20.1.2022   

DA

Den Europæiske Unions Tidende

C 29/7


Lægemidler — Liste over markedsføringstilladelser udstedt af EØS-EFTA-staterne i første halvdel af 2021

(2022/C 29/04)

underudvalg i for frie varebevægelser

Til Det Blandede EØS-Udvalgs underretning

Under henvisning til afgørelse truffet af Det Blandede EØS-Udvalg nr. 74/1999 af 28. maj 1999 opfordres Det Blandede EØS-Udvalg til på sit møde den 24. september 2021 at notere sig følgende lister over markedsføringstilladelser for lægemidler udstedt i perioden 1. januar-30. juni 2021:

Bilag I

Liste over nye markedsføringstilladelser

Bilag II

Liste over fornyede markedsføringstilladelser

Bilag III

Liste over udvidede markedsføringstilladelser

Bilag IV

Liste over tilbagetrukne markedsføringstilladelser

Bilag V

Liste over suspenderede markedsføringstilladelser


BILAG I

Liste over nye markedsføringstilladelser

Følgende markedsføringstilladelser er blevet udstedt i EØS-EFTA-staterne i perioden 1. januar-30. juni 2021:

EU-Nummer

Produkt

Land

Udstedelsesdato

EU/1/20/1515

Abevmy

Island

12.5.2021

EU/1/20/1515

Abevmy

Liechtenstein

30.4.2021

EU/1/20/1515

Abevmy

Norge

28.4.2021

EU/1/20/1512

Abirateron Accord

Liechtenstein

30.4.2021

EU/1/20/1512

Abiraterone Accord

Island

14.5.2021

EU/1/20/1512

Abiraterone Accord

Norge

6.5.2021

EU/1/21/1553

Abiraterone Krka

Liechtenstein

30.6.2021

EU/1/21/1553

Abiraterone Krka

Norge

30.6.2021

EU/1/20/1476

Adakveo (særlige vilkår)

Liechtenstein

15.1.2021

EU/1/21/1554

Adtralza

Liechtenstein

30.6.2021

EU/1/21/1554

Adtralza

Norge

22.6.2021

EU/1/20/1509

Alymsys

Island

14.4.2021

EU/1/20/1509

Alymsys

Liechtenstein

30.4.2021

EU/1/20/1509

Alymsys

Norge

8.4.2021

EU/1/20/1469

Arikayce liposomal

Liechtenstein

15.1.2021

EU/1/20/1475

Arsenic trioxide medac

Liechtenstein

28.2.2021

EU/2/18/228

Arti-Cell Forte

Liechtenstein

28.2.2021

EU/1/20/1473

Ayvakyt

Liechtenstein

28.2.2021

EU/1/18/1339

Bevespi Aerosphere

Liechtenstein

28.2.2021

EU/2/99/017

Bovalto Ibraxion

Liechtenstein

28.2.2021

EU/1/21/1534

BroPair Spiromax

Island

14.4.2021

EU/1/21/1534

BroPair Spiromax

Liechtenstein

30.4.2021

EU/1/21/1534

BroPair Spiromax

Norge

8.4.2021

EU/2/10/112

BTVPUR AlSap 1

Liechtenstein

28.2.2021

EU/2/09/094

BTVPUR AlSap 8

Liechtenstein

28.2.2021

EU/1/20/1505

Byfavo

Island

26.4.2021

EU/1/20/1505

Byfavo

Norge

8.4.2021

EU/1/20/1505

Byvafo

Liechtenstein

30.4.2021

EU/120/1448

Cabazitaxel Accord

Liechtenstein

28.2.2021

EU/1/20/1479

Calquence

Liechtenstein

15.1.2021

EU/1/21/1560

Celsunax

Liechtenstein

30.6.2021

EU/1/21/1560

Celsunax

Norge

23.6.2021

EU/2/20/264

CircoMax Myco

Island

4.1.2021

EU/2/20/264

CircoMax Myco

Liechtenstein

15.1.2021

EU/1/19/1395

Clopidogrel/Acetylsalicylic acid Mylan

Liechtenstein

28.2.2021

EU/1/20/1528

Comirnaty (særlige vilkår)

Liechtenstein

15.1.2021

EU/1/21/1542

Copiktra

Island

9.6.2021

EU/1/21/1542

Copiktra

Liechtenstein

30.6.2021

EU/1/21/1542

Copiktra

Norge

3.6.2021

EU/2/18/230

Cortacare

Liechtenstein

28.2.2021

EU/1/21/1529

COVID-19 Vaccine AstraZeneca

Island

29.1.2021

EU/1/21/1529

COVID-19 Vaccine AstraZeneca

Liechtenstein

28.2.2021

EU/1/20/1529

COVID-19 Vaccine AstraZeneca (Vaxzevria)

Norge

29.1.2021

EU/1/20/1525

COVID-19 Vaccine Janssen

Island

11.3.2021

EU/1/20/1525

COVID-19 Vaccine Janssen

Liechtenstein

30.4.2021

EU/1/20/1525

COVID-19 Vaccine Janssen

Norge

11.3.2021

EU/1/20/1507

COVID-19 Vaccine Moderna

Island

6.1.2021

EU/1/20/1507

COVID-19 Vaccine Moderna (særlige vilkår)

Liechtenstein

15.1.2021

EU/1/20/1507

COVID-19 Vaccine Moderna (Spikevax)

Norge

6.1.2021

EU/2/21/271

Credelio Plus

Island

26.4.2021

EU/2/21/271

Credelio Plus

Liechtenstein

30.4.2021

EU/2/21/271

Credelio Plus

Norge

19.4.2021

EU/1/17/1248

Darunavir Krka d.d.

Liechtenstein

28.2.2021

EU/2/21/270

Daxocox

Island

14.5.2021

EU/2/21/270

Daxocox

Liechtenstein

30.4.2021

EU/2/21/270

Daxocox

Norge

3.6.2021

EU/1/19/1412

Deferasirox Accord

Liechtenstein

28.2.2021

EU/1/21/1547

Drovelis

Island

8.6.2021

EU/1/21/1547

Drovelis

Liechtenstein

30.6.2021

EU/1/21/1547

Drovelis

Norge

3.6.2021

EU/1/18/1284

Dzuveo

Liechtenstein

28.2.2021

EU/1/21/1549

Efmody

Island

10.6.2021

EU/1/21/1549

Efmody

Liechtenstein

30.4.2021

EU/1/21/1549

Efmody

Norge

10.6.2021

EU/1/20/1504

Elzonris

Island

19.1.2021

EU/1/20/1504

Elzonris

Liechtenstein

28.2.2021

EU/1/20/1504

Elzonris

Norge

18.1.2021

EU/1/18/1330

Emgality

Liechtenstein

28.2.2021

EU/1/20/1438

Enerzair Breezhaler

Liechtenstein

28.2.2021

EU/1/20/1508

Enhertu

Island

28.1.2021

EU/1/20/1508

Enhertu

Liechtenstein

28.2.2021

EU/1/20/1508

Enhertu

Norge

26.1.2021

EU/1/21/1559

Enspryng

Liechtenstein

30.6.2021

EU/2/20/268

Enteroporc Coli

Island

21.1.2021

EU/2/20/268

Enteroporc Coli

Liechtenstein

15.1.2021

EU/2/20/268

Enteroporc Coli

Norge

3.6.2021

EU/2/20/262

Enteroporc Coli AC

Island

8.1.2021

EU/2/20/262

Enteroporc Coli AC

Liechtenstein

15.1.2021

EU/1/20/1472

Equidacent

Liechtenstein

15.1.2021

EU/1/19/1392

Ervebo

Liechtenstein

28.2.2021

EU/1/12/750

Esmya

Island

1.2.2021

EU/1/21/1551

Evkeeza

Liechtenstein

30.6.2021

EU/1/21/1551

Evkeeza

Norge

30.6.2021

EU/1/21/1531

Evrysdi

Island

14.4.2021

EU/1/21/1531

Evrysdi

Liechtenstein

30.4.2021

EU/1/21/1531

Evrysdi

Norge

8.4.2021

EU/1/20/1489

Exparel liposomal

Liechtenstein

28.2.2021

EU/1/20/1477

Fampridine Accord

Liechtenstein

15.1.2021

EU/1/20/1491

Fintepla

Island

22.1.2021

EU/1/20/1491

Fintepla

Liechtenstein

15.1.2021

EU/1/20/1491

Fintepla

Norge

15.1.2021

EU/1/18/1326

Flucelvax Tetra

Liechtenstein

28.2.2021

EU/1/19/1375

Grasustek

Liechtenstein

28.2.2021

EU/1/20/1503

Heplisav B

Island

22.2.2021

EU/1/20/1503

Heplisav B

Liechtenstein

28.2.2021

EU/1/20/1503

Heplisav B

Norge

25.2.2021

EU/2/20/258

Increxxa

Liechtenstein

28.2.2021

EU/2/20/258

Increxxa

Norge

22.2.2021

EU/2/17/208

Ingelvac PCV FLEX

Liechtenstein

28.2.2021

EU/2/17/213

Innovax-ND-IBD

Liechtenstein

28.2.2021

EU/2/20/256

Innovax-ND-ILT

Liechtenstein

15.1.2021

EU/2/20/256

Innovax-ND-ILT

Norge

4.1.2021

EU/1/20/1514

Inrebic

Island

19.2.2021

EU/1/20/1514

Inrebic

Liechtenstein

28.2.2021

EU/1/20/1514

Inrebic

Norge

11.2.2021

EU/2/18/232

Isemid

Liechtenstein

28.2.2021

EU/1/19/1396

Ivozall

Liechtenstein

28.2.2021

EU/1/21/1557

Jayempi

Liechtenstein

30.6.2021

EU/1/21/1557

Jayempi

Norge

30.6.2021

EU/1/21/1538

Jemperli

Island

12.5.2021

EU/1/21/1538

Jemperli

Liechtenstein

30.4.2021

EU/1/21/1538

Jemperli

Norge

28.4.2021

EU/1/20/1480

Jyseleca

Liechtenstein

15.1.2021

EU/1/21/1532

Kesimpta

Island

15.4.2021

EU/1/21/1532

Kesimpta

Liechtenstein

30.4.2021

EU/1/21/1532

Kesimpta

Norge

8.4.2021

EU/1/20/1506

Kixelle

Island

18.2.2021

EU/1/20/1506

Kixelle

Liechtenstein

28.2.2021

EU/1/20/1506

Kixelle

Norge

11.2.2021

EU/1/21/1552

Koselugo

Liechtenstein

30.6.2021

EU/1/21/1552

Koselugo

Norge

22.6.2021

EU/1/20/1520

Lenalidomide Krka

Island

4.3.2021

EU/1/20/1520

Lenalidomide Krka

Liechtenstein

28.2.2021

EU/1/20/1520

Lenalidomide Krka

Norge

21.6.2021

EU/1/20/1521

Lenalidomide Krka d.d.

Island

5.3.2021

EU/1/20/1521

Lenalidomide Krka d.d.

Liechtenstein

30.4.2021

EU/1/20/1521

Lenalidomide Krka d.d.

Norge

16.6.2021

EU/1/20/1519

Lenalidomide Krka d.d. Novo mesto

Island

24.2.2021

EU/1/20/1519

Lenalidomide Krka d.d. Novo mesto

Liechtenstein

28.2.2021

EU/1/20/1519

Lenalidomide Krka d.d. Novo mesto

Norge

18.6.2021

EU/1/20/1490

Lenalidomide Mylan

Island

11.1.2021

EU/1/20/1490

Lenalidomide Mylan

Liechtenstein

28.2.2021

EU/1/20/1494

Leqvio

Island

5.1.2021

EU/1/20/1494

Leqvio

Liechtenstein

15.1.2021

EU/1/20/1516

Lextemy

Island

12.5.2021

EU/1/20/1516

Lextemy

Liechtenstein

30.4.2021

EU/1/20/1516

Lextemy

Norge

28.4.2021

EU/1/20/1493

Libmeldy

Island

14.1.2021

EU/1/20/1493

Libmeldy

Liechtenstein

15.1.2021

EU/1/20/1493

Libmeldy

Norge

8.1.2021

EU/2/20/261

Librela

Liechtenstein

15.1.2021

EU/2/20/261

Librela

Norge

4.1.2021

EU/1/20/1470

Lumeblue

Liechtenstein

28.2.2021

EU/1/20/1522

Lumoxiti

Island

19.2.2021

EU/1/20/1522

Lumoxiti

Liechtenstein

28.2.2021

EU/1/20/1522

Lumoxiti

Norge

11.2.2021

EU/1/21/1548

Lydisilka

Island

8.6.2021

EU/1/21/1548

Lydisilka

Liechtenstein

30.6.2021

EU/1/21/1548

Lydisilka

Norge

31.5.2021

EU/1/20/1483

MenQuadfi

Liechtenstein

15.1.2021

EU/2/20/259

Mhyosphere PCV ID

Liechtenstein

28.2.2021

EU/2/20/259

Mhyosphere PCV ID

Norge

4.1.2021

EU/1/20/1445

Mvabea

Liechtenstein

28.2.2021

EU/1/18/1325

Namuscla

Liechtenstein

28.2.2021

EU/2/20/267

NexGard Combo

Island

25.1.2021

EU/2/20/267

NexGard Combo

Liechtenstein

28.2.2021

EU/2/20/267

NexGard Combo

Norge

20.1.2021

EU/1/21/1537

Nexpovio

Island

30.3.2021

EU/1/21/1537

Nexpovio

Liechtenstein

30.4.2021

EU/1/21/1537

Nexpovio

Norge

8.4.2021

EU/1/18/1290

Nityr

Liechtenstein

28.2.2021

EU/2/20/265

Nobivac DP Plus

Island

4.1.2021

EU/2/20/265

Nobivac DP Plus

Liechtenstein

15.1.2021

EU/1/19/1364

Nuceiva

Liechtenstein

28.2.2021

EU/1/20/1486

Nyvepria

Liechtenstein

15.1.2021

EU/1/20/1485

Obiltoxaximab SFL (under særlige omstændigheder)

Liechtenstein

15.1.2021

EU/1/20/1523

Ogluo

Island

22.2.2021

EU/1/20/1523

Ogluo

Liechtenstein

28.2.2021

EU/1/20/1523

Ogluo

Norge

23.2.2021

EU/1/20/1499

Onbevzi

Island

19.1.2021

EU/1/20/1499

Onbevzi

Liechtenstein

28.2.2021

EU/1/20/1499

Onbevzi

Norge

15.1.2021

EU/1/21/1530

Ontozry

Island

15.4.2021

EU/1/21/1530

Ontozry

Liechtenstein

30.4.2021

EU/1/21/1530

Ontozry

Norge

9.4.2021

EU/1/21/1556

Onureg

Liechtenstein

30.6.2021

EU/1/21/1556

Onureg

Norge

22.6.2021

EU/1/21/1544

Orladeyo

Island

14.5.2021

EU/1/21/1544

Orladeyo

Liechtenstein

30.6.2021

EU/1/21/1544

Orladeyo

Norge

6.5.2021

EU2/20/260

OvuGel

Liechtenstein

28.2.2021

EU/2/20/260

OvuGel

Norge

4.1.2021

EU/1/20/1496

Oxlumo

Liechtenstein

15.1.2021

EU/1/20/1510

Oyavas

Island

14.4.2021

EU/1/20/1510

Oyavas

Liechtenstein

30.4.2021

EU/1/20/1510

Oyavas

Norge

8.4.2021

EU/1/20/1495

Palforzia

Island

18.1.2021

EU/1/20/1495

Palforzia

Liechtenstein

28.2.2021

EU/1/20/1495

Palforzia

Norge

15.1.2021

EU/1/21/1535

Pemazyre

Island

30.3.2021

EU/1/21/1535

Pemazyre

Liechtenstein

30.4.2021

EU/1/21/1535

Pemazyre

Norge

8.4.2021

EU/1/20/1487

Phelinun

Liechtenstein

28.2.2021

EU/1/20/1497

Phesgo

Island

11.1.2021

EU/1/20/1497

Phesgo

Liechtenstein

15.1.2021

EU/1/21/1550

Ponvory

Island

9.6.2021

EU/1/21/1550

Ponvory

Liechtenstein

30.6.2021

EU/1/21/1550

Ponvory

Norge

4.6.2021

EU/2/20/254

Prevexxion RN

Liechtenstein

28.2.2021

EU/2/20/255

Prevexxion RN+HVT+IBD

Norge

4.1.2021

EU/2/17/211

Prevomax

Liechtenstein

28.2.2021

EU/1/20/1482

Rekambys

Island

11.1.2021

EU/1/20/1482

Rekambys

Liechtenstein

15.1.2021

EU/1/20/1482

Rekambys

Norge

5.1.2021

EU/1/20/1527

Retsevmo

Island

19.2.2021

EU/1/20/1527

Retsevmo

Liechtenstein

28.2.2021

EU/1/20/1527

Retsevmo

Norge

11.2.2021

EU/2/20/263

Rexxolide

Island

4.1.2021

EU/2/20/263

Rexxolide

Liechtenstein

28.2.2021

EU/1/19/1400

Rhokiinsa

Liechtenstein

28.2.2021

EU/1/20/1488

Rivaroxaban Accord

Liechtenstein

15.1.2021

EU/1/20/1502

Roclanda

Island

12.1.2021

EU/1/20/1502

Roclanda

Liechtenstein

28.2.2021

EU/1/20/1502

Roclanda

Norge

14.1.2021

EU/1/20/1460

Rozlytrek

Liechtenstein

28.2.2021

EU/1/20/1518

Rukobia

Island

19.2.2021

EU/1/20/1518

Rukobia

Liechtenstein

28.2.2021

EU/1/20/1518

Rukobia

Norge

11.2.2021

EU/1/20/1431

Ruxience

Liechtenstein

28.2.2021

EU/1/20/1435

Sarclisa

Liechtenstein

28.2.2021

EU/1/21/1533

Seffalair Spiromax

Island

14.4.2021

EU/1/21/1533

Seffalair Spiromax

Liechtenstein

30.4.2021

EU/1/21/1533

Seffalair Spiromax

Norge

8.4.2021

EU/1/20/1517

Sibnayal

Island

14.5.2021

EU/1/20/1517

Sibnayal

Liechtenstein

30.6.2021

EU/1/20/1517

Sibnayal

Norge

5.5.2021

EU/1/20/1501

Sogroya

Island

15.4.2021

EU/1/20/1501

Sogroya

Liechtenstein

30.4.2021

EU/1/20/1501

Sogroya

Norge

8.4.2021

EU/2/20/269

Solensia

Liechtenstein

28.2.2021

EU/2/20/269

Solensia

Norge

14.6.2021

EU/1/19/1421

Staquis

Liechtenstein

28.2.2021

EU/1/20/1511

Sunitinib Accord

Island

4.3.2021

EU/1/20/1511

Sunitinib Accord

Liechtenstein

30.4.2021

EU/1/20/1511

Sunitinib Accord

Norge

5.3.2021

EU/1/20/1484

Supemtek

Liechtenstein

15.1.2021

EU2/09/099

Suvaxyn PCV

Liechtenstein

28.2.2021

EU/2/18/231

Syvazul BTV

Liechtenstein

28.2.2021

EU/1/20/1492

Tecartus

Island

8.1.2021

EU/1/20/1492

Tecartus (særlige vilkår)

Liechtenstein

15.1.2021

EU/1/19/1378

Temybric Ellipta

Liechtenstein

28.2.2021

EU/1/21/1536

Thiotepa Riemser

Island

15.4.2021

EU/1/21/1536

Thiotepa Riemser

Liechtenstein

30.4.2021

EU/1/21/1536

Thiotepa Riemser

Norge

8.4.2021

EU/1/18/1351

Trecondi

Liechtenstein

15.1.2021

EU/1/19/1419

Trepulmix

Liechtenstein

28.2.2021

EU/1/20/1498

Trixeo Aerosphere

Island

8.1.2021

EU/1/20/1498

Trixeo Aerosphere

Liechtenstein

28.2.2021

EU/1/20/1526

Tukysa

Island

19.2.2021

EU/1/20/1526

Tukysa

Liechtenstein

28.2.2021

EU/1/20/1526

Tukysa

Norge

25.2.2021

EU/2/20/257

Tulinovet

Liechtenstein

15.1.2021

EU/2/20/252

Tulissin

Liechtenstein

28.2.2021

EU/2/21/272

Ultifend ND IBD

Island

12.5.2021

EU/2/21/272

Ultifend ND IBD

Liechtenstein

30.4.2021

EU/2/21/272

Ultifend ND IBD

Norge

29.4.2021

EU/1/20/1524

Vazkepa

Island

30.3.2021

EU/1/20/1524

Vazkepa

Liechtenstein

30.4.2021

EU/1/20/1524

Vazkepa

Norge

8.4.2021

EU/2/20/266

Vectormune FP ILT

Island

5.1.2021

EU/2/20/266

Vectormune FP ILT

Liechtenstein

15.1.2021

EU/2/20/266

Vectormune FP ILT

Norge

4.1.2021

EU/1/18/1298

Veyvondi

Liechtenstein

28.2.2021

EU/1/20/1481

Vocabria

Island

26.1.2021

EU/1/20/1481

Vocabria

Liechtenstein

28.2.2021

EU/1/20/1500

Xofluza

Island

12.1.2021

EU/1/20/1500

Xofluza

Liechtenstein

28.2.2021

EU/1/20/1500

Xofluza

Norge

14.1.2021

EU/1/20/1513

Yuflyma

Island

24.2.2021

EU/1/20/1513

Yuflyma

Liechtenstein

28.2.2021

EU/1/20/1513

Yuflyma

Norge

25.2.2021

EU/2/17/210

Zeleris

Liechtenstein

28.2.2021

EU/2/09/186

Zulvac 8 Bovis

Liechtenstein

28.2.2021

EU/2/17/207

Zulvac BTV Ovis

Liechtenstein

28.2.2021

EU/1/20/1478

Zynrelef

Liechtenstein

15.1.2021


BILAG II

Liste over fornyede markedsføringstilladelser

Følgende markedsføringstilladelser er blevet fornyet i EØS-EFTA-staterne i perioden 1. januar-30. juni 2021:

EU-Nummer

Produkt

Land

Udstedelsesdato

EU/1/12/794

ADCETRIS

Liechtenstein

15.1.2021

EU/1/16/1098

Alprolix

Island

25.2.2021

EU/1/16/1098

Alprolix

Liechtenstein

30.4.2021

EU/1/16/1098

Alprolix

Norge

23.3.2021

EU/1/16/1092

Amlodipine/Valsartan Mylan

Island

25.1.2021

EU/1/16/1092

Amlodipine/Valsartan Mylan

Liechtenstein

28.2.2021

EU/1/15/1045

Aripiprazole Accord

Liechtenstein

15.1.2021

EU/1/16/1091

Atazanavir Mylan

Island

17.5.2021

EU/1/16/1091

Atazanavir Mylan

Liechtenstein

30.4.2021

EU/1/16/1091

Atazanavir Mylan

Norge

3.5.2021

EU/1/15/1074

Benepali

Liechtenstein

15.1.2021

EU/1/20/1474

Blenrep

Liechtenstein

30.6.2021

EU/1/16/1114

Bortezomib Hospira

Island

17.5.2021

EU/1/16/1114

Bortezomib Hospira

Liechtenstein

30.6.2021

EU/1/16/1114

Bortezomib Hospira

Norge

7.5.2021

EU/1/16/1102

Bortezomib SUN

Liechtenstein

30.6.2021

EU/1/16/1102

Bortezomib SUN

Norge

30.6.2021

EU/1/13/818

Bosulif

Island

22.2.2021

EU/1/13/818

Bosulif

Norge

8.3.2021

EU/1/13/818

Bosulif

Liechtenstein

28.2.2021

EU/1/15/1073

Briviact

Liechtenstein

15.1.2021

EU/1/16/1136

Cabometyx

Island

12.5.2021

EU/1/16/1136

Cabometyx

Liechtenstein

30.4.2021

EU/1/16/1136

Cabometyx

Norge

3.5.2021

EU/1/11/749

Caprelsa

Island

15.1.2021

EU/1/11/749

Caprelsa

Norge

3.2.2021

EU/1/11/749

Caprelsa

Liechtenstein

28.2.2021

EU/1/15/1055

Ciambra

Liechtenstein

28.2.2021

EU/1/15/1054

Cinacalcet Mylan

Liechtenstein

15.1.2021

EU/1/16/1125

Cinqaero

Island

10.6.2021

EU/1/16/1125

Cinqaero

Liechtenstein

30.6.2021

EU/1/16/1125

Cinqaero

Norge

10.6.2021

EU/1/16/1087

Coagadex

Island

14.4.2021

EU/1/16/1087

Coagadex

Liechtenstein

30.4.2021

EU/1/16/1087

Coagadex

Norge

7.4.2021

EU/1/13/890

Cometriq

Island

11.3.2021

EU/1/13/890

Cometriq

Liechtenstein

28.2.2021

EU/1/17/1262

Crysvita

Island

2.2.2021

EU/1/17/1262

Crysvita

Liechtenstein

28.2.2021

EU/1/17/1262

Crysvita

Norge

2.2.2021

EU/1/13/875

Deltyba

Island

26.4.2021

EU/1/13/875

Deltyba

Liechtenstein

30.4.2021

EU/1/16/1099

Descovy

Island

10.3.2021

EU/1/16/1099

Descovy

Liechtenstein

28.2.2021

EU/1/16/1099

Descovy

Norge

15.3.2021

EU/1/15/1051

Ebymect

Liechtenstein

28.2.2021

EU/1/15/1052

Edistride

Liechtenstein

28.2.2021

EU/1/11/691

Eliquis

Island

19.1.2021

EU/1/11/691

Eliquis

Liechtenstein

28.2.2021

EU/1/11/691

Eliquis

Norge

18.1.2021

EU/1/15/1046

Elocta

Norge

22.2.2021

EU/1/16/1088

Empliciti

Island

13.1.2021

EU/1/16/1088

Empliciti

Liechtenstein

15.1.2021

EU/1/16/1105

EndolucinBeta

Island

18.2.2021

EU/1/16/1105

EndolucinBeta

Liechtenstein

28.2.2021

EU/1/16/1105

EndolucinBeta

Norge

16.2.2021

EU/1/16/1116

Epclusa

Island

25.3.2021

EU/1/16/1116

Epclusa

Liechtenstein

30.4.2021

EU/1/16/1116

Epclusa

Norge

25.3.2021

EU/1/15/1069

Episalvan

Liechtenstein

15.1.2021

EU/1/15/1065

Eptifibatid Accord

Liechtenstein

15.1.2021

EU/1/19/1392

Ervebo

Norge

3.2.2021

EU/1/19/1392

Ervebo-Ebola Zaire-Impfstoff

Liechtenstein

15.1.2021

EU/2/16/194

Evalon

Island

24.2.2021

EU/2/16/194

Evalon

Liechtenstein

28.2.2021

EU/2/16/194

Evalon

Norge

26.2.2021

EU/1/15/1075

Feraccru

Liechtenstein

15.1.2021

EU/1/16/1106

Flixabi

Island

10.3.2021

EU/1/16/1106

Flixabi

Liechtenstein

30.4.2021

EU/1/16/1106

Flixabi

Norge

7.4.2021

EU/1/15/1082

Galafold

Island

25.2.2021

EU/1/15/1082

Galafold

Liechtenstein

28.2.2021

EU/1/15/1082

Galafold

Norge

23.2.2021

EU/1/15/1061

Genvoya

Liechtenstein

28.2.2021

EU/1/11/677

Gilenya

Liechtenstein

15.1.2021

EU/1/15/1008

Hetlioz

Liechtenstein

28.2.2021

EU/1/14/987

Holoclar

Island

25.1.2021

EU/1/14/987

Holoclar

Liechtenstein

28.2.2021

EU/1/16/1095

Idelvion

Island

18.2.2021

EU/1/16/1095

Idelvion

Liechtenstein

28.2.2021

EU/1/16/1095

Idelvion

Norge

11.2.2021

EU/1/15/1064

Imlygic

Liechtenstein

15.1.2021

EU/2/15/193

Imrestor

Liechtenstein

15.1.2021

EU/1/11/676

Jevtana

Island

8.1.2021

EU/1/11/676

Jevtana

Liechtenstein

15.1.2021

EU/1/16/1128

Kisplyx

Liechtenstein

30.6.2021

EU/1/16/1128

Kisplyx

Norge

22.6.2021

EU/1/15/1076

Kovaltry

Liechtenstein

15.1.2021

EU/2/16/195

Letifend

Island

24.2.2021

EU/2/16/195

Letifend

Liechtenstein

28.2.2021

EU/2/16/195

Letifend

Norge

5.3.2021

EU/1/19/1376

Libtayo

Liechtenstein

30.6.2021

EU/1/19/1376

Libtayo

Island

21.5.2021

EU/1/19/1376

Libtayo

Norge

21.5.2021

EU/1/16/1096

Lonsurf

Island

8.1.2021

EU/1/16/1096

Lonsurf

Liechtenstein

15.1.2021

EU/1/16/1096

Lonsurf

Norge

8.1.2021

EU/1/15/1067

Lopinavir/Ritonavir Mylan

Liechtenstein

15.1.2021

EU/1/19/1355

Lorviqua

Island

26.4.2021

EU/1/19/1355

Lorviqua

Liechtenstein

30.4.2021

EU/1/19/1355

Lorviqua

Norge

8.4.2021

EU/1/15/1078

Natpar

Island

27.4.2021

EU/1/15/1078

Natpar

Liechtenstein

30.4.2021

EU/1/15/1078

Natpar

Norge

26.4.2021

EU/1/15/1053

Neofordex

Island

15.1.2021

EU/1/15/1053

Neofordex

Liechtenstein

15.1.2021

EU/1/15/1053

Neofordex

Norge

31.1.2021

EU/1/16/1103

Neparvis

Island

22.2.2021

EU/1/16/1103

Neparvis

Liechtenstein

28.2.2021

EU/1/16/1103

Neparvis

Norge

16.2.2021

EU/1/16/1094

Ninlaro

Liechtenstein

15.1.2021

EU/1/16/1094

Ninlaro

Norge

22.2.2021

EU/1/16/1124

Nordimet

Liechtenstein

30.6.2021

EU/1/16/1124

Nordimet

Norge

25.6.2021

EU/1/15/1035

Obizur

Liechtenstein

28.2.2021

EU/1/16/1139

Ocaliva

Island

25.1.2021

EU/1/16/1139

Ocaliva

Norge

3.2.2021

EU/1/16/1139

Ocaliva

Liechtenstein

28.2.2021

EU/1/16/1112

Odefsey

Island

19.1.2021

EU/1/16/1112

Odefsey

Liechtenstein

28.2.2021

EU/1/16/1112

Odefsey

Norge

14.1.2021

EU/1/15/1070

Oncaspar

Liechtenstein

15.1.2021

EU/1/18/1345

Ondexxya

Island

2.3.2021

EU/1/18/1345

Ondexxya

Liechtenstein

28.2.2021

EU/1/18/1345

Ondexxya

Norge

8.3.2021

EU/1/15/1066

Ongentys

Island

15.3.2021

EU/1/15/1066

Ongentys

Liechtenstein

28.2.2021

EU/1/15/1066

Ongentys

Norge

15.3.2021

EU/1/15/1059

Orkambi

Liechtenstein

15.1.2021

EU/1/16/1104

Palonosetron Accord

Island

22.2.2021

EU/1/16/1104

Palonosetron Accord

Liechtenstein

28.2.2021

EU/1/16/1104

Palonosetron Accord

Norge

26.2.2021

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Island

16.3.2021

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Liechtenstein

30.4.2021

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Norge

24.3.2021

EU/1/15/1071

Pemetrexed Accord

Liechtenstein

28.2.2021

EU/1/16/1115

Pemetrexed Fresenius Kabi

Island

12.5.2021

EU/1/16/1115

Pemetrexed Fresenius Kabi

Liechtenstein

30.4.2021

EU/1/16/1115

Pemetrexed Fresenius Kabi

Norge

20.5.2021

EU/1/15/1057

Pemetrexed Hospira

Liechtenstein

28.2.2021

EU/1/19/1388

Polivy

Island

5.1.2021

EU/1/19/1388

Polivy

Liechtenstein

15.1.2021

EU/1/16/1108

Qtern

Island

9.6.2021

EU/1/16/1108

Qtern

Liechtenstein

30.4.2021

EU/1/16/1108

Qtern

Norge

3.6.2021

EU/1/16/1090

Rasagiline Mylan

Liechtenstein

15.1.2021

EU/1/20/1460

Rozlytrek

Liechtenstein

30.6.2021

EU/1/17/1250

Rubraca

Island

15.3.2021

EU/1/17/1250

Rubraca

Liechtenstein

30.4.2021

EU/1/17/1250

Rubraca

Norge

11.3.2021

EU/2/16/196

Sevohale

Island

14.5.2021

EU/2/16/196

Sevohale

Liechtenstein

30.4.2021

EU/2/16/196

Sevohale

Norge

7.5.2021

EU/1/16/1135

Sialanar

Liechtenstein

30.6.2021

EU/1/16/1135

Sialanar

Norge

30.6.2021

EU/1/13/901

Sirturo

Island

14.1.2021

EU/1/13/901

Sirturo

Liechtenstein

28.2.2021

EU/1/13/901

Sirturo

Norge

8.2.2021

EU/1/15/1072

Spectrila

Liechtenstein

15.1.2021

EU/1/16/1097

Strimvelis

Island

14.5.2021

EU/1/16/1097

Strimvelis

Liechtenstein

30.6.2021

EU/1/16/1097

Strimvelis

Norge

7.5.2021

EU/1/15/1085

Taltz

Island

29.1.2021

EU/1/15/1085

Taltz

Liechtenstein

15.1.2021

EU/1/15/1085

Taltz

Norge

14.1.2021

EU/1/13/902

Translarna

Liechtenstein

28.2.2021

EU/1/15/1083

Uptravi

Island

8.1.2021

EU/1/15/1083

Uptravi

Liechtenstein

15.1.2021

EU/1/15/1079

Vaxelis

Liechtenstein

15.1.2021

EU/2/15/188

Vectormune ND

Island

18.2.2021

EU/2/15/188

Vectormune ND

Liechtenstein

28.2.2021

EU/1/20/1459

Veklury

Liechtenstein

30.6.2021

EU/1/15/1068

Wakix

Island

29.1.2021

EU/1/15/1068

Wakix

Liechtenstein

28.2.2021

EU/1/19/1360

Waylivra

Island

18.2.2021

EU/1/19/1360

Waylivra

Norge

1.3.2021

EU/1/19/1360

Waylivra

Liechtenstein

28.2.2021

EU/1/15/1042

Zalviso

Liechtenstein

15.1.2021

EU/1/16/1109

Zavicefta

Island

24.2.2021

EU/1/16/1109

Zavicefta

Liechtenstein

28.2.2021

EU/1/16/1109

Zavicefta

Norge

26.2.2021

EU/1/16/1119

Zepatier

Island

14.5.2021

EU/1/16/1119

Zepatier

Liechtenstein

30.6.2021

EU/1/16/1119

Zepatier

Norge

18.5.2021

EU/1/11/690

Zoely

Island

25.5.2021

EU/1/11/690

Zoely

Liechtenstein

30.6.2021

EU/1/11/690

Zoely

Norge

31.5.2021

EU/1/20/1443

Zolgensma

Island

8.6.2021

EU/1/20/1443

Zolgensma

Liechtenstein

30.6.2021

EU/1/20/1443

Zolgensma

Norge

2.6.2021

EU/1/16/1093

Zonisamide Mylan

Island

4.1.2021

EU/1/16/1093

Zonisamide Mylan

Liechtenstein

28.2.2021


BILAG III

Liste over udvidede markedsføringstilladelser

Følgende markedsføringstilladelser er blevet udstedt i EØS-EFTA-staterne i perioden 1. januar-30. juni 2021:

EU-Nummer

Produkt

Land

Udstedelsesdato

EU/1/13/838/006

Aubagio

Norge

22.6.2021

EU/1/18/1336/009

Buvidal

Island

16.6.2021

EU/1/18/1336/009

Buvidal

Norge

3.6.2021

EU/1/06/367/013

Diacomit

Island

10.6.2021

EU/1/06/367/013

Diacomit

Norge

10.6.2021

EU/2/11/128/004-010

Emdocam

Island

25.5.2021

EU/1/18/1319/009-010

Hulio

Island

18.1.2021

EU/1/18/1319/009-010

Hulio

Norge

18.1.2021

EU/1/20/1447/006-007

Insulin Aspart Sanofi

Island

14.5.2021

EU/1/20/1447/006-007

Insulin Aspart Sanofi

Norge

4.5.2021

EU/1/19/1364/002

Nuceiva

Island

29.1.2021

EU/1/19/1364/002

Nuceiva

Norge

27.1.2021

EU/1/14/934/007-008

Plegridy

Island

8.1.2021

EU/1/08/442/025-031

Pradaxa

Island

21.1.2021

EU/1/08/442/025-031

Pradaxa

Norge

19.1.2021

EU/1/13/901/003

Sirturo

Island

15.4.2021

EU/1/13/901/003

Sirturo

Norge

8.4.2021

EU/1/19/1361/002-003

Skyrizi

Island

10.6.2021

EU/1/19/1361/002-003

Skyrizi

Norge

4.6.2021

EU/1/10/622/003

Tepadina

Island

15.4.2021

EU/1/10/622/003

Tepadina

Norge

19.4.2021

EU/1/13/892/007

Tivicay

Island

25.1.2021

EU/1/13/892/007

Tivicay

Norge

18.1.2021

EU/1/17/1208/006-009

Trimbow

Island

29.1.2021

EU/1/17/1208/010-012

Trimbow

Island

26.4.2021

EU/1/17/1208/006-009

Trimbow

Norge

26.1.2021

EU/1/17/1208/010-012

Trimbow

Norge

12.4.2021

EU/1/06/346/002

Tysabri

Island

15.4.2021

EU/1/06/346/002

Tysabri

Norge

8.4.2021

EU/1/08/472/050-051

Xarelto

Island

1.2.2021

EU/1/17/472/050-051

Xarelto

Norge

26.1.2021

EU/1/18/1312/003-004

Xerava

Island

2.3.2021

EU/1/18/1312/003-004

Xerava

Norge

5.3.2021


BILAG IV

Liste over tilbagetrukne markedsføringstilladelser

Følgende markedsføringstilladelser er blevet trukket tilbage i EØS-EFTA-staterne i perioden 1. januar-30. juni 2021:

EU-Nummer

Produkt

Land

Dato for tilbagetrækning

EU/2/08/088

Acticam

Island

26.3.2021

EU/2/08/088

Acticam

Liechtenstein

30.4.2021

EU/2/08/088

Acticam

Norge

26.3.2021

EU/1/16/1122

Aerivio Spiromax

Liechtenstein

28.2.2021

EU/1/16/1123

Airexar Spiromax

Liechtenstein

28.2.2021

EU/1/18/1269

Alpivab

Liechtenstein

15.1.2021

EU/1/07/390

Altargo

Liechtenstein

28.2.2021

EU/1/10/625

Arzerra

Liechtenstein

28.2.2021

EU/1/06/355

ATryn

Liechtenstein

28.2.2021

EU/1/19/1382

Azacitidin Celgene

Liechtenstein

30.6.2021

EU/1/19/1382

Azacitidine Celgene

Island

25.5.2021

EU/1/19/1382

Azacitidine Celgene

Norge

16.6.2021

EU/1/15/1081

Caspofungin Accord

Island

25.2.2021

EU/1/15/1081

Caspofungin Accord

Liechtenstein

28.2.2021

EU/1/10/623

Clopidogrel/Acetylsalicylic acid Zentiva

Liechtenstein

28.2.2021

EU/1/10/623

Clopidogrel/Acetylsalicylic acid Zentiva

Norge

1.3.2021

EU/1/96/024

Crixivan

Island

14.4.2021

EU/1/96/024

Crixivan

Liechtenstein

30.4.2021

EU/1/96/024

Crixivan

Norge

16.6.2021

EU/1/17/1240

Cyltezo

Liechtenstein

28.2.2021

EU/1/01/187

DepoCyte

Liechtenstein

28.2.2021

EU/1/18/1300

Duzallo

Liechtenstein

28.2.2021

EU/1/13/908

Eperzan

Liechtenstein

28.2.2021

EU/1/09/510

Fertavid

Liechtenstein

28.2.2021

EU/1/18/1288

Halimatoz

Island

12.1.2021

EU/1/18/1288

Halimatoz

Liechtenstein

28.2.2021

EU/1/18/1288

Halimatoz

Norge

9.2.2021

EU/1/00/144

Helixate NexGen

Liechtenstein

28.2.2021

EU/1/13/876

Imatinib Medac

Liechtenstein

28.2.2021

EU/1/17/1243

Imatinib Teva B.V.

Liechtenstein

28.2.2021

EU/1/08/505

Intanza

Liechtenstein

28.2.2021

EU/1/01/191

Ketek

Liechtenstein

28.2.2021

EU/1/13/895

Kolbam

Liechtenstein

28.2.2021

EU/1/20/1516

Lextemy

Liechtenstein

30.6.2021

EU/1/16/1162

Lusduna

Liechtenstein

28.2.2021

EU/1/05/325

Macugen

Liechtenstein

28.2.2021

EU/1/04/297

Nodetrip (tidl.Xeristar)

Liechtenstein

30.6.2021

EU/1/04/297

Nodetrip (tidl.Xeristar)

Norge

16.6.2021

EU/1/01/186

Nonafact

Liechtenstein

28.2.2021

EU/1/15/1044

Numient

Liechtenstein

28.2.2021

EU/1/14/924

Olysio

Liechtenstein

28.2.2021

EU/1/04/287

Osseor

Liechtenstein

28.2.2021

EU/1/00/131

PegIntron

Island

17.5.2021

EU/1/00/131

PegIntron

Liechtenstein

30.4.2021

EU/1/00/131

PegIntron

Norge

6.5.2021

EU/1/15/1084

Portrazza

Island

2.3.2021

EU/1/15/1084

Portrazza

Liechtenstein

28.2.2021

EU/1/08/453

Prepandrix

Island

14.1.2021

EU/1/08/453

Prepandrix

Liechtenstein

28.2.2021

EU/1/08/453

Prepandrix

Norge

9.2.2021

EU/1/04/288

Protelos

Liechtenstein

28.2.2021

EU/1/20/1463

Qutavina

Liechtenstein

15.1.2021

EU/1/10/634

Ribavirin Mylan

Liechtenstein

28.2.2021

EU/1/07/388

Sebivo

Liechtenstein

15.1.2021

EU/1/06/358

Silgard

Liechtenstein

28.2.2021

EU/1/16/1163

Solymbic

Liechtenstein

28.2.2021

EU/1/15/1017

Taxespira

Liechtenstein

28.2.2021

EU/1/09/610

Telmisartan Teva

Island

9.6.2021

EU/1/09/610

Telmisartan Teva

Liechtenstein

30.6.2021

EU/1/09/610

Telmisartan Teva

Norge

16.6.2021

EU/1/09/552

Topotecan Teva

Liechtenstein

28.2.2021

EU/1/16/1126

Truberzi

Island

12.1.2021

EU/1/16/1126

Truberzi

Liechtenstein

15.1.2021

EU/1/16/1126

Truberzi

Norge

3.2.2021

EU/1/18/1303

Udenyca

Island

18.2.2021

EU/1/18/1303

Udenyca

Liechtenstein

28.2.2021

EU/1/18/1303

Udenyca

Norge

15.2.2021

EU/1/17/1180

Varuby

Liechtenstein

28.2.2021

EU/1/12/752

Vepacel

Liechtenstein

15.1.2021

EU/1/11/705

Vibativ

Liechtenstein

28.2.2021

EU/1/11/704

Victrelis

Liechtenstein

28.2.2021

EU/1/00/132

ViraferonPeg

Island

19.1.2021

EU/1/00/132

ViraferonPeg

Liechtenstein

28.2.2021

EU/1/00/132

ViraferonPeg

Norge

29.1.2021

EU/1/11/671

Xiapex

Liechtenstein

28.2.2021

EU/1/16/1121

Zalmoxis

Liechtenstein

28.2.2021


BILAG V

Liste over suspenderede markedsføringstilladelser

Følgende markedsføringstilladelser er blevet suspenderet i EØS-EFTA-staterne i perioden 1. januar-30. juni 2021:

EU-Nummer

Produkt

Land

Suspensionsdato