# C_2019068EN.01000501.xml

| 21.2.2019 | EN | Official Journal of the European Union | C 68/5 |
| --- | --- | --- | --- |

21.2.2019

EN

Official Journal of the European Union

C 68/5

---

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2018

(2019/C 68/06)

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 January — 30 June 2018, at their meeting on 26 October 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| Annex IV | List of withdrawn marketing authorisations |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List of withdrawn marketing authorisations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 January — 30 June 2018:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/13/901 | Sirturo | Liechtenstein | 30.4.2018 |
| EU/1/15/1047 | Blincyto | Liechtenstein | 30.6.2018 |
| EU/1/17/1173 | Lokelma | Iceland | 26.3.2018 |
| EU/1/17/1173 | Lokelma | Liechtenstein | 30.4.2018 |
| EU/1/17/1173 | Lokelma | Norway | 16.4.2018 |
| EU/1/17/1231 | Ocrevus | Iceland | 11.1.2018 |
| EU/1/17/1231 | Ocrevus | Liechtenstein | 28.2.2018 |
| EU/1/17/1231 | Ocrevus | Norway | 17.1.2018 |
| EU/1/17/1234 | Tremfya | Norway | 18.1.2018 |
| EU/1/17/1244 | Tacforius | Iceland | 5.1.2018 |
| EU/1/17/1244 | Tacforius | Norway | 3.1.2018 |
| EU/1/17/1245 | Prevymis | Iceland | 19.1.2018 |
| EU/1/17/1245 | PREVYMIS | Liechtenstein | 28.2.2018 |
| EU/1/17/1245 | PREVYMIS | Norway | 5.2.2018 |
| EU/1/17/1246 | Mvasi | Iceland | 24.1.2018 |
| EU/1/17/1246 | Mvasi | Norway | 30.1.2018 |
| EU/1/17/1247 | Adynovi | Iceland | 11.1.2018 |
| EU/1/17/1247 | ADYNOVI | Liechtenstein | 28.2.2018 |
| EU/1/17/1247 | ADYNOVI | Norway | 19.1.2018 |
| EU/1/17/1248 | Darunavir Krka d.d. | Iceland | 24.1.2018 |
| EU/1/17/1248 | Darunavir Krka d.d. | Norway | 14.2.2018 |
| EU/1/17/1249 | Darunavir Krka | Iceland | 26.1.2018 |
| EU/1/17/1249 | Darunavir Krka | Liechtenstein | 28.2.2018 |
| EU/1/17/1249 | Darunavir Krka | Norway | 14.2.2018 |
| EU/1/17/1250 | Rubraca | Iceland | 5.6.2018 |
| EU/1/17/1250 | Rubraca | Liechtenstein | 30.6.2018 |
| EU/1/17/1250 | Rubraca | Norway | 31.5.2018 |
| EU/1/17/1251 | Ozempic | Iceland | 15.2.2018 |
| EU/1/17/1251 | Ozempic | Liechtenstein | 28.2.2018 |
| EU/1/17/1251 | Ozempic | Norway | 14.2.2018 |
| EU/1/17/1252 | Fasenra | Iceland | 11.1.2018 |
| EU/1/17/1252 | Fasenra | Liechtenstein | 28.2.2018 |
| EU/1/17/1252 | Fasenra | Norway | 16.1.2018 |
| EU/1/17/1253 | Fulvestrant Mylan | Iceland | 12.2.2018 |
| EU/1/17/1253 | Fulvestrant Mylan | Liechtenstein | 28.2.2018 |
| EU/1/17/1253 | Fulvestrant Mylan | Norway | 29.5.2018 |
| EU/1/17/1254 | Jorveza | Iceland | 15.1.2018 |
| EU/1/17/1254 | Jorveza | Liechtenstein | 28.2.2018 |
| EU/1/17/1254 | Jorveza | Norway | 19.1.2018 |
| EU/1/17/1255 | Intrarosa | Iceland | 7.2.2018 |
| EU/1/17/1255 | Intrarosa | Liechtenstein | 28.2.2018 |
| EU/1/17/1256 | Anagrelide Mylan | Iceland | 26.2.2018 |
| EU/1/17/1256 | Anagrelid Mylan | Liechtenstein | 28.2.2018 |
| EU/1/17/1256 | Anagrelide Mylan | Norway | 27.2.2018 |
| EU/1/17/1257 | Herzuma | Iceland | 15.2.2018 |
| EU/1/17/1257 | Herzuma | Liechtenstein | 28.2.2018 |
| EU/1/17/1257 | Herzuma | Norway | 14.2.2018 |
| EU/1/17/1258 | Lamzede | Iceland | 11.4.2018 |
| EU/1/17/1258 | Lamzede | Liechtenstein | 30.4.2018 |
| EU/1/17/1258 | Lamzede | Norway | 16.4.2018 |
| EU/1/17/1260 | Alkindi | Iceland | 15.2.2018 |
| EU/1/17/1260 | Alkindi | Liechtenstein | 28.2.2018 |
| EU/1/17/1260 | Alkindi | Norway | 2.3.2018 |
| EU/1/17/1261 | Alofisel | Iceland | 10.4.2018 |
| EU/1/17/1261 | Alofisel | Liechtenstein | 30.4.2018 |
| EU/1/17/1261 | Alofisel | Norway | 9.4.2018 |
| EU/1/17/1262 | Crysvita | Iceland | 26.2.2018 |
| EU/1/17/1262 | CRYSVITA | Liechtenstein | 30.4.2018 |
| EU/1/17/1262 | CRYSVITA | Norway | 9.4.2018 |
| EU/1/17/1263 | Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | Iceland | 15.2.2018 |
| EU/1/17/1263 | Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | Liechtenstein | 28.2.2018 |
| EU/1/17/1263 | Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | Norway | 14.2.2018 |
| EU/1/18/1265 | Segluromet | Iceland | 10.4.2018 |
| EU/1/18/1265 | Segluromet | Liechtenstein | 30.4.2018 |
| EU/1/18/1265 | Segluromet | Norway | 9.4.2018 |
| EU/1/18/1266 | Steglujan | Iceland | 11.4.2018 |
| EU/1/18/1266 | Steglujan | Liechtenstein | 30.4.2018 |
| EU/1/18/1266 | Steglujan | Norway | 7.4.2018 |
| EU/1/18/1267 | Steglatro | Iceland | 10.4.2018 |
| EU/1/18/1267 | Steglatro | Liechtenstein | 30.4.2018 |
| EU/1/18/1267 | Stegatro | Norway | 9.4.2018 |
| EU/1/18/1269 | Alpivab | Iceland | 11.5.2018 |
| EU/1/18/1269 | Alpivab | Liechtenstein | 30.4.2018 |
| EU/1/18/1269 | Alpivab | Norway | 26.6.2018 |
| EU/1/18/1270 | Semglee | Iceland | 10.4.2018 |
| EU/1/18/1270 | Semglee | Liechtenstein | 30.4.2018 |
| EU/1/18/1270 | Semglee | Norway | 23.5.2018 |
| EU/1/18/1271 | Hemlibra | Iceland | 2.3.2018 |
| EU/1/18/1271 | Hemlibra | Liechtenstein | 28.2.2018 |
| EU/1/18/1271 | Hemlibra | Norway | 8.3.2018 |
| EU/1/18/1272 | Shingrix | Iceland | 26.3.2018 |
| EU/1/18/1272 | Shingrix | Liechtenstein | 30.4.2018 |
| EU/1/18/1272 | Shingrix | Norway | 5.4.2018 |
| EU/1/18/1273 | Prasugrel Mylan | Iceland | 29.5.2018 |
| EU/1/18/1273 | Prasugrel Mylan | Liechtenstein | 30.6.2018 |
| EU/1/18/1274 | Trydonis | Iceland | 23.5.2018 |
| EU/1/18/1274 | Trydonis | Liechtenstein | 30.6.2018 |
| EU/1/18/1274 | Trydonis | Norway | 28.5.2018 |
| EU/1/18/1275 | Riarify | Iceland | 23.5.2018 |
| EU/1/18/1275 | Riarify | Liechtenstein | 30.6.2018 |
| EU/1/18/1277 | Mylotarg | Iceland | 16.5.2018 |
| EU/1/18/1277 | Mylotarg | Liechtenstein | 30.6.2018 |
| EU/1/18/1277 | Mylotarg | Norway | 4.5.2018 |
| EU/1/18/1279 | AMGLIDIA | Iceland | 5.6.2018 |
| EU/1/18/1279 | AMGLIDIA | Liechtenstein | 30.6.2018 |
| EU/1/18/1279 | AMGLIDIA | Norway | 26.6.2018 |
| EU/1/18/1280 | Zessly | Iceland | 4.6.2018 |
| EU/1/18/1280 | Zessly | Liechtenstein | 30.6.2018 |
| EU/1/18/1280 | Zessly | Norway | 15.6.2018 |
| EU/1/18/1281 | Kanjinti | Iceland | 29.5.2018 |
| EU/1/18/1281 | KANJINTI | Liechtenstein | 30.6.2018 |
| EU/1/18/1281 | KANJINTI | Norway | 24.5.2018 |
| EU/1/18/1282 | Juluca | Iceland | 29.5.2018 |
| EU/1/18/1282 | Juluca | Liechtenstein | 30.6.2018 |
| EU/1/18/1282 | Juluca | Norway | 24.5.2018 |
| EU/1/18/1283 | Pemetrexed Krka | Iceland | 30.5.2018 |
| EU/1/18/1283 | Pemetrexed Krka | Liechtenstein | 30.6.2018 |
| EU/1/18/1283 | Pemetrexed Krka | Norway | 31.5.2018 |
| EU/1/18/1289 | Biktarvy | Iceland | 28.6.2018 |
| EU/1/18/1289 | Bictarvy | Liechtenstein | 30.6.2018 |
| EU/1/18/1289 | Biktarvy | Norway | 27.6.2018 |
| EU/2/17/216 | Oxybee | Iceland | 26.3.2018 |
| EU/2/17/216 | Oxybee | Liechtenstein | 30.4.2018 |
| EU/2/17/216 | Oxybee | Norway | 20.4.2018 |
| EU/2/17/219 | Rabitec | Iceland | 4.1.2018 |
| EU/2/17/219 | Rabitec | Liechtenstein | 28.2.2018 |
| EU/2/17/219 | Rabitec | Norway | 9.1.2018 |
| EU/2/17/220 | MiPet Easecto | Iceland | 26.2.2018 |
| EU/2/17/220 | MiPet Easecto | Norway | 20.4.2018 |
| EU/2/17/221 | GALLIPRANT | Iceland | 17.1.2018 |
| EU/2/17/221 | GALLIPRANT | Liechtenstein | 28.2.2018 |
| EU/2/17/221 | GALLIPRANT | Norway | 24.1.2018 |
| EU/2/17/222 | Clevor | Iceland | 3.5.2018 |
| EU/2/17/222 | Clevor | Liechtenstein | 30.4.2018 |
| EU/2/17/222 | Clevor | Norway | 7.5.2018 |
| EU/2/17/223 | Suvaxyn Circo | Iceland | 12.4.2018 |
| EU/1/17/223 | Suvaxyn Circo | Liechtenstein | 28.2.2018 |
| EU/2/17/223 | Suvaxyn Circo | Norway | 13.2.2018 |
| EU/2/18/224 | Bravecto Plus | Iceland | 28.5.2018 |
| EU/2/18/224 | Bravecto Plus | Liechtenstein | 30.6.2018 |
| EU/2/18/224 | Bravecto Plus | Norway | 1.6.2018 |
| EU/2/18/225 | Dany’s BienenWohl | Iceland | 21.6.2018 |
| EU/2/18/225 | Dany’s BienenWohl | Liechtenstein | 30.6.2018 |
| EU/2/18/225 | Dany’s BienenWohl | Norway | 29.6.2018 |

EU-Number

Product

Country

Date of authorisation

EU/1/13/901

Sirturo

Liechtenstein

30.4.2018

EU/1/15/1047

Blincyto

Liechtenstein

30.6.2018

EU/1/17/1173

Lokelma

Iceland

26.3.2018

EU/1/17/1173

Lokelma

Liechtenstein

30.4.2018

EU/1/17/1173

Lokelma

Norway

16.4.2018

EU/1/17/1231

Ocrevus

Iceland

11.1.2018

EU/1/17/1231

Ocrevus

Liechtenstein

28.2.2018

EU/1/17/1231

Ocrevus

Norway

17.1.2018

EU/1/17/1234

Tremfya

Norway

18.1.2018

EU/1/17/1244

Tacforius

Iceland

5.1.2018

EU/1/17/1244

Tacforius

Norway

3.1.2018

EU/1/17/1245

Prevymis

Iceland

19.1.2018

EU/1/17/1245

PREVYMIS

Liechtenstein

28.2.2018

EU/1/17/1245

PREVYMIS

Norway

5.2.2018

EU/1/17/1246

Mvasi

Iceland

24.1.2018

EU/1/17/1246

Mvasi

Norway

30.1.2018

EU/1/17/1247

Adynovi

Iceland

11.1.2018

EU/1/17/1247

ADYNOVI

Liechtenstein

28.2.2018

EU/1/17/1247

ADYNOVI

Norway

19.1.2018

EU/1/17/1248

Darunavir Krka d.d.

Iceland

24.1.2018

EU/1/17/1248

Darunavir Krka d.d.

Norway

14.2.2018

EU/1/17/1249

Darunavir Krka

Iceland

26.1.2018

EU/1/17/1249

Darunavir Krka

Liechtenstein

28.2.2018

EU/1/17/1249

Darunavir Krka

Norway

14.2.2018

EU/1/17/1250

Rubraca

Iceland

5.6.2018

EU/1/17/1250

Rubraca

Liechtenstein

30.6.2018

EU/1/17/1250

Rubraca

Norway

31.5.2018

EU/1/17/1251

Ozempic

Iceland

15.2.2018

EU/1/17/1251

Ozempic

Liechtenstein

28.2.2018

EU/1/17/1251

Ozempic

Norway

14.2.2018

EU/1/17/1252

Fasenra

Iceland

11.1.2018

EU/1/17/1252

Fasenra

Liechtenstein

28.2.2018

EU/1/17/1252

Fasenra

Norway

16.1.2018

EU/1/17/1253

Fulvestrant Mylan

Iceland

12.2.2018

EU/1/17/1253

Fulvestrant Mylan

Liechtenstein

28.2.2018

EU/1/17/1253

Fulvestrant Mylan

Norway

29.5.2018

EU/1/17/1254

Jorveza

Iceland

15.1.2018

EU/1/17/1254

Jorveza

Liechtenstein

28.2.2018

EU/1/17/1254

Jorveza

Norway

19.1.2018

EU/1/17/1255

Intrarosa

Iceland

7.2.2018

EU/1/17/1255

Intrarosa

Liechtenstein

28.2.2018

EU/1/17/1256

Anagrelide Mylan

Iceland

26.2.2018

EU/1/17/1256

Anagrelid Mylan

Liechtenstein

28.2.2018

EU/1/17/1256

Anagrelide Mylan

Norway

27.2.2018

EU/1/17/1257

Herzuma

Iceland

15.2.2018

EU/1/17/1257

Herzuma

Liechtenstein

28.2.2018

EU/1/17/1257

Herzuma

Norway

14.2.2018

EU/1/17/1258

Lamzede

Iceland

11.4.2018

EU/1/17/1258

Lamzede

Liechtenstein

30.4.2018

EU/1/17/1258

Lamzede

Norway

16.4.2018

EU/1/17/1260

Alkindi

Iceland

15.2.2018

EU/1/17/1260

Alkindi

Liechtenstein

28.2.2018

EU/1/17/1260

Alkindi

Norway

2.3.2018

EU/1/17/1261

Alofisel

Iceland

10.4.2018

EU/1/17/1261

Alofisel

Liechtenstein

30.4.2018

EU/1/17/1261

Alofisel

Norway

9.4.2018

EU/1/17/1262

Crysvita

Iceland

26.2.2018

EU/1/17/1262

CRYSVITA

Liechtenstein

30.4.2018

EU/1/17/1262

CRYSVITA

Norway

9.4.2018

EU/1/17/1263

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

Iceland

15.2.2018

EU/1/17/1263

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

Liechtenstein

28.2.2018

EU/1/17/1263

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

Norway

14.2.2018

EU/1/18/1265

Segluromet

Iceland

10.4.2018

EU/1/18/1265

Segluromet

Liechtenstein

30.4.2018

EU/1/18/1265

Segluromet

Norway

9.4.2018

EU/1/18/1266

Steglujan

Iceland

11.4.2018

EU/1/18/1266

Steglujan

Liechtenstein

30.4.2018

EU/1/18/1266

Steglujan

Norway

7.4.2018

EU/1/18/1267

Steglatro

Iceland

10.4.2018

EU/1/18/1267

Steglatro

Liechtenstein

30.4.2018

EU/1/18/1267

Stegatro

Norway

9.4.2018

EU/1/18/1269

Alpivab

Iceland

11.5.2018

EU/1/18/1269

Alpivab

Liechtenstein

30.4.2018

EU/1/18/1269

Alpivab

Norway

26.6.2018

EU/1/18/1270

Semglee

Iceland

10.4.2018

EU/1/18/1270

Semglee

Liechtenstein

30.4.2018

EU/1/18/1270

Semglee

Norway

23.5.2018

EU/1/18/1271

Hemlibra

Iceland

2.3.2018

EU/1/18/1271

Hemlibra

Liechtenstein

28.2.2018

EU/1/18/1271

Hemlibra

Norway

8.3.2018

EU/1/18/1272

Shingrix

Iceland

26.3.2018

EU/1/18/1272

Shingrix

Liechtenstein

30.4.2018

EU/1/18/1272

Shingrix

Norway

5.4.2018

EU/1/18/1273

Prasugrel Mylan

Iceland

29.5.2018

EU/1/18/1273

Prasugrel Mylan

Liechtenstein

30.6.2018

EU/1/18/1274

Trydonis

Iceland

23.5.2018

EU/1/18/1274

Trydonis

Liechtenstein

30.6.2018

EU/1/18/1274

Trydonis

Norway

28.5.2018

EU/1/18/1275

Riarify

Iceland

23.5.2018

EU/1/18/1275

Riarify

Liechtenstein

30.6.2018

EU/1/18/1277

Mylotarg

Iceland

16.5.2018

EU/1/18/1277

Mylotarg

Liechtenstein

30.6.2018

EU/1/18/1277

Mylotarg

Norway

4.5.2018

EU/1/18/1279

AMGLIDIA

Iceland

5.6.2018

EU/1/18/1279

AMGLIDIA

Liechtenstein

30.6.2018

EU/1/18/1279

AMGLIDIA

Norway

26.6.2018

EU/1/18/1280

Zessly

Iceland

4.6.2018

EU/1/18/1280

Zessly

Liechtenstein

30.6.2018

EU/1/18/1280

Zessly

Norway

15.6.2018

EU/1/18/1281

Kanjinti

Iceland

29.5.2018

EU/1/18/1281

KANJINTI

Liechtenstein

30.6.2018

EU/1/18/1281

KANJINTI

Norway

24.5.2018

EU/1/18/1282

Juluca

Iceland

29.5.2018

EU/1/18/1282

Juluca

Liechtenstein

30.6.2018

EU/1/18/1282

Juluca

Norway

24.5.2018

EU/1/18/1283

Pemetrexed Krka

Iceland

30.5.2018

EU/1/18/1283

Pemetrexed Krka

Liechtenstein

30.6.2018

EU/1/18/1283

Pemetrexed Krka

Norway

31.5.2018

EU/1/18/1289

Biktarvy

Iceland

28.6.2018

EU/1/18/1289

Bictarvy

Liechtenstein

30.6.2018

EU/1/18/1289

Biktarvy

Norway

27.6.2018

EU/2/17/216

Oxybee

Iceland

26.3.2018

EU/2/17/216

Oxybee

Liechtenstein

30.4.2018

EU/2/17/216

Oxybee

Norway

20.4.2018

EU/2/17/219

Rabitec

Iceland

4.1.2018

EU/2/17/219

Rabitec

Liechtenstein

28.2.2018

EU/2/17/219

Rabitec

Norway

9.1.2018

EU/2/17/220

MiPet Easecto

Iceland

26.2.2018

EU/2/17/220

MiPet Easecto

Norway

20.4.2018

EU/2/17/221

GALLIPRANT

Iceland

17.1.2018

EU/2/17/221

GALLIPRANT

Liechtenstein

28.2.2018

EU/2/17/221

GALLIPRANT

Norway

24.1.2018

EU/2/17/222

Clevor

Iceland

3.5.2018

EU/2/17/222

Clevor

Liechtenstein

30.4.2018

EU/2/17/222

Clevor

Norway

7.5.2018

EU/2/17/223

Suvaxyn Circo

Iceland

12.4.2018

EU/1/17/223

Suvaxyn Circo

Liechtenstein

28.2.2018

EU/2/17/223

Suvaxyn Circo

Norway

13.2.2018

EU/2/18/224

Bravecto Plus

Iceland

28.5.2018

EU/2/18/224

Bravecto Plus

Liechtenstein

30.6.2018

EU/2/18/224

Bravecto Plus

Norway

1.6.2018

EU/2/18/225

Dany’s BienenWohl

Iceland

21.6.2018

EU/2/18/225

Dany’s BienenWohl

Liechtenstein

30.6.2018

EU/2/18/225

Dany’s BienenWohl

Norway

29.6.2018

---

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 2018:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/08/442 | Pradaxa | Iceland | 12.1.2018 |
| EU/1/08/442 | Pradaxa | Liechtenstein | 28.2.2018 |
| EU/1/08/442 | Pradaxa | Norway | 18.1.2018 |
| EU/1/08/443 | Thalidomide Celgene | Iceland | 14.2.2018 |
| EU/1/08/443 | Thalidomide Celgene | Liechtenstein | 28.2.2018 |
| EU/1/08/443 | Thalidomide Celgene | Norway | 6.3.2018 |
| EU/1/08/448 | Mycamine | Iceland | 26.2.2018 |
| EU/1/08/472 | Xarelto | Iceland | 30.5.2018 |
| EU/1/08/472 | Xarelto | Liechtenstein | 30.6.2018 |
| EU/1/08/472 | Xarelto | Norway | 21.6.2018 |
| EU/1/10/628 | Votrient | Iceland | 18.1.2018 |
| EU/1/10/628 | Votrient | Liechtenstein | 28.2.2018 |
| EU/1/10/628 | Votrient | Norway | 17.1.2018 |
| EU/1/11/749 | Caprelsa | Iceland | 15.2.2018 |
| EU/1/11/749 | Caprelsa | Liechtenstein | 28.2.2018 |
| EU/1/11/749 | Caprelsa | Norway | 15.2.2018 |
| EU/1/12/764 | Pixuvri | Iceland | 11.4.2018 |
| EU/1/12/764 | Pixuvri | Liechtenstein | 30.4.2018 |
| EU/1/12/764 | Pixuvri | Norway | 4.4.2018 |
| EU/1/13/813 | Perjeta | Norway | 3.1.2018 |
| EU/1/13/817 | Actelsar HCT | Iceland | 5.1.2018 |
| EU/1/13/817 | Actelsar HCT | Norway | 4.1.2018 |
| EU/1/13/818 | Bosulif | Iceland | 26.2.2018 |
| EU/1/13/818 | Bosulif | Liechtenstein | 28.2.2018 |
| EU/1/13/818 | Bosulif | Norway | 21.2.2018 |
| EU/1/13/820 | Marixino | Iceland | 24.1.2018 |
| EU/1/13/820 | Marixino | Liechtenstein | 28.2.2018 |
| EU/1/13/820 | Marixino | Norway | 14.2.2018 |
| EU/1/13/821 | Tolucombi | Iceland | 29.1.2018 |
| EU/1/13/821 | Tolucombi | Norway | 20.3.2018 |
| EU/1/13/822 | PHEBURANE | Iceland | 10.4.2018 |
| EU/1/13/822 | PHEBURANE | Liechtenstein | 30.4.2018 |
| EU/1/13/822 | PHEBURANE | Norway | 16.4.2018 |
| EU/1/13/823 | Adasuve | Iceland | 24.1.2018 |
| EU/1/13/823 | Adasuve | Norway | 16.3.2018 |
| EU/1/13/824 | Nemdatine | Iceland | 29.1.2018 |
| EU/1/13/825 | Imatinib Actavis | Iceland | 12.1.2018 |
| EU/1/13/825 | Imatinib Actavis | Liechtenstein | 28.2.2018 |
| EU/1/13/825 | Imatinib Actavis | Norway | 12.1.2018 |
| EU/1/13/826 | Memantine LEK | Iceland | 29.1.2018 |
| EU/1/13/827 | Memantine Mylan | Iceland | 29.1.2018 |
| EU/1/13/828 | Hexacima | Iceland | 29.1.2018 |
| EU/1/13/829 | Hexyon | Iceland | 29.1.2018 |
| EU/1/13/829 | Hexyon | Liechtenstein | 30.6.2018 |
| EU/1/13/829 | Hexyon | Norway | 12.2.2018 |
| EU/1/13/830 | Stribild | Iceland | 16.5.2018 |
| EU/1/13/830 | Stribild | Norway | 7.5.2018 |
| EU/1/13/832 | Stayveer | Iceland | 24.1.2018 |
| EU/1/13/832 | Stayveer | Liechtenstein | 28.2.2018 |
| EU/1/13/832 | Stayveer | Norway | 24.1.2018 |
| EU/1/13/835 | Voriconazole Accord | Iceland | 14.2.2018 |
| EU/1/13/835 | Voriconazol Accord | Liechtenstein | 28.2.2018 |
| EU/1/13/835 | Voriconazole Accord | Norway | 2.3.2018 |
| EU/1/13/836 | Memantine ratiopharm | Iceland | 3.5.2018 |
| EU/1/13/836 | Memantin ratiopharm | Liechtenstein | 30.4.2018 |
| EU/1/13/836 | Memantine ratiopharm | Norway | 7.5.2018 |
| EU/1/13/838 | AUBAGIO | Iceland | 15.6.2018 |
| EU/1/13/838 | AUBAGIO | Liechtenstein | 30.6.2018 |
| EU/1/13/838 | AUBAGIO | Norway | 21.6.2018 |
| EU/1/13/839 | Iclusig | Iceland | 23.2.2018 |
| EU/1/13/839 | Iclusig | Liechtenstein | 28.2.2018 |
| EU/1/13/839 | Iclusig | Norway | 20.2.2018 |
| EU/1/13/840 | HyQvia | Iceland | 18.1.2018 |
| EU/1/13/840 | HyQvia | Liechtenstein | 28.2.2018 |
| EU/1/13/840 | HyQvia | Norway | 16.1.2018 |
| EU/1/13/841 | Spedra | Iceland | 22.5.2018 |
| EU/1/13/841 | Spedra | Liechtenstein | 30.6.2018 |
| EU/1/13/841 | Spedra | Norway | 15.5.2018 |
| EU/1/13/842 | Incresync | Iceland | 15.6.2018 |
| EU/1/13/842 | Incresync | Liechtenstein | 30.6.2018 |
| EU/1/13/843 | Vipdomet | Iceland | 15.6.2018 |
| EU/1/13/843 | Vipdomet | Liechtenstein | 30.6.2018 |
| EU/1/13/844 | Vipidia | Iceland | 15.6.2018 |
| EU/1/13/844 | Vipidia | Liechtenstein | 30.6.2018 |
| EU/1/13/844 | Vipidia | Norway | 26.6.2018 |
| EU/1/13/845 | Imatinib Accord | Iceland | 16.5.2018 |
| EU/1/13/845 | Imatinib Accord | Liechtenstein | 30.6.2018 |
| EU/1/13/845 | Imatinib Accord | Norway | 4.5.2018 |
| EU/1/13/846 | Xtandi | Iceland | 23.2.2018 |
| EU/1/13/846 | Xtandi | Liechtenstein | 28.2.2018 |
| EU/1/13/846 | Xtandi | Norway | 2.3.2018 |
| EU/1/13/851 | Lojuxta | Iceland | 22.5.2018 |
| EU/1/13/851 | Lojuxta | Liechtenstein | 30.6.2018 |
| EU/1/13/851 | Lojuxta | Norway | 23.5.2018 |
| EU/1/13/852 | Atosiban SUN | Iceland | 15.6.2018 |
| EU/1/13/852 | Atosiban SUN | Liechtenstein | 30.6.2018 |
| EU/1/13/852 | Atosiban SUN | Norway | 25.6.2018 |
| EU/1/13/853 | Remsima | Iceland | 29.6.2018 |
| EU/1/13/853 | Remsima | Liechtenstein | 30.6.2018 |
| EU/1/13/854 | Inflectra | Iceland | 28.6.2018 |
| EU/1/13/854 | Inflectra | Liechtenstein | 30.6.2018 |
| EU/1/13/855 | IMVANEX | Iceland | 22.5.2018 |
| EU/1/13/855 | Imvanex | Liechtenstein | 30.6.2018 |
| EU/1/13/855 | Imvanex | Norway | 15.5.2018 |
| EU/1/13/856 | Lonquex | Iceland | 25.5.2018 |
| EU/1/13/856 | Lonquex | Liechtenstein | 30.6.2018 |
| EU/1/13/856 | Lonquex | Norway | 25.5.2018 |
| EU/1/13/857 | Voncento | Iceland | 23.5.2018 |
| EU/1/13/857 | Voncento | Liechtenstein | 30.6.2018 |
| EU/1/13/857 | Voncento | Norway | 23.5.2018 |
| EU/1/13/858 | Stivarga | Iceland | 30.5.2018 |
| EU/1/13/858 | Stivarga | Liechtenstein | 30.6.2018 |
| EU/1/13/858 | Stivarga | Norway | 31.5.2018 |
| EU/1/13/862 | Ultibro Breezhaler | Iceland | 30.5.2018 |
| EU/1/13/862 | Ultibro Breezhaler | Liechtenstein | 30.6.2018 |
| EU/1/13/862 | Ultibro Breezhaler | Norway | 21.6.2018 |
| EU/1/13/863 | Xoterna Breezhaler | Iceland | 30.5.2018 |
| EU/1/13/863 | Xoterna Breezhaler | Liechtenstein | 30.6.2018 |
| EU/1/13/863 | Xoterna Breezhaler | Norway | 21.6.2018 |
| EU/1/13/865 | Tafinlar | Iceland | 28.5.2018 |
| EU/1/13/865 | Tafinlar | Liechtenstein | 30.6.2018 |
| EU/1/13/865 | Tafinlar | Norway | 18.5.2018 |
| EU/1/13/866 | Cholib | Iceland | 15.6.2018 |
| EU/1/13/866 | Cholib | Liechtenstein | 30.6.2018 |
| EU/1/13/866 | Cholib | Norway | 16.5.2018 |
| EU/1/13/871 | Ovaleap | Iceland | 29.5.2018 |
| EU/1/13/871 | Ovaleap | Liechtenstein | 30.6.2018 |
| EU/1/13/871 | Ovaleap | Norway | 16.5.2018 |
| EU/1/13/873 | Xofigo | Iceland | 29.6.2018 |
| EU/1/13/873 | Xofigo | Liechtenstein | 30.6.2018 |
| EU/1/13/875 | Deltyba | Iceland | 16.5.2018 |
| EU/1/13/875 | Deltyba | Liechtenstein | 30.6.2018 |
| EU/1/13/875 | Deltyba | Norway | 16.5.2018 |
| EU/1/13/876 | Imatinib medac | Iceland | 16.5.2018 |
| EU/1/13/876 | Imatinib Medac | Liechtenstein | 30.6.2018 |
| EU/1/13/876 | Imatinib medac | Norway | 4.5.2018 |
| EU/1/13/879 | Giotrif | Iceland | 29.5.2018 |
| EU/1/13/879 | Giotrif | Liechtenstein | 30.6.2018 |
| EU/1/13/879 | Giotrif | Norway | 24.5.2018 |
| EU/1/13/890 | Cometriq | Iceland | 18.1.2018 |
| EU/1/13/890 | Cometriq | Liechtenstein | 30.4.2018 |
| EU/1/13/890 | Cometriq | Norway | 17.1.2018 |
| EU/1/13/901 | Sirturo | Iceland | 14.3.2018 |
| EU/1/13/901 | Sirturo | Norway | 22.3.2018 |
| EU/1/14/987 | Holoclar | Norway | 4.1.2018 |
| EU/1/15/1047 | Blincyto | Iceland | 16.5.2018 |
| EU/1/15/1047 | Blincyto | Norway | 26.6.2018 |
| EU/1/15/1078 | Natpar | Iceland | 16.5.2018 |
| EU/1/15/1078 | Natpar | Liechtenstein | 30.6.2018 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 AstraZeneca | Iceland | 12.4.2018 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 Astra Zeneca | Liechtenstein | 30.4.2018 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 | Norway | 10.4.2018 |
| EU/2/12/145 | Kexxtone | Iceland | 4.1.2018 |
| EU/2/12/146 | Semintra | Iceland | 22.1.2018 |
| EU/2/12/146 | Semintra | Liechtenstein | 28.2.2018 |
| EU/2/12/146 | Semintra | Norway | 30.1.2018 |
| EU/2/13/148 | Meloxidolor | Iceland | 16.5.2018 |
| EU/2/13/148 | Meloxidolor | Liechtenstein | 30.6.2018 |
| EU/2/13/148 | Meloxidolor | Norway | 16.5.2018 |
| EU/2/13/149 | ECOPORC SHIGA | Iceland | 13.4.2018 |
| EU/2/13/149 | ECOPORC SHIGA | Liechtenstein | 30.4.2018 |
| EU/2/13/149 | ECOPORC SHIGA | Norway | 20.4.2018 |
| EU/2/13/150 | Oncept IL-2 | Iceland | 26.3.2018 |
| EU/2/13/150 | Oncept IL-2 | Liechtenstein | 30.4.2018 |
| EU/2/13/150 | Oncept IL-2 | Norway | 19.4.2018 |
| EU/2/13/151 | Equilis West Nile | Iceland | 15.5.2018 |
| EU/2/13/151 | Equilis West Nile | Liechtenstein | 30.4.2018 |
| EU/2/13/151 | Equilis West Nile | Norway | 7.5.2018 |
| EU/2/13/152 | ProZinc | Iceland | 3.5.2018 |
| EU/2/13/152 | ProZinc | Liechtenstein | 30.4.2018 |
| EU/2/13/152 | ProZinc | Norway | 7.5.2018 |
| EU/2/13/153 | Aftovaxpur Doe | Iceland | 21.6.2018 |
| EU/2/13/153 | Aftovaxpur Doe | Liechtenstein | 30.6.2018 |
| EU/2/13/153 | Aftovaxpur Doe | Norway | 28.6.2018 |

EU-Number

Product

Country

Date of authorisation

EU/1/08/442

Pradaxa

Iceland

12.1.2018

EU/1/08/442

Pradaxa

Liechtenstein

28.2.2018

EU/1/08/442

Pradaxa

Norway

18.1.2018

EU/1/08/443

Thalidomide Celgene

Iceland

14.2.2018

EU/1/08/443

Thalidomide Celgene

Liechtenstein

28.2.2018

EU/1/08/443

Thalidomide Celgene

Norway

6.3.2018

EU/1/08/448

Mycamine

Iceland

26.2.2018

EU/1/08/472

Xarelto

Iceland

30.5.2018

EU/1/08/472

Xarelto

Liechtenstein

30.6.2018

EU/1/08/472

Xarelto

Norway

21.6.2018

EU/1/10/628

Votrient

Iceland

18.1.2018

EU/1/10/628

Votrient

Liechtenstein

28.2.2018

EU/1/10/628

Votrient

Norway

17.1.2018

EU/1/11/749

Caprelsa

Iceland

15.2.2018

EU/1/11/749

Caprelsa

Liechtenstein

28.2.2018

EU/1/11/749

Caprelsa

Norway

15.2.2018

EU/1/12/764

Pixuvri

Iceland

11.4.2018

EU/1/12/764

Pixuvri

Liechtenstein

30.4.2018

EU/1/12/764

Pixuvri

Norway

4.4.2018

EU/1/13/813

Perjeta

Norway

3.1.2018

EU/1/13/817

Actelsar HCT

Iceland

5.1.2018

EU/1/13/817

Actelsar HCT

Norway

4.1.2018

EU/1/13/818

Bosulif

Iceland

26.2.2018

EU/1/13/818

Bosulif

Liechtenstein

28.2.2018

EU/1/13/818

Bosulif

Norway

21.2.2018

EU/1/13/820

Marixino

Iceland

24.1.2018

EU/1/13/820

Marixino

Liechtenstein

28.2.2018

EU/1/13/820

Marixino

Norway

14.2.2018

EU/1/13/821

Tolucombi

Iceland

29.1.2018

EU/1/13/821

Tolucombi

Norway

20.3.2018

EU/1/13/822

PHEBURANE

Iceland

10.4.2018

EU/1/13/822

PHEBURANE

Liechtenstein

30.4.2018

EU/1/13/822

PHEBURANE

Norway

16.4.2018

EU/1/13/823

Adasuve

Iceland

24.1.2018

EU/1/13/823

Adasuve

Norway

16.3.2018

EU/1/13/824

Nemdatine

Iceland

29.1.2018

EU/1/13/825

Imatinib Actavis

Iceland

12.1.2018

EU/1/13/825

Imatinib Actavis

Liechtenstein

28.2.2018

EU/1/13/825

Imatinib Actavis

Norway

12.1.2018

EU/1/13/826

Memantine LEK

Iceland

29.1.2018

EU/1/13/827

Memantine Mylan

Iceland

29.1.2018

EU/1/13/828

Hexacima

Iceland

29.1.2018

EU/1/13/829

Hexyon

Iceland

29.1.2018

EU/1/13/829

Hexyon

Liechtenstein

30.6.2018

EU/1/13/829

Hexyon

Norway

12.2.2018

EU/1/13/830

Stribild

Iceland

16.5.2018

EU/1/13/830

Stribild

Norway

7.5.2018

EU/1/13/832

Stayveer

Iceland

24.1.2018

EU/1/13/832

Stayveer

Liechtenstein

28.2.2018

EU/1/13/832

Stayveer

Norway

24.1.2018

EU/1/13/835

Voriconazole Accord

Iceland

14.2.2018

EU/1/13/835

Voriconazol Accord

Liechtenstein

28.2.2018

EU/1/13/835

Voriconazole Accord

Norway

2.3.2018

EU/1/13/836

Memantine ratiopharm

Iceland

3.5.2018

EU/1/13/836

Memantin ratiopharm

Liechtenstein

30.4.2018

EU/1/13/836

Memantine ratiopharm

Norway

7.5.2018

EU/1/13/838

AUBAGIO

Iceland

15.6.2018

EU/1/13/838

AUBAGIO

Liechtenstein

30.6.2018

EU/1/13/838

AUBAGIO

Norway

21.6.2018

EU/1/13/839

Iclusig

Iceland

23.2.2018

EU/1/13/839

Iclusig

Liechtenstein

28.2.2018

EU/1/13/839

Iclusig

Norway

20.2.2018

EU/1/13/840

HyQvia

Iceland

18.1.2018

EU/1/13/840

HyQvia

Liechtenstein

28.2.2018

EU/1/13/840

HyQvia

Norway

16.1.2018

EU/1/13/841

Spedra

Iceland

22.5.2018

EU/1/13/841

Spedra

Liechtenstein

30.6.2018

EU/1/13/841

Spedra

Norway

15.5.2018

EU/1/13/842

Incresync

Iceland

15.6.2018

EU/1/13/842

Incresync

Liechtenstein

30.6.2018

EU/1/13/843

Vipdomet

Iceland

15.6.2018

EU/1/13/843

Vipdomet

Liechtenstein

30.6.2018

EU/1/13/844

Vipidia

Iceland

15.6.2018

EU/1/13/844

Vipidia

Liechtenstein

30.6.2018

EU/1/13/844

Vipidia

Norway

26.6.2018

EU/1/13/845

Imatinib Accord

Iceland

16.5.2018

EU/1/13/845

Imatinib Accord

Liechtenstein

30.6.2018

EU/1/13/845

Imatinib Accord

Norway

4.5.2018

EU/1/13/846

Xtandi

Iceland

23.2.2018

EU/1/13/846

Xtandi

Liechtenstein

28.2.2018

EU/1/13/846

Xtandi

Norway

2.3.2018

EU/1/13/851

Lojuxta

Iceland

22.5.2018

EU/1/13/851

Lojuxta

Liechtenstein

30.6.2018

EU/1/13/851

Lojuxta

Norway

23.5.2018

EU/1/13/852

Atosiban SUN

Iceland

15.6.2018

EU/1/13/852

Atosiban SUN

Liechtenstein

30.6.2018

EU/1/13/852

Atosiban SUN

Norway

25.6.2018

EU/1/13/853

Remsima

Iceland

29.6.2018

EU/1/13/853

Remsima

Liechtenstein

30.6.2018

EU/1/13/854

Inflectra

Iceland

28.6.2018

EU/1/13/854

Inflectra

Liechtenstein

30.6.2018

EU/1/13/855

IMVANEX

Iceland

22.5.2018

EU/1/13/855

Imvanex

Liechtenstein

30.6.2018

EU/1/13/855

Imvanex

Norway

15.5.2018

EU/1/13/856

Lonquex

Iceland

25.5.2018

EU/1/13/856

Lonquex

Liechtenstein

30.6.2018

EU/1/13/856

Lonquex

Norway

25.5.2018

EU/1/13/857

Voncento

Iceland

23.5.2018

EU/1/13/857

Voncento

Liechtenstein

30.6.2018

EU/1/13/857

Voncento

Norway

23.5.2018

EU/1/13/858

Stivarga

Iceland

30.5.2018

EU/1/13/858

Stivarga

Liechtenstein

30.6.2018

EU/1/13/858

Stivarga

Norway

31.5.2018

EU/1/13/862

Ultibro Breezhaler

Iceland

30.5.2018

EU/1/13/862

Ultibro Breezhaler

Liechtenstein

30.6.2018

EU/1/13/862

Ultibro Breezhaler

Norway

21.6.2018

EU/1/13/863

Xoterna Breezhaler

Iceland

30.5.2018

EU/1/13/863

Xoterna Breezhaler

Liechtenstein

30.6.2018

EU/1/13/863

Xoterna Breezhaler

Norway

21.6.2018

EU/1/13/865

Tafinlar

Iceland

28.5.2018

EU/1/13/865

Tafinlar

Liechtenstein

30.6.2018

EU/1/13/865

Tafinlar

Norway

18.5.2018

EU/1/13/866

Cholib

Iceland

15.6.2018

EU/1/13/866

Cholib

Liechtenstein

30.6.2018

EU/1/13/866

Cholib

Norway

16.5.2018

EU/1/13/871

Ovaleap

Iceland

29.5.2018

EU/1/13/871

Ovaleap

Liechtenstein

30.6.2018

EU/1/13/871

Ovaleap

Norway

16.5.2018

EU/1/13/873

Xofigo

Iceland

29.6.2018

EU/1/13/873

Xofigo

Liechtenstein

30.6.2018

EU/1/13/875

Deltyba

Iceland

16.5.2018

EU/1/13/875

Deltyba

Liechtenstein

30.6.2018

EU/1/13/875

Deltyba

Norway

16.5.2018

EU/1/13/876

Imatinib medac

Iceland

16.5.2018

EU/1/13/876

Imatinib Medac

Liechtenstein

30.6.2018

EU/1/13/876

Imatinib medac

Norway

4.5.2018

EU/1/13/879

Giotrif

Iceland

29.5.2018

EU/1/13/879

Giotrif

Liechtenstein

30.6.2018

EU/1/13/879

Giotrif

Norway

24.5.2018

EU/1/13/890

Cometriq

Iceland

18.1.2018

EU/1/13/890

Cometriq

Liechtenstein

30.4.2018

EU/1/13/890

Cometriq

Norway

17.1.2018

EU/1/13/901

Sirturo

Iceland

14.3.2018

EU/1/13/901

Sirturo

Norway

22.3.2018

EU/1/14/987

Holoclar

Norway

4.1.2018

EU/1/15/1047

Blincyto

Iceland

16.5.2018

EU/1/15/1047

Blincyto

Norway

26.6.2018

EU/1/15/1078

Natpar

Iceland

16.5.2018

EU/1/15/1078

Natpar

Liechtenstein

30.6.2018

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Iceland

12.4.2018

EU/1/16/1089

Pandemic influenza vaccine H5N1 Astra Zeneca

Liechtenstein

30.4.2018

EU/1/16/1089

Pandemic influenza vaccine H5N1

Norway

10.4.2018

EU/2/12/145

Kexxtone

Iceland

4.1.2018

EU/2/12/146

Semintra

Iceland

22.1.2018

EU/2/12/146

Semintra

Liechtenstein

28.2.2018

EU/2/12/146

Semintra

Norway

30.1.2018

EU/2/13/148

Meloxidolor

Iceland

16.5.2018

EU/2/13/148

Meloxidolor

Liechtenstein

30.6.2018

EU/2/13/148

Meloxidolor

Norway

16.5.2018

EU/2/13/149

ECOPORC SHIGA

Iceland

13.4.2018

EU/2/13/149

ECOPORC SHIGA

Liechtenstein

30.4.2018

EU/2/13/149

ECOPORC SHIGA

Norway

20.4.2018

EU/2/13/150

Oncept IL-2

Iceland

26.3.2018

EU/2/13/150

Oncept IL-2

Liechtenstein

30.4.2018

EU/2/13/150

Oncept IL-2

Norway

19.4.2018

EU/2/13/151

Equilis West Nile

Iceland

15.5.2018

EU/2/13/151

Equilis West Nile

Liechtenstein

30.4.2018

EU/2/13/151

Equilis West Nile

Norway

7.5.2018

EU/2/13/152

ProZinc

Iceland

3.5.2018

EU/2/13/152

ProZinc

Liechtenstein

30.4.2018

EU/2/13/152

ProZinc

Norway

7.5.2018

EU/2/13/153

Aftovaxpur Doe

Iceland

21.6.2018

EU/2/13/153

Aftovaxpur Doe

Liechtenstein

30.6.2018

EU/2/13/153

Aftovaxpur Doe

Norway

28.6.2018

---

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 2018:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/10/636/008 | Daxas | Iceland | 22.5.2018 |
| EU/1/10/636/008 | Daxas | Norway | 23.4.2018 |
| EU/1/11/700/003-007 | Benlysta | Iceland | 10.1.2018 |
| EU/1/11/700/003-007 | Benlysta | Norway | 22.1.2018 |
| EU/1/11/710/016 | Votubia | Iceland | 18.6.2018 |
| EU/1/11/710/016 | Votubia | Norway | 8.6.2018 |
| EU/1/13/818/006-007 | Bosulif | Iceland | 30.5.2018 |
| EU/1/13/818/006-007 | Bosulif | Norway | 29.5.2018 |
| EU/1/14/936/005-007 | Nuwiq | Iceland | 11.4.2018 |
| EU/1/14/936/005-007 | Nuwiq | Norway | 20.4.2018 |
| EU/1/14/945/003-006 | IMBRUVICA | Norway | 29.6.2018 |
| EU/1/14/959/002-005 | Lynparza | Iceland | 24.5.2018 |
| EU/1/14/959/002-005 | Lynparza | Norway | 8.5.2018 |
| EU/1/15/1019/002 | Bortezomib Accord | Iceland | 18.6.2018 |
| EU/1/15/1019/002 | Bortezomib Accord | Norway | 14.6.2018 |
| EU/1/15/1059/005 | Orkambi | Iceland | 18.1.2018 |
| EU/1/15/1059/005 | Orkambi | Norway | 17.1.2018 |
| EU/1/15/1070/002 | Oncaspar | Norway | 3.1.2018 |
| EU/2/12/146/003 | Semintra | Iceland | 25.5.2018 |
| EU/2/12/146/003 | Semintra | Norway | 24.5.2018 |

EU-Number

Product

Country

Date of authorisation

EU/1/10/636/008

Daxas

Iceland

22.5.2018

EU/1/10/636/008

Daxas

Norway

23.4.2018

EU/1/11/700/003-007

Benlysta

Iceland

10.1.2018

EU/1/11/700/003-007

Benlysta

Norway

22.1.2018

EU/1/11/710/016

Votubia

Iceland

18.6.2018

EU/1/11/710/016

Votubia

Norway

8.6.2018

EU/1/13/818/006-007

Bosulif

Iceland

30.5.2018

EU/1/13/818/006-007

Bosulif

Norway

29.5.2018

EU/1/14/936/005-007

Nuwiq

Iceland

11.4.2018

EU/1/14/936/005-007

Nuwiq

Norway

20.4.2018

EU/1/14/945/003-006

IMBRUVICA

Norway

29.6.2018

EU/1/14/959/002-005

Lynparza

Iceland

24.5.2018

EU/1/14/959/002-005

Lynparza

Norway

8.5.2018

EU/1/15/1019/002

Bortezomib Accord

Iceland

18.6.2018

EU/1/15/1019/002

Bortezomib Accord

Norway

14.6.2018

EU/1/15/1059/005

Orkambi

Iceland

18.1.2018

EU/1/15/1059/005

Orkambi

Norway

17.1.2018

EU/1/15/1070/002

Oncaspar

Norway

3.1.2018

EU/2/12/146/003

Semintra

Iceland

25.5.2018

EU/2/12/146/003

Semintra

Norway

24.5.2018

---

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 2018:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/04/289 | Angiox | Liechtenstein | 30.6.2018 |
| EU/1/06/368 | Insulin Human Winthrop | Iceland | 17.1.2018 |
| EU/1/06/368 | Insulin Human Winthrop | Liechtenstein | 30.4.2018 |
| EU/1/06/368 | Insulin Human Winthrop | Norway | 22.1.2018 |
| EU/1/07/394 | Optaflu | Iceland | 12.2.2018 |
| EU/1/08/507 | Idflu | Iceland | 11.4.2018 |
| EU/1/08/507 | IDflu | Liechtenstein | 30.4.2018 |
| EU/1/08/507 | IDflu | Norway | 5.4.2018 |
| EU/1/11/705 | Vibativ | Iceland | 11.4.2018 |
| EU/1/11/705 | Vibativ | Norway | 6.4.2018 |
| EU/1/11/666 | Libertek | Iceland | 17.1.2018 |
| EU/1/11/666 | Libertek | Liechtenstein | 28.2.2018 |
| EU/1/11/666 | Libertek | Norway | 22.1.2018 |
| EU/1/11/668 | Daliresp | Iceland | 17.1.2018 |
| EU/1/11/668 | Daliresp | Liechtenstein | 28.2.2018 |
| EU/1/11/668 | Daliresp | Norway | 22.1.2018 |
| EU/1/12/772 | Zoledronic acid Teva Pharma | Iceland | 7.2.2018 |
| EU/1/12/772 | Zoledronsäure Teva Pharma | Liechtenstein | 28.2.2018 |
| EU/1/12/722 | Zoledronic acid Teva Pharma | Norway | 7.2.2018 |
| EU/1/14/924 | Olysio | Iceland | 1.5.2018 |
| EU/1/14/924 | Olysio | Norway | 1.5.2018 |
| EU/1/14/985 | Raplixa | Iceland | 11.4.2018 |
| EU/1/14/985 | Raplixa | Norway | 12.4.2018 |
| EU/1/16/1107 | Zinbryta | Iceland | 25.4.2018 |
| EU/1/16/1107 | Zinbryta | Liechtenstein | 30.4.2018 |
| EU/1/16/1107 | Zinbryta | Norway | 19.4.2018 |
| EU/1/17/1243 | Imatinib Teva B.V. | Iceland | 24.5.2018 |
| EU/1/17/1243 | Imatinib Teva B.V. | Norway | 8.5.2018 |
| EU/1/97/032 | LeukoScan | Iceland | 9.2.2018 |
| EU/1/97/032 | LeukoScan | Liechtenstein | 28.2.2018 |
| EU/1/97/032 | LeukoScan | Norway | 21.2.2018 |
| EU/2/07/077 | Meloxivet | Iceland | 15.6.2018 |
| EU/2/07/077 | Meloxivet | Liechtenstein | 30.6.2018 |
| EU/2/07/077 | Meloxivet | Norway | 25.5.2018 |
| EU/2/09/094 | BTVPUR AISap 8 | Iceland | 24.5.2018 |
| EU/2/09/094 | BTVPUR AlSap 8 | Norway | 6.6.2018 |
| EU/2/10/112 | BTVPUR ALSap 1 | Iceland | 24.5.2018 |
| EU/2/10/112 | BTVPUR AlSap 1 | Norway | 6.6.2018 |
| EU/2/11/125 | Certifect | Iceland | 23.5.2018 |
| EU/2/11/125 | CERTIFECT | Liechtenstein | 30.6.2018 |
| EU/2/11/125 | CERTIFECT | Norway | 22.6.2018 |

EU-Number

Product

Country

Date of withdrawal

EU/1/04/289

Angiox

Liechtenstein

30.6.2018

EU/1/06/368

Insulin Human Winthrop

Iceland

17.1.2018

EU/1/06/368

Insulin Human Winthrop

Liechtenstein

30.4.2018

EU/1/06/368

Insulin Human Winthrop

Norway

22.1.2018

EU/1/07/394

Optaflu

Iceland

12.2.2018

EU/1/08/507

Idflu

Iceland

11.4.2018

EU/1/08/507

IDflu

Liechtenstein

30.4.2018

EU/1/08/507

IDflu

Norway

5.4.2018

EU/1/11/705

Vibativ

Iceland

11.4.2018

EU/1/11/705

Vibativ

Norway

6.4.2018

EU/1/11/666

Libertek

Iceland

17.1.2018

EU/1/11/666

Libertek

Liechtenstein

28.2.2018

EU/1/11/666

Libertek

Norway

22.1.2018

EU/1/11/668

Daliresp

Iceland

17.1.2018

EU/1/11/668

Daliresp

Liechtenstein

28.2.2018

EU/1/11/668

Daliresp

Norway

22.1.2018

EU/1/12/772

Zoledronic acid Teva Pharma

Iceland

7.2.2018

EU/1/12/772

Zoledronsäure Teva Pharma

Liechtenstein

28.2.2018

EU/1/12/722

Zoledronic acid Teva Pharma

Norway

7.2.2018

EU/1/14/924

Olysio

Iceland

1.5.2018

EU/1/14/924

Olysio

Norway

1.5.2018

EU/1/14/985

Raplixa

Iceland

11.4.2018

EU/1/14/985

Raplixa

Norway

12.4.2018

EU/1/16/1107

Zinbryta

Iceland

25.4.2018

EU/1/16/1107

Zinbryta

Liechtenstein

30.4.2018

EU/1/16/1107

Zinbryta

Norway

19.4.2018

EU/1/17/1243

Imatinib Teva B.V.

Iceland

24.5.2018

EU/1/17/1243

Imatinib Teva B.V.

Norway

8.5.2018

EU/1/97/032

LeukoScan

Iceland

9.2.2018

EU/1/97/032

LeukoScan

Liechtenstein

28.2.2018

EU/1/97/032

LeukoScan

Norway

21.2.2018

EU/2/07/077

Meloxivet

Iceland

15.6.2018

EU/2/07/077

Meloxivet

Liechtenstein

30.6.2018

EU/2/07/077

Meloxivet

Norway

25.5.2018

EU/2/09/094

BTVPUR AISap 8

Iceland

24.5.2018

EU/2/09/094

BTVPUR AlSap 8

Norway

6.6.2018

EU/2/10/112

BTVPUR ALSap 1

Iceland

24.5.2018

EU/2/10/112

BTVPUR AlSap 1

Norway

6.6.2018

EU/2/11/125

Certifect

Iceland

23.5.2018

EU/2/11/125

CERTIFECT

Liechtenstein

30.6.2018

EU/2/11/125

CERTIFECT

Norway

22.6.2018

---

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 2018:

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

EU-Number

Product

Country

Date of suspension

---