# C_2018205EN.01000701.xml

| 14.6.2018 | EN | Official Journal of the European Union | C 205/7 |
| --- | --- | --- | --- |

14.6.2018

EN

Official Journal of the European Union

C 205/7

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Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2017

(2018/C 205/05)

Subcommittee I on the free movement of goods

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

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 January-30 June 2017, at their meeting on 15 December 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| Annex IV | List of withdrawn marketing authorisations |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

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List of withdrawn marketing authorisations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

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ANNEX I

List of new marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January-30 June 2017:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/11/699 | Fampyra (Switch to non-conditional) | Liechtenstein | 30.6.2017 |
| EU/1/12/771 | Zoledronsäure Teva | Liechtenstein | 30.6.2017 |
| EU/1/15/1049 | Cystadrops | Liechtenstein | 28.2.2017 |
| EU/1/15/1049 | Cystadrops | Norway | 27.1.2017 |
| EU/1/15/1049 | CYSTADROPS | Iceland | 30.1.2017 |
| EU/1/15/1078 | Natpar | Liechtenstein | 30.4.2017 |
| EU/1/15/1078 | Natpar | Norway | 10.5.2017 |
| EU/1/15/1078 | Natpar | Iceland | 15.5.2017 |
| EU/1/16/1086 | TAGRISSO (Switch to non-conditional) | Liechtenstein | 30.4.2017 |
| EU/1/16/1110 | Chenodeoxycholic acid Leadiant | Norway | 20.4.2017 |
| EU/1/16/1110 | Chenodeoxycholic acid Leadiant | Liechtenstein | 30.6.2017 |
| EU/1/16/1110 | Chenodeoxycholic acid Leadiant | Iceland | 9.5.2017 |
| EU/1/16/1133 | Emtricitabine/Tenofovir disoproxil Mylan | Liechtenstein | 28.2.2017 |
| EU/1/16/1133 | Emtricitabine/Tenofovir disoproxil Mylan | Norway | 16.1.2017 |
| EU/1/16/1133 | Emtricitabine/Tenofovir disoproxil Mylan | Iceland | 5.1.2017 |
| EU/1/16/1139 | OCALIVA | Liechtenstein | 30.4.2017 |
| EU/1/16/1140 | Darunavir Mylan | Liechtenstein | 28.2.2017 |
| EU/1/16/1140 | Darunavir Mylan | Norway | 16.1.2017 |
| EU/1/16/1140 | Darunavir Mylan | Iceland | 11.1.2017 |
| EU/1/16/1150 | Rekovelle | Norway | 6.1.2017 |
| EU/1/16/1150 | REKOVELLE | Iceland | 4.1.2017 |
| EU/1/16/1152 | Roteas | Liechtenstein | 30.4.2017 |
| EU/1/16/1152 | Roteas | Norway | 10.5.2017 |
| EU/1/16/1152 | Roteas | Iceland | 10.5.2017 |
| EU/1/16/1153 | Tadalafil Generics | Liechtenstein | 28.2.2017 |
| EU/1/16/1153 | Tadalafil Generics | Norway | 24.1.2017 |
| EU/1/16/1153 | Tadalafil Generics | Iceland | 13.1.2017 |
| EU/1/16/1154 | Vemlidy | Liechtenstein | 28.2.2017 |
| EU/1/16/1154 | Vemlidy | Norway | 1.2.2017 |
| EU/1/16/1154 | Vemlidy | Iceland | 13.1.2017 |
| EU/1/16/1156 | ZINPLAVA | Liechtenstein | 28.2.2017 |
| EU/1/16/1156 | ZINPLAVA | Norway | 26.1.2017 |
| EU/1/16/1156 | Zinplava | Iceland | 24.1.2017 |
| EU/1/16/1157 | Suliqua | Liechtenstein | 28.2.2017 |
| EU/1/16/1157 | Suliqua | Norway | 25.1.2017 |
| EU/1/16/1157 | Suliqua | Iceland | 24.1.2017 |
| EU/1/16/1158 | AFSTYLA | Liechtenstein | 28.2.2017 |
| EU/1/16/1158 | AFSTYLA | Norway | 11.1.2017 |
| EU/1/16/1158 | Afstyla | Iceland | 11.1.2017 |
| EU/1/16/1159 | Terrosa | Liechtenstein | 28.2.2017 |
| EU/1/16/1159 | Terrosa | Norway | 11.1.2017 |
| EU/1/16/1159 | Terrosa | Iceland | 11.1.2017 |
| EU/1/16/1160 | Fiasp | Liechtenstein | 28.2.2017 |
| EU/1/16/1160 | Fiasp | Norway | 25.1.2017 |
| EU/1/16/1160 | Fiasp | Iceland | 23.1.2017 |
| EU/1/16/1161 | Movymia | Liechtenstein | 28.2.2017 |
| EU/1/16/1161 | Movymia | Norway | 26.1.2017 |
| EU/1/16/1161 | Movymia | Iceland | 24.1.2017 |
| EU/1/16/1162 | Lusduna | Liechtenstein | 28.2.2017 |
| EU/1/16/1162 | Lusduna | Norway | 19.1.2017 |
| EU/1/16/1162 | Lusduna | Iceland | 12.1.2017 |
| EU/1/16/1163 | SOLYMBIC | Liechtenstein | 30.4.2017 |
| EU/1/16/1163 | SOLYMBIC | Norway | 6.4.2017 |
| EU/1/16/1163 | Solymbic | Iceland | 6.4.2017 |
| EU/1/16/1164 | AMGEVITA | Liechtenstein | 30.4.2017 |
| EU/1/16/1164 | AMGEVITA | Norway | 6.4.2017 |
| EU/1/16/1164 | Amgevita | Iceland | 6.4.2017 |
| EU/1/16/1165 | LIFMIOR | Liechtenstein | 28.2.2017 |
| EU/1/16/1165 | LIFMIOR | Norway | 21.2.2017 |
| EU/1/16/1165 | Lifmior | Iceland | 21.2.2017 |
| EU/1/16/1166 | Pregabalin Zentiva k.s | Liechtenstein | 30.4.2017 |
| EU/1/16/1166 | Pregabalin Zentiva k.s. | Norway | 13.3.2017 |
| EU/1/16/1166 | Pregabalin Zentiva k.s. | Iceland | 14.3.2017 |
| EU/1/16/1167 | Truxima | Liechtenstein | 30.4.2017 |
| EU/1/16/1167 | Truxima | Norway | 28.2.2017 |
| EU/1/16/1167 | Truxima | Iceland | 15.3.2017 |
| EU/1/16/1168 | Vihuma | Liechtenstein | 30.4.2017 |
| EU/1/16/1168 | Vihuma | Norway | 17.3.2017 |
| EU/1/16/1168 | Vihuma | Iceland | 10.3.2017 |
| EU/1/16/1169 | Alecensa | Liechtenstein | 28.2.2017 |
| EU/1/16/1169 | Alecensa | Norway | 7.3.2017 |
| EU/1/16/1169 | Alecensa | Iceland | 15.3.2017 |
| EU/1/16/1170 | Olumiant | Liechtenstein | 28.2.2017 |
| EU/1/16/1170 | Olumiant | Norway | 22.2.2017 |
| EU/1/16/1170 | OLUMIANT | Iceland | 21.2.2017 |
| EU/1/16/1171 | Ledaga | Liechtenstein | 30.4.2017 |
| EU/1/16/1171 | Ledaga | Norway | 15.3.2017 |
| EU/1/16/1171 | LEDAGA | Iceland | 14.3.2017 |
| EU/1/17/1172 | Jylamvo | Liechtenstein | 30.4.2017 |
| EU/1/17/1172 | Jylamvo | Norway | 4.4.2017 |
| EU/1/17/1172 | Jylamvo | Iceland | 26.4.2017 |
| EU/1/17/1174 | Rolufta | Liechtenstein | 30.4.2017 |
| EU/1/17/1174 | Rolufta | Norway | 7.4.2017 |
| EU/1/17/1174 | Rolufta | Iceland | 24.3.2017 |
| EU/1/17/1175 | Daptomycin Hospira | Liechtenstein | 30.4.2017 |
| EU/1/17/1175 | Daptomycin Hospira | Norway | 18.4.2017 |
| EU/1/17/1175 | Daptomycin Hospira | Iceland | 7.4.2017 |
| EU/1/17/1176 | Yargesa | Liechtenstein | 30.4.2017 |
| EU/1/17/1176 | Yargesa | Norway | 7.4.2017 |
| EU/1/17/1176 | Yargesa | Iceland | 7.4.2017 |
| EU/1/17/1177 | Tadalafil Lilly | Liechtenstein | 30.4.2017 |
| EU/1/17/1177 | Tadalafil Lilly | Norway | 18.4.2017 |
| EU/1/17/1177 | Tadalafil Lilly | Iceland | 6.4.2017 |
| EU/1/17/1178 | Xeljanz | Liechtenstein | 30.4.2017 |
| EU/1/17/1178 | Xeljanz | Norway | 6.4.2017 |
| EU/1/17/1178 | XELJANZ | Iceland | 6.4.2017 |
| EU/1/17/1180 | Varuby | Liechtenstein | 30.4.2017 |
| EU/1/17/1180 | Varuby | Norway | 10.5.2017 |
| EU/1/17/1180 | Varuby | Iceland | 10.5.2017 |
| EU/1/17/1182 | Emtricitabine/Tenofovir disoproxil Krka d.d. | Liechtenstein | 30.6.2017 |
| EU/1/17/1182 | Emtricitabine/Tenofovir disoproxil Krka d.d. | Norway | 22.5.2017 |
| EU/1/17/1182 | Emtricitabine/Tenofovir disoproxil KrKa d.d. | Iceland | 12.5.2017 |
| EU/1/17/1183 | Pemetrexed Hospira UK Limited | Norway | 9.5.2017 |
| EU/1/17/1183 | Pemetrexed Hospira UK Limited | Iceland | 12.5.2017 |
| EU/1/17/1183 | Pemetrexed Hospira UK Ltd | Liechtenstein | 30.6.2017 |
| EU/1/17/1184 | Riximyo | Liechtenstein | 30.6.2017 |
| EU/1/17/1184 | Riximyo | Norway | 26.6.2017 |
| EU/1/17/1185 | Rixathon | Liechtenstein | 30.6.2017 |
| EU/1/17/1185 | Rixathon | Norway | 23.6.2017 |
| EU/1/17/1186 | Axumin | Liechtenstein | 30.6.2017 |
| EU/1/17/1186 | Axumin | Norway | 31.5.2017 |
| EU/1/17/1186 | Axumin | Iceland | 21.6.2017 |
| EU/1/17/1187 | Trumenba | Liechtenstein | 30.6.2017 |
| EU/1/17/1187 | Trumenba | Norway | 9.6.2017 |
| EU/1/17/1187 | Trumenba | Iceland | 21.6.2017 |
| EU/1/17/1188 | Spinraza | Liechtenstein | 30.6.2017 |
| EU/1/17/1188 | Spinraza | Norway | 8.6.2017 |
| EU/1/17/1188 | Spinraza | Iceland | 30.6.2017 |
| EU/1/17/1189 | Elmiron | Liechtenstein | 30.6.2017 |
| EU/1/17/1189 | Elmiron | Norway | 20.6.2017 |
| EU/1/17/1189 | Elmiron | Iceland | 30.6.2017 |
| EU/1/17/1190 | Ivabradine Accord | Liechtenstein | 30.6.2017 |
| EU/1/17/1190 | Ivabradine Accord | Norway | 12.6.2017 |
| EU/1/17/1190 | Ivabradine Accord | Iceland | 7.6.2017 |
| EU/1/17/1191 | Dinutuximab beta Apeiron | Liechtenstein | 30.6.2017 |
| EU/1/17/1191 | Dinutuximab beta Apeiron | Norway | 12.5.2017 |
| EU/1/17/1191 | Dinutuximab beta Apeiron | Iceland | 23.5.2017 |
| EU/1/17/1192 | Brineura | Liechtenstein | 30.6.2017 |
| EU/1/17/1192 | Brineura | Norway | 6.6.2017 |
| EU/1/17/1192 | Brineura | Iceland | 30.6.2017 |
| EU/1/17/1193 | Refixia | Liechtenstein | 30.6.2017 |
| EU/1/17/1193 | Refixia | Norway | 22.6.2017 |
| EU/1/17/1193 | Refixia | Iceland | 30.6.2017 |
| EU/1/17/1194 | Febuxostat Mylan | Liechtenstein | 30.6.2017 |
| EU/1/17/1194 | Febuxostat Mylan | Norway | 26.6.2017 |
| EU/1/17/1195 | Erelzi | Liechtenstein | 30.6.2017 |
| EU/1/17/1196 | Kevzara | Liechtenstein | 30.6.2017 |
| EU/1/17/1201 | Skilarence | Liechtenstein | 30.6.2017 |
| EU/1/17/1202 | Ucedane | Liechtenstein | 30.6.2017 |
| EU/2/16/200 | Cepedex | Norway | 4.1.2017 |
| EU/2/16/201 | Halagon | Norway | 4.1.2017 |
| EU/2/16/201 | Halagon | Iceland | 4.1.2017 |
| EU/2/16/202 | Coliprotec F4/F18 | Liechtenstein | 28.2.2017 |
| EU/2/16/202 | Coliprotec F4/F18 | Norway | 21.2.2017 |
| EU/2/16/202 | Coliprotec F4/F18 | Iceland | 9.3.2017 |
| EU/2/16/203 | VarroMed | Liechtenstein | 28.2.2017 |
| EU/2/16/203 | VarroMed | Norway | 21.2.2017 |
| EU/2/16/203 | VarroMed | Iceland | 15.2.2017 |
| EU/2/16/204 | Stronghold Plus | Liechtenstein | 28.2.2017 |
| EU/2/16/204 | Stronghold Plus | Norway | 27.2.2017 |
| EU/2/16/204 | Stronghold Plus | Iceland | 15.2.2017 |
| EU/2/17/205 | CYTOPOINT | Liechtenstein | 30.4.2017 |
| EU/2/17/205 | CYTOPOINT | Norway | 23.5.2017 |
| EU/2/17/205 | CYTOPOINT | Iceland | 12.5.2017 |
| EU/2/17/206 | Credelio | Liechtenstein | 30.6.2017 |
| EU/2/17/206 | Credelio | Norway | 23.5.2017 |
| EU/2/17/206 | Credelio | Iceland | 12.5.2017 |
| EU/2/17/207 | Zulvac BTV Ovis | Norway | 18.5.2017 |
| EU/2/17/207 | Zulvac BTV Ovis | Iceland | 12.5.2017 |
| EU/2/17/208 | Ingelvac PCV FLEX | Liechtenstein | 30.6.2017 |
| EU/2/17/208 | Ingelvac PCV FLEX | Norway | 8.6.2017 |
| EU/2/17/208 | Ingelvac PCV FLEX | Iceland | 13.6.2017 |
| EU/2/17/209 | RESPIPORC FLUpan H1N1 | Liechtenstein | 30.6.2017 |
| EU/2/17/209 | RESPIPORC FLUpan H1N1 | Norway | 2.6.2017 |
| EU/2/17/209 | RESPIPORC FLUpan H1N1 | Iceland | 13.6.2017 |
| EU/2/17/210 | Zeleris | Norway | 7.6.2017 |
| EU/2/17/210 | Zeleris | Iceland | 19.5.2017 |

EU Number

Product

Country

Date of authorisation

EU/1/11/699

Fampyra (Switch to non-conditional)

Liechtenstein

30.6.2017

EU/1/12/771

Zoledronsäure Teva

Liechtenstein

30.6.2017

EU/1/15/1049

Cystadrops

Liechtenstein

28.2.2017

EU/1/15/1049

Cystadrops

Norway

27.1.2017

EU/1/15/1049

CYSTADROPS

Iceland

30.1.2017

EU/1/15/1078

Natpar

Liechtenstein

30.4.2017

EU/1/15/1078

Natpar

Norway

10.5.2017

EU/1/15/1078

Natpar

Iceland

15.5.2017

EU/1/16/1086

TAGRISSO (Switch to non-conditional)

Liechtenstein

30.4.2017

EU/1/16/1110

Chenodeoxycholic acid Leadiant

Norway

20.4.2017

EU/1/16/1110

Chenodeoxycholic acid Leadiant

Liechtenstein

30.6.2017

EU/1/16/1110

Chenodeoxycholic acid Leadiant

Iceland

9.5.2017

EU/1/16/1133

Emtricitabine/Tenofovir disoproxil Mylan

Liechtenstein

28.2.2017

EU/1/16/1133

Emtricitabine/Tenofovir disoproxil Mylan

Norway

16.1.2017

EU/1/16/1133

Emtricitabine/Tenofovir disoproxil Mylan

Iceland

5.1.2017

EU/1/16/1139

OCALIVA

Liechtenstein

30.4.2017

EU/1/16/1140

Darunavir Mylan

Liechtenstein

28.2.2017

EU/1/16/1140

Darunavir Mylan

Norway

16.1.2017

EU/1/16/1140

Darunavir Mylan

Iceland

11.1.2017

EU/1/16/1150

Rekovelle

Norway

6.1.2017

EU/1/16/1150

REKOVELLE

Iceland

4.1.2017

EU/1/16/1152

Roteas

Liechtenstein

30.4.2017

EU/1/16/1152

Roteas

Norway

10.5.2017

EU/1/16/1152

Roteas

Iceland

10.5.2017

EU/1/16/1153

Tadalafil Generics

Liechtenstein

28.2.2017

EU/1/16/1153

Tadalafil Generics

Norway

24.1.2017

EU/1/16/1153

Tadalafil Generics

Iceland

13.1.2017

EU/1/16/1154

Vemlidy

Liechtenstein

28.2.2017

EU/1/16/1154

Vemlidy

Norway

1.2.2017

EU/1/16/1154

Vemlidy

Iceland

13.1.2017

EU/1/16/1156

ZINPLAVA

Liechtenstein

28.2.2017

EU/1/16/1156

ZINPLAVA

Norway

26.1.2017

EU/1/16/1156

Zinplava

Iceland

24.1.2017

EU/1/16/1157

Suliqua

Liechtenstein

28.2.2017

EU/1/16/1157

Suliqua

Norway

25.1.2017

EU/1/16/1157

Suliqua

Iceland

24.1.2017

EU/1/16/1158

AFSTYLA

Liechtenstein

28.2.2017

EU/1/16/1158

AFSTYLA

Norway

11.1.2017

EU/1/16/1158

Afstyla

Iceland

11.1.2017

EU/1/16/1159

Terrosa

Liechtenstein

28.2.2017

EU/1/16/1159

Terrosa

Norway

11.1.2017

EU/1/16/1159

Terrosa

Iceland

11.1.2017

EU/1/16/1160

Fiasp

Liechtenstein

28.2.2017

EU/1/16/1160

Fiasp

Norway

25.1.2017

EU/1/16/1160

Fiasp

Iceland

23.1.2017

EU/1/16/1161

Movymia

Liechtenstein

28.2.2017

EU/1/16/1161

Movymia

Norway

26.1.2017

EU/1/16/1161

Movymia

Iceland

24.1.2017

EU/1/16/1162

Lusduna

Liechtenstein

28.2.2017

EU/1/16/1162

Lusduna

Norway

19.1.2017

EU/1/16/1162

Lusduna

Iceland

12.1.2017

EU/1/16/1163

SOLYMBIC

Liechtenstein

30.4.2017

EU/1/16/1163

SOLYMBIC

Norway

6.4.2017

EU/1/16/1163

Solymbic

Iceland

6.4.2017

EU/1/16/1164

AMGEVITA

Liechtenstein

30.4.2017

EU/1/16/1164

AMGEVITA

Norway

6.4.2017

EU/1/16/1164

Amgevita

Iceland

6.4.2017

EU/1/16/1165

LIFMIOR

Liechtenstein

28.2.2017

EU/1/16/1165

LIFMIOR

Norway

21.2.2017

EU/1/16/1165

Lifmior

Iceland

21.2.2017

EU/1/16/1166

Pregabalin Zentiva k.s

Liechtenstein

30.4.2017

EU/1/16/1166

Pregabalin Zentiva k.s.

Norway

13.3.2017

EU/1/16/1166

Pregabalin Zentiva k.s.

Iceland

14.3.2017

EU/1/16/1167

Truxima

Liechtenstein

30.4.2017

EU/1/16/1167

Truxima

Norway

28.2.2017

EU/1/16/1167

Truxima

Iceland

15.3.2017

EU/1/16/1168

Vihuma

Liechtenstein

30.4.2017

EU/1/16/1168

Vihuma

Norway

17.3.2017

EU/1/16/1168

Vihuma

Iceland

10.3.2017

EU/1/16/1169

Alecensa

Liechtenstein

28.2.2017

EU/1/16/1169

Alecensa

Norway

7.3.2017

EU/1/16/1169

Alecensa

Iceland

15.3.2017

EU/1/16/1170

Olumiant

Liechtenstein

28.2.2017

EU/1/16/1170

Olumiant

Norway

22.2.2017

EU/1/16/1170

OLUMIANT

Iceland

21.2.2017

EU/1/16/1171

Ledaga

Liechtenstein

30.4.2017

EU/1/16/1171

Ledaga

Norway

15.3.2017

EU/1/16/1171

LEDAGA

Iceland

14.3.2017

EU/1/17/1172

Jylamvo

Liechtenstein

30.4.2017

EU/1/17/1172

Jylamvo

Norway

4.4.2017

EU/1/17/1172

Jylamvo

Iceland

26.4.2017

EU/1/17/1174

Rolufta

Liechtenstein

30.4.2017

EU/1/17/1174

Rolufta

Norway

7.4.2017

EU/1/17/1174

Rolufta

Iceland

24.3.2017

EU/1/17/1175

Daptomycin Hospira

Liechtenstein

30.4.2017

EU/1/17/1175

Daptomycin Hospira

Norway

18.4.2017

EU/1/17/1175

Daptomycin Hospira

Iceland

7.4.2017

EU/1/17/1176

Yargesa

Liechtenstein

30.4.2017

EU/1/17/1176

Yargesa

Norway

7.4.2017

EU/1/17/1176

Yargesa

Iceland

7.4.2017

EU/1/17/1177

Tadalafil Lilly

Liechtenstein

30.4.2017

EU/1/17/1177

Tadalafil Lilly

Norway

18.4.2017

EU/1/17/1177

Tadalafil Lilly

Iceland

6.4.2017

EU/1/17/1178

Xeljanz

Liechtenstein

30.4.2017

EU/1/17/1178

Xeljanz

Norway

6.4.2017

EU/1/17/1178

XELJANZ

Iceland

6.4.2017

EU/1/17/1180

Varuby

Liechtenstein

30.4.2017

EU/1/17/1180

Varuby

Norway

10.5.2017

EU/1/17/1180

Varuby

Iceland

10.5.2017

EU/1/17/1182

Emtricitabine/Tenofovir disoproxil Krka d.d.

Liechtenstein

30.6.2017

EU/1/17/1182

Emtricitabine/Tenofovir disoproxil Krka d.d.

Norway

22.5.2017

EU/1/17/1182

Emtricitabine/Tenofovir disoproxil KrKa d.d.

Iceland

12.5.2017

EU/1/17/1183

Pemetrexed Hospira UK Limited

Norway

9.5.2017

EU/1/17/1183

Pemetrexed Hospira UK Limited

Iceland

12.5.2017

EU/1/17/1183

Pemetrexed Hospira UK Ltd

Liechtenstein

30.6.2017

EU/1/17/1184

Riximyo

Liechtenstein

30.6.2017

EU/1/17/1184

Riximyo

Norway

26.6.2017

EU/1/17/1185

Rixathon

Liechtenstein

30.6.2017

EU/1/17/1185

Rixathon

Norway

23.6.2017

EU/1/17/1186

Axumin

Liechtenstein

30.6.2017

EU/1/17/1186

Axumin

Norway

31.5.2017

EU/1/17/1186

Axumin

Iceland

21.6.2017

EU/1/17/1187

Trumenba

Liechtenstein

30.6.2017

EU/1/17/1187

Trumenba

Norway

9.6.2017

EU/1/17/1187

Trumenba

Iceland

21.6.2017

EU/1/17/1188

Spinraza

Liechtenstein

30.6.2017

EU/1/17/1188

Spinraza

Norway

8.6.2017

EU/1/17/1188

Spinraza

Iceland

30.6.2017

EU/1/17/1189

Elmiron

Liechtenstein

30.6.2017

EU/1/17/1189

Elmiron

Norway

20.6.2017

EU/1/17/1189

Elmiron

Iceland

30.6.2017

EU/1/17/1190

Ivabradine Accord

Liechtenstein

30.6.2017

EU/1/17/1190

Ivabradine Accord

Norway

12.6.2017

EU/1/17/1190

Ivabradine Accord

Iceland

7.6.2017

EU/1/17/1191

Dinutuximab beta Apeiron

Liechtenstein

30.6.2017

EU/1/17/1191

Dinutuximab beta Apeiron

Norway

12.5.2017

EU/1/17/1191

Dinutuximab beta Apeiron

Iceland

23.5.2017

EU/1/17/1192

Brineura

Liechtenstein

30.6.2017

EU/1/17/1192

Brineura

Norway

6.6.2017

EU/1/17/1192

Brineura

Iceland

30.6.2017

EU/1/17/1193

Refixia

Liechtenstein

30.6.2017

EU/1/17/1193

Refixia

Norway

22.6.2017

EU/1/17/1193

Refixia

Iceland

30.6.2017

EU/1/17/1194

Febuxostat Mylan

Liechtenstein

30.6.2017

EU/1/17/1194

Febuxostat Mylan

Norway

26.6.2017

EU/1/17/1195

Erelzi

Liechtenstein

30.6.2017

EU/1/17/1196

Kevzara

Liechtenstein

30.6.2017

EU/1/17/1201

Skilarence

Liechtenstein

30.6.2017

EU/1/17/1202

Ucedane

Liechtenstein

30.6.2017

EU/2/16/200

Cepedex

Norway

4.1.2017

EU/2/16/201

Halagon

Norway

4.1.2017

EU/2/16/201

Halagon

Iceland

4.1.2017

EU/2/16/202

Coliprotec F4/F18

Liechtenstein

28.2.2017

EU/2/16/202

Coliprotec F4/F18

Norway

21.2.2017

EU/2/16/202

Coliprotec F4/F18

Iceland

9.3.2017

EU/2/16/203

VarroMed

Liechtenstein

28.2.2017

EU/2/16/203

VarroMed

Norway

21.2.2017

EU/2/16/203

VarroMed

Iceland

15.2.2017

EU/2/16/204

Stronghold Plus

Liechtenstein

28.2.2017

EU/2/16/204

Stronghold Plus

Norway

27.2.2017

EU/2/16/204

Stronghold Plus

Iceland

15.2.2017

EU/2/17/205

CYTOPOINT

Liechtenstein

30.4.2017

EU/2/17/205

CYTOPOINT

Norway

23.5.2017

EU/2/17/205

CYTOPOINT

Iceland

12.5.2017

EU/2/17/206

Credelio

Liechtenstein

30.6.2017

EU/2/17/206

Credelio

Norway

23.5.2017

EU/2/17/206

Credelio

Iceland

12.5.2017

EU/2/17/207

Zulvac BTV Ovis

Norway

18.5.2017

EU/2/17/207

Zulvac BTV Ovis

Iceland

12.5.2017

EU/2/17/208

Ingelvac PCV FLEX

Liechtenstein

30.6.2017

EU/2/17/208

Ingelvac PCV FLEX

Norway

8.6.2017

EU/2/17/208

Ingelvac PCV FLEX

Iceland

13.6.2017

EU/2/17/209

RESPIPORC FLUpan H1N1

Liechtenstein

30.6.2017

EU/2/17/209

RESPIPORC FLUpan H1N1

Norway

2.6.2017

EU/2/17/209

RESPIPORC FLUpan H1N1

Iceland

13.6.2017

EU/2/17/210

Zeleris

Norway

7.6.2017

EU/2/17/210

Zeleris

Iceland

19.5.2017

---

ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January-30 June 2017:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/02/226 | InductosOs | Liechtenstein | 30.6.2017 |
| EU/1/06/362 | Byetta | Norway | 24.1.2017 |
| EU/1/06/364 | Adrovance | Norway | 28.3.2017 |
| EU/1/06/365 | Elaprase | Norway | 23.1.2016 |
| EU/1/06/366 | Tandemact | Norway | 27.1.2017 |
| EU/1/07/388 | Sebivo | Liechtenstein | 28.2.2017 |
| EU/1/07/388 | Sebivo | Norway | 16.1.2017 |
| EU/1/07/388 | Sebivo | Iceland | 5.1.2017 |
| EU/1/07/391 | Revlimid | Liechtenstein | 28.2.2017 |
| EU/1/07/391 | Revlimid | Norway | 23.2.2017 |
| EU/1/07/391 | Revlimid | Iceland | 21.2.2017 |
| EU/1/07/396 | Pergoveris | Liechtenstein | 30.6.2017 |
| EU/1/07/396 | Pergoveris | Norway | 23.5.2017 |
| EU/1/07/396 | Pergoveris | Iceland | 23.5.2017 |
| EU/1/07/397 | Siklos | Liechtenstein | 30.4.2017 |
| EU/1/07/397 | Siklos | Norway | 5.5.2017 |
| EU/1/07/397 | Siklos | Iceland | 11.5.2017 |
| EU/1/07/403 | Atriance | Liechtenstein | 30.6.2017 |
| EU/1/07/403 | Atriance | Norway | 26.6.2017 |
| EU/1/07/404 | Flebogamma DIF | Liechtenstein | 30.4.2017 |
| EU/1/07/404 | Flebogamma DIF | Norway | 10.5.2017 |
| EU/1/07/404 | Flebogamma DIF | Iceland | 11.5.2017 |
| EU/1/07/405 | Rasilez | Liechtenstein | 30.6.2017 |
| EU/1/07/405 | Rasilez | Norway | 12.6.2017 |
| EU/1/07/405 | Rasilez | Iceland | 6.6.2017 |
| EU/1/11/699 | Fampyra | Norway | 20.6.2017 |
| EU/1/11/699 | Fampyra | Iceland | 6.6.2017 |
| EU/1/11/749 | Caprelsa | Liechtenstein | 28.2.2017 |
| EU/1/11/749 | Caprelsa | Norway | 2.3.2017 |
| EU/1/11/749 | Caprelsa | Iceland | 24.2.2017 |
| EU/1/12/752 | Vepacel | Liechtenstein | 28.2.2017 |
| EU/1/12/752 | Vepacel | Norway | 19.1.2017 |
| EU/1/12/752 | Vepacel | Iceland | 12.1.2017 |
| EU/1/12/757 | Pioglitazon Teva | Liechtenstein | 30.4.2017 |
| EU/1/12/757 | Pioglitazone Teva | Norway | 21.3.2017 |
| EU/1/12/757 | Pioglitazone Teva | Iceland | 10.3.2017 |
| EU/1/12/758 | Pioglitazon Teva Pharma | Liechtenstein | 30.4.2017 |
| EU/1/12/758 | Pioglitazone Teva Pharma | Norway | 17.3.2017 |
| EU/1/12/758 | Pioglitazone Teva Pharma | Iceland | 10.3.2017 |
| EU/1/12/759 | Zoledronic acid Actavis | Norway | 4.1.2017 |
| EU/1/12/759 | Zoledronic acid Actavis | Iceland | 4.1.2017 |
| EU/1/12/760 | Bronchitol | Liechtenstein | 28.2.2017 |
| EU/1/12/760 | Bronchitol | Norway | 23.1.2017 |
| EU/1/12/760 | Bronchitol | Iceland | 23.1.2017 |
| EU/1/12/761 | Capecitabin Teva | Liechtenstein | 28.2.2017 |
| EU/1/12/761 | Capecitabine Teva | Norway | 25.1.2017 |
| EU/1/12/761 | Capecitabine Teva | Iceland | 23.1.2017 |
| EU/1/12/762 | Capecitabin Accord | Liechtenstein | 28.2.2017 |
| EU/1/12/762 | Capecitabine Accord | Norway | 25.1.2017 |
| EU/1/12/762 | Capecitabine Accord | Iceland | 23.1.2017 |
| EU/1/12/763 | Ecansya | Iceland | 4.1.2017 |
| EU/1/12/764 | Pixuvri | Liechtenstein | 30.4.2017 |
| EU/1/12/764 | Pixuvri | Norway | 29.3.2017 |
| EU/1/12/764 | Pixuvri | Iceland | 6.4.2017 |
| EU/1/12/766 | SANCUSO | Liechtenstein | 28.2.2017 |
| EU/1/12/766 | SANCUSO | Norway | 23.1.2017 |
| EU/1/12/766 | Sancuso | Iceland | 13.1.2017 |
| EU/1/12/767 | Nimenrix | Liechtenstein | 30.4.2017 |
| EU/1/12/767 | Nimenrix | Norway | 14.3.2017 |
| EU/1/12/767 | Nimenrix | Iceland | 14.3.2017 |
| EU/1/12/768 | Riluzol Zentiva | Liechtenstein | 28.2.2017 |
| EU/1/12/768 | Riluzole Zentiva | Norway | 24.1.2017 |
| EU/1/12/768 | Riluzole Zentiva | Iceland | 13.1.2017 |
| EU/1/12/769 | Docetaxel Accord | Norway | 3.3.2017 |
| EU/1/12/769 | Docetaxel Accord | Iceland | 10.3.2017 |
| EU/1/12/770 | Docetaxel Kabi | Liechtenstein | 30.4.2017 |
| EU/1/12/770 | Docetaxel Kabi | Norway | 3.3.2017 |
| EU/1/12/770 | Docetaxel Kabi | Iceland | 10.3.2017 |
| EU/1/12/771 | Zoledronic acid Teva | Norway | 20.6.2017 |
| EU/1/12/771 | Zoledronic Acid Teva | Iceland | 6.6.2017 |
| EU/1/12/772 | Zoledronic acid Teva Pharma | Norway | 20.6.2017 |
| EU/1/12/772 | Zoledronic acid Teva Pharma | Iceland | 6.6.2017 |
| EU/1/12/772 | Zoledronsäure Teva Pharma | Liechtenstein | 30.6.2017 |
| EU/1/12/773 | Jakavi | Liechtenstein | 30.6.2017 |
| EU/1/12/773 | Jakavi | Norway | 12.5.2017 |
| EU/1/12/773 | Jakavi | Iceland | 11.5.2017 |
| EU/1/12/775 | NovoThirteen | Liechtenstein | 30.6.2017 |
| EU/1/12/775 | NovoThirteen | Norway | 15.6.2017 |
| EU/1/12/775 | NovoThirteen | Iceland | 7.6.2017 |
| EU/1/12/776 | Fycompa | Liechtenstein | 30.4.2017 |
| EU/1/12/776 | Fycompa | Norway | 18.4.2017 |
| EU/1/12/776 | Fycompa | Iceland | 24.4.2017 |
| EU/1/12/777 | Inlyta | Liechtenstein | 30.6.2017 |
| EU/1/12/777 | Inlyta | Norway | 14.6.2017 |
| EU/1/12/777 | Inlyta | Iceland | 8.6.2017 |
| EU/1/12/778 | Eklira Genuair | Liechtenstein | 30.4.2017 |
| EU/1/12/778 | Eklira Genuair | Norway | 10.5.2017 |
| EU/1/12/778 | Eklira Genuair | Iceland | 10.5.2017 |
| EU/1/12/779 | Zoledronic acid medac | Iceland | 18.5.2017 |
| EU/1/12/779 | Zoledronsäure medac | Liechtenstein | 30.6.2017 |
| EU/1/12/779 | Zoledronsyre medac | Norway | 22.5.2017 |
| EU/1/12/780 | Jentadueto | Liechtenstein | 30.4.2017 |
| EU/1/12/780 | Jentadueto | Norway | 6.4.2017 |
| EU/1/12/780 | Jentadueto | Iceland | 6.4.2017 |
| EU/1/12/781 | Bretaris Genuair | Liechtenstein | 30.4.2017 |
| EU/1/12/781 | Bretaris Genuair | Norway | 10.5.2017 |
| EU/1/12/781 | Bretaris Genuair | Iceland | 10.5.2017 |
| EU/1/12/782 | Kalydeco | Liechtenstein | 30.6.2017 |
| EU/1/12/782 | Kalydeco | Norway | 19.5.2017 |
| EU/1/12/782 | Kalydeco | Iceland | 11.5.2017 |
| EU/1/12/783 | Zyclara | Liechtenstein | 30.4.2017 |
| EU/1/12/783 | Zyclara | Norway | 6.4.2017 |
| EU/1/12/783 | Zyclara | Iceland | 7.4.2017 |
| EU/1/12/785 | Zinforo | Liechtenstein | 30.6.2017 |
| EU/1/12/785 | Zinforo | Norway | 19.5.2017 |
| EU/1/12/785 | Zinforo | Iceland | 11.5.2017 |
| EU/1/12/786 | Zoledronic acid Mylan | Norway | 26.6.2017 |
| EU/1/12/786 | Zoledronic acid Mylan | Iceland | 7.6.2017 |
| EU/1/12/786 | Zoledronsäure Mylan | Liechtenstein | 30.6.2017 |
| EU/1/12/787 | Revestive | Liechtenstein | 30.6.2017 |
| EU/1/12/792 | Dacogen | Liechtenstein | 30.6.2017 |
| EU/1/12/792 | Dacogen | Norway | 1.6.2017 |
| EU/1/12/792 | Dacogen | Iceland | 6.6.2017 |
| EU/1/12/802 | Capecitabin medac | Liechtenstein | 30.6.2017 |
| EU/1/12/802 | Capecitabine medac | Norway | 26.6.2017 |
| EU/1/13/818 | Bosulif | Liechtenstein | 30.4.2017 |
| EU/1/13/818 | Bosulif | Norway | 5.4.2017 |
| EU/1/13/818 | Bosulif | Iceland | 7.4.2017 |
| EU/1/13/875 | Deltyba | Liechtenstein | 30.4.2017 |
| EU/1/13/875 | Deltyba | Norway | 14.3.2017 |
| EU/1/13/875 | Deltyba | Iceland | 14.3.2017 |
| EU/1/13/890 | Cometriq | Liechtenstein | 28.2.2017 |
| EU/1/13/890 | Cometriq | Iceland | 23.1.2017 |
| EU/1/13/901 | Sirturo | Liechtenstein | 28.2.2017 |
| EU/1/13/901 | Sirturo | Norway | 11.5.2017 |
| EU/1/13/901 | SIRTURO | Iceland | 6.1.2017 |
| EU/1/13/902 | Translarna | Liechtenstein | 28.2.2017 |
| EU/1/13/902 | Translarna | Liechtenstein | 30.6.2017 |
| EU/1/13/902 | Translarna | Norway | 1.2.2017 |
| EU/1/14/987 | Holoclar | Norway | 4.1.2017 |
| EU/1/14/987 | Holoclar | Iceland | 4.1.2017 |
| EU/1/15/999 | Zykadia | Liechtenstein | 30.4.2017 |
| EU/1/15/999 | Zykadia | Norway | 30.5.2017 |
| EU/1/15/999 | Zykadia | Iceland | 21.4.2017 |
| EU/1/16/1086 | Tagrisso | Norway | 2.1.2017 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 MedImmune | Iceland | 10.5.2017 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 MedImmune | Liechtenstein | 30.4.2017 |
| EU/1/16/1089 | Pandemic Influenza Vaccine H5N1 MedImmune | Norway | 29.6.2017 |
| EU/1/16/1101 | Darzalex | Liechtenstein | 30.4.2017 |
| EU/1/16/1101 | Darzalex | Norway | 12.5.2017 |
| EU/1/16/1101 | Darzalex | Iceland | 11.5.2017 |
| EU/2/07/072 | Suprelorin | Liechtenstein | 30.6.2017 |
| EU/2/07/072 | Suprelorin | Norway | 2.6.2017 |
| EU/2/07/072 | Suprelorin | Iceland | 23.5.2017 |
| EU/2/11/137 | Activyl Tick Plus | Iceland | 4.1.2017 |
| EU/2/12/139 | Zulvac 1+8 Bovis | Norway | 3.1.2017 |
| EU/2/12/140 | Poulvac E. coli | Liechtenstein | 30.6.2017 |
| EU/2/12/140 | Poulvac E. Coli | Iceland | 23.5.2017 |
| EU/2/12/140 | Poulvac E.coli | Norway | 23.5.2017 |
| EU/2/12/141 | Porcilis ColiClos | Liechtenstein | 30.4.2017 |
| EU/2/12/141 | Porcilis ColiClos | Norway | 28.4.2017 |
| EU/2/12/141 | Porcilis ColiClos | Iceland | 10.4.2017 |
| EU/2/12/142 | Cardalis | Liechtenstein | 30.6.2017 |
| EU/2/12/142 | Cardalis | Norway | 28.6.2017 |
| EU/2/12/143 | Nobivac L4 | Norway | 20.3.2017 |
| EU/2/12/143 | Nobivac L4 | Liechtenstein | 30.4.2017 |
| EU/2/12/143 | Nobivac L4 | Iceland | 24.3.2017 |

EU Number

Product

Country

Date of authorisation

EU/1/02/226

InductosOs

Liechtenstein

30.6.2017

EU/1/06/362

Byetta

Norway

24.1.2017

EU/1/06/364

Adrovance

Norway

28.3.2017

EU/1/06/365

Elaprase

Norway

23.1.2016

EU/1/06/366

Tandemact

Norway

27.1.2017

EU/1/07/388

Sebivo

Liechtenstein

28.2.2017

EU/1/07/388

Sebivo

Norway

16.1.2017

EU/1/07/388

Sebivo

Iceland

5.1.2017

EU/1/07/391

Revlimid

Liechtenstein

28.2.2017

EU/1/07/391

Revlimid

Norway

23.2.2017

EU/1/07/391

Revlimid

Iceland

21.2.2017

EU/1/07/396

Pergoveris

Liechtenstein

30.6.2017

EU/1/07/396

Pergoveris

Norway

23.5.2017

EU/1/07/396

Pergoveris

Iceland

23.5.2017

EU/1/07/397

Siklos

Liechtenstein

30.4.2017

EU/1/07/397

Siklos

Norway

5.5.2017

EU/1/07/397

Siklos

Iceland

11.5.2017

EU/1/07/403

Atriance

Liechtenstein

30.6.2017

EU/1/07/403

Atriance

Norway

26.6.2017

EU/1/07/404

Flebogamma DIF

Liechtenstein

30.4.2017

EU/1/07/404

Flebogamma DIF

Norway

10.5.2017

EU/1/07/404

Flebogamma DIF

Iceland

11.5.2017

EU/1/07/405

Rasilez

Liechtenstein

30.6.2017

EU/1/07/405

Rasilez

Norway

12.6.2017

EU/1/07/405

Rasilez

Iceland

6.6.2017

EU/1/11/699

Fampyra

Norway

20.6.2017

EU/1/11/699

Fampyra

Iceland

6.6.2017

EU/1/11/749

Caprelsa

Liechtenstein

28.2.2017

EU/1/11/749

Caprelsa

Norway

2.3.2017

EU/1/11/749

Caprelsa

Iceland

24.2.2017

EU/1/12/752

Vepacel

Liechtenstein

28.2.2017

EU/1/12/752

Vepacel

Norway

19.1.2017

EU/1/12/752

Vepacel

Iceland

12.1.2017

EU/1/12/757

Pioglitazon Teva

Liechtenstein

30.4.2017

EU/1/12/757

Pioglitazone Teva

Norway

21.3.2017

EU/1/12/757

Pioglitazone Teva

Iceland

10.3.2017

EU/1/12/758

Pioglitazon Teva Pharma

Liechtenstein

30.4.2017

EU/1/12/758

Pioglitazone Teva Pharma

Norway

17.3.2017

EU/1/12/758

Pioglitazone Teva Pharma

Iceland

10.3.2017

EU/1/12/759

Zoledronic acid Actavis

Norway

4.1.2017

EU/1/12/759

Zoledronic acid Actavis

Iceland

4.1.2017

EU/1/12/760

Bronchitol

Liechtenstein

28.2.2017

EU/1/12/760

Bronchitol

Norway

23.1.2017

EU/1/12/760

Bronchitol

Iceland

23.1.2017

EU/1/12/761

Capecitabin Teva

Liechtenstein

28.2.2017

EU/1/12/761

Capecitabine Teva

Norway

25.1.2017

EU/1/12/761

Capecitabine Teva

Iceland

23.1.2017

EU/1/12/762

Capecitabin Accord

Liechtenstein

28.2.2017

EU/1/12/762

Capecitabine Accord

Norway

25.1.2017

EU/1/12/762

Capecitabine Accord

Iceland

23.1.2017

EU/1/12/763

Ecansya

Iceland

4.1.2017

EU/1/12/764

Pixuvri

Liechtenstein

30.4.2017

EU/1/12/764

Pixuvri

Norway

29.3.2017

EU/1/12/764

Pixuvri

Iceland

6.4.2017

EU/1/12/766

SANCUSO

Liechtenstein

28.2.2017

EU/1/12/766

SANCUSO

Norway

23.1.2017

EU/1/12/766

Sancuso

Iceland

13.1.2017

EU/1/12/767

Nimenrix

Liechtenstein

30.4.2017

EU/1/12/767

Nimenrix

Norway

14.3.2017

EU/1/12/767

Nimenrix

Iceland

14.3.2017

EU/1/12/768

Riluzol Zentiva

Liechtenstein

28.2.2017

EU/1/12/768

Riluzole Zentiva

Norway

24.1.2017

EU/1/12/768

Riluzole Zentiva

Iceland

13.1.2017

EU/1/12/769

Docetaxel Accord

Norway

3.3.2017

EU/1/12/769

Docetaxel Accord

Iceland

10.3.2017

EU/1/12/770

Docetaxel Kabi

Liechtenstein

30.4.2017

EU/1/12/770

Docetaxel Kabi

Norway

3.3.2017

EU/1/12/770

Docetaxel Kabi

Iceland

10.3.2017

EU/1/12/771

Zoledronic acid Teva

Norway

20.6.2017

EU/1/12/771

Zoledronic Acid Teva

Iceland

6.6.2017

EU/1/12/772

Zoledronic acid Teva Pharma

Norway

20.6.2017

EU/1/12/772

Zoledronic acid Teva Pharma

Iceland

6.6.2017

EU/1/12/772

Zoledronsäure Teva Pharma

Liechtenstein

30.6.2017

EU/1/12/773

Jakavi

Liechtenstein

30.6.2017

EU/1/12/773

Jakavi

Norway

12.5.2017

EU/1/12/773

Jakavi

Iceland

11.5.2017

EU/1/12/775

NovoThirteen

Liechtenstein

30.6.2017

EU/1/12/775

NovoThirteen

Norway

15.6.2017

EU/1/12/775

NovoThirteen

Iceland

7.6.2017

EU/1/12/776

Fycompa

Liechtenstein

30.4.2017

EU/1/12/776

Fycompa

Norway

18.4.2017

EU/1/12/776

Fycompa

Iceland

24.4.2017

EU/1/12/777

Inlyta

Liechtenstein

30.6.2017

EU/1/12/777

Inlyta

Norway

14.6.2017

EU/1/12/777

Inlyta

Iceland

8.6.2017

EU/1/12/778

Eklira Genuair

Liechtenstein

30.4.2017

EU/1/12/778

Eklira Genuair

Norway

10.5.2017

EU/1/12/778

Eklira Genuair

Iceland

10.5.2017

EU/1/12/779

Zoledronic acid medac

Iceland

18.5.2017

EU/1/12/779

Zoledronsäure medac

Liechtenstein

30.6.2017

EU/1/12/779

Zoledronsyre medac

Norway

22.5.2017

EU/1/12/780

Jentadueto

Liechtenstein

30.4.2017

EU/1/12/780

Jentadueto

Norway

6.4.2017

EU/1/12/780

Jentadueto

Iceland

6.4.2017

EU/1/12/781

Bretaris Genuair

Liechtenstein

30.4.2017

EU/1/12/781

Bretaris Genuair

Norway

10.5.2017

EU/1/12/781

Bretaris Genuair

Iceland

10.5.2017

EU/1/12/782

Kalydeco

Liechtenstein

30.6.2017

EU/1/12/782

Kalydeco

Norway

19.5.2017

EU/1/12/782

Kalydeco

Iceland

11.5.2017

EU/1/12/783

Zyclara

Liechtenstein

30.4.2017

EU/1/12/783

Zyclara

Norway

6.4.2017

EU/1/12/783

Zyclara

Iceland

7.4.2017

EU/1/12/785

Zinforo

Liechtenstein

30.6.2017

EU/1/12/785

Zinforo

Norway

19.5.2017

EU/1/12/785

Zinforo

Iceland

11.5.2017

EU/1/12/786

Zoledronic acid Mylan

Norway

26.6.2017

EU/1/12/786

Zoledronic acid Mylan

Iceland

7.6.2017

EU/1/12/786

Zoledronsäure Mylan

Liechtenstein

30.6.2017

EU/1/12/787

Revestive

Liechtenstein

30.6.2017

EU/1/12/792

Dacogen

Liechtenstein

30.6.2017

EU/1/12/792

Dacogen

Norway

1.6.2017

EU/1/12/792

Dacogen

Iceland

6.6.2017

EU/1/12/802

Capecitabin medac

Liechtenstein

30.6.2017

EU/1/12/802

Capecitabine medac

Norway

26.6.2017

EU/1/13/818

Bosulif

Liechtenstein

30.4.2017

EU/1/13/818

Bosulif

Norway

5.4.2017

EU/1/13/818

Bosulif

Iceland

7.4.2017

EU/1/13/875

Deltyba

Liechtenstein

30.4.2017

EU/1/13/875

Deltyba

Norway

14.3.2017

EU/1/13/875

Deltyba

Iceland

14.3.2017

EU/1/13/890

Cometriq

Liechtenstein

28.2.2017

EU/1/13/890

Cometriq

Iceland

23.1.2017

EU/1/13/901

Sirturo

Liechtenstein

28.2.2017

EU/1/13/901

Sirturo

Norway

11.5.2017

EU/1/13/901

SIRTURO

Iceland

6.1.2017

EU/1/13/902

Translarna

Liechtenstein

28.2.2017

EU/1/13/902

Translarna

Liechtenstein

30.6.2017

EU/1/13/902

Translarna

Norway

1.2.2017

EU/1/14/987

Holoclar

Norway

4.1.2017

EU/1/14/987

Holoclar

Iceland

4.1.2017

EU/1/15/999

Zykadia

Liechtenstein

30.4.2017

EU/1/15/999

Zykadia

Norway

30.5.2017

EU/1/15/999

Zykadia

Iceland

21.4.2017

EU/1/16/1086

Tagrisso

Norway

2.1.2017

EU/1/16/1089

Pandemic influenza vaccine H5N1 MedImmune

Iceland

10.5.2017

EU/1/16/1089

Pandemic influenza vaccine H5N1 MedImmune

Liechtenstein

30.4.2017

EU/1/16/1089

Pandemic Influenza Vaccine H5N1 MedImmune

Norway

29.6.2017

EU/1/16/1101

Darzalex

Liechtenstein

30.4.2017

EU/1/16/1101

Darzalex

Norway

12.5.2017

EU/1/16/1101

Darzalex

Iceland

11.5.2017

EU/2/07/072

Suprelorin

Liechtenstein

30.6.2017

EU/2/07/072

Suprelorin

Norway

2.6.2017

EU/2/07/072

Suprelorin

Iceland

23.5.2017

EU/2/11/137

Activyl Tick Plus

Iceland

4.1.2017

EU/2/12/139

Zulvac 1+8 Bovis

Norway

3.1.2017

EU/2/12/140

Poulvac E. coli

Liechtenstein

30.6.2017

EU/2/12/140

Poulvac E. Coli

Iceland

23.5.2017

EU/2/12/140

Poulvac E.coli

Norway

23.5.2017

EU/2/12/141

Porcilis ColiClos

Liechtenstein

30.4.2017

EU/2/12/141

Porcilis ColiClos

Norway

28.4.2017

EU/2/12/141

Porcilis ColiClos

Iceland

10.4.2017

EU/2/12/142

Cardalis

Liechtenstein

30.6.2017

EU/2/12/142

Cardalis

Norway

28.6.2017

EU/2/12/143

Nobivac L4

Norway

20.3.2017

EU/2/12/143

Nobivac L4

Liechtenstein

30.4.2017

EU/2/12/143

Nobivac L4

Iceland

24.3.2017

---

ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January-30 June 2017:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/03/256/020 | Humira | Norway | 6.4.2017 |
| EU/1/03/256/020 | Humira | Iceland | 10.4.2017 |
| EU/1/07/396/004-006 | Pergoveris | Norway | 8.5.2017 |
| EU/1/07/396/004-006 | Pergoveris | Iceland | 23.5.2017 |
| EU/1/09/514/021-023 | Zebinix | Iceland | 4.1.2017 |
| EU/1/09/514/024 | Zebinix | Norway | 4.1.2017 |
| EU/1/09/564/004 | Ilaris | Norway | 7.3.2017 |
| EU/1/09/564/004 | Ilaris | Iceland | 14.3.2017 |
| EU/1/10/641/002 | Ruconest | Norway | 26.1.2017 |
| EU/1/10/641/002 | Ruconest | Iceland | 30.1.2017 |
| EU/1/10/655/012-014 | Brilique | Norway | 18.5.2017 |
| EU/1/10/655/012-014 | Brilique | Iceland | 6.6.2017 |
| EU/1/11/667/005-011 | Esbriet | Norway | 9.5.2017 |
| EU/1/11/667/005-011 | Esbriet | Iceland | 11.5.2017 |
| EU/1/13/860/003 | Nexium Control | Norway | 23.6.2017 |
| EU/1/13/892/003-006 | Tivicay | Norway | 2.3.2017 |
| EU/1/13/892/003-006 | Tivicay | Iceland | 13.3.2017 |
| EU/1/15/1016/006-007 | Repatha | Norway | 17.2.2017 |
| EU/1/15/1016/006-007 | Repatha | Iceland | 24.2.2017 |
| EU/1/15/1074/005 | Benepali | Norway | 31.5.2017 |
| EU/1/15/1074/005 | Benepali | Iceland | 7.6.2017 |
| EU/1/97/047/009 | BeneFIX | Norway | 22.3.2017 |
| EU/1/97/047/009 | BeneFIX | Iceland | 7.4.2017 |
| EU/2/04/042/015-018 | Novem | Iceland | 6.6.2017 |
| EU/2/08/083/006-009 | EQUIOXX | Norway | 9.2.2017 |
| EU/2/08/083/006-009 | Equioxx | Iceland | 15.2.2017 |

EU Number

Product

Country

Date of authorisation

EU/1/03/256/020

Humira

Norway

6.4.2017

EU/1/03/256/020

Humira

Iceland

10.4.2017

EU/1/07/396/004-006

Pergoveris

Norway

8.5.2017

EU/1/07/396/004-006

Pergoveris

Iceland

23.5.2017

EU/1/09/514/021-023

Zebinix

Iceland

4.1.2017

EU/1/09/514/024

Zebinix

Norway

4.1.2017

EU/1/09/564/004

Ilaris

Norway

7.3.2017

EU/1/09/564/004

Ilaris

Iceland

14.3.2017

EU/1/10/641/002

Ruconest

Norway

26.1.2017

EU/1/10/641/002

Ruconest

Iceland

30.1.2017

EU/1/10/655/012-014

Brilique

Norway

18.5.2017

EU/1/10/655/012-014

Brilique

Iceland

6.6.2017

EU/1/11/667/005-011

Esbriet

Norway

9.5.2017

EU/1/11/667/005-011

Esbriet

Iceland

11.5.2017

EU/1/13/860/003

Nexium Control

Norway

23.6.2017

EU/1/13/892/003-006

Tivicay

Norway

2.3.2017

EU/1/13/892/003-006

Tivicay

Iceland

13.3.2017

EU/1/15/1016/006-007

Repatha

Norway

17.2.2017

EU/1/15/1016/006-007

Repatha

Iceland

24.2.2017

EU/1/15/1074/005

Benepali

Norway

31.5.2017

EU/1/15/1074/005

Benepali

Iceland

7.6.2017

EU/1/97/047/009

BeneFIX

Norway

22.3.2017

EU/1/97/047/009

BeneFIX

Iceland

7.4.2017

EU/2/04/042/015-018

Novem

Iceland

6.6.2017

EU/2/08/083/006-009

EQUIOXX

Norway

9.2.2017

EU/2/08/083/006-009

Equioxx

Iceland

15.2.2017

---

ANNEX IV

List of withdrawn marketing authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January-30 June 2017:

| EU Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/00/137 | Avandia | Liechtenstein | 28.2.2017 |
| EU/1/03/258 | Avandamet | Liechtenstein | 28.2.2017 |
| EU/1/06/373 | Imprida | Liechtenstein | 30.4.2017 |
| EU/1/06/373 | Imprida | Norway | 19.4.2017 |
| EU/1/06/373 | Imprida | Iceland | 21.4.2017 |
| EU/1/07/385 | Focetria | Liechtenstein | 28.2.2017 |
| EU/1/08/500 | Fablyn | Liechtenstein | 28.2.2017 |
| EU/1/09/512 | Removab | Liechtenstein | 30.6.2017 |
| EU/1/09/512 | Removab | Norway | 23.6.2017 |
| EU/1/09/512 | Removab | Iceland | 12.6.2017 |
| EU/1/09/532 | Clopidogrel Acino | Liechtenstein | 28.2.2017 |
| EU/1/09/532 | Clopidogrel Acino | Norway | 9.2.2017 |
| EU/1/09/532 | Clopidogrel Acino | Iceland | 3.2.2017 |
| EU/1/09/561 | Clopidogrel Teva Pharma | Liechtenstein | 30.6.2017 |
| EU/1/09/561 | Clopidogrel Teva Pharma | Norway | 28.6.2017 |
| EU/1/10/657 | Prepandemic Influenza | Liechtenstein | 28.2.2017 |
| EU/1/11/720 | Incivo | Iceland | 3.2.2017 |
| EU/1/11/721 | Paglitaz | Liechtenstein | 28.2.2017 |
| EU/1/14/942 | Clopidogrel/Acetylsalicylsäure Teva | Liechtenstein | 28.2.2017 |
| EU/1/14/948 | Budesonide/Formoterol Teva | Norway | 19.1.2017 |
| EU/1/14/948 | Budesonide/Formoterol Teva | Iceland | 5.1.2017 |
| EU/1/14/949 | Vylaer Spiromax | Liechtenstein | 28.2.2017 |
| EU/1/14/949 | Vylaer Spiromax | Norway | 19.1.2017 |
| EU/1/14/949 | Vylaer Spiromax | Iceland | 13.1.2017 |
| EU/1/14/950 | Budesonide/Formoterol Teva Pharma B.V. | Norway | 19.1.2017 |
| EU/1/14/950 | Budesonide/Formoterol Teva Pharma B.V. | Iceland | 5.1.2017 |
| EU/1/15/1022 | Unituxin | Norway | 19.4.2017 |
| EU/1/15/1022 | Unituxin | Iceland | 6.4.2017 |
| EU/1/15/995 | DUTREBIS | Liechtenstein | 30.4.2017 |
| EU/1/15/995 | DUTREBIS | Norway | 9.5.2017 |
| EU/1/15/995 | DUTREBIS | Iceland | 11.5.2017 |
| EU/2/11/127 | RECUVYRA | Iceland | 3.2.2017 |

EU Number

Product

Country

Date of withdrawal

EU/1/00/137

Avandia

Liechtenstein

28.2.2017

EU/1/03/258

Avandamet

Liechtenstein

28.2.2017

EU/1/06/373

Imprida

Liechtenstein

30.4.2017

EU/1/06/373

Imprida

Norway

19.4.2017

EU/1/06/373

Imprida

Iceland

21.4.2017

EU/1/07/385

Focetria

Liechtenstein

28.2.2017

EU/1/08/500

Fablyn

Liechtenstein

28.2.2017

EU/1/09/512

Removab

Liechtenstein

30.6.2017

EU/1/09/512

Removab

Norway

23.6.2017

EU/1/09/512

Removab

Iceland

12.6.2017

EU/1/09/532

Clopidogrel Acino

Liechtenstein

28.2.2017

EU/1/09/532

Clopidogrel Acino

Norway

9.2.2017

EU/1/09/532

Clopidogrel Acino

Iceland

3.2.2017

EU/1/09/561

Clopidogrel Teva Pharma

Liechtenstein

30.6.2017

EU/1/09/561

Clopidogrel Teva Pharma

Norway

28.6.2017

EU/1/10/657

Prepandemic Influenza

Liechtenstein

28.2.2017

EU/1/11/720

Incivo

Iceland

3.2.2017

EU/1/11/721

Paglitaz

Liechtenstein

28.2.2017

EU/1/14/942

Clopidogrel/Acetylsalicylsäure Teva

Liechtenstein

28.2.2017

EU/1/14/948

Budesonide/Formoterol Teva

Norway

19.1.2017

EU/1/14/948

Budesonide/Formoterol Teva

Iceland

5.1.2017

EU/1/14/949

Vylaer Spiromax

Liechtenstein

28.2.2017

EU/1/14/949

Vylaer Spiromax

Norway

19.1.2017

EU/1/14/949

Vylaer Spiromax

Iceland

13.1.2017

EU/1/14/950

Budesonide/Formoterol Teva Pharma B.V.

Norway

19.1.2017

EU/1/14/950

Budesonide/Formoterol Teva Pharma B.V.

Iceland

5.1.2017

EU/1/15/1022

Unituxin

Norway

19.4.2017

EU/1/15/1022

Unituxin

Iceland

6.4.2017

EU/1/15/995

DUTREBIS

Liechtenstein

30.4.2017

EU/1/15/995

DUTREBIS

Norway

9.5.2017

EU/1/15/995

DUTREBIS

Iceland

11.5.2017

EU/2/11/127

RECUVYRA

Iceland

3.2.2017

---

ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 January-30 June 2017:

| EU Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| | | | |
| | | | |
| | | | |

EU Number

Product

Country

Date of suspension

---