příloha IV |
Seznam zrušených registrací |
|
Příloha V |
Seznam pozastavených registrací |
PŘÍLOHA I
Seznam nových registrací
Státy ESVO EHP udělily v období od 1. července do 31. prosince 2020 tyto registrace:
|
Číslo EU |
Přípravek |
Země |
Datum registrace |
|
EU/1/20/1476 |
Adakveo |
Island |
6.11.2020 |
|
EU/1/20/1476 |
Adakveo |
Norsko |
5.11.2020 |
|
EU/1/20/1458 |
Apixaban Accord |
Island |
10.8.2020 |
|
EU/1/20/1458 |
Apixaban Accord |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1458 |
Apixaban Accord |
Norsko |
10.8.2020 |
|
EU/1/20/1469 |
Arikayce liposomal |
Norsko |
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 |
Norsko |
29.9.2020 |
|
EU/1/20/1454 |
Aybintio |
Island |
25.8.2020 |
|
EU/120/1454 |
Aybintio |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1454 |
Aybintio |
Norsko |
25.8.2020 |
|
EU/1/20/1473 |
AYVAKYT |
Island |
14.10.2020 |
|
EU/1/20/1473 |
Ayvakyt |
Norsko |
29.9.2020 |
|
EU/1/17/1214 |
Bavencio |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1474 |
Blenrep |
Island |
14.9.2020 |
|
EU/1/20/1474 |
Blenrep |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1474 |
Blenrep |
Norsko |
2.9.2020 |
|
EU/1/19/1403 |
Budesonid/Formoterol Teva Pharma B.V. |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1448 |
Cabazitaxel Accord |
Island |
3.9.2020 |
|
EU/1/20/1448 |
Cabazitaxel Accord |
Norsko |
28.10.2020 |
|
EU/1/20/1479 |
Calquence |
Island |
10.11.2020 |
|
EU/1/20/1479 |
Calquence |
Norsko |
11.11.2020 |
|
EU/2/20/264 |
Circomax Myco |
Norsko |
16.12.2020 |
|
EU/1/20/1528 |
Comirnaty |
Island |
21.12.2020 |
|
EU/1/20/1528 |
Comirnaty |
Norsko |
21.12.2020 |
|
EU/1/20/1451 |
Daurismo |
Island |
20.7.2020 |
|
EU/1/20/1451 |
Daurismo |
Norsko |
3.7.2020 |
|
EU/1/20/1438 |
Enerzair Breezhaler |
Island |
21.7.2020 |
|
EU/1/20/1438 |
Enezair Breezhaler |
Norsko |
14.7.2020 |
|
EU/2/20/262 |
Enteroporc Coli AC |
Norsko |
16.12.2020 |
|
EU/1/20/1472 |
Equidacent |
Island |
14.10.2020 |
|
EU/1/20/1472 |
Equidacent |
Norsko |
29.9.2020 |
|
EU/1/20/1489 |
Exparel liposomal |
Island |
3.12.2020 |
|
EU/1/20/1489 |
Exparel liposomal |
Norsko |
24.11.2020 |
|
EU/1/20/1477 |
Fampridine Accord |
Island |
15.10.2020 |
|
EU/1/20/1477 |
Fampridine Accord |
Norsko |
1.10.2020 |
|
EU/1/20/1450 |
Fingolimod Accord |
Island |
20.7.2020 |
|
EU/1/20/1450 |
Fingolimod Accord |
Norsko |
13.7.2020 |
|
EU/1/20/1465 |
Gencebok |
Island |
25.8.2020 |
|
EU/1/20/1465 |
Gencebok |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1465 |
Gencebok |
Norsko |
2.9.2020 |
|
EU/1/20/1446 |
Hepcludex |
Island |
12.8.2020 |
|
EU/1/20/1446 |
Hepcludex |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1446 |
Hepcludex |
Norsko |
10.8.2020 |
|
EU/1/20/1471 |
Idefirix |
Island |
2.9.2020 |
|
EU/1/20/1471 |
Idefirix |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1471 |
Idefirix |
Norsko |
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 |
Norsko |
3.7.2020 |
|
EU/1/20/1480 |
Jyseleca |
Island |
14.10.2020 |
|
EU/1/20/1480 |
Jyseleca |
Norsko |
30.9.2020 |
|
EU/1/20/1468 |
Kaftrio |
Island |
25.8.2020 |
|
EU/1/20/1468 |
Kaftrio |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1468 |
Kaftrio |
Norsko |
3.9.2020 |
|
EU/1/20/1494 |
Leqvio |
Norsko |
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 |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1462 |
Livogiva |
Norsko |
7.9.2020 |
|
EU/1/20/1483 |
MenQuadfi |
Island |
2.12.2020 |
|
EU/1/20/1483 |
MenQuadfi |
Norsko |
30.11.2020 |
|
EU/1/20/1470 |
Methylthioninium chloride Cosmo |
Island |
27.8.2020 |
|
EU/1/20/1470 |
Methylthioninium chloride Cosmo |
Norsko |
3.9.2020 |
|
EU/2/20/259 |
Mhyosphere PCV ID |
Island |
14.10.2020 |
|
EU/2/19/247 |
Mirataz |
Norsko |
11.8.2020 |
|
EU/1/20/1445 |
Mvabea |
Island |
21.7.2020 |
|
EU/1/20/1445 |
Mvabea |
Norsko |
13.7.2020 |
|
EU/2/20/265 |
Nobivac DP PLUS |
Norsko |
17.12.2020 |
|
EU/1/20/1424 |
Nustendi |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1486 |
Nyvepria |
Island |
3.12.2020 |
|
EU/1/20/1486 |
Nyvepria |
Norsko |
24.11.2020 |
|
EU/1/20/1485 |
Obiltoxaximab SFL |
Island |
8.12.2020 |
|
EU/1/20/1485 |
Obiltoxaximab SFL |
Norsko |
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 |
Norsko |
24.11.2020 |
|
EU/1/20/1487 |
PHELINUN |
Island |
3.12.2020 |
|
EU/1/20/1487 |
PHELINUN |
Norsko |
2.12.2020 |
|
EU/1/20/1497 |
Phesgo |
Norsko |
23.12.2020 |
|
EU/1/20/1455 |
Piqray |
Island |
11.8.2020 |
|
EU/1/20/1455 |
Piqray |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1455 |
Piqray |
Norsko |
10.8.2020 |
|
EU/1/20/1437 |
Pretomanid FGK |
Island |
12.8.2020 |
|
EU/1/20/1437 |
Pretomanid FGK |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1437 |
Pretomanid FGK |
Norsko |
10.8.2020 |
|
EU/2/20/254 |
Prevexxion RN |
Island |
10.8.2020 |
|
EU/2/20/254 |
Prevexxion RN |
Norsko |
10.8.2020 |
|
EU/2/20/255 |
Prevexxion RN+HVT+IBD |
Island |
27.7.2020 |
|
EU/2/20/255 |
Prevexxion RN+HVT+IBD |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1463 |
Qutavina |
Island |
2.9.2020 |
|
EU/1/20/1463 |
Qutavina |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1463 |
Qutavina |
Norsko |
7.9.2020 |
|
EU/1/20/1452 |
Reblozyl |
Island |
20.7.2020 |
|
EU/1/20/1452 |
Reblozyl |
Norsko |
3.7.2020 |
|
EU/2/20/263 |
Rexxolide |
Norsko |
16.12.2020 |
|
EU/1/20/1488 |
Rivaroxaban Accord |
Island |
1.12.2020 |
|
EU/1/20/1488 |
Rivaroxaban Accord |
Norsko |
2.12.2020 |
|
EU/1/20/1460 |
Rozlytrek |
Island |
12.8.2020 |
|
EU/1/20/1460 |
Rozlytrek |
Norsko |
10.8.2020 |
|
EU/1/20/1484 |
Supemtek |
Island |
1.12.2020 |
|
EU/1/20/1484 |
Supemtek |
Norsko |
24.11.2020 |
|
EU/1/20/1492 |
Tecartus |
Norsko |
30.12.2020 |
|
EU/1/20/1498 |
TRIXEO AEROSPHERE |
Norsko |
16.12.2020 |
|
EU/2/20/257 |
Tulinovet |
Island |
21.9.2020 |
|
EU/2/20/257 |
Tulinovet |
Norsko |
8.12.2020 |
|
EU/1/20/1459 |
Veklury |
Island |
3.7.2020 |
|
EU1/20/1459 |
Veklury |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1459 |
Veklury |
Norsko |
3.7.2020 |
|
EU/1/20/1481 |
Vocabria |
Norsko |
30.12.2020 |
|
EU/1/20/1457 |
Xenleta |
Island |
11.8.2020 |
|
EU/1/20/1457 |
Xenleta |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1457 |
Xenleta |
Norsko |
10.8.2020 |
|
EU/1/20/1444 |
Zabdeno |
Island |
21.7.2020 |
|
EU/1/20/1444 |
Zabdeno |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1444 |
Zabdeno |
Norsko |
14.7.2020 |
|
EU/1/20/1456 |
Zercepac |
Island |
11.8.2020 |
|
EU/1/20/1456 |
Zercepac |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1456 |
Zercepac |
Norsko |
10.8.2020 |
|
EU/1/20/1440 |
Zimbus Breezhaler |
Island |
21.7.2020 |
|
EU/1/20/1440 |
Zimbus Breezhaler |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/20/1440 |
Zimbus Breezhaler |
Norsko |
13.7.2020 |
|
EU/1/20/1478 |
ZYNRELEF |
Island |
16.10.2020 |
|
EU/1/20/1478 |
Zynrelef |
Norsko |
1.10.2020 |
PŘÍLOHA II
Seznam obnovených registrací
Státy ESVO EHP obnovily v období od 1. července do 31. prosince 2020 tyto registrace:
|
Číslo EU |
Přípravek |
Země |
Datum registrace |
|
EU/1/12/794 |
ADCETRIS |
Island |
2.10.2020 |
|
EU/1/12/794 |
ADCETRIS |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/12/794 |
ADCETRIS |
Norsko |
14.10.2020 |
|
EU/1/15/1045 |
Aripiprazole Accord |
Island |
15.10.2020 |
|
EU/1/15/1045 |
Aripiprazole Accord |
Norsko |
9.10.2020 |
|
EU/1/15/1029 |
Aripiprazole Sandoz |
Island |
20.7.2020 |
|
EU/1/15/1029 |
Aripiprazole Sandoz |
Norsko |
21.7.2020 |
|
EU/1/15/1063 |
Armisarte |
Island |
25.8.2020 |
|
EU/1/15/1063 |
Armisarte |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/15/1063 |
Armisarte |
Norsko |
28.8.2020 |
|
EU/1/17/1214 |
Bavencio |
Island |
10.8.2020 |
|
EU/1/17/1214 |
Bavencio |
Norsko |
25.8.2020 |
|
EU/1/15/1074 |
Benepali |
Island |
7.12.2020 |
|
EU/1/15/1074 |
Benepali |
Norsko |
26.11.2020 |
|
EU/1/15/1073 |
Briviact |
Island |
19.10.2020 |
|
EU/1/15/1073 |
Briviact |
Norsko |
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 |
Norsko |
10.8.2020 |
|
EU/1/15/1054 |
Cinacalcet Mylan |
Island |
13.10.2020 |
|
EU/1/15/1054 |
Cinacalcet Mylan |
Norsko |
1.10.2020 |
|
EU/1/15/1048 |
Cotellic |
Island |
17.7.2020 |
|
EU/1/15/1048 |
Cotellic |
Norsko |
3.7.2020 |
|
EU/1/15/1036 |
CRESEMBA |
Island |
24.8.2020 |
|
EU/1/15/1036 |
Cresemba |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/15/1036 |
Cresemba |
Norsko |
28.8.2020 |
|
EU/1/15/1028 |
Duloxetine Zentiva |
Island |
24.8.2020 |
|
EU/1/15/1028 |
Duloxetine Zentiva |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/15/1028 |
Duloxetine Zentiva |
Norsko |
2.9.2020 |
|
EU/1/15/1051 |
Ebymect |
Island |
3.9.2020 |
|
EU/1/15/1051 |
Ebymect |
Norsko |
7.9.2020 |
|
EU/1/15/1052 |
Edistride |
Island |
15.10.2020 |
|
EU/1/15/1052 |
Edistride |
Norsko |
1.10.2020 |
|
EU/1/15/1046 |
Elocta |
Island |
25.8.2020 |
|
EU/1/15/1046 |
Elocta |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/15/1058 |
Entresto |
Island |
20.7.2020 |
|
EU/1/15/1058 |
Entresto |
Norsko |
3.7.2020 |
|
EU/1/15/1069 |
Episalvan |
Island |
13.10.2020 |
|
EU/1/15/1069 |
Episalvan |
Norsko |
7.10.2020 |
|
EU/1/15/1065 |
Eptifibatide Accord |
Island |
15.10.2020 |
|
EU/1/15/1065 |
Eptifibatide Accord |
Norsko |
8.10.2020 |
|
EU/1/19/1392 |
Ervebo |
Island |
21.9.2020 |
|
EU1/19/1392 |
Ervebo |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/19/1392 |
Ervebo |
Norsko |
21.9.2020 |
|
EU/1/15/1075 |
Feraccru |
Island |
10.12.2020 |
|
EU/1/15/1075 |
Feraccru |
Norsko |
3.12.2020 |
|
EU/2/15/185 |
Fortekor Plus |
Island |
10.8.2020 |
|
EU/2/15/185 |
Fortekor Plus |
Lichtenštejnsko |
31.8.2020 |
|
EU/2/15/185 |
Fortekor Plus |
Norsko |
10.8.2020 |
|
EU/1/15/1061 |
Genvoya |
Island |
2.10.2020 |
|
EU/1/15/1061 |
Genvoya |
Norsko |
29.9.2020 |
|
EU/1/11/677 |
Gilenya |
Island |
27.11.2020 |
|
EU/1/11/677 |
Gilenya |
Norsko |
23.11.2020 |
|
EU/1/15/1008 |
Hetlioz |
Island |
20.7.2020 |
|
EU/1/15/1008 |
Hetlioz |
Norsko |
13.7.2020 |
|
EU/1/15/1064 |
Imlygic |
Island |
7.12.2020 |
|
EU/1/15/1064 |
Imlygic |
Norsko |
23.11.2020 |
|
EU/2/15/193 |
Imrestor |
Island |
16.10.2020 |
|
EU/2/15/193 |
Imrestor |
Norsko |
9.10.2020 |
|
EU/1/15/1040 |
Intuniv |
Island |
17.7.2020 |
|
EU/1/15/1040 |
Intuniv |
Norsko |
3.7.2020 |
|
EU/1/11/676 |
Jevtana |
Norsko |
22.12.2020 |
|
EU/1/15/1076 |
Kovaltry |
Island |
13.10.2020 |
|
EU/1/15/1076 |
Kovaltry |
Norsko |
7.10.2020 |
|
EU/1/15/1060 |
Kyprolis |
Island |
17.7.2020 |
|
EU/1/15/1060 |
Kyprolis |
Norsko |
3.7.2020 |
|
EU/1/15/1067 |
Lopinavir/Ritonavir Mylan |
Island |
27.11.2020 |
|
EU/1/15/1067 |
Lopinavir/Ritonavir Mylan |
Norsko |
24.11.2020 |
|
EU/1/15/1078 |
Natpar |
Norsko |
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 |
Norsko |
10.8.2020 |
|
EU/1/15/1043 |
Nucala |
Island |
24.8.2020 |
|
EU/1/15/1043 |
Nucala |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/15/1043 |
Nucala |
Norsko |
19.8.2020 |
|
EU/1/15/1035 |
Obizur |
Island |
9.12.2020 |
|
EU/1/15/1035 |
Obizur |
Norsko |
26.11.2020 |
|
EU/1/15/1018 |
Omidria |
Island |
10.8.2020 |
|
EU/1/15/1018 |
Omidria |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/15/1018 |
Omidria |
Norsko |
10.8.2020 |
|
EU/1/15/1070 |
Oncaspar |
Island |
7.12.2020 |
|
EU/1/15/1070 |
Oncaspar |
Norsko |
26.11.2020 |
|
EU/1/18/1345 |
Ondexxya |
Norsko |
13.8.2020 |
|
EU/1/15/1059 |
Orkambi |
Island |
7.12.2020 |
|
EU/1/15/1059 |
Orkambi |
Norsko |
23.11.2020 |
|
EU/1/15/1071 |
Pemetrexed Accord |
Island |
6.11.2020 |
|
EU1/15/1071 |
Pemetrexed Accord |
Norsko |
9.10.2020 |
|
EU/1/15/1057 |
Pemetrexed Hospira |
Island |
14.8.2020 |
|
EU/1/15/1057 |
Pemetrexed Hospira |
Norsko |
21.8.2020 |
|
EU/1/15/1038 |
Pemetrexed medac |
Island |
26.8.2020 |
|
EU/1/15/1038 |
Pemetrexed medac |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/15/1038 |
Pemetrexed medac |
Norsko |
3.9.2020 |
|
EU/1/15/1037 |
Pemetrexed Sandoz |
Island |
31.8.2020 |
|
EU/1/15/1037 |
Pemetrexed Sandoz |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/15/1037 |
Pemetrexed Sandoz |
Norsko |
3.9.2020 |
|
EU/1/19/1388 |
Polivy |
Norsko |
17.12.2020 |
|
EU/1/15/1056 |
Praxbind |
Island |
11.8.2020 |
|
EU/1/15/1056 |
Praxbind |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/15/1056 |
Praxbind |
Norsko |
10.8.2020 |
|
EU/1/15/1027 |
Pregabalin Accord |
Island |
20.7.2020 |
|
EU/1/15/1027 |
Pregabalin Accord |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/15/1027 |
Pregabalin Accord |
Norsko |
14.7.2020 |
|
EU/1/15/1011 |
Pregabalin Sandoz |
Island |
17.7.2020 |
|
EU/1/15/1011 |
Pregabalin Sandoz |
Norsko |
13.7.2020 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Island |
17.7.2020 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Norsko |
13.7.2020 |
|
EU/1/10/618 |
Prolia |
Norsko |
14.8.2020 |
|
EU/1/16/1090 |
Rasagiline Mylan |
Island |
9.12.2020 |
|
EU/1/16/1090 |
Rasagiline Mylan |
Norsko |
26.11.2020 |
|
EU/1/15/1062 |
Ravicti |
Island |
27.8.2020 |
|
EU/1/15/1062 |
Ravicti |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/15/1062 |
Ravicti |
Norsko |
3.9.2020 |
|
EU/1/15/1020 |
Raxone |
Island |
14.8.2020 |
|
EU/1/15/1020 |
Raxone |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/15/1020 |
Raxone |
Norsko |
19.8.2020 |
|
EU/2/15/191 |
Simparica |
Island |
26.8.2020 |
|
EU/2/15/191 |
Simparica |
Lichtenštejnsko |
31.8.2020 |
|
EU/2/15/191 |
Simparica |
Norsko |
2.9.2020 |
|
EU/1/15/1072 |
Spectrila |
Island |
15.10.2020 |
|
EU/1/15/1072 |
Spectrila |
Norsko |
29.9.2020 |
|
EU/2/15/190 |
Suvaxyn Circo + MH RTU |
Island |
21.9.2020 |
|
EU/2/15/190 |
Suvaxyn Circo + MH RTU |
Lichtenštejnsko |
31.8.2020 |
|
EU/2/15/190 |
Suvaxyn Circo + MH RTU |
Norsko |
29.9.2020 |
|
EU/1/13/902 |
Translarna |
Island |
11.8.2020 |
|
EU/1/13/902 |
Translarna |
Norsko |
20.8.2020 |
|
EU/2/15/184 |
UpCard |
Island |
17.7.2020 |
|
EU/2/15/184 |
Upcard |
Norsko |
3.7.2020 |
|
EU/1/15/1083 |
Uptravi |
Norsko |
21.12.2020 |
|
EU/1/15/1079 |
VAXELIS |
Island |
13.10.2020 |
|
EU/1/15/1079 |
Vaxelis |
Norsko |
15.10.2020 |
|
EU/2/15/188 |
Vectormune ND |
Lichtenštejnsko |
31.8.2020 |
|
EU/2/15/188 |
Vectormune ND |
Norsko |
29.7.2020 |
|
EU/1/19/1385 |
VITRAKVI |
Island |
28.8.2020 |
|
EU/1/19/1385 |
VITRAKVI |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/19/1385 |
VITRAKVI |
Norsko |
7.9.2020 |
|
EU/1/11/710 |
Votubia |
Island |
10.8.2020 |
|
EU/1/11/710 |
Votubia |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/11/710 |
Votubia |
Norsko |
10.8.2020 |
|
EU/1/10/646 |
VPRIV |
Island |
10.8.2020 |
|
EU/1/10/646 |
VPRIV |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/10/646 |
VPRIV |
Norsko |
10.8.2020 |
|
EU/1/15/1042 |
Zalviso |
Island |
15.10.2020 |
|
EU/1/15/1042 |
Zalviso |
Norsko |
7.10.2020 |
|
EU/1/16/1093 |
Zonisamide Mylan |
Norsko |
15.12.2020 |
|
EU/2/15/189 |
Zycortal |
Island |
27.8.2020 |
|
EU/2/15/189 |
Zycortal |
Lichtenštejnsko |
31.8.2020 |
|
EU/2//15/189 |
Zycortal |
Norsko |
3.9.2020 |
PŘÍLOHA III
Seznam prodloužených registrací
Státy ESVO EHP prodloužily v období od 1. července do 31. prosince 2020 tyto registrace:
|
Číslo EU |
Přípravek |
Země |
Datum registrace |
|
EU/1/14/980/008-011 |
Cosentyx |
Island |
9.12.2020 |
|
EU/1/14/980/008-011 |
Cosentyx |
Norsko |
30.11.2020 |
|
EU/1/16/1116/002 |
Epclusa |
Island |
31.8.2020 |
|
EU/1/16/1116/002 |
Epclusa |
Norsko |
3.9.2020 |
|
EU/1/14/958/003-005 |
Harvoni |
Island |
21.7.2020 |
|
EU/1/14/958 |
Harvoni |
Norsko |
14.7.2020 |
|
EU/1/16/1095/009 |
IDELVION |
Island |
27.8.2020 |
|
EU/1/16/1095/009 |
IDELVION |
Norsko |
3.9.2020 |
|
EU/1/12/782/007 |
Kalydeco |
Island |
9.12.2020 |
|
EU/1/12/782 |
Kalydeco |
Norsko |
25.11.2020 |
|
EU/1/15/1071/004-007 |
Pemetrexed Accord |
Island |
8.12.2020 |
|
EU/1/15/1071 |
Pemetrexed Accord |
Norsko |
16.11.2020 |
|
EU/1/15/1057/004-006 |
Pemetrexed Hospira |
Island |
15.10.2020 |
|
EU/1/15/1057 |
Pemetrexed Hospira |
Norsko |
30.9.2020 |
|
EU/1/14/934 |
Plegridy |
Norsko |
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 |
Norsko |
3.7.2020 |
|
EU/1/06/359/007-018 |
Suboxone |
Island |
21.7.2020 |
|
EU/1/06/359/007-018 |
Suboxone |
Norsko |
17.7.2020 |
|
EU/1/18/1306/002 |
Symkevi |
Island |
9.12.2020 |
|
EU/1/18/1306 |
Symkevi |
Norsko |
25.11.2020 |
|
EU/1/14/956/011-016 |
Trulicity |
Island |
9.12.2020 |
|
EU/1/14/956/011-016 |
Trulicity |
Norsko |
2.12.2020 |
|
EU/1/19/1371/002-003 |
Ultomiris |
Island |
3.12.2020 |
|
EU/1/19/1371/002-003 |
Ultomiris |
Norsko |
25.11.2020 |
|
EU/1/14/943/005 |
Velphoro |
Island |
27.11.2020 |
|
EU/1/14/943/005 |
Velphoro |
Norsko |
23.11.2020 |
PŘÍLOHA IV
Seznam zrušených registrací
Státy ESVO EHP zrušily v období od 1. července do 31. prosince 2020 tyto registrace:
|
Číslo EU |
Přípravek |
Země |
Datum zrušení |
|
EU/1/18/1269 |
Alpivab |
Island |
9.12.2020 |
|
EU/1/18/1269 |
Alpivab |
Norsko |
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 |
Norsko |
10.9.2020 |
|
EU/1/13/895 |
Kolbam |
Island |
20.7.2020 |
|
EU/1/13/895 |
Kolbam |
Norsko |
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 |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/19/1401 |
Qtrilmet |
Norsko |
8.10.2020 |
|
EU/1/20/1463 |
Qutavina |
Island |
10.12.2020 |
|
EU/1/20/1463 |
Qutavina |
Norsko |
18.12.2020 |
|
EU/1/10/634 |
Ribavirin Mylan |
Island |
5.11.2020 |
|
EU/1/10/634 |
Ribavirin Mylan |
Norsko |
5.11.2020 |
|
EU/1/07/388 |
Sebivo |
Island |
27.11.2020 |
|
EU/1/07/388 |
Sebivo |
Norsko |
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 |
Norsko |
8.10.2020 |
|
EU/1/96/009 |
Zerit |
Island |
17.7.2020 |
|
EU/1/96/009 |
Zerit |
Norsko |
8.7.2020 |
|
EU/2/09/105 |
Zulvac 8 Bovis |
Island |
12.11.2020 |
|
EU/2/09/105 |
Zulvac 8 Bovis |
Norsko |
11.11.2020 |
|
EU/1/15/1080 |
Zurampic |
Island |
12.8.2020 |
|
EU/1/15/1080 |
Zurampic |
Lichtenštejnsko |
31.8.2020 |
|
EU/1/15/1080 |
Zurampic |
Norsko |
10.9.2020 |
PŘÍLOHA V
Seznam pozastavených registrací
Státy ESVO EHP pozastavily v období od 1. července do 31. prosince 2020 tyto registrace:
|
Číslo EU |
Přípravek |
Země |
Datum pozastavení |
|
EU/1/12/750 |
Esmya |
Island |
26.8.2020 |
|
EU/1/18/1309 |
Ulipristal Acetate Gedeon Richter 5 |
Island |
26.8.2020 |