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Document E2018G0607(03)
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2016
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2016
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2016
OJ C 195, 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 |
EN |
Official Journal of the European Union |
C 195/26 |
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2016
(2018/C 195/11)
Subcommittee I on the free movement of goods
To be noted by the EEA Joint Committee
With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 July-31 December 2016, at their meeting on 17 March 2017:
|
Annex I |
List of new marketing authorisations |
|
Annex II |
List of renewed marketing authorisations |
|
Annex III |
List of extended marketing authorisations |
|
Annex IV |
List of withdrawn marketing authorisations |
|
Annex V |
List of suspended marketing authorisations |
ANNEX I
List of new marketing authorisations
The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July-31 December 2016:
|
EU Number |
Product |
Country |
Date of authorisation |
|
EU/1/12/793 |
Xalkori (Switch to non-conditional) |
Liechtenstein |
31.12.2016 |
|
EU/1/13/848 |
Erivedge (Switch to non-conditional) |
Liechtenstein |
31.12.2016 |
|
EU/1/15/1066 |
Ongentys |
Iceland |
13.7.2016 |
|
EU/1/15/1066 |
Ongentys |
Norway |
4.7.2016 |
|
EU/1/16/1091 |
Atazanavir Mylan |
Iceland |
29.8.2016 |
|
EU/1/16/1091 |
Atazanavir Mylan |
Norway |
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 |
Iceland |
7.12.2016 |
|
EU/1/16/1094 |
Ninlaro |
Norway |
28.11.2016 |
|
EU/1/16/1102 |
Bortezomib SUN |
Iceland |
11.8.2016 |
|
EU/1/16/1102 |
Bortezomib SUN |
Norway |
12.8.2016 |
|
EU/1/16/1102 |
Bortezomib SUN |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1103 |
Neparvis |
Iceland |
4.7.2016 |
|
EU/1/16/1105 |
EndolucinBeta |
Iceland |
25.7.2016 |
|
EU/1/16/1105 |
EndolucinBeta |
Norway |
27.7.2016 |
|
EU/1/16/1105 |
EndolucinBeta |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1107 |
ZINBRYTA |
Iceland |
14.7.2016 |
|
EU/1/16/1107 |
Zinbryta |
Norway |
7.7.2016 |
|
EU/1/16/1107 |
Zinbryta |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1108 |
Qtern |
Iceland |
25.7.2016 |
|
EU/1/16/1108 |
Qtern |
Norway |
4.8.2016 |
|
EU/1/16/1108 |
Qtern |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1109 |
ZAVICEFTA |
Iceland |
12.7.2016 |
|
EU/1/16/1109 |
Zavicefta |
Norway |
1.7.2016 |
|
EU/1/16/1112 |
Odefsey |
Iceland |
12.7.2016 |
|
EU/1/16/1113 |
Enzepi |
Iceland |
14.7.2016 |
|
EU/1/16/1113 |
Enzepi |
Norway |
26.7.2016 |
|
EU/1/16/1113 |
Enzepi |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1114 |
Bortezomib Hospira |
Iceland |
10.8.2016 |
|
EU/1/16/1114 |
Bortezomib Hospira |
Norway |
12.8.2016 |
|
EU/1/16/1114 |
Bortezomib Hospira |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1115 |
Pemetrexed Fresenius Kabi |
Iceland |
16.8.2016 |
|
EU/1/16/1115 |
Pemetrexed Fresenius Kabi |
Norway |
11.8.2016 |
|
EU/1/16/1116 |
Epclusa |
Iceland |
12.7.2016 |
|
EU/1/16/1116 |
Epclusa |
Norway |
11.7.2016 |
|
EU/1/16/1116 |
Epclusa |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1119 |
Zepatier |
Iceland |
11.8.2016 |
|
EU/1/16/1119 |
Zepatier |
Norway |
4.8.2016 |
|
EU/1/16/1119 |
Zepatier |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1121 |
Zalmoxis |
Iceland |
7.9.2016 |
|
EU/1/16/1121 |
Zalmoxis |
Norway |
16.9.2016 |
|
EU/1/16/1121 |
Zalmoxis |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1122 |
Aerivio Spiromax |
Iceland |
2.9.2016 |
|
EU/1/16/1122 |
Aerivio Spiromax |
Norway |
8.9.2016 |
|
EU/1/16/1122 |
Aerivio Spiromax |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1123 |
Airexar Spiromax |
Iceland |
2.9.2016 |
|
EU/1/16/1123 |
Airexar Spiromax |
Norway |
13.9.2016 |
|
EU/1/16/1123 |
Airexar Spiromax |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1124 |
Nordimet |
Iceland |
7.9.2016 |
|
EU/1/16/1124 |
Nordimet |
Norway |
30.8.2016 |
|
EU/1/16/1124 |
Nordimet |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1125 |
Cinqaero |
Iceland |
7.9.2016 |
|
EU/1/16/1125 |
Cinqaero |
Norway |
31.8.2016 |
|
EU/1/16/1125 |
Cinqaero |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1126 |
Truberzi |
Iceland |
7.10.2016 |
|
EU/1/16/1126 |
Truberzi |
Norway |
6.10.2016 |
|
EU/1/16/1126 |
Truberzi |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1127 |
Tenofovir disoproxil Zentiva |
Iceland |
6.10.2016 |
|
EU/1/16/1127 |
Tenofovir disoproxil Zentiva |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1127 |
Tenofovir disoproxil Zentiva |
Norway |
13.10.2016 |
|
EU/1/16/1128 |
Kisplyx |
Iceland |
7.9.2016 |
|
EU/1/16/1128 |
Kisplyx |
Norway |
31.8.2016 |
|
EU/1/16/1128 |
Kisplyx |
Liechtenstein |
31.8.2016 |
|
EU/1/16/1129 |
Tenofovir disoproxil Mylan |
Iceland |
16.12.2016 |
|
EU/1/16/1129 |
Tenofovir disoproxil Mylan |
Norway |
21.12.2016 |
|
EU/1/16/1130 |
Onivyde |
Iceland |
1.11.2016 |
|
EU/1/16/1130 |
Onivyde |
Norway |
4.11.2016 |
|
EU/1/16/1130 |
Onivyde |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1131 |
Thorinane |
Iceland |
6.10.2016 |
|
EU/1/16/1131 |
Thorinane |
Norway |
23.9.2016 |
|
EU/1/16/1131 |
Thorinane |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1132 |
Inhixa |
Iceland |
7.10.2016 |
|
EU/1/16/1132 |
Inhixa |
Norway |
5.10.2016 |
|
EU/1/16/1132 |
Inhixa |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1134 |
Mysildecard |
Iceland |
6.10.2016 |
|
EU/1/16/1134 |
Mysildecard |
Norway |
29.9.2016 |
|
EU/1/16/1134 |
Mysildecard |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1135 |
Sialanar |
Iceland |
7.10.2016 |
|
EU/1/16/1135 |
Sialanar |
Norway |
14.10.2016 |
|
EU/1/16/1135 |
Sialanar |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1136 |
Cabometyx |
Iceland |
6.10.2016 |
|
EU/1/16/1136 |
CABOMETYX |
Norway |
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 |
Iceland |
6.12.2016 |
|
EU/1/16/1137 |
Granpidam |
Norway |
28.11.2016 |
|
EU/1/16/1138 |
Venclyxto |
Iceland |
8.12.2016 |
|
EU/1/16/1138 |
Venclyxto |
Norway |
13.12.2016 |
|
EU/1/16/1139 |
Ocaliva |
Iceland |
19.12.2016 |
|
EU/1/16/1139 |
OCALIVA |
Norway |
12.12.2016 |
|
EU/1/16/1141 |
SomaKit TOC |
Iceland |
15.12.2016 |
|
EU/1/16/1141 |
SomaKit TOC |
Norway |
15.12.2016 |
|
EU/1/16/1142 |
Parsabiv |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1142 |
Parsabiv |
Iceland |
1.12.2016 |
|
EU/1/16/1142 |
Parsabiv |
Norway |
22.11.2016 |
|
EU/1/16/1143 |
Lartruvo |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1143 |
Lartruvo |
Iceland |
1.12.2016 |
|
EU/1/16/1143 |
Lartruvo |
Norway |
18.11.2016 |
|
EU/1/16/1144 |
Ivabradine Zentiva |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1144 |
Ivabradine Zentiva |
Iceland |
2.12.2016 |
|
EU/1/16/1144 |
Ivabradine Zentiva |
Norway |
28.11.2016 |
|
EU/1/16/1145 |
Ivabradine JensonR |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1145 |
Ivabradine JensonR |
Iceland |
2.12.2016 |
|
EU/1/16/1145 |
Ivabradine JensonR |
Norway |
5.12.2016 |
|
EU/1/16/1146 |
Glyxambi |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1146 |
Glyxambi |
Iceland |
5.12.2016 |
|
EU/1/16/1146 |
Glyxambi |
Norway |
9.12.2016 |
|
EU/1/16/1147 |
IBRANCE |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1147 |
Ibrance |
Iceland |
1.12.2016 |
|
EU/1/16/1147 |
IBRANCE |
Norway |
15.11.2016 |
|
EU/1/16/1148 |
Emtricitabin/Tenofovir disoproxil Zentiva |
Liechtenstein |
31.12.2016 |
|
EU/1/16/1148 |
Emtricitabine/Tenofovir disoproxil Zentiva |
Iceland |
1.12.2016 |
|
EU/1/16/1148 |
Emtricitabine/Tenofovir disoproxil Zentvia |
Norway |
15.11.2016 |
|
EU/1/16/1151 |
Emtricitabine/Tenofovir disproxil Krka |
Norway |
21.12.2016 |
|
EU/1/16/1151 |
Emtricitabine/Tenofovir disoproxil Krka |
Iceland |
14.12.2016 |
|
EU/2/16/196 |
Sevocalm |
Norway |
11.7.2016 |
|
EU/2/16/196 |
Sevocalm |
Liechtenstein |
31.8.2016 |
|
EU/2/16/196 |
Sevocalm |
Iceland |
12.7.2016 |
|
EU/2/16/198 |
Sedadex |
Iceland |
22.8.2016 |
|
EU/2/16/198 |
Sedadex |
Norway |
30.8.2016 |
|
EU/2/16/198 |
Sedadex |
Liechtenstein |
31.8.2016 |
|
EU/2/16/199 |
Eravac |
Iceland |
10.10.2016 |
|
EU/2/16/199 |
ERAVAC |
Norway |
5.10.2016 |
|
EU/2/16/199 |
ERAVAC |
Liechtenstein |
31.10.2016 |
|
EU/2/16/200 |
Cepedex |
Iceland |
19.12.2016 |
ANNEX II
List of renewed marketing authorisations
The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July-31 December 2016:
|
EU Number |
Product |
Country |
Date of authorisation |
|
EU/1/06/347 |
Sutent |
Liechtenstein |
31.12.2016 |
|
EU/1/06/347 |
Sutent |
Iceland |
1.12.2016 |
|
EU/1/06/347 |
Sutent |
Norway |
15.11.2016 |
|
EU/1/06/355 |
ATryn |
Iceland |
26.7.2016 |
|
EU/1/06/355 |
ATryn |
Norway |
10.8.2016 |
|
EU/1/06/355 |
ATryn |
Liechtenstein |
31.8.2016 |
|
EU/1/06/360 |
Champix |
Iceland |
13.7.2016 |
|
EU/1/06/360 |
Champix |
Norway |
7.7.2016 |
|
EU/1/06/360 |
Champix |
Liechtenstein |
31.8.2016 |
|
EU/1/06/361 |
Luminity |
Iceland |
26.7.2016 |
|
EU/1/06/361 |
Luminity |
Norway |
6.8.2016 |
|
EU/1/06/361 |
Luminity |
Liechtenstein |
31.8.2016 |
|
EU/1/06/362 |
Byetta |
Iceland |
18.8.2016 |
|
EU/1/06/363 |
Sprycel |
Iceland |
18.8.2016 |
|
EU/1/06/363 |
Sprycel |
Norway |
12.8.2016 |
|
EU/1/06/363 |
Sprycel |
Liechtenstein |
31.8.2016 |
|
EU/1/06/364 |
Adrovance |
Iceland |
16.10.2016 |
|
EU/1/06/365 |
Elaprase |
Iceland |
16.10.2016 |
|
EU/1/06/366 |
Tandemact |
Iceland |
16.10.2016 |
|
EU/1/06/374 |
Lucentis |
Liechtenstein |
31.12.2016 |
|
EU/1/06/374 |
Lucentis |
Iceland |
2.12.2016 |
|
EU/1/06/374 |
Lucentis |
Norway |
22.11.2016 |
|
EU/1/06/379 |
Cystadane |
Iceland |
7.12.2016 |
|
EU/1/06/379 |
Cystadane |
Norway |
29.11.2016 |
|
EU/1/11/699 |
Fampyra |
Norway |
8.7.2016 |
|
EU/1/11/701 |
Levatiracetam Teva |
Norway |
4.8.2016 |
|
EU/1/11/701 |
Levetiracetam Teva |
Iceland |
26.7.2016 |
|
EU/1/11/701 |
Levetiracetam Teva |
Liechtenstein |
31.8.2016 |
|
EU/1/11/706 |
Levodopa/Carbidopa/Entacapone Orion |
Norway |
15.9.2016 |
|
EU/1/11/711 |
Matever |
Iceland |
14.7.2016 |
|
EU/1/11/711 |
Matever |
Norway |
7.7.2016 |
|
EU/1/11/711 |
Matever |
Liechtenstein |
31.8.2016 |
|
EU/1/11/712 |
Levetiracetam Accord |
Iceland |
10.8.2016 |
|
EU/1/11/712 |
Levetiracetam Accord |
Norway |
11.8.2016 |
|
EU/1/11/712 |
Levetiracetam Accord |
Liechtenstein |
31.8.2016 |
|
EU/1/11/713 |
Levetiracetam Actavis |
Iceland |
5.10.2016 |
|
EU/1/11/713 |
Levetiracetam Actavis |
Norway |
30.9.2016 |
|
EU/1/11/713 |
Levetiracetam Actavis |
Liechtenstein |
31.10.2016 |
|
EU/1/11/715 |
Plenadren |
Iceland |
15.8.2016 |
|
EU/1/11/715 |
Plenadren |
Norway |
15.8.2016 |
|
EU/1/11/715 |
Plenadren |
Liechtenstein |
31.8.2016 |
|
EU/1/11/716 |
Eurartesim |
Iceland |
15.9.2016 |
|
EU/1/11/716 |
Eurartesim |
Norway |
15.9.2016 |
|
EU/1/11/716 |
Eurartesim |
Liechtenstein |
31.10.2016 |
|
EU/1/11/717 |
Vyndaqel |
Iceland |
10.8.2016 |
|
EU/1/11/717 |
Vyndaqel |
Norway |
11.8.2016 |
|
EU/1/11/717 |
Vyndaqel |
Liechtenstein |
31.8.2016 |
|
EU/1/11/719 |
Telmisartan Teva Pharma |
Iceland |
12.7.2016 |
|
EU/1/11/722 |
Pioglitazone Accord |
Iceland |
13.12.2016 |
|
EU/1/11/722 |
Pioglitazone Accord |
Norway |
21.12.2016 |
|
EU/1/11/727 |
Xaluprine |
Liechtenstein |
31.12.2016 |
|
EU/1/11/727 |
Xaluprine |
Iceland |
6.12.2016 |
|
EU/1/11/727 |
Xaluprine |
Norway |
5.12.2016 |
|
EU/1/11/728 |
Pramipexole Accord |
Iceland |
26.7.2016 |
|
EU/1/11/728 |
Pramipexole Accord |
Norway |
4.8.2016 |
|
EU/1/11/728 |
Pramipexole Accord |
Liechtenstein |
31.8.2016 |
|
EU/1/11/731 |
Komboglyze |
Iceland |
26.7.2016 |
|
EU/1/11/731 |
Komboglyze |
Norway |
11.8.2016 |
|
EU/1/11/731 |
Komboglyze |
Liechtenstein |
31.8.2016 |
|
EU/1/11/732 |
Desloratadine Teva |
Iceland |
15.8.2016 |
|
EU/1/11/732 |
Desloratadine Teva |
Norway |
22.8.2016 |
|
EU/1/11/733 |
Dificlir |
Iceland |
29.8.2016 |
|
EU/1/11/733 |
Dificlir |
Norway |
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 |
Iceland |
2.12.2016 |
|
EU/1/11/734 |
Edarbi |
Norway |
22.11.2016 |
|
EU/1/11/736 |
EDURANT |
Iceland |
10.8.2016 |
|
EU/1/11/736 |
EDURANT |
Norway |
11.8.2016 |
|
EU/1/11/736 |
EDURANT |
Liechtenstein |
31.8.2016 |
|
EU/1/11/737 |
Eviplera |
Iceland |
10.8.2016 |
|
EU/1/11/737 |
Eviplera |
Norway |
11.8.2016 |
|
EU/1/11/737 |
Eviplera |
Liechtenstein |
31.8.2016 |
|
EU/1/11/738 |
Levetiracetam Actavis Group |
Iceland |
15.8.2016 |
|
EU/1/11/738 |
Levetiracetam Actavis Group |
Norway |
2.9.2016 |
|
EU/1/11/738 |
Levetiracetam Actavis Group |
Liechtenstein |
31.8.2016 |
|
EU/1/11/739 |
Dasselta |
Iceland |
22.8.2016 |
|
EU/1/11/739 |
Dasselta |
Norway |
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 |
Iceland |
7.12.2016 |
|
EU/1/11/740 |
Ameluz |
Norway |
5.12.2016 |
|
EU/1/11/741 |
Levetiracetam SUN |
Liechtenstein |
31.12.2016 |
|
EU/1/11/741 |
Levetiracetam Sun |
Iceland |
5.12.2016 |
|
EU/1/11/741 |
Levetiracetam SUN |
Norway |
23.11.2016 |
|
EU/1/11/742 |
Efavirenz Teva |
Iceland |
16.10.2016 |
|
EU/1/11/742 |
Efavirenz Teva |
Norway |
21.10.2016 |
|
EU/1/11/743 |
Repaglinide Accord |
Iceland |
14.10.2016 |
|
EU/1/11/743 |
Repaglinide Accord |
Norway |
21.10.2016 |
|
EU/1/11/745 |
Desloratadin Actavis |
Liechtenstein |
31.12.2016 |
|
EU/1/11/745 |
Desloratadine Actavis |
Iceland |
2.12.2016 |
|
EU/1/11/745 |
Desloratadine Actavis |
Norway |
25.11.2016 |
|
EU/1/11/746 |
Desloratadine ratiopharm |
Iceland |
15.8.2016 |
|
EU/1/11/746 |
Desloratadine ratiopharm |
Norway |
22.8.2016 |
|
EU/1/11/746 |
Desloratadine ratiopharm |
Liechtenstein |
31.8.2016 |
|
EU/1/11/747 |
Colobreathe |
Iceland |
10.10.2016 |
|
EU/1/11/747 |
Colobreathe |
Norway |
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 |
Iceland |
5.12.2016 |
|
EU/1/12/750 |
Esmya |
Norway |
29.11.2016 |
|
EU/1/12/751 |
Zelboraf |
Norway |
6.10.2016 |
|
EU/1/12/751 |
Zelboraf |
Iceland |
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 |
Iceland |
6.12.2016 |
|
EU/1/12/753 |
Signifor |
Norway |
24.11.2016 |
|
EU/1/12/755 |
Pioglitazone Actavis |
Liechtenstein |
31.12.2016 |
|
EU/1/12/755 |
Pioglitazone Actavis |
Norway |
9.12.2016 |
|
EU/1/12/755 |
Pioglitazone Actavis |
Iceland |
2.12.2016 |
|
EU/1/12/756 |
Glidipion |
Norway |
9.12.2016 |
|
EU/1/12/756 |
Glidipion |
Liechtenstein |
31.12.2016 |
|
EU/1/12/756 |
Glidipion |
Iceland |
2.12.2016 |
|
EU/1/12/763 |
Ecansya |
Norway |
23.12.2016 |
|
EU/1/12/793 |
XALKORI |
Iceland |
10.8.2016 |
|
EU/1/12/793 |
XALKORI |
Norway |
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 |
Iceland |
2.11.2016 |
|
EU/1/12/794 |
ADCETRIS |
Norway |
8.11.2016 |
|
EU/1/15/1047 |
Blincyto |
Iceland |
10.10.2016 |
|
EU/1/15/1047 |
Blincyto |
Norway |
29.9.2016 |
|
EU/1/15/1047 |
Blincyto |
Liechtenstein |
31.10.2016 |
|
EU/1/16/1086 |
Tagrisso |
Iceland |
19.12.2016 |
|
EU/2/06/061 |
Nobilis Influenza H5N2 |
Iceland |
13.7.2016 |
|
EU/2/11/128 |
Emdocam |
Iceland |
13.7.2016 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Iceland |
25.8.2016 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Norway |
30.8.2016 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Liechtenstein |
31.10.2016 |
|
EU/2/11/133 |
Recocam |
Iceland |
17.8.2016 |
|
EU/2/11/133 |
Recocam |
Norway |
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 |
Iceland |
2.12.2016 |
|
EU/2/11/134 |
Inflacam |
Norway |
25.11.2016 |
|
EU/2/11/135 |
Panacur AquaSol |
Liechtenstein |
31.8.2016 |
|
EU/2/11/135 |
Panacur AquaSol |
Iceland |
2.9.2016 |
|
EU/2/11/135 |
Panacur AquaSol |
Norway |
5.9.2016 |
|
EU/2/11/137 |
Activyl Tick Plus |
Norway |
23.12.2016 |
|
EU/2/12/139 |
Zulvac 1+8 Bovis |
Iceland |
19.12.2016 |
ANNEX III
List of extended marketing authorisations
The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July-31 December 2016:
|
EU Number |
Product |
Country |
Date of authorisation |
|
EU/1/03/267/012 |
Reyataz |
Iceland |
13.7.2016 |
|
EU/1/08/494/005 |
Stelara |
Norway |
24.11.2016 |
|
EU/1/08/494/005 |
Stelara |
Iceland |
5.12.2016 |
|
EU/1/11/714/002-003 |
Zytiga |
Iceland |
1.12.2016 |
|
EU/1/11/714/003 |
Zytiga |
Norway |
25.11.2016 |
|
EU/1/12/776/024 |
Fycompa |
Iceland |
11.10.2016 |
|
EU/1/12/776/024 |
Fycompa |
Norway |
10.10.2016 |
|
EU/1/14/939/005-006 |
Daklinza |
Iceland |
13.7.2016 |
|
EU/1/14/939/005-006 |
Daklinza |
Norway |
4.7.2016 |
|
EU/1/15/1024/002 |
KEYTRUDA |
Iceland |
24.8.2016 |
|
EU/1/15/1024/002 |
KEYTRUDA |
Norway |
26.8.2016 |
|
EU/2/97/004/050-053 |
Metacam |
Norway |
29.8.2016 |
ANNEX IV
List of withdrawn marketing authorisations
The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July-31 December 2016:
|
EU Number |
Product |
Country |
Date of withdrawal |
|
EU/1/00/137 |
Avandia |
Iceland |
12.8.2016 |
|
EU/1/03/258 |
Avandamet |
Iceland |
12.8.2016 |
|
EU/1/07/385 |
Focetria |
Iceland |
12.8.2016 |
|
EU/1/08/489 |
Opgenra |
Iceland |
14.7.2016 |
|
EU/1/08/489 |
Opgenra |
Norway |
11.8.2016 |
|
EU/1/08/489 |
Opgenra |
Liechtenstein |
31.8.2016 |
|
EU/1/08/500 |
Fablyn |
Iceland |
12.8.2016 |
|
EU/1/08/506 |
Celvapan |
Iceland |
7.12.2016 |
|
EU/1/08/506 |
Celvapan |
Liechtenstein |
31.12.2016 |
|
EU/1/08/506 |
Celvapan |
Norway |
21.12.2016 |
|
EU/1/09/518 |
PANTECTA Control |
Iceland |
7.10.2016 |
|
EU/1/09/518 |
PANTECTA Control |
Norway |
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 |
Iceland |
15.8.2016 |
|
EU/1/09/563 |
ChondroCelect |
Norway |
11.8.2016 |
|
EU/1/10/657 |
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Dia |
Iceland |
12.8.2016 |
|
EU/1/11/721 |
Paglitaz |
Iceland |
12.8.2016 |
|
EU/1/12/810 |
Krystexxa |
Iceland |
14.7.2016 |
|
EU/1/12/810 |
Krystexxa |
Norway |
6.7.2016 |
|
EU/1/12/810 |
Krystexxa |
Liechtenstein |
31.8.2016 |
|
EU/1/13/831 |
Capecitabine SUN |
Iceland |
13.7.2016 |
|
EU/1/13/831 |
Capecitabine SUN |
Norway |
6.7.2016 |
|
EU/1/13/883 |
Vitekta |
Iceland |
10.11.2016 |
|
EU/1/13/883 |
Vitekta |
Liechtenstein |
31.12.2016 |
|
EU/1/13/883 |
Vitekta |
Norway |
15.12.2016 |
|
EU/1/14/942 |
Clopidogrel/Acetylsalicylic acid Teva |
Iceland |
26.7.2016 |
ANNEX V
List of suspended marketing authorisations
The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 July-31 December 2016:
|
EU Number |
Product |
Country |
Date of suspension |
|
EU/2/15/192 |
Velactis |
Iceland |
30.8.2016 |
|
EU/2/15/192 |
Velactis |
Norway |
29.8.2016 |
|
EU/2/15/192 |
Velactis |
Liechtenstein |
31.8.2016 |