EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document E2018G0607(03)
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2016
Lægemidler — liste over markedsføringstilladelser udstedt af EØS-EFTA-staterne i anden halvdel af 2016
Lægemidler — liste over markedsføringstilladelser udstedt af EØS-EFTA-staterne i anden halvdel af 2016
EUT C 195 af 7.6.2018, p. 26–43
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
7.6.2018 |
DA |
Den Europæiske Unions Tidende |
C 195/26 |
Lægemidler — liste over markedsføringstilladelser udstedt af EØS-EFTA-staterne i anden halvdel af 2016
(2018/C 195/11)
Underudvalg I for frie varebevægelser
Til Det Blandede EØS-Udvalgs underretning
Under henvisning til afgørelse truffet af Det Blandede EØS-Udvalg nr. 74/1999 af 28. maj 1999 opfordres Det Blandede EØS-Udvalg til på sit møde den 17. marts 2017 at notere sig følgende lister over markedsføringstilladelser for lægemidler udstedt i perioden 1. juli-31. december 2016:
|
Bilag I |
Liste over nye markedsføringstilladelser |
|
Bilag II |
Liste over fornyede markedsføringstilladelser |
|
Bilag III |
Liste over udvidede markedsføringstilladelser |
|
Bilag IV |
Liste over tilbagetrukne markedsføringstilladelser |
|
Bilag V |
Liste over suspenderede markedsføringstilladelser |
BILAG I
Liste over nye markedsføringstilladelser
Følgende markedsføringstilladelser er blevet udstedt i EØS-EFTA-staterne i perioden 1. juli-31. december 2016:
|
EU-nummer |
Produkt |
Land |
Godkendelsens dato: |
|
EU/1/12/793 |
Xalkori (skift til markedsføringstilladelse uden særlige vilkår) |
Liechtenstein |
31.12.2016 |
|
EU/1/13/848 |
Erivedge (skift til markedsføringstilladelse uden særlige vilkår) |
Liechtenstein |
31.12.2016 |
|
EU/1/15/1066 |
Ongentys |
Island |
13.7.2016 |
|
EU/1/15/1066 |
Ongentys |
Norge |
4.7.2016 |
|
EU/1/16/1091 |
Atazanavir Mylan |
Island |
29.8.2016 |
|
EU/1/16/1091 |
Atazanavir Mylan |
Norge |
2.9.2016 |
|
EU/1/16/1091 |
Atazanavir Mylan |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1094 |
Ninlaro |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1094 |
Ninlaro |
Island |
7.12.2016 |
|
EU/1/16/1094 |
Ninlaro |
Norge |
28.11.2016 |
|
EU/1/16/1102 |
Bortezomib SUN |
Island |
11.8.2016 |
|
EU/1/16/1102 |
Bortezomib SUN |
Norge |
12.8.2016 |
|
EU/1/16/1102 |
Bortezomib SUN |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1103 |
Neparvis |
Island |
4.7.2016 |
|
EU/1/16/1105 |
EndolucinBeta |
Island |
25.7.2016 |
|
EU/1/16/1105 |
EndolucinBeta |
Norge |
27.7.2016 |
|
EU/1/16/1105 |
EndolucinBeta |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1107 |
ZINBRYTA |
Island |
14.7.2016 |
|
EU/1/16/1107 |
Zinbryta |
Norge |
7.7.2016 |
|
EU/1/16/1107 |
Zinbryta |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1108 |
Qtern |
Island |
25.7.2016 |
|
EU/1/16/1108 |
Qtern |
Norge |
4.8.2016 |
|
EU/1/16/1108 |
Qtern |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1109 |
ZAVICEFTA |
Island |
12.7.2016 |
|
EU/1/16/1109 |
Zavicefta |
Norge |
1.7.2016 |
|
EU/1/16/1112 |
Odefsey |
Island |
12.7.2016 |
|
EU/1/16/1113 |
Enzepi |
Island |
14.7.2016 |
|
EU/1/16/1113 |
Enzepi |
Norge |
26.7.2016 |
|
EU/1/16/1113 |
Enzepi |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1114 |
Bortezomib Hospira |
Island |
10.8.2016 |
|
EU/1/16/1114 |
Bortezomib Hospira |
Norge |
12.8.2016 |
|
EU/1/16/1114 |
Bortezomib Hospira |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1115 |
Pemetrexed Fresenius Kabi |
Island |
16.8.2016 |
|
EU/1/16/1115 |
Pemetrexed Fresenius Kabi |
Norge |
11.8.2016 |
|
EU/1/16/1116 |
Epclusa |
Island |
12.7.2016 |
|
EU/1/16/1116 |
Epclusa |
Norge |
11.7.2016 |
|
EU/1/16/1116 |
Epclusa |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1119 |
Zepatier |
Island |
11.8.2016 |
|
EU/1/16/1119 |
Zepatier |
Norge |
4.8.2016 |
|
EU/1/16/1119 |
Zepatier |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1121 |
Zalmoxis |
Island |
7.9.2016 |
|
EU/1/16/1121 |
Zalmoxis |
Norge |
16.9.2016 |
|
EU/1/16/1121 |
Zalmoxis |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1122 |
Aerivio Spiromax |
Island |
2.9.2016 |
|
EU/1/16/1122 |
Aerivio Spiromax |
Norge |
8.9.2016 |
|
EU/1/16/1122 |
Aerivio Spiromax |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1123 |
Airexar Spiromax |
Island |
2.9.2016 |
|
EU/1/16/1123 |
Airexar Spiromax |
Norge |
13.9.2016 |
|
EU/1/16/1123 |
Airexar Spiromax |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1124 |
Nordimet |
Island |
7.9.2016 |
|
EU/1/16/1124 |
Nordimet |
Norge |
30.8.2016 |
|
EU/1/16/1124 |
Nordimet |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1125 |
Cinqaero |
Island |
7.9.2016 |
|
EU/1/16/1125 |
Cinqaero |
Norge |
31.8.2016 |
|
EU/1/16/1125 |
Cinqaero |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1126 |
Truberzi |
Island |
7.10.2016 |
|
EU/1/16/1126 |
Truberzi |
Norge |
6.10.2016 |
|
EU/1/16/1126 |
Truberzi |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1127 |
Tenofovir disoproxil Zentiva |
Island |
6.10.2016 |
|
EU/1/16/1127 |
Tenofovir disoproxil Zentiva |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1127 |
Tenofovir disoproxil Zentiva |
Norge |
13.10.2016 |
|
EU/1/16/1128 |
Kisplyx |
Island |
7.9.2016 |
|
EU/1/16/1128 |
Kisplyx |
Norge |
31.8.2016 |
|
EU/1/16/1128 |
Kisplyx |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1129 |
Tenofovir disoproxil Mylan |
Island |
16.12.2016 |
|
EU/1/16/1129 |
Tenofovir disoproxil Mylan |
Norge |
21.12.2016 |
|
EU/1/16/1130 |
Onivyde |
Island |
1.11.2016 |
|
EU/1/16/1130 |
Onivyde |
Norge |
4.11.2016 |
|
EU/1/16/1130 |
Onivyde |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1131 |
Thorinane |
Island |
6.10.2016 |
|
EU/1/16/1131 |
Thorinane |
Norge |
23.9.2016 |
|
EU/1/16/1131 |
Thorinane |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1132 |
Inhixa |
Island |
7.10.2016 |
|
EU/1/16/1132 |
Inhixa |
Norge |
5.10.2016 |
|
EU/1/16/1132 |
Inhixa |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1134 |
Mysildecard |
Island |
6.10.2016 |
|
EU/1/16/1134 |
Mysildecard |
Norge |
29.9.2016 |
|
EU/1/16/1134 |
Mysildecard |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1135 |
Sialanar |
Island |
7.10.2016 |
|
EU/1/16/1135 |
Sialanar |
Norge |
14.10.2016 |
|
EU/1/16/1135 |
Sialanar |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1136 |
Cabometyx |
Island |
6.10.2016 |
|
EU/1/16/1136 |
CABOMETYX |
Norge |
20.9.2016 |
|
EU/1/16/1136 |
CABOMETYX |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1137 |
Granpidam |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1137 |
Granpidam |
Island |
6.12.2016 |
|
EU/1/16/1137 |
Granpidam |
Norge |
28.11.2016 |
|
EU/1/16/1138 |
Venclyxto |
Island |
8.12.2016 |
|
EU/1/16/1138 |
Venclyxto |
Norge |
13.12.2016 |
|
EU/1/16/1139 |
Ocaliva |
Island |
19.12.2016 |
|
EU/1/16/1139 |
OCALIVA |
Norge |
12.12.2016 |
|
EU/1/16/1141 |
SomaKit TOC |
Island |
15.12.2016 |
|
EU/1/16/1141 |
SomaKit TOC |
Norge |
15.12.2016 |
|
EU/1/16/1142 |
Parsabiv |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1142 |
Parsabiv |
Island |
1.12.2016 |
|
EU/1/16/1142 |
Parsabiv |
Norge |
22.11.2016 |
|
EU/1/16/1143 |
Lartruvo |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1143 |
Lartruvo |
Island |
1.12.2016 |
|
EU/1/16/1143 |
Lartruvo |
Norge |
18.11.2016 |
|
EU/1/16/1144 |
Ivabradine Zentiva |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1144 |
Ivabradine Zentiva |
Island |
2.12.2016 |
|
EU/1/16/1144 |
Ivabradine Zentiva |
Norge |
28.11.2016 |
|
EU/1/16/1145 |
Ivabradine JensonR |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1145 |
Ivabradine JensonR |
Island |
2.12.2016 |
|
EU/1/16/1145 |
Ivabradine JensonR |
Norge |
5.12.2016 |
|
EU/1/16/1146 |
Glyxambi |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1146 |
Glyxambi |
Island |
5.12.2016 |
|
EU/1/16/1146 |
Glyxambi |
Norge |
9.12.2016 |
|
EU/1/16/1147 |
IBRANCE |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1147 |
Ibrance |
Island |
1.12.2016 |
|
EU/1/16/1147 |
IBRANCE |
Norge |
15.11.2016 |
|
EU/1/16/1148 |
Emtricitabin/Tenofovir disoproxil Zentiva |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1148 |
Emtricitabine/Tenofovir disoproxil Zentiva |
Island |
1.12.2016 |
|
EU/1/16/1148 |
Emtricitabine/Tenofovir disoproxil Zentvia |
Norge |
15.11.2016 |
|
EU/1/16/1151 |
Emtricitabine/Tenofovir disproxil Krka |
Norge |
21.12.2016 |
|
EU/1/16/1151 |
Emtricitabine/Tenofovir disoproxil Krka |
Island |
14.12.2016 |
|
EU/2/16/196 |
Sevocalm |
Norge |
11.7.2016 |
|
EU/2/16/196 |
Sevocalm |
Liechtenstein |
31.8.2016 |
|
EU/2/16/196 |
Sevocalm |
Island |
12.7.2016 |
|
EU/2/16/198 |
Sedadex |
Island |
22.8.2016 |
|
EU/2/16/198 |
Sedadex |
Norge |
30.8.2016 |
|
EU/2/16/198 |
Sedadex |
Liechtenstein |
31.8.2016 |
|
EU/2/16/199 |
Eravac |
Island |
10.10.2016 |
|
EU/2/16/199 |
ERAVAC |
Norge |
5.10.2016 |
|
EU/2/16/199 |
ERAVAC |
Liechtenstein |
31.10.2016 |
|
EU/2/16/200 |
Cepedex |
Island |
19.12.2016 |
BILAG II
Liste over fornyede markedsføringstilladelser
Følgende markedsføringstilladelser er blevet forlænget i EØS-EFTA-staterne i perioden 1. juli-31. december 2016:
|
EU-nummer |
Produkt |
Land |
Godkendelsens dato: |
|
EU/1/06/347 |
Sutent |
Liechtenstein |
31.12.2016 |
|
EU/1/06/347 |
Sutent |
Island |
1.12.2016 |
|
EU/1/06/347 |
Sutent |
Norge |
15.11.2016 |
|
EU/1/06/355 |
ATryn |
Island |
26.7.2016 |
|
EU/1/06/355 |
ATryn |
Norge |
10.8.2016 |
|
EU/1/06/355 |
ATryn |
Liechtenstein |
31.8.2016 |
|
EU/1/06/360 |
Champix |
Island |
13.7.2016 |
|
EU/1/06/360 |
Champix |
Norge |
7.7.2016 |
|
EU/1/06/360 |
Champix |
Liechtenstein |
31.8.2016 |
|
EU/1/06/361 |
Luminity |
Island |
26.7.2016 |
|
EU/1/06/361 |
Luminity |
Norge |
6.8.2016 |
|
EU/1/06/361 |
Luminity |
Liechtenstein |
31.8.2016 |
|
EU/1/06/362 |
Byetta |
Island |
18.8.2016 |
|
EU/1/06/363 |
Sprycel |
Island |
18.8.2016 |
|
EU/1/06/363 |
Sprycel |
Norge |
12.8.2016 |
|
EU/1/06/363 |
Sprycel |
Liechtenstein |
31.8.2016 |
|
EU/1/06/364 |
Adrovance |
Island |
16.10.2016 |
|
EU/1/06/365 |
Elaprase |
Island |
16.10.2016 |
|
EU/1/06/366 |
Tandemact |
Island |
16.10.2016 |
|
EU/1/06/374 |
Lucentis |
Liechtenstein |
31.12.2016 |
|
EU/1/06/374 |
Lucentis |
Island |
2.12.2016 |
|
EU/1/06/374 |
Lucentis |
Norge |
22.11.2016 |
|
EU/1/06/379 |
Cystadane |
Island |
7.12.2016 |
|
EU/1/06/379 |
Cystadane |
Norge |
29.11.2016 |
|
EU/1/11/699 |
Fampyra |
Norge |
8.7.2016 |
|
EU/1/11/701 |
Levatiracetam Teva |
Norge |
4.8.2016 |
|
EU/1/11/701 |
Levetiracetam Teva |
Island |
26.7.2016 |
|
EU/1/11/701 |
Levetiracetam Teva |
Liechtenstein |
31.8.2016 |
|
EU/1/11/706 |
Levodopa/Carbidopa/Entacapone Orion |
Norge |
15.9.2016 |
|
EU/1/11/711 |
Matever |
Island |
14.7.2016 |
|
EU/1/11/711 |
Matever |
Norge |
7.7.2016 |
|
EU/1/11/711 |
Matever |
Liechtenstein |
31.8.2016 |
|
EU/1/11/712 |
Levetiracetam Accord |
Island |
10.8.2016 |
|
EU/1/11/712 |
Levetiracetam Accord |
Norge |
11.8.2016 |
|
EU/1/11/712 |
Levetiracetam Accord |
Liechtenstein |
31.8.2016 |
|
EU/1/11/713 |
Levetiracetam Actavis |
Island |
5.10.2016 |
|
EU/1/11/713 |
Levetiracetam Actavis |
Norge |
30.9.2016 |
|
EU/1/11/713 |
Levetiracetam Actavis |
Liechtenstein |
31.10.2016 |
|
EU/1/11/715 |
Plenadren |
Island |
15.8.2016 |
|
EU/1/11/715 |
Plenadren |
Norge |
15.8.2016 |
|
EU/1/11/715 |
Plenadren |
Liechtenstein |
31.8.2016 |
|
EU/1/11/716 |
Eurartesim |
Island |
15.9.2016 |
|
EU/1/11/716 |
Eurartesim |
Norge |
15.9.2016 |
|
EU/1/11/716 |
Eurartesim |
Liechtenstein |
31.10.2016 |
|
EU/1/11/717 |
Vyndaqel |
Island |
10.8.2016 |
|
EU/1/11/717 |
Vyndaqel |
Norge |
11.8.2016 |
|
EU/1/11/717 |
Vyndaqel |
Liechtenstein |
31.8.2016 |
|
EU/1/11/719 |
Telmisartan Teva Pharma |
Island |
12.7.2016 |
|
EU/1/11/722 |
Pioglitazone Accord |
Island |
13.12.2016 |
|
EU/1/11/722 |
Pioglitazone Accord |
Norge |
21.12.2016 |
|
EU/1/11/727 |
Xaluprine |
Liechtenstein |
31.12.2016 |
|
EU/1/11/727 |
Xaluprine |
Island |
6.12.2016 |
|
EU/1/11/727 |
Xaluprine |
Norge |
5.12.2016 |
|
EU/1/11/728 |
Pramipexole Accord |
Island |
26.7.2016 |
|
EU/1/11/728 |
Pramipexole Accord |
Norge |
4.8.2016 |
|
EU/1/11/728 |
Pramipexole Accord |
Liechtenstein |
31.8.2016 |
|
EU/1/11/731 |
Komboglyze |
Island |
26.7.2016 |
|
EU/1/11/731 |
Komboglyze |
Norge |
11.8.2016 |
|
EU/1/11/731 |
Komboglyze |
Liechtenstein |
31.8.2016 |
|
EU/1/11/732 |
Desloratadine Teva |
Island |
15.8.2016 |
|
EU/1/11/732 |
Desloratadine Teva |
Norge |
22.8.2016 |
|
EU/1/11/733 |
Dificlir |
Island |
29.8.2016 |
|
EU/1/11/733 |
Dificlir |
Norge |
30.8.2016 |
|
EU/1/11/733 |
Dificlir |
Liechtenstein |
31.8.2016 |
|
EU/1/11/734 |
Edarbi |
Liechtenstein |
31.12.2016 |
|
EU/1/11/734 |
Edarbi |
Island |
2.12.2016 |
|
EU/1/11/734 |
Edarbi |
Norge |
22.11.2016 |
|
EU/1/11/736 |
EDURANT |
Island |
10.8.2016 |
|
EU/1/11/736 |
EDURANT |
Norge |
11.8.2016 |
|
EU/1/11/736 |
EDURANT |
Liechtenstein |
31.8.2016 |
|
EU/1/11/737 |
Eviplera |
Island |
10.8.2016 |
|
EU/1/11/737 |
Eviplera |
Norge |
11.8.2016 |
|
EU/1/11/737 |
Eviplera |
Liechtenstein |
31.8.2016 |
|
EU/1/11/738 |
Levetiracetam Actavis Group |
Island |
15.8.2016 |
|
EU/1/11/738 |
Levetiracetam Actavis Group |
Norge |
2.9.2016 |
|
EU/1/11/738 |
Levetiracetam Actavis Group |
Liechtenstein |
31.8.2016 |
|
EU/1/11/739 |
Dasselta |
Island |
22.8.2016 |
|
EU/1/11/739 |
Dasselta |
Norge |
5.9.2016 |
|
EU/1/11/739 |
Dasselta |
Liechtenstein |
31.8.2016 |
|
EU/1/11/740 |
Ameluz |
Liechtenstein |
31.12.2016 |
|
EU/1/11/740 |
Ameluz |
Island |
7.12.2016 |
|
EU/1/11/740 |
Ameluz |
Norge |
5.12.2016 |
|
EU/1/11/741 |
Levetiracetam SUN |
Liechtenstein |
31.12.2016 |
|
EU/1/11/741 |
Levetiracetam Sun |
Island |
5.12.2016 |
|
EU/1/11/741 |
Levetiracetam SUN |
Norge |
23.11.2016 |
|
EU/1/11/742 |
Efavirenz Teva |
Island |
16.10.2016 |
|
EU/1/11/742 |
Efavirenz Teva |
Norge |
21.10.2016 |
|
EU/1/11/743 |
Repaglinide Accord |
Island |
14.10.2016 |
|
EU/1/11/743 |
Repaglinide Accord |
Norge |
21.10.2016 |
|
EU/1/11/745 |
Desloratadin Actavis |
Liechtenstein |
31.12.2016 |
|
EU/1/11/745 |
Desloratadine Actavis |
Island |
2.12.2016 |
|
EU/1/11/745 |
Desloratadine Actavis |
Norge |
25.11.2016 |
|
EU/1/11/746 |
Desloratadine ratiopharm |
Island |
15.8.2016 |
|
EU/1/11/746 |
Desloratadine ratiopharm |
Norge |
22.8.2016 |
|
EU/1/11/746 |
Desloratadine ratiopharm |
Liechtenstein |
31.8.2016 |
|
EU/1/11/747 |
Colobreathe |
Island |
10.10.2016 |
|
EU/1/11/747 |
Colobreathe |
Norge |
13.10.2016 |
|
EU/1/11/747 |
Colobreathe |
Liechtenstein |
31.10.2016 |
|
EU/1/12/750 |
Esmya |
Liechtenstein |
31.12.2016 |
|
EU/1/12/750 |
Esmya |
Island |
5.12.2016 |
|
EU/1/12/750 |
Esmya |
Norge |
29.11.2016 |
|
EU/1/12/751 |
Zelboraf |
Norge |
6.10.2016 |
|
EU/1/12/751 |
Zelboraf |
Island |
10.10.2016 |
|
EU/1/12/751 |
Zelboraf |
Liechtenstein |
31.10.2016 |
|
EU/1/12/753 |
Signifor |
Liechtenstein |
31.12.2016 |
|
EU/1/12/753 |
Signifor |
Island |
6.12.2016 |
|
EU/1/12/753 |
Signifor |
Norge |
24.11.2016 |
|
EU/1/12/755 |
Pioglitazone Actavis |
Liechtenstein |
31.12.2016 |
|
EU/1/12/755 |
Pioglitazone Actavis |
Norge |
9.12.2016 |
|
EU/1/12/755 |
Pioglitazone Actavis |
Island |
2.12.2016 |
|
EU/1/12/756 |
Glidipion |
Norge |
9.12.2016 |
|
EU/1/12/756 |
Glidipion |
Liechtenstein |
31.12.2016 |
|
EU/1/12/756 |
Glidipion |
Island |
2.12.2016 |
|
EU/1/12/763 |
Ecansya |
Norge |
23.12.2016 |
|
EU/1/12/793 |
XALKORI |
Island |
10.8.2016 |
|
EU/1/12/793 |
XALKORI |
Norge |
12.8.2016 |
|
EU/1/12/793 |
XALKORI |
Liechtenstein |
31.8.2016 |
|
EU/1/12/794 |
ADCETRIS |
Liechtenstein |
31.10.2016 |
|
EU/1/12/794 |
ADCETRIS |
Island |
2.11.2016 |
|
EU/1/12/794 |
ADCETRIS |
Norge |
8.11.2016 |
|
EU/1/15/1047 |
Blincyto |
Island |
10.10.2016 |
|
EU/1/15/1047 |
Blincyto |
Norge |
29.9.2016 |
|
EU/1/15/1047 |
Blincyto |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1086 |
Tagrisso |
Island |
19.12.2016 |
|
EU/2/06/061 |
Nobilis Influenza H5N2 |
Island |
13.7.2016 |
|
EU/2/11/128 |
Emdocam |
Island |
13.7.2016 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Island |
25.8.2016 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Norge |
30.8.2016 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Liechtenstein |
31.10.2016 |
|
EU/2/11/133 |
Recocam |
Island |
17.8.2016 |
|
EU/2/11/133 |
Recocam |
Norge |
25.8.2016 |
|
EU/2/11/133 |
Recocam |
Liechtenstein |
31.8.2016 |
|
EU/2/11/134 |
Inflacam |
Liechtenstein |
31.12.2016 |
|
EU/2/11/134 |
Inflacam |
Island |
2.12.2016 |
|
EU/2/11/134 |
Inflacam |
Norge |
25.11.2016 |
|
EU/2/11/135 |
Panacur AquaSol |
Liechtenstein |
31.8.2016 |
|
EU/2/11/135 |
Panacur AquaSol |
Island |
2.9.2016 |
|
EU/2/11/135 |
Panacur AquaSol |
Norge |
5.9.2016 |
|
EU/2/11/137 |
Activyl Tick Plus |
Norge |
23.12.2016 |
|
EU/2/12/139 |
Zulvac 1 + 8 Bovis |
Island |
19.12.2016 |
BILAG III
Liste over udvidede markedsføringstilladelser
Følgende markedsføringstilladelser er blevet udvidet i EØS-EFTA-staterne i perioden 1. juli-31. december 2016:
|
EU-nummer |
Produkt |
Land |
Godkendelsens dato: |
|
EU/1/03/267/012 |
Reyataz |
Island |
13.7.2016 |
|
EU/1/08/494/005 |
Stelara |
Norge |
24.11.2016 |
|
EU/1/08/494/005 |
Stelara |
Island |
5.12.2016 |
|
EU/1/11/714/002-003 |
Zytiga |
Island |
1.12.2016 |
|
EU/1/11/714/003 |
Zytiga |
Norge |
25.11.2016 |
|
EU/1/12/776/024 |
Fycompa |
Island |
11.10.2016 |
|
EU/1/12/776/024 |
Fycompa |
Norge |
10.10.2016 |
|
EU/1/14/939/005-006 |
Daklinza |
Island |
13.7.2016 |
|
EU/1/14/939/005-006 |
Daklinza |
Norge |
4.7.2016 |
|
EU/1/15/1024/002 |
KEYTRUDA |
Island |
24.8.2016 |
|
EU/1/15/1024/002 |
KEYTRUDA |
Norge |
26.8.2016 |
|
EU/2/97/004/050-053 |
Metacam |
Norge |
29.8.2016 |
BILAG IV
Liste over tilbagetrukne markedsføringstilladelser
Følgende markedsføringstilladelser er blevet trukket tilbage i EØS-EFTA-staterne i perioden 1. juli-31. december 2016:
|
EU-nummer |
Vare |
Land |
Tilbagetrækningsdato |
|
EU/1/00/137 |
Avandia |
Island |
12.8.2016 |
|
EU/1/03/258 |
Avandamet |
Island |
12.8.2016 |
|
EU/1/07/385 |
Focetria |
Island |
12.8.2016 |
|
EU/1/08/489 |
Opgenra |
Island |
14.7.2016 |
|
EU/1/08/489 |
Opgenra |
Norge |
11.8.2016 |
|
EU/1/08/489 |
Opgenra |
Liechtenstein |
31.8.2016 |
|
EU/1/08/500 |
Fablyn |
Island |
12.8.2016 |
|
EU/1/08/506 |
Celvapan |
Island |
7.12.2016 |
|
EU/1/08/506 |
Celvapan |
Liechtenstein |
31.12.2016 |
|
EU/1/08/506 |
Celvapan |
Norge |
21.12.2016 |
|
EU/1/09/518 |
PANTECTA Control |
Island |
7.10.2016 |
|
EU/1/09/518 |
PANTECTA Control |
Norge |
20.10.2016 |
|
EU/1/09/518 |
PANTECTA Control |
Liechtenstein |
31.10.2016 |
|
EU/1/09/563 |
ChondroCelect |
Liechtenstein |
31.8.2016 |
|
EU/1/09/563 |
ChondroCelect |
Island |
15.8.2016 |
|
EU/1/09/563 |
ChondroCelect |
Norge |
11.8.2016 |
|
EU/1/10/657 |
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Dia |
Island |
12.8.2016 |
|
EU/1/11/721 |
Paglitaz |
Island |
12.8.2016 |
|
EU/1/12/810 |
Krystexxa |
Island |
14.7.2016 |
|
EU/1/12/810 |
Krystexxa |
Norge |
6.7.2016 |
|
EU/1/12/810 |
Krystexxa |
Liechtenstein |
31.8.2016 |
|
EU/1/13/831 |
Capecitabine SUN |
Island |
13.7.2016 |
|
EU/1/13/831 |
Capecitabine SUN |
Norge |
6.7.2016 |
|
EU/1/13/883 |
Vitekta |
Island |
10.11.2016 |
|
EU/1/13/883 |
Vitekta |
Liechtenstein |
31.12.2016 |
|
EU/1/13/883 |
Vitekta |
Norge |
15.12.2016 |
|
EU/1/14/942 |
Clopidogrel/Acetylsalicylic acid Teva |
Island |
26.7.2016 |
BILAG V
Liste over suspenderede markedsføringstilladelser
Følgende markedsføringstilladelser er blevet suspenderet i EØS-EFTA-staterne i perioden 1. juli-31. december 2016:
|
EU-nummer |
Vare |
Land |
Suspensionsdato |
|
EU/2/15/192 |
Velactis |
Island |
30.8.2016 |
|
EU/2/15/192 |
Velactis |
Norge |
29.8.2016 |
|
EU/2/15/192 |
Velactis |
Liechtenstein |
31.8.2016 |