# C_2020123EN.01000601.xml

| 16.4.2020 | EN | Official Journal of the European Union | C 123/6 |
| --- | --- | --- | --- |

16.4.2020

EN

Official Journal of the European Union

C 123/6

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Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2018

(2020/C 123/06)

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 July – 31 December 2018, at their meeting on 29 March 2019:

| 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| Annex IV | List of withdrawn marketing authorisations |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List of withdrawn marketing authorisations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 July–31 December 2018:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/13/859 | Corbilta | Liechtenstein | 31.8.2018 |
| EU/1/16/1115 | Pemetrexed Fresenius Kabi | Liechtenstein | 31.8.2018 |
| EU/1/16/1138 | Venclyxto (without conditions) | Liechtenstein | 31.12.2018 |
| EU/1/17/1219 | Verkazia | Iceland | 25.7.2018 |
| EU/1/17/1219 | Verkazia | Norway | 18.9.2018 |
| EU/1/17/1234 | Tremfya | Liechtenstein | 31.8.2018 |
| EU/1/17/1246 | Mvasi | Liechtenstein | 31.8.2018 |
| EU/1/17/1255 | Intrarosa | Norway | 21.8.2018 |
| EU/1/18/1264 | Alunbrig | Iceland | 6.12.2018 |
| EU/1/18/1264 | Alunbrig | Norway | 18.12.2018 |
| EU/1/18/1264 | Alunbrig | Liechtenstein | 31.12.2018 |
| EU/1/18/1273 | Prasugrel Mylan | Norway | 3.7.2018 |
| EU/1/18/1275 | Riarify | Norway | 17.8.2018 |
| EU/1/18/1276 | Myalepta | Iceland | 21.8.2018 |
| EU/1/18/1276 | Myalepta | Norway | 17.8.2018 |
| EU/1/18/1276 | Myalepta | Liechtenstein | 31.8.2018 |
| EU/1/18/1278 | Carmustine Obvius | Liechtenstein | 31.10.2018 |
| EU/1/18/1278 | Carmustine Obvius | Iceland | 17.8.2018 |
| EU/1/18/1278 | Carmustine Obvius | Norway | 9.8.2018 |
| EU/1/18/1284 | Dzuveo | Iceland | 2.7.2018 |
| EU/1/18/1286 | Hyrimoz | Iceland | 16.8.2018 |
| EU/1/18/1286 | Hyrimoz | Norway | 7.8.2018 |
| EU/1/18/1286 | Hyrimoz | Liechtenstein | 31.8.2018 |
| EU/1/18/1287 | Hefiya | Iceland | 20.8.2018 |
| EU/1/18/1287 | Hefiya | Norway | 7.8.2018 |
| EU/1/18/1287 | Hefiya | Liechtenstein | 31.8.2018 |
| EU/1/18/1288 | Halimatoz | Iceland | 20.8.2018 |
| EU/1/18/1288 | Halimatoz | Norway | 7.8.2018 |
| EU/1/18/1288 | Halimatoz | Liechtenstein | 31.8.2018 |
| EU/1/18/1290 | Nityr | Iceland | 28.8.2018 |
| EU/1/18/1290 | Nityr | Norway | 17.8.2018 |
| EU/1/18/1292 | Apealea | Iceland | 30.11.2018 |
| EU/1/18/1292 | Apealea | Liechtenstein | 31.12.2018 |
| EU/1/18/1293 | Aimovig | Iceland | 16.8.2018 |
| EU/1/18/1293 | Aimovig | Norway | 7.8.2018 |
| EU/1/18/1293 | Aimovig | Liechtenstein | 31.8.2018 |
| EU/1/18/1294 | Rxulti | Iceland | 21.8.2018 |
| EU/1/18/1294 | Rxulti | Norway | 21.8.2018 |
| EU/1/18/1294 | Rxulti | Liechtenstein | 31.8.2018 |
| EU/1/18/1295 | Trazimera | Iceland | 21.8.2018 |
| EU/1/18/1295 | Trazimera | Norway | 7.8.2018 |
| EU/1/18/1295 | Trazimera | Liechtenstein | 31.8.2018 |
| EU/1/18/1296 | Tegsedi | Iceland | 25.7.2018 |
| EU/1/18/1296 | Tegsedi | Norway | 6.8.2018 |
| EU/1/18/1296 | Tegsedi | Liechtenstein | 31.8.2018 |
| EU/1/18/1297 | Kymriah | Iceland | 21.9.2018 |
| EU/1/18/1297 | Kymriah | Norway | 31.8.2018 |
| EU/1/18/1297 | Kymriah | Liechtenstein | 31.10.2018 |
| EU/1/18/1298 | Veyvondi | Iceland | 26.9.2018 |
| EU/1/18/1298 | VEYVONDI | Norway | 25.9.2018 |
| EU/1/18/1299 | Yescarta | Iceland | 21.9.2018 |
| EU/1/18/1299 | Yescarta | Norway | 31.8.2018 |
| EU/1/18/1299 | Yescarta | Liechtenstein | 31.10.2018 |
| EU/1/18/1300 | Duzallo | Iceland | 30.8.2018 |
| EU/1/18/1300 | Duzallo | Norway | 4.9.2018 |
| EU/1/18/1300 | Duzallo | Liechtenstein | 31.10.2018 |
| EU/1/18/1301 | Mepsevii | Iceland | 21.9.2018 |
| EU/1/18/1301 | Mepsevii | Norway | 4.9.2018 |
| EU/1/18/1302 | Kigabeq | Iceland | 23.10.2018 |
| EU/1/18/1302 | Kigabeq | Norway | 16.10.2018 |
| EU/1/18/1302 | Kigabeq | Liechtenstein | 31.10.2018 |
| EU/1/18/1303 | Udenyca | Iceland | 5.11.2018 |
| EU/1/18/1303 | Udenyca | Liechtenstein | 31.10.2018 |
| EU/1/18/1305 | Cablivi | Iceland | 26.9.2018 |
| EU/1/18/1305 | Cablivi | Norway | 25.9.2018 |
| EU/1/18/1306 | Symkevi | Iceland | 13.11.2018 |
| EU/1/18/1306 | Symkevi | Norway | 12.11.2018 |
| EU/1/18/1307 | Verzenios | Iceland | 24.10.2018 |
| EU/1/18/1307 | Verzenios | Norway | 8.10.2018 |
| EU/1/18/1307 | Verzenios | Liechtenstein | 31.10.2018 |
| EU/1/18/1308 | Vyxeos | Iceland | 21.9.2018 |
| EU/1/18/1308 | Vyxeos | Norway | 31.8.2018 |
| EU/1/18/1308 | Vyxeos | Liechtenstein | 31.10.2018 |
| EU/1/18/1309 | Ulipristal Acetate Gedeon Richter | Liechtenstein | 31.8.2018 |
| EU/1/18/1309 | Ulipristal Acetate Gedeon Richter | Iceland | 31.8.2018 |
| EU/1/18/1309 | Ulipristal Acetate Gedeon Richter | Norway | 12.9.2018 |
| EU/1/18/1310 | Deferiprone Lipomed | Iceland | 23.10.2018 |
| EU/1/18/1310 | Deferiprone Lipomed | Norway | 1.10.2018 |
| EU/1/18/1310 | Deferiprone Lipomed | Liechtenstein | 31.10.2018 |
| EU/1/18/1311 | Nerlynx | Iceland | 26.9.2018 |
| EU/1/18/1311 | Nerlynx | Norway | 21.9.2018 |
| EU/1/18/1311 | Nerlynx | Liechtenstein | 31.10.2018 |
| EU/1/18/1312 | Xerava | Iceland | 24.10.2018 |
| EU/1/18/1312 | Xerava | Norway | 25.10.2018 |
| EU/1/18/1313 | Pelgraz | Iceland | 23.10.2018 |
| EU/1/18/1313 | Pelgraz | Norway | 8.10.2018 |
| EU/1/18/1313 | Pelgraz | Liechtenstein | 31.10.2018 |
| EU/1/18/1303 | Udenyca | Norway | 1.10.2018 |
| EU/1/18/1314 | Braftovi | Iceland | 11.10.2018 |
| EU/1/18/1314 | Braftovi | Norway | 25.9.2018 |
| EU/1/18/1314 | Braftovi | Liechtenstein | 31.10.2018 |
| EU/1/18/1315 | Mektovi | Iceland | 11.10.2018 |
| EU/1/18/1315 | Mektovi | Norway | 25.9.2018 |
| EU/1/18/1315 | Mektovi | Liechtenstein | 31.10.2018 |
| EU/1/18/1316 | Lenalidomide Accord | Iceland | 23.10.2018 |
| EU/1/18/1316 | Lenalidomide Accord | Norway | 16.10.2018 |
| EU/1/18/1316 | Lenalidomide Accord | Liechtenstein | 31.10.2018 |
| EU/1/18/1318 | Slenyto | Iceland | 23.10.2018 |
| EU/1/18/1318 | Slenyto | Norway | 16.10.2018 |
| EU/1/18/1318 | Slenyto | Liechtenstein | 31.10.2018 |
| EU/1/18/1319 | Hulio | Iceland | 12.10.2018 |
| EU/1/18/1319 | Hulio | Norway | 16.10.2018 |
| EU/1/18/1319 | Hulio | Liechtenstein | 31.10.2018 |
| EU/1/18/1320 | Onpattro | Iceland | 24.9.2018 |
| EU/1/18/1320 | Onpattro | Norway | 11.9.2018 |
| EU/1/18/1321 | Gefitinib Mylan | Iceland | 25.10.2018 |
| EU/1/18/1321 | Gefitinib Mylan | Norway | 8.10.2018 |
| EU/1/18/1321 | Gefitinib Mylan | Liechtenstein | 31.10.2018 |
| EU/1/18/1322 | Imfinzi | Iceland | 23.10.2018 |
| EU/1/18/1322 | Imfinzi | Norway | 8.10.2018 |
| EU/1/18/1322 | Imfinzi | Liechtenstein | 31.10.2018 |
| EU/1/18/1323 | Ilumetri | Iceland | 12.10.2018 |
| EU/1/18/1323 | Ilumetri | Norway | 16.10.2018 |
| EU/1/18/1323 | Ilumetri | Liechtenstein | 31.10.2018 |
| EU/1/18/1324 | Jivi | Iceland | 6.12.2018 |
| EU/1/18/1324 | Jivi | Norway | 6.12.2018 |
| EU/1/18/1324 | Jivi | Liechtenstein | 31.12.2018 |
| EU/1/18/1327 | Ziextenzo | Iceland | 10.12.2018 |
| EU/1/18/1327 | Ziextenzo | Norway | 5.12.2018 |
| EU/1/18/1327 | Ziextenzo | Liechtenstein | 31.12.2018 |
| EU/1/18/1328 | Pelmeg | Iceland | 4.12.2018 |
| EU/1/18/1328 | Pelmeg | Norway | 5.12.2018 |
| EU/1/18/1328 | Pelmeg | Liechtenstein | 31.12.2018 |
| EU/1/18/1329 | Fulphila | Iceland | 3.12.2018 |
| EU/1/18/1329 | Fulphila | Norway | 5.12.2018 |
| EU/1/18/1329 | Fulphila | Liechtenstein | 31.12.2018 |
| EU/1/18/1330 | Emgality | Iceland | 3.12.2018 |
| EU/1/18/1330 | Emgality | Norway | 30.11.2018 |
| EU/1/18/1331 | Luxturna | Iceland | 11.12.2018 |
| EU/1/18/1331 | Luxturna | Norway | 20.12.2018 |
| EU/1/18/1332 | Pifeltro | Iceland | 5.12.2018 |
| EU/1/18/1332 | Pifeltro | Norway | 13.12.2018 |
| EU/1/18/1332 | Pifeltro | Liechtenstein | 31.12.2018 |
| EU/1/18/1333 | Delstrigo | Iceland | 12.12.2018 |
| EU/1/18/1333 | Delstrigo | Norway | 13.12.2018 |
| EU/1/18/1333 | Delstrigo | Liechtenstein | 31.12.2018 |
| EU/1/18/1334 | Vabomere | Iceland | 30.11.2018 |
| EU/1/18/1334 | Vabomere | Norway | 13.12.2018 |
| EU/1/18/1334 | Vabomere | Liechtenstein | 31.12.2018 |
| EU/1/18/1335 | Poteligeo | Iceland | 6.12.2018 |
| EU/1/18/1335 | Poteligeo | Liechtenstein | 31.12.2018 |
| EU/1/18/1335 | Poteligeo | Norway | 18.12.2018 |
| EU/1/18/1336 | Buvidal | Iceland | 3.12.2018 |
| EU/1/18/1336 | Buvidal | Norway | 5.12.2018 |
| EU/1/18/1336 | Buvidal | Liechtenstein | 31.12.2018 |
| EU/1/18/1340 | Takhzyro | Iceland | 5.12.2018 |
| EU/1/18/1340 | TAKHZYRO | Norway | 6.12.2018 |
| EU/1/18/1340 | TAKHZYRO | Liechtenstein | 31.12.2018 |
| EU/1/18/1341 | Ogivri | Liechtenstein | 31.12.2018 |
| EU/1/17/1219 | Verkazia | Liechtenstein | 31.8.2018 |
| EU/2/17/220 | MiPet Easecto | Liechtenstein | 31.8.2018 |
| EU/2/18/227 | UBAC | Iceland | 11.9.2018 |
| EU/2/18/227 | UBAC | Norway | 24.8.2018 |
| EU/2/18/227 | UBAC | Liechtenstein | 31.8.2018 |
| EU/2/18/230 | Cortacare | Iceland | 25.9.2018 |
| EU/2/18/230 | Cortacare | Norway | 24.9.2018 |
| EU/1/18/1284 | Dzuveo | Norway | 6.7.2018 |

EU-Number

Product

Country

Date of authorisation

EU/1/13/859

Corbilta

Liechtenstein

31.8.2018

EU/1/16/1115

Pemetrexed Fresenius Kabi

Liechtenstein

31.8.2018

EU/1/16/1138

Venclyxto (without conditions)

Liechtenstein

31.12.2018

EU/1/17/1219

Verkazia

Iceland

25.7.2018

EU/1/17/1219

Verkazia

Norway

18.9.2018

EU/1/17/1234

Tremfya

Liechtenstein

31.8.2018

EU/1/17/1246

Mvasi

Liechtenstein

31.8.2018

EU/1/17/1255

Intrarosa

Norway

21.8.2018

EU/1/18/1264

Alunbrig

Iceland

6.12.2018

EU/1/18/1264

Alunbrig

Norway

18.12.2018

EU/1/18/1264

Alunbrig

Liechtenstein

31.12.2018

EU/1/18/1273

Prasugrel Mylan

Norway

3.7.2018

EU/1/18/1275

Riarify

Norway

17.8.2018

EU/1/18/1276

Myalepta

Iceland

21.8.2018

EU/1/18/1276

Myalepta

Norway

17.8.2018

EU/1/18/1276

Myalepta

Liechtenstein

31.8.2018

EU/1/18/1278

Carmustine Obvius

Liechtenstein

31.10.2018

EU/1/18/1278

Carmustine Obvius

Iceland

17.8.2018

EU/1/18/1278

Carmustine Obvius

Norway

9.8.2018

EU/1/18/1284

Dzuveo

Iceland

2.7.2018

EU/1/18/1286

Hyrimoz

Iceland

16.8.2018

EU/1/18/1286

Hyrimoz

Norway

7.8.2018

EU/1/18/1286

Hyrimoz

Liechtenstein

31.8.2018

EU/1/18/1287

Hefiya

Iceland

20.8.2018

EU/1/18/1287

Hefiya

Norway

7.8.2018

EU/1/18/1287

Hefiya

Liechtenstein

31.8.2018

EU/1/18/1288

Halimatoz

Iceland

20.8.2018

EU/1/18/1288

Halimatoz

Norway

7.8.2018

EU/1/18/1288

Halimatoz

Liechtenstein

31.8.2018

EU/1/18/1290

Nityr

Iceland

28.8.2018

EU/1/18/1290

Nityr

Norway

17.8.2018

EU/1/18/1292

Apealea

Iceland

30.11.2018

EU/1/18/1292

Apealea

Liechtenstein

31.12.2018

EU/1/18/1293

Aimovig

Iceland

16.8.2018

EU/1/18/1293

Aimovig

Norway

7.8.2018

EU/1/18/1293

Aimovig

Liechtenstein

31.8.2018

EU/1/18/1294

Rxulti

Iceland

21.8.2018

EU/1/18/1294

Rxulti

Norway

21.8.2018

EU/1/18/1294

Rxulti

Liechtenstein

31.8.2018

EU/1/18/1295

Trazimera

Iceland

21.8.2018

EU/1/18/1295

Trazimera

Norway

7.8.2018

EU/1/18/1295

Trazimera

Liechtenstein

31.8.2018

EU/1/18/1296

Tegsedi

Iceland

25.7.2018

EU/1/18/1296

Tegsedi

Norway

6.8.2018

EU/1/18/1296

Tegsedi

Liechtenstein

31.8.2018

EU/1/18/1297

Kymriah

Iceland

21.9.2018

EU/1/18/1297

Kymriah

Norway

31.8.2018

EU/1/18/1297

Kymriah

Liechtenstein

31.10.2018

EU/1/18/1298

Veyvondi

Iceland

26.9.2018

EU/1/18/1298

VEYVONDI

Norway

25.9.2018

EU/1/18/1299

Yescarta

Iceland

21.9.2018

EU/1/18/1299

Yescarta

Norway

31.8.2018

EU/1/18/1299

Yescarta

Liechtenstein

31.10.2018

EU/1/18/1300

Duzallo

Iceland

30.8.2018

EU/1/18/1300

Duzallo

Norway

4.9.2018

EU/1/18/1300

Duzallo

Liechtenstein

31.10.2018

EU/1/18/1301

Mepsevii

Iceland

21.9.2018

EU/1/18/1301

Mepsevii

Norway

4.9.2018

EU/1/18/1302

Kigabeq

Iceland

23.10.2018

EU/1/18/1302

Kigabeq

Norway

16.10.2018

EU/1/18/1302

Kigabeq

Liechtenstein

31.10.2018

EU/1/18/1303

Udenyca

Iceland

5.11.2018

EU/1/18/1303

Udenyca

Liechtenstein

31.10.2018

EU/1/18/1305

Cablivi

Iceland

26.9.2018

EU/1/18/1305

Cablivi

Norway

25.9.2018

EU/1/18/1306

Symkevi

Iceland

13.11.2018

EU/1/18/1306

Symkevi

Norway

12.11.2018

EU/1/18/1307

Verzenios

Iceland

24.10.2018

EU/1/18/1307

Verzenios

Norway

8.10.2018

EU/1/18/1307

Verzenios

Liechtenstein

31.10.2018

EU/1/18/1308

Vyxeos

Iceland

21.9.2018

EU/1/18/1308

Vyxeos

Norway

31.8.2018

EU/1/18/1308

Vyxeos

Liechtenstein

31.10.2018

EU/1/18/1309

Ulipristal Acetate Gedeon Richter

Liechtenstein

31.8.2018

EU/1/18/1309

Ulipristal Acetate Gedeon Richter

Iceland

31.8.2018

EU/1/18/1309

Ulipristal Acetate Gedeon Richter

Norway

12.9.2018

EU/1/18/1310

Deferiprone Lipomed

Iceland

23.10.2018

EU/1/18/1310

Deferiprone Lipomed

Norway

1.10.2018

EU/1/18/1310

Deferiprone Lipomed

Liechtenstein

31.10.2018

EU/1/18/1311

Nerlynx

Iceland

26.9.2018

EU/1/18/1311

Nerlynx

Norway

21.9.2018

EU/1/18/1311

Nerlynx

Liechtenstein

31.10.2018

EU/1/18/1312

Xerava

Iceland

24.10.2018

EU/1/18/1312

Xerava

Norway

25.10.2018

EU/1/18/1313

Pelgraz

Iceland

23.10.2018

EU/1/18/1313

Pelgraz

Norway

8.10.2018

EU/1/18/1313

Pelgraz

Liechtenstein

31.10.2018

EU/1/18/1303

Udenyca

Norway

1.10.2018

EU/1/18/1314

Braftovi

Iceland

11.10.2018

EU/1/18/1314

Braftovi

Norway

25.9.2018

EU/1/18/1314

Braftovi

Liechtenstein

31.10.2018

EU/1/18/1315

Mektovi

Iceland

11.10.2018

EU/1/18/1315

Mektovi

Norway

25.9.2018

EU/1/18/1315

Mektovi

Liechtenstein

31.10.2018

EU/1/18/1316

Lenalidomide Accord

Iceland

23.10.2018

EU/1/18/1316

Lenalidomide Accord

Norway

16.10.2018

EU/1/18/1316

Lenalidomide Accord

Liechtenstein

31.10.2018

EU/1/18/1318

Slenyto

Iceland

23.10.2018

EU/1/18/1318

Slenyto

Norway

16.10.2018

EU/1/18/1318

Slenyto

Liechtenstein

31.10.2018

EU/1/18/1319

Hulio

Iceland

12.10.2018

EU/1/18/1319

Hulio

Norway

16.10.2018

EU/1/18/1319

Hulio

Liechtenstein

31.10.2018

EU/1/18/1320

Onpattro

Iceland

24.9.2018

EU/1/18/1320

Onpattro

Norway

11.9.2018

EU/1/18/1321

Gefitinib Mylan

Iceland

25.10.2018

EU/1/18/1321

Gefitinib Mylan

Norway

8.10.2018

EU/1/18/1321

Gefitinib Mylan

Liechtenstein

31.10.2018

EU/1/18/1322

Imfinzi

Iceland

23.10.2018

EU/1/18/1322

Imfinzi

Norway

8.10.2018

EU/1/18/1322

Imfinzi

Liechtenstein

31.10.2018

EU/1/18/1323

Ilumetri

Iceland

12.10.2018

EU/1/18/1323

Ilumetri

Norway

16.10.2018

EU/1/18/1323

Ilumetri

Liechtenstein

31.10.2018

EU/1/18/1324

Jivi

Iceland

6.12.2018

EU/1/18/1324

Jivi

Norway

6.12.2018

EU/1/18/1324

Jivi

Liechtenstein

31.12.2018

EU/1/18/1327

Ziextenzo

Iceland

10.12.2018

EU/1/18/1327

Ziextenzo

Norway

5.12.2018

EU/1/18/1327

Ziextenzo

Liechtenstein

31.12.2018

EU/1/18/1328

Pelmeg

Iceland

4.12.2018

EU/1/18/1328

Pelmeg

Norway

5.12.2018

EU/1/18/1328

Pelmeg

Liechtenstein

31.12.2018

EU/1/18/1329

Fulphila

Iceland

3.12.2018

EU/1/18/1329

Fulphila

Norway

5.12.2018

EU/1/18/1329

Fulphila

Liechtenstein

31.12.2018

EU/1/18/1330

Emgality

Iceland

3.12.2018

EU/1/18/1330

Emgality

Norway

30.11.2018

EU/1/18/1331

Luxturna

Iceland

11.12.2018

EU/1/18/1331

Luxturna

Norway

20.12.2018

EU/1/18/1332

Pifeltro

Iceland

5.12.2018

EU/1/18/1332

Pifeltro

Norway

13.12.2018

EU/1/18/1332

Pifeltro

Liechtenstein

31.12.2018

EU/1/18/1333

Delstrigo

Iceland

12.12.2018

EU/1/18/1333

Delstrigo

Norway

13.12.2018

EU/1/18/1333

Delstrigo

Liechtenstein

31.12.2018

EU/1/18/1334

Vabomere

Iceland

30.11.2018

EU/1/18/1334

Vabomere

Norway

13.12.2018

EU/1/18/1334

Vabomere

Liechtenstein

31.12.2018

EU/1/18/1335

Poteligeo

Iceland

6.12.2018

EU/1/18/1335

Poteligeo

Liechtenstein

31.12.2018

EU/1/18/1335

Poteligeo

Norway

18.12.2018

EU/1/18/1336

Buvidal

Iceland

3.12.2018

EU/1/18/1336

Buvidal

Norway

5.12.2018

EU/1/18/1336

Buvidal

Liechtenstein

31.12.2018

EU/1/18/1340

Takhzyro

Iceland

5.12.2018

EU/1/18/1340

TAKHZYRO

Norway

6.12.2018

EU/1/18/1340

TAKHZYRO

Liechtenstein

31.12.2018

EU/1/18/1341

Ogivri

Liechtenstein

31.12.2018

EU/1/17/1219

Verkazia

Liechtenstein

31.8.2018

EU/2/17/220

MiPet Easecto

Liechtenstein

31.8.2018

EU/2/18/227

UBAC

Iceland

11.9.2018

EU/2/18/227

UBAC

Norway

24.8.2018

EU/2/18/227

UBAC

Liechtenstein

31.8.2018

EU/2/18/230

Cortacare

Iceland

25.9.2018

EU/2/18/230

Cortacare

Norway

24.9.2018

EU/1/18/1284

Dzuveo

Norway

6.7.2018

---

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 2018:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/06/367 | Diacomit | Iceland | 12.10.2018 |
| EU/1/06/367 | Diacomit | Norway | 16.10.2018 |
| EU/1/06/367 | Diacomit | Liechtenstein | 31.10.2018 |
| EU/1/08/448 | Mycamine | Norway | 17.8.2018 |
| EU/1/08/448 | Mycamine | Liechtenstein | 31.8.2018 |
| EU/1/08/468 | INTELENCE | Iceland | 30.8.2018 |
| EU/1/08/468 | Intelence | Norway | 5.9.2018 |
| EU/1/08/468 | Intelence | Liechtenstein | 31.8.2018 |
| EU/1/08/473 | Evicel | Iceland | 30.8.2018 |
| EU/1/08/473 | Evicel | Norway | 19.9.2018 |
| EU/1/08/473 | Evicel | Liechtenstein | 31.10.2018 |
| EU/1/08/477 | Ceplene | Iceland | 28.8.2018 |
| EU/1/08/477 | Ceplene | Norway | 17.8.2018 |
| EU/1/08/491 | Rasilez HCT | Iceland | 25.9.2018 |
| EU/1/08/491 | Rasilez HCT | Norway | 19.9.2018 |
| EU/1/08/499 | Valdoxan | Liechtenstein | 31.12.2018 |
| EU/1/08/501 | Ixiaro | Iceland | 7.12.2018 |
| EU/1/08/501 | Ixiaro | Norway | 17.12.2018 |
| EU/1/08/501 | Ixiaro | Liechtenstein | 31.12.2018 |
| EU/1/09/508 | Synflorix | Iceland | 5.12.2018 |
| EU/1/09/508 | Synflorix | Norway | 5.12.2018 |
| EU/1/09/508 | Synflorix | Liechtenstein | 31.12.2018 |
| EU/1/12/794 | ADCETRIS | Iceland | 24.10.2018 |
| EU/1/12/794 | Adcetris | Norway | 26.9.2018 |
| EU/1/12/794 | ADCETRIS | Liechtenstein | 31.10.2018 |
| EU/1/13/817 | Actelsar HCT | Liechtenstein | 31.8.2018 |
| EU/1/13/821 | Tolucombi | Liechtenstein | 31.8.2018 |
| EU/1/13/823 | Adasuve | Liechtenstein | 31.8.2018 |
| EU/1/13/824 | Nemdatine | Norway | 8.8.2018 |
| EU/1/13/824 | Nemdatine | Liechtenstein | 31.8.2018 |
| EU/1/13/826 | Memantine LEK | Norway | 21.8.2018 |
| EU/1/13/826 | Memantine LEK | Liechtenstein | 31.8.2018 |
| EU/1/13/827 | Memantine Mylan | Norway | 11.10.2018 |
| EU/1/13/827 | Memantine Mylan | Liechtenstein | 31.8.2018 |
| EU/1/13/828 | Hexacima | Norway | 17.8.2018 |
| EU/1/13/828 | Hexacima | Liechtenstein | 31.8.2018 |
| EU/1/13/834 | Zoledronic Acid Accord | Iceland | 4.12.2018 |
| EU/1/13/834 | Zoledronic acid Accord | Norway | 30.11.2018 |
| EU/1/13/834 | Zoledronic acid Accord | Liechtenstein | 31.12.2018 |
| EU/1/13/837 | Tecfidera | Iceland | 12.10.2018 |
| EU/1/13/837 | Tecfidera | Norway | 16.10.2018 |
| EU/1/13/837 | Tecfidera | Liechtenstein | 31.10.2018 |
| EU/1/13/842 | Incresync | Norway | 3.7.2018 |
| EU/1/13/843 | Vipdomet | Norway | 3.7.2018 |
| EU/1/13/850 | Imnovid | Iceland | 26.7.2018 |
| EU/1/13/850 | Imnovid | Norway | 6.8.2018 |
| EU/1/13/850 | Imnovid | Liechtenstein | 31.10.2018 |
| EU/1/13/853 | Remsima | Norway | 6.7.2018 |
| EU/1/13/854 | Inflectra | Norway | 6.7.2018 |
| EU/1/13/859 | Corbilta | Iceland | 20.7.2018 |
| EU/1/13/859 | Corbilta | Norway | 6.8.2018 |
| EU/1/13/860 | Nexium Control | Iceland | 19.7.2018 |
| EU/1/13/860 | Nexium Control | Norway | 6.8.2018 |
| EU/1/13/861 | Procysbi | Iceland | 17.8.2018 |
| EU/1/13/861 | Procysbi | Norway | 17.8.2018 |
| EU/1/13/861 | Procysbi | Liechtenstein | 31.8.2018 |
| EU/1/13/869 | Lemtrada | Iceland | 20.7.2018 |
| EU/1/13/869 | Lemtrada | Liechtenstein | 31.8.2018 |
| EU/1/13/869 | Lemtrada | Norway | 6.8.2018 |
| EU/1/13/872 | Tybost | Iceland | 17.8.2018 |
| EU/1/13/872 | Tybost | Norway | 21.8.2018 |
| EU/1/13/872 | Tybost | Liechtenstein | 31.8.2018 |
| EU/1/13/873 | Xofigo | Norway | 9.7.2018 |
| EU/1/13/877 | Grastofil | Iceland | 24.10.2018 |
| EU/1/13/877 | Grastofil | Norway | 12.10.2018 |
| EU/1/13/877 | Grastofil | Liechtenstein | 31.10.2018 |
| EU/1/13/878 | Defitelio | Iceland | 9.11.2018 |
| EU/1/13/878 | Defitelio | Norway | 25.10.2018 |
| EU/1/13/878 | Defitelio | Liechtenstein | 31.10.2018 |
| EU/1/13/880 | Memantin Accord | Norway | 21.8.2018 |
| EU/1/13/880 | Memantine Accord | Iceland | 21.8.2018 |
| EU/1/13/880 | Memantine Accord | Liechtenstein | 31.8.2018 |
| EU/1/13/881 | Fortacin | Iceland | 10.10.2018 |
| EU/1/13/881 | Fortacin | Norway | 16.10.2018 |
| EU/1/13/881 | Fortacin | Liechtenstein | 31.10.2018 |
| EU/1/13/882 | ABILIFY MAINTENA | Iceland | 25.9.2018 |
| EU/1/13/882 | ABILIFY MAINTENA | Norway | 4.9.2018 |
| EU/1/13/882 | ABILIFY MAINTENA | Liechtenstein | 31.8.2018 |
| EU/1/13/884 | Invokana | Iceland | 17.8.2018 |
| EU/1/13/884 | Invokana | Norway | 21.8.2018 |
| EU/1/13/884 | Invokana | Liechtenstein | 31.8.2018 |
| EU/1/13/885 | Kadcyla | Iceland | 10.10.2018 |
| EU/1/13/885 | Kadcyla | Norway | 23.9.2018 |
| EU/1/13/885 | Kadcyla | Liechtenstein | 31.10.2018 |
| EU/1/13/886 | Relvar Ellipta | Iceland | 17.8.2018 |
| EU/1/13/886 | Relvar Ellipta | Norway | 17.8.2018 |
| EU/1/13/886 | Relvar Ellipta | Liechtenstein | 31.8.2018 |
| EU/1/13/887 | Fluenz Tetra | Iceland | 4.12.2018 |
| EU/1/13/887 | Fluenz Tetra | Norway | 18.12.2018 |
| EU/1/13/887 | Fluenz Tetra | Liechtenstein | 31.12.2018 |
| EU/1/13/888 | NovoEight | Iceland | 20.8.2018 |
| EU/1/13/888 | NovoEight | Norway | 30.7.2018 |
| EU/1/13/888 | NovoEight | Liechtenstein | 31.8.2018 |
| EU/1/13/889 | Levetiracetam Hospira | Iceland | 30.11.2018 |
| EU/1/13/889 | Levetiracetam Hospira | Norway | 5.12.2018 |
| EU/1/13/891 | Brintellix | Iceland | 4.12.2018 |
| EU/1/13/891 | Brintellix | Norway | 30.11.2018 |
| EU/1/13/891 | Brintellix | Liechtenstein | 31.12.2018 |
| EU/1/13/892 | Tivicay | Iceland | 12.10.2018 |
| EU/1/13/892 | Tivicay | Norway | 16.10.2018 |
| EU/1/13/892 | Tivicay | Liechtenstein | 31.10.2018 |
| EU/1/13/893 | Opsumit | Iceland | 28.8.2018 |
| EU/1/13/893 | Opsumit | Norway | 7.9.2018 |
| EU/1/13/893 | Opsumit | Liechtenstein | 31.10.2018 |
| EU/1/13/894 | Sovaldi | Iceland | 10.10.2018 |
| EU/1/13/894 | Sovaldi | Norway | 16.10.2018 |
| EU/1/13/894 | Sovaldi | Liechtenstein | 31.10.2018 |
| EU/1/13/900 | Xigduo | Iceland | 24.10.2018 |
| EU/1/13/900 | Xigduo | Norway | 16.10.2018 |
| EU/1/13/900 | Xigduo | Liechtenstein | 31.10.2018 |
| EU/1/13/902 | Translarna | Iceland | 29.8.2018 |
| EU/1/13/902 | Translarna | Norway | 1.11.2018 |
| EU/1/13/904 | Mirvaso | Iceland | 7.12.2018 |
| EU/1/13/904 | Mirvaso | Norway | 13.12.2018 |
| EU/1/13/904 | Mirvaso | Liechtenstein | 31.12.2018 |
| EU/1/13/905 | IZBA | Norway | 6.12.2018 |
| EU/1/13/906 | Neuraceq | Iceland | 4.12.2018 |
| EU/1/13/906 | Neuraceq | Norway | 5.12.2018 |
| EU/1/13/906 | Neuraceq | Liechtenstein | 31.12.2018 |
| EU/1/13/909 | Bemfola | Iceland | 16.11.2018 |
| EU/1/13/909 | Bemfola | Norway | 6.12.2018 |
| EU/1/14/913 | Latuda | Iceland | 30.11.2018 |
| EU/1/14/913 | Latuda | Norway | 30.11.2018 |
| EU/1/14/929 | Revinty Ellipta | Iceland | 17.8.2018 |
| EU/1/14/929 | Revinty Ellipta | Norway | 17.8.2018 |
| EU/1/14/929 | Revinty Ellipta | Liechtenstein | 31.8.2018 |
| EU/1/15/1078 | Natpar | Norway | 16.8.2018 |
| EU/1/16/1094 | Ninlaro | Iceland | 10.10.2018 |
| EU/1/16/1094 | Ninlaro | Norway | 24.9.2018 |
| EU/1/16/1094 | Ninlaro | Liechtenstein | 31.10.2018 |
| EU/1/16/1121 | Zalmoxis | Iceland | 28.8.2018 |
| EU/1/16/1121 | Zalmoxis | Norway | 1.11.2018 |
| EU/1/16/1138 | Venclyxto | Iceland | 26.9.2018 |
| EU/1/16/1138 | Venclyxto | Norway | 14.9.2018 |
| EU/1/16/1138 | Venclyxto | Liechtenstein | 31.10.2018 |
| EU/1/16/1143 | Lartruvo | Iceland | 10.10.2018 |
| EU/1/16/1143 | Lartruvo | Norway | 27.9.2018 |
| EU/1/16/1143 | Lartruvo | Liechtenstein | 31.10.2018 |
| EU/1/17/1214 | Bavencio | Iceland | 26.9.2018 |
| EU/1/17/1214 | Bavencio | Norway | 14.9.2018 |
| EU/1/17/1214 | Bavencio | Liechtenstein | 31.10.2018 |
| EU/1/13/909 | Bemfola | Liechtenstein | 31.12.2018 |
| EU/2/08/080 | Reconcile | Iceland | 26.7.2018 |
| EU/2/08/080 | Reconcile | Norway | 27.7.2018 |
| EU/2/08/080 | Reconcile | Liechtenstein | 31.8.2018 |
| EU/2/13/154 | Apoquel | Iceland | 20.8.2018 |
| EU/2/13/154 | Apoquel | Norway | 13.8.2018 |
| EU/2/13/154 | Apoquel | Liechtenstein | 31.8.2018 |
| EU/2/13/156 | Vectra 3D | Iceland | 25.9.2018 |
| EU/2/13/156 | Vectra 3D | Norway | 21.9.2018 |
| EU/2/13/157 | BROADLINE | Iceland | 24.10.2018 |
| EU/2/13/157 | Broadline | Norway | 16.10.2018 |
| EU/2/13/157 | BROADLINE | Liechtenstein | 31.10.2018 |

EU-Number

Product

Country

Date of authorisation

EU/1/06/367

Diacomit

Iceland

12.10.2018

EU/1/06/367

Diacomit

Norway

16.10.2018

EU/1/06/367

Diacomit

Liechtenstein

31.10.2018

EU/1/08/448

Mycamine

Norway

17.8.2018

EU/1/08/448

Mycamine

Liechtenstein

31.8.2018

EU/1/08/468

INTELENCE

Iceland

30.8.2018

EU/1/08/468

Intelence

Norway

5.9.2018

EU/1/08/468

Intelence

Liechtenstein

31.8.2018

EU/1/08/473

Evicel

Iceland

30.8.2018

EU/1/08/473

Evicel

Norway

19.9.2018

EU/1/08/473

Evicel

Liechtenstein

31.10.2018

EU/1/08/477

Ceplene

Iceland

28.8.2018

EU/1/08/477

Ceplene

Norway

17.8.2018

EU/1/08/491

Rasilez HCT

Iceland

25.9.2018

EU/1/08/491

Rasilez HCT

Norway

19.9.2018

EU/1/08/499

Valdoxan

Liechtenstein

31.12.2018

EU/1/08/501

Ixiaro

Iceland

7.12.2018

EU/1/08/501

Ixiaro

Norway

17.12.2018

EU/1/08/501

Ixiaro

Liechtenstein

31.12.2018

EU/1/09/508

Synflorix

Iceland

5.12.2018

EU/1/09/508

Synflorix

Norway

5.12.2018

EU/1/09/508

Synflorix

Liechtenstein

31.12.2018

EU/1/12/794

ADCETRIS

Iceland

24.10.2018

EU/1/12/794

Adcetris

Norway

26.9.2018

EU/1/12/794

ADCETRIS

Liechtenstein

31.10.2018

EU/1/13/817

Actelsar HCT

Liechtenstein

31.8.2018

EU/1/13/821

Tolucombi

Liechtenstein

31.8.2018

EU/1/13/823

Adasuve

Liechtenstein

31.8.2018

EU/1/13/824

Nemdatine

Norway

8.8.2018

EU/1/13/824

Nemdatine

Liechtenstein

31.8.2018

EU/1/13/826

Memantine LEK

Norway

21.8.2018

EU/1/13/826

Memantine LEK

Liechtenstein

31.8.2018

EU/1/13/827

Memantine Mylan

Norway

11.10.2018

EU/1/13/827

Memantine Mylan

Liechtenstein

31.8.2018

EU/1/13/828

Hexacima

Norway

17.8.2018

EU/1/13/828

Hexacima

Liechtenstein

31.8.2018

EU/1/13/834

Zoledronic Acid Accord

Iceland

4.12.2018

EU/1/13/834

Zoledronic acid Accord

Norway

30.11.2018

EU/1/13/834

Zoledronic acid Accord

Liechtenstein

31.12.2018

EU/1/13/837

Tecfidera

Iceland

12.10.2018

EU/1/13/837

Tecfidera

Norway

16.10.2018

EU/1/13/837

Tecfidera

Liechtenstein

31.10.2018

EU/1/13/842

Incresync

Norway

3.7.2018

EU/1/13/843

Vipdomet

Norway

3.7.2018

EU/1/13/850

Imnovid

Iceland

26.7.2018

EU/1/13/850

Imnovid

Norway

6.8.2018

EU/1/13/850

Imnovid

Liechtenstein

31.10.2018

EU/1/13/853

Remsima

Norway

6.7.2018

EU/1/13/854

Inflectra

Norway

6.7.2018

EU/1/13/859

Corbilta

Iceland

20.7.2018

EU/1/13/859

Corbilta

Norway

6.8.2018

EU/1/13/860

Nexium Control

Iceland

19.7.2018

EU/1/13/860

Nexium Control

Norway

6.8.2018

EU/1/13/861

Procysbi

Iceland

17.8.2018

EU/1/13/861

Procysbi

Norway

17.8.2018

EU/1/13/861

Procysbi

Liechtenstein

31.8.2018

EU/1/13/869

Lemtrada

Iceland

20.7.2018

EU/1/13/869

Lemtrada

Liechtenstein

31.8.2018

EU/1/13/869

Lemtrada

Norway

6.8.2018

EU/1/13/872

Tybost

Iceland

17.8.2018

EU/1/13/872

Tybost

Norway

21.8.2018

EU/1/13/872

Tybost

Liechtenstein

31.8.2018

EU/1/13/873

Xofigo

Norway

9.7.2018

EU/1/13/877

Grastofil

Iceland

24.10.2018

EU/1/13/877

Grastofil

Norway

12.10.2018

EU/1/13/877

Grastofil

Liechtenstein

31.10.2018

EU/1/13/878

Defitelio

Iceland

9.11.2018

EU/1/13/878

Defitelio

Norway

25.10.2018

EU/1/13/878

Defitelio

Liechtenstein

31.10.2018

EU/1/13/880

Memantin Accord

Norway

21.8.2018

EU/1/13/880

Memantine Accord

Iceland

21.8.2018

EU/1/13/880

Memantine Accord

Liechtenstein

31.8.2018

EU/1/13/881

Fortacin

Iceland

10.10.2018

EU/1/13/881

Fortacin

Norway

16.10.2018

EU/1/13/881

Fortacin

Liechtenstein

31.10.2018

EU/1/13/882

ABILIFY MAINTENA

Iceland

25.9.2018

EU/1/13/882

ABILIFY MAINTENA

Norway

4.9.2018

EU/1/13/882

ABILIFY MAINTENA

Liechtenstein

31.8.2018

EU/1/13/884

Invokana

Iceland

17.8.2018

EU/1/13/884

Invokana

Norway

21.8.2018

EU/1/13/884

Invokana

Liechtenstein

31.8.2018

EU/1/13/885

Kadcyla

Iceland

10.10.2018

EU/1/13/885

Kadcyla

Norway

23.9.2018

EU/1/13/885

Kadcyla

Liechtenstein

31.10.2018

EU/1/13/886

Relvar Ellipta

Iceland

17.8.2018

EU/1/13/886

Relvar Ellipta

Norway

17.8.2018

EU/1/13/886

Relvar Ellipta

Liechtenstein

31.8.2018

EU/1/13/887

Fluenz Tetra

Iceland

4.12.2018

EU/1/13/887

Fluenz Tetra

Norway

18.12.2018

EU/1/13/887

Fluenz Tetra

Liechtenstein

31.12.2018

EU/1/13/888

NovoEight

Iceland

20.8.2018

EU/1/13/888

NovoEight

Norway

30.7.2018

EU/1/13/888

NovoEight

Liechtenstein

31.8.2018

EU/1/13/889

Levetiracetam Hospira

Iceland

30.11.2018

EU/1/13/889

Levetiracetam Hospira

Norway

5.12.2018

EU/1/13/891

Brintellix

Iceland

4.12.2018

EU/1/13/891

Brintellix

Norway

30.11.2018

EU/1/13/891

Brintellix

Liechtenstein

31.12.2018

EU/1/13/892

Tivicay

Iceland

12.10.2018

EU/1/13/892

Tivicay

Norway

16.10.2018

EU/1/13/892

Tivicay

Liechtenstein

31.10.2018

EU/1/13/893

Opsumit

Iceland

28.8.2018

EU/1/13/893

Opsumit

Norway

7.9.2018

EU/1/13/893

Opsumit

Liechtenstein

31.10.2018

EU/1/13/894

Sovaldi

Iceland

10.10.2018

EU/1/13/894

Sovaldi

Norway

16.10.2018

EU/1/13/894

Sovaldi

Liechtenstein

31.10.2018

EU/1/13/900

Xigduo

Iceland

24.10.2018

EU/1/13/900

Xigduo

Norway

16.10.2018

EU/1/13/900

Xigduo

Liechtenstein

31.10.2018

EU/1/13/902

Translarna

Iceland

29.8.2018

EU/1/13/902

Translarna

Norway

1.11.2018

EU/1/13/904

Mirvaso

Iceland

7.12.2018

EU/1/13/904

Mirvaso

Norway

13.12.2018

EU/1/13/904

Mirvaso

Liechtenstein

31.12.2018

EU/1/13/905

IZBA

Norway

6.12.2018

EU/1/13/906

Neuraceq

Iceland

4.12.2018

EU/1/13/906

Neuraceq

Norway

5.12.2018

EU/1/13/906

Neuraceq

Liechtenstein

31.12.2018

EU/1/13/909

Bemfola

Iceland

16.11.2018

EU/1/13/909

Bemfola

Norway

6.12.2018

EU/1/14/913

Latuda

Iceland

30.11.2018

EU/1/14/913

Latuda

Norway

30.11.2018

EU/1/14/929

Revinty Ellipta

Iceland

17.8.2018

EU/1/14/929

Revinty Ellipta

Norway

17.8.2018

EU/1/14/929

Revinty Ellipta

Liechtenstein

31.8.2018

EU/1/15/1078

Natpar

Norway

16.8.2018

EU/1/16/1094

Ninlaro

Iceland

10.10.2018

EU/1/16/1094

Ninlaro

Norway

24.9.2018

EU/1/16/1094

Ninlaro

Liechtenstein

31.10.2018

EU/1/16/1121

Zalmoxis

Iceland

28.8.2018

EU/1/16/1121

Zalmoxis

Norway

1.11.2018

EU/1/16/1138

Venclyxto

Iceland

26.9.2018

EU/1/16/1138

Venclyxto

Norway

14.9.2018

EU/1/16/1138

Venclyxto

Liechtenstein

31.10.2018

EU/1/16/1143

Lartruvo

Iceland

10.10.2018

EU/1/16/1143

Lartruvo

Norway

27.9.2018

EU/1/16/1143

Lartruvo

Liechtenstein

31.10.2018

EU/1/17/1214

Bavencio

Iceland

26.9.2018

EU/1/17/1214

Bavencio

Norway

14.9.2018

EU/1/17/1214

Bavencio

Liechtenstein

31.10.2018

EU/1/13/909

Bemfola

Liechtenstein

31.12.2018

EU/2/08/080

Reconcile

Iceland

26.7.2018

EU/2/08/080

Reconcile

Norway

27.7.2018

EU/2/08/080

Reconcile

Liechtenstein

31.8.2018

EU/2/13/154

Apoquel

Iceland

20.8.2018

EU/2/13/154

Apoquel

Norway

13.8.2018

EU/2/13/154

Apoquel

Liechtenstein

31.8.2018

EU/2/13/156

Vectra 3D

Iceland

25.9.2018

EU/2/13/156

Vectra 3D

Norway

21.9.2018

EU/2/13/157

BROADLINE

Iceland

24.10.2018

EU/2/13/157

Broadline

Norway

16.10.2018

EU/2/13/157

BROADLINE

Liechtenstein

31.10.2018

---

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 2018:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/06/363/016 | Sprycel | Norway | 2.7.2018 |
| EU/1/06/363/016 | Sprycel | Iceland | 20.7.2018 |
| EU/1/09/521/008 | Renvela | Iceland | 12.10.2018 |
| EU/1/09/521/008 | Renvela | Norway | 20.9.2018 |
| EU/1/11/677/007-008 | Gilenya | Norway | 30.11.2018 |
| EU/1/11/677/007-008 | Gilenya | Iceland | 5.12.2018 |
| EU/1/11/696/005 | Bydureon | Iceland | 25.9.2018 |
| EU/1/11/696/005 | Bydureon | Norway | 27.8.2018 |
| EU/1/14/945/005-012 | IMBRUVICA | Iceland | 20.7.2018 |
| EU/1/14/952/005 | Sevelamer carbonate Zentiva | Iceland | 12.10.2018 |
| EU/1/14/952/005 | Sevelamer carbonate Zentiva | Norway | 20.9.2018 |
| EU/1/15/1046/008-010 | Elocta | Norway | 7.12.2018 |
| EU/1/16/1132/069-072 | Inhixa | Iceland | 11.10.2018 |
| EU/1/16/1168 | Vihuma | Norway | 20.12.2018 |
| EU/1/17/1178/005-009 | Xeljanz | Norway | 3.9.2018 |
| EU/1/17/1178/005-009 | XELJANZ | Iceland | 25.9.2018 |
| EU/2/07/078/022-023 | Rheumocam | Norway | 19.12.2018 |
| EU/2/07/078/022-023 | Rheumocam | Iceland | 4.12.2018 |
| EU/2/11/134/023-024 | Inflacam | Norway | 26.11.2018 |
| EU/2/11/134/023-024 | Inflacam | Iceland | 10.12.2018 |
| EU/2/17/206/016-021 | Credelio | Norway | 24.9.2018 |
| EU/2/17/206/016-021 | Credelio | Iceland | 25.7.2018 |

EU-Number

Product

Country

Date of authorisation

EU/1/06/363/016

Sprycel

Norway

2.7.2018

EU/1/06/363/016

Sprycel

Iceland

20.7.2018

EU/1/09/521/008

Renvela

Iceland

12.10.2018

EU/1/09/521/008

Renvela

Norway

20.9.2018

EU/1/11/677/007-008

Gilenya

Norway

30.11.2018

EU/1/11/677/007-008

Gilenya

Iceland

5.12.2018

EU/1/11/696/005

Bydureon

Iceland

25.9.2018

EU/1/11/696/005

Bydureon

Norway

27.8.2018

EU/1/14/945/005-012

IMBRUVICA

Iceland

20.7.2018

EU/1/14/952/005

Sevelamer carbonate Zentiva

Iceland

12.10.2018

EU/1/14/952/005

Sevelamer carbonate Zentiva

Norway

20.9.2018

EU/1/15/1046/008-010

Elocta

Norway

7.12.2018

EU/1/16/1132/069-072

Inhixa

Iceland

11.10.2018

EU/1/16/1168

Vihuma

Norway

20.12.2018

EU/1/17/1178/005-009

Xeljanz

Norway

3.9.2018

EU/1/17/1178/005-009

XELJANZ

Iceland

25.9.2018

EU/2/07/078/022-023

Rheumocam

Norway

19.12.2018

EU/2/07/078/022-023

Rheumocam

Iceland

4.12.2018

EU/2/11/134/023-024

Inflacam

Norway

26.11.2018

EU/2/11/134/023-024

Inflacam

Iceland

10.12.2018

EU/2/17/206/016-021

Credelio

Norway

24.9.2018

EU/2/17/206/016-021

Credelio

Iceland

25.7.2018

---

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 2018:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/01/187 | DepoCyte | Iceland | 25.7.2018 |
| EU/1/01/187 | DepoCyte | Norway | 24.7.2018 |
| EU/1/04/283 | Ariclaim | Iceland | 25.7.2018 |
| EU/1/04/283 | Ariclaim | Norway | 24.7.2018 |
| EU/1/04/283 | Ariclaim | Liechtenstein | 31.12.2018 |
| EU/1/04/289 | Angiox | Norway | 15.8.2018 |
| EU/1/08/505 | Intanza | Iceland | 27.8.2018 |
| EU/1/08/505 | Intanza | Norway | 22.8.2018 |
| EU/1/11/681 | Trobalt | Iceland | 26.7.2018 |
| EU/1/11/681 | Trobalt | Norway | 15.8.2018 |
| EU/1/11/704 | Victrelis | Iceland | 19.7.2018 |
| EU/1/11/704 | Victrelis | Norway | 18.7.2018 |
| EU/1/12/791 | Glybera | Iceland | 17.7.2018 |
| EU/1/13/908 | Eperzan | Iceland | 10.12.2018 |
| EU/1/13/908 | Eperzan | Norway | 11.12.2018 |
| EU/1/14/953 | Tasermity | Iceland | 17.7.2018 |
| EU/1/15/1017 | Taxespira | Iceland | 13.11.2018 |
| EU/1/15/1017 | Taxespira | Norway | 23.11.2018 |
| EU/1/15/1050 | IONSYS | Norway | 24.10.2018 |
| EU/1/15/1050 | IONSYS | Liechtenstein | 31.10.2018 |
| EU/1/15/1050 | IONSYS | Iceland | 25.10.2018 |
| EU/1/16/1145 | Ivabradine JensonR | Iceland | 11.12.2018 |
| EU/1/16/1145 | Ivabradine JensonR | Norway | 18.12.2018 |
| EU/1/16/1145 | Ivabradine JensonR | Liechtenstein | 31.12.2018 |
| EU/1/16/1162 | Lusduna | Iceland | 19.11.2018 |
| EU/1/16/1162 | Lusduna | Norway | 29.10.2018 |
| EU/1/16/1163 | Solymbic | Iceland | 17.7.2018 |
| EU/1/16/1163 | Solymbic | Norway | 18.7.2018 |
| EU/2/09/102 | Gripovac 3 | Iceland | 28.8.2018 |
| EU/2/09/102 | Gripovac 3 | Norway | 20.9.2018 |
| EU/2/09/102 | Gripovac 3 | Liechtenstein | 31.10.2018 |
| EU/2/13/155 | Trifexis | Norway | 19.9.2018 |

EU-Number

Product

Country

Date of withdrawal

EU/1/01/187

DepoCyte

Iceland

25.7.2018

EU/1/01/187

DepoCyte

Norway

24.7.2018

EU/1/04/283

Ariclaim

Iceland

25.7.2018

EU/1/04/283

Ariclaim

Norway

24.7.2018

EU/1/04/283

Ariclaim

Liechtenstein

31.12.2018

EU/1/04/289

Angiox

Norway

15.8.2018

EU/1/08/505

Intanza

Iceland

27.8.2018

EU/1/08/505

Intanza

Norway

22.8.2018

EU/1/11/681

Trobalt

Iceland

26.7.2018

EU/1/11/681

Trobalt

Norway

15.8.2018

EU/1/11/704

Victrelis

Iceland

19.7.2018

EU/1/11/704

Victrelis

Norway

18.7.2018

EU/1/12/791

Glybera

Iceland

17.7.2018

EU/1/13/908

Eperzan

Iceland

10.12.2018

EU/1/13/908

Eperzan

Norway

11.12.2018

EU/1/14/953

Tasermity

Iceland

17.7.2018

EU/1/15/1017

Taxespira

Iceland

13.11.2018

EU/1/15/1017

Taxespira

Norway

23.11.2018

EU/1/15/1050

IONSYS

Norway

24.10.2018

EU/1/15/1050

IONSYS

Liechtenstein

31.10.2018

EU/1/15/1050

IONSYS

Iceland

25.10.2018

EU/1/16/1145

Ivabradine JensonR

Iceland

11.12.2018

EU/1/16/1145

Ivabradine JensonR

Norway

18.12.2018

EU/1/16/1145

Ivabradine JensonR

Liechtenstein

31.12.2018

EU/1/16/1162

Lusduna

Iceland

19.11.2018

EU/1/16/1162

Lusduna

Norway

29.10.2018

EU/1/16/1163

Solymbic

Iceland

17.7.2018

EU/1/16/1163

Solymbic

Norway

18.7.2018

EU/2/09/102

Gripovac 3

Iceland

28.8.2018

EU/2/09/102

Gripovac 3

Norway

20.9.2018

EU/2/09/102

Gripovac 3

Liechtenstein

31.10.2018

EU/2/13/155

Trifexis

Norway

19.9.2018

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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 2018:

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

EU-Number

Product

Country

Date of suspension

---