# C_2020123EN.01002101.xml

| 16.4.2020 | EN | Official Journal of the European Union | C 123/21 |
| --- | --- | --- | --- |

16.4.2020

EN

Official Journal of the European Union

C 123/21

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

(2020/C 123/07)

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 2019, at their meeting on 25 October 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| Annex IV | List of withdrawn marketing authorisations |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List of withdrawn marketing authorisations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 January-30 June 2019:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/16/1138 | Venclyxto | Norway | 7.2.2019 |
| EU/1/18/1291 | Rizmoic | Liechtenstein | 28.2.2019 |
| EU/1/18/1291 | Rizmoic | Norway | 1.3.2019 |
| EU/1/18/1291 | Rizmoic | Iceland | 21.2.2019 |
| EU/1/18/1292 | Apealea | Norway | 7.1.2019 |
| EU/1/18/1306 | Symkevi | Liechtenstein | 28.2.2019 |
| EU/1/18/1317 | Pazenir | Liechtenstein | 30.6.2019 |
| EU/1/18/1317 | Pazenir | Norway | 23.5.2019 |
| EU/1/18/1317 | Pazenir | Iceland | 12.6.2019 |
| EU/1/18/1325 | Namuscla | Norway | 3.1.2019 |
| EU/1/18/1325 | Namuscla | Iceland | 9.1.2019 |
| EU/1/18/1326 | Flucelvax Tetra | Norway | 4.1.2019 |
| EU/1/18/1326 | Flucelvax Tetra | Iceland | 9.1.2019 |
| EU/1/18/1331 | Luxturna | Liechtenstein | 28.2.2019 |
| EU/1/18/1337 | Macimorelin Aeterna Zentaris | Liechtenstein | 28.2.2019 |
| EU/1/18/1337 | Macimorelin Aeterna Zentaris | Norway | 23.1.2019 |
| EU/1/18/1337 | Macimorelin Aeterna Zentaris | Iceland | 22.1.2019 |
| EU/1/18/1338 | Dengvaxia | Norway | 4.1.2019 |
| EU/1/18/1338 | Dengvaxia | Iceland | 8.1.2019 |
| EU/1/18/1339 | Bevespi Aeroshere | Norway | 4.1.2019 |
| EU/1/18/1339 | Bevespi Aerosphere | Iceland | 9.1.2019 |
| EU/1/18/1341 | Ogivri | Norway | 4.1.2019 |
| EU/1/18/1341 | Ogivri | Iceland | 8.1.2019 |
| EU/1/18/1342 | Erleada | Liechtenstein | 28.2.2019 |
| EU/1/18/1342 | Erleada | Norway | 23.1.2019 |
| EU/1/18/1342 | Erleada | Iceland | 22.1.2019 |
| EU/1/18/1343 | Silodosin Recordati | Liechtenstein | 28.2.2019 |
| EU/1/18/1343 | Silodosin Recordati | Norway | 23.1.2019 |
| EU/1/18/1343 | Silodosin Recordati | Iceland | 24.1.2019 |
| EU/1/18/1344 | Zirabev | Liechtenstein | 28.2.2019 |
| EU/1/18/1344 | Zirabev | Norway | 25.2.2019 |
| EU/1/18/1344 | Zirabev | Iceland | 22.2.2019 |
| EU/1/18/1345 | Ondexxya | Liechtenstein | 30.6.2019 |
| EU/1/18/1345 | Ondexxya | Norway | 14.5.2019 |
| EU/1/18/1345 | Ondexxya | Iceland | 14.6.2019 |
| EU/1/18/1346 | Miglustat Dipharma | Liechtenstein | 28.2.2019 |
| EU/1/18/1346 | Miglustat Dipharma | Norway | 1.3.2019 |
| EU/1/18/1346 | Miglustat Dipharma | Iceland | 21.2.2019 |
| EU/1/18/1347 | Febuxostat Krka | Liechtenstein | 30.4.2019 |
| EU/1/18/1347 | Febuxostat Krka | Norway | 24.4.2019 |
| EU/1/18/1347 | Febuxostat Krka | Iceland | 29.5.2019 |
| EU/1/18/1348 | Lusutrombopag Shionogi | Liechtenstein | 28.2.2019 |
| EU/1/18/1348 | Lusutrombopag Shionogi | Norway | 4.3.2019 |
| EU/1/18/1348 | Lusutrombopag Shionogi | Iceland | 22.2.2019 |
| EU/1/18/1349 | Dectova | Liechtenstein | 30.6.2019 |
| EU/1/18/1349 | Dectova | Norway | 10.5.2019 |
| EU/1/18/1349 | Dectova | Iceland | 26.6.2019 |
| EU/1/18/1350 | Tobramycin PARI | Liechtenstein | 28.2.2019 |
| EU/1/18/1350 | Tobramycin PARI | Norway | 1.3.2019 |
| EU/1/18/1350 | Tobramycin PARI | Iceland | 22.2.2019 |
| EU/1/18/1351 | Trecondi | Liechtenstein | 30.6.2019 |
| EU/1/18/1351 | Trecondi | Iceland | 26.6.2019 |
| EU/1/18/1352 | Besremi | Liechtenstein | 28.2.2019 |
| EU/1/18/1352 | Besremi | Norway | 1.3.2019 |
| EU/1/18/1352 | Besremi | Iceland | 19.2.2019 |
| EU/1/19/1353 | Atazanavir Krka | Liechtenstein | 30.4.2019 |
| EU/1/19/1353 | Atazanavir Krka | Norway | 16.4.2019 |
| EU/1/19/1353 | Atazanavir Krka | Iceland | 26.4.2019 |
| EU/1/19/1354 | Vizimpro | Liechtenstein | 30.4.2019 |
| EU/1/19/1354 | Vizimpro | Norway | 8.4.2019 |
| EU/1/19/1354 | Vizimpro | Iceland | 24.5.2019 |
| EU/1/19/1355 | Lorviqua | Liechtenstein | 30.6.2019 |
| EU/1/19/1355 | Lorviqua | Norway | 23.5.2019 |
| EU/1/19/1355 | Lorviqua | Iceland | 12.6.2019 |
| EU/1/19/1356 | Idacio | Liechtenstein | 30.4.2019 |
| EU/1/19/1356 | Idacio | Norway | 12.4.2019 |
| EU/1/19/1356 | Idacio | Iceland | 27.5.2019 |
| EU/1/19/1357 | Kromeya | Liechtenstein | 30.4.2019 |
| EU/1/19/1357 | Kromeya | Norway | 8.4.2019 |
| EU/1/19/1357 | Kromeya | Iceland | 2.5.2019 |
| EU/1/19/1358 | AJOVY | Liechtenstein | 30.4.2019 |
| EU/1/19/1358 | AJOVY | Norway | 8.4.2019 |
| EU/1/19/1358 | AJOVY | Iceland | 24.5.2019 |
| EU/1/19/1360 | Waylivra | Liechtenstein | 30.6.2019 |
| EU/1/19/1360 | Waylivra | Norway | 20.5.2019 |
| EU/1/19/1360 | Waylivra | Iceland | 12.6.2019 |
| EU/1/19/1361 | Skyrizi | Liechtenstein | 30.6.2019 |
| EU/1/19/1361 | Skyrizi | Norway | 3.5.2019 |
| EU/1/19/1361 | Skyrizi | Iceland | 4.6.2019 |
| EU/1/19/1362 | Palynzig | Norway | 22.5.2019 |
| EU/1/19/1362 | Palynziq | Liechtenstein | 30.6.2019 |
| EU/1/19/1362 | Palynziq | Iceland | 4.6.2019 |
| EU/1/19/1363 | Zynquista | Liechtenstein | 30.6.2019 |
| EU/1/19/1363 | Zynquista | Norway | 27.5.2019 |
| EU/1/19/1363 | Zynquista | Iceland | 29.5.2019 |
| EU/1/19/1367 | Zynteglo | Liechtenstein | 30.6.2019 |
| EU/1/19/1367 | Zynteglo | Norway | 7.6.2019 |
| EU/1/19/1367 | Zynteglo | Iceland | 19.6.2019 |
| EU/1/19/1368 | Ambrisentan Mylan | Liechtenstein | 30.6.2019 |
| EU/1/19/1368 | Ambrisentan Mylan | Norway | 26.6.2019 |
| EU/1/19/1368 | Ambrisentan Mylan | Iceland | 25.6.2019 |
| EU/1/19/1369 | Sixmo | Liechtenstein | 30.6.2019 |
| EU/1/19/1373 | Doptelet | Liechtenstein | 30.6.2019 |
| EU/1/19/1373 | Doptelet | Norway | 26.6.2019 |
| EU/1/19/1373 | Doptelet | Iceland | 28.6.2019 |
| EU/1/19/1374 | Esperoct | Norway | 26.6.2019 |
| EU/1/19/1374 | Esperoct | Iceland | 25.6.2019 |
| EU/1/19/1377 | Talzenna | Liechtenstein | 30.6.2019 |
| EU/1/19/1378 | Temybric Ellipta | Norway | 21.6.2019 |
| EU/1/19/1378 | Temybric Ellipta | Iceland | 19.6.2019 |
| EU/2/14/163 | Versican Plus DHPPi/L4R | Liechtenstein | 30.4.2019 |
| EU/2/18/226 | HorStem | Liechtenstein | 30.6.2019 |
| EU/2/18/226 | HorStem | Norway | 26.6.2019 |
| EU/2/18/228 | Arti-Cell Forte | Norway | 8.5.2019 |
| EU/2/18/231 | Syvazul BTV | Norway | 13.1.2019 |
| EU/2/18/231 | Syvazul BTV | Iceland | 22.1.2019 |
| EU/2/18/232 | Isemid | Norway | 13.1.2019 |
| EU/2/18/232 | Isemid | Iceland | 24.1.2019 |
| EU/2/18/233 | EVANT | Liechtenstein | 28.2.2019 |
| EU/2/18/233 | EVANT | Norway | 20.2.2019 |
| EU/2/18/233 | EVANT | Iceland | 21.2.2019 |
| EU/2/18/234 | Kriptazen | Liechtenstein | 28.2.2019 |
| EU/2/18/234 | Kriptazen | Norway | 20.2.2019 |
| EU/2/18/234 | Kriptazen | Iceland | 20.2.2019 |
| EU/2/19/235 | Forceris | Liechtenstein | 30.6.2019 |
| EU/2/19/235 | Forceris | Norway | 15.5.2019 |
| EU/2/19/235 | Forceris | Iceland | 20.6.2019 |
| EU/2/19/236 | Chanhold | Liechtenstein | 30.6.2019 |
| EU/2/19/236 | Chanhold | Norway | 27.6.2019 |
| EU/2/19/236 | Chanhold | Iceland | 21.6.2019 |
| EU/2/19/237 | ReproCyc ParvoFLEX | Liechtenstein | 30.6.2019 |
| EU/2/19/237 | ReproCyc ParvoFLEX | Norway | 27.6.2019 |
| EU/2/19/237 | ReproCyc ParvoFLEX | Iceland | 20.6.2019 |
| EU/2/19/238 | Felisecto Plus | Liechtenstein | 30.6.2019 |
| EU/2/19/238 | Felisecto Plus | Norway | 27.6.2019 |
| EU/2/19/238 | Felisecto Plus | Iceland | 20.6.2019 |
| EU/2/19/239 | Baycox Iron | Liechtenstein | 30.6.2019 |
| EU/2/19/239 | Baycox Iron | Norway | 26.6.2019 |
| EU/2/19/239 | Baycox Iron | Iceland | 21.6.2019 |
| EU/2/19/240 | Afoxolaner MERIAL | Liechtenstein | 30.6.2019 |
| EU/2/19/240 | Afoxolaner MERIAL | Norway | 27.6.2019 |

EU-Number

Product

Country

Date of authorisation

EU/1/16/1138

Venclyxto

Norway

7.2.2019

EU/1/18/1291

Rizmoic

Liechtenstein

28.2.2019

EU/1/18/1291

Rizmoic

Norway

1.3.2019

EU/1/18/1291

Rizmoic

Iceland

21.2.2019

EU/1/18/1292

Apealea

Norway

7.1.2019

EU/1/18/1306

Symkevi

Liechtenstein

28.2.2019

EU/1/18/1317

Pazenir

Liechtenstein

30.6.2019

EU/1/18/1317

Pazenir

Norway

23.5.2019

EU/1/18/1317

Pazenir

Iceland

12.6.2019

EU/1/18/1325

Namuscla

Norway

3.1.2019

EU/1/18/1325

Namuscla

Iceland

9.1.2019

EU/1/18/1326

Flucelvax Tetra

Norway

4.1.2019

EU/1/18/1326

Flucelvax Tetra

Iceland

9.1.2019

EU/1/18/1331

Luxturna

Liechtenstein

28.2.2019

EU/1/18/1337

Macimorelin Aeterna Zentaris

Liechtenstein

28.2.2019

EU/1/18/1337

Macimorelin Aeterna Zentaris

Norway

23.1.2019

EU/1/18/1337

Macimorelin Aeterna Zentaris

Iceland

22.1.2019

EU/1/18/1338

Dengvaxia

Norway

4.1.2019

EU/1/18/1338

Dengvaxia

Iceland

8.1.2019

EU/1/18/1339

Bevespi Aeroshere

Norway

4.1.2019

EU/1/18/1339

Bevespi Aerosphere

Iceland

9.1.2019

EU/1/18/1341

Ogivri

Norway

4.1.2019

EU/1/18/1341

Ogivri

Iceland

8.1.2019

EU/1/18/1342

Erleada

Liechtenstein

28.2.2019

EU/1/18/1342

Erleada

Norway

23.1.2019

EU/1/18/1342

Erleada

Iceland

22.1.2019

EU/1/18/1343

Silodosin Recordati

Liechtenstein

28.2.2019

EU/1/18/1343

Silodosin Recordati

Norway

23.1.2019

EU/1/18/1343

Silodosin Recordati

Iceland

24.1.2019

EU/1/18/1344

Zirabev

Liechtenstein

28.2.2019

EU/1/18/1344

Zirabev

Norway

25.2.2019

EU/1/18/1344

Zirabev

Iceland

22.2.2019

EU/1/18/1345

Ondexxya

Liechtenstein

30.6.2019

EU/1/18/1345

Ondexxya

Norway

14.5.2019

EU/1/18/1345

Ondexxya

Iceland

14.6.2019

EU/1/18/1346

Miglustat Dipharma

Liechtenstein

28.2.2019

EU/1/18/1346

Miglustat Dipharma

Norway

1.3.2019

EU/1/18/1346

Miglustat Dipharma

Iceland

21.2.2019

EU/1/18/1347

Febuxostat Krka

Liechtenstein

30.4.2019

EU/1/18/1347

Febuxostat Krka

Norway

24.4.2019

EU/1/18/1347

Febuxostat Krka

Iceland

29.5.2019

EU/1/18/1348

Lusutrombopag Shionogi

Liechtenstein

28.2.2019

EU/1/18/1348

Lusutrombopag Shionogi

Norway

4.3.2019

EU/1/18/1348

Lusutrombopag Shionogi

Iceland

22.2.2019

EU/1/18/1349

Dectova

Liechtenstein

30.6.2019

EU/1/18/1349

Dectova

Norway

10.5.2019

EU/1/18/1349

Dectova

Iceland

26.6.2019

EU/1/18/1350

Tobramycin PARI

Liechtenstein

28.2.2019

EU/1/18/1350

Tobramycin PARI

Norway

1.3.2019

EU/1/18/1350

Tobramycin PARI

Iceland

22.2.2019

EU/1/18/1351

Trecondi

Liechtenstein

30.6.2019

EU/1/18/1351

Trecondi

Iceland

26.6.2019

EU/1/18/1352

Besremi

Liechtenstein

28.2.2019

EU/1/18/1352

Besremi

Norway

1.3.2019

EU/1/18/1352

Besremi

Iceland

19.2.2019

EU/1/19/1353

Atazanavir Krka

Liechtenstein

30.4.2019

EU/1/19/1353

Atazanavir Krka

Norway

16.4.2019

EU/1/19/1353

Atazanavir Krka

Iceland

26.4.2019

EU/1/19/1354

Vizimpro

Liechtenstein

30.4.2019

EU/1/19/1354

Vizimpro

Norway

8.4.2019

EU/1/19/1354

Vizimpro

Iceland

24.5.2019

EU/1/19/1355

Lorviqua

Liechtenstein

30.6.2019

EU/1/19/1355

Lorviqua

Norway

23.5.2019

EU/1/19/1355

Lorviqua

Iceland

12.6.2019

EU/1/19/1356

Idacio

Liechtenstein

30.4.2019

EU/1/19/1356

Idacio

Norway

12.4.2019

EU/1/19/1356

Idacio

Iceland

27.5.2019

EU/1/19/1357

Kromeya

Liechtenstein

30.4.2019

EU/1/19/1357

Kromeya

Norway

8.4.2019

EU/1/19/1357

Kromeya

Iceland

2.5.2019

EU/1/19/1358

AJOVY

Liechtenstein

30.4.2019

EU/1/19/1358

AJOVY

Norway

8.4.2019

EU/1/19/1358

AJOVY

Iceland

24.5.2019

EU/1/19/1360

Waylivra

Liechtenstein

30.6.2019

EU/1/19/1360

Waylivra

Norway

20.5.2019

EU/1/19/1360

Waylivra

Iceland

12.6.2019

EU/1/19/1361

Skyrizi

Liechtenstein

30.6.2019

EU/1/19/1361

Skyrizi

Norway

3.5.2019

EU/1/19/1361

Skyrizi

Iceland

4.6.2019

EU/1/19/1362

Palynzig

Norway

22.5.2019

EU/1/19/1362

Palynziq

Liechtenstein

30.6.2019

EU/1/19/1362

Palynziq

Iceland

4.6.2019

EU/1/19/1363

Zynquista

Liechtenstein

30.6.2019

EU/1/19/1363

Zynquista

Norway

27.5.2019

EU/1/19/1363

Zynquista

Iceland

29.5.2019

EU/1/19/1367

Zynteglo

Liechtenstein

30.6.2019

EU/1/19/1367

Zynteglo

Norway

7.6.2019

EU/1/19/1367

Zynteglo

Iceland

19.6.2019

EU/1/19/1368

Ambrisentan Mylan

Liechtenstein

30.6.2019

EU/1/19/1368

Ambrisentan Mylan

Norway

26.6.2019

EU/1/19/1368

Ambrisentan Mylan

Iceland

25.6.2019

EU/1/19/1369

Sixmo

Liechtenstein

30.6.2019

EU/1/19/1373

Doptelet

Liechtenstein

30.6.2019

EU/1/19/1373

Doptelet

Norway

26.6.2019

EU/1/19/1373

Doptelet

Iceland

28.6.2019

EU/1/19/1374

Esperoct

Norway

26.6.2019

EU/1/19/1374

Esperoct

Iceland

25.6.2019

EU/1/19/1377

Talzenna

Liechtenstein

30.6.2019

EU/1/19/1378

Temybric Ellipta

Norway

21.6.2019

EU/1/19/1378

Temybric Ellipta

Iceland

19.6.2019

EU/2/14/163

Versican Plus DHPPi/L4R

Liechtenstein

30.4.2019

EU/2/18/226

HorStem

Liechtenstein

30.6.2019

EU/2/18/226

HorStem

Norway

26.6.2019

EU/2/18/228

Arti-Cell Forte

Norway

8.5.2019

EU/2/18/231

Syvazul BTV

Norway

13.1.2019

EU/2/18/231

Syvazul BTV

Iceland

22.1.2019

EU/2/18/232

Isemid

Norway

13.1.2019

EU/2/18/232

Isemid

Iceland

24.1.2019

EU/2/18/233

EVANT

Liechtenstein

28.2.2019

EU/2/18/233

EVANT

Norway

20.2.2019

EU/2/18/233

EVANT

Iceland

21.2.2019

EU/2/18/234

Kriptazen

Liechtenstein

28.2.2019

EU/2/18/234

Kriptazen

Norway

20.2.2019

EU/2/18/234

Kriptazen

Iceland

20.2.2019

EU/2/19/235

Forceris

Liechtenstein

30.6.2019

EU/2/19/235

Forceris

Norway

15.5.2019

EU/2/19/235

Forceris

Iceland

20.6.2019

EU/2/19/236

Chanhold

Liechtenstein

30.6.2019

EU/2/19/236

Chanhold

Norway

27.6.2019

EU/2/19/236

Chanhold

Iceland

21.6.2019

EU/2/19/237

ReproCyc ParvoFLEX

Liechtenstein

30.6.2019

EU/2/19/237

ReproCyc ParvoFLEX

Norway

27.6.2019

EU/2/19/237

ReproCyc ParvoFLEX

Iceland

20.6.2019

EU/2/19/238

Felisecto Plus

Liechtenstein

30.6.2019

EU/2/19/238

Felisecto Plus

Norway

27.6.2019

EU/2/19/238

Felisecto Plus

Iceland

20.6.2019

EU/2/19/239

Baycox Iron

Liechtenstein

30.6.2019

EU/2/19/239

Baycox Iron

Norway

26.6.2019

EU/2/19/239

Baycox Iron

Iceland

21.6.2019

EU/2/19/240

Afoxolaner MERIAL

Liechtenstein

30.6.2019

EU/2/19/240

Afoxolaner MERIAL

Norway

27.6.2019

---

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 2019:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/08/498 | Thymanax | Liechtenstein | 28.2.2019 |
| EU/1/08/498 | Thymanax | Norway | 28.1.2019 |
| EU/1/08/498 | Thymanax | Iceland | 21.1.2019 |
| EU/1/08/499 | Valdoxan | Norway | 3.1.2019 |
| EU/1/08/499 | Valdoxan | Iceland | 8.1.2019 |
| EU/1/08/502 | Mepact | Liechtenstein | 30.4.2019 |
| EU/1/08/502 | Mepact | Norway | 7.3.2019 |
| EU/1/08/502 | Mepact | Iceland | 20.3.2019 |
| EU/1/09/521 | Renvela | Liechtenstein | 28.2.2019 |
| EU/1/09/521 | Renvela | Norway | 7.3.2019 |
| EU/1/09/521 | Renvela | Iceland | 4.3.2019 |
| EU/1/09/524 | Qutenza | Liechtenstein | 30.4.2019 |
| EU/1/09/524 | Qutenza | Norway | 8.4.2019 |
| EU/1/09/524 | Qutenza | Iceland | 2.5.2019 |
| EU/1/09/538 | Afinitor | Liechtenstein | 30.4.2019 |
| EU/1/09/538 | Afinitor | Norway | 12.4.2019 |
| EU/1/09/538 | Afinitor | Iceland | 30.4.2019 |
| EU/1/09/564 | Ilaris | Liechtenstein | 30.6.2019 |
| EU/1/09/564 | Ilaris | Norway | 20.6.2019 |
| EU/1/09/564 | Ilaris | Iceland | 24.6.2019 |
| EU/1/11/749 | Caprelsa | Liechtenstein | 28.2.2019 |
| EU/1/11/749 | Caprelsa | Norway | 7.2.2019 |
| EU/1/11/749 | Caprelsa | Iceland | 23.1.2019 |
| EU/1/12/764 | Pixuvri | Norway | 20.6.2019 |
| EU/1/12/764 | Pixuvri | Iceland | 24.6.2019 |
| EU/1/13/818 | Bosulif | Liechtenstein | 28.2.2019 |
| EU/1/13/818 | Bosulif | Norway | 26.2.2019 |
| EU/1/13/818 | Bosulif | Iceland | 22.2.2019 |
| EU/1/13/870 | Orphacol | Liechtenstein | 30.6.2019 |
| EU/1/13/870 | Orphacol | Norway | 14.5.2019 |
| EU/1/13/870 | Orphacol | Iceland | 11.6.2019 |
| EU/1/13/875 | Deltyba | Liechtenstein | 30.4.2019 |
| EU/1/13/875 | Deltyba | Norway | 23.4.2019 |
| EU/1/13/875 | Deltyba | Iceland | 2.5.2019 |
| EU/1/13/890 | Cometriq | Liechtenstein | 30.4.2019 |
| EU/1/13/890 | Cometriq | Iceland | 14.6.2019 |
| EU/1/13/896 | Granupas | Liechtenstein | 28.2.2019 |
| EU/1/13/896 | Granupas | Norway | 4.1.2019 |
| EU/1/13/896 | Granupas | Iceland | 9.1.2019 |
| EU/1/13/901 | Sirturo | Norway | 17.1.2019 |
| EU/1/13/901 | Sirturo | Iceland | 21.1.2019 |
| EU/1/13/905 | IZBA | Iceland | 7.1.2019 |
| EU/1/13/907 | Adempas | Liechtenstein | 28.2.2019 |
| EU/1/13/907 | Adempas | Norway | 14.2.2019 |
| EU/1/13/907 | Adempas | Iceland | 24.1.2019 |
| EU/1/14/898 | Anoro Ellipta | Liechtenstein | 28.2.2019 |
| EU/1/14/898 | Anoro Ellipta | Norway | 23.1.2019 |
| EU/1/14/898 | Anoro Ellipta | Iceland | 23.1.2019 |
| EU/1/14/899 | Laventair Ellipta | Norway | 23.1.2019 |
| EU/1/14/899 | Laventair Ellipta | Iceland | 21.1.2019 |
| EU/1/14/914 | Vimizim | Liechtenstein | 28.2.2019 |
| EU/1/14/914 | Vimizim | Norway | 29.1.2019 |
| EU/1/14/914 | Vimizim | Iceland | 30.1.2019 |
| EU/1/14/915 | Ebilfumin | Liechtenstein | 28.2.2019 |
| EU/1/14/915 | Ebilfumin | Norway | 14.3.2019 |
| EU/1/14/915 | Ebilfumin | Iceland | 22.2.2019 |
| EU/1/14/916 | Pregabalin Pfizer | Iceland | 10.1.2019 |
| EU/1/14/917 | Ulunar Breezhaler | Liechtenstein | 28.2.2019 |
| EU/1/14/917 | Ulunar Breezhaler | Norway | 23.1.2019 |
| EU/1/14/917 | Ulunar Breezhaler | Iceland | 23.1.2019 |
| EU/1/14/918 | Vokanamet | Liechtenstein | 28.2.2019 |
| EU/1/14/918 | Vokanamet | Norway | 3.1.2019 |
| EU/1/14/918 | Vokanamet | Iceland | 9.1.2019 |
| EU/1/14/919 | Hemangiol | Liechtenstein | 28.2.2019 |
| EU/1/14/919 | Hemangiol | Norway | 22.1.2019 |
| EU/1/14/919 | Hemangiol | Iceland | 21.1.2019 |
| EU/1/14/920 | DuoResp Spiromax | Liechtenstein | 30.4.2019 |
| EU/1/14/920 | DuoResp Spiromax | Norway | 23.4.2019 |
| EU/1/14/920 | DuoResp Spiromax | Iceland | 7.6.2019 |
| EU/1/14/921 | BiResp Spiromax | Liechtenstein | 30.4.2019 |
| EU/1/14/921 | BiResp Spiromax | Norway | 23.4.2019 |
| EU/1/14/921 | BiResp Spiromax | Iceland | 7.6.2019 |
| EU/1/14/922 | Incruse Ellipta | Norway | 23.1.2019 |
| EU/1/14/922 | Incruse Ellipta | Iceland | 21.1.2019 |
| EU/1/14/923 | Entyvio | Norway | 7.1.2019 |
| EU/1/14/923 | Entyvio | Iceland | 9.1.2019 |
| EU/1/14/928 | Sylvant | Liechtenstein | 30.4.2019 |
| EU/1/14/928 | Sylvant | Norway | 29.4.2019 |
| EU/1/14/928 | Sylvant | Iceland | 7.6.2019 |
| EU/1/14/930 | Jardiance | Liechtenstein | 28.2.2019 |
| EU/1/14/930 | Jardiance | Norway | 14.3.2019 |
| EU/1/14/930 | Jardiance | Iceland | 19.2.2019 |
| EU/1/14/931 | Mekinist | Liechtenstein | 28.2.2019 |
| EU/1/14/931 | Mekinist | Norway | 25.2.2019 |
| EU/1/14/931 | Mekinist | Iceland | 20.2.2019 |
| EU/1/14/933 | Simbrinza | Liechtenstein | 28.2.2019 |
| EU/1/14/933 | Simbrinza | Norway | 20.3.2019 |
| EU/1/14/933 | Simbrinza | Iceland | 4.3.2019 |
| EU/1/14/934 | Plegridy | Liechtenstein | 30.4.2019 |
| EU/1/14/934 | Plegridy | Norway | 29.3.2019 |
| EU/1/14/934 | Plegridy | Iceland | 5.6.2019 |
| EU/1/14/935 | Envarsus | Liechtenstein | 30.6.2019 |
| EU/1/14/935 | Envarsus | Norway | 25.6.2019 |
| EU/1/14/935 | Envarsus | Iceland | 19.6.2019 |
| EU/1/14/936 | Nuwiq | Liechtenstein | 30.6.2019 |
| EU/1/14/936 | Nuwiq | Norway | 20.5.2019 |
| EU/1/14/936 | Nuwiq | Iceland | 11.6.2019 |
| EU/1/14/937 | Gazyvaro | Liechtenstein | 30.4.2019 |
| EU/1/14/937 | Gazyvaro | Norway | 23.4.2019 |
| EU/1/14/937 | Gazyvaro | Iceland | 7.6.2019 |
| EU/1/14/938 | Zydelig | Liechtenstein | 30.6.2019 |
| EU/1/14/938 | Zydelig | Norway | 8.5.2019 |
| EU/1/14/938 | Zydelig | Iceland | 5.6.2019 |
| EU/1/14/943 | Velphoro | Liechtenstein | 30.4.2019 |
| EU/1/14/943 | Velphoro | Norway | 29.3.2019 |
| EU/1/14/943 | Velphoro | Iceland | 28.3.2019 |
| EU/1/14/946 | Accofil | Norway | 21.6.2019 |
| EU/1/14/946 | Accofil | Iceland | 19.6.2019 |
| EU/1/14/951 | Busulfan Fresenius Kabi | Liechtenstein | 30.6.2019 |
| EU/1/14/951 | Busulfan Fresenius Kabi | Iceland | 27.6.2019 |
| EU/1/14/987 | Holoclar | Liechtenstein | 28.2.2019 |
| EU/1/14/987 | Holoclar | Norway | 5.2.2019 |
| EU/1/14/987 | Holoclar | Iceland | 30.1.2019 |
| EU/1/15/1078 | Natpar | Norway | 13.5.2019 |
| EU/1/15/1078 | Natpar | Iceland | 11.6.2019 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 AstraZeneca | Liechtenstein | 30.6.2019 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 AstraZeneca | Iceland | 13.6.2019 |
| EU/1/16/1139 | Ocaliva | Norway | 7.1.2019 |
| EU/1/16/1139 | Ocaliva | Iceland | 9.1.2019 |
| EU/1/16/1139 | Ocaliva | Liechtenstein | 28.2.2019 |
| EU/1/17/1214 | Bavencio | Liechtenstein | 30.6.2019 |
| EU/1/17/1214 | Bavencio | Norway | 27.6.2019 |
| EU/1/17/1214 | Bavencio | Iceland | 27.6.2019 |
| EU/1/17/1250 | Rubraca | Norway | 21.3.2019 |
| EU/1/17/1250 | Rubraca | Iceland | 21.3.2019 |
| EU/2/08/090 | Loxicom | Liechtenstein | 28.2.2019 |
| EU/2/08/090 | Loxicom | Norway | 20.2.2019 |
| EU/2/08/090 | Loxicom | Iceland | 31.1.2019 |
| EU/2/09/099 | Suvaxyn PCV | Liechtenstein | 30.6.2019 |
| EU/2/09/099 | Suvaxyn PCV | Iceland | 19.6.2019 |
| EU/2/09/099 | Suvaxyn PCV | Norway | 11.6.2019 |
| EU/2/13/158 | Bravecto | Liechtenstein | 28.2.2019 |
| EU/2/13/158 | Bravecto | Norway | 20.2.2019 |
| EU/2/13/158 | Bravecto | Iceland | 20.2.2019 |
| EU/2/13/159 | NexGard | Norway | 15.1.2019 |
| EU/2/13/159 | NexGard | Iceland | 10.1.2019 |
| EU/2/13/160 | Fungitraxx | Liechtenstein | 30.4.2019 |
| EU/2/13/160 | Fungitraxx | Norway | 12.4.2019 |
| EU/2/13/160 | Fungitraxx | Iceland | 27.3.2019 |
| EU/2/14/161 | Equisolon | Liechtenstein | 28.2.2019 |
| EU/2/14/161 | Equisolon | Norway | 12.2.2019 |
| EU/2/14/161 | Equisolon | Iceland | 15.2.2019 |
| EU/2/14/162 | Parvoduk | Norway | 17.1.2019 |
| EU/2/14/162 | Parvoduk | Iceland | 15.1.2019 |
| EU/2/14/163 | Versican Plus DHPPi/L4R | Norway | 23.4.2019 |
| EU/2/14/164 | Versican Plus DHPPi/L4 | Liechtenstein | 30.4.2019 |
| EU/2/14/164 | Versican Plus DHPPi/L4 | Norway | 23.4.2019 |
| EU/2/14/165 | Vectra Felis | Liechtenstein | 28.2.2019 |
| EU/2/14/165 | Vectra Felis | Norway | 20.2.2019 |
| EU/2/14/165 | Vectra Felis | Iceland | 20.2.2019 |
| EU/2/14/166 | ERYSENG | Liechtenstein | 30.6.2019 |
| EU/2/14/166 | ERYSENG | Norway | 24.6.2019 |
| EU/2/14/166 | ERYSENG | Iceland | 19.6.2019 |
| EU/2/14/167 | ERYSENG PARVO | Liechtenstein | 30.6.2019 |
| EU/2/14/167 | ERYSENG PARVO | Norway | 21.5.2019 |
| EU/2/14/167 | ERYSENG PARVO | Iceland | 19.6.2019 |
| EU/2/14/168 | Versican Plus Pi | Liechtenstein | 30.4.2019 |
| EU/2/14/168 | Versican Plus Pi | Norway | 23.4.2019 |
| EU/2/14/168 | Versican Plus Pi | Iceland | 13.6.2019 |
| EU/2/14/169 | Versican Plus DHPPi | Norway | 23.4.2019 |
| EU/2/14/169 | Versican Plus DHPPi | Iceland | 13.6.2019 |
| EU/2/14/171 | Versican Plus L4 | Liechtenstein | 30.4.2019 |
| EU/2/14/171 | Versican Plus L4 | Norway | 23.4.2019 |
| EU/2/14/171 | Versican Plus L4 | Iceland | 14.6.2019 |
| EU/2/14/173 | Versican Plus Pi/L4R | Liechtenstein | 30.6.2019 |
| EU/2/14/173 | Versican Plus Pi/L4R | Norway | 20.6.2019 |
| EU/2/14/173 | Versican Plus Pi/L4R | Iceland | 19.6.2019 |
| EU/2/14/174 | Nobilis IB Primo QX | Norway | 24.6.2019 |
| EU/2/14/174 | Nobilis IB Primo QX | Iceland | 19.6.2019 |
| EU2/14/172 | Versican Plus Pi/L4 | Norway | 24.4.2019 |
| EU2/14/172 | Versican Plus Pi/L4 | Iceland | 14.6.2019 |

EU-Number

Product

Country

Date of authorisation

EU/1/08/498

Thymanax

Liechtenstein

28.2.2019

EU/1/08/498

Thymanax

Norway

28.1.2019

EU/1/08/498

Thymanax

Iceland

21.1.2019

EU/1/08/499

Valdoxan

Norway

3.1.2019

EU/1/08/499

Valdoxan

Iceland

8.1.2019

EU/1/08/502

Mepact

Liechtenstein

30.4.2019

EU/1/08/502

Mepact

Norway

7.3.2019

EU/1/08/502

Mepact

Iceland

20.3.2019

EU/1/09/521

Renvela

Liechtenstein

28.2.2019

EU/1/09/521

Renvela

Norway

7.3.2019

EU/1/09/521

Renvela

Iceland

4.3.2019

EU/1/09/524

Qutenza

Liechtenstein

30.4.2019

EU/1/09/524

Qutenza

Norway

8.4.2019

EU/1/09/524

Qutenza

Iceland

2.5.2019

EU/1/09/538

Afinitor

Liechtenstein

30.4.2019

EU/1/09/538

Afinitor

Norway

12.4.2019

EU/1/09/538

Afinitor

Iceland

30.4.2019

EU/1/09/564

Ilaris

Liechtenstein

30.6.2019

EU/1/09/564

Ilaris

Norway

20.6.2019

EU/1/09/564

Ilaris

Iceland

24.6.2019

EU/1/11/749

Caprelsa

Liechtenstein

28.2.2019

EU/1/11/749

Caprelsa

Norway

7.2.2019

EU/1/11/749

Caprelsa

Iceland

23.1.2019

EU/1/12/764

Pixuvri

Norway

20.6.2019

EU/1/12/764

Pixuvri

Iceland

24.6.2019

EU/1/13/818

Bosulif

Liechtenstein

28.2.2019

EU/1/13/818

Bosulif

Norway

26.2.2019

EU/1/13/818

Bosulif

Iceland

22.2.2019

EU/1/13/870

Orphacol

Liechtenstein

30.6.2019

EU/1/13/870

Orphacol

Norway

14.5.2019

EU/1/13/870

Orphacol

Iceland

11.6.2019

EU/1/13/875

Deltyba

Liechtenstein

30.4.2019

EU/1/13/875

Deltyba

Norway

23.4.2019

EU/1/13/875

Deltyba

Iceland

2.5.2019

EU/1/13/890

Cometriq

Liechtenstein

30.4.2019

EU/1/13/890

Cometriq

Iceland

14.6.2019

EU/1/13/896

Granupas

Liechtenstein

28.2.2019

EU/1/13/896

Granupas

Norway

4.1.2019

EU/1/13/896

Granupas

Iceland

9.1.2019

EU/1/13/901

Sirturo

Norway

17.1.2019

EU/1/13/901

Sirturo

Iceland

21.1.2019

EU/1/13/905

IZBA

Iceland

7.1.2019

EU/1/13/907

Adempas

Liechtenstein

28.2.2019

EU/1/13/907

Adempas

Norway

14.2.2019

EU/1/13/907

Adempas

Iceland

24.1.2019

EU/1/14/898

Anoro Ellipta

Liechtenstein

28.2.2019

EU/1/14/898

Anoro Ellipta

Norway

23.1.2019

EU/1/14/898

Anoro Ellipta

Iceland

23.1.2019

EU/1/14/899

Laventair Ellipta

Norway

23.1.2019

EU/1/14/899

Laventair Ellipta

Iceland

21.1.2019

EU/1/14/914

Vimizim

Liechtenstein

28.2.2019

EU/1/14/914

Vimizim

Norway

29.1.2019

EU/1/14/914

Vimizim

Iceland

30.1.2019

EU/1/14/915

Ebilfumin

Liechtenstein

28.2.2019

EU/1/14/915

Ebilfumin

Norway

14.3.2019

EU/1/14/915

Ebilfumin

Iceland

22.2.2019

EU/1/14/916

Pregabalin Pfizer

Iceland

10.1.2019

EU/1/14/917

Ulunar Breezhaler

Liechtenstein

28.2.2019

EU/1/14/917

Ulunar Breezhaler

Norway

23.1.2019

EU/1/14/917

Ulunar Breezhaler

Iceland

23.1.2019

EU/1/14/918

Vokanamet

Liechtenstein

28.2.2019

EU/1/14/918

Vokanamet

Norway

3.1.2019

EU/1/14/918

Vokanamet

Iceland

9.1.2019

EU/1/14/919

Hemangiol

Liechtenstein

28.2.2019

EU/1/14/919

Hemangiol

Norway

22.1.2019

EU/1/14/919

Hemangiol

Iceland

21.1.2019

EU/1/14/920

DuoResp Spiromax

Liechtenstein

30.4.2019

EU/1/14/920

DuoResp Spiromax

Norway

23.4.2019

EU/1/14/920

DuoResp Spiromax

Iceland

7.6.2019

EU/1/14/921

BiResp Spiromax

Liechtenstein

30.4.2019

EU/1/14/921

BiResp Spiromax

Norway

23.4.2019

EU/1/14/921

BiResp Spiromax

Iceland

7.6.2019

EU/1/14/922

Incruse Ellipta

Norway

23.1.2019

EU/1/14/922

Incruse Ellipta

Iceland

21.1.2019

EU/1/14/923

Entyvio

Norway

7.1.2019

EU/1/14/923

Entyvio

Iceland

9.1.2019

EU/1/14/928

Sylvant

Liechtenstein

30.4.2019

EU/1/14/928

Sylvant

Norway

29.4.2019

EU/1/14/928

Sylvant

Iceland

7.6.2019

EU/1/14/930

Jardiance

Liechtenstein

28.2.2019

EU/1/14/930

Jardiance

Norway

14.3.2019

EU/1/14/930

Jardiance

Iceland

19.2.2019

EU/1/14/931

Mekinist

Liechtenstein

28.2.2019

EU/1/14/931

Mekinist

Norway

25.2.2019

EU/1/14/931

Mekinist

Iceland

20.2.2019

EU/1/14/933

Simbrinza

Liechtenstein

28.2.2019

EU/1/14/933

Simbrinza

Norway

20.3.2019

EU/1/14/933

Simbrinza

Iceland

4.3.2019

EU/1/14/934

Plegridy

Liechtenstein

30.4.2019

EU/1/14/934

Plegridy

Norway

29.3.2019

EU/1/14/934

Plegridy

Iceland

5.6.2019

EU/1/14/935

Envarsus

Liechtenstein

30.6.2019

EU/1/14/935

Envarsus

Norway

25.6.2019

EU/1/14/935

Envarsus

Iceland

19.6.2019

EU/1/14/936

Nuwiq

Liechtenstein

30.6.2019

EU/1/14/936

Nuwiq

Norway

20.5.2019

EU/1/14/936

Nuwiq

Iceland

11.6.2019

EU/1/14/937

Gazyvaro

Liechtenstein

30.4.2019

EU/1/14/937

Gazyvaro

Norway

23.4.2019

EU/1/14/937

Gazyvaro

Iceland

7.6.2019

EU/1/14/938

Zydelig

Liechtenstein

30.6.2019

EU/1/14/938

Zydelig

Norway

8.5.2019

EU/1/14/938

Zydelig

Iceland

5.6.2019

EU/1/14/943

Velphoro

Liechtenstein

30.4.2019

EU/1/14/943

Velphoro

Norway

29.3.2019

EU/1/14/943

Velphoro

Iceland

28.3.2019

EU/1/14/946

Accofil

Norway

21.6.2019

EU/1/14/946

Accofil

Iceland

19.6.2019

EU/1/14/951

Busulfan Fresenius Kabi

Liechtenstein

30.6.2019

EU/1/14/951

Busulfan Fresenius Kabi

Iceland

27.6.2019

EU/1/14/987

Holoclar

Liechtenstein

28.2.2019

EU/1/14/987

Holoclar

Norway

5.2.2019

EU/1/14/987

Holoclar

Iceland

30.1.2019

EU/1/15/1078

Natpar

Norway

13.5.2019

EU/1/15/1078

Natpar

Iceland

11.6.2019

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Liechtenstein

30.6.2019

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Iceland

13.6.2019

EU/1/16/1139

Ocaliva

Norway

7.1.2019

EU/1/16/1139

Ocaliva

Iceland

9.1.2019

EU/1/16/1139

Ocaliva

Liechtenstein

28.2.2019

EU/1/17/1214

Bavencio

Liechtenstein

30.6.2019

EU/1/17/1214

Bavencio

Norway

27.6.2019

EU/1/17/1214

Bavencio

Iceland

27.6.2019

EU/1/17/1250

Rubraca

Norway

21.3.2019

EU/1/17/1250

Rubraca

Iceland

21.3.2019

EU/2/08/090

Loxicom

Liechtenstein

28.2.2019

EU/2/08/090

Loxicom

Norway

20.2.2019

EU/2/08/090

Loxicom

Iceland

31.1.2019

EU/2/09/099

Suvaxyn PCV

Liechtenstein

30.6.2019

EU/2/09/099

Suvaxyn PCV

Iceland

19.6.2019

EU/2/09/099

Suvaxyn PCV

Norway

11.6.2019

EU/2/13/158

Bravecto

Liechtenstein

28.2.2019

EU/2/13/158

Bravecto

Norway

20.2.2019

EU/2/13/158

Bravecto

Iceland

20.2.2019

EU/2/13/159

NexGard

Norway

15.1.2019

EU/2/13/159

NexGard

Iceland

10.1.2019

EU/2/13/160

Fungitraxx

Liechtenstein

30.4.2019

EU/2/13/160

Fungitraxx

Norway

12.4.2019

EU/2/13/160

Fungitraxx

Iceland

27.3.2019

EU/2/14/161

Equisolon

Liechtenstein

28.2.2019

EU/2/14/161

Equisolon

Norway

12.2.2019

EU/2/14/161

Equisolon

Iceland

15.2.2019

EU/2/14/162

Parvoduk

Norway

17.1.2019

EU/2/14/162

Parvoduk

Iceland

15.1.2019

EU/2/14/163

Versican Plus DHPPi/L4R

Norway

23.4.2019

EU/2/14/164

Versican Plus DHPPi/L4

Liechtenstein

30.4.2019

EU/2/14/164

Versican Plus DHPPi/L4

Norway

23.4.2019

EU/2/14/165

Vectra Felis

Liechtenstein

28.2.2019

EU/2/14/165

Vectra Felis

Norway

20.2.2019

EU/2/14/165

Vectra Felis

Iceland

20.2.2019

EU/2/14/166

ERYSENG

Liechtenstein

30.6.2019

EU/2/14/166

ERYSENG

Norway

24.6.2019

EU/2/14/166

ERYSENG

Iceland

19.6.2019

EU/2/14/167

ERYSENG PARVO

Liechtenstein

30.6.2019

EU/2/14/167

ERYSENG PARVO

Norway

21.5.2019

EU/2/14/167

ERYSENG PARVO

Iceland

19.6.2019

EU/2/14/168

Versican Plus Pi

Liechtenstein

30.4.2019

EU/2/14/168

Versican Plus Pi

Norway

23.4.2019

EU/2/14/168

Versican Plus Pi

Iceland

13.6.2019

EU/2/14/169

Versican Plus DHPPi

Norway

23.4.2019

EU/2/14/169

Versican Plus DHPPi

Iceland

13.6.2019

EU/2/14/171

Versican Plus L4

Liechtenstein

30.4.2019

EU/2/14/171

Versican Plus L4

Norway

23.4.2019

EU/2/14/171

Versican Plus L4

Iceland

14.6.2019

EU/2/14/173

Versican Plus Pi/L4R

Liechtenstein

30.6.2019

EU/2/14/173

Versican Plus Pi/L4R

Norway

20.6.2019

EU/2/14/173

Versican Plus Pi/L4R

Iceland

19.6.2019

EU/2/14/174

Nobilis IB Primo QX

Norway

24.6.2019

EU/2/14/174

Nobilis IB Primo QX

Iceland

19.6.2019

EU2/14/172

Versican Plus Pi/L4

Norway

24.4.2019

EU2/14/172

Versican Plus Pi/L4

Iceland

14.6.2019

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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 2019:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/02/204/002 | Trisenox | Norway | 21.6.2019 |
| EU/1/02/204/002 | Trisenox | Iceland | 20.6.2019 |
| EU/1/07/389/013-014 | Orencia | Norway | 24.4.2019 |
| EU/1/07/389/013-014 | Orencia | Iceland | 18.6.2019 |
| EU/1/09/546/009 | Simponi | Norway | 18.2.2019 |
| EU/1/09/546/009 | Simponi | Iceland | 21.2.2019 |
| EU/1/15/1046/008-010 | Elocta | Iceland | 8.1.2019 |
| EU/1/15/1059/006-007 | Orkambi | Norway | 23.1.2019 |
| EU/1/15/1059/006-007 | Orkambi | Iceland | 23.1.2019 |
| EU/1/15/999/004 | Zykadia | Norway | 11.4.2019 |
| EU/1/15/999/004 | Zykadia | Iceland | 13.6.2019 |
| EU/1/16/1168/005-007 | Vihuma | Iceland | 10.1.2019 |
| EU/1/17/1229/009-016 | Dupixent | Norway | 21.5.2019 |
| EU/1/17/1229/009-016 | Dupixent | Iceland | 19.6.2019 |
| EU/1/18/1293/004-006 | Aimovig | Norway | 20.5.2019 |
| EU/1/18/1293/004-006 | Aimovig | Iceland | 18.6.2019 |

EU-Number

Product

Country

Date of authorisation

EU/1/02/204/002

Trisenox

Norway

21.6.2019

EU/1/02/204/002

Trisenox

Iceland

20.6.2019

EU/1/07/389/013-014

Orencia

Norway

24.4.2019

EU/1/07/389/013-014

Orencia

Iceland

18.6.2019

EU/1/09/546/009

Simponi

Norway

18.2.2019

EU/1/09/546/009

Simponi

Iceland

21.2.2019

EU/1/15/1046/008-010

Elocta

Iceland

8.1.2019

EU/1/15/1059/006-007

Orkambi

Norway

23.1.2019

EU/1/15/1059/006-007

Orkambi

Iceland

23.1.2019

EU/1/15/999/004

Zykadia

Norway

11.4.2019

EU/1/15/999/004

Zykadia

Iceland

13.6.2019

EU/1/16/1168/005-007

Vihuma

Iceland

10.1.2019

EU/1/17/1229/009-016

Dupixent

Norway

21.5.2019

EU/1/17/1229/009-016

Dupixent

Iceland

19.6.2019

EU/1/18/1293/004-006

Aimovig

Norway

20.5.2019

EU/1/18/1293/004-006

Aimovig

Iceland

18.6.2019

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ANNEX IV

List of withdrawn marketing authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January-30 June 2019:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/01/186 | Nonafact | Norway | 20.6.2019 |
| EU/1/01/186 | Nonafact | Iceland | 20.6.2019 |
| EU/1/01/191 | Ketek | Norway | 20.6.2019 |
| EU/1/01/191 | Ketek | Iceland | 25.6.2019 |
| EU/1/05/325 | Macugen | Norway | 4.1.2019 |
| EU/1/05/325 | Macugen | Iceland | 10.1.2019 |
| EU/1/06/355 | ATryn | Norway | 8.3.2019 |
| EU/1/06/355 | ATryn | Iceland | 4.3.2019 |
| EU/1/06/358 | Silgard | Norway | 18.2.2019 |
| EU/1/06/358 | Silgard | Iceland | 19.3.2019 |
| EU/1/07/390 | Altargo | Norway | 26.2.2019 |
| EU/1/09/536 | Topotecan Actavis | Liechtenstein | 28.2.2019 |
| EU/1/09/536 | Topotecan Actavis | Norway | 6.2.2019 |
| EU/1/09/536 | Topotecan Actavis | Iceland | 22.1.2019 |
| EU/1/09/552 | Topotecan Teva | Iceland | 29.5.2019 |
| EU/1/10/625 | Arzerra | Norway | 25.2.2019 |
| EU/1/10/625 | Arzerra | Iceland | 5.3.2019 |
| EU/1/10/651 | Clopidogrel HCS | Liechtenstein | 30.6.2019 |
| EU/1/10/651 | Clopidogrel HCS | Norway | 20.6.2019 |
| EU/1/10/651 | Clopidogrel HCS | Iceland | 20.6.2019 |
| EU/1/13/849 | Somatropin Biopartners | Iceland | 1.2.2019 |
| EU/1/13/876 | Imatinib Medac | Norway | 26.2.2019 |
| EU/1/13/876 | Imatinib medac | Iceland | 22.2.2019 |
| EU/1/14/932 | Vantobra | Norway | 26.2.2019 |
| EU/1/14/932 | Vantobra | Iceland | 21.2.2019 |
| EU/1/15/1044 | Numient | Norway | 24.4.2019 |
| EU/1/15/1044 | Numient | Iceland | 2.5.2019 |
| EU/1/16/1100 | Palonosetron Hospira | Liechtenstein | 30.6.2019 |
| EU/1/16/1123 | Airexar Spiromax | Norway | 14.5.2019 |
| EU/1/16/1123 | Airexar Spiromax | Iceland | 29.5.2019 |
| EU/1/17/1206 | Rituzena | Norway | 14.5.2019 |
| EU/1/17/1206 | Rituzena | Iceland | 29.5.2019 |
| EU/1/17/1240 | Cyltezo | Norway | 6.2.2019 |
| EU/1/17/1240 | Cyltezo | Iceland | 22.1.2019 |
| EU/2/13/155 | Trifexis | Iceland | 1.2.2019 |
| EU/2/17/208 | Ingelvac PCV FLEX | Iceland | 28.6.2019 |

EU-Number

Product

Country

Date of withdrawal

EU/1/01/186

Nonafact

Norway

20.6.2019

EU/1/01/186

Nonafact

Iceland

20.6.2019

EU/1/01/191

Ketek

Norway

20.6.2019

EU/1/01/191

Ketek

Iceland

25.6.2019

EU/1/05/325

Macugen

Norway

4.1.2019

EU/1/05/325

Macugen

Iceland

10.1.2019

EU/1/06/355

ATryn

Norway

8.3.2019

EU/1/06/355

ATryn

Iceland

4.3.2019

EU/1/06/358

Silgard

Norway

18.2.2019

EU/1/06/358

Silgard

Iceland

19.3.2019

EU/1/07/390

Altargo

Norway

26.2.2019

EU/1/09/536

Topotecan Actavis

Liechtenstein

28.2.2019

EU/1/09/536

Topotecan Actavis

Norway

6.2.2019

EU/1/09/536

Topotecan Actavis

Iceland

22.1.2019

EU/1/09/552

Topotecan Teva

Iceland

29.5.2019

EU/1/10/625

Arzerra

Norway

25.2.2019

EU/1/10/625

Arzerra

Iceland

5.3.2019

EU/1/10/651

Clopidogrel HCS

Liechtenstein

30.6.2019

EU/1/10/651

Clopidogrel HCS

Norway

20.6.2019

EU/1/10/651

Clopidogrel HCS

Iceland

20.6.2019

EU/1/13/849

Somatropin Biopartners

Iceland

1.2.2019

EU/1/13/876

Imatinib Medac

Norway

26.2.2019

EU/1/13/876

Imatinib medac

Iceland

22.2.2019

EU/1/14/932

Vantobra

Norway

26.2.2019

EU/1/14/932

Vantobra

Iceland

21.2.2019

EU/1/15/1044

Numient

Norway

24.4.2019

EU/1/15/1044

Numient

Iceland

2.5.2019

EU/1/16/1100

Palonosetron Hospira

Liechtenstein

30.6.2019

EU/1/16/1123

Airexar Spiromax

Norway

14.5.2019

EU/1/16/1123

Airexar Spiromax

Iceland

29.5.2019

EU/1/17/1206

Rituzena

Norway

14.5.2019

EU/1/17/1206

Rituzena

Iceland

29.5.2019

EU/1/17/1240

Cyltezo

Norway

6.2.2019

EU/1/17/1240

Cyltezo

Iceland

22.1.2019

EU/2/13/155

Trifexis

Iceland

1.2.2019

EU/2/17/208

Ingelvac PCV FLEX

Iceland

28.6.2019

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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 January-30 June 2019:

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

EU-Number

Product

Country

Date of suspension

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