# C_2018305EN.01001501.xml

| 30.8.2018 | EN | Official Journal of the European Union | C 305/15 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/15

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

(2018/C 305/12)

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 2017, at their meeting on 23 March 2018:

| 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| Annex IV | List of withdrawn marketing authorisations |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List of withdrawn marketing authorisations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

---

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 2017:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/02/226 | InductOs | Iceland | 18.8.2017 |
| EU/1/15/999 | Zykadia (Switch to non-conditional) | Liechtenstein | 31.8.2017 |
| EU/1/16/1138 | Venclyxto | Liechtenstein | 31.12.2017 |
| EU/1/16/1155 | Kyntheum | Iceland | 16.8.2017 |
| EU/1/16/1155 | Kyntheum | Liechtenstein | 31.8.2017 |
| EU/1/16/1155 | Kyntheum | Norway | 14.8.2017 |
| EU/1/17/1179 | Veltassa | Iceland | 11.8.2017 |
| EU/1/17/1179 | Veltassa | Liechtenstein | 31.8.2017 |
| EU/1/17/1179 | Veltassa | Norway | 9.8.2017 |
| EU/1/17/1181 | Spherox | Iceland | 24.7.2017 |
| EU/1/17/1181 | Spherox | Liechtenstein | 31.8.2017 |
| EU/1/17/1181 | Spherox | Norway | 13.9.2017 |
| EU/1/17/1184 | Riximyo | Iceland | 11.7.2017 |
| EU/1/17/1185 | Rixathon | Iceland | 11.7.2017 |
| EU/1/17/1191 | Dinutuximab beta Apeiron | Liechtenstein | 31.8.2017 |
| EU/1/17/1194 | Febuxostat Mylan | Iceland | 11.7.2017 |
| EU/1/17/1195 | Erelzi | Iceland | 14.7.2017 |
| EU/1/17/1195 | Erelzi | Norway | 7.7.2017 |
| EU/1/17/1196 | Kevzara | Iceland | 14.7.2017 |
| EU/1/17/1196 | Kevzara | Norway | 5.7.2017 |
| EU/1/17/1197 | Oxervate | Iceland | 24.7.2017 |
| EU/1/17/1197 | OXERVATE | Liechtenstein | 31.8.2017 |
| EU/1/17/1197 | OXERVATE | Norway | 17.7.2017 |
| EU/1/17/1199 | Cuprior | Iceland | 13.9.2017 |
| EU/1/17/1199 | Cuprior | Liechtenstein | 31.10.2017 |
| EU/1/17/1199 | Cuprior | Norway | 13.9.2017 |
| EU/1/17/1200 | Besponsa | Iceland | 24.7.2017 |
| EU/1/17/1200 | Besponsa | Liechtenstein | 31.8.2017 |
| EU/1/17/1200 | Besponsa | Norway | 13.7.2017 |
| EU/1/17/1201 | Skilarence | Iceland | 14.7.2017 |
| EU/1/17/1201 | Skilarence | Norway | 7.7.2017 |
| EU/1/17/1202 | Ucedane | Iceland | 12.7.2017 |
| EU/1/17/1202 | Ucedane | Norway | 5.7.2017 |
| EU/1/17/1203 | Insulin lispro Sanofi | Iceland | 11.8.2017 |
| EU/1/17/1203 | Insulin Lispro Sanofi | Liechtenstein | 31.8.2017 |
| EU/1/17/1203 | Insulin lispro Sanofi | Norway | 18.8.2017 |
| EU/1/17/1205 | Blitzima | Iceland | 9.8.2017 |
| EU/1/17/1205 | Blitzima | Liechtenstein | 31.8.2017 |
| EU/1/17/1205 | Blitzima | Norway | 1.8.2017 |
| EU/1/17/1206 | Tuxella | Iceland | 9.8.2017 |
| EU/1/17/1206 | Tuxella | Liechtenstein | 31.8.2017 |
| EU/1/17/1206 | Tuxella | Norway | 1.8.2017 |
| EU/1/17/1207 | Ritemvia | Liechtenstein | 31.8.2017 |
| EU/1/17/1207 | Ritemvia | Iceland | 10.8.2017 |
| EU/1/17/1207 | Ritemvia | Norway | 1.8.2017 |
| EU/1/17/1208 | Trimbow | Iceland | 11.8.2017 |
| EU/1/17/1208 | Trimbow | Liechtenstein | 31.8.2017 |
| EU/1/17/1208 | Trimbow | Norway | 9.8.2017 |
| EU/1/17/1209 | Reagila | Iceland | 9.8.2017 |
| EU/1/17/1209 | Reagila | Liechtenstein | 31.8.2017 |
| EU/1/17/1209 | Reaglia | Norway | 9.8.2017 |
| EU/1/17/1210 | Efavirenz/Emtricitabin/Tenofovirdisproksil Zentiva | Norway | 8.8.2017 |
| EU/1/17/1210 | Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | Iceland | 10.8.2017 |
| EU/1/17/1210 | Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | Liechtenstein | 31.8.2017 |
| EU/1/17/1211 | Entecavir Accord | Iceland | 5.10.2017 |
| EU/1/17/1211 | Entecavir Accord | Liechtenstein | 31.10.2017 |
| EU/1/17/1211 | Entecavir Accord | Norway | 20.10.2017 |
| EU/1/17/1212 | Mavenclad | Iceland | 13.9.2017 |
| EU/1/17/1212 | MAVENCLAD | Norway | 30.8.2017 |
| EU/1/17/1212 | MAVENCLAD | Liechtenstein | 31.8.2017 |
| EU/1/17/1213 | Maviret | Iceland | 17.8.2017 |
| EU/1/17/1213 | Maviret | Liechtenstein | 31.8.2017 |
| EU/1/17/1213 | Maviret | Norway | 7.8.2017 |
| EU/1/17/1214 | Bavencio | Iceland | 4.10.2017 |
| EU/1/17/1214 | Bavencio | Liechtenstein | 31.10.2017 |
| EU/1/17/1214 | Bavencio | Norway | 25.9.2017 |
| EU/1/17/1215 | Fotivda | Iceland | 13.9.2017 |
| EU/1/17/1215 | Fotivda | Liechtenstein | 31.8.2017 |
| EU/1/17/1215 | Fotivda | Norway | 31.8.2017 |
| EU/1/17/1216 | Imraldi | Iceland | 12.9.2017 |
| EU/1/17/1216 | Imraldi | Liechtenstein | 31.8.2017 |
| EU/1/17/1216 | Imraldi | Norway | 11.9.2017 |
| EU/1/17/1217 | Nitisinone MendeliKABS | Iceland | 19.9.2017 |
| EU/1/17/1217 | Nitisinone MendeliKABS | Liechtenstein | 31.8.2017 |
| EU/1/17/1217 | Nitisinone MendeliKABS | Norway | 1.9.2017 |
| EU/1/17/1218 | Rydapt | Iceland | 4.10.2017 |
| EU/1/17/1218 | Rydapt | Liechtenstein | 31.10.2017 |
| EU/1/17/1218 | Rydapt | Norway | 25.9.2017 |
| EU/1/17/1220 | Tecentriq | Liechtenstein | 31.10.2017 |
| EU/1/17/1220 | Tecentriq | Norway | 27.9.2017 |
| EU/1/17/1220 | Tecentriq | Iceland | 5.10.2017 |
| EU/1/17/1221 | Kisqali | Iceland | 12.9.2017 |
| EU/1/17/1221 | Kisqali | Norway | 30.8.2017 |
| EU/1/17/1221 | Kisqali | Liechtenstein | 31.8.2017 |
| EU/1/17/1222 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Iceland | 8.11.2017 |
| EU/1/17/1222 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Liechtenstein | 31.10.2017 |
| EU/1/17/1222 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Norway | 27.9.2017 |
| EU/1/17/1223 | Vosevi | Iceland | 16.8.2017 |
| EU/1/17/1223 | Vosevi | Liechtenstein | 31.8.2017 |
| EU/1/17/1223 | Vosevi | Norway | 8.8.2017 |
| EU/1/17/1224 | Xermelo | Iceland | 4.10.2017 |
| EU/1/17/1224 | Xermelo | Liechtenstein | 31.10.2017 |
| EU/1/17/1224 | Xermelo | Norway | 3.10.2017 |
| EU/1/17/1225 | Symtuza | Iceland | 5.10.2017 |
| EU/1/17/1225 | Symtuza | Liechtenstein | 31.10.2017 |
| EU/1/17/1225 | Symtuza | Norway | 11.10.2017 |
| EU/1/17/1226 | Lutathera | Iceland | 10.10.2017 |
| EU/1/17/1226 | Lutathera | Liechtenstein | 31.10.2017 |
| EU/1/17/1226 | Lutathera | Norway | 3.10.2017 |
| EU/1/17/1227 | Entecavir Mylan | Iceland | 4.10.2017 |
| EU/1/17/1227 | Entecavir Mylan | Liechtenstein | 31.10.2017 |
| EU/1/17/1227 | Entecavir Mylan | Norway | 27.9.2017 |
| EU/1/17/1228 | Tookad | Iceland | 29.11.2017 |
| EU/1/17/1228 | TOOKAD | Liechtenstein | 31.12.2017 |
| EU/1/17/1228 | TOOKAD | Norway | 22.11.2017 |
| EU/1/17/1229 | Dupixent | Iceland | 10.10.2017 |
| EU/1/17/1229 | Dupixent | Liechtenstein | 31.10.2017 |
| EU/1/17/1229 | Dupixent | Norway | 10.10.2017 |
| EU/1/17/1230 | Lacosamide Accord | Iceland | 5.10.2017 |
| EU/1/17/1230 | Lacosamide Accord | Liechtenstein | 31.10.2017 |
| EU/1/17/1230 | Lacosamide Accord | Norway | 27.9.2017 |
| EU/1/17/1232 | Miglustat Gen.Orph | Iceland | 30.11.2017 |
| EU/1/17/1232 | Miglustat Gen.Orph | Liechtenstein | 31.12.2017 |
| EU/1/17/1232 | Miglustat Gen.Orph | Norway | 27.11.2017 |
| EU/1/17/1233 | Zubsolv | Iceland | 29.11.2017 |
| EU/1/17/1233 | Zubsolv | Liechtenstein | 31.12.2017 |
| EU/1/17/1233 | Zubsolv | Norway | 22.11.2017 |
| EU/1/17/1234 | Tremfya | Iceland | 4.12.2017 |
| EU/1/17/1235 | Zejula | Iceland | 4.12.2017 |
| EU/1/17/1235 | Zejula | Liechtenstein | 31.12.2017 |
| EU/1/17/1235 | Zejula | Norway | 27.11.2017 |
| EU/1/17/1236 | Trelegy Ellipta | Iceland | 30.11.2017 |
| EU/1/17/1236 | Trelegy Ellipta | Liechtenstein | 31.12.2017 |
| EU/1/17/1236 | Trelegy Ellipta | Norway | 22.11.2017 |
| EU/1/17/1237 | Elebrato Ellipta | Iceland | 30.11.2017 |
| EU/1/17/1237 | Elebrato Ellipta | Liechtenstein | 31.12.2017 |
| EU/1/17/1237 | Elebrato Ellipta | Norway | 27.11.2017 |
| EU/1/17/1238 | Nyxoid | Iceland | 29.11.2017 |
| EU/1/17/1238 | Nyxoid | Liechtenstein | 31.12.2017 |
| EU/1/17/1238 | Nyxoid | Norway | 27.11.2017 |
| EU/1/17/1239 | VeraSeal | Iceland | 30.11.2017 |
| EU/1/17/1239 | VeraSeal | Liechtenstein | 31.12.2017 |
| EU/1/17/1239 | VeraSeal | Norway | 1.12.2017 |
| EU/1/17/1240 | Cyltezo | Iceland | 29.11.2017 |
| EU/1/17/1240 | Cyltezo | Liechtenstein | 31.12.2017 |
| EU/1/17/1240 | Cyltezo | Norway | 1.12.2017 |
| EU/1/17/1241 | Ontruzant | Iceland | 30.11.2017 |
| EU/1/17/1241 | Ontruzant | Liechtenstein | 31.12.2017 |
| EU/1/17/1241 | Ontruzant | Norway | 27.11.2017 |
| EU/1/17/1242 | Ritonavir Mylan | Iceland | 29.11.2017 |
| EU/1/17/1242 | Ritonavir Mylan | Liechtenstein | 31.12.2017 |
| EU/1/17/1242 | Ritonavir Mylan | Norway | 22.11.2017 |
| EU/1/17/1243 | Imatinib Teva B.V. | Iceland | 30.11.2017 |
| EU/1/17/1243 | Imatinib Teva B.V. | Liechtenstein | 31.12.2017 |
| EU/1/17/1243 | Imatinib Teva B.V. | Norway | 22.11.2017 |
| EU/1/17/1244 | Tacforius | Liechtenstein | 31.12.2017 |
| EU/2/16/197 | CLYNAV | Iceland | 13.7.2017 |
| EU/2/16/197 | CLYNAV | Liechtenstein | 31.8.2017 |
| EU/2/16/197 | CLYNAV | Norway | 18.7.2017 |
| EU/2/17/211 | Prevomax | Iceland | 13.7.2017 |
| EU/2/17/211 | Prevomax | Norway | 6.7.2017 |
| EU/2/17/212 | Exzolt | Iceland | 30.8.2017 |
| EU/2/17/212 | Exzolt | Liechtenstein | 31.10.2017 |
| EU/2/17/212 | Exzolt | Norway | 15.9.2017 |
| EU/2/17/213 | Innovax-ND-IBD | Iceland | 11.9.2017 |
| EU/2/17/213 | Innovax-ND-IBD | Norway | 18.9.2017 |
| EU/2/17/214 | VEPURED | Iceland | 12.9.2017 |
| EU/2/17/214 | VEPURED | Norway | 15.9.2017 |
| EU/2/17/215 | Suvaxyn PRRS MLV | Iceland | 11.9.2017 |
| EU/2/17/215 | Suvaxyn PRRS MLV | Liechtenstein | 31.10.2017 |
| EU/2/17/215 | Suvaxyn PRRS MLV | Norway | 18.9.2017 |
| EU/2/17/217 | Nobivac LeuFel | Iceland | 9.11.2017 |
| EU/2/17/217 | Nobivac LeuFel | Liechtenstein | 31.12.2017 |
| EU/2/17/217 | Nobivac LeuFel | Norway | 14.11.2017 |
| EU/2/17/218 | Bovilis Blue-8 | Iceland | 1.12.2017 |
| EU/2/17/218 | Bovilis Blue-8 | Liechtenstein | 31.12.2017 |
| EU/2/17/218 | Bovilis Blue-8 | Norway | 19.12.2017 |

EU Number

Product

Country

Date of authorisation

EU/1/02/226

InductOs

Iceland

18.8.2017

EU/1/15/999

Zykadia (Switch to non-conditional)

Liechtenstein

31.8.2017

EU/1/16/1138

Venclyxto

Liechtenstein

31.12.2017

EU/1/16/1155

Kyntheum

Iceland

16.8.2017

EU/1/16/1155

Kyntheum

Liechtenstein

31.8.2017

EU/1/16/1155

Kyntheum

Norway

14.8.2017

EU/1/17/1179

Veltassa

Iceland

11.8.2017

EU/1/17/1179

Veltassa

Liechtenstein

31.8.2017

EU/1/17/1179

Veltassa

Norway

9.8.2017

EU/1/17/1181

Spherox

Iceland

24.7.2017

EU/1/17/1181

Spherox

Liechtenstein

31.8.2017

EU/1/17/1181

Spherox

Norway

13.9.2017

EU/1/17/1184

Riximyo

Iceland

11.7.2017

EU/1/17/1185

Rixathon

Iceland

11.7.2017

EU/1/17/1191

Dinutuximab beta Apeiron

Liechtenstein

31.8.2017

EU/1/17/1194

Febuxostat Mylan

Iceland

11.7.2017

EU/1/17/1195

Erelzi

Iceland

14.7.2017

EU/1/17/1195

Erelzi

Norway

7.7.2017

EU/1/17/1196

Kevzara

Iceland

14.7.2017

EU/1/17/1196

Kevzara

Norway

5.7.2017

EU/1/17/1197

Oxervate

Iceland

24.7.2017

EU/1/17/1197

OXERVATE

Liechtenstein

31.8.2017

EU/1/17/1197

OXERVATE

Norway

17.7.2017

EU/1/17/1199

Cuprior

Iceland

13.9.2017

EU/1/17/1199

Cuprior

Liechtenstein

31.10.2017

EU/1/17/1199

Cuprior

Norway

13.9.2017

EU/1/17/1200

Besponsa

Iceland

24.7.2017

EU/1/17/1200

Besponsa

Liechtenstein

31.8.2017

EU/1/17/1200

Besponsa

Norway

13.7.2017

EU/1/17/1201

Skilarence

Iceland

14.7.2017

EU/1/17/1201

Skilarence

Norway

7.7.2017

EU/1/17/1202

Ucedane

Iceland

12.7.2017

EU/1/17/1202

Ucedane

Norway

5.7.2017

EU/1/17/1203

Insulin lispro Sanofi

Iceland

11.8.2017

EU/1/17/1203

Insulin Lispro Sanofi

Liechtenstein

31.8.2017

EU/1/17/1203

Insulin lispro Sanofi

Norway

18.8.2017

EU/1/17/1205

Blitzima

Iceland

9.8.2017

EU/1/17/1205

Blitzima

Liechtenstein

31.8.2017

EU/1/17/1205

Blitzima

Norway

1.8.2017

EU/1/17/1206

Tuxella

Iceland

9.8.2017

EU/1/17/1206

Tuxella

Liechtenstein

31.8.2017

EU/1/17/1206

Tuxella

Norway

1.8.2017

EU/1/17/1207

Ritemvia

Liechtenstein

31.8.2017

EU/1/17/1207

Ritemvia

Iceland

10.8.2017

EU/1/17/1207

Ritemvia

Norway

1.8.2017

EU/1/17/1208

Trimbow

Iceland

11.8.2017

EU/1/17/1208

Trimbow

Liechtenstein

31.8.2017

EU/1/17/1208

Trimbow

Norway

9.8.2017

EU/1/17/1209

Reagila

Iceland

9.8.2017

EU/1/17/1209

Reagila

Liechtenstein

31.8.2017

EU/1/17/1209

Reaglia

Norway

9.8.2017

EU/1/17/1210

Efavirenz/Emtricitabin/Tenofovirdisproksil Zentiva

Norway

8.8.2017

EU/1/17/1210

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

Iceland

10.8.2017

EU/1/17/1210

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

Liechtenstein

31.8.2017

EU/1/17/1211

Entecavir Accord

Iceland

5.10.2017

EU/1/17/1211

Entecavir Accord

Liechtenstein

31.10.2017

EU/1/17/1211

Entecavir Accord

Norway

20.10.2017

EU/1/17/1212

Mavenclad

Iceland

13.9.2017

EU/1/17/1212

MAVENCLAD

Norway

30.8.2017

EU/1/17/1212

MAVENCLAD

Liechtenstein

31.8.2017

EU/1/17/1213

Maviret

Iceland

17.8.2017

EU/1/17/1213

Maviret

Liechtenstein

31.8.2017

EU/1/17/1213

Maviret

Norway

7.8.2017

EU/1/17/1214

Bavencio

Iceland

4.10.2017

EU/1/17/1214

Bavencio

Liechtenstein

31.10.2017

EU/1/17/1214

Bavencio

Norway

25.9.2017

EU/1/17/1215

Fotivda

Iceland

13.9.2017

EU/1/17/1215

Fotivda

Liechtenstein

31.8.2017

EU/1/17/1215

Fotivda

Norway

31.8.2017

EU/1/17/1216

Imraldi

Iceland

12.9.2017

EU/1/17/1216

Imraldi

Liechtenstein

31.8.2017

EU/1/17/1216

Imraldi

Norway

11.9.2017

EU/1/17/1217

Nitisinone MendeliKABS

Iceland

19.9.2017

EU/1/17/1217

Nitisinone MendeliKABS

Liechtenstein

31.8.2017

EU/1/17/1217

Nitisinone MendeliKABS

Norway

1.9.2017

EU/1/17/1218

Rydapt

Iceland

4.10.2017

EU/1/17/1218

Rydapt

Liechtenstein

31.10.2017

EU/1/17/1218

Rydapt

Norway

25.9.2017

EU/1/17/1220

Tecentriq

Liechtenstein

31.10.2017

EU/1/17/1220

Tecentriq

Norway

27.9.2017

EU/1/17/1220

Tecentriq

Iceland

5.10.2017

EU/1/17/1221

Kisqali

Iceland

12.9.2017

EU/1/17/1221

Kisqali

Norway

30.8.2017

EU/1/17/1221

Kisqali

Liechtenstein

31.8.2017

EU/1/17/1222

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Iceland

8.11.2017

EU/1/17/1222

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Liechtenstein

31.10.2017

EU/1/17/1222

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Norway

27.9.2017

EU/1/17/1223

Vosevi

Iceland

16.8.2017

EU/1/17/1223

Vosevi

Liechtenstein

31.8.2017

EU/1/17/1223

Vosevi

Norway

8.8.2017

EU/1/17/1224

Xermelo

Iceland

4.10.2017

EU/1/17/1224

Xermelo

Liechtenstein

31.10.2017

EU/1/17/1224

Xermelo

Norway

3.10.2017

EU/1/17/1225

Symtuza

Iceland

5.10.2017

EU/1/17/1225

Symtuza

Liechtenstein

31.10.2017

EU/1/17/1225

Symtuza

Norway

11.10.2017

EU/1/17/1226

Lutathera

Iceland

10.10.2017

EU/1/17/1226

Lutathera

Liechtenstein

31.10.2017

EU/1/17/1226

Lutathera

Norway

3.10.2017

EU/1/17/1227

Entecavir Mylan

Iceland

4.10.2017

EU/1/17/1227

Entecavir Mylan

Liechtenstein

31.10.2017

EU/1/17/1227

Entecavir Mylan

Norway

27.9.2017

EU/1/17/1228

Tookad

Iceland

29.11.2017

EU/1/17/1228

TOOKAD

Liechtenstein

31.12.2017

EU/1/17/1228

TOOKAD

Norway

22.11.2017

EU/1/17/1229

Dupixent

Iceland

10.10.2017

EU/1/17/1229

Dupixent

Liechtenstein

31.10.2017

EU/1/17/1229

Dupixent

Norway

10.10.2017

EU/1/17/1230

Lacosamide Accord

Iceland

5.10.2017

EU/1/17/1230

Lacosamide Accord

Liechtenstein

31.10.2017

EU/1/17/1230

Lacosamide Accord

Norway

27.9.2017

EU/1/17/1232

Miglustat Gen.Orph

Iceland

30.11.2017

EU/1/17/1232

Miglustat Gen.Orph

Liechtenstein

31.12.2017

EU/1/17/1232

Miglustat Gen.Orph

Norway

27.11.2017

EU/1/17/1233

Zubsolv

Iceland

29.11.2017

EU/1/17/1233

Zubsolv

Liechtenstein

31.12.2017

EU/1/17/1233

Zubsolv

Norway

22.11.2017

EU/1/17/1234

Tremfya

Iceland

4.12.2017

EU/1/17/1235

Zejula

Iceland

4.12.2017

EU/1/17/1235

Zejula

Liechtenstein

31.12.2017

EU/1/17/1235

Zejula

Norway

27.11.2017

EU/1/17/1236

Trelegy Ellipta

Iceland

30.11.2017

EU/1/17/1236

Trelegy Ellipta

Liechtenstein

31.12.2017

EU/1/17/1236

Trelegy Ellipta

Norway

22.11.2017

EU/1/17/1237

Elebrato Ellipta

Iceland

30.11.2017

EU/1/17/1237

Elebrato Ellipta

Liechtenstein

31.12.2017

EU/1/17/1237

Elebrato Ellipta

Norway

27.11.2017

EU/1/17/1238

Nyxoid

Iceland

29.11.2017

EU/1/17/1238

Nyxoid

Liechtenstein

31.12.2017

EU/1/17/1238

Nyxoid

Norway

27.11.2017

EU/1/17/1239

VeraSeal

Iceland

30.11.2017

EU/1/17/1239

VeraSeal

Liechtenstein

31.12.2017

EU/1/17/1239

VeraSeal

Norway

1.12.2017

EU/1/17/1240

Cyltezo

Iceland

29.11.2017

EU/1/17/1240

Cyltezo

Liechtenstein

31.12.2017

EU/1/17/1240

Cyltezo

Norway

1.12.2017

EU/1/17/1241

Ontruzant

Iceland

30.11.2017

EU/1/17/1241

Ontruzant

Liechtenstein

31.12.2017

EU/1/17/1241

Ontruzant

Norway

27.11.2017

EU/1/17/1242

Ritonavir Mylan

Iceland

29.11.2017

EU/1/17/1242

Ritonavir Mylan

Liechtenstein

31.12.2017

EU/1/17/1242

Ritonavir Mylan

Norway

22.11.2017

EU/1/17/1243

Imatinib Teva B.V.

Iceland

30.11.2017

EU/1/17/1243

Imatinib Teva B.V.

Liechtenstein

31.12.2017

EU/1/17/1243

Imatinib Teva B.V.

Norway

22.11.2017

EU/1/17/1244

Tacforius

Liechtenstein

31.12.2017

EU/2/16/197

CLYNAV

Iceland

13.7.2017

EU/2/16/197

CLYNAV

Liechtenstein

31.8.2017

EU/2/16/197

CLYNAV

Norway

18.7.2017

EU/2/17/211

Prevomax

Iceland

13.7.2017

EU/2/17/211

Prevomax

Norway

6.7.2017

EU/2/17/212

Exzolt

Iceland

30.8.2017

EU/2/17/212

Exzolt

Liechtenstein

31.10.2017

EU/2/17/212

Exzolt

Norway

15.9.2017

EU/2/17/213

Innovax-ND-IBD

Iceland

11.9.2017

EU/2/17/213

Innovax-ND-IBD

Norway

18.9.2017

EU/2/17/214

VEPURED

Iceland

12.9.2017

EU/2/17/214

VEPURED

Norway

15.9.2017

EU/2/17/215

Suvaxyn PRRS MLV

Iceland

11.9.2017

EU/2/17/215

Suvaxyn PRRS MLV

Liechtenstein

31.10.2017

EU/2/17/215

Suvaxyn PRRS MLV

Norway

18.9.2017

EU/2/17/217

Nobivac LeuFel

Iceland

9.11.2017

EU/2/17/217

Nobivac LeuFel

Liechtenstein

31.12.2017

EU/2/17/217

Nobivac LeuFel

Norway

14.11.2017

EU/2/17/218

Bovilis Blue-8

Iceland

1.12.2017

EU/2/17/218

Bovilis Blue-8

Liechtenstein

31.12.2017

EU/2/17/218

Bovilis Blue-8

Norway

19.12.2017

---

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 2017:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/07/401 | alli | Iceland | 14.7.2017 |
| EU/1/07/401 | alli | Liechtenstein | 31.8.2017 |
| EU/1/07/401 | alli | Norway | 5.7.2017 |
| EU/1/07/402 | Increlex | Iceland | 12.7.2017 |
| EU/1/07/402 | INCRELEX | Norway | 5.7.2017 |
| EU/1/07/403 | Atriance | Iceland | 11.7.2017 |
| EU/1/07/416 | Ecalta | Iceland | 13.9.2017 |
| EU/1/07/416 | Ecalta | Liechtenstein | 31.10.2017 |
| EU/1/07/416 | Ecalta | Norway | 22.9.2017 |
| EU/1/07/421 | Glubrava | Iceland | 30.11.2017 |
| EU/1/07/421 | Glubrava | Liechtenstein | 31.12.2017 |
| EU/1/07/421 | Glubrava | Norway | 22.11.2017 |
| EU/1/07/424 | Torisel | Iceland | 24.7.2017 |
| EU/1/07/424 | Torisel | Liechtenstein | 31.8.2017 |
| EU/1/07/424 | Torisel | Norway | 1.8.2017 |
| EU/1/08/446 | Privigen | Iceland | 4.12.2017 |
| EU/1/08/446 | Privigen | Liechtenstein | 31.12.2017 |
| EU/1/08/446 | Privigen | Norway | 5.12.2017 |
| EU/1/08/453 | Prepandrix | Iceland | 4.12.2017 |
| EU/1/08/453 | Prepandrix | Liechtenstein | 31.12.2017 |
| EU/1/08/453 | Prepandrix | Norway | 5.12.2017 |
| EU/1/12/784 | Cuprymina | Iceland | 11.8.2017 |
| EU/1/12/784 | Cuprymina | Liechtenstein | 31.8.2017 |
| EU/1/12/784 | Cuprymina | Norway | 9.8.2017 |
| EU/1/12/787 | Revestive | Iceland | 13.7.2017 |
| EU/1/12/787 | Revestive | Norway | 5.7.2017 |
| EU/1/12/788 | Seebri Breezhaler | Iceland | 11.8.2017 |
| EU/1/12/788 | Seebri Breezhaler | Liechtenstein | 31.8.2017 |
| EU/1/12/788 | Seebri Breezhaler | Norway | 9.8.2017 |
| EU/1/12/789 | Enurev Breezhaler | Iceland | 24.7.2017 |
| EU/1/12/789 | Enurev Breezhaler | Liechtenstein | 31.8.2017 |
| EU/1/12/789 | Enurev Breezhaler | Norway | 9.8.2017 |
| EU/1/12/790 | Tovanor Breezhaler | Iceland | 14.8.2017 |
| EU/1/12/790 | Tovanor Breezhaler | Liechtenstein | 31.8.2017 |
| EU/1/12/790 | Tovanor Breezhaler | Norway | 9.8.2017 |
| EU/1/12/794 | Adcetris | Iceland | 4.12.2017 |
| EU/1/12/794 | ADCETRIS | Liechtenstein | 31.12.2017 |
| EU/1/12/794 | ADCETRIS | Norway | 27.11.2017 |
| EU/1/12/795 | Forxiga | Iceland | 13.9.2017 |
| EU/1/12/795 | Forxiga | Liechtenstein | 31.10.2017 |
| EU/1/12/795 | Forxiga | Norway | 27.9.2017 |
| EU/1/12/796 | Picato | Iceland | 24.7.2017 |
| EU/1/12/796 | Picato | Liechtenstein | 31.8.2017 |
| EU/1/12/796 | Picato | Norway | 8.8.2017 |
| EU/1/12/797 | Eylea | Iceland | 10.8.2017 |
| EU/1/12/797 | Eylea | Liechtenstein | 31.8.2017 |
| EU/1/12/797 | Eylea | Norway | 18.8.2017 |
| EU/1/12/798 | Ibandronic acid Accord | Iceland | 6.10.2017 |
| EU/1/12/798 | Ibandronic acid Accord | Liechtenstein | 31.10.2017 |
| EU/1/12/798 | Ibandronic acid Accord | Norway | 27.9.2017 |
| EU/1/12/799 | Memantine Merz | Iceland | 24.7.2017 |
| EU/1/12/799 | Memantine Merz | Liechtenstein | 31.8.2017 |
| EU/1/12/799 | Memantine Merz | Norway | 9.8.2017 |
| EU/1/12/800 | Zoledronic Acid Hospira | Iceland | 11.9.2017 |
| EU/1/12/800 | Zoledronic acid Hospira | Liechtenstein | 31.8.2017 |
| EU/1/12/800 | Zoledronsyre Hospira | Norway | 4.9.2017 |
| EU/1/12/801 | Constella | Iceland | 14.9.2017 |
| EU/1/12/801 | Constella | Liechtenstein | 31.10.2017 |
| EU/1/12/801 | Constella | Norway | 22.9.2017 |
| EU/1/12/802 | Capecitabine medac | Iceland | 12.7.2017 |
| EU/1/12/803 | NexoBrid | Iceland | 30.11.2017 |
| EU/1/12/803 | NexoBrid | Liechtenstein | 31.12.2017 |
| EU/1/12/803 | NexoBrid | Norway | 11.12.2017 |
| EU/1/12/805 | AMYViD | Iceland | 9.10.2017 |
| EU/1/12/805 | Amyvid | Liechtenstein | 31.10.2017 |
| EU/1/12/805 | Amyvid | Norway | 3.10.2017 |
| EU/1/12/806 | Ryzodeg | Iceland | 4.10.2017 |
| EU/1/12/806 | Ryzodeg | Liechtenstein | 31.10.2017 |
| EU/1/12/806 | Ryzodeg | Norway | 10.10.2017 |
| EU/1/12/807 | Tresiba | Iceland | 9.10.2017 |
| EU/1/12/807 | Tresiba | Liechtenstein | 31.10.2017 |
| EU/1/12/807 | Tresiba | Norway | 10.10.2017 |
| EU/1/12/808 | Imatinib Teva | Iceland | 9.10.2017 |
| EU/1/12/808 | Imatinib Teva | Liechtenstein | 31.10.2017 |
| EU/1/12/808 | Imatinib Teva | Norway | 27.9.2017 |
| EU/1/12/809 | Betmiga | Iceland | 6.10.2017 |
| EU/1/12/809 | Betmiga | Liechtenstein | 31.10.2017 |
| EU/1/12/809 | Betmiga | Norway | 3.10.2017 |
| EU/1/12/811 | Lyxumia | Iceland | 6.10.2017 |
| EU/1/12/811 | Lyxumia | Liechtenstein | 31.10.2017 |
| EU/1/12/811 | Lyxumia | Norway | 9.10.2017 |
| EU/1/12/812 | Bexsero | Iceland | 9.10.2017 |
| EU/1/12/812 | Bexsero | Liechtenstein | 31.10.2017 |
| EU/1/12/812 | Bexsero | Norway | 3.10.2017 |
| EU/1/12/814 | Zaltrap | Iceland | 9.10.2017 |
| EU/1/12/814 | ZALTRAP | Liechtenstein | 31.10.2017 |
| EU/1/12/814 | ZALTRAP | Norway | 27.9.2017 |
| EU/1/12/815 | Selincro | Iceland | 30.11.2017 |
| EU/1/12/815 | Selincro | Liechtenstein | 31.12.2017 |
| EU/1/12/815 | Selincro | Norway | 1.12.2017 |
| EU/1/13/813 | Perjeta | Iceland | 19.12.2017 |
| EU/1/13/813 | Perjeta | Liechtenstein | 31.12.2017 |
| EU/1/13/817 | Actelsar HCT | Liechtenstein | 31.12.2017 |
| EU/1/13/819 | JETREA | Iceland | 15.12.2017 |
| EU/1/13/819 | JETREA | Liechtenstein | 31.12.2017 |
| EU/1/13/819 | JETREA | Norway | 19.12.2017 |
| EU/1/13/902 | Translarna | Iceland | 12.7.2017 |
| EU/1/13/902 | Translarna | Norway | 5.7.2017 |
| EU/1/14/987 | Holoclar | Iceland | 19.12.2017 |
| EU/1/16/1094 | Ninlaro | Iceland | 6.10.2017 |
| EU/1/16/1094 | Ninlaro | Liechtenstein | 31.10.2017 |
| EU/1/16/1094 | Ninlaro | Norway | 26.9.2017 |
| EU/1/16/1121 | Zalmoxis | Iceland | 24.7.2017 |
| EU/1/16/1121 | Zalmoxis | Liechtenstein | 31.8.2017 |
| EU/1/16/1121 | Zalmoxis | Norway | 4.8.2017 |
| EU/1/16/1138 | Venclyxto | Iceland | 6.11.2017 |
| EU/1/16/1138 | Venclyxto | Norway | 14.11.2017 |
| EU/1/16/1139 | Ocaliva | Iceland | 8.12.2017 |
| EU/1/16/1139 | OCALIVA | Liechtenstein | 31.12.2017 |
| EU/1/16/1139 | OCALIVA | Norway | 18.12.2017 |
| EU/1/16/1143 | Lartruvo | Iceland | 6.10.2017 |
| EU/1/16/1143 | Lartruvo | Liechtenstein | 31.10.2017 |
| EU/1/16/1143 | Lartruvo | Norway | 27.9.2017 |
| EU/1/16/1169 | Alecensa | Iceland | 8.12.2017 |
| EU/1/16/1169 | Alecensa | Liechtenstein | 31.12.2017 |
| EU/1/16/1169 | Alecensa | Norway | 15.12.2017 |
| EU/1/43/890 | Cometriq | Norway | 3.8.2017 |
| EU/2/12/142 | Cardalis | Iceland | 4.7.2017 |
| EU/2/12/144 | Contacera | Iceland | 5.12.2017 |
| EU/2/12/144 | Contacera | Liechtenstein | 31.12.2017 |
| EU/2/12/144 | Contacera | Norway | 15.12.2017 |
| EU/2/12/145 | Kexxtone | Liechtenstein | 31.12.2017 |
| EU/2/12/145 | Kexxtone | Norway | 28.12.2017 |
| EU/2/12/147 | Pexion | Iceland | 5.12.2017 |
| EU/2/12/147 | Pexion | Liechtenstein | 31.12.2017 |
| EU/2/12/147 | Pexion | Norway | 6.12.2017 |

EU Number

Product

Country

Date of authorisation

EU/1/07/401

alli

Iceland

14.7.2017

EU/1/07/401

alli

Liechtenstein

31.8.2017

EU/1/07/401

alli

Norway

5.7.2017

EU/1/07/402

Increlex

Iceland

12.7.2017

EU/1/07/402

INCRELEX

Norway

5.7.2017

EU/1/07/403

Atriance

Iceland

11.7.2017

EU/1/07/416

Ecalta

Iceland

13.9.2017

EU/1/07/416

Ecalta

Liechtenstein

31.10.2017

EU/1/07/416

Ecalta

Norway

22.9.2017

EU/1/07/421

Glubrava

Iceland

30.11.2017

EU/1/07/421

Glubrava

Liechtenstein

31.12.2017

EU/1/07/421

Glubrava

Norway

22.11.2017

EU/1/07/424

Torisel

Iceland

24.7.2017

EU/1/07/424

Torisel

Liechtenstein

31.8.2017

EU/1/07/424

Torisel

Norway

1.8.2017

EU/1/08/446

Privigen

Iceland

4.12.2017

EU/1/08/446

Privigen

Liechtenstein

31.12.2017

EU/1/08/446

Privigen

Norway

5.12.2017

EU/1/08/453

Prepandrix

Iceland

4.12.2017

EU/1/08/453

Prepandrix

Liechtenstein

31.12.2017

EU/1/08/453

Prepandrix

Norway

5.12.2017

EU/1/12/784

Cuprymina

Iceland

11.8.2017

EU/1/12/784

Cuprymina

Liechtenstein

31.8.2017

EU/1/12/784

Cuprymina

Norway

9.8.2017

EU/1/12/787

Revestive

Iceland

13.7.2017

EU/1/12/787

Revestive

Norway

5.7.2017

EU/1/12/788

Seebri Breezhaler

Iceland

11.8.2017

EU/1/12/788

Seebri Breezhaler

Liechtenstein

31.8.2017

EU/1/12/788

Seebri Breezhaler

Norway

9.8.2017

EU/1/12/789

Enurev Breezhaler

Iceland

24.7.2017

EU/1/12/789

Enurev Breezhaler

Liechtenstein

31.8.2017

EU/1/12/789

Enurev Breezhaler

Norway

9.8.2017

EU/1/12/790

Tovanor Breezhaler

Iceland

14.8.2017

EU/1/12/790

Tovanor Breezhaler

Liechtenstein

31.8.2017

EU/1/12/790

Tovanor Breezhaler

Norway

9.8.2017

EU/1/12/794

Adcetris

Iceland

4.12.2017

EU/1/12/794

ADCETRIS

Liechtenstein

31.12.2017

EU/1/12/794

ADCETRIS

Norway

27.11.2017

EU/1/12/795

Forxiga

Iceland

13.9.2017

EU/1/12/795

Forxiga

Liechtenstein

31.10.2017

EU/1/12/795

Forxiga

Norway

27.9.2017

EU/1/12/796

Picato

Iceland

24.7.2017

EU/1/12/796

Picato

Liechtenstein

31.8.2017

EU/1/12/796

Picato

Norway

8.8.2017

EU/1/12/797

Eylea

Iceland

10.8.2017

EU/1/12/797

Eylea

Liechtenstein

31.8.2017

EU/1/12/797

Eylea

Norway

18.8.2017

EU/1/12/798

Ibandronic acid Accord

Iceland

6.10.2017

EU/1/12/798

Ibandronic acid Accord

Liechtenstein

31.10.2017

EU/1/12/798

Ibandronic acid Accord

Norway

27.9.2017

EU/1/12/799

Memantine Merz

Iceland

24.7.2017

EU/1/12/799

Memantine Merz

Liechtenstein

31.8.2017

EU/1/12/799

Memantine Merz

Norway

9.8.2017

EU/1/12/800

Zoledronic Acid Hospira

Iceland

11.9.2017

EU/1/12/800

Zoledronic acid Hospira

Liechtenstein

31.8.2017

EU/1/12/800

Zoledronsyre Hospira

Norway

4.9.2017

EU/1/12/801

Constella

Iceland

14.9.2017

EU/1/12/801

Constella

Liechtenstein

31.10.2017

EU/1/12/801

Constella

Norway

22.9.2017

EU/1/12/802

Capecitabine medac

Iceland

12.7.2017

EU/1/12/803

NexoBrid

Iceland

30.11.2017

EU/1/12/803

NexoBrid

Liechtenstein

31.12.2017

EU/1/12/803

NexoBrid

Norway

11.12.2017

EU/1/12/805

AMYViD

Iceland

9.10.2017

EU/1/12/805

Amyvid

Liechtenstein

31.10.2017

EU/1/12/805

Amyvid

Norway

3.10.2017

EU/1/12/806

Ryzodeg

Iceland

4.10.2017

EU/1/12/806

Ryzodeg

Liechtenstein

31.10.2017

EU/1/12/806

Ryzodeg

Norway

10.10.2017

EU/1/12/807

Tresiba

Iceland

9.10.2017

EU/1/12/807

Tresiba

Liechtenstein

31.10.2017

EU/1/12/807

Tresiba

Norway

10.10.2017

EU/1/12/808

Imatinib Teva

Iceland

9.10.2017

EU/1/12/808

Imatinib Teva

Liechtenstein

31.10.2017

EU/1/12/808

Imatinib Teva

Norway

27.9.2017

EU/1/12/809

Betmiga

Iceland

6.10.2017

EU/1/12/809

Betmiga

Liechtenstein

31.10.2017

EU/1/12/809

Betmiga

Norway

3.10.2017

EU/1/12/811

Lyxumia

Iceland

6.10.2017

EU/1/12/811

Lyxumia

Liechtenstein

31.10.2017

EU/1/12/811

Lyxumia

Norway

9.10.2017

EU/1/12/812

Bexsero

Iceland

9.10.2017

EU/1/12/812

Bexsero

Liechtenstein

31.10.2017

EU/1/12/812

Bexsero

Norway

3.10.2017

EU/1/12/814

Zaltrap

Iceland

9.10.2017

EU/1/12/814

ZALTRAP

Liechtenstein

31.10.2017

EU/1/12/814

ZALTRAP

Norway

27.9.2017

EU/1/12/815

Selincro

Iceland

30.11.2017

EU/1/12/815

Selincro

Liechtenstein

31.12.2017

EU/1/12/815

Selincro

Norway

1.12.2017

EU/1/13/813

Perjeta

Iceland

19.12.2017

EU/1/13/813

Perjeta

Liechtenstein

31.12.2017

EU/1/13/817

Actelsar HCT

Liechtenstein

31.12.2017

EU/1/13/819

JETREA

Iceland

15.12.2017

EU/1/13/819

JETREA

Liechtenstein

31.12.2017

EU/1/13/819

JETREA

Norway

19.12.2017

EU/1/13/902

Translarna

Iceland

12.7.2017

EU/1/13/902

Translarna

Norway

5.7.2017

EU/1/14/987

Holoclar

Iceland

19.12.2017

EU/1/16/1094

Ninlaro

Iceland

6.10.2017

EU/1/16/1094

Ninlaro

Liechtenstein

31.10.2017

EU/1/16/1094

Ninlaro

Norway

26.9.2017

EU/1/16/1121

Zalmoxis

Iceland

24.7.2017

EU/1/16/1121

Zalmoxis

Liechtenstein

31.8.2017

EU/1/16/1121

Zalmoxis

Norway

4.8.2017

EU/1/16/1138

Venclyxto

Iceland

6.11.2017

EU/1/16/1138

Venclyxto

Norway

14.11.2017

EU/1/16/1139

Ocaliva

Iceland

8.12.2017

EU/1/16/1139

OCALIVA

Liechtenstein

31.12.2017

EU/1/16/1139

OCALIVA

Norway

18.12.2017

EU/1/16/1143

Lartruvo

Iceland

6.10.2017

EU/1/16/1143

Lartruvo

Liechtenstein

31.10.2017

EU/1/16/1143

Lartruvo

Norway

27.9.2017

EU/1/16/1169

Alecensa

Iceland

8.12.2017

EU/1/16/1169

Alecensa

Liechtenstein

31.12.2017

EU/1/16/1169

Alecensa

Norway

15.12.2017

EU/1/43/890

Cometriq

Norway

3.8.2017

EU/2/12/142

Cardalis

Iceland

4.7.2017

EU/2/12/144

Contacera

Iceland

5.12.2017

EU/2/12/144

Contacera

Liechtenstein

31.12.2017

EU/2/12/144

Contacera

Norway

15.12.2017

EU/2/12/145

Kexxtone

Liechtenstein

31.12.2017

EU/2/12/145

Kexxtone

Norway

28.12.2017

EU/2/12/147

Pexion

Iceland

5.12.2017

EU/2/12/147

Pexion

Liechtenstein

31.12.2017

EU/2/12/147

Pexion

Norway

6.12.2017

---

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 2017:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/177/002 | SonoVue | Norway | 4.9.2017 |
| EU/1/03/256/022 | Humira | Iceland | 19.12.2017 |
| EU/1/03/256/022 | Humira | Norway | 10.11.2017 |
| EU/1/04/292/013-015 | Mimpara | Iceland | 15.9.2017 |
| EU/1/04/292/013-015 | Mimpara | Norway | 28.8.2017 |
| EU/1/06/356/020-022 | Exjade | Norway | 28.11.2017 |
| EU/1/06/356/020-022 | Exjade | Iceland | 1.12.2017 |
| EU/1/07/418/011-013 | Celsentri | Norway | 3.8.2017 |
| EU/1/07/418/011-013 | Celsentri | Iceland | 13.7.2017 |
| EU/1/07/422/015 | Tasigna | Iceland | 4.12.2017 |
| EU/1/07/422/015 | Tasigna | Norway | 28.11.2017 |
| EU/1/07/436/006 | Isentress | Iceland | 9.8.2017 |
| EU/1/07/436/006 | Isentress | Norway | 7.8.2017 |
| EU/1/08/481/004-005 | Kuvan | Iceland | 10.8.2017 |
| EU/1/08/481/004-005 | Kuvan | Norway | 13.7.2017 |
| EU/1/09/522/003 | ellaOne | Iceland | 1.12.2017 |
| EU/1/09/522/003 | ellaOne | Norway | 10.11.2017 |
| EU/1/09/531/022-033 | Instanyl | Iceland | 6.11.2017 |
| EU/1/09/539/005-006 | Samsca | Iceland | 5.10.2017 |
| EU/1/09/539/005-006 | Samsca | Norway | 18.9.2017 |
| EU/1/10/618 | Prolia | Norway | 27.9.2017 |
| EU/1/11/703 | Xgeva | Norway | 27.9.2017 |
| EU/1/12/753/018-019 | Signifor | Iceland | 4.10.2017 |
| EU/1/12/753/018-019 | Signifor | Norway | 18.9.2017 |
| EU/1/12/787/003 | Revestive | Norway | 5.7.2017 |
| EU/1/12/787/003 | Revestive | Iceland | 13.7.2017 |
| EU/1/13/846/002-003 | Xtandi | Norway | 3.10.2017 |
| EU/1/13/846/002-003 | Xtandi | Iceland | 6.10.2017 |
| EU/1/13/860/003 | Nexium Control | Iceland | 11.7.2017 |
| EU/1/13/860/003 | Nexium Control | Norway | 5.7.2017 |
| EU/1/15/1070/002 | Oncaspar | Iceland | 19.12.2017 |

EU Number

Product

Country

Date of authorisation

EU/1/01/177/002

SonoVue

Norway

4.9.2017

EU/1/03/256/022

Humira

Iceland

19.12.2017

EU/1/03/256/022

Humira

Norway

10.11.2017

EU/1/04/292/013-015

Mimpara

Iceland

15.9.2017

EU/1/04/292/013-015

Mimpara

Norway

28.8.2017

EU/1/06/356/020-022

Exjade

Norway

28.11.2017

EU/1/06/356/020-022

Exjade

Iceland

1.12.2017

EU/1/07/418/011-013

Celsentri

Norway

3.8.2017

EU/1/07/418/011-013

Celsentri

Iceland

13.7.2017

EU/1/07/422/015

Tasigna

Iceland

4.12.2017

EU/1/07/422/015

Tasigna

Norway

28.11.2017

EU/1/07/436/006

Isentress

Iceland

9.8.2017

EU/1/07/436/006

Isentress

Norway

7.8.2017

EU/1/08/481/004-005

Kuvan

Iceland

10.8.2017

EU/1/08/481/004-005

Kuvan

Norway

13.7.2017

EU/1/09/522/003

ellaOne

Iceland

1.12.2017

EU/1/09/522/003

ellaOne

Norway

10.11.2017

EU/1/09/531/022-033

Instanyl

Iceland

6.11.2017

EU/1/09/539/005-006

Samsca

Iceland

5.10.2017

EU/1/09/539/005-006

Samsca

Norway

18.9.2017

EU/1/10/618

Prolia

Norway

27.9.2017

EU/1/11/703

Xgeva

Norway

27.9.2017

EU/1/12/753/018-019

Signifor

Iceland

4.10.2017

EU/1/12/753/018-019

Signifor

Norway

18.9.2017

EU/1/12/787/003

Revestive

Norway

5.7.2017

EU/1/12/787/003

Revestive

Iceland

13.7.2017

EU/1/13/846/002-003

Xtandi

Norway

3.10.2017

EU/1/13/846/002-003

Xtandi

Iceland

6.10.2017

EU/1/13/860/003

Nexium Control

Iceland

11.7.2017

EU/1/13/860/003

Nexium Control

Norway

5.7.2017

EU/1/15/1070/002

Oncaspar

Iceland

19.12.2017

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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 2017:

| EU Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/00/167 | Prevenar | Liechtenstein | 31.12.2017 |
| EU/1/00/167 | Prevenar | Norway | 11.12.2017 |
| EU/1/00/167 | Prevenar | Iceland | 1.12.2017 |
| EU/1/07/394 | Optaflu | Norway | 18.10.2017 |
| EU/1/07/398 | Optimark | Iceland | 10.10.2017 |
| EU/1/09/561 | Clopidogrel Teva Pharma | Iceland | 11.7.2017 |
| EU/1/11/674 | Repso | Liechtenstein | 31.8.2017 |
| EU/1/11/674 | Repso | Norway | 8.8.2017 |
| EU/1/11/674 | Repso | Iceland | 10.8.2017 |
| EU/1/13/868 | EVARREST | Liechtenstein | 31.12.2017 |
| EU/1/13/868 | EVARREST | Norway | 28.11.2017 |
| EU/1/13/868 | EVARREST | Iceland | 4.12.2017 |
| EU/1/14/976 | Zontivity | Liechtenstein | 31.8.2017 |
| EU/1/15/996 | Ristempa | Liechtenstein | 31.10.2017 |
| EU/1/15/996 | Ristempa | Norway | 9.10.2017 |
| EU/1/15/996 | Ristempa | Iceland | 9.10.2017 |
| EU/1/16/1113 | Enzepi | Iceland | 11.8.2017 |
| EU/1/16/1113 | Enzepi | Liechtenstein | 31.8.2017 |
| EU/1/16/1113 | Enzepi | Norway | 8.8.2017 |

EU Number

Product

Country

Date of withdrawal

EU/1/00/167

Prevenar

Liechtenstein

31.12.2017

EU/1/00/167

Prevenar

Norway

11.12.2017

EU/1/00/167

Prevenar

Iceland

1.12.2017

EU/1/07/394

Optaflu

Norway

18.10.2017

EU/1/07/398

Optimark

Iceland

10.10.2017

EU/1/09/561

Clopidogrel Teva Pharma

Iceland

11.7.2017

EU/1/11/674

Repso

Liechtenstein

31.8.2017

EU/1/11/674

Repso

Norway

8.8.2017

EU/1/11/674

Repso

Iceland

10.8.2017

EU/1/13/868

EVARREST

Liechtenstein

31.12.2017

EU/1/13/868

EVARREST

Norway

28.11.2017

EU/1/13/868

EVARREST

Iceland

4.12.2017

EU/1/14/976

Zontivity

Liechtenstein

31.8.2017

EU/1/15/996

Ristempa

Liechtenstein

31.10.2017

EU/1/15/996

Ristempa

Norway

9.10.2017

EU/1/15/996

Ristempa

Iceland

9.10.2017

EU/1/16/1113

Enzepi

Iceland

11.8.2017

EU/1/16/1113

Enzepi

Liechtenstein

31.8.2017

EU/1/16/1113

Enzepi

Norway

8.8.2017

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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 2017:

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

EU Number

Product

Country

Date of suspension

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