This document is an excerpt from the EUR-Lex website
Document E2017G0223(01)
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2016
Medicamente – Lista autorizațiilor de comercializare acordate de către statele AELS care fac parte din SEE în prima jumătate a anului 2016
Medicamente – Lista autorizațiilor de comercializare acordate de către statele AELS care fac parte din SEE în prima jumătate a anului 2016
JO C 58, 23.2.2017, p. 10–27
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
23.2.2017 |
RO |
Jurnalul Oficial al Uniunii Europene |
C 58/10 |
Medicamente – Lista autorizațiilor de comercializare acordate de către statele AELS care fac parte din SEE în prima jumătate a anului 2016
(2017/C 58/08)
Subcomitetul I pentru libera circulație a mărfurilor
În atenția Comitetului mixt al SEE
Referitor la Decizia nr. 74/1999 a Comitetului mixt al SEE din 28 mai 1999, Comitetul mixt al SEE este invitat să ia notă, în cadrul reuniunii sale din 28 octombrie 2016, de următoarele liste cuprinzând autorizațiile de comercializare a medicamentelor în perioada 1 ianuarie-30 iunie 2016:
|
Anexa I |
Lista noilor autorizații de comercializare |
|
Anexa II |
Lista autorizațiilor de comercializare reînnoite |
|
Anexa III |
Lista autorizațiilor de comercializare prelungite |
|
Anexa IV |
Lista autorizațiilor de comercializare retrase |
|
Anexa V |
Lista autorizațiilor de comercializare suspendate |
ANEXA I
Lista noilor autorizații de comercializare
Următoarele autorizații de comercializare au fost acordate în statele AELS care fac parte din SEE în perioada 1 ianuarie-30 iunie 2016:
|
Număr UE |
Produs |
Țară |
Data autorizării |
|
EU/1/15/1053 |
Neofordex |
Liechtenstein |
30.4.2016 |
|
EU/1/15/1053 |
Neofordex |
Islanda |
31.3.2016 |
|
EU/1/15/1053 |
Neofordex |
Norvegia |
1.4.2016 |
|
EU/1/15/1063 |
Pemetrexed Actavis |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1063 |
Pemetrexed Actavis |
Norvegia |
25.1.2016 |
|
EU/1/15/1063 |
Pemetrexed Actavis |
Islanda |
25.1.2016 |
|
EU/1/15/1064 |
Imlygic |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1064 |
Imlygic |
Norvegia |
20.1.2016 |
|
EU/1/15/1064 |
Imlygic |
Islanda |
14.1.2016 |
|
EU/1/15/1065 |
Eptifibatid Accord |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1065 |
Eptifibatide Accord |
Norvegia |
18.1.2016 |
|
EU/1/15/1065 |
Eptifibatide Accord |
Islanda |
14.1.2016 |
|
EU/1/15/1066 |
Ongentys |
Liechtenstein |
30.6.2016 |
|
EU/1/15/1067 |
Lopinavir/Ritonavir Mylan |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1067 |
Lopinavir/Ritonavir Mylan |
Norvegia |
21.1.2016 |
|
EU/1/15/1067 |
Lopinavir/Ritonavir Mylan |
Islanda |
20.1.2016 |
|
EU/1/15/1068 |
Wakix |
Liechtenstein |
30.4.2016 |
|
EU/1/15/1068 |
Wakix |
Norvegia |
19.4.2016 |
|
EU/1/15/1068 |
WAKIX |
Islanda |
22.4.2016 |
|
EU/1/15/1069 |
Episalvan |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1069 |
Episalvan |
Norvegia |
20.1.2016 |
|
EU/1/15/1069 |
Episalvan |
Islanda |
19.1.2016 |
|
EU/1/15/1070 |
Oncaspar |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1070 |
Oncaspar |
Norvegia |
25.1.2016 |
|
EU/1/15/1070 |
Oncaspar |
Islanda |
25.1.2016 |
|
EU/1/15/1071 |
Pemetrexed Accord |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1071 |
Pemetrexed Accord |
Norvegia |
25.1.2016 |
|
EU/1/15/1071 |
Pemetrexed Accord |
Islanda |
25.1.2016 |
|
EU/1/15/1072 |
Spectrila |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1072 |
Spectrila |
Norvegia |
19.1.2016 |
|
EU/1/15/1072 |
Spectrila |
Islanda |
19.1.2016 |
|
EU/1/15/1073 |
Briviact |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1073 |
Briviact |
Norvegia |
21.1.2016 |
|
EU/1/15/1073 |
Briviact |
Islanda |
25.1.2016 |
|
EU/1/15/1074 |
Benepali |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1074 |
Benepali |
Norvegia |
19.1.2016 |
|
EU/1/15/1074 |
Benepali |
Islanda |
19.1.2016 |
|
EU/1/15/1075 |
Feraccru |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1075 |
Feraccru |
Norvegia |
7.3.2016 |
|
EU/1/15/1075 |
Feraccru |
Islanda |
18.3.2016 |
|
EU/1/15/1076 |
Kovaltry |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1076 |
Kovaltry |
Norvegia |
10.3.2016 |
|
EU/1/15/1076 |
Kovaltry |
Islanda |
16.3.2016 |
|
EU/1/15/1077 |
Iblias |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1077 |
Iblias |
Norvegia |
10.3.2016 |
|
EU/1/15/1077 |
Iblias |
Islanda |
16.3.2016 |
|
EU/1/15/1079 |
Vaxelis |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1079 |
Vaxelis |
Norvegia |
29.2.2016 |
|
EU/1/15/1079 |
VAXELIS |
Islanda |
1.3.2016 |
|
EU/1/15/1080 |
Zurampic |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1080 |
Zurampic |
Norvegia |
3.3.2016 |
|
EU/1/15/1080 |
Zurampic |
Islanda |
16.3.2016 |
|
EU/1/15/1081 |
Caspofungin Accord |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1081 |
Caspofungin Accord |
Norvegia |
29.2.2016 |
|
EU/1/15/1081 |
Caspofungin Accord |
Islanda |
25.2.2016 |
|
EU/1/15/1082 |
Galafold |
Liechtenstein |
30.6.2016 |
|
EU/1/15/1082 |
Galafold |
Norvegia |
14.6.2016 |
|
EU/1/15/1082 |
Galafold |
Islanda |
14.6.2016 |
|
EU/1/15/1083 |
Uptravi |
Liechtenstein |
30.6.2016 |
|
EU/1/15/1083 |
Uptravi |
Islanda |
26.5.2016 |
|
EU/1/15/1083 |
Uptravi |
Norvegia |
30.5.2016 |
|
EU/1/15/1084 |
Portrazza |
Liechtenstein |
29.2.2016 |
|
EU/1/15/1084 |
Portrazza |
Norvegia |
26.2.2016 |
|
EU/1/15/1084 |
Portrazza |
Islanda |
15.3.2016 |
|
EU/1/15/1085 |
Taltz |
Liechtenstein |
30.4.2016 |
|
EU/1/15/1085 |
Taltz |
Norvegia |
9.5.2016 |
|
EU/1/15/1085 |
Taltz |
Islanda |
20.5.2016 |
|
EU/1/16/1086 |
TAGRISSO |
Liechtenstein |
29.2.2016 |
|
EU/1/16/1086 |
Tagrisso |
Norvegia |
19.2.2016 |
|
EU/1/16/1086 |
Tagrisso |
Islanda |
11.2.2016 |
|
EU/1/16/1087 |
Coagadex |
Liechtenstein |
30.4.2016 |
|
EU/1/16/1087 |
Coagadex |
Norvegia |
1.4.2016 |
|
EU/1/16/1087 |
Coagadex |
Islanda |
22.3.2016 |
|
EU/1/16/1088 |
Empliciti |
Liechtenstein |
30.6.2016 |
|
EU/1/16/1088 |
Empliciti |
Norvegia |
24.5.2016 |
|
EU/1/16/1088 |
Empliciti |
Islanda |
19.5.2016 |
|
EU/1/16/1089 |
Vaccin împotriva gripei pandemice H5N1 MedImmune |
Liechtenstein |
30.6.2016 |
|
EU/1/16/1089 |
Vaccin împotriva gripei pandemice H5N1 MedImmune |
Norvegia |
30.5.2016 |
|
EU/1/16/1089 |
Vaccin împotriva gripei pandemice H5N1 MedImmune |
Islanda |
30.5.2016 |
|
EU/1/16/1090 |
Rasagiline Mylan |
Liechtenstein |
30.4.2016 |
|
EU/1/16/1090 |
Rasagiline Mylan |
Norvegia |
19.4.2016 |
|
EU/1/16/1090 |
Rasagiline Mylan |
Islanda |
22.4.2016 |
|
EU/1/16/1092 |
Amlodipin/Valsartan Mylan |
Liechtenstein |
30.4.2016 |
|
EU/1/16/1092 |
Amlodipine/Valsartan Mylan |
Norvegia |
11.4.2016 |
|
EU/1/16/1092 |
Amlodipine/Valsartan Mylan |
Islanda |
31.3.2016 |
|
EU/1/16/1093 |
Zonisamide Mylan |
Liechtenstein |
30.4.2016 |
|
EU/1/16/1093 |
Zonisamide Mylan |
Norvegia |
19.4.2016 |
|
EU/1/16/1093 |
Zonisamide Mylan |
Islanda |
22.4.2016 |
|
EU/1/16/1095 |
IDELVION |
Liechtenstein |
30.6.2016 |
|
EU/1/16/1095 |
IDELVION |
Norvegia |
30.5.2016 |
|
EU/1/16/1095 |
IDELVION |
Islanda |
23.5.2016 |
|
EU/1/16/1096 |
Lonsurf |
Liechtenstein |
30.4.2016 |
|
EU/1/16/1096 |
Lonsurf |
Norvegia |
9.5.2016 |
|
EU/1/16/1096 |
LONSURF |
Islanda |
20.5.2016 |
|
EU/1/16/1097 |
Strimvelis |
Liechtenstein |
30.6.2016 |
|
EU/1/16/1097 |
Strimvelis |
Norvegia |
9.6.2016 |
|
EU/1/16/1097 |
Strimvelis |
Islanda |
16.6.2016 |
|
EU/1/16/1098 |
ALPROLIX |
Liechtenstein |
30.6.2016 |
|
EU/1/16/1098 |
Alprolix |
Norvegia |
25.5.2016 |
|
EU/1/16/1098 |
Alprolix |
Islanda |
20.5.2016 |
|
EU/1/16/1099 |
Descovy |
Liechtenstein |
30.4.2016 |
|
EU/1/16/1099 |
Descovy |
Norvegia |
27.4.2016 |
|
EU/1/16/1099 |
Descovy |
Islanda |
18.5.2016 |
|
EU/1/16/1100 |
Palonosetron Hospira |
Liechtenstein |
30.4.2016 |
|
EU/1/16/1100 |
Palonosetron Hospira |
Norvegia |
19.4.2016 |
|
EU/1/16/1100 |
Palonosetron Hospira |
Islanda |
27.4.2016 |
|
EU/1/16/1101 |
Darzalex |
Liechtenstein |
30.6.2016 |
|
EU/1/16/1101 |
Darzalex |
Norvegia |
30.5.2016 |
|
EU/1/16/1101 |
Darzalex |
Islanda |
30.5.2016 |
|
EU/1/16/1103 |
Neparvis |
Liechtenstein |
30.6.2016 |
|
EU/1/16/1103 |
Neparvis |
Norvegia |
24.6.2016 |
|
EU/1/16/1104 |
Palonosetron Accord |
Principatul Liechtenstein |
30.6.2016 |
|
EU/1/16/1104 |
Palonosteron Accord |
Norvegia |
14.6.2016 |
|
EU/1/16/1104 |
Palonosetron Accord |
Islanda |
14.6.2016 |
|
EU/1/16/1106 |
Flixabi |
Liechtenstein |
30.6.2016 |
|
EU/1/16/1106 |
Flixabi |
Norvegia |
17.6.2016 |
|
EU/1/16/1106 |
Flixabi |
Islanda |
15.6.2016 |
|
EU/1/16/1109 |
Zavicefta |
Liechtenstein |
30.6.2016 |
|
EU/1/16/1112 |
Odefsey |
Liechtenstein |
30.6.2016 |
|
EU/1/16/1112 |
Odefsey |
Norvegia |
24.6.2016 |
|
EU/2/15/192 |
Velactis |
Norvegia |
4.1.2016 |
|
EU/2/15/193 |
Imrestor |
Norvegia |
5.1.2016 |
|
EU/2/15/193 |
Imrestor |
Islanda |
4.1.2016 |
|
EU/2/16/194 |
Evalon |
Liechtenstein |
30.4.2016 |
|
EU/2/16/194 |
Evalon |
Norvegia |
11.5.2016 |
|
EU/2/16/194 |
Evalon |
Islanda |
13.5.2016 |
|
EU/2/16/195 |
LETIFEND |
Liechtenstein |
30.4.2016 |
|
EU/2/16/195 |
Letifend |
Norvegia |
27.4.2016 |
|
EU/2/16/195 |
Letifend |
Islanda |
18.5.2016 |
ANEXA II
Lista autorizațiilor de comercializare reînnoite
Următoarele autorizații de comercializare au fost reînnoite în statele AELS care fac parte din SEE în perioada 1 ianuarie-30 iunie 2016:
|
Număr UE |
Produs |
Țară |
Data autorizării |
|
EU/1/05/323 |
ProQuad |
Islanda |
4.1.2016 |
|
EU/1/05/323 |
ProQuad |
Norvegia |
11.1.2016 |
|
EU/1/05/330 |
Rotarix |
Liechtenstein |
29.2.2016 |
|
EU/1/05/330 |
Rotarix |
Islanda |
20.1.2016 |
|
EU/1/05/330 |
Rotarix |
Norvegia |
20.1.2016 |
|
EU/1/05/331 |
Neupro |
Liechtenstein |
29.2.2016 |
|
EU/1/05/331 |
Neupro |
Islanda |
28.1.2016 |
|
EU/1/05/331 |
Neupro |
Norvegia |
4.2.2016 |
|
EU/1/06/334 |
Evoltra |
Liechtenstein |
29.2.2016 |
|
EU/1/06/334 |
Evoltra |
Norvegia |
19.1.2016 |
|
EU/1/06/334 |
Evoltra |
Islanda |
20.1.2016 |
|
EU/1/06/336 |
Tygacil |
Liechtenstein |
29.2.2016 |
|
EU/1/06/336 |
Tygacil |
Norvegia |
18.3.2016 |
|
EU/1/06/336 |
Tygacil |
Islanda |
18.3.2016 |
|
EU/1/06/341 |
Zostavax |
Liechtenstein |
29.2.2016 |
|
EU/1/06/341 |
Zostavax |
Norvegia |
29.2.2016 |
|
EU/1/06/341 |
Zostavax |
Islanda |
18.2.2016 |
|
EU/1/06/346 |
Tysabri |
Norvegia |
29.4.2016 |
|
EU/1/06/346 |
Tysabri |
Islanda |
12.5.2016 |
|
EU/1/06/354 |
Competact |
Liechtenstein |
30.4.2016 |
|
EU/1/06/354 |
Competact |
Norvegia |
12.5.2016 |
|
EU/1/06/354 |
Competact |
Islanda |
18.5.2016 |
|
EU/1/06/356 |
Exjade |
Liechtenstein |
30.4.2016 |
|
EU/1/06/356 |
Exjade |
Norvegia |
2.5.2016 |
|
EU/1/06/356 |
Exjade |
Islanda |
12.5.2016 |
|
EU/1/09/543 |
Cayston |
Liechtenstein |
30.6.2016 |
|
EU/1/09/543 |
Cayston |
Norvegia |
14.6.2016 |
|
EU/1/09/543 |
Cayston |
Islanda |
13.6.2016 |
|
EU/1/10/652 |
TOBI Podhaler |
Liechtenstein |
29.2.2016 |
|
EU/1/10/652 |
TOBI Podhaler |
Norvegia |
1.3.2016 |
|
EU/1/10/652 |
TOBI Podhaler |
Islanda |
17.3.2016 |
|
EU/1/11/671 |
Xiapex |
Liechtenstein |
29.2.2016 |
|
EU/1/11/671 |
Xiapex |
Norvegia |
25.1.2016 |
|
EU/1/11/671 |
Xiapex |
Islanda |
27.1.2016 |
|
EU/1/11/672 |
Xeplion |
Norvegia |
11.1.2016 |
|
EU/1/11/672 |
Xeplion |
Islanda |
4.1.2016 |
|
EU/1/11/674 |
Repso |
Liechtenstein |
29.2.2016 |
|
EU/1/11/674 |
Repso |
Norvegia |
25.1.2016 |
|
EU/1/11/674 |
Repso |
Islanda |
20.1.2016 |
|
EU/1/11/679 |
Pravafenix |
Liechtenstein |
29.2.2016 |
|
EU/1/11/679 |
Pravafenix |
Norvegia |
2.2.2016 |
|
EU/1/11/679 |
Pravafenix |
Islanda |
26.1.2016 |
|
EU/1/11/681 |
Trobalt |
Liechtenstein |
29.2.2016 |
|
EU/1/11/681 |
Trobalt |
Norvegia |
25.1.2016 |
|
EU/1/11/681 |
Trobalt |
Islanda |
26.1.2016 |
|
EU/1/11/682 |
Methylthioninium Chloride Proveblue |
Norvegia |
29.2.2016 |
|
EU/1/11/682 |
Methylthioninium chloride Proveblue |
Islanda |
16.2.2016 |
|
EU/1/11/682 |
Methylthioniniumchlorid Proveblue |
Liechtenstein |
29.2.2016 |
|
EU/1/11/685 |
Ibandronic acid Sandoz |
Norvegia |
11.5.2016 |
|
EU/1/11/685 |
Ibandronic acid Sandoz |
Islanda |
27.4.2016 |
|
EU/1/11/687 |
Hizentra |
Liechtenstein |
29.2.2016 |
|
EU/1/11/687 |
Hizentra |
Norvegia |
29.2.2016 |
|
EU/1/11/687 |
Hizentra |
Islanda |
17.3.2016 |
|
EU/1/11/688 |
Cinryze |
Liechtenstein |
30.6.2016 |
|
EU/1/11/688 |
Cinryze |
Norvegia |
22.6.2016 |
|
EU/1/11/688 |
Cinryze |
Islanda |
13.6.2016 |
|
EU/1/11/690 |
Zoely |
Liechtenstein |
30.4.2016 |
|
EU/1/11/690 |
Zoely |
Norvegia |
29.4.2016 |
|
EU/1/11/690 |
Zoely |
Islanda |
18.5.2016 |
|
EU/1/11/691 |
Eliquis |
Liechtenstein |
29.2.2016 |
|
EU/1/11/691 |
Eliquis |
Norvegia |
2.2.2016 |
|
EU/1/11/691 |
Eliquis |
Islanda |
26.1.2016 |
|
EU/1/11/692 |
Yellox |
Liechtenstein |
29.2.2016 |
|
EU/1/11/692 |
Yellox |
Norvegia |
2.2.2016 |
|
EU/1/11/692 |
Yellox |
Islanda |
19.1.2016 |
|
EU/1/11/693 |
Rivastigmin Actavis |
Norvegia |
3.3.2016 |
|
EU/1/11/693 |
Rivastigmine Actavis |
Liechtenstein |
29.2.2016 |
|
EU/1/11/693 |
Rivastigmine Actavis |
Islanda |
15.3.2016 |
|
EU/1/11/694 |
NULOJIX |
Liechtenstein |
29.2.2016 |
|
EU/1/11/694 |
NULOJIX |
Norvegia |
26.2.2016 |
|
EU/1/11/694 |
Nulojix |
Islanda |
17.3.2016 |
|
EU/1/11/695 |
Leganto |
Liechtenstein |
29.2.2016 |
|
EU/1/11/695 |
Leganto |
Norvegia |
1.2.2016 |
|
EU/1/11/695 |
Leganto |
Islanda |
26.1.2016 |
|
EU/1/11/696 |
BYDUREON |
Liechtenstein |
29.2.2016 |
|
EU/1/11/696 |
BYDUREON |
Norvegia |
10.3.2016 |
|
EU/1/11/696 |
Bydureon |
Islanda |
17.3.2016 |
|
EU/1/11/697 |
Temozolomide SUN |
Liechtenstein |
30.4.2016 |
|
EU/1/11/697 |
Temozolomide SUN |
Norvegia |
29.4.2016 |
|
EU/1/11/697 |
Temozolomide SUN |
Islanda |
18.5.2016 |
|
EU/1/11/698 |
Yervoy |
Liechtenstein |
30.4.2016 |
|
EU/1/11/698 |
Yervoy |
Norvegia |
29.4.2016 |
|
EU/1/11/698 |
Yervoy |
Islanda |
18.5.2016 |
|
EU/1/11/699 |
Fampyra |
Liechtenstein |
30.6.2016 |
|
EU/1/11/699 |
Fampyra |
Islanda |
15.6.2016 |
|
EU/1/11/700 |
Benlysta |
Liechtenstein |
29.2.2016 |
|
EU/1/11/700 |
Benlysta |
Norvegia |
26.2.2016 |
|
EU/1/11/700 |
Benlysta |
Islanda |
18.3.2016 |
|
EU/1/11/702 |
Levetiracetam ratiopharm |
Liechtenstein |
30.4.2016 |
|
EU/1/11/702 |
Levetiracetam ratiopharm |
Norvegia |
18.5.2016 |
|
EU/1/11/702 |
Levetiracetam ratiopharm |
Islanda |
19.5.2016 |
|
EU/1/11/703 |
Xgeva |
Liechtenstein |
30.6.2016 |
|
EU/1/11/703 |
XGEVA |
Norvegia |
18.5.2016 |
|
EU/1/11/703 |
XGEVA |
Islanda |
13.5.2016 |
|
EU/1/11/704 |
Victrelis |
Liechtenstein |
29.2.2016 |
|
EU/1/11/704 |
Victrelis |
Islanda |
17.3.2016 |
|
EU/1/11/704 |
Victrelis |
Norvegia |
3.3.2016 |
|
EU/1/11/705 |
Vibativ |
Liechtenstein |
30.6.2016 |
|
EU/1/11/705 |
Vibativ |
Islanda |
13.6.2016 |
|
EU/1/11/705 |
Vibativ |
Norvegia |
9.6.2016 |
|
EU/1/11/706 |
Levodopa/Carbidopa/Entacapone Orion |
Liechtenstein |
30.6.2016 |
|
EU/1/11/706 |
Levodopa/Carbidopa/Entacapone Orion |
Islanda |
15.6.2016 |
|
EU/1/11/707 |
Trajenta |
Liechtenstein |
30.4.2016 |
|
EU/1/11/707 |
Trajenta |
Norvegia |
19.4.2016 |
|
EU/1/11/707 |
Trajenta |
Islanda |
31.3.2016 |
|
EU/1/11/708 |
Entacapone Orion |
Liechtenstein |
30.4.2016 |
|
EU/1/11/708 |
Entacapone Orion |
Norvegia |
21.4.2016 |
|
EU/1/11/708 |
Entacapone Orion |
Islanda |
26.4.2016 |
|
EU/1/11/709 |
Buccolam |
Liechtenstein |
30.6.2016 |
|
EU/1/11/709 |
Buccolam |
Norvegia |
24.6.2016 |
|
EU/1/11/709 |
Buccolam |
Islanda |
13.6.2016 |
|
EU/1/11/714 |
Zytiga |
Liechtenstein |
30.6.2016 |
|
EU/1/11/714 |
Zytiga |
Norvegia |
14.6.2016 |
|
EU/1/11/714 |
Zytiga |
Islanda |
13.6.2016 |
|
EU/1/11/718 |
Dexdor |
Liechtenstein |
30.6.2016 |
|
EU/1/11/718 |
Dexdor |
Norvegia |
20.6.2016 |
|
EU/1/11/718 |
Dexdor |
Islanda |
13.6.2016 |
|
EU/1/11/719 |
Telmisartan Teva Pharma |
Liechtenstein |
30.6.2016 |
|
EU/1/11/719 |
Telmisartan Teva Pharma |
Norvegia |
23.6.2016 |
|
EU/1/11/749 |
Caprelsa |
Norvegia |
14.1.2016 |
|
EU/1/11/749 |
Caprelsa |
Islanda |
14.1.2016 |
|
EU/1/12/764 |
Pixuvri |
Liechtenstein |
30.4.2016 |
|
EU/1/12/764 |
Pixuvri |
Norvegia |
1.4.2016 |
|
EU/1/12/764 |
Pixuvri |
Islanda |
31.3.2016 |
|
EU/1/13/818 |
Bosulif |
Norvegia |
14.1.2016 |
|
EU/1/13/818 |
Bosulif |
Islanda |
13.1.2016 |
|
EU/1/13/848 |
Erivedge |
Norvegia |
16.6.2016 |
|
EU/1/13/848 |
Erivedge |
Islanda |
15.6.2016 |
|
EU/1/13/875 |
Deltyba |
Norvegia |
29.3.2016 |
|
EU/1/13/875 |
Deltyba |
Islanda |
22.3.2016 |
|
EU/1/13/890 |
Cometriq |
Liechtenstein |
29.2.2016 |
|
EU/1/13/890 |
Cometriq |
Norvegia |
20.1.2016 |
|
EU/1/13/890 |
Cometriq |
Islanda |
19.1.2016 |
|
EU/1/13/901 |
Sirturo |
Liechtenstein |
29.2.2016 |
|
EU/1/13/901 |
Sirturo |
Norvegia |
14.1.2016 |
|
EU/1/13/901 |
SIRTURO |
Islanda |
13.1.2016 |
|
EU/1/14/987 |
Holoclar |
Islanda |
4.1.2016 |
|
EU/1/15/999 |
Zykadia |
Liechtenstein |
30.4.2016 |
|
EU/1/15/999 |
Zykadia |
Norvegia |
6.4.2016 |
|
EU/1/15/999 |
Zykadia |
Islanda |
31.3.2016 |
|
EU/2/06/061 |
Nobilis Influenza H5N2 |
Norvegia |
28.6.2016 |
|
EU/2/10/107 |
Veraflox |
Liechtenstein |
29.2.2016 |
|
EU/2/10/107 |
Veraflox |
Norvegia |
13.1.2016 |
|
EU/2/10/107 |
Veraflox |
Islanda |
15.1.2016 |
|
EU/2/10/115 |
Comfortis |
Liechtenstein |
29.2.2016 |
|
EU/2/10/115 |
Comfortis |
Norvegia |
18.1.2016 |
|
EU/2/10/115 |
Comfortis |
Islanda |
15.1.2016 |
|
EU/2/10/116 |
Melosus |
Liechtenstein |
29.2.2016 |
|
EU/2/10/116 |
Melosus |
Norvegia |
22.1.2016 |
|
EU/2/10/116 |
Melosus |
Islanda |
22.1.2016 |
|
EU/2/10/118 |
Activyl |
Liechtenstein |
29.2.2016 |
|
EU/2/10/118 |
Activyl |
Norvegia |
29.1.2016 |
|
EU/2/10/118 |
Activyl |
Islanda |
15.1.2016 |
|
EU/2/10/119 |
Cimalgex |
Liechtenstein |
29.2.2016 |
|
EU/2/10/119 |
Cimalgex |
Norvegia |
19.1.2016 |
|
EU/2/10/119 |
Cimalgex |
Islanda |
15.1.2016 |
|
EU/2/11/120 |
Zulvac 1 + 8 Ovis |
Liechtenstein |
29.2.2016 |
|
EU/2/11/120 |
Zulvac 1 + 8 Ovis |
Norvegia |
19.1.2016 |
|
EU/2/11/120 |
Zulvac 1 + 8 Ovis |
Islanda |
15.1.2016 |
|
EU/2/11/121 |
CaniLeish |
Liechtenstein |
29.2.2016 |
|
EU/2/11/121 |
CaniLeish |
Norvegia |
18.1.2016 |
|
EU/2/11/121 |
CaniLeish |
Islanda |
15.1.2016 |
|
EU/2/11/122 |
BLUEVAC BTV8 |
Liechtenstein |
30.4.2016 |
|
EU/2/11/122 |
BLUEVAC BTV8 |
Norvegia |
29.3.2016 |
|
EU/2/11/122 |
Bluevac BTV8 |
Islanda |
29.3.2016 |
|
EU/2/11/123 |
Procox |
Liechtenstein |
29.2.2016 |
|
EU/2/11/123 |
Procox |
Norvegia |
20.1.2016 |
|
EU/2/11/123 |
Procox |
Islanda |
20.1.2016 |
|
EU/2/11/124 |
Zuprevo |
Liechtenstein |
30.6.2016 |
|
EU/2/11/124 |
Zuprevo |
Norvegia |
1.6.2016 |
|
EU/2/11/124 |
Zuprevo |
Islanda |
26.5.2016 |
|
EU/2/11/125 |
CERTIFECT |
Liechtenstein |
30.4.2016 |
|
EU/2/11/125 |
Certifect |
Norvegia |
4.5.2016 |
|
EU/2/11/125 |
Certifect |
Islanda |
12.5.2016 |
|
EU/2/11/126 |
MS-H Impfstoff |
Liechtenstein |
30.6.2016 |
|
EU/2/11/126 |
MS-H Vaccine |
Islanda |
23.5.2016 |
|
EU/2/11/126 |
MS-H-Vaksine |
Norvegia |
24.5.2016 |
|
EU/2/11/128 |
Emdocam |
Liechtenstein |
30.6.2016 |
|
EU/2/11/128 |
Emdocam |
Norvegia |
27.6.2016 |
|
EU/2/11/129 |
Proteq West Nile |
Liechtenstein |
30.6.2016 |
|
EU/2/11/129 |
Proteq West Nile |
Norvegia |
24.5.2016 |
|
EU/2/11/129 |
Proteq West Nile |
Islanda |
23.5.2016 |
|
EU/2/11/130 |
Zulvac 1 Bovis |
Liechtenstein |
30.4.2016 |
|
EU/2/11/130 |
Zulvac 1 Bovis |
Norvegia |
2.5.2016 |
|
EU/2/11/130 |
Zulvac 1 Bovis |
Islanda |
13.5.2016 |
|
EU/2/11/131 |
Zulvac 1 Ovis |
Liechtenstein |
30.4.2016 |
|
EU/2/11/131 |
Zulvac 1 Ovis |
Norvegia |
2.5.2016 |
|
EU/2/11/131 |
Zulvac 1 Ovis |
Islanda |
13.5.2016 |
ANEXA III
Lista autorizațiilor de comercializare prelungite
Următoarele autorizații de comercializare au fost prelungite în statele AELS care fac parte din SEE în perioada 1 ianuarie-30 iunie 2016:
|
Număr UE |
Produs |
Țară |
Data autorizării |
|
EU/1/03/262/011 |
Emend |
Norvegia |
15.1.2016 |
|
EU/1/03/262/011 |
Emend |
Islanda |
14.1.2016 |
|
EU/1/06/356/011-019 |
Exjade |
Norvegia |
1.4.2016 |
|
EU/1/06/356/011-019 |
Exjade |
Islanda |
31.3.2016 |
|
EU/1/10/612/010-013 |
Revolade |
Norvegia |
14.4.2016 |
|
EU/1/10/612/010-013 |
Revolade |
Islanda |
26.4.2016 |
|
EU/1/10/655/007-011 |
Brilique |
Norvegia |
26.2.2016 |
|
EU/1/10/655/007-011 |
Brilique |
Islanda |
18.3.2016 |
|
EU/1/13/851/004-006 |
Lojuxta |
Norvegia |
1.3.2016 |
|
EU/1/13/851/004-006 |
Lojuxta |
Islanda |
18.3.2016 |
|
EU/1/14/971/007-010 |
Trevicta |
Norvegia |
7.6.2016 |
|
EU/1/14/971/007-010 |
TREVICTA |
Islanda |
15.6.2016 |
|
EU/1/98/067/004 |
Mabthera |
Islanda |
15.6.2016 |
|
EU/1/98/067/004 |
Mabthera |
Norvegia |
26.5.2016 |
|
EU/2/13/158/016-031 |
Bravecto |
Norvegia |
7.6.2016 |
|
EU/2/13/158/016-031 |
Bravecto |
Islanda |
25.5.2016 |
ANEXA IV
Lista autorizațiilor de comercializare retrase
Următoarele autorizații de comercializare au fost retrase în statele AELS care fac parte din SEE în perioada 1 ianuarie-30 iunie 2016:
|
Număr UE |
Produs |
Țară |
Data retragerii |
|
EU/1/01/179 |
Osigraft |
Norvegia |
18.1.2016 |
|
EU/1/01/179 |
Osigraft |
Islanda |
4.1.2016 |
|
EU/1/05/314 |
Kepivance |
Liechtenstein |
30.4.2016 |
|
EU/1/05/314 |
Kepivance |
Islanda |
29.3.2016 |
|
EU/1/05/314 |
Kepivance |
Norvegia |
22.3.2016 |
|
EU/1/13/831 |
Capecitabin SUN |
Liechtenstein |
30.6.2016 |
|
EU/1/13/833 |
Nuedexta |
Liechtenstein |
30.4.2016 |
|
EU/1/13/833 |
Nuedexta |
Norvegia |
31.3.2016 |
|
EU/1/13/833 |
NUEDEXTA |
Islanda |
21.3.2016 |
|
EU/1/14/942 |
Clopidogrel/Acetylsalicylic acid Teva |
Norvegia |
15.6.2016 |
|
EU/2/12/138 |
RevitaCAM |
Liechtenstein |
30.6.2016 |
|
EU/2/12/138 |
RevitaCAM |
Norvegia |
15.6.2016 |
|
EU/2/12/138 |
RevitaCAM |
Islanda |
13.6.2016 |
ANEXA V
Lista autorizațiilor de comercializare suspendate
Următoarele autorizații de comercializare au fost suspendate în statele AELS care fac parte din SEE în perioada 1 ianuarie-30 iunie 2016:
|
Număr UE |
Produs |
Țară |
Data suspendării |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|