This document is an excerpt from the EUR-Lex website
Document E2021G0812(03)
Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2020 2021/C 324/10 Subcommittee I on the free movement of goods To be noted by the EEA Joint Committee
Medicamentos — Lista de autorizaciones de comercialización concedidas por los Estados AELC-EEE para el segundo semestre de 2020 2021/C 324/10 Subcomité I: libre circulación de mercancías A la atención del Comité Mixto del EEE
Medicamentos — Lista de autorizaciones de comercialización concedidas por los Estados AELC-EEE para el segundo semestre de 2020 2021/C 324/10 Subcomité I: libre circulación de mercancías A la atención del Comité Mixto del EEE
DO C 324 de 12.8.2021, p. 16–28
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
12.8.2021 |
ES |
Diario Oficial de la Unión Europea |
C 324/16 |
Medicamentos — Lista de autorizaciones de comercialización concedidas por los Estados AELC-EEE para el segundo semestre de 2020
(2021/C 324/10)
Subcomité I: libre circulación de mercancías
A la atención del Comité Mixto del EEE
Con referencia a la Decisión n.o 74/1999 del Comité Mixto del EEE, de 28 de mayo de 1999, se invita al Comité Mixto del EEE a que tome nota, en su reunión de 19 de marzo de 2021, de las siguientes listas relativas a autorizaciones de comercialización de medicamentos para el período del 1 de julio al 31 de diciembre de 2020:
|
Anexo I |
Lista de nuevas autorizaciones de comercialización |
|
Anexo II |
Lista de autorizaciones de comercialización renovadas |
|
Anexo III |
Lista de autorizaciones de comercialización ampliadas |
|
Anexo IV |
Lista de autorizaciones de comercialización retiradas |
|
Anexo V |
Lista de autorizaciones de comercialización suspendidas |
ANEXO I
Lista de nuevas autorizaciones de comercialización
En los Estados AELC-EEE se han concedido, durante el período del 1 de julio al 31 de diciembre de 2020, las siguientes autorizaciones de comercialización:
|
Número UE |
Producto |
País |
Fecha de autorización |
|
EU/1/20/1476 |
Adakveo |
Islandia |
6.11.2020 |
|
EU/1/20/1476 |
Adakveo |
Noruega |
5.11.2020 |
|
EU/1/20/1458 |
Apixaban Accord |
Islandia |
10.8.2020 |
|
EU/1/20/1458 |
Apixaban Accord |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1458 |
Apixaban Accord |
Noruega |
10.8.2020 |
|
EU/1/20/1469 |
Arikayce liposomal |
Noruega |
2.11.2020 |
|
EU/1/20/1469 |
Arikayce liposomal |
Islandia |
5.11.2020 |
|
EU/1/20/1475 |
Arsenic trioxide medac |
Islandia |
14.10.2020 |
|
EU/1/20/1475 |
Arsenic trioxide medac |
Noruega |
29.9.2020 |
|
EU/1/20/1454 |
Aybintio |
Islandia |
25.8.2020 |
|
EU/120/1454 |
Aybintio |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1454 |
Aybintio |
Noruega |
25.8.2020 |
|
EU/1/20/1473 |
AYVAKYT |
Islandia |
14.10.2020 |
|
EU/1/20/1473 |
Ayvakyt |
Noruega |
29.9.2020 |
|
EU/1/17/1214 |
Bavencio |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1474 |
Blenrep |
Islandia |
14.9.2020 |
|
EU/1/20/1474 |
Blenrep |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1474 |
Blenrep |
Noruega |
2.9.2020 |
|
EU/1/19/1403 |
Budesonid/Formoterol Teva Pharma B.V. |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1448 |
Cabazitaxel Accord |
Islandia |
3.9.2020 |
|
EU/1/20/1448 |
Cabazitaxel Accord |
Noruega |
28.10.2020 |
|
EU/1/20/1479 |
Calquence |
Islandia |
10.11.2020 |
|
EU/1/20/1479 |
Calquence |
Noruega |
11.11.2020 |
|
EU/2/20/264 |
Circomax Myco |
Noruega |
16.12.2020 |
|
EU/1/20/1528 |
Comirnaty |
Islandia |
21.12.2020 |
|
EU/1/20/1528 |
Comirnaty |
Noruega |
21.12.2020 |
|
EU/1/20/1451 |
Daurismo |
Islandia |
20.7.2020 |
|
EU/1/20/1451 |
Daurismo |
Noruega |
3.7.2020 |
|
EU/1/20/1438 |
Enerzair Breezhaler |
Islandia |
21.7.2020 |
|
EU/1/20/1438 |
Enezair Breezhaler |
Noruega |
14.7.2020 |
|
EU/2/20/262 |
Enteroporc Coli AC |
Noruega |
16.12.2020 |
|
EU/1/20/1472 |
Equidacent |
Islandia |
14.10.2020 |
|
EU/1/20/1472 |
Equidacent |
Noruega |
29.9.2020 |
|
EU/1/20/1489 |
Exparel liposomal |
Islandia |
3.12.2020 |
|
EU/1/20/1489 |
Exparel liposomal |
Noruega |
24.11.2020 |
|
EU/1/20/1477 |
Fampridine Accord |
Islandia |
15.10.2020 |
|
EU/1/20/1477 |
Fampridine Accord |
Noruega |
1.10.2020 |
|
EU/1/20/1450 |
Fingolimod Accord |
Islandia |
20.7.2020 |
|
EU/1/20/1450 |
Fingolimod Accord |
Noruega |
13.7.2020 |
|
EU/1/20/1465 |
Gencebok |
Islandia |
25.8.2020 |
|
EU/1/20/1465 |
Gencebok |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1465 |
Gencebok |
Noruega |
2.9.2020 |
|
EU/1/20/1446 |
Hepcludex |
Islandia |
12.8.2020 |
|
EU/1/20/1446 |
Hepcludex |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1446 |
Hepcludex |
Noruega |
10.8.2020 |
|
EU/1/20/1471 |
Idefirix |
Islandia |
2.9.2020 |
|
EU/1/20/1471 |
Idefirix |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1471 |
Idefirix |
Noruega |
8.9.2020 |
|
EU/2/20/258 |
Increxxa |
Islandia |
21.9.2020 |
|
EU/2/20/256 |
Innovax-ND-ILT |
Islandia |
16.10.2020 |
|
EU/1/20/1447 |
Insulin Aspart Sanofi |
Islandia |
20.7.2020 |
|
EU/1/20/144 |
Insulin aspart Sanofi |
Noruega |
3.7.2020 |
|
EU/1/20/1480 |
Jyseleca |
Islandia |
14.10.2020 |
|
EU/1/20/1480 |
Jyseleca |
Noruega |
30.9.2020 |
|
EU/1/20/1468 |
Kaftrio |
Islandia |
25.8.2020 |
|
EU/1/20/1468 |
Kaftrio |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1468 |
Kaftrio |
Noruega |
3.9.2020 |
|
EU/1/20/1494 |
Leqvio |
Noruega |
15.12.2020 |
|
EU/2/20/261 |
Librela |
Islandia |
13.11.2020 |
|
EU/1/20/1462 |
Livogiva |
Islandia |
2.9.2020 |
|
EU/1/20/1462 |
Livogiva |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1462 |
Livogiva |
Noruega |
7.9.2020 |
|
EU/1/20/1483 |
MenQuadfi |
Islandia |
2.12.2020 |
|
EU/1/20/1483 |
MenQuadfi |
Noruega |
30.11.2020 |
|
EU/1/20/1470 |
Methylthioninium chloride Cosmo |
Islandia |
27.8.2020 |
|
EU/1/20/1470 |
Methylthioninium chloride Cosmo |
Noruega |
3.9.2020 |
|
EU/2/20/259 |
Mhyosphere PCV ID |
Islandia |
14.10.2020 |
|
EU/2/19/247 |
Mirataz |
Noruega |
11.8.2020 |
|
EU/1/20/1445 |
Mvabea |
Islandia |
21.7.2020 |
|
EU/1/20/1445 |
Mvabea |
Noruega |
13.7.2020 |
|
EU/2/20/265 |
Nobivac DP PLUS |
Noruega |
17.12.2020 |
|
EU/1/20/1424 |
Nustendi |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1486 |
Nyvepria |
Islandia |
3.12.2020 |
|
EU/1/20/1486 |
Nyvepria |
Noruega |
24.11.2020 |
|
EU/1/20/1485 |
Obiltoxaximab SFL |
Islandia |
8.12.2020 |
|
EU/1/20/1485 |
Obiltoxaximab SFL |
Noruega |
24.11.2020 |
|
EU/2/20/260 |
OvuGel |
Islandia |
8.12.2020 |
|
EU/1/20/1496 |
Oxlumo |
Islandia |
2.12.2020 |
|
EU/1/20/1496 |
Oxlumo |
Noruega |
24.11.2020 |
|
EU/1/20/1487 |
PHELINUN |
Islandia |
3.12.2020 |
|
EU/1/20/1487 |
PHELINUN |
Noruega |
2.12.2020 |
|
EU/1/20/1497 |
Phesgo |
Noruega |
23.12.2020 |
|
EU/1/20/1455 |
Piqray |
Islandia |
11.8.2020 |
|
EU/1/20/1455 |
Piqray |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1455 |
Piqray |
Noruega |
10.8.2020 |
|
EU/1/20/1437 |
Pretomanid FGK |
Islandia |
12.8.2020 |
|
EU/1/20/1437 |
Pretomanid FGK |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1437 |
Pretomanid FGK |
Noruega |
10.8.2020 |
|
EU/2/20/254 |
Prevexxion RN |
Islandia |
10.8.2020 |
|
EU/2/20/254 |
Prevexxion RN |
Noruega |
10.8.2020 |
|
EU/2/20/255 |
Prevexxion RN+HVT+IBD |
Islandia |
27.7.2020 |
|
EU/2/20/255 |
Prevexxion RN+HVT+IBD |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1463 |
Qutavina |
Islandia |
2.9.2020 |
|
EU/1/20/1463 |
Qutavina |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1463 |
Qutavina |
Noruega |
7.9.2020 |
|
EU/1/20/1452 |
Reblozyl |
Islandia |
20.7.2020 |
|
EU/1/20/1452 |
Reblozyl |
Noruega |
3.7.2020 |
|
EU/2/20/263 |
Rexxolide |
Noruega |
16.12.2020 |
|
EU/1/20/1488 |
Rivaroxaban Accord |
Islandia |
1.12.2020 |
|
EU/1/20/1488 |
Rivaroxaban Accord |
Noruega |
2.12.2020 |
|
EU/1/20/1460 |
Rozlytrek |
Islandia |
12.8.2020 |
|
EU/1/20/1460 |
Rozlytrek |
Noruega |
10.8.2020 |
|
EU/1/20/1484 |
Supemtek |
Islandia |
1.12.2020 |
|
EU/1/20/1484 |
Supemtek |
Noruega |
24.11.2020 |
|
EU/1/20/1492 |
Tecartus |
Noruega |
30.12.2020 |
|
EU/1/20/1498 |
TRIXEO AEROSPHERE |
Noruega |
16.12.2020 |
|
EU/2/20/257 |
Tulinovet |
Islandia |
21.9.2020 |
|
EU/2/20/257 |
Tulinovet |
Noruega |
8.12.2020 |
|
EU/1/20/1459 |
Veklury |
Islandia |
3.7.2020 |
|
EU1/20/1459 |
Veklury |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1459 |
Veklury |
Noruega |
3.7.2020 |
|
EU/1/20/1481 |
Vocabria |
Noruega |
30.12.2020 |
|
EU/1/20/1457 |
Xenleta |
Islandia |
11.8.2020 |
|
EU/1/20/1457 |
Xenleta |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1457 |
Xenleta |
Noruega |
10.8.2020 |
|
EU/1/20/1444 |
Zabdeno |
Islandia |
21.7.2020 |
|
EU/1/20/1444 |
Zabdeno |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1444 |
Zabdeno |
Noruega |
14.7.2020 |
|
EU/1/20/1456 |
Zercepac |
Islandia |
11.8.2020 |
|
EU/1/20/1456 |
Zercepac |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1456 |
Zercepac |
Noruega |
10.8.2020 |
|
EU/1/20/1440 |
Zimbus Breezhaler |
Islandia |
21.7.2020 |
|
EU/1/20/1440 |
Zimbus Breezhaler |
Liechtenstein |
31.8.2020 |
|
EU/1/20/1440 |
Zimbus Breezhaler |
Noruega |
13.7.2020 |
|
EU/1/20/1478 |
ZYNRELEF |
Islandia |
16.10.2020 |
|
EU/1/20/1478 |
Zynrelef |
Noruega |
1.10.2020 |
ANEXO II
Lista de autorizaciones de comercialización renovadas
En los Estados AELC-EEE se han renovado, durante el período del 1 de julio al 31 de diciembre de 2020, las siguientes autorizaciones de comercialización:
|
Número UE |
Producto |
País |
Fecha de autorización |
|
EU/1/12/794 |
ADCETRIS |
Islandia |
2.10.2020 |
|
EU/1/12/794 |
ADCETRIS |
Liechtenstein |
31.8.2020 |
|
EU/1/12/794 |
ADCETRIS |
Noruega |
14.10.2020 |
|
EU/1/15/1045 |
Aripiprazole Accord |
Islandia |
15.10.2020 |
|
EU/1/15/1045 |
Aripiprazole Accord |
Noruega |
9.10.2020 |
|
EU/1/15/1029 |
Aripiprazole Sandoz |
Islandia |
20.7.2020 |
|
EU/1/15/1029 |
Aripiprazole Sandoz |
Noruega |
21.7.2020 |
|
EU/1/15/1063 |
Armisarte |
Islandia |
25.8.2020 |
|
EU/1/15/1063 |
Armisarte |
Liechtenstein |
31.8.2020 |
|
EU/1/15/1063 |
Armisarte |
Noruega |
28.8.2020 |
|
EU/1/17/1214 |
Bavencio |
Islandia |
10.8.2020 |
|
EU/1/17/1214 |
Bavencio |
Noruega |
25.8.2020 |
|
EU/1/15/1074 |
Benepali |
Islandia |
7.12.2020 |
|
EU/1/15/1074 |
Benepali |
Noruega |
26.11.2020 |
|
EU/1/15/1073 |
Briviact |
Islandia |
19.10.2020 |
|
EU/1/15/1073 |
Briviact |
Noruega |
20.10.2020 |
|
EU/2/15/183 |
Canigen L4 |
Islandia |
26.8.2020 |
|
EU/1/15/1055 |
CIAMBRA |
Islandia |
11.8.2020 |
|
EU/1/15/1055 |
Ciambra |
Noruega |
10.8.2020 |
|
EU/1/15/1054 |
Cinacalcet Mylan |
Islandia |
13.10.2020 |
|
EU/1/15/1054 |
Cinacalcet Mylan |
Noruega |
1.10.2020 |
|
EU/1/15/1048 |
Cotellic |
Islandia |
17.7.2020 |
|
EU/1/15/1048 |
Cotellic |
Noruega |
3.7.2020 |
|
EU/1/15/1036 |
CRESEMBA |
Islandia |
24.8.2020 |
|
EU/1/15/1036 |
Cresemba |
Liechtenstein |
31.8.2020 |
|
EU/1/15/1036 |
Cresemba |
Noruega |
28.8.2020 |
|
EU/1/15/1028 |
Duloxetine Zentiva |
Islandia |
24.8.2020 |
|
EU/1/15/1028 |
Duloxetine Zentiva |
Liechtenstein |
31.8.2020 |
|
EU/1/15/1028 |
Duloxetine Zentiva |
Noruega |
2.9.2020 |
|
EU/1/15/1051 |
Ebymect |
Islandia |
3.9.2020 |
|
EU/1/15/1051 |
Ebymect |
Noruega |
7.9.2020 |
|
EU/1/15/1052 |
Edistride |
Islandia |
15.10.2020 |
|
EU/1/15/1052 |
Edistride |
Noruega |
1.10.2020 |
|
EU/1/15/1046 |
Elocta |
Islandia |
25.8.2020 |
|
EU/1/15/1046 |
Elocta |
Liechtenstein |
31.8.2020 |
|
EU/1/15/1058 |
Entresto |
Islandia |
20.7.2020 |
|
EU/1/15/1058 |
Entresto |
Noruega |
3.7.2020 |
|
EU/1/15/1069 |
Episalvan |
Islandia |
13.10.2020 |
|
EU/1/15/1069 |
Episalvan |
Noruega |
7.10.2020 |
|
EU/1/15/1065 |
Eptifibatide Accord |
Islandia |
15.10.2020 |
|
EU/1/15/1065 |
Eptifibatide Accord |
Noruega |
8.10.2020 |
|
EU/1/19/1392 |
Ervebo |
Islandia |
21.9.2020 |
|
EU1/19/1392 |
Ervebo |
Liechtenstein |
31.8.2020 |
|
EU/1/19/1392 |
Ervebo |
Noruega |
21.9.2020 |
|
EU/1/15/1075 |
Feraccru |
Islandia |
10.12.2020 |
|
EU/1/15/1075 |
Feraccru |
Noruega |
3.12.2020 |
|
EU/2/15/185 |
Fortekor Plus |
Islandia |
10.8.2020 |
|
EU/2/15/185 |
Fortekor Plus |
Liechtenstein |
31.8.2020 |
|
EU/2/15/185 |
Fortekor Plus |
Noruega |
10.8.2020 |
|
EU/1/15/1061 |
Genvoya |
Islandia |
2.10.2020 |
|
EU/1/15/1061 |
Genvoya |
Noruega |
29.9.2020 |
|
EU/1/11/677 |
Gilenya |
Islandia |
27.11.2020 |
|
EU/1/11/677 |
Gilenya |
Noruega |
23.11.2020 |
|
EU/1/15/1008 |
Hetlioz |
Islandia |
20.7.2020 |
|
EU/1/15/1008 |
Hetlioz |
Noruega |
13.7.2020 |
|
EU/1/15/1064 |
Imlygic |
Islandia |
7.12.2020 |
|
EU/1/15/1064 |
Imlygic |
Noruega |
23.11.2020 |
|
EU/2/15/193 |
Imrestor |
Islandia |
16.10.2020 |
|
EU/2/15/193 |
Imrestor |
Noruega |
9.10.2020 |
|
EU/1/15/1040 |
Intuniv |
Islandia |
17.7.2020 |
|
EU/1/15/1040 |
Intuniv |
Noruega |
3.7.2020 |
|
EU/1/11/676 |
Jevtana |
Noruega |
22.12.2020 |
|
EU/1/15/1076 |
Kovaltry |
Islandia |
13.10.2020 |
|
EU/1/15/1076 |
Kovaltry |
Noruega |
7.10.2020 |
|
EU/1/15/1060 |
Kyprolis |
Islandia |
17.7.2020 |
|
EU/1/15/1060 |
Kyprolis |
Noruega |
3.7.2020 |
|
EU/1/15/1067 |
Lopinavir/Ritonavir Mylan |
Islandia |
27.11.2020 |
|
EU/1/15/1067 |
Lopinavir/Ritonavir Mylan |
Noruega |
24.11.2020 |
|
EU/1/15/1078 |
Natpar |
Noruega |
17.8.2020 |
|
EU/1/16/1094 |
Ninlaro |
Islandia |
7.12.2020 |
|
EU/2/15/186 |
Novaquin |
Islandia |
24.7.2020 |
|
EU/2/15/186 |
Novaquin |
Noruega |
10.8.2020 |
|
EU/1/15/1043 |
Nucala |
Islandia |
24.8.2020 |
|
EU/1/15/1043 |
Nucala |
Liechtenstein |
31.8.2020 |
|
EU/1/15/1043 |
Nucala |
Noruega |
19.8.2020 |
|
EU/1/15/1035 |
Obizur |
Islandia |
9.12.2020 |
|
EU/1/15/1035 |
Obizur |
Noruega |
26.11.2020 |
|
EU/1/15/1018 |
Omidria |
Islandia |
10.8.2020 |
|
EU/1/15/1018 |
Omidria |
Liechtenstein |
31.8.2020 |
|
EU/1/15/1018 |
Omidria |
Noruega |
10.8.2020 |
|
EU/1/15/1070 |
Oncaspar |
Islandia |
7.12.2020 |
|
EU/1/15/1070 |
Oncaspar |
Noruega |
26.11.2020 |
|
EU/1/18/1345 |
Ondexxya |
Noruega |
13.8.2020 |
|
EU/1/15/1059 |
Orkambi |
Islandia |
7.12.2020 |
|
EU/1/15/1059 |
Orkambi |
Noruega |
23.11.2020 |
|
EU/1/15/1071 |
Pemetrexed Accord |
Islandia |
6.11.2020 |
|
EU1/15/1071 |
Pemetrexed Accord |
Noruega |
9.10.2020 |
|
EU/1/15/1057 |
Pemetrexed Hospira |
Islandia |
14.8.2020 |
|
EU/1/15/1057 |
Pemetrexed Hospira |
Noruega |
21.8.2020 |
|
EU/1/15/1038 |
Pemetrexed medac |
Islandia |
26.8.2020 |
|
EU/1/15/1038 |
Pemetrexed medac |
Liechtenstein |
31.8.2020 |
|
EU/1/15/1038 |
Pemetrexed medac |
Noruega |
3.9.2020 |
|
EU/1/15/1037 |
Pemetrexed Sandoz |
Islandia |
31.8.2020 |
|
EU/1/15/1037 |
Pemetrexed Sandoz |
Liechtenstein |
31.8.2020 |
|
EU/1/15/1037 |
Pemetrexed Sandoz |
Noruega |
3.9.2020 |
|
EU/1/19/1388 |
Polivy |
Noruega |
17.12.2020 |
|
EU/1/15/1056 |
Praxbind |
Islandia |
11.8.2020 |
|
EU/1/15/1056 |
Praxbind |
Liechtenstein |
31.8.2020 |
|
EU/1/15/1056 |
Praxbind |
Noruega |
10.8.2020 |
|
EU/1/15/1027 |
Pregabalin Accord |
Islandia |
20.7.2020 |
|
EU/1/15/1027 |
Pregabalin Accord |
Liechtenstein |
31.8.2020 |
|
EU/1/15/1027 |
Pregabalin Accord |
Noruega |
14.7.2020 |
|
EU/1/15/1011 |
Pregabalin Sandoz |
Islandia |
17.7.2020 |
|
EU/1/15/1011 |
Pregabalin Sandoz |
Noruega |
13.7.2020 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Islandia |
17.7.2020 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Noruega |
13.7.2020 |
|
EU/1/10/618 |
Prolia |
Noruega |
14.8.2020 |
|
EU/1/16/1090 |
Rasagiline Mylan |
Islandia |
9.12.2020 |
|
EU/1/16/1090 |
Rasagiline Mylan |
Noruega |
26.11.2020 |
|
EU/1/15/1062 |
Ravicti |
Islandia |
27.8.2020 |
|
EU/1/15/1062 |
Ravicti |
Liechtenstein |
31.8.2020 |
|
EU/1/15/1062 |
Ravicti |
Noruega |
3.9.2020 |
|
EU/1/15/1020 |
Raxone |
Islandia |
14.8.2020 |
|
EU/1/15/1020 |
Raxone |
Liechtenstein |
31.8.2020 |
|
EU/1/15/1020 |
Raxone |
Noruega |
19.8.2020 |
|
EU/2/15/191 |
Simparica |
Islandia |
26.8.2020 |
|
EU/2/15/191 |
Simparica |
Liechtenstein |
31.8.2020 |
|
EU/2/15/191 |
Simparica |
Noruega |
2.9.2020 |
|
EU/1/15/1072 |
Spectrila |
Islandia |
15.10.2020 |
|
EU/1/15/1072 |
Spectrila |
Noruega |
29.9.2020 |
|
EU/2/15/190 |
Suvaxyn Circo + MH RTU |
Islandia |
21.9.2020 |
|
EU/2/15/190 |
Suvaxyn Circo + MH RTU |
Liechtenstein |
31.8.2020 |
|
EU/2/15/190 |
Suvaxyn Circo + MH RTU |
Noruega |
29.9.2020 |
|
EU/1/13/902 |
Translarna |
Islandia |
11.8.2020 |
|
EU/1/13/902 |
Translarna |
Noruega |
20.8.2020 |
|
EU/2/15/184 |
UpCard |
Islandia |
17.7.2020 |
|
EU/2/15/184 |
Upcard |
Noruega |
3.7.2020 |
|
EU/1/15/1083 |
Uptravi |
Noruega |
21.12.2020 |
|
EU/1/15/1079 |
VAXELIS |
Islandia |
13.10.2020 |
|
EU/1/15/1079 |
Vaxelis |
Noruega |
15.10.2020 |
|
EU/2/15/188 |
Vectormune ND |
Liechtenstein |
31.8.2020 |
|
EU/2/15/188 |
Vectormune ND |
Noruega |
29.7.2020 |
|
EU/1/19/1385 |
VITRAKVI |
Islandia |
28.8.2020 |
|
EU/1/19/1385 |
VITRAKVI |
Liechtenstein |
31.8.2020 |
|
EU/1/19/1385 |
VITRAKVI |
Noruega |
7.9.2020 |
|
EU/1/11/710 |
Votubia |
Islandia |
10.8.2020 |
|
EU/1/11/710 |
Votubia |
Liechtenstein |
31.8.2020 |
|
EU/1/11/710 |
Votubia |
Noruega |
10.8.2020 |
|
EU/1/10/646 |
VPRIV |
Islandia |
10.8.2020 |
|
EU/1/10/646 |
VPRIV |
Liechtenstein |
31.8.2020 |
|
EU/1/10/646 |
VPRIV |
Noruega |
10.8.2020 |
|
EU/1/15/1042 |
Zalviso |
Islandia |
15.10.2020 |
|
EU/1/15/1042 |
Zalviso |
Noruega |
7.10.2020 |
|
EU/1/16/1093 |
Zonisamide Mylan |
Noruega |
15.12.2020 |
|
EU/2/15/189 |
Zycortal |
Islandia |
27.8.2020 |
|
EU/2/15/189 |
Zycortal |
Liechtenstein |
31.8.2020 |
|
EU/2/15/189 |
Zycortal |
Noruega |
3.9.2020 |
ANEXO III
Lista de autorizaciones de comercialización ampliadas
En los Estados AELC-EEE se han ampliado, durante el período del 1 de julio al 31 de diciembre de 2020, las siguientes autorizaciones de comercialización:
|
Número UE |
Producto |
País |
Fecha de autorización |
|
EU/1/14/980/008-011 |
Cosentyx |
Islandia |
9.12.2020 |
|
EU/1/14/980/008-011 |
Cosentyx |
Noruega |
30.11.2020 |
|
EU/1/16/1116/002 |
Epclusa |
Islandia |
31.8.2020 |
|
EU/1/16/1116/002 |
Epclusa |
Noruega |
3.9.2020 |
|
EU/1/14/958/003-005 |
Harvoni |
Islandia |
21.7.2020 |
|
EU/1/14/958 |
Harvoni |
Noruega |
14.7.2020 |
|
EU/1/16/1095/009 |
IDELVION |
Islandia |
27.8.2020 |
|
EU/1/16/1095/009 |
IDELVION |
Noruega |
3.9.2020 |
|
EU/1/12/782/007 |
Kalydeco |
Islandia |
9.12.2020 |
|
EU/1/12/782 |
Kalydeco |
Noruega |
25.11.2020 |
|
EU/1/15/1071/004-007 |
Pemetrexed Accord |
Islandia |
8.12.2020 |
|
EU/1/15/1071 |
Pemetrexed Accord |
Noruega |
16.11.2020 |
|
EU/1/15/1057/004-006 |
Pemetrexed Hospira |
Islandia |
15.10.2020 |
|
EU/1/15/1057 |
Pemetrexed Hospira |
Noruega |
30.9.2020 |
|
EU/1/14/934 |
Plegridy |
Noruega |
14.12.2020 |
|
EU/1/15/1031/019-020 |
Praluent |
Islandia |
24.8.2020 |
|
EU/1/13/894/003-005 |
Sovaldi |
Islandia |
20.7.2020 |
|
EU/1/13/894 |
Sovaldi |
Noruega |
3.7.2020 |
|
EU/1/06/359/007-018 |
Suboxone |
Islandia |
21.7.2020 |
|
EU/1/06/359/007-018 |
Suboxone |
Noruega |
17.7.2020 |
|
EU/1/18/1306/002 |
Symkevi |
Islandia |
9.12.2020 |
|
EU/1/18/1306 |
Symkevi |
Noruega |
25.11.2020 |
|
EU/1/14/956/011-016 |
Trulicity |
Islandia |
9.12.2020 |
|
EU/1/14/956/011-016 |
Trulicity |
Noruega |
2.12.2020 |
|
EU/1/19/1371/002-003 |
Ultomiris |
Islandia |
3.12.2020 |
|
EU/1/19/1371/002-003 |
Ultomiris |
Noruega |
25.11.2020 |
|
EU/1/14/943/005 |
Velphoro |
Islandia |
27.11.2020 |
|
EU/1/14/943/005 |
Velphoro |
Noruega |
23.11.2020 |
ANEXO IV
Lista de autorizaciones de comercialización retiradas
En los Estados AELC-EEE se han retirado, durante el período del 1 de julio al 31 de diciembre de 2020, las siguientes autorizaciones de comercialización:
|
Número UE |
Producto |
País |
Fecha de retirada |
|
EU/1/18/1269 |
Alpivab |
Islandia |
9.12.2020 |
|
EU/1/18/1269 |
Alpivab |
Noruega |
10.12.2020 |
|
EU/1/10/623 |
Clopidogrel/Acetylsalicylic acid Zentiva |
Islandia |
14.8.2020 |
|
EU/1/18/1300 |
Duzallo |
Islandia |
11.8.2020 |
|
EU/1/18/1300 |
Duzallo |
Noruega |
10.9.2020 |
|
EU/1/13/895 |
Kolbam |
Islandia |
20.7.2020 |
|
EU/1/13/895 |
Kolbam |
Noruega |
11.8.2020 |
|
EU/1/00/149 |
Panretin |
Islandia |
13.11.2020 |
|
EU/1/19/1401 |
Qtrilmet |
Islandia |
24.8.2020 |
|
EU/1/19/1401 |
Qtrilmet |
Liechtenstein |
31.8.2020 |
|
EU/1/19/1401 |
Qtrilmet |
Noruega |
8.10.2020 |
|
EU/1/20/1463 |
Qutavina |
Islandia |
10.12.2020 |
|
EU/1/20/1463 |
Qutavina |
Noruega |
18.12.2020 |
|
EU/1/10/634 |
Ribavirin Mylan |
Islandia |
5.11.2020 |
|
EU/1/10/634 |
Ribavirin Mylan |
Noruega |
5.11.2020 |
|
EU/1/07/388 |
Sebivo |
Islandia |
27.11.2020 |
|
EU/1/07/388 |
Sebivo |
Noruega |
23.11.2020 |
|
EU/2/09/099 |
Suvaxyn PCV |
Islandia |
24.7.2020 |
|
EU/1/12/752 |
Vepacel |
Islandia |
14.10.2020 |
|
EU/1/12/752 |
Vepacel |
Noruega |
8.10.2020 |
|
EU/1/96/009 |
Zerit |
Islandia |
17.7.2020 |
|
EU/1/96/009 |
Zerit |
Noruega |
8.7.2020 |
|
EU/2/09/105 |
Zulvac 8 Bovis |
Islandia |
12.11.2020 |
|
EU/2/09/105 |
Zulvac 8 Bovis |
Noruega |
11.11.2020 |
|
EU/1/15/1080 |
Zurampic |
Islandia |
12.8.2020 |
|
EU/1/15/1080 |
Zurampic |
Liechtenstein |
31.8.2020 |
|
EU/1/15/1080 |
Zurampic |
Noruega |
10.9.2020 |
ANEXO V
Lista de autorizaciones de comercialización suspendidas
En los Estados AELC-EEE se han suspendido, durante el período del 1 de julio al 31 de diciembre de 2020, las siguientes autorizaciones de comercialización:
|
Número UE |
Producto |
País |
Fecha de suspensión |
|
EU/1/12/750 |
Esmya |
Islandia |
26.8.2020 |
|
EU/1/18/1309 |
Ulipristal Acetate Gedeon Richter 5 |
Islandia |
26.8.2020 |