|
12.8.2021 |
MT |
Il-Ġurnal Uffiċjali tal-Unjoni Ewropea |
C 324/16 |
Prodotti mediċinali — Lista ta’ awtorizzazzjonijiet tal-kummerċjalizzazzjoni mogħtija mill-Istati taż-ŻEE-EFTA għat-tieni nofs tas-sena 2020
(2021/C 324/10)
Sottokumitat I dwar il-moviment liberu tal-merkanzija
Għall-attenzjoni tal-Kumitat Konġunt taż-ŻEE
B’referenza għad-Deċiżjoni tal-Kumitat Konġunt taż-ŻEE Nru 74/1999 tat-28 ta’ Mejju 1999, il-Kumitat Konġunt taż-ŻEE huwa mistieden li jinnota l-listi li ġejjin rigward l-awtorizzazzjonijiet għat-tqegħid fis-suq ta’ prodotti mediċinali għall-perjodu mill-1 ta’ Lulju sal-31 ta’ Diċembru 2020, fil-laqgħa tagħhom tad-19 ta’ Marzu 2021:
|
Annness I |
Lista ta’ awtorizzazzjonijiet tal-kummerċjalizzazzjoni ġodda |
|
Anness II |
Lista ta’ awtorizzazzjonijiet tal-kummerċjalizzazzjoni mġedda |
|
Anness III |
Lista ta’ awtorizzazzjonijiet tal-kummerċjalizzazzjoni estiżi |
|
Anness IV |
Lista ta’ awtorizzazzjonijiet ta’ kummerċjalizzazzjoni rtirati |
|
Anness V |
Lista ta’ awtorizzazzjonijiet tal-kummerċjalizzazzjoni sospiżi |
ANNESS I
Lista ta’ awtorizzazzjonijiet tal-kummerċjalizzazzjoni ġodda
L-awtorizzazzjonijiet ta’ kummerċjalizzazzjoni li ġejjin ingħataw fl-Istati EFTA taż-ŻEE matul il-perjodu bejn l-1 ta’ Lulju u l-31 ta’ Diċembru 2020:
|
Numru tal-UE |
Prodott |
Pajjiż |
Data tal-awtorizzazzjoni |
|
UE/1/20/1476 |
Adakveo |
L-Iżlanda |
6.11.2020 |
|
UE/1/20/1476 |
Adakveo |
In-Norveġja |
5.11.2020 |
|
UE/1/20/1458 |
Apixaban Accord |
L-Iżlanda |
10.8.2020 |
|
UE/1/20/1458 |
Apixaban Accord |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1458 |
Apixaban Accord |
In-Norveġja |
10.8.2020 |
|
UE/1/20/1469 |
Arikayce liposomal |
In-Norveġja |
2.11.2020 |
|
UE/1/20/1469 |
Arikayce liposomal |
L-Iżlanda |
5.11.2020 |
|
UE/1/20/1475 |
Arsenic trioxide medac |
L-Iżlanda |
14.10.2020 |
|
UE/1/20/1475 |
Arsenic trioxide medac |
In-Norveġja |
29.9.2020 |
|
UE/1/20/1454 |
Aybintio |
L-Iżlanda |
25.8.2020 |
|
EU/120/1454 |
Aybintio |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1454 |
Aybintio |
In-Norveġja |
25.8.2020 |
|
UE/1/20/1473 |
AYVAKYT |
L-Iżlanda |
14.10.2020 |
|
UE/1/20/1473 |
Ayvakyt |
In-Norveġja |
29.9.2020 |
|
UE/1/17/1214 |
Bavencio |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1474 |
Blenrep |
L-Iżlanda |
14.9.2020 |
|
UE/1/20/1474 |
Blenrep |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1474 |
Blenrep |
In-Norveġja |
2.9.2020 |
|
UE/1/19/1403 |
Budesonid/Formoterol Teva Pharma B.V. |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1448 |
Cabazitaxel Accord |
L-Iżlanda |
3.9.2020 |
|
UE/1/20/1448 |
Cabazitaxel Accord |
In-Norveġja |
28.10.2020 |
|
UE/1/20/1479 |
Calquence |
L-Iżlanda |
10.11.2020 |
|
UE/1/20/1479 |
Calquence |
In-Norveġja |
11.11.2020 |
|
UE/2/20/264 |
Circomax Myco |
In-Norveġja |
16.12.2020 |
|
UE/1/20/1528 |
Comirnaty |
L-Iżlanda |
21.12.2020 |
|
UE/1/20/1528 |
Comirnaty |
In-Norveġja |
21.12.2020 |
|
UE/1/20/1451 |
Daurismo |
L-Iżlanda |
20.7.2020 |
|
UE/1/20/1451 |
Daurismo |
In-Norveġja |
3.7.2020 |
|
UE/1/20/1438 |
Enerzair Breezhaler |
L-Iżlanda |
21.7.2020 |
|
UE/1/20/1438 |
Enezair Breezhaler |
In-Norveġja |
14.7.2020 |
|
UE/2/20/262 |
Enteroporc Coli AC |
In-Norveġja |
16.12.2020 |
|
UE/1/20/1472 |
Equidacent |
L-Iżlanda |
14.10.2020 |
|
UE/1/20/1472 |
Equidacent |
In-Norveġja |
29.9.2020 |
|
UE/1/20/1489 |
Exparel liposomal |
L-Iżlanda |
3.12.2020 |
|
UE/1/20/1489 |
Exparel liposomal |
In-Norveġja |
24.11.2020 |
|
UE/1/20/1477 |
Fampridine Accord |
L-Iżlanda |
15.10.2020 |
|
UE/1/20/1477 |
Fampridine Accord |
In-Norveġja |
1.10.2020 |
|
UE/1/20/1450 |
Fingolimod Accord |
L-Iżlanda |
20.7.2020 |
|
UE/1/20/1450 |
Fingolimod Accord |
In-Norveġja |
13.7.2020 |
|
UE/1/20/1465 |
Gencebok |
L-Iżlanda |
25.8.2020 |
|
UE/1/20/1465 |
Gencebok |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1465 |
Gencebok |
In-Norveġja |
2.9.2020 |
|
UE/1/20/1446 |
Hepcludex |
L-Iżlanda |
12.8.2020 |
|
UE/1/20/1446 |
Hepcludex |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1446 |
Hepcludex |
In-Norveġja |
10.8.2020 |
|
UE/1/20/1471 |
Idefirix |
L-Iżlanda |
2.9.2020 |
|
UE/1/20/1471 |
Idefirix |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1471 |
Idefirix |
In-Norveġja |
8.9.2020 |
|
UE/2/20/258 |
Increxxa |
L-Iżlanda |
21.9.2020 |
|
UE/2/20/256 |
Innovax-ND-ILT |
L-Iżlanda |
16.10.2020 |
|
UE/1/20/1447 |
Insulin Aspart Sanofi |
L-Iżlanda |
20.7.2020 |
|
UE/1/20/144 |
Insulin aspart Sanofi |
In-Norveġja |
3.7.2020 |
|
UE/1/20/1480 |
Jyseleca |
L-Iżlanda |
14.10.2020 |
|
UE/1/20/1480 |
Jyseleca |
In-Norveġja |
30.9.2020 |
|
UE/1/20/1468 |
Kaftrio |
L-Iżlanda |
25.8.2020 |
|
UE/1/20/1468 |
Kaftrio |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1468 |
Kaftrio |
In-Norveġja |
3.9.2020 |
|
UE/1/20/1494 |
Leqvio |
In-Norveġja |
15.12.2020 |
|
UE/2/20/261 |
Librela |
L-Iżlanda |
13.11.2020 |
|
UE/1/20/1462 |
Livogiva |
L-Iżlanda |
2.9.2020 |
|
UE/1/20/1462 |
Livogiva |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1462 |
Livogiva |
In-Norveġja |
7.9.2020 |
|
UE/1/20/1483 |
MenQuadfi |
L-Iżlanda |
2.12.2020 |
|
UE/1/20/1483 |
MenQuadfi |
In-Norveġja |
30.11.2020 |
|
UE/1/20/1470 |
Methylthioninium chloride Cosmo |
L-Iżlanda |
27.8.2020 |
|
UE/1/20/1470 |
Methylthioninium chloride Cosmo |
In-Norveġja |
3.9.2020 |
|
UE/2/20/259 |
Mhyosphere PCV ID |
L-Iżlanda |
14.10.2020 |
|
UE/2/19/247 |
Mirataz |
In-Norveġja |
11.8.2020 |
|
UE/1/20/1445 |
Mvabea |
L-Iżlanda |
21.7.2020 |
|
UE/1/20/1445 |
Mvabea |
In-Norveġja |
13.7.2020 |
|
UE/2/20/265 |
Nobivac DP PLUS |
In-Norveġja |
17.12.2020 |
|
UE/1/20/1424 |
Nustendi |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1486 |
Nyvepria |
L-Iżlanda |
3.12.2020 |
|
UE/1/20/1486 |
Nyvepria |
In-Norveġja |
24.11.2020 |
|
UE/1/20/1485 |
Obiltoxaximab SFL |
L-Iżlanda |
8.12.2020 |
|
UE/1/20/1485 |
Obiltoxaximab SFL |
In-Norveġja |
24.11.2020 |
|
UE/2/20/260 |
OvuGel |
L-Iżlanda |
8.12.2020 |
|
UE/1/20/1496 |
Oxlumo |
L-Iżlanda |
2.12.2020 |
|
UE/1/20/1496 |
Oxlumo |
In-Norveġja |
24.11.2020 |
|
UE/1/20/1487 |
PHELINUN |
L-Iżlanda |
3.12.2020 |
|
UE/1/20/1487 |
PHELINUN |
In-Norveġja |
2.12.2020 |
|
UE/1/20/1497 |
Phesgo |
In-Norveġja |
23.12.2020 |
|
UE/1/20/1455 |
Piqray |
L-Iżlanda |
11.8.2020 |
|
UE/1/20/1455 |
Piqray |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1455 |
Piqray |
In-Norveġja |
10.8.2020 |
|
UE/1/20/1437 |
Pretomanid FGK |
L-Iżlanda |
12.8.2020 |
|
UE/1/20/1437 |
Pretomanid FGK |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1437 |
Pretomanid FGK |
In-Norveġja |
10.8.2020 |
|
UE/2/20/254 |
Prevexxion RN |
L-Iżlanda |
10.8.2020 |
|
UE/2/20/254 |
Prevexxion RN |
In-Norveġja |
10.8.2020 |
|
UE/2/20/255 |
Prevexxion RN+HVT+IBD |
L-Iżlanda |
27.7.2020 |
|
UE/2/20/255 |
Prevexxion RN+HVT+IBD |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1463 |
Qutavina |
L-Iżlanda |
2.9.2020 |
|
UE/1/20/1463 |
Qutavina |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1463 |
Qutavina |
In-Norveġja |
7.9.2020 |
|
UE/1/20/1452 |
Reblozyl |
L-Iżlanda |
20.7.2020 |
|
UE/1/20/1452 |
Reblozyl |
In-Norveġja |
3.7.2020 |
|
UE/2/20/263 |
Rexxolide |
In-Norveġja |
16.12.2020 |
|
UE/1/20/1488 |
Rivaroxaban Accord |
L-Iżlanda |
1.12.2020 |
|
UE/1/20/1488 |
Rivaroxaban Accord |
In-Norveġja |
2.12.2020 |
|
UE/1/20/1460 |
Rozlytrek |
L-Iżlanda |
12.8.2020 |
|
UE/1/20/1460 |
Rozlytrek |
In-Norveġja |
10.8.2020 |
|
UE/1/20/1484 |
Supemtek |
L-Iżlanda |
1.12.2020 |
|
UE/1/20/1484 |
Supemtek |
In-Norveġja |
24.11.2020 |
|
UE/1/20/1492 |
Tecartus |
In-Norveġja |
30.12.2020 |
|
UE/1/20/1498 |
TRIXEO AEROSPHERE |
In-Norveġja |
16.12.2020 |
|
UE/2/20/257 |
Tulinovet |
L-Iżlanda |
21.9.2020 |
|
UE/2/20/257 |
Tulinovet |
In-Norveġja |
8.12.2020 |
|
UE/1/20/1459 |
Veklury |
L-Iżlanda |
3.7.2020 |
|
EU1/20/1459 |
Veklury |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1459 |
Veklury |
In-Norveġja |
3.7.2020 |
|
UE/1/20/1481 |
Vocabria |
In-Norveġja |
30.12.2020 |
|
UE/1/20/1457 |
Xenleta |
L-Iżlanda |
11.8.2020 |
|
UE/1/20/1457 |
Xenleta |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1457 |
Xenleta |
In-Norveġja |
10.8.2020 |
|
UE/1/20/1444 |
Zabdeno |
L-Iżlanda |
21.7.2020 |
|
UE/1/20/1444 |
Zabdeno |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1444 |
Zabdeno |
In-Norveġja |
14.7.2020 |
|
UE/1/20/1456 |
Zercepac |
L-Iżlanda |
11.8.2020 |
|
UE/1/20/1456 |
Zercepac |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1456 |
Zercepac |
In-Norveġja |
10.8.2020 |
|
UE/1/20/1440 |
Zimbus Breezhaler |
L-Iżlanda |
21.7.2020 |
|
UE/1/20/1440 |
Zimbus Breezhaler |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/20/1440 |
Zimbus Breezhaler |
In-Norveġja |
13.7.2020 |
|
UE/1/20/1478 |
ZYNRELEF |
L-Iżlanda |
16.10.2020 |
|
UE/1/20/1478 |
Zynrelef |
In-Norveġja |
1.10.2020 |
ANNESS II
Lista ta’ awtorizzazzjonijiet tal-kummerċjalizzazzjoni mġedda
L-awtorizzazzjonijiet ta’ kummerċjalizzazzjoni li ġejjin ġew imġedda fl-Istati EFTA taż-ŻEE matul il-perjodu bejn l-1 ta’ Lulju u l-31 ta’ Diċembru 2020:
|
Numru tal-UE |
Prodott |
Pajjiż |
Data tal-awtorizzazzjoni |
|
UE/1/12/794 |
ADCETRIS |
L-Iżlanda |
2.10.2020 |
|
UE/1/12/794 |
ADCETRIS |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/12/794 |
ADCETRIS |
In-Norveġja |
14.10.2020 |
|
UE/1/15/1045 |
Aripiprazole Accord |
L-Iżlanda |
15.10.2020 |
|
UE/1/15/1045 |
Aripiprazole Accord |
In-Norveġja |
9.10.2020 |
|
UE/1/15/1029 |
Aripiprazole Sandoz |
L-Iżlanda |
20.7.2020 |
|
UE/1/15/1029 |
Aripiprazole Sandoz |
In-Norveġja |
21.7.2020 |
|
UE/1/15/1063 |
Armisarte |
L-Iżlanda |
25.8.2020 |
|
UE/1/15/1063 |
Armisarte |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/15/1063 |
Armisarte |
In-Norveġja |
28.8.2020 |
|
UE/1/17/1214 |
Bavencio |
L-Iżlanda |
10.8.2020 |
|
UE/1/17/1214 |
Bavencio |
In-Norveġja |
25.8.2020 |
|
UE/1/15/1074 |
Benepali |
L-Iżlanda |
7.12.2020 |
|
UE/1/15/1074 |
Benepali |
In-Norveġja |
26.11.2020 |
|
UE/1/15/1073 |
Briviact |
L-Iżlanda |
19.10.2020 |
|
UE/1/15/1073 |
Briviact |
In-Norveġja |
20.10.2020 |
|
UE/2/15/183 |
Canigen L4 |
L-Iżlanda |
26.8.2020 |
|
UE/1/15/1055 |
CIAMBRA |
L-Iżlanda |
11.8.2020 |
|
UE/1/15/1055 |
Ciambra |
In-Norveġja |
10.8.2020 |
|
UE/1/15/1054 |
Cinacalcet Mylan |
L-Iżlanda |
13.10.2020 |
|
UE/1/15/1054 |
Cinacalcet Mylan |
In-Norveġja |
1.10.2020 |
|
UE/1/15/1048 |
Cotellic |
L-Iżlanda |
17.7.2020 |
|
UE/1/15/1048 |
Cotellic |
In-Norveġja |
3.7.2020 |
|
UE/1/15/1036 |
CRESEMBA |
L-Iżlanda |
24.8.2020 |
|
UE/1/15/1036 |
Cresemba |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/15/1036 |
Cresemba |
In-Norveġja |
28.8.2020 |
|
UE/1/15/1028 |
Duloxetine Zentiva |
L-Iżlanda |
24.8.2020 |
|
UE/1/15/1028 |
Duloxetine Zentiva |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/15/1028 |
Duloxetine Zentiva |
In-Norveġja |
2.9.2020 |
|
UE/1/15/1051 |
Ebymect |
L-Iżlanda |
3.9.2020 |
|
UE/1/15/1051 |
Ebymect |
In-Norveġja |
7.9.2020 |
|
UE/1/15/1052 |
Edistride |
L-Iżlanda |
15.10.2020 |
|
UE/1/15/1052 |
Edistride |
In-Norveġja |
1.10.2020 |
|
UE/1/15/1046 |
Elocta |
L-Iżlanda |
25.8.2020 |
|
UE/1/15/1046 |
Elocta |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/15/1058 |
Entresto |
L-Iżlanda |
20.7.2020 |
|
UE/1/15/1058 |
Entresto |
In-Norveġja |
3.7.2020 |
|
UE/1/15/1069 |
Episalvan |
L-Iżlanda |
13.10.2020 |
|
UE/1/15/1069 |
Episalvan |
In-Norveġja |
7.10.2020 |
|
UE/1/15/1065 |
Eptifibatide Accord |
L-Iżlanda |
15.10.2020 |
|
UE/1/15/1065 |
Eptifibatide Accord |
In-Norveġja |
8.10.2020 |
|
UE/1/19/1392 |
Ervebo |
L-Iżlanda |
21.9.2020 |
|
UE1/19/1392 |
Ervebo |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/19/1392 |
Ervebo |
In-Norveġja |
21.9.2020 |
|
UE/1/15/1075 |
Feraccru |
L-Iżlanda |
10.12.2020 |
|
UE/1/15/1075 |
Feraccru |
In-Norveġja |
3.12.2020 |
|
UE/2/15/185 |
Fortekor Plus |
L-Iżlanda |
10.8.2020 |
|
UE/2/15/185 |
Fortekor Plus |
Il-Liechtenstein |
31.8.2020 |
|
UE/2/15/185 |
Fortekor Plus |
In-Norveġja |
10.8.2020 |
|
UE/1/15/1061 |
Genvoya |
L-Iżlanda |
2.10.2020 |
|
UE/1/15/1061 |
Genvoya |
In-Norveġja |
29.9.2020 |
|
UE/1/11/677 |
Gilenya |
L-Iżlanda |
27.11.2020 |
|
UE/1/11/677 |
Gilenya |
In-Norveġja |
23.11.2020 |
|
UE/1/15/1008 |
Hetlioz |
L-Iżlanda |
20.7.2020 |
|
UE/1/15/1008 |
Hetlioz |
In-Norveġja |
13.7.2020 |
|
UE/1/15/1064 |
Imlygic |
L-Iżlanda |
7.12.2020 |
|
UE/1/15/1064 |
Imlygic |
In-Norveġja |
23.11.2020 |
|
UE/2/15/193 |
Imrestor |
L-Iżlanda |
16.10.2020 |
|
UE/2/15/193 |
Imrestor |
In-Norveġja |
9.10.2020 |
|
UE/1/15/1040 |
Intuniv |
L-Iżlanda |
17.7.2020 |
|
UE/1/15/1040 |
Intuniv |
In-Norveġja |
3.7.2020 |
|
UE/1/11/676 |
Jevtana |
In-Norveġja |
22.12.2020 |
|
UE/1/15/1076 |
Kovaltry |
L-Iżlanda |
13.10.2020 |
|
UE/1/15/1076 |
Kovaltry |
In-Norveġja |
7.10.2020 |
|
UE/1/15/1060 |
Kyprolis |
L-Iżlanda |
17.7.2020 |
|
UE/1/15/1060 |
Kyprolis |
In-Norveġja |
3.7.2020 |
|
UE/1/15/1067 |
Lopinavir/Ritonavir Mylan |
L-Iżlanda |
27.11.2020 |
|
UE/1/15/1067 |
Lopinavir/Ritonavir Mylan |
In-Norveġja |
24.11.2020 |
|
UE/1/15/1078 |
Natpar |
In-Norveġja |
17.8.2020 |
|
UE/1/16/1094 |
Ninlaro |
L-Iżlanda |
7.12.2020 |
|
UE/2/15/186 |
Novaquin |
L-Iżlanda |
24.7.2020 |
|
UE/2/15/186 |
Novaquin |
In-Norveġja |
10.8.2020 |
|
UE/1/15/1043 |
Nucala |
L-Iżlanda |
24.8.2020 |
|
UE/1/15/1043 |
Nucala |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/15/1043 |
Nucala |
In-Norveġja |
19.8.2020 |
|
UE/1/15/1035 |
Obizur |
L-Iżlanda |
9.12.2020 |
|
UE/1/15/1035 |
Obizur |
In-Norveġja |
26.11.2020 |
|
UE/1/15/1018 |
Omidria |
L-Iżlanda |
10.8.2020 |
|
UE/1/15/1018 |
Omidria |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/15/1018 |
Omidria |
In-Norveġja |
10.8.2020 |
|
UE/1/15/1070 |
Oncaspar |
L-Iżlanda |
7.12.2020 |
|
UE/1/15/1070 |
Oncaspar |
In-Norveġja |
26.11.2020 |
|
UE/1/18/1345 |
Ondexxya |
In-Norveġja |
13.8.2020 |
|
UE/1/15/1059 |
Orkambi |
L-Iżlanda |
7.12.2020 |
|
UE/1/15/1059 |
Orkambi |
In-Norveġja |
23.11.2020 |
|
UE/1/15/1071 |
Pemetrexed Accord |
L-Iżlanda |
6.11.2020 |
|
UE1/15/1071 |
Pemetrexed Accord |
In-Norveġja |
9.10.2020 |
|
UE/1/15/1057 |
Pemetrexed Hospira |
L-Iżlanda |
14.8.2020 |
|
UE/1/15/1057 |
Pemetrexed Hospira |
In-Norveġja |
21.8.2020 |
|
UE/1/15/1038 |
Pemetrexed medac |
L-Iżlanda |
26.8.2020 |
|
UE/1/15/1038 |
Pemetrexed medac |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/15/1038 |
Pemetrexed medac |
In-Norveġja |
3.9.2020 |
|
UE/1/15/1037 |
Pemetrexed Sandoz |
L-Iżlanda |
31.8.2020 |
|
UE/1/15/1037 |
Pemetrexed Sandoz |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/15/1037 |
Pemetrexed Sandoz |
In-Norveġja |
3.9.2020 |
|
UE/1/19/1388 |
Polivy |
In-Norveġja |
17.12.2020 |
|
UE/1/15/1056 |
Praxbind |
L-Iżlanda |
11.8.2020 |
|
UE/1/15/1056 |
Praxbind |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/15/1056 |
Praxbind |
In-Norveġja |
10.8.2020 |
|
UE/1/15/1027 |
Pregabalin Accord |
L-Iżlanda |
20.7.2020 |
|
UE/1/15/1027 |
Pregabalin Accord |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/15/1027 |
Pregabalin Accord |
In-Norveġja |
14.7.2020 |
|
UE/1/15/1011 |
Pregabalin Sandoz |
L-Iżlanda |
17.7.2020 |
|
UE/1/15/1011 |
Pregabalin Sandoz |
In-Norveġja |
13.7.2020 |
|
UE/1/15/1012 |
Pregabalin Sandoz GmbH |
L-Iżlanda |
17.7.2020 |
|
UE/1/15/1012 |
Pregabalin Sandoz GmbH |
In-Norveġja |
13.7.2020 |
|
UE/1/10/618 |
Prolia |
In-Norveġja |
14.8.2020 |
|
UE/1/16/1090 |
Rasagiline Mylan |
L-Iżlanda |
9.12.2020 |
|
UE/1/16/1090 |
Rasagiline Mylan |
In-Norveġja |
26.11.2020 |
|
UE/1/15/1062 |
Ravicti |
L-Iżlanda |
27.8.2020 |
|
UE/1/15/1062 |
Ravicti |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/15/1062 |
Ravicti |
In-Norveġja |
3.9.2020 |
|
UE/1/15/1020 |
Raxone |
L-Iżlanda |
14.8.2020 |
|
UE/1/15/1020 |
Raxone |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/15/1020 |
Raxone |
In-Norveġja |
19.8.2020 |
|
UE/2/15/191 |
Simparica |
L-Iżlanda |
26.8.2020 |
|
UE/2/15/191 |
Simparica |
Il-Liechtenstein |
31.8.2020 |
|
UE/2/15/191 |
Simparica |
In-Norveġja |
2.9.2020 |
|
UE/1/15/1072 |
Spectrila |
L-Iżlanda |
15.10.2020 |
|
UE/1/15/1072 |
Spectrila |
In-Norveġja |
29.9.2020 |
|
UE/2/15/190 |
Suvaxyn Circo + MH RTU |
L-Iżlanda |
21.9.2020 |
|
UE/2/15/190 |
Suvaxyn Circo + MH RTU |
Il-Liechtenstein |
31.8.2020 |
|
UE/2/15/190 |
Suvaxyn Circo + MH RTU |
In-Norveġja |
29.9.2020 |
|
UE/1/13/902 |
Translarna |
L-Iżlanda |
11.8.2020 |
|
UE/1/13/902 |
Translarna |
In-Norveġja |
20.8.2020 |
|
UE/2/15/184 |
UpCard |
L-Iżlanda |
17.7.2020 |
|
UE/2/15/184 |
Upcard |
In-Norveġja |
3.7.2020 |
|
UE/1/15/1083 |
Uptravi |
In-Norveġja |
21.12.2020 |
|
UE/1/15/1079 |
VAXELIS |
L-Iżlanda |
13.10.2020 |
|
UE/1/15/1079 |
Vaxelis |
In-Norveġja |
15.10.2020 |
|
UE/2/15/188 |
Vectormune ND |
Il-Liechtenstein |
31.8.2020 |
|
UE/2/15/188 |
Vectormune ND |
In-Norveġja |
29.7.2020 |
|
UE/1/19/1385 |
VITRAKVI |
L-Iżlanda |
28.8.2020 |
|
UE/1/19/1385 |
VITRAKVI |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/19/1385 |
VITRAKVI |
In-Norveġja |
7.9.2020 |
|
UE/1/11/710 |
Votubia |
L-Iżlanda |
10.8.2020 |
|
UE/1/11/710 |
Votubia |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/11/710 |
Votubia |
In-Norveġja |
10.8.2020 |
|
UE/1/10/646 |
VPRIV |
L-Iżlanda |
10.8.2020 |
|
UE/1/10/646 |
VPRIV |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/10/646 |
VPRIV |
In-Norveġja |
10.8.2020 |
|
UE/1/15/1042 |
Zalviso |
L-Iżlanda |
15.10.2020 |
|
UE/1/15/1042 |
Zalviso |
In-Norveġja |
7.10.2020 |
|
UE/1/16/1093 |
Zonisamide Mylan |
In-Norveġja |
15.12.2020 |
|
UE/2/15/189 |
Zycortal |
L-Iżlanda |
27.8.2020 |
|
UE/2/15/189 |
Zycortal |
Il-Liechtenstein |
31.8.2020 |
|
EU/2//15/189 |
Zycortal |
In-Norveġja |
3.9.2020 |
ANNESS III
Lista ta’ awtorizzazzjonijiet tal-kummerċjalizzazzjoni estiżi
L-awtorizzazzjonijiet ta’ kummerċjalizzazzjoni li ġejjin ġew estiżi fl-Istati EFTA taż-ŻEE matul il-perjodu bejn l-1 ta’ Lulju u l-31 ta’ Diċembru 2020:
|
Numru tal-UE |
Prodott |
Pajjiż |
Data tal-awtorizzazzjoni |
|
UE/1/14/980/008-011 |
Cosentyx |
L-Iżlanda |
9.12.2020 |
|
UE/1/14/980/008-011 |
Cosentyx |
In-Norveġja |
30.11.2020 |
|
UE/1/16/1116/002 |
Epclusa |
L-Iżlanda |
31.8.2020 |
|
UE/1/16/1116/002 |
Epclusa |
In-Norveġja |
3.9.2020 |
|
UE/1/14/958/003-005 |
Harvoni |
L-Iżlanda |
21.7.2020 |
|
UE/1/14/958 |
Harvoni |
In-Norveġja |
14.7.2020 |
|
UE/1/16/1095/009 |
IDELVION |
L-Iżlanda |
27.8.2020 |
|
UE/1/16/1095/009 |
IDELVION |
In-Norveġja |
3.9.2020 |
|
UE/1/12/782/007 |
Kalydeco |
L-Iżlanda |
9.12.2020 |
|
UE/1/12/782 |
Kalydeco |
In-Norveġja |
25.11.2020 |
|
UE/1/15/1071/004-007 |
Pemetrexed Accord |
L-Iżlanda |
8.12.2020 |
|
UE/1/15/1071 |
Pemetrexed Accord |
In-Norveġja |
16.11.2020 |
|
UE/1/15/1057/004-006 |
Pemetrexed Hospira |
L-Iżlanda |
15.10.2020 |
|
UE/1/15/1057 |
Pemetrexed Hospira |
In-Norveġja |
30.9.2020 |
|
UE/1/14/934 |
Plegridy |
In-Norveġja |
14.12.2020 |
|
UE/1/15/1031/019-020 |
Praluent |
L-Iżlanda |
24.8.2020 |
|
UE/1/13/894/003-005 |
Sovaldi |
L-Iżlanda |
20.7.2020 |
|
UE/1/13/894 |
Sovaldi |
In-Norveġja |
3.7.2020 |
|
UE/1/06/359/007-018 |
Suboxone |
L-Iżlanda |
21.7.2020 |
|
UE/1/06/359/007-018 |
Suboxone |
In-Norveġja |
17.7.2020 |
|
UE/1/18/1306/002 |
Symkevi |
L-Iżlanda |
9.12.2020 |
|
UE/1/18/1306 |
Symkevi |
In-Norveġja |
25.11.2020 |
|
UE/1/14/956/011-016 |
Trulicity |
L-Iżlanda |
9.12.2020 |
|
UE/1/14/956/011-016 |
Trulicity |
In-Norveġja |
2.12.2020 |
|
UE/1/19/1371/002-003 |
Ultomiris |
L-Iżlanda |
3.12.2020 |
|
UE/1/19/1371/002-003 |
Ultomiris |
In-Norveġja |
25.11.2020 |
|
UE/1/14/943/005 |
Velphoro |
L-Iżlanda |
27.11.2020 |
|
UE/1/14/943/005 |
Velphoro |
In-Norveġja |
23.11.2020 |
ANNESS IV
Lista ta’ awtorizzazzjonijiet ta’ kummerċjalizzazzjoni rtirati
L-awtorizzazzjonijiet ta’ kummerċjalizzazzjoni li ġejjin ġew irtirati fl-Istati EFTA taż-ŻEE matul il-perjodu bejn l-1 ta’ Lulju u l-31 ta’ Diċembru 2020:
|
Numru tal-UE |
Prodott |
Pajjiż |
Data tal-irtirar |
|
UE/1/18/1269 |
Alpivab |
L-Iżlanda |
9.12.2020 |
|
UE/1/18/1269 |
Alpivab |
In-Norveġja |
10.12.2020 |
|
UE/1/10/623 |
Clopidogrel/Acetylsalicylic acid Zentiva |
L-Iżlanda |
14.8.2020 |
|
UE/1/18/1300 |
Duzallo |
L-Iżlanda |
11.8.2020 |
|
UE/1/18/1300 |
Duzallo |
In-Norveġja |
10.9.2020 |
|
UE/1/13/895 |
Kolbam |
L-Iżlanda |
20.7.2020 |
|
UE/1/13/895 |
Kolbam |
In-Norveġja |
11.8.2020 |
|
UE/1/00/149 |
Panretin |
L-Iżlanda |
13.11.2020 |
|
UE/1/19/1401 |
Qtrilmet |
L-Iżlanda |
24.8.2020 |
|
UE/1/19/1401 |
Qtrilmet |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/19/1401 |
Qtrilmet |
In-Norveġja |
8.10.2020 |
|
UE/1/20/1463 |
Qutavina |
L-Iżlanda |
10.12.2020 |
|
UE/1/20/1463 |
Qutavina |
In-Norveġja |
18.12.2020 |
|
UE/1/10/634 |
Ribavirin Mylan |
L-Iżlanda |
5.11.2020 |
|
UE/1/10/634 |
Ribavirin Mylan |
In-Norveġja |
5.11.2020 |
|
UE/1/07/388 |
Sebivo |
L-Iżlanda |
27.11.2020 |
|
UE/1/07/388 |
Sebivo |
In-Norveġja |
23.11.2020 |
|
UE/2/09/099 |
Suvaxyn PCV |
L-Iżlanda |
24.7.2020 |
|
UE/1/12/752 |
Vepacel |
L-Iżlanda |
14.10.2020 |
|
UE/1/12/752 |
Vepacel |
In-Norveġja |
8.10.2020 |
|
UE/1/96/009 |
Zerit |
L-Iżlanda |
17.7.2020 |
|
UE/1/96/009 |
Zerit |
In-Norveġja |
8.7.2020 |
|
UE/2/09/105 |
Zulvac 8 Bovis |
L-Iżlanda |
12.11.2020 |
|
UE/2/09/105 |
Zulvac 8 Bovis |
In-Norveġja |
11.11.2020 |
|
UE/1/15/1080 |
Zurampic |
L-Iżlanda |
12.8.2020 |
|
UE/1/15/1080 |
Zurampic |
Il-Liechtenstein |
31.8.2020 |
|
UE/1/15/1080 |
Zurampic |
In-Norveġja |
10.9.2020 |
ANNESS V
Lista ta’ awtorizzazzjonijiet tal-kummerċjalizzazzjoni sospiżi
L-awtorizzazzjonijiet ta’ kummerċjalizzazzjoni li ġejjin ġew sospiżi fl-Istati EFTA taż-ŻEE matul il-perjodu bejn l-1 ta’ Lulju u l-31 ta’ Diċembru 2020:
|
Numru tal-UE |
Prodott |
Pajjiż |
Data tas-sospensjoni |
|
UE/1/12/750 |
Esmya |
L-Iżlanda |
26.8.2020 |
|
UE/1/18/1309 |
Ulipristal Acetate Gedeon Richter 5 |
L-Iżlanda |
26.8.2020 |