# C_2020308EN.01000901.xml

| 17.9.2020 | EN | Official Journal of the European Union | C 308/9 |
| --- | --- | --- | --- |

17.9.2020

EN

Official Journal of the European Union

C 308/9

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Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2019

(2020/C 308/06)

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 2019, at their meeting on 20 March 2020.

| Annex I | List of new marketing authorisations |
| --- | --- |

Annex I

List of new marketing authorisations

| Annex II | List of renewed marketing authorisations |
| --- | --- |

Annex II

List of renewed marketing authorisations

| Annex III | List of extended marketing authorisations |
| --- | --- |

Annex III

List of extended marketing authorisations

| Annex IV | List of withdrawn marketing authorisations |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

Annex IV

List of withdrawn marketing authorisations

| Annex V | List of suspended 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 2019:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/2/19/240 | Afoxolaner Merial | Iceland | 30.8.2019 |
| EU/1/19/1398 | Arsenic Trioxide Accord | Iceland | 2.12.2019 |
| EU/1/19/1398 | Arsenic Trioxide Accord | Liechtenstein | 31.12.2019 |
| EU/1/19/1398 | Arsenic Trioxide Accord | Norway | 26.11.2019 |
| EU/2/18/228 | Arti-Cell Forte | Iceland | 16.7.2019 |
| EU/1/19/1382 | Azacitidin Celgene | Iceland | 29.8.2019 |
| EU/1/19/1382 | Azacitidin Celgene | Liechtenstein | 31.8.2019 |
| EU/1/19/1382 | Azacitidin Celgene | Norway | 8.8.2019 |
| EU/1/19/1406 | BAQSIMI | Iceland | 30.12.2019 |
| EU/1/19/1406 | BAQSIMI | Liechtenstein | 31.12.2019 |
| EU/1/19/1397 | Bortezomib Fresenius Kabi | Iceland | 29.11.2019 |
| EU/1/19/1397 | Bortezomib Fresenius Kabi | Liechtenstein | 31.12.2019 |
| EU/1/19/1397 | Bortezomib Fresenius Kabi | Norway | 10.12.2019 |
| EU/1/19/1365 | Cufence | Iceland | 9.10.2019 |
| EU/1/19/1365 | Cufence | Liechtenstein | 31.8.2019 |
| EU/1/19/1365 | Cufence | Norway | 12.8.2019 |
| EU/1/19/1386 | Deferasirox Mylan | Iceland | 11.10.2019 |
| EU/1/19/1386 | Deferasirox Mylan | Liechtenstein | 31.10.2019 |
| EU/1/19/1386 | Deferasirox Mylan | Norway | 8.10.2019 |
| EU/1/19/1370 | Dovato | Iceland | 19.7.2019 |
| EU/1/19/1370 | Dovato | Liechtenstein | 31.8.2019 |
| EU/1/19/1370 | Dovato | Norway | 04.07.2019 |
| EU/1/19/1389 | Epidyolex | Iceland | 18.10.2019 |
| EU/1/19/1389 | Epidyolex | Liechtenstein | 31.10.2019 |
| EU/1/19/1389 | Epidyolex | Norway | 16.10.2019 |
| EU/1/19/1392 | Ervebo | Iceland | 4.12.2019 |
| EU/1/19/1392 | Ervebo | Liechtenstein | 31.12.2019 |
| EU/1/19/1392 | Ervebo | Norway | 19.11.2019 |
| EU/1/19/1374 | Esperoct | Liechtenstein | 31.8.2019 |
| EU/1/19/1411 | Evenity | Iceland | 12.12.2019 |
| EU/1/19/1411 | Evenity | Liechtenstein | 31.12.2019 |
| EU/2/19/242 | EVICTO | Iceland | 27.8.2019 |
| EU/2/19/242 | EVICTO | Liechtenstein | 31.8.2019 |
| EU/2/19/242 | EVICTO | Norway | 13.08.2019 |
| EU/1/19/1384 | Giapreza | Iceland | 29.8.2019 |
| EU/1/19/1384 | Giapreza | Liechtenstein | 31.8.2019 |
| EU/1/19/1384 | Giapreza | Norway | 25.09.2019 |
| EU/1/19/1375 | Grasustek | Iceland | 24.7.2019 |
| EU/1/19/1375 | Grasustek | Norway | 31.10.2019 |
| EU/2/19/245 | Gumbohatch | Iceland | 29.11.2019 |
| EU/2/19/245 | Gumbohatch | Liechtenstein | 31.12.2019 |
| EU/2/18/226 | HorStem | Iceland | 16.7.2019 |
| EU/1/17/1216 | Imraldi | Norway | 16.09.2019 |
| EU/1/19/1390 | Inbrija | Iceland | 11.10.2019 |
| EU/1/19/1390 | Inbrija | Liechtenstein | 31.10.2019 |
| EU/1/19/1390 | Inbrija | Norway | 16.10.2019 |
| EU/1/19/1396 | Ivozall | Iceland | 28.11.2019 |
| EU/1/19/1396 | Ivozall | Norway | 26.11.2019 |
| EU/1/19/1383 | Lacosamid UCB | Iceland | 3.9.2019 |
| EU/1/19/1383 | Lacosamid UCB | Liechtenstein | 31.8.2019 |
| EU/1/19/1383 | Lacosamid UCB | Norway | 18.10.2019 |
| EU/1/19/1376 | LIBTAYO | Iceland | 19.7.2019 |
| EU/1/19/1376 | LIBTAYO | Liechtenstein | 31.8.2019 |
| EU/1/19/1376 | LIBTAYO | Norway | 05.8.2019 |
| EU/1/19/1381 | LysaKare | Iceland | 26.8.2019 |
| EU/1/19/1381 | LysaKare | Liechtenstein | 31.8.2019 |
| EU/1/19/1381 | LysaKare | Norway | 12.8.2019 |
| EU/1/18/1301 | Mepsevii | Liechtenstein | 31.8.2019 |
| EU/2/19/247 | Mirataz | Iceland | 30.12.2019 |
| EU/2/19/247 | Mirataz | Liechtenstein | 31.12.2019 |
| EU/2/19/241 | NASYM | Iceland | 27.8.2019 |
| EU/2/19/241 | NASYM | Liechtenstein | 31.8.2019 |
| EU/2/19/241 | NASYM | Norway | 16.8.2019 |
| EU/2/19/246 | Neptra | Iceland | 30.12.2019 |
| EU/2/19/246 | Neptra | Liechtenstein | 31.12.2019 |
| EU/2/19/244 | Nobivac Myxo-RHD Plus | Iceland | 4.12.2019 |
| EU/2/19/244 | Nobivac Myxo-RHD Plus | Liechtenstein | 31.12.2019 |
| EU/1/19/1364 | Nuceiva | Iceland | 18.10.2019 |
| EU/1/19/1364 | Nuceiva | Norway | 18.10.2019 |
| EU/1/18/1320 | Onpattro | Liechtenstein | 31.12.2019 |
| EU/1/19/1388 | Polivy | Liechtenstein | 31.12.2019 |
| EU/1/19/1379 | Posaconazole Accord | Iceland | 28.8.2019 |
| EU/1/19/1379 | Posaconazole Accord | Liechtenstein | 31.8.2019 |
| EU/1/19/1379 | Posaconazole Accord | Norway | 26.8.2019 |
| EU/1/19/1380 | Posaconazole AHCL | Iceland | 27.8.2019 |
| EU/1/19/1380 | Posaconazole AHCL | Liechtenstein | 31.8.2019 |
| EU/1/19/1380 | Posaconazole AHCL | Norway | 12.8.2019 |
| EU/1/19/1401 | Qtrilmet | Iceland | 18.11.2019 |
| EU/1/19/1401 | Qtrilmet | Liechtenstein | 31.12.2019 |
| EU/1/19/1401 | Qtrilmet | Norway | 6.12.2019 |
| EU/1/19/1393 | Quofenix | Iceland | 30.12.2019 |
| EU/1/19/1393 | Quofenix | Liechtenstein | 31.12.2019 |
| EU/1/19/1400 | Rhokiinsa | Iceland | 5.12.2019 |
| EU/1/19/1400 | Rhokiinsa | Norway | 17.12.2019 |
| EU/1/19/1404 | Rinvoq | Iceland | 30.12.2019 |
| EU/1/19/1404 | Rinvoq | Liechtenstein | 31.12.2019 |
| EU/1/19/1387 | Senstend | Iceland | 4.12.2019 |
| EU/1/19/1387 | Senstend | Norway | 4.12.2019 |
| EU/2/19/243 | Simparica Trio | Iceland | 10.10.2019 |
| EU/2/19/243 | Simparica Trio | Liechtenstein | 31.10.2019 |
| EU/2/19/243 | Simparica Trio | Norway | 11.11.2019 |
| EU/1/19/1369 | Sixmo | Iceland | 17.7.2019 |
| EU/1/19/1369 | Sixmo | Norway | 15.7.2019 |
| EU/1/19/1410 | Spravato | Liechtenstein | 31.12.2019 |
| EU/1/19/1372 | Striascan | Iceland | 2.7.2019 |
| EU/1/19/1372 | Striascan | Liechtenstein | 31.8.2019 |
| EU/1/19/1372 | Striascan | Norway | 11.7.2019 |
| EU/1/19/1377 | Talzenna | Iceland | 16.7.2019 |
| EU/1/19/1377 | Talzenna | Norway | 15.7.2019 |
| EU/1/19/1359 | Trogarzo | Iceland | 5.11.2019 |
| EU/1/19/1359 | Trogarzo | Liechtenstein | 31.10.2019 |
| EU/1/19/1359 | Trogarzo | Norway | 18.10.2019 |
| EU/1/19/1371 | Ultomiris | Iceland | 22.7.2019 |
| EU/1/19/1371 | Ultomiris | Liechtenstein | 31.8.2019 |
| EU/1/19/1371 | Ultomiris | Norway | 17.7.2019 |
| EU/1/19/1385 | VITRAKVI | Iceland | 5.11.2019 |
| EU/1/19/1385 | VITRAKVI | Liechtenstein | 31.10.2019 |
| EU/1/19/1385 | VITRAKVI | Norway | 18.10.2019 |
| EU/1/18/1312 | Xerava | Liechtenstein | 31.12.2019 |
| EU/1/19/1399 | Xospata | Iceland | 6.11.2019 |
| EU/1/19/1399 | Xospata | Norway | 30.10.2019 |
| EU/1/19/1366 | Xromi | Iceland | 19.7.2019 |
| EU/1/19/1366 | Xromi | Liechtenstein | 31.8.2019 |
| EU/1/19/1366 | Xromi | Norway | 17.7.2019 |

EU-Number

Product

Country

Date of authorisation

EU/2/19/240

Afoxolaner Merial

Iceland

30.8.2019

EU/1/19/1398

Arsenic Trioxide Accord

Iceland

2.12.2019

EU/1/19/1398

Arsenic Trioxide Accord

Liechtenstein

31.12.2019

EU/1/19/1398

Arsenic Trioxide Accord

Norway

26.11.2019

EU/2/18/228

Arti-Cell Forte

Iceland

16.7.2019

EU/1/19/1382

Azacitidin Celgene

Iceland

29.8.2019

EU/1/19/1382

Azacitidin Celgene

Liechtenstein

31.8.2019

EU/1/19/1382

Azacitidin Celgene

Norway

8.8.2019

EU/1/19/1406

BAQSIMI

Iceland

30.12.2019

EU/1/19/1406

BAQSIMI

Liechtenstein

31.12.2019

EU/1/19/1397

Bortezomib Fresenius Kabi

Iceland

29.11.2019

EU/1/19/1397

Bortezomib Fresenius Kabi

Liechtenstein

31.12.2019

EU/1/19/1397

Bortezomib Fresenius Kabi

Norway

10.12.2019

EU/1/19/1365

Cufence

Iceland

9.10.2019

EU/1/19/1365

Cufence

Liechtenstein

31.8.2019

EU/1/19/1365

Cufence

Norway

12.8.2019

EU/1/19/1386

Deferasirox Mylan

Iceland

11.10.2019

EU/1/19/1386

Deferasirox Mylan

Liechtenstein

31.10.2019

EU/1/19/1386

Deferasirox Mylan

Norway

8.10.2019

EU/1/19/1370

Dovato

Iceland

19.7.2019

EU/1/19/1370

Dovato

Liechtenstein

31.8.2019

EU/1/19/1370

Dovato

Norway

04.07.2019

EU/1/19/1389

Epidyolex

Iceland

18.10.2019

EU/1/19/1389

Epidyolex

Liechtenstein

31.10.2019

EU/1/19/1389

Epidyolex

Norway

16.10.2019

EU/1/19/1392

Ervebo

Iceland

4.12.2019

EU/1/19/1392

Ervebo

Liechtenstein

31.12.2019

EU/1/19/1392

Ervebo

Norway

19.11.2019

EU/1/19/1374

Esperoct

Liechtenstein

31.8.2019

EU/1/19/1411

Evenity

Iceland

12.12.2019

EU/1/19/1411

Evenity

Liechtenstein

31.12.2019

EU/2/19/242

EVICTO

Iceland

27.8.2019

EU/2/19/242

EVICTO

Liechtenstein

31.8.2019

EU/2/19/242

EVICTO

Norway

13.08.2019

EU/1/19/1384

Giapreza

Iceland

29.8.2019

EU/1/19/1384

Giapreza

Liechtenstein

31.8.2019

EU/1/19/1384

Giapreza

Norway

25.09.2019

EU/1/19/1375

Grasustek

Iceland

24.7.2019

EU/1/19/1375

Grasustek

Norway

31.10.2019

EU/2/19/245

Gumbohatch

Iceland

29.11.2019

EU/2/19/245

Gumbohatch

Liechtenstein

31.12.2019

EU/2/18/226

HorStem

Iceland

16.7.2019

EU/1/17/1216

Imraldi

Norway

16.09.2019

EU/1/19/1390

Inbrija

Iceland

11.10.2019

EU/1/19/1390

Inbrija

Liechtenstein

31.10.2019

EU/1/19/1390

Inbrija

Norway

16.10.2019

EU/1/19/1396

Ivozall

Iceland

28.11.2019

EU/1/19/1396

Ivozall

Norway

26.11.2019

EU/1/19/1383

Lacosamid UCB

Iceland

3.9.2019

EU/1/19/1383

Lacosamid UCB

Liechtenstein

31.8.2019

EU/1/19/1383

Lacosamid UCB

Norway

18.10.2019

EU/1/19/1376

LIBTAYO

Iceland

19.7.2019

EU/1/19/1376

LIBTAYO

Liechtenstein

31.8.2019

EU/1/19/1376

LIBTAYO

Norway

05.8.2019

EU/1/19/1381

LysaKare

Iceland

26.8.2019

EU/1/19/1381

LysaKare

Liechtenstein

31.8.2019

EU/1/19/1381

LysaKare

Norway

12.8.2019

EU/1/18/1301

Mepsevii

Liechtenstein

31.8.2019

EU/2/19/247

Mirataz

Iceland

30.12.2019

EU/2/19/247

Mirataz

Liechtenstein

31.12.2019

EU/2/19/241

NASYM

Iceland

27.8.2019

EU/2/19/241

NASYM

Liechtenstein

31.8.2019

EU/2/19/241

NASYM

Norway

16.8.2019

EU/2/19/246

Neptra

Iceland

30.12.2019

EU/2/19/246

Neptra

Liechtenstein

31.12.2019

EU/2/19/244

Nobivac Myxo-RHD Plus

Iceland

4.12.2019

EU/2/19/244

Nobivac Myxo-RHD Plus

Liechtenstein

31.12.2019

EU/1/19/1364

Nuceiva

Iceland

18.10.2019

EU/1/19/1364

Nuceiva

Norway

18.10.2019

EU/1/18/1320

Onpattro

Liechtenstein

31.12.2019

EU/1/19/1388

Polivy

Liechtenstein

31.12.2019

EU/1/19/1379

Posaconazole Accord

Iceland

28.8.2019

EU/1/19/1379

Posaconazole Accord

Liechtenstein

31.8.2019

EU/1/19/1379

Posaconazole Accord

Norway

26.8.2019

EU/1/19/1380

Posaconazole AHCL

Iceland

27.8.2019

EU/1/19/1380

Posaconazole AHCL

Liechtenstein

31.8.2019

EU/1/19/1380

Posaconazole AHCL

Norway

12.8.2019

EU/1/19/1401

Qtrilmet

Iceland

18.11.2019

EU/1/19/1401

Qtrilmet

Liechtenstein

31.12.2019

EU/1/19/1401

Qtrilmet

Norway

6.12.2019

EU/1/19/1393

Quofenix

Iceland

30.12.2019

EU/1/19/1393

Quofenix

Liechtenstein

31.12.2019

EU/1/19/1400

Rhokiinsa

Iceland

5.12.2019

EU/1/19/1400

Rhokiinsa

Norway

17.12.2019

EU/1/19/1404

Rinvoq

Iceland

30.12.2019

EU/1/19/1404

Rinvoq

Liechtenstein

31.12.2019

EU/1/19/1387

Senstend

Iceland

4.12.2019

EU/1/19/1387

Senstend

Norway

4.12.2019

EU/2/19/243

Simparica Trio

Iceland

10.10.2019

EU/2/19/243

Simparica Trio

Liechtenstein

31.10.2019

EU/2/19/243

Simparica Trio

Norway

11.11.2019

EU/1/19/1369

Sixmo

Iceland

17.7.2019

EU/1/19/1369

Sixmo

Norway

15.7.2019

EU/1/19/1410

Spravato

Liechtenstein

31.12.2019

EU/1/19/1372

Striascan

Iceland

2.7.2019

EU/1/19/1372

Striascan

Liechtenstein

31.8.2019

EU/1/19/1372

Striascan

Norway

11.7.2019

EU/1/19/1377

Talzenna

Iceland

16.7.2019

EU/1/19/1377

Talzenna

Norway

15.7.2019

EU/1/19/1359

Trogarzo

Iceland

5.11.2019

EU/1/19/1359

Trogarzo

Liechtenstein

31.10.2019

EU/1/19/1359

Trogarzo

Norway

18.10.2019

EU/1/19/1371

Ultomiris

Iceland

22.7.2019

EU/1/19/1371

Ultomiris

Liechtenstein

31.8.2019

EU/1/19/1371

Ultomiris

Norway

17.7.2019

EU/1/19/1385

VITRAKVI

Iceland

5.11.2019

EU/1/19/1385

VITRAKVI

Liechtenstein

31.10.2019

EU/1/19/1385

VITRAKVI

Norway

18.10.2019

EU/1/18/1312

Xerava

Liechtenstein

31.12.2019

EU/1/19/1399

Xospata

Iceland

6.11.2019

EU/1/19/1399

Xospata

Norway

30.10.2019

EU/1/19/1366

Xromi

Iceland

19.7.2019

EU/1/19/1366

Xromi

Liechtenstein

31.8.2019

EU/1/19/1366

Xromi

Norway

17.7.2019

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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 2019:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/14/944 | Abasaglar | Iceland | 28.8.2019 |
| EU/1/14/944 | Abasaglar | Liechtenstein | 31.8.2019 |
| EU/1/14/944 | Abasaglar | Norway | 16.8.2019 |
| EU/1/12/794 | ADCETRIS | Iceland | 18.10.2019 |
| EU/1/12/794 | ADCETRIS | Norway | 29.10.2019 |
| EU/1/09/578 | Adjupanrix | Iceland | 29.8.2019 |
| EU/1/09/578 | Adjupanrix | Norway | 12.8.2019 |
| EU/1/17/1214 | Bavencio | Liechtenstein | 31.10.2019 |
| EU/2/14/176 | Bovela | Iceland | 15.11.2019 |
| EU/2/14/176 | Bovela | Liechtenstein | 31.12.2019 |
| EU/2/14/176 | Bovela | Norway | 27.11.2019 |
| EU/1/14/963 | Brimica Genuair | Iceland | 29.8.2019 |
| EU/1/14/963 | Brimica Genuair | Liechtenstein | 31.8.2019 |
| EU/1/14/963 | Brimica Genuair | Norway | 20.09.2019 |
| EU/1/14/951 | Busulfan Fresenius Kabi | Norway | 15.07.2019 |
| EU/1/14/974 | Cerdelga | Iceland | 30.12.2019 |
| EU/1/14/974 | Cerdelga | Liechtenstein | 31.12.2019 |
| EU/1/14/975 | Clopidogrel ratiopharm | Iceland | 15.11.2019 |
| EU/1/14/975 | Clopidogrel ratiopharm | Liechtenstein | 31.12.2019 |
| EU/1/14/975 | Clopidogrel ratiopharm | Norway | 9.12.2019 |
| EU/1/13/890 | Cometriq | Norway | 3.07.2019 |
| EU/1/14/980 | Cosentyx | Iceland | 10.9.2019 |
| EU/1/14/980 | Cosentyx | Liechtenstein | 31.10.2019 |
| EU/1/14/980 | Cosentyx | Norway | 18.09.2019 |
| EU/1/17/1262 | Crysvita | Iceland | 27.12.2019 |
| EU/1/17/1262 | Crysvita | Liechtenstein | 31.12.2019 |
| EU/1/14/957 | Cyramza | Iceland | 10.10.2019 |
| EU/1/14/957 | Cyramza | Norway | 3.10.2019 |
| EU/1/14/964 | Duaklir Genuair | Iceland | 29.8.2019 |
| EU/1/14/964 | Duaklir Genuair | Liechtenstein | 31.8.2019 |
| EU/1/14/964 | Duaklir Genuair | Norway | 20.09.2019 |
| EU/1/14/960 | DUAVIVE | Iceland | 15.11.2019 |
| EU/1/14/960 | DUAVIVE | Liechtenstein | 31.12.2019 |
| EU/1/14/960 | DUAVIVE | Norway | 9.12.2019 |
| EU/1/14/972 | Duloxetin Lilly | Iceland | 28.8.2019 |
| EU/1/14/972 | Duloxetin Lilly | Liechtenstein | 31.8.2019 |
| EU/1/14/972 | Duloxetin Lilly | Norway | 30.8.2019 |
| EU/1/14/983 | Exviera | Iceland | 10.10.2019 |
| EU/1/14/983 | Exviera | Norway | 18.10.2019 |
| EU/1/09/601 | Firdapse | Iceland | 30.8.2019 |
| EU/1/09/601 | Firdapse | Liechtenstein | 31.8.2019 |
| EU/1/09/601 | Firdapse | Norway | 18.9.2019 |
| EU/1/14/958 | Harvoni | Iceland | 29.8.2019 |
| EU/1/14/958 | Harvoni | Liechtenstein | 31.8.2019 |
| EU/1/14/958 | Harvoni | Norway | 16.8.2019 |
| EU/1/14/945 | IMBRUVICA | Iceland | 16.7.2019 |
| EU/1/14/945 | IMBRUVICA | Liechtenstein | 31.8.2019 |
| EU/1/14/945 | IMBRUVICA | Norway | 2.7.2019 |
| EU/1/09/531 | Instanyl | Iceland | 23.7.2019 |
| EU/1/09/531 | Instanyl | Liechtenstein | 31.8.2019 |
| EU/1/09/531 | Instanyl | Norway | 16.7.2019 |
| EU/1/15/994 | Kengrexal | Iceland | 27.12.2019 |
| EU/1/15/994 | Kengrexal | Liechtenstein | 31.12.2019 |
| EU/1/14/965 | Ketoconazole HRA | Iceland | 5.9.2019 |
| EU/1/14/965 | Ketoconazole HRA | Liechtenstein | 31.8.2019 |
| EU/1/14/965 | Ketoconazole HRA | Norway | 12.8.2019 |
| EU/1/14/955 | Lymphoseek | Iceland | 18.10.2019 |
| EU/1/14/955 | Lymphoseek | Norway | 25.9.2019 |
| EU/1/14/959 | Lynparza | Iceland | 10.10.2019 |
| EU/1/14/959 | Lynparza | Norway | 18.10.2019 |
| EU/1/14/962 | Moventig | Iceland | 9.10.2019 |
| EU/1/14/962 | Moventig | Norway | 31.10.2019 |
| EU/1/09/591 | Multaq | Iceland | 9.10.2019 |
| EU/1/09/591 | Multaq | Norway | 21.10.2019 |
| EU/2/14/177 | Nexgard Spectra | Iceland | 15.11.2019 |
| EU/2/14/177 | Nexgard Spectra | Liechtenstein | 31.12.2019 |
| EU/2/14/177 | Nexgard Spectra | Norway | 27.11.2019 |
| EU/1/16/1094 | Ninlaro | Iceland | 18.10.2019 |
| EU/1/14/979 | Ofev | Iceland | 18.10.2019 |
| EU/1/14/979 | Ofev | Norway | 21.10.2019 |
| EU/2/14/170 | Osurnia | Iceland | 22.7.2019 |
| EU/2/14/170 | Osurnia | Liechtenstein | 31.8.2019 |
| EU/2/14/170 | Osurnia | Norway | 16.7.2019 |
| EU/1/14/981 | Otezla | Iceland | 30.8.2019 |
| EU/1/14/981 | Otezla | Liechtenstein | 31.8.2019 |
| EU/1/14/981 | Otezla | Norway | 28.9.2019 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 AstraZeneca | Norway | 8.7.2019 |
| EU/2/14/175 | Porcilis PCV M Hyo | Iceland | 9.10.2019 |
| EU/2/14/175 | Porcilis PCV M Hyo | Norway | 14.10.2019 |
| EU/1/14/977 | Rasagiline ratiopharm | Iceland | 21.10.2019 |
| EU/1/14/967 | Rezolsta | Iceland | 28.8.2019 |
| EU/1/14/967 | Rezolsta | Liechtenstein | 31.8.2019 |
| EU/1/14/967 | Rezolsta | Norway | 16.8.2019 |
| EU/1/14/970 | RIXUBIS | Iceland | 5.12.2019 |
| EU/1/15/992 | Saxenda | Iceland | 27.12.2019 |
| EU/1/15/992 | Saxenda | Liechtenstein | 31.12.2019 |
| EU/1/14/969 | SCENESSE | Iceland | 5.12.2019 |
| EU/1/14/969 | SCENESSE | Liechtenstein | 31.12.2019 |
| EU/1/14/969 | SCENESSE | Norway | 6.12.2019 |
| EU/1/14/978 | Senshio | Iceland | 6.11.2019 |
| EU/1/14/978 | Senshio | Liechtenstein | 31.10.2019 |
| EU/1/14/978 | Senshio | Norway | 21.11.2019 |
| EU/1/14/952 | Sevelamer carbonate Winthrop | Iceland | 15.11.2019 |
| EU/1/14/952 | Sevelamer carbonate Winthrop | Liechtenstein | 31.12.2019 |
| EU/1/14/952 | Sevelamer carbonate Winthrop | Norway | 27.11.2019 |
| EU/2/14/179 | Suvaxyn CSF Marker | Iceland | 15.11.2019 |
| EU/2/14/179 | Suvaxyn CSF Marker | Liechtenstein | 31.12.2019 |
| EU/2/14/179 | Suvaxyn CSF Marker | Norway | 27.11.2019 |
| EU/1/14/961 | Tadalafil Mylan | Iceland | 28.8.2019 |
| EU/1/14/961 | Tadalafil Mylan | Liechtenstein | 31.8.2019 |
| EU/1/14/961 | Tadalafil Mylan | Norway | 12.8.2019 |
| EU/1/13/902 | Translarna | Iceland | 28.8.2019 |
| EU/1/13/902 | Translarna | Liechtenstein | 31.8.2019 |
| EU/1/13/902 | Translarna | Norway | 26.8.2019 |
| EU/1/14/971 | TREVICTA | Iceland | 6.12.2019 |
| EU/1/14/971 | TREVICTA | Norway | 4.12.2019 |
| EU/1/14/940 | Triumeq | Iceland | 21.10.2019 |
| EU/1/14/940 | Triumeq | Norway | 16.8.2019 |
| EU/1/14/956 | Trulicity | Iceland | 29.8.2019 |
| EU/1/14/956 | Trulicity | Liechtenstein | 31.8.2019 |
| EU/1/14/956 | Trulicity | Norway | 25.9.2019 |
| EU/1/07/440 | Tyverb | Iceland | 9.10.2019 |
| EU/1/07/440 | Tyverb | Norway | 21.10.2019 |
| EU/1/14/954 | Vargatef | Iceland | 29.8.2019 |
| EU/1/14/954 | Vargatef | Liechtenstein | 31.8.2019 |
| EU/1/14/954 | Vargatef | Norway | 2.9.2019 |
| EU/1/07/423 | Vectibix | Iceland | 9.10.2019 |
| EU/1/07/423 | Vectibix | Norway | 21.10.2019 |
| EU/1/14/982 | Viekirax | Iceland | 18.10.2019 |
| EU/1/14/982 | Viekirax | Norway | 18.10.2019 |
| EU/1/14/941 | Vizamyl | Iceland | 28.8.2019 |
| EU/1/14/941 | Vizamyl | Liechtenstein | 31.8.2019 |
| EU/1/14/941 | Vizamyl | Norway | 12.8.2019 |
| EU/1/14/984 | Xadago | Iceland | 9.10.2019 |
| EU/1/14/947 | Xultophy | Iceland | 21.10.2019 |
| EU/1/14/947 | Xultophy | Norway | 7.8.2019 |
| EU/1/14/986 | Xydalba | Iceland | 12.12.2019 |
| EU/1/14/986 | Xydalba | Liechtenstein | 31.12.2019 |

EU-Number

Product

Country

Date of authorisation

EU/1/14/944

Abasaglar

Iceland

28.8.2019

EU/1/14/944

Abasaglar

Liechtenstein

31.8.2019

EU/1/14/944

Abasaglar

Norway

16.8.2019

EU/1/12/794

ADCETRIS

Iceland

18.10.2019

EU/1/12/794

ADCETRIS

Norway

29.10.2019

EU/1/09/578

Adjupanrix

Iceland

29.8.2019

EU/1/09/578

Adjupanrix

Norway

12.8.2019

EU/1/17/1214

Bavencio

Liechtenstein

31.10.2019

EU/2/14/176

Bovela

Iceland

15.11.2019

EU/2/14/176

Bovela

Liechtenstein

31.12.2019

EU/2/14/176

Bovela

Norway

27.11.2019

EU/1/14/963

Brimica Genuair

Iceland

29.8.2019

EU/1/14/963

Brimica Genuair

Liechtenstein

31.8.2019

EU/1/14/963

Brimica Genuair

Norway

20.09.2019

EU/1/14/951

Busulfan Fresenius Kabi

Norway

15.07.2019

EU/1/14/974

Cerdelga

Iceland

30.12.2019

EU/1/14/974

Cerdelga

Liechtenstein

31.12.2019

EU/1/14/975

Clopidogrel ratiopharm

Iceland

15.11.2019

EU/1/14/975

Clopidogrel ratiopharm

Liechtenstein

31.12.2019

EU/1/14/975

Clopidogrel ratiopharm

Norway

9.12.2019

EU/1/13/890

Cometriq

Norway

3.07.2019

EU/1/14/980

Cosentyx

Iceland

10.9.2019

EU/1/14/980

Cosentyx

Liechtenstein

31.10.2019

EU/1/14/980

Cosentyx

Norway

18.09.2019

EU/1/17/1262

Crysvita

Iceland

27.12.2019

EU/1/17/1262

Crysvita

Liechtenstein

31.12.2019

EU/1/14/957

Cyramza

Iceland

10.10.2019

EU/1/14/957

Cyramza

Norway

3.10.2019

EU/1/14/964

Duaklir Genuair

Iceland

29.8.2019

EU/1/14/964

Duaklir Genuair

Liechtenstein

31.8.2019

EU/1/14/964

Duaklir Genuair

Norway

20.09.2019

EU/1/14/960

DUAVIVE

Iceland

15.11.2019

EU/1/14/960

DUAVIVE

Liechtenstein

31.12.2019

EU/1/14/960

DUAVIVE

Norway

9.12.2019

EU/1/14/972

Duloxetin Lilly

Iceland

28.8.2019

EU/1/14/972

Duloxetin Lilly

Liechtenstein

31.8.2019

EU/1/14/972

Duloxetin Lilly

Norway

30.8.2019

EU/1/14/983

Exviera

Iceland

10.10.2019

EU/1/14/983

Exviera

Norway

18.10.2019

EU/1/09/601

Firdapse

Iceland

30.8.2019

EU/1/09/601

Firdapse

Liechtenstein

31.8.2019

EU/1/09/601

Firdapse

Norway

18.9.2019

EU/1/14/958

Harvoni

Iceland

29.8.2019

EU/1/14/958

Harvoni

Liechtenstein

31.8.2019

EU/1/14/958

Harvoni

Norway

16.8.2019

EU/1/14/945

IMBRUVICA

Iceland

16.7.2019

EU/1/14/945

IMBRUVICA

Liechtenstein

31.8.2019

EU/1/14/945

IMBRUVICA

Norway

2.7.2019

EU/1/09/531

Instanyl

Iceland

23.7.2019

EU/1/09/531

Instanyl

Liechtenstein

31.8.2019

EU/1/09/531

Instanyl

Norway

16.7.2019

EU/1/15/994

Kengrexal

Iceland

27.12.2019

EU/1/15/994

Kengrexal

Liechtenstein

31.12.2019

EU/1/14/965

Ketoconazole HRA

Iceland

5.9.2019

EU/1/14/965

Ketoconazole HRA

Liechtenstein

31.8.2019

EU/1/14/965

Ketoconazole HRA

Norway

12.8.2019

EU/1/14/955

Lymphoseek

Iceland

18.10.2019

EU/1/14/955

Lymphoseek

Norway

25.9.2019

EU/1/14/959

Lynparza

Iceland

10.10.2019

EU/1/14/959

Lynparza

Norway

18.10.2019

EU/1/14/962

Moventig

Iceland

9.10.2019

EU/1/14/962

Moventig

Norway

31.10.2019

EU/1/09/591

Multaq

Iceland

9.10.2019

EU/1/09/591

Multaq

Norway

21.10.2019

EU/2/14/177

Nexgard Spectra

Iceland

15.11.2019

EU/2/14/177

Nexgard Spectra

Liechtenstein

31.12.2019

EU/2/14/177

Nexgard Spectra

Norway

27.11.2019

EU/1/16/1094

Ninlaro

Iceland

18.10.2019

EU/1/14/979

Ofev

Iceland

18.10.2019

EU/1/14/979

Ofev

Norway

21.10.2019

EU/2/14/170

Osurnia

Iceland

22.7.2019

EU/2/14/170

Osurnia

Liechtenstein

31.8.2019

EU/2/14/170

Osurnia

Norway

16.7.2019

EU/1/14/981

Otezla

Iceland

30.8.2019

EU/1/14/981

Otezla

Liechtenstein

31.8.2019

EU/1/14/981

Otezla

Norway

28.9.2019

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Norway

8.7.2019

EU/2/14/175

Porcilis PCV M Hyo

Iceland

9.10.2019

EU/2/14/175

Porcilis PCV M Hyo

Norway

14.10.2019

EU/1/14/977

Rasagiline ratiopharm

Iceland

21.10.2019

EU/1/14/967

Rezolsta

Iceland

28.8.2019

EU/1/14/967

Rezolsta

Liechtenstein

31.8.2019

EU/1/14/967

Rezolsta

Norway

16.8.2019

EU/1/14/970

RIXUBIS

Iceland

5.12.2019

EU/1/15/992

Saxenda

Iceland

27.12.2019

EU/1/15/992

Saxenda

Liechtenstein

31.12.2019

EU/1/14/969

SCENESSE

Iceland

5.12.2019

EU/1/14/969

SCENESSE

Liechtenstein

31.12.2019

EU/1/14/969

SCENESSE

Norway

6.12.2019

EU/1/14/978

Senshio

Iceland

6.11.2019

EU/1/14/978

Senshio

Liechtenstein

31.10.2019

EU/1/14/978

Senshio

Norway

21.11.2019

EU/1/14/952

Sevelamer carbonate Winthrop

Iceland

15.11.2019

EU/1/14/952

Sevelamer carbonate Winthrop

Liechtenstein

31.12.2019

EU/1/14/952

Sevelamer carbonate Winthrop

Norway

27.11.2019

EU/2/14/179

Suvaxyn CSF Marker

Iceland

15.11.2019

EU/2/14/179

Suvaxyn CSF Marker

Liechtenstein

31.12.2019

EU/2/14/179

Suvaxyn CSF Marker

Norway

27.11.2019

EU/1/14/961

Tadalafil Mylan

Iceland

28.8.2019

EU/1/14/961

Tadalafil Mylan

Liechtenstein

31.8.2019

EU/1/14/961

Tadalafil Mylan

Norway

12.8.2019

EU/1/13/902

Translarna

Iceland

28.8.2019

EU/1/13/902

Translarna

Liechtenstein

31.8.2019

EU/1/13/902

Translarna

Norway

26.8.2019

EU/1/14/971

TREVICTA

Iceland

6.12.2019

EU/1/14/971

TREVICTA

Norway

4.12.2019

EU/1/14/940

Triumeq

Iceland

21.10.2019

EU/1/14/940

Triumeq

Norway

16.8.2019

EU/1/14/956

Trulicity

Iceland

29.8.2019

EU/1/14/956

Trulicity

Liechtenstein

31.8.2019

EU/1/14/956

Trulicity

Norway

25.9.2019

EU/1/07/440

Tyverb

Iceland

9.10.2019

EU/1/07/440

Tyverb

Norway

21.10.2019

EU/1/14/954

Vargatef

Iceland

29.8.2019

EU/1/14/954

Vargatef

Liechtenstein

31.8.2019

EU/1/14/954

Vargatef

Norway

2.9.2019

EU/1/07/423

Vectibix

Iceland

9.10.2019

EU/1/07/423

Vectibix

Norway

21.10.2019

EU/1/14/982

Viekirax

Iceland

18.10.2019

EU/1/14/982

Viekirax

Norway

18.10.2019

EU/1/14/941

Vizamyl

Iceland

28.8.2019

EU/1/14/941

Vizamyl

Liechtenstein

31.8.2019

EU/1/14/941

Vizamyl

Norway

12.8.2019

EU/1/14/984

Xadago

Iceland

9.10.2019

EU/1/14/947

Xultophy

Iceland

21.10.2019

EU/1/14/947

Xultophy

Norway

7.8.2019

EU/1/14/986

Xydalba

Iceland

12.12.2019

EU/1/14/986

Xydalba

Liechtenstein

31.12.2019

---

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 2019:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/13/853/006-014 | Remsima | Iceland | 5.12.2019 |
| EU/1/15/1043/003-006 | Nucala | Iceland | 28.8.2019 |
| EU/1/15/1043/003-006 | Nucala | Norway | 31.7.2019 |
| | | | |
| EU/1/17/1216/009 | Imraldi | Iceland | 30.8.2019 |
| EU/1/17/1220/002 | Tecentriq | Iceland | 30.8.2019 |
| EU/1/17/1220/002 | Tecentriq | Norway | 26.8.2019 |
| | | | |
| EU/1/12/782/006 | Kalydeco | Norway | 17.12.2019 |

EU-Number

Product

Country

Date of authorisation

EU/1/13/853/006-014

Remsima

Iceland

5.12.2019

EU/1/15/1043/003-006

Nucala

Iceland

28.8.2019

EU/1/15/1043/003-006

Nucala

Norway

31.7.2019

EU/1/17/1216/009

Imraldi

Iceland

30.8.2019

EU/1/17/1220/002

Tecentriq

Iceland

30.8.2019

EU/1/17/1220/002

Tecentriq

Norway

26.8.2019

EU/1/12/782/006

Kalydeco

Norway

17.12.2019

---

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 2019:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/16/1122 | Aerivio Spiromax | Iceland | 21.10.2019 |
| EU/1/16/1122 | Aerivio Spiromax | Norway | 29.10.2019 |
| EU/1/07/390 | Altargo | Iceland | 28.8.2019 |
| EU/2/99/017 | Bovalto Ibraxion | Iceland | 16.7.2019 |
| EU/1/14/939 | Daklinza | Iceland | 13.12.2019 |
| EU/1/15/1077 | Iblias | Iceland | 10.9.2019 |
| EU/1/15/1077 | Iblias | Liechtenstein | 31.10.2019 |
| EU/1/15/1077 | Iblias | Norway | 3.9.2019 |
| EU/2/17/208 | Ingelvac PCV FLEX | Norway | 23.08.2019 |
| EU/1/19/1357 | Kromeya | Liechtenstein | 31.12.2019 |
| EU/1/19/1357 | Kromeya | Norway | 17.12.2019 |
| EU/1/16/1143 | Lartruvo | Iceland | 26.8.2019 |
| EU/1/16/1143 | Lartruvo | Liechtenstein | 31.8.2019 |
| EU/1/16/1143 | Lartruvo | Norway | 5.8.2019 |
| EU/1/13/847 | MACI | Iceland | 6.11.2019 |
| EU/1/16/1100 | Palonosetron Hospira | Iceland | 2.7.2019 |
| EU/1/16/1100 | Palonosetron Hospira | Norway | 23.8.2019 |
| EU/1/13/849 | Somatropin Biopartners | Norway | 26.8.2019 |
| EU/1/16/1131 | Thorinane | Iceland | 6.11.2019 |
| EU/1/09/552 | Topotecan Teva | Norway | 23.08.2019 |
| EU/1/16/1121 | Zalmoxis | Iceland | 18.10.2019 |
| EU/1/16/1121 | Zalmoxis | Norway | 30.10.2019 |

EU-Number

Product

Country

Date of withdrawal

EU/1/16/1122

Aerivio Spiromax

Iceland

21.10.2019

EU/1/16/1122

Aerivio Spiromax

Norway

29.10.2019

EU/1/07/390

Altargo

Iceland

28.8.2019

EU/2/99/017

Bovalto Ibraxion

Iceland

16.7.2019

EU/1/14/939

Daklinza

Iceland

13.12.2019

EU/1/15/1077

Iblias

Iceland

10.9.2019

EU/1/15/1077

Iblias

Liechtenstein

31.10.2019

EU/1/15/1077

Iblias

Norway

3.9.2019

EU/2/17/208

Ingelvac PCV FLEX

Norway

23.08.2019

EU/1/19/1357

Kromeya

Liechtenstein

31.12.2019

EU/1/19/1357

Kromeya

Norway

17.12.2019

EU/1/16/1143

Lartruvo

Iceland

26.8.2019

EU/1/16/1143

Lartruvo

Liechtenstein

31.8.2019

EU/1/16/1143

Lartruvo

Norway

5.8.2019

EU/1/13/847

MACI

Iceland

6.11.2019

EU/1/16/1100

Palonosetron Hospira

Iceland

2.7.2019

EU/1/16/1100

Palonosetron Hospira

Norway

23.8.2019

EU/1/13/849

Somatropin Biopartners

Norway

26.8.2019

EU/1/16/1131

Thorinane

Iceland

6.11.2019

EU/1/09/552

Topotecan Teva

Norway

23.08.2019

EU/1/16/1121

Zalmoxis

Iceland

18.10.2019

EU/1/16/1121

Zalmoxis

Norway

30.10.2019

---

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 2019:

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

EU-Number

Product

Country

Date of suspension

---