Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the first half of 2020 2021/C 39/04 Subcommittee I on the free movement of goods To be noted by the EEA Joint Committee
Date: 2021-02-04
Institutions: Standing Committee of the EFTA States
Subjects: EFTA countries, European Economic Area, free movement of goods, market approval, medicinal product, withdrawal from the market








C_2021039EN.01000601.xml










4.2.2021   


EN


Official Journal of the European Union


C 39/6






Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the first half of 2020
(2021/C 39/04)
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 2020, at their meeting on 25 September 2020.







Annex I

List of new marketing authorisations











Annex II

List of renewed marketing authorisations











Annex III

List of extended marketing authorisations











Annex IV

List of withdrawn marketing authorisations











Annex V

List of suspended marketing authorisations








ANNEX I
List of new marketing authorisations
The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January-30 June 2020:








EU-Number


Product


Country


Date of authorisation




EU/1/19/1415


Amsparity


Iceland


19.2.2020




EU/1/19/1415


Amsparity


Liechtenstein


29.2.2020




EU/1/19/1415


Amsparity


Norway


20.2.2020




EU/1/20/1427


Arsenic trioxide Mylan


Iceland


20.4.2020




EU/1/20/1427


Arsenic trioxide Mylan


Liechtenstein


30.4.2020




EU/1/20/1427


Arsenic trioxide Mylan


Norway


14.4.2020




EU/2/19/249


Aservo EquiHaler


Iceland


18.2.2020




EU/2/19/249


Aservo EquiHaler


Liechtenstein


29.2.2020




EU/2/19/249


Aservo EquiHaler


Norway


5.3.2020




EU/1/20/1439


Atectura Breezhaler


Iceland


23.6.2020




EU/1/20/1439


Atectura Breezhaler


Liechtenstein


30.6.2020




EU/1/20/1439


Atectura Breezhaler


Norway


8.6.2020




EU/1/19/1413


Azacitidine Accord


Iceland


19.2.2020




EU/1/19/1413


Azacitidine Accord


Liechtenstein


29.2.2020




EU/1/19/1413


Azacitidine Accord


Norway


21.2.2020




EU/1/19/1416


Azacitidine Betapharm


Iceland


16.4.2020




EU/1/19/1416


Azacitidine Betapharm


Liechtenstein


30.4.2020




EU/1/19/1416


Azacitidine Betapharm


Norway


31.3.2020




EU/1/20/1426


Azacitidine Mylan


Iceland


17.4.2020




EU/1/20/1426


Azacitidine Mylan


Liechtenstein


30.4.2020




EU/1/20/1426


Azacitidine Mylan


Norway


2.4.2020




EU/1/19/1406


Baqsimi


Norway


13.1.2020




EU/1/20/1441


Bemrist Breezhaler


Iceland


22.6.2020




EU/1/20/1441


Bemrist Breezhaler


Liechtenstein


30.6.2020




EU/1/20/1441


Bemrist Breezhaler


Norway


8.6.2020




EU/1/19/1417


Beovu


Iceland


18.2.2020




EU/1/19/1417


Beovu


Liechtenstein


29.2.2020




EU/1/19/1417


Beovu


Norway


19.2.2020




EU/1/19/1403


Budesonide/Formoterol Teva Pharma B.V.


Iceland


22.5.2020




EU/1/19/1403


Budesonide/Formoterol Teva Pharma B.V.


Liechtenstein


30.4.2020




EU/1/19/1403


Budesonide/Formoterol Teva Pharma B.V.


Norway


14.4.2020




EU/1/19/1409


Cegfila


Iceland


9.1.2020




EU/1/20/1429


Cinacalcet Accordpharma


Iceland


21.4.2020




EU/1/20/1429


Cinacalcet Accordpharma


Norway


14.4.2020




EU/1/19/1395


Clopidogrel/Acetylsalicylic acid Mylan


Iceland


20.1.2020




EU/1/19/1395


Clopidogrel/Acetylsalicylic acid Mylan


Norway


7.2.2020




EU/1/20/1451


Daurismo


Liechtenstein


30.6.2020




EU/1/19/1412


Deferasirox Accord


Iceland


15.1.2020




EU/1/19/1412


Deferasirox Accord


Norway


22.1.2020




EU/1/19/1418


Dexmedetomidin Accord


Iceland


18.2.2020




EU/1/19/1418


Dexmedetomidin Accord


Liechtenstein


29.2.2020




EU/1/19/1418


Dexmedetomidin Accord


Norway


19.2.2020




EU/1/19/1411


Evenity


Norway


3.1.2020




EU/1/20/1434


Fetcroja


Iceland


19.5.2020




EU/1/20/1434


Fetcroja


Liechtenstein


30.4.2020




EU/1/20/1434


Fetcroja


Norway


8.5.2020




EU/1/20/1450


Fingolimod Accord


Liechtenstein


30.6.2020




EU/1/20/1433


Fluad Tetra


Iceland


16.6.2020




EU/1/20/1433


Fluad Tetra


Liechtenstein


30.6.2020




EU/1/20/1433


Fluad Tetra


Norway


2.6.2020




EU/1/20/1428


Givlaari


Iceland


20.3.2020




EU/1/20/1428


Givlaari


Liechtenstein


30.4.2020




EU/1/20/1428


Givlaari


Norway


6.3.2020




EU/2/19/245


Gumbohatch


Norway


29.6.2020




EU/1/20/1447


Insulin aspart Sanofi


Liechtenstein


30.6.2020




EU/1/19/1407


Isturisa


Liechtenstein


29.2.2020




EU/1/19/1407


Isturisa


Iceland


16.1.2020




EU/1/19/1407


Isturisa


Liechtenstein


30.4.2020




EU/1/19/1407


Isturisa


Norway


3.2.2020




EU/1/20/1422


Liumjev


Iceland


17.4.2020




EU/1/20/1422


Liumjev


Liechtenstein


30.4.2020




EU/1/20/1422


Liumjev


Norway


31.3.2020




EU/2/20/253


Lydaxx


Iceland


2.6.2020




EU/2/20/253


Lydaxx


Norway


9.6.2020




EU/1/19/1414


Mayzent


Iceland


21.2.2020




EU/1/19/1414


Mayzent


Liechtenstein


29.2.2020




EU/1/19/1414


Mayzent


Norway


27.1.2020




EU/1/20/1436


Nepexto


Iceland


16.6.2020




EU/1/20/1436


Nepexto


Liechtenstein


30.6.2020




EU/1/20/1436


Nepexto


Norway


9.6.2020




EU/2/19/246


Neptra


Norway


6.1.2020




EU/1/20/1425


Nilemdo


Iceland


20.4.2020




EU/1/20/1425


Nilemdo


Liechtenstein


30.4.2020




EU/1/20/1425


Nilemdo


Norway


15.4.2020




EU/1/20/1432


Nubeqa


Iceland


17.4.2020




EU/1/20/1432


Nubeqa


Liechtenstein


30.4.2020




EU/1/20/1432


Nubeqa


Norway


1.4.2020




EU/1/20/1424


Nustendi


Iceland


17.4.2020




EU/1/20/1424


Nustendi


Norway


3.4.2020




EU/1/20/1453


Paliperidone Janssen-Cilag International


Iceland


26.6.2020




EU/1/20/1453


Paliperidone Janssen-Cilag International


Liechtenstein


30.6.2020




EU/1/20/1453


Paliperidone Janssen-Cilag International


Norway


29.6.2020




EU/1/19/1409


Pegfilgrastim Mundipharma


Norway


9.1.2020




EU/1/19/1388


Polivy


Iceland


24.1.2020




EU/1/19/1388


Polivy


Liechtenstein


29.2.2020




EU/1/19/1388


Polivy


Norway


27.1.2020




EU/1/19/1393


Quofenix


Norway


9.1.2020




EU/1/20/1452


Reblozyl


Liechtenstein


30.6.2020




EU/1/19/1420


Recarbrio


Iceland


18.2.2020




EU/1/19/1420


Recarbrio


Liechtenstein


29.2.2020




EU/1/19/1420


Recarbrio


Liechtenstein


30.4.2020




EU/1/19/1420


Recarbrio


Norway


19.2.2020




EU/1/19/1420


Recarbrio


Norway


23.4.2020




EU/1/20/1430


Rybelsus


Liechtenstein


30.4.2020




EU/1/19/1404


Rinvoq


Norway


3.1.2020




EU/1/20/1431


Ruxience


Iceland


20.4.2020




EU/1/20/1431


Ruxience


Norway


14.4.2020




EU/1/20/1430


Rybelsus


Iceland


22.4.2020




EU/1/20/1430


Rybelsus


Norway


14.4.2020




EU/1/20/1435


Sarclisa


Iceland


23.6.2020




EU/1/20/1435


Sarclisa


Norway


12.6.2020




EU/1/19/1387


Senstend


Liechtenstein


29.2.2020




EU/1/19/1410


Spravato


Iceland


3.1.2020




EU/1/19/1410


Spravato


Norway


15.1.2020




EU/1/19/1421


Staquis


Iceland


20.4.2020




EU/1/19/1421


Staquis


Norway


3.4.2020




EU/2/19/248


Stelfonta


Iceland


20.2.2020




EU/2/19/248


Stelfonta


Liechtenstein


29.2.2020




EU/2/19/248


Stelfonta


Norway


30.1.2020




EU/1/19/1408


Sunosi


Iceland


24.1.2020




EU/1/19/1408


Sunosi


Liechtenstein


29.2.2020




EU/1/19/1408


Sunosi


Norway


27.1.2020




EU/1/19/1405


Tavlesse


Iceland


15.1.2020




EU/1/19/1405


Tavlesse


Liechtenstein


29.2.2020




EU/1/19/1405


Tavlesse


Norway


7.2.2020




EU/1/19/1394


Tigecycline Accord


Iceland


29.4.2020




EU/1/19/1394


Tigecycline Accord


Liechtenstein


30.4.2020




EU/1/19/1394


Tigecycline Accord


Norway


17.4.2020




EU/1/19/1419


Trepulmix


Iceland


21.4.2020




EU/1/19/1419


Trepulmix


Liechtenstein


30.4.2020




EU/1/19/1419


Trepulmix


Norway


14.4.2020




EU/2/20/251


Tulaven


Iceland


29.4.2020




EU/2/20/251


Tulaven


Liechtenstein


30.4.2020




EU/2/20/251


Tulaven


Norway


29.4.2020




EU/2/20/252


TULISSIN


Iceland


19.5.2020




EU/1/18/1309


Ulipristal Acetate Gedeon Richter


Liechtenstein


30.4.2020




EU/1/20/1423


Vaxchora


Iceland


21.4.2020




EU/1/20/1423


Vaxchora


Liechtenstein


30.4.2020




EU/1/20/1423


Vaxchora


Norway


17.4.2020




EU/2/20/250


Vectormune FP ILT + AE


Iceland


29.4.2020




EU/2/20/250


Vectormune FP ILT + AE


Liechtenstein


30.4.2020




EU/2/20/250


Vectormune FP ILT + AE


Norway


29.4.2020




EU/1/19/1399


Xospata


Liechtenstein


29.2.2020




EU/1/20/1442


Zeposia


Iceland


22.6.2020




EU/1/20/1442


Zeposia


Liechtenstein


30.6.2020




EU/1/20/1442


Zeposia


Norway


15.6.2020




EU/1/20/1443


Zolgensma


Iceland


20.5.2020




EU/1/20/1443


Zolgensma


Liechtenstein


30.6.2020




EU/1/20/1443


Zolgensma


Norway


20.5.2020









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 2020:








EU-Number


Product


Country


Date of authorisation




EU/1/15/1001


Akynzeo


Iceland


15.1.2020




EU/1/15/1001


Akynzeo


Liechtenstein


29.2.2020




EU/1/15/1001


Akynzeo


Norway


22.1.2020




EU/1/15/1005


Aripiprazole Mylan Pharma


Iceland


13.3.2020




EU/1/15/1005


Aripiprazole Mylan Pharma


Norway


10.3.2020




EU/1/15/1029


Aripiprazole Sandoz


Liechtenstein


30.6.2020




EU/1/15/1009


Aripiprazole Zentiva


Iceland


22.6.2020




EU/1/15/1009


Aripiprazole Zentiva


Liechtenstein


30.6.2020




EU/1/15/1009


Aripiprazole Zentiva


Norway


18.6.2020




EU/1/15/1019


Bortezomib Accord


Iceland


20.5.2020




EU/1/15/1019


Bortezomib Accord


Liechtenstein


30.6.2020




EU/1/15/1019


Bortezomib Accord


Norway


15.5.2020




EU/1/13/818


Bosulif


Iceland


27.2.2020




EU/1/13/818


Bosulif


Liechtenstein


29.2.2020




EU/1/13/818


Bosulif


Norway


25.2.2020




EU/1/10/645


Brinavess


Iceland


22.6.2020




EU/1/10/645


Brinavess


Liechtenstein


30.6.2020




EU/1/10/645


Brinavess


Norway


8.6.2020




EU/2/15/183


Canigen L4


Liechtenstein


30.4.2020




EU/2/15/183


Canigen L4


Norway


28.4.2020




EU/1/11/749


Caprelsa


Iceland


21.1.2020




EU/1/11/749


Caprelsa


Liechtenstein


29.2.2020




EU/1/11/749


Caprelsa


Norway


23.1.2020




EU/1/14/974


Cerdelga


Norway


3.1.2020




EU/2/14/180


Coliprotec F4


Iceland


24.1.2020




EU/2/14/180


Coliprotec F4


Liechtenstein


29.2.2020




EU/2/14/180


Coliprotec F4


Norway


12.2.2020




EU/1/13/890


Cometriq


Iceland


20.3.2020




EU/1/13/890


Cometriq


Liechtenstein


29.2.2020




EU/1/13/890


Cometriq


Liechtenstein


30.4.2020




EU/1/13/890


Cometriq


Norway


10.3.2020




EU/1/15/1048


Cotellic


Liechtenstein


30.6.2020




EU/1/17/1262


Crysvita


Norway


20.1.2020




EU/1/10/636


Daxas


Iceland


2.6.2020




EU/1/10/636


Daxas


Liechtenstein


30.6.2020




EU/1/10/636


Daxas


Norway


3.6.2020




EU/1/13/875


Deltyba


Iceland


19.5.2020




EU/1/13/875


Deltyba


Liechtenstein


30.4.2020




EU/1/13/875


Deltyba


Norway


30.4.2020




EU/1/15/1010


Duloxetine Mylan


Iceland


27.2.2020




EU/1/15/1010


Duloxetine Mylan


Liechtenstein


29.2.2020




EU/1/15/1010


Duloxetine Mylan


Norway


24.2.2020




EU/1/15/1025


Evotaz


Norway


8.4.2020




EU/1/15/1058


Entresto


Liechtenstein


30.6.2020




EU/1/15/1023


Farydak


Iceland


22.5.2020




EU/1/15/1023


Farydak


Liechtenstein


30.4.2020




EU/1/15/1023


Farydak


Norway


7.5.2020




EU/1/15/1007


Gardasil 9


Iceland


23.1.2020




EU/1/15/1007


Gardasil 9


Liechtenstein


29.2.2020




EU/1/15/1007


Gardasil 9


Norway


23.1.2020




EU/1/14/987


Holoclar


Iceland


13.3.2020




EU/1/14/987


Holoclar


Liechtenstein


30.4.2020




EU/1/14/987


Holoclar


Norway


16.3.2020




EU/1/15/990


Ikervis


Iceland


13.3.2020




EU/2/15/182


Innovax-ILT


Iceland


30.4.2020




EU/2/15/182


Innovax-ILT


Liechtenstein


30.4.2020




EU/2/15/182


Innovax-ILT


Norway


5.5.2020




EU/1/15/1041


Ivabradine Anpharm


Norway


2.6.2020




EU/1/15/1040


Intuniv


Liechtenstein


30.6.2020




EU/1/15/1000


Jinarc


Iceland


22.5.2020




EU/1/15/1000


Jinarc


Liechtenstein


30.4.2020




EU/1/15/1000


Jinarc


Norway


14.4.2020




EU/1/15/1033


Kanuma


Iceland


22.5.2020




EU/1/15/1033


Kanuma


Liechtenstein


30.4.2020




EU/1/15/1033


Kanuma


Norway


23.4.2020




EU/1/15/994


Kengrexal


Norway


13.1.2020




EU/1/15/1024


Keytruda


Iceland


16.4.2020




EU/1/15/1024


Keytruda


Norway


2.4.2020




EU/1/15/1060


Kyprolis


Liechtenstein


30.6.2020




EU/1/15/1002


Lenvima


Iceland


3.6.2020




EU/1/15/1002


Lenvima


Liechtenstein


30.6.2020




EU/1/15/1002


Lenvima


Norway


2.6.2020




EU/1/19/1376


Libtayo


Iceland


2.6.2020




EU/1/19/1376


Libtayo


Liechtenstein


30.6.2020




EU/1/19/1376


Libtayo


Norway


2.6.2020




EU/1/15/993


Lixiana


Iceland


13.3.2020




EU/1/15/993


Lixiana


Norway


10.3.2020




EU/1/19/1355


Lorviqua


Iceland


19.5.2020




EU/1/19/1355


Lorviqua


Norway


16.4.2020




EU/1/15/1013


Lumark


Iceland


19.5.2020




EU/1/15/1013


Lumark


Liechtenstein


30.4.2020




EU/1/15/1013


Lumark


Norway


5.5.2020




EU/1/14/988


Mysimba


Iceland


23.1.2020




EU/1/14/988


Mysimba


Liechtenstein


29.2.2020




EU/1/14/988


Mysimba


Norway


23.1.2020




EU/1/15/1078


Natpar


Iceland


24.6.2020




EU/1/15/1078


Natpar


Liechtenstein


30.4.2020




EU/2/15/186


Novaquin


Liechtenstein


30.6.2020




EU/1/16/1139


Ocaliva


Iceland


20.5.2020




EU/1/16/1139


Ocaliva


Liechtenstein


30.4.2020




EU/1/16/1139


Ocaliva


Norway


12.5.2020




EU/1/15/1030


Odomzo


Iceland


16.6.2020




EU/1/15/1030


Odomzo


Liechtenstein


30.6.2020




EU/1/15/1030


Odomzo


Norway


3.6.2020




EU/1/18/1345


Ondexxya


Iceland


25.5.2020




EU/1/18/1345


Ondexxya


Liechtenstein


30.4.2020




EU/1/15/1014


Opdivo


Iceland


19.5.2020




EU/1/15/1014


Opdivo


Liechtenstein


30.4.2020




EU/1/15/1014


Opdivo


Norway


8.5.2020




EU/1/15/989


Orbactiv


Iceland


21.1.2020




EU/1/15/989


Orbactiv


Liechtenstein


29.2.2020




EU/1/15/989


Orbactiv


Norway


22.1.2020




EU/1/16/1089


Pandemic influenza vaccine H5N1 AstraZeneca


Iceland


20.3.2020




EU/1/16/1089


Pandemic influenza vaccine H5N1 AstraZeneca


Liechtenstein


29.2.2020




EU/1/16/1089


Pandemic influenza vaccine H5N1 AstraZeneca


Liechtenstein


30.4.2020




EU/1/16/1089


Pandemic influenza vaccine H5N1 AstraZeneca


Norway


24.3.2020




EU/1/15/1034


Pemetrexed Lilly


Iceland


22.6.2020




EU/1/15/1034


Pemetrexed Lilly


Liechtenstein


30.6.2020




EU/1/15/1034


Pemetrexed Lilly


Norway


15.6.2020




EU/2/15/187


Porcilis PCV ID


Iceland


22.6.2020




EU/2/15/187


Porcilis PCV ID


Liechtenstein


30.6.2020




EU/1/15/1031


Praluent


Iceland


23.6.2020




EU/1/15/1031


Praluent


Liechtenstein


30.6.2020




EU/1/15/1031


Praluent


Norway


18.6.2020




EU/1/15/997


Pregabalin Mylan


Iceland


16.4.2020




EU/1/15/997


Pregabalin Mylan


Liechtenstein


30.4.2020




EU/1/15/997


Pregabalin Mylan


Norway


16.4.2020




EU/1/15/998


Pregabalin Mylan Pharma


Iceland


22.5.2020




EU/1/15/998


Pregabalin Mylan Pharma


Liechtenstein


30.4.2020




EU/1/15/998


Pregabalin Mylan Pharma


Norway


16.4.2020




EU/1/14/916


Pregabalin Pfizer


Norway


10.6.2020




EU/1/15/1011


Pregabalin Sandoz


Liechtenstein


30.6.2020




EU/1/15/1012


Pregabalin Sandoz GmbH


Liechtenstein


30.6.2020




EU/1/15/1021


Pregabalin Zentiva


Iceland


16.6.2020




EU/1/15/1021


Pregabalin Zentiva


Liechtenstein


30.6.2020




EU/1/15/1021


Pregabalin Zentiva


Norway


2.6.2020




EU/2/15/187


Porcilis PCV ID


Norway


9.6.2020




EU/1/10/618


Prolia


Iceland


23.1.2020




EU/1/10/618


Prolia


Liechtenstein


29.2.2020




EU/1/14/973


Quinsair


Iceland


19.2.2020




EU/1/14/973


Quinsair


Liechtenstein


29.2.2020




EU/1/14/973


Quinsair


Norway


19.2.2020




EU/1/15/1016


Repatha


Iceland


22.4.2020




EU/1/15/1016


Repatha


Liechtenstein


30.4.2020




EU/1/15/1016


Repatha


Norway


22.4.2020




EU/1/15/1006


Respreeza


Iceland


22.5.2020




EU/1/15/1006


Respreeza


Liechtenstein


30.4.2020




EU/1/15/1006


Respreeza


Norway


28.4.2020




EU/1/17/1250


Rubraca


Iceland


22.5.2020




EU/1/17/1250


Rubraca


Liechtenstein


30.4.2020




EU/1/17/1250


Rubraca


Norway


23.4.2020




EU/1/15/992


Saxenda


Norway


3.1.2020




EU/2/15/181


Sileo


Iceland


19.5.2020




EU/2/15/181


Sileo


Liechtenstein


30.4.2020




EU/2/15/181


Sileo


Norway


12.5.2020




EU/1/13/901


Sirturo


Iceland


15.1.2020




EU/1/13/901


Sirturo


Liechtenstein


29.2.2020




EU/1/13/901


Sirturo


Norway


23.1.2020




EU/1/15/991


Sivextro


Iceland


15.1.2020




EU/1/15/991


Sivextro


Liechtenstein


29.2.2020




EU/1/15/991


Sivextro


Norway


22.1.2020




EU/1/15/1015


Strensiq


Iceland


20.5.2020




EU/1/15/1015


Strensiq


Norway


5.5.2020




EU/1/15/1003


Synjardy


Iceland


16.4.2020




EU/1/15/1003


Synjardy


Liechtenstein


30.4.2020




EU/1/15/1003


Synjardy


Norway


14.4.2020




EU/1/15/1004


Voriconazole Hikma


Iceland


25.5.2020




EU/1/15/1004


Voriconazole Hikma


Norway


24.3.2020




EU/1/19/1360


Waylivra


Iceland


21.3.2020




EU/1/19/1360


Waylivra


Liechtenstein


30.4.2020




EU/1/19/1360


Waylivra


Norway


26.5.2020




EU/1/15/1032


Zerbaxa


Iceland


30.4.2020




EU/1/15/1032


Zerbaxa


Liechtenstein


30.4.2020




EU/1/15/1032


Zerbaxa


Norway


28.4.2020




EU/2/14/178


Zulvac SBV


Iceland


21.1.2020




EU/2/14/178


Zulvac SBV


Liechtenstein


29.2.2020




EU/2/14/178


Zulvac SBV


Norway


12.2.2020




EU/1/19/1367


Zynteglo


Iceland


22.5.2020




EU/1/19/1367


Zynteglo


Liechtenstein


30.4.2020




EU/1/19/1367


Zynteglo


Norway


11.5.2020









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 2020:








EU-Number


Product


Country


Date of authorisation




EU/1/15/1001/003


Akynzeo


Iceland


16.4.2020




EU/1/15/1001/003


Akynzeo


Norway


23.3.2020




EU/1/16/1101/004


Darzalex


Iceland


23.6.2020




EU/1/11/733/005


Dificlir


Iceland


20.3.2020




EU/1/11/733/005


Dificlir


Norway


20.2.2020




EU/1/14/923/002-007


Entyvio


Iceland


24.6.2020




EU/1/14/923/002-007


Entyvio


Norway


28.4.2020




EU/1/18/1288/007


Halimatoz


Iceland


20.4.2020




EU/1/18/1287/007


Hefiya


Iceland


20.4.2020




EU/1/18/1286/007


Hyrimoz


Iceland


20.4.2020




EU/1/16/1147/010-018


Ibrance


Iceland


22.4.2020




EU/1/16/1147/010-015


Ibrance


Norway


19.2.2020




EU/1/17/1254/007-011


Jorveza


Iceland


16.6.2020




EU/1/17/1254/007-011


Jorveza


Norway


2.6.2020




EU/1/12/782/006


Kalydeco


Iceland


2.1.2020




EU/1/16/1115/003-005


Pemetrexed Fresenius Kabi


Iceland


19.2.2020




EU/1/16/1115/003-005


Pemetrexed Fresenius Kabi


Norway


19.2.2020




EU/1/11/717/003-004


Vyndaqel


Iceland


22.4.2020




EU/1/11/717/003-004


Vyndaqel


Norway


24.2.2020




EU/1/17/1178/010-013


XELJANZ


Iceland


2.1.2020









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 2020:








EU-Number


Product


Country


Date of withdrawal




EU/1/09/541


Clopidogrel ratiopharm GmbH


Iceland


23.1.2020




EU/1/09/541


Clopidogrel ratiopharm GmbH


Liechtenstein


29.2.2020




EU/1/09/541


Clopidogrel ratiopharm GmbH


Norway


13.1.2020




EU/1/09/510


Fertavid


Iceland


30.1.2020




EU/1/09/510


Fertavid


Norway


23.1.2020




EU/1/15/1039


Fexeric


Iceland


27.2.2020




EU/1/00/144


Helixate NexGen


Iceland


3.1.2020




EU/1/19/1357


KROMEYA


Iceland


3.1.2020




EU/1/16/1165


Lifmior


Iceland


27.2.2020




EU/1/04/287


Osseor


Iceland


22.5.2020




EU/1/04/287


Osseor


Norway


8.5.2020




EU/1/12/796


Picato


Iceland


20.2.2020




EU/1/12/796


Picato


Liechtenstein


29.2.2020




EU/1/12/796


Picato


Norway


11.2.2020




EU/1/04/288


Protelos


Iceland


22.5.2020




EU/1/04/288


Protelos


Norway


8.5.2020




EU/2/09/099


Suvaxyn PCV


Norway


28.4.2020




EU/1/17/1180


Varuby


Iceland


30.1.2020




EU/1/17/1180


Varuby


Norway


23.1.2020




EU/1/11/671


Xiapex


Iceland


6.1.2020




EU/1/96/009


Zerit


Liechtenstein


30.6.2020




EU/2/11/130


Zulvac 1 Bovis


Iceland


20.3.2020




EU/2/11/130


Zulvac 1 Bovis


Norway


18.2.2020




EU/2/11/131


Zulvac 1 Ovis


Iceland


20.3.2020




EU/2/11/131


Zulvac 1 Ovis


Norway


13.3.2020









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 2020:








EU-Number


Product


Country


Date of suspension




EU/1/12/750


Esmya


Norway


2.4.2020




EU/1/12/796


Picato


Norway


22.1.2020




EU/1/18/1309


Ulipristal Acetate Richter


Norway


28.5.2020