# C_2016347EN.01001901.xml

| 22.9.2016 | EN | Official Journal of the European Union | C 347/19 |
| --- | --- | --- | --- |

22.9.2016

EN

Official Journal of the European Union

C 347/19

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Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2015

(2016/C 347/05)

Subcommittee I on the free movement of goods

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

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 2015, at their meeting on 18 March 2016:

| Annex I | List of new marketing authorisations |
| --- | --- |
| Annex II | List of renewed marketing authorisations |
| Annex III | List of extended marketing authorisations |
| Annex IV | List of withdrawn marketing authorisations |
| Annex V | List of suspended marketing authorisations |

Annex I

List of new marketing authorisations

Annex II

List of renewed marketing authorisations

Annex III

List of extended marketing authorisations

Annex IV

List of withdrawn marketing authorisations

Annex V

List of suspended marketing authorisations

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ANNEX I

List of new marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July-31 December 2015:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/11/710 | Votubia (switch to non-conditional) | Liechtenstein | 31.12.2015 |
| EU/1/13/895 | Kolbam | Iceland | 14.12.2015 |
| EU/1/13/895 | Kolbam | Norway | 15.12.2015 |
| EU/1/13/895 | Kolbam | Liechtenstein | 31.12.2015 |
| EU/1/15/1005 | Aripiprazole Pharmathen | Iceland | 23.7.2015 |
| EU/1/15/1005 | Aripiprazole Pharmathen | Liechtenstein | 31.8.2015 |
| EU/1/15/1005 | Aripiprazole Pharmathen | Norway | 16.7.2015 |
| EU/1/15/1006 | Respreeza | Iceland | 31.8.2015 |
| EU/1/15/1006 | Respreeza | Liechtenstein | 31.8.2015 |
| EU/1/15/1006 | Respreeza | Norway | 28.8.2015 |
| EU/1/15/1007 | Gardasil 9 | Iceland | 8.7.2015 |
| EU/1/15/1008 | Hetlioz | Iceland | 4.8.2015 |
| EU/1/15/1008 | Hetlioz | Liechtenstein | 31.8.2015 |
| EU/1/15/1008 | Hetlioz | Norway | 16.7.2015 |
| EU/1/15/1009 | Aripiprazole Zentiva | Iceland | 23.7.2015 |
| EU/1/15/1009 | Aripiprazole Zentiva | Norway | 16.7.2015 |
| EU/1/15/1010 | Duloxetine Mylan | Iceland | 9.7.2015 |
| EU/1/15/1010 | Duloxetine Mylan | Norway | 9.7.2015 |
| EU/1/15/1011 | Pregabalin Sandoz | Iceland | 10.7.2015 |
| EU/1/15/1011 | Pregabalin Sandoz | Norway | 17.7.2015 |
| EU/1/15/1012 | Pregabalin Sandoz GmbH | Iceland | 10.7.2015 |
| EU/1/15/1012 | Pregabalin Sandoz GmbH | Norway | 17.7.2015 |
| EU/1/15/1013 | Lumark | Norway | 13.7.2015 |
| EU/1/15/1013 | Lumark | Iceland | 10.7.2015 |
| EU/1/15/1014 | OPDIVO | Iceland | 10.7.2015 |
| EU/1/15/1014 | Opdivo | Norway | 2.7.2015 |
| EU/1/15/1015 | Strensiq | Iceland | 10.9.2015 |
| EU/1/15/1015 | Strensiq | Liechtenstein | 31.10.2015 |
| EU/1/15/1015 | Strensiq | Norway | 14.9.2015 |
| EU/1/15/1016 | Repatha | Iceland | 14.8.2015 |
| EU/1/15/1016 | Repatha | Liechtenstein | 31.8.2015 |
| EU/1/15/1016 | Repatha | Norway | 5.8.2015 |
| EU/1/15/1017 | Docetaxel Hospira UK Limited | Iceland | 4.9.2015 |
| EU/1/15/1017 | Docetaxel Hospira UK limited | Liechtenstein | 31.10.2015 |
| EU/1/15/1017 | Docetaxel Hospira UK Limited | Norway | 7.9.2015 |
| EU/1/15/1018 | Omidria | Iceland | 19.8.2015 |
| EU/1/15/1018 | Omidria | Liechtenstein | 31.8.2015 |
| EU/1/15/1018 | Omidria | Norway | 26.8.2015 |
| EU/1/15/1019 | Bortezomib Accord | Iceland | 19.8.2015 |
| EU/1/15/1019 | Bortezomib Accord | Liechtenstein | 31.8.2015 |
| EU/1/15/1019 | Bortezomib Accord | Norway | 11.8.2015 |
| EU/1/15/1020 | Raxone | Iceland | 15.9.2015 |
| EU/1/15/1020 | Raxone | Liechtenstein | 31.10.2015 |
| EU/1/15/1020 | Raxone | Norway | 30.9.2015 |
| EU/1/15/1021 | Pregabalin Zentiva | Iceland | 14.8.2015 |
| EU/1/15/1021 | Pregabalin Zentiva | Liechtenstein | 31.8.2015 |
| EU/1/15/1021 | Pregabalin Zentiva | Norway | 10.8.2015 |
| EU/1/15/1022 | Unituxin | Iceland | 21.8.2015 |
| EU/1/15/1022 | Unituxin | Liechtenstein | 31.8.2015 |
| EU/1/15/1022 | Unituxin | Norway | 25.8.2015 |
| EU/1/15/1023 | Farydak | Iceland | 4.9.2015 |
| EU/1/15/1023 | Farydak | Liechtenstein | 31.10.2015 |
| EU/1/15/1023 | Farydak | Norway | 7.9.2015 |
| EU/1/15/1024 | Keytruda | Iceland | 13.8.2015 |
| EU/1/15/1024 | Keytruda | Liechtenstein | 31.8.2015 |
| EU/1/15/1024 | Keytruda | Norway | 11.8.2015 |
| EU/1/15/1025 | Evotaz | Iceland | 12.8.2015 |
| EU/1/15/1025 | Evotaz | Liechtenstein | 31.8.2015 |
| EU/1/15/1025 | Evotaz | Norway | 10.8.2015 |
| EU/1/15/1026 | Nivolumab BMS | Iceland | 28.12.2015 |
| EU/1/15/1026 | Nivolumab BMS | Liechtenstein | 31.8.2015 |
| EU/1/15/1026 | Nivolumab BMS | Norway | 11.8.2015 |
| EU/1/15/1027 | Pregabalin Accord | Iceland | 2.9.2015 |
| EU/1/15/1027 | Pregabalin Accord | Liechtenstein | 31.10.2015 |
| EU/1/15/1027 | Pregabalin Accord | Norway | 7.9.2015 |
| EU/1/15/1028 | Duloxetine Zentiva | Iceland | 31.8.2015 |
| EU/1/15/1028 | Duloxetine Zentiva | Liechtenstein | 31.8.2015 |
| EU/1/15/1028 | Duloxetine Zentiva | Norway | 23.9.2015 |
| EU/1/15/1029 | Aripiprazole Sandoz | Iceland | 31.8.2015 |
| EU/1/15/1029 | Aripiprazole Sandoz | Liechtenstein | 31.8.2015 |
| EU/1/15/1029 | Aripiprazole Sandoz | Norway | 25.8.2015 |
| EU/1/15/1030 | Odomzo | Iceland | 1.9.2015 |
| EU/1/15/1030 | Odomzo | Liechtenstein | 31.8.2015 |
| EU/1/15/1030 | Odomzo | Norway | 4.9.2015 |
| EU/1/15/1031 | Praluent | Iceland | 16.10.2015 |
| EU/1/15/1031 | Praluent | Liechtenstein | 31.10.2015 |
| EU/1/15/1031 | Praluent | Norway | 1.10.2015 |
| EU/1/15/1032 | Zerbaxa | Iceland | 23.9.2015 |
| EU/1/15/1032 | Zerbaxa | Liechtenstein | 31.10.2015 |
| EU/1/15/1032 | Zerbaxa | Norway | 13.10.2015 |
| EU/1/15/1033 | Kanuma | Iceland | 2.9.2015 |
| EU/1/15/1033 | Kanuma | Liechtenstein | 31.8.2015 |
| EU/1/15/1033 | Kanuma | Norway | 10.9.2015 |
| EU/1/15/1034 | Pemetrexed Lilly | Iceland | 21.9.2015 |
| EU/1/15/1034 | Pemetrexed Lilly | Liechtenstein | 31.10.2015 |
| EU/1/15/1034 | Pemetrexed Lilly | Norway | 21.9.2015 |
| EU/1/15/1035 | Obizur | Iceland | 18.11.2015 |
| EU/1/15/1035 | Obizur | Norway | 30.11.2015 |
| EU/1/15/1035 | Obizur | Liechtenstein | 31.12.2015 |
| EU/1/15/1036 | Cresemba | Iceland | 23.10.2015 |
| EU/1/15/1036 | Cresemba | Liechtenstein | 31.10.2015 |
| EU/1/15/1036 | Cresemba | Norway | 11.11.2015 |
| EU/1/15/1037 | Pemetrexed Sandoz | Iceland | 15.10.2015 |
| EU/1/15/1037 | Pemetrexed Sandoz | Liechtenstein | 31.10.2015 |
| EU/1/15/1037 | Pemetrexed Sandoz | Norway | 24.9.2015 |
| EU/1/15/1038 | Pemetrexed medac | Iceland | 11.12.2015 |
| EU/1/15/1038 | Pemetrexed medac | Norway | 14.12.2015 |
| EU/1/15/1038 | Pemetrexed medac | Liechtenstein | 31.12.2015 |
| EU/1/15/1039 | Fexeric | Iceland | 16.10.2015 |
| EU/1/15/1039 | Fexeric | Liechtenstein | 31.10.2015 |
| EU/1/15/1039 | Fexeric | Norway | 13.10.2015 |
| EU/1/15/1040 | Intuniv | Iceland | 21.9.2015 |
| EU/1/15/1040 | Intuniv | Liechtenstein | 31.10.2015 |
| EU/1/15/1040 | Intuniv | Norway | 23.9.2015 |
| EU/1/15/1041 | Ivabradine Anpharm | Iceland | 15.10.2015 |
| EU/1/15/1041 | Ivabradine Anpharm | Liechtenstein | 31.10.2015 |
| EU/1/15/1041 | Ivabradine Anpharm | Norway | 1.10.2015 |
| EU/1/15/1042 | Zalviso | Liechtenstein | 31.10.2015 |
| EU/1/15/1042 | Zalviso | Iceland | 16.10.2015 |
| EU/1/15/1042 | Zalviso | Norway | 13.10.2015 |
| EU/1/15/1043 | Nucala | Iceland | 29.12.2015 |
| EU/1/15/1043 | Nucala | Norway | 10.12.2015 |
| EU/1/15/1043 | Nucala | Liechtenstein | 31.12.2015 |
| EU/1/15/1044 | Numient | Iceland | 14.12.2015 |
| EU/1/15/1044 | Numient | Norway | 22.12.2015 |
| EU/1/15/1044 | Numient | Liechtenstein | 31.12.2015 |
| EU/1/15/1045 | Aripiprazole Accord | Iceland | 20.11.2015 |
| EU/1/15/1045 | Aripiprazole Accord | Norway | 3.12.2015 |
| EU/1/15/1045 | Aripiprazole Accord | Liechtenstein | 31.12.2015 |
| EU/1/15/1046 | Elocta | Iceland | 11.12.2015 |
| EU/1/15/1046 | Elocta | Norway | 17.12.2015 |
| EU/1/15/1046 | Elocta | Liechtenstein | 31.12.2015 |
| EU/1/15/1047 | Blincyto | Iceland | 23.12.2015 |
| EU/1/15/1047 | Blincyto | Norway | 1.12.2015 |
| EU/1/15/1047 | Blincyto | Liechtenstein | 31.12.2015 |
| EU/1/15/1048 | Cotellic | Iceland | 11.12.2015 |
| EU/1/15/1048 | Cotellic | Norway | 30.11.2015 |
| EU/1/15/1048 | Cotellic | Liechtenstein | 31.12.2015 |
| EU/1/15/1050 | Ionsys | Iceland | 24.11.2015 |
| EU/1/15/1050 | Ionsys | Norway | 10.12.2015 |
| EU/1/15/1050 | Ionsys | Liechtenstein | 31.12.2015 |
| EU/1/15/1051 | Ebymect | Iceland | 23.11.2015 |
| EU/1/15/1051 | Ebymect | Norway | 10.12.2015 |
| EU/1/15/1051 | Ebymect | Liechtenstein | 31.12.2015 |
| EU/1/15/1052 | Edistride | Iceland | 17.11.2015 |
| EU/1/15/1052 | Edistride | Norway | 3.12.2015 |
| EU/1/15/1052 | Edistride | Liechtenstein | 31.12.2015 |
| EU/1/15/1054 | Cinacalcet Mylan | Iceland | 24.11.2015 |
| EU/1/15/1054 | Cinacalcet Mylan | Norway | 30.11.2015 |
| EU/1/15/1054 | Cinacalcet Mylan | Liechtenstein | 31.12.2015 |
| EU/1/15/1055 | Ciambra | Iceland | 29.12.2015 |
| EU/1/15/1055 | Ciambra | Norway | 10.12.2015 |
| EU/1/15/1055 | Ciambra | Liechtenstein | 31.12.2015 |
| EU/1/15/1056 | Praxbind | Iceland | 11.12.2015 |
| EU/1/15/1056 | Praxbind | Norway | 10.12.2015 |
| EU/1/15/1056 | Praxbind | Liechtenstein | 31.12.2015 |
| EU/1/15/1057 | Pemetrexed Hospira | Iceland | 11.12.2015 |
| EU/1/15/1057 | Pemetrexed Hospira | Norway | 1.12.2015 |
| EU/1/15/1057 | Pemetrexed Hospira | Liechtenstein | 31.12.2015 |
| EU/1/15/1058 | Entresto | Iceland | 11.12.2015 |
| EU/1/15/1058 | Entresto | Norway | 26.11.2015 |
| EU/1/15/1058 | Entresto | Liechtenstein | 31.12.2015 |
| EU/1/15/1059 | Orkambi | Iceland | 8.12.2015 |
| EU/1/15/1059 | Orkambi | Norway | 10.12.2015 |
| EU/1/15/1059 | Orkambi | Liechtenstein | 31.12.2015 |
| EU/1/15/1060 | Kyprolis | Iceland | 24.11.2015 |
| EU/1/15/1060 | Kyprolis | Norway | 1.12.2015 |
| EU/1/15/1060 | Kyprolis | Liechtenstein | 31.12.2015 |
| EU/1/15/1061 | Genvoya | Iceland | 9.12.2015 |
| EU/1/15/1061 | Genvoya | Norway | 10.12.2015 |
| EU/1/15/1061 | Genvoya | Liechtenstein | 31.12.2015 |
| EU/1/15/1062 | Ravicti | Iceland | 15.12.2015 |
| EU/1/15/1062 | Ravicti | Norway | 10.12.2015 |
| EU/1/15/1062 | Ravicti | Liechtenstein | 31.12.2015 |
| EU/1/15/993 | Lixiana | Iceland | 10.7.2015 |
| EU/1/15/993 | Lixiana | Norway | 6.7.2015 |
| EU/1/15/997 | Pregabalin Mylan | Iceland | 13.7.2015 |
| EU/1/15/997 | Pregabalin Mylan | Liechtenstein | 31.8.2015 |
| EU/1/15/997 | Pregabalin Mylan | Norway | 16.7.2015 |
| EU/1/15/998 | Pregabalin Mylan Pharma | Iceland | 13.7.2015 |
| EU/1/15/998 | Pregabalin Mylan Pharma | Liechtenstein | 31.8.2015 |
| EU/1/15/998 | Pregabalin Mylan Pharma | Norway | 16.7.2015 |
| EU/2/15/181 | Sileo | Iceland | 8.7.2015 |
| EU/2/15/182 | Innovax ILT | Liechtenstein | 31.8.2015 |
| EU/2/15/182 | Innovax-ILT | Iceland | 24.7.2015 |
| EU/2/15/182 | Innovax-ILT | Norway | 30.7.2015 |
| EU/2/15/183 | Canigen L4 | Iceland | 6.8.2015 |
| EU/2/15/183 | Canigen L4 | Liechtenstein | 31.8.2015 |
| EU/2/15/183 | Canigen L4 | Norway | 30.7.2015 |
| EU/2/15/184 | UpCard | Iceland | 20.8.2015 |
| EU/2/15/184 | UpCard | Liechtenstein | 31.10.2015 |
| EU/2/15/184 | UpCard | Norway | 10.8.2015 |
| EU/2/15/185 | Fortekor Plus | Iceland | 21.9.2015 |
| EU/2/15/185 | Fortekor Plus | Liechtenstein | 31.10.2015 |
| EU/2/15/185 | Fortekor Plus | Norway | 6.10.2015 |
| EU/2/15/186 | Novaquin | Iceland | 15.9.2015 |
| EU/2/15/186 | Novaquin | Liechtenstein | 31.10.2015 |
| EU/2/15/186 | Novaquin | Norway | 6.10.2015 |
| EU/2/15/187 | Porcilis PCV ID | Iceland | 2.9.2015 |
| EU/2/15/187 | Porcilis PCV ID | Liechtenstein | 31.10.2015 |
| EU/2/15/187 | Porcilis PCV ID | Norway | 9.9.2015 |
| EU/2/15/188 | Vectormune ND | Iceland | 21.9.2015 |
| EU/2/15/188 | Vectormune ND | Liechtenstein | 31.10.2015 |
| EU/2/15/188 | Vectormune ND | Norway | 6.10.2015 |
| EU/2/15/189 | Zycortal | Iceland | 20.11.2015 |
| EU/2/15/189 | Zycortal | Norway | 3.12.2015 |
| EU/2/15/189 | Zycortal | Liechtenstein | 31.12.2015 |
| EU/2/15/190 | Suvaxyn Circo + MH RTU | Norway | 4.12.2015 |
| EU/2/15/190 | Suvaxyn Circo + MH RTU | Liechtenstein | 31.12.2015 |
| EU/2/15/190 | Suvaxyn Circo + MH RTU | Iceland | 16.11.2015 |
| EU/2/15/191 | Simparica | Iceland | 20.11.2015 |
| EU/2/15/191 | Simparica | Norway | 4.12.2015 |
| EU/2/15/191 | Simparica | Liechtenstein | 31.12.2015 |
| EU/2/15/192 | Velactis | Iceland | 30.12.2015 |
| EU/2/15/192 | Velactis | Liechtenstein | 31.12.2015 |
| EU/2/15/193 | Imrestor | Liechtenstein | 31.12.2015 |

EU Number

Product

Country

Date of authorisation

EU/1/11/710

Votubia (switch to non-conditional)

Liechtenstein

31.12.2015

EU/1/13/895

Kolbam

Iceland

14.12.2015

EU/1/13/895

Kolbam

Norway

15.12.2015

EU/1/13/895

Kolbam

Liechtenstein

31.12.2015

EU/1/15/1005

Aripiprazole Pharmathen

Iceland

23.7.2015

EU/1/15/1005

Aripiprazole Pharmathen

Liechtenstein

31.8.2015

EU/1/15/1005

Aripiprazole Pharmathen

Norway

16.7.2015

EU/1/15/1006

Respreeza

Iceland

31.8.2015

EU/1/15/1006

Respreeza

Liechtenstein

31.8.2015

EU/1/15/1006

Respreeza

Norway

28.8.2015

EU/1/15/1007

Gardasil 9

Iceland

8.7.2015

EU/1/15/1008

Hetlioz

Iceland

4.8.2015

EU/1/15/1008

Hetlioz

Liechtenstein

31.8.2015

EU/1/15/1008

Hetlioz

Norway

16.7.2015

EU/1/15/1009

Aripiprazole Zentiva

Iceland

23.7.2015

EU/1/15/1009

Aripiprazole Zentiva

Norway

16.7.2015

EU/1/15/1010

Duloxetine Mylan

Iceland

9.7.2015

EU/1/15/1010

Duloxetine Mylan

Norway

9.7.2015

EU/1/15/1011

Pregabalin Sandoz

Iceland

10.7.2015

EU/1/15/1011

Pregabalin Sandoz

Norway

17.7.2015

EU/1/15/1012

Pregabalin Sandoz GmbH

Iceland

10.7.2015

EU/1/15/1012

Pregabalin Sandoz GmbH

Norway

17.7.2015

EU/1/15/1013

Lumark

Norway

13.7.2015

EU/1/15/1013

Lumark

Iceland

10.7.2015

EU/1/15/1014

OPDIVO

Iceland

10.7.2015

EU/1/15/1014

Opdivo

Norway

2.7.2015

EU/1/15/1015

Strensiq

Iceland

10.9.2015

EU/1/15/1015

Strensiq

Liechtenstein

31.10.2015

EU/1/15/1015

Strensiq

Norway

14.9.2015

EU/1/15/1016

Repatha

Iceland

14.8.2015

EU/1/15/1016

Repatha

Liechtenstein

31.8.2015

EU/1/15/1016

Repatha

Norway

5.8.2015

EU/1/15/1017

Docetaxel Hospira UK Limited

Iceland

4.9.2015

EU/1/15/1017

Docetaxel Hospira UK limited

Liechtenstein

31.10.2015

EU/1/15/1017

Docetaxel Hospira UK Limited

Norway

7.9.2015

EU/1/15/1018

Omidria

Iceland

19.8.2015

EU/1/15/1018

Omidria

Liechtenstein

31.8.2015

EU/1/15/1018

Omidria

Norway

26.8.2015

EU/1/15/1019

Bortezomib Accord

Iceland

19.8.2015

EU/1/15/1019

Bortezomib Accord

Liechtenstein

31.8.2015

EU/1/15/1019

Bortezomib Accord

Norway

11.8.2015

EU/1/15/1020

Raxone

Iceland

15.9.2015

EU/1/15/1020

Raxone

Liechtenstein

31.10.2015

EU/1/15/1020

Raxone

Norway

30.9.2015

EU/1/15/1021

Pregabalin Zentiva

Iceland

14.8.2015

EU/1/15/1021

Pregabalin Zentiva

Liechtenstein

31.8.2015

EU/1/15/1021

Pregabalin Zentiva

Norway

10.8.2015

EU/1/15/1022

Unituxin

Iceland

21.8.2015

EU/1/15/1022

Unituxin

Liechtenstein

31.8.2015

EU/1/15/1022

Unituxin

Norway

25.8.2015

EU/1/15/1023

Farydak

Iceland

4.9.2015

EU/1/15/1023

Farydak

Liechtenstein

31.10.2015

EU/1/15/1023

Farydak

Norway

7.9.2015

EU/1/15/1024

Keytruda

Iceland

13.8.2015

EU/1/15/1024

Keytruda

Liechtenstein

31.8.2015

EU/1/15/1024

Keytruda

Norway

11.8.2015

EU/1/15/1025

Evotaz

Iceland

12.8.2015

EU/1/15/1025

Evotaz

Liechtenstein

31.8.2015

EU/1/15/1025

Evotaz

Norway

10.8.2015

EU/1/15/1026

Nivolumab BMS

Iceland

28.12.2015

EU/1/15/1026

Nivolumab BMS

Liechtenstein

31.8.2015

EU/1/15/1026

Nivolumab BMS

Norway

11.8.2015

EU/1/15/1027

Pregabalin Accord

Iceland

2.9.2015

EU/1/15/1027

Pregabalin Accord

Liechtenstein

31.10.2015

EU/1/15/1027

Pregabalin Accord

Norway

7.9.2015

EU/1/15/1028

Duloxetine Zentiva

Iceland

31.8.2015

EU/1/15/1028

Duloxetine Zentiva

Liechtenstein

31.8.2015

EU/1/15/1028

Duloxetine Zentiva

Norway

23.9.2015

EU/1/15/1029

Aripiprazole Sandoz

Iceland

31.8.2015

EU/1/15/1029

Aripiprazole Sandoz

Liechtenstein

31.8.2015

EU/1/15/1029

Aripiprazole Sandoz

Norway

25.8.2015

EU/1/15/1030

Odomzo

Iceland

1.9.2015

EU/1/15/1030

Odomzo

Liechtenstein

31.8.2015

EU/1/15/1030

Odomzo

Norway

4.9.2015

EU/1/15/1031

Praluent

Iceland

16.10.2015

EU/1/15/1031

Praluent

Liechtenstein

31.10.2015

EU/1/15/1031

Praluent

Norway

1.10.2015

EU/1/15/1032

Zerbaxa

Iceland

23.9.2015

EU/1/15/1032

Zerbaxa

Liechtenstein

31.10.2015

EU/1/15/1032

Zerbaxa

Norway

13.10.2015

EU/1/15/1033

Kanuma

Iceland

2.9.2015

EU/1/15/1033

Kanuma

Liechtenstein

31.8.2015

EU/1/15/1033

Kanuma

Norway

10.9.2015

EU/1/15/1034

Pemetrexed Lilly

Iceland

21.9.2015

EU/1/15/1034

Pemetrexed Lilly

Liechtenstein

31.10.2015

EU/1/15/1034

Pemetrexed Lilly

Norway

21.9.2015

EU/1/15/1035

Obizur

Iceland

18.11.2015

EU/1/15/1035

Obizur

Norway

30.11.2015

EU/1/15/1035

Obizur

Liechtenstein

31.12.2015

EU/1/15/1036

Cresemba

Iceland

23.10.2015

EU/1/15/1036

Cresemba

Liechtenstein

31.10.2015

EU/1/15/1036

Cresemba

Norway

11.11.2015

EU/1/15/1037

Pemetrexed Sandoz

Iceland

15.10.2015

EU/1/15/1037

Pemetrexed Sandoz

Liechtenstein

31.10.2015

EU/1/15/1037

Pemetrexed Sandoz

Norway

24.9.2015

EU/1/15/1038

Pemetrexed medac

Iceland

11.12.2015

EU/1/15/1038

Pemetrexed medac

Norway

14.12.2015

EU/1/15/1038

Pemetrexed medac

Liechtenstein

31.12.2015

EU/1/15/1039

Fexeric

Iceland

16.10.2015

EU/1/15/1039

Fexeric

Liechtenstein

31.10.2015

EU/1/15/1039

Fexeric

Norway

13.10.2015

EU/1/15/1040

Intuniv

Iceland

21.9.2015

EU/1/15/1040

Intuniv

Liechtenstein

31.10.2015

EU/1/15/1040

Intuniv

Norway

23.9.2015

EU/1/15/1041

Ivabradine Anpharm

Iceland

15.10.2015

EU/1/15/1041

Ivabradine Anpharm

Liechtenstein

31.10.2015

EU/1/15/1041

Ivabradine Anpharm

Norway

1.10.2015

EU/1/15/1042

Zalviso

Liechtenstein

31.10.2015

EU/1/15/1042

Zalviso

Iceland

16.10.2015

EU/1/15/1042

Zalviso

Norway

13.10.2015

EU/1/15/1043

Nucala

Iceland

29.12.2015

EU/1/15/1043

Nucala

Norway

10.12.2015

EU/1/15/1043

Nucala

Liechtenstein

31.12.2015

EU/1/15/1044

Numient

Iceland

14.12.2015

EU/1/15/1044

Numient

Norway

22.12.2015

EU/1/15/1044

Numient

Liechtenstein

31.12.2015

EU/1/15/1045

Aripiprazole Accord

Iceland

20.11.2015

EU/1/15/1045

Aripiprazole Accord

Norway

3.12.2015

EU/1/15/1045

Aripiprazole Accord

Liechtenstein

31.12.2015

EU/1/15/1046

Elocta

Iceland

11.12.2015

EU/1/15/1046

Elocta

Norway

17.12.2015

EU/1/15/1046

Elocta

Liechtenstein

31.12.2015

EU/1/15/1047

Blincyto

Iceland

23.12.2015

EU/1/15/1047

Blincyto

Norway

1.12.2015

EU/1/15/1047

Blincyto

Liechtenstein

31.12.2015

EU/1/15/1048

Cotellic

Iceland

11.12.2015

EU/1/15/1048

Cotellic

Norway

30.11.2015

EU/1/15/1048

Cotellic

Liechtenstein

31.12.2015

EU/1/15/1050

Ionsys

Iceland

24.11.2015

EU/1/15/1050

Ionsys

Norway

10.12.2015

EU/1/15/1050

Ionsys

Liechtenstein

31.12.2015

EU/1/15/1051

Ebymect

Iceland

23.11.2015

EU/1/15/1051

Ebymect

Norway

10.12.2015

EU/1/15/1051

Ebymect

Liechtenstein

31.12.2015

EU/1/15/1052

Edistride

Iceland

17.11.2015

EU/1/15/1052

Edistride

Norway

3.12.2015

EU/1/15/1052

Edistride

Liechtenstein

31.12.2015

EU/1/15/1054

Cinacalcet Mylan

Iceland

24.11.2015

EU/1/15/1054

Cinacalcet Mylan

Norway

30.11.2015

EU/1/15/1054

Cinacalcet Mylan

Liechtenstein

31.12.2015

EU/1/15/1055

Ciambra

Iceland

29.12.2015

EU/1/15/1055

Ciambra

Norway

10.12.2015

EU/1/15/1055

Ciambra

Liechtenstein

31.12.2015

EU/1/15/1056

Praxbind

Iceland

11.12.2015

EU/1/15/1056

Praxbind

Norway

10.12.2015

EU/1/15/1056

Praxbind

Liechtenstein

31.12.2015

EU/1/15/1057

Pemetrexed Hospira

Iceland

11.12.2015

EU/1/15/1057

Pemetrexed Hospira

Norway

1.12.2015

EU/1/15/1057

Pemetrexed Hospira

Liechtenstein

31.12.2015

EU/1/15/1058

Entresto

Iceland

11.12.2015

EU/1/15/1058

Entresto

Norway

26.11.2015

EU/1/15/1058

Entresto

Liechtenstein

31.12.2015

EU/1/15/1059

Orkambi

Iceland

8.12.2015

EU/1/15/1059

Orkambi

Norway

10.12.2015

EU/1/15/1059

Orkambi

Liechtenstein

31.12.2015

EU/1/15/1060

Kyprolis

Iceland

24.11.2015

EU/1/15/1060

Kyprolis

Norway

1.12.2015

EU/1/15/1060

Kyprolis

Liechtenstein

31.12.2015

EU/1/15/1061

Genvoya

Iceland

9.12.2015

EU/1/15/1061

Genvoya

Norway

10.12.2015

EU/1/15/1061

Genvoya

Liechtenstein

31.12.2015

EU/1/15/1062

Ravicti

Iceland

15.12.2015

EU/1/15/1062

Ravicti

Norway

10.12.2015

EU/1/15/1062

Ravicti

Liechtenstein

31.12.2015

EU/1/15/993

Lixiana

Iceland

10.7.2015

EU/1/15/993

Lixiana

Norway

6.7.2015

EU/1/15/997

Pregabalin Mylan

Iceland

13.7.2015

EU/1/15/997

Pregabalin Mylan

Liechtenstein

31.8.2015

EU/1/15/997

Pregabalin Mylan

Norway

16.7.2015

EU/1/15/998

Pregabalin Mylan Pharma

Iceland

13.7.2015

EU/1/15/998

Pregabalin Mylan Pharma

Liechtenstein

31.8.2015

EU/1/15/998

Pregabalin Mylan Pharma

Norway

16.7.2015

EU/2/15/181

Sileo

Iceland

8.7.2015

EU/2/15/182

Innovax ILT

Liechtenstein

31.8.2015

EU/2/15/182

Innovax-ILT

Iceland

24.7.2015

EU/2/15/182

Innovax-ILT

Norway

30.7.2015

EU/2/15/183

Canigen L4

Iceland

6.8.2015

EU/2/15/183

Canigen L4

Liechtenstein

31.8.2015

EU/2/15/183

Canigen L4

Norway

30.7.2015

EU/2/15/184

UpCard

Iceland

20.8.2015

EU/2/15/184

UpCard

Liechtenstein

31.10.2015

EU/2/15/184

UpCard

Norway

10.8.2015

EU/2/15/185

Fortekor Plus

Iceland

21.9.2015

EU/2/15/185

Fortekor Plus

Liechtenstein

31.10.2015

EU/2/15/185

Fortekor Plus

Norway

6.10.2015

EU/2/15/186

Novaquin

Iceland

15.9.2015

EU/2/15/186

Novaquin

Liechtenstein

31.10.2015

EU/2/15/186

Novaquin

Norway

6.10.2015

EU/2/15/187

Porcilis PCV ID

Iceland

2.9.2015

EU/2/15/187

Porcilis PCV ID

Liechtenstein

31.10.2015

EU/2/15/187

Porcilis PCV ID

Norway

9.9.2015

EU/2/15/188

Vectormune ND

Iceland

21.9.2015

EU/2/15/188

Vectormune ND

Liechtenstein

31.10.2015

EU/2/15/188

Vectormune ND

Norway

6.10.2015

EU/2/15/189

Zycortal

Iceland

20.11.2015

EU/2/15/189

Zycortal

Norway

3.12.2015

EU/2/15/189

Zycortal

Liechtenstein

31.12.2015

EU/2/15/190

Suvaxyn Circo + MH RTU

Norway

4.12.2015

EU/2/15/190

Suvaxyn Circo + MH RTU

Liechtenstein

31.12.2015

EU/2/15/190

Suvaxyn Circo + MH RTU

Iceland

16.11.2015

EU/2/15/191

Simparica

Iceland

20.11.2015

EU/2/15/191

Simparica

Norway

4.12.2015

EU/2/15/191

Simparica

Liechtenstein

31.12.2015

EU/2/15/192

Velactis

Iceland

30.12.2015

EU/2/15/192

Velactis

Liechtenstein

31.12.2015

EU/2/15/193

Imrestor

Liechtenstein

31.12.2015

---

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 2015:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/146 | Keppra | Iceland | 31.8.2015 |
| EU/1/00/146 | Keppra | Liechtenstein | 31.10.2015 |
| EU/1/00/146 | Keppra | Norway | 8.9.2015 |
| EU/1/05/310 | Fosavance | Iceland | 24.8.2015 |
| EU/1/05/312 | Xyrem | Iceland | 15.10.2015 |
| EU/1/05/312 | Xyrem | Liechtenstein | 31.10.2015 |
| EU/1/05/312 | Xyrem | Norway | 14.10.2015 |
| EU/1/05/315 | Aptivus | Iceland | 10.7.2015 |
| EU/1/05/315 | Aptivus | Norway | 2.7.2015 |
| EU/1/05/319 | Xolair | Iceland | 9.7.2015 |
| EU/1/05/319 | Xolair | Norway | 7.7.2015 |
| EU/1/05/323 | ProQuad | Liechtenstein | 31.12.2015 |
| EU/1/05/325 | Macugen | Iceland | 9.12.2015 |
| EU/1/05/325 | Macugen | Norway | 30.11.2015 |
| EU/1/05/325 | Macugen | Liechtenstein | 31.12.2015 |
| EU/1/10/639 | Telmisartan Actavis | Iceland | 9.7.2015 |
| EU/1/10/639 | Telmisartan Actavis | Norway | 8.7.2015 |
| EU/1/10/641 | Ruconest | Iceland | 16.10.2015 |
| EU/1/10/641 | Ruconest | Norway | 14.10.2015 |
| EU/1/10/641 | Ruconest | Liechtenstein | 31.12.2015 |
| EU/1/10/642 | Ibandronic Acid Teva | Iceland | 9.7.2015 |
| EU/1/10/642 | Ibandronic Acid Teva | Norway | 16.7.2015 |
| EU/1/10/644 | PecFent | Iceland | 27.8.2015 |
| EU/1/10/644 | PecFent | Norway | 10.8.2015 |
| EU/1/10/645 | Brinavess | Iceland | 19.8.2015 |
| EU/1/10/645 | Brinavess | Liechtenstein | 31.8.2015 |
| EU/1/10/645 | Brinavess | Norway | 26.8.2015 |
| EU/1/10/646 | VPRIV | Iceland | 9.7.2015 |
| EU/1/10/646 | VPRIV | Norway | 7.7.2015 |
| EU/1/10/648 | Twynsta | Iceland | 1.9.2015 |
| EU/1/10/648 | Twynsta | Liechtenstein | 31.10.2015 |
| EU/1/10/648 | Twynsta | Norway | 8.9.2015 |
| EU/1/10/651 | Clopidogrel HCS | Iceland | 9.7.2015 |
| EU/1/10/651 | Clopidogrel HCS | Norway | 1.7.2015 |
| EU/1/10/654 | Leflunomide ratiopharm | Iceland | 10.7.2015 |
| EU/1/10/654 | Leflunomide ratiopharm | Norway | 2.7.2015 |
| EU/1/10/655 | Brilique | Iceland | 13.8.2015 |
| EU/1/10/655 | Brilique | Liechtenstein | 31.8.2015 |
| EU/1/10/655 | Brilique | Norway | 26.8.2015 |
| EU/1/10/658 | Aflunov | Iceland | 13.8.2015 |
| EU/1/10/658 | Aflunov | Liechtenstein | 31.8.2015 |
| EU/1/10/658 | Aflunov | Norway | 14.8.2015 |
| EU/1/10/659 | Iasibon | Norway | 20.10.2015 |
| EU/1/10/659 | Iasibon | Iceland | 14.10.2015 |
| EU/1/10/659 | Iasibon | Liechtenstein | 31.10.2015 |
| EU/1/10/660 | Potactasol | Iceland | 22.10.2015 |
| EU/1/10/660 | Potactasol | Liechtenstein | 31.10.2015 |
| EU/1/10/660 | Potactasol | Norway | 16.10.2015 |
| EU/1/10/663 | Lamivudine/Zidovudine Teva | Norway | 10.12.2015 |
| EU/1/10/663 | Lamivudine/Zidovudine Teva | Iceland | 9.12.2015 |
| EU/1/10/663 | Lamivudine/Zidovudine Teva | Liechtenstein | 31.12.2015 |
| EU/1/10/665 | Entacapone Teva | Iceland | 10.12.2015 |
| EU/1/10/665 | Entacapone Teva | Norway | 10.12.2015 |
| EU/1/10/665 | Entacapone Teva | Liechtenstein | 31.12.2015 |
| EU/1/11/667 | Esbriet | Iceland | 15.9.2015 |
| EU/1/11/667 | Esbriet | Liechtenstein | 31.10.2015 |
| EU/1/11/667 | Esbriet | Norway | 16.9.2015 |
| EU/1/11/669 | Teysuno | Iceland | 8.12.2015 |
| EU/1/11/669 | Teysuno | Norway | 1.12.2015 |
| EU/1/11/669 | Teysuno | Liechtenstein | 31.12.2015 |
| EU/1/11/672 | Xeplion | Liechtenstein | 31.12.2015 |
| EU/1/11/673 | Ifirmacombi | Iceland | 10.12.2015 |
| EU/1/11/673 | Ifirmacombi | Norway | 30.11.2015 |
| EU/1/11/673 | Ifirmacombi | Liechtenstein | 31.12.2015 |
| EU/1/11/676 | Jevtana | Iceland | 10.12.2015 |
| EU/1/11/676 | Jevtana | Norway | 27.11.2015 |
| EU/1/11/676 | Jevtana | Liechtenstein | 31.12.2015 |
| EU/1/11/677 | Gilenya | Iceland | 8.12.2015 |
| EU/1/11/677 | Gilenya | Norway | 27.11.2015 |
| EU/1/11/678 | Halaven | Iceland | 9.12.2015 |
| EU/1/11/678 | Halaven | Norway | 27.11.2015 |
| EU/1/11/678 | Halaven | Liechtenstein | 31.12.2015 |
| EU/1/11/699 | Fampyra | Iceland | 25.8.2015 |
| EU/1/11/699 | Fampyra | Liechtenstein | 31.8.2015 |
| EU/1/11/699 | Fampyra | Norway | 3.8.2015 |
| EU/1/11/710 | Votubia | Iceland | 19.8.2015 |
| EU/1/11/710 | Votubia | Liechtenstein | 31.8.2015 |
| EU/1/11/710 | Votubia | Norway | 14.8.2015 |
| EU/1/12/793 | Xalkori | Iceland | 13.8.2015 |
| EU/1/12/793 | Xalkori | Liechtenstein | 31.8.2015 |
| EU/1/12/793 | Xalkori | Norway | 17.8.2015 |
| EU/1/12/794 | Adcetris | Iceland | 15.10.2015 |
| EU/1/12/794 | Adcetris | Norway | 30.9.2015 |
| EU/1/12/794 | Adcetris | Liechtenstein | 31.12.2015 |
| EU/1/13/902 | Translarna | Iceland | 19.8.2015 |
| EU/1/13/902 | Translarna | Liechtenstein | 31.8.2015 |
| EU/1/13/902 | Translarna | Norway | 26.8.2016 |
| EU/1/14/987 | Holoclar | Norway | 17.12.2015 |
| EU/1/14/987 | Holoclar | Liechtenstein | 31.12.2015 |
| EU/2/05/055 | Equilis Te | Iceland | 9.7.2015 |
| EU/2/10/108 | BTVPUR AlSap 2-4 | Iceland | 20.8.2015 |
| EU/2/10/108 | BTVPUR AlSap 2-4 | Liechtenstein | 31.8.2015 |
| EU/2/10/108 | BTVPUR AlSap 2-4 | Norway | 10.8.2015 |
| EU/2/10/109 | Rhiniseng | Iceland | 23.7.2015 |
| EU/2/10/109 | Rhiniseng | Norway | 29.7.2015 |
| EU/2/10/110 | Coxevac | Iceland | 20.8.2015 |
| EU/2/10/110 | Coxevac | Liechtenstein | 31.8.2015 |
| EU/2/10/110 | Coxevac | Norway | 13.8.2015 |
| EU/2/10/111 | Meloxoral | Iceland | 15.9.2015 |
| EU/2/10/111 | Meloxoral | Liechtenstein | 31.10.2015 |
| EU/2/10/111 | Meloxoral | Norway | 6.10.2015 |
| EU/2/10/112 | BTVPUR ALSap 1 | Iceland | 15.9.2015 |
| EU/2/10/112 | BTVPUR AlSap 1 | Liechtenstein | 31.10.2015 |
| EU/2/10/112 | BTVPUR AlSap 1 | Norway | 6.10.2015 |
| EU/2/10/113 | BTVPUR ALSap 1-8 | Iceland | 15.9.2015 |
| EU/2/10/113 | BTVPUR AlSap 1-8 | Norway | 6.10.2015 |
| EU/2/10/114 | Hiprabovis IBR Marker Live | Iceland | 20.11.2015 |
| EU/2/10/114 | Hiprabovis IBR Marker Live | Norway | 3.12.2015 |
| EU/2/10/114 | Hiprabovis IBR Marker Live | Liechtenstein | 31.12.2015 |
| EU/2/10/117 | Purevax Rabies | Iceland | 30.12.2015 |
| EU/2/10/117 | Purevax Rabies | Norway | 18.12.2015 |
| EU/2/10/117 | Purevax Rabies | Liechtenstein | 31.12.2015 |

EU Number

Product

Country

Date of authorisation

EU/1/00/146

Keppra

Iceland

31.8.2015

EU/1/00/146

Keppra

Liechtenstein

31.10.2015

EU/1/00/146

Keppra

Norway

8.9.2015

EU/1/05/310

Fosavance

Iceland

24.8.2015

EU/1/05/312

Xyrem

Iceland

15.10.2015

EU/1/05/312

Xyrem

Liechtenstein

31.10.2015

EU/1/05/312

Xyrem

Norway

14.10.2015

EU/1/05/315

Aptivus

Iceland

10.7.2015

EU/1/05/315

Aptivus

Norway

2.7.2015

EU/1/05/319

Xolair

Iceland

9.7.2015

EU/1/05/319

Xolair

Norway

7.7.2015

EU/1/05/323

ProQuad

Liechtenstein

31.12.2015

EU/1/05/325

Macugen

Iceland

9.12.2015

EU/1/05/325

Macugen

Norway

30.11.2015

EU/1/05/325

Macugen

Liechtenstein

31.12.2015

EU/1/10/639

Telmisartan Actavis

Iceland

9.7.2015

EU/1/10/639

Telmisartan Actavis

Norway

8.7.2015

EU/1/10/641

Ruconest

Iceland

16.10.2015

EU/1/10/641

Ruconest

Norway

14.10.2015

EU/1/10/641

Ruconest

Liechtenstein

31.12.2015

EU/1/10/642

Ibandronic Acid Teva

Iceland

9.7.2015

EU/1/10/642

Ibandronic Acid Teva

Norway

16.7.2015

EU/1/10/644

PecFent

Iceland

27.8.2015

EU/1/10/644

PecFent

Norway

10.8.2015

EU/1/10/645

Brinavess

Iceland

19.8.2015

EU/1/10/645

Brinavess

Liechtenstein

31.8.2015

EU/1/10/645

Brinavess

Norway

26.8.2015

EU/1/10/646

VPRIV

Iceland

9.7.2015

EU/1/10/646

VPRIV

Norway

7.7.2015

EU/1/10/648

Twynsta

Iceland

1.9.2015

EU/1/10/648

Twynsta

Liechtenstein

31.10.2015

EU/1/10/648

Twynsta

Norway

8.9.2015

EU/1/10/651

Clopidogrel HCS

Iceland

9.7.2015

EU/1/10/651

Clopidogrel HCS

Norway

1.7.2015

EU/1/10/654

Leflunomide ratiopharm

Iceland

10.7.2015

EU/1/10/654

Leflunomide ratiopharm

Norway

2.7.2015

EU/1/10/655

Brilique

Iceland

13.8.2015

EU/1/10/655

Brilique

Liechtenstein

31.8.2015

EU/1/10/655

Brilique

Norway

26.8.2015

EU/1/10/658

Aflunov

Iceland

13.8.2015

EU/1/10/658

Aflunov

Liechtenstein

31.8.2015

EU/1/10/658

Aflunov

Norway

14.8.2015

EU/1/10/659

Iasibon

Norway

20.10.2015

EU/1/10/659

Iasibon

Iceland

14.10.2015

EU/1/10/659

Iasibon

Liechtenstein

31.10.2015

EU/1/10/660

Potactasol

Iceland

22.10.2015

EU/1/10/660

Potactasol

Liechtenstein

31.10.2015

EU/1/10/660

Potactasol

Norway

16.10.2015

EU/1/10/663

Lamivudine/Zidovudine Teva

Norway

10.12.2015

EU/1/10/663

Lamivudine/Zidovudine Teva

Iceland

9.12.2015

EU/1/10/663

Lamivudine/Zidovudine Teva

Liechtenstein

31.12.2015

EU/1/10/665

Entacapone Teva

Iceland

10.12.2015

EU/1/10/665

Entacapone Teva

Norway

10.12.2015

EU/1/10/665

Entacapone Teva

Liechtenstein

31.12.2015

EU/1/11/667

Esbriet

Iceland

15.9.2015

EU/1/11/667

Esbriet

Liechtenstein

31.10.2015

EU/1/11/667

Esbriet

Norway

16.9.2015

EU/1/11/669

Teysuno

Iceland

8.12.2015

EU/1/11/669

Teysuno

Norway

1.12.2015

EU/1/11/669

Teysuno

Liechtenstein

31.12.2015

EU/1/11/672

Xeplion

Liechtenstein

31.12.2015

EU/1/11/673

Ifirmacombi

Iceland

10.12.2015

EU/1/11/673

Ifirmacombi

Norway

30.11.2015

EU/1/11/673

Ifirmacombi

Liechtenstein

31.12.2015

EU/1/11/676

Jevtana

Iceland

10.12.2015

EU/1/11/676

Jevtana

Norway

27.11.2015

EU/1/11/676

Jevtana

Liechtenstein

31.12.2015

EU/1/11/677

Gilenya

Iceland

8.12.2015

EU/1/11/677

Gilenya

Norway

27.11.2015

EU/1/11/678

Halaven

Iceland

9.12.2015

EU/1/11/678

Halaven

Norway

27.11.2015

EU/1/11/678

Halaven

Liechtenstein

31.12.2015

EU/1/11/699

Fampyra

Iceland

25.8.2015

EU/1/11/699

Fampyra

Liechtenstein

31.8.2015

EU/1/11/699

Fampyra

Norway

3.8.2015

EU/1/11/710

Votubia

Iceland

19.8.2015

EU/1/11/710

Votubia

Liechtenstein

31.8.2015

EU/1/11/710

Votubia

Norway

14.8.2015

EU/1/12/793

Xalkori

Iceland

13.8.2015

EU/1/12/793

Xalkori

Liechtenstein

31.8.2015

EU/1/12/793

Xalkori

Norway

17.8.2015

EU/1/12/794

Adcetris

Iceland

15.10.2015

EU/1/12/794

Adcetris

Norway

30.9.2015

EU/1/12/794

Adcetris

Liechtenstein

31.12.2015

EU/1/13/902

Translarna

Iceland

19.8.2015

EU/1/13/902

Translarna

Liechtenstein

31.8.2015

EU/1/13/902

Translarna

Norway

26.8.2016

EU/1/14/987

Holoclar

Norway

17.12.2015

EU/1/14/987

Holoclar

Liechtenstein

31.12.2015

EU/2/05/055

Equilis Te

Iceland

9.7.2015

EU/2/10/108

BTVPUR AlSap 2-4

Iceland

20.8.2015

EU/2/10/108

BTVPUR AlSap 2-4

Liechtenstein

31.8.2015

EU/2/10/108

BTVPUR AlSap 2-4

Norway

10.8.2015

EU/2/10/109

Rhiniseng

Iceland

23.7.2015

EU/2/10/109

Rhiniseng

Norway

29.7.2015

EU/2/10/110

Coxevac

Iceland

20.8.2015

EU/2/10/110

Coxevac

Liechtenstein

31.8.2015

EU/2/10/110

Coxevac

Norway

13.8.2015

EU/2/10/111

Meloxoral

Iceland

15.9.2015

EU/2/10/111

Meloxoral

Liechtenstein

31.10.2015

EU/2/10/111

Meloxoral

Norway

6.10.2015

EU/2/10/112

BTVPUR ALSap 1

Iceland

15.9.2015

EU/2/10/112

BTVPUR AlSap 1

Liechtenstein

31.10.2015

EU/2/10/112

BTVPUR AlSap 1

Norway

6.10.2015

EU/2/10/113

BTVPUR ALSap 1-8

Iceland

15.9.2015

EU/2/10/113

BTVPUR AlSap 1-8

Norway

6.10.2015

EU/2/10/114

Hiprabovis IBR Marker Live

Iceland

20.11.2015

EU/2/10/114

Hiprabovis IBR Marker Live

Norway

3.12.2015

EU/2/10/114

Hiprabovis IBR Marker Live

Liechtenstein

31.12.2015

EU/2/10/117

Purevax Rabies

Iceland

30.12.2015

EU/2/10/117

Purevax Rabies

Norway

18.12.2015

EU/2/10/117

Purevax Rabies

Liechtenstein

31.12.2015

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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 July-31 December 2015:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/02/240/009-012 | Somavert | Iceland | 13.8.2015 |
| EU/1/02/240/009-012 | Somavert | Norway | 6.8.2015 |
| EU/1/04/303/005 | Orfadin | Iceland | 10.7.2015 |
| EU/1/04/303/005 | Orfadin | Norway | 13.7.2015 |
| EU/1/06/359/005-006 | Suboxone | Iceland | 20.11.2015 |
| EU/1/06/359/005-006 | Suboxone | Norway | 3.12.2015 |
| EU/1/12/782/003-004 | Kalydeco | Iceland | 8.12.2015 |
| EU/1/12/782/003-004 | Kalydeco | Norway | 10.12.2015 |
| EU/1/12/782/006 | Iclusig | Norway | 14.12.2015 |
| EU/1/13/839/006 | Iclusig | Iceland | 23.12.2015 |
| EU/1/96/016/009 | Norvir | Iceland | 2.9.2015 |
| EU/1/96/016/009 | Norvir | Norway | 8.9.2015 |
| EU/2/11/134/021 | Inflacam | Iceland | 30.12.2015 |
| EU/2/11/134/021 | Inflacam | Norway | 30.12.2015 |

EU Number

Product

Country

Date of authorisation

EU/1/02/240/009-012

Somavert

Iceland

13.8.2015

EU/1/02/240/009-012

Somavert

Norway

6.8.2015

EU/1/04/303/005

Orfadin

Iceland

10.7.2015

EU/1/04/303/005

Orfadin

Norway

13.7.2015

EU/1/06/359/005-006

Suboxone

Iceland

20.11.2015

EU/1/06/359/005-006

Suboxone

Norway

3.12.2015

EU/1/12/782/003-004

Kalydeco

Iceland

8.12.2015

EU/1/12/782/003-004

Kalydeco

Norway

10.12.2015

EU/1/12/782/006

Iclusig

Norway

14.12.2015

EU/1/13/839/006

Iclusig

Iceland

23.12.2015

EU/1/96/016/009

Norvir

Iceland

2.9.2015

EU/1/96/016/009

Norvir

Norway

8.9.2015

EU/2/11/134/021

Inflacam

Iceland

30.12.2015

EU/2/11/134/021

Inflacam

Norway

30.12.2015

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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 July-31 December 2015:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/179 | Osigraft | Liechtenstein | 31.12.2015 |
| EU/1/08/450 | Biograstim | Iceland | 22.10.2015 |
| EU/1/08/450 | Biograstim | Liechtenstein | 31.10.2015 |
| EU/1/08/450 | Biograstim | Norway | 7.10.2015 |
| EU/1/08/452 | Pandemrix | Iceland | 17.11.2015 |
| EU/1/11/686 | Rasilamlo | Iceland | 23.7.2015 |
| EU/1/11/686 | Rasilamlo | Norway | 18.8.2015 |
| EU/1/14/912 | Zoledronic acid Teva Generics | Iceland | 12.8.2015 |
| EU/1/14/912 | Zoledronic acid Teva Generics | Norway | 25.9.2015 |
| EU/1/15/1026 | Nivolumab BMS | Iceland | 28.12.2015 |
| EU/1/15/1026 | Nivolumab BMS | Norway | 9.12.2015 |
| EU/1/15/1026 | Nivolumab BMS | Liechtenstein | 31.12.2015 |
| EU/1/99/102 | Sonata | Iceland | 6.8.2015 |
| EU/1/99/102 | Sonata | Liechtenstein | 31.8.2015 |
| EU/1/99/102 | Sonata | Norway | 18.8.2015 |
| EU/2/06/064 | ProMeris | Iceland | 7.8.2015 |
| EU/2/06/064 | ProMeris | Liechtenstein | 31.8.2015 |
| EU/2/06/064 | ProMeris | Norway | 18.8.2015 |
| EU/2/06/065 | ProMeris Duo | Iceland | 7.8.2015 |
| EU/2/06/065 | ProMeris Duo | Liechtenstein | 31.8.2015 |
| EU/2/06/065 | ProMeris Duo | Norway | 26.8.2015 |
| EU/2/97/003 | Dicural | Iceland | 6.11.2015 |
| EU/2/97/003 | Dicural | Liechtenstein | 31.10.2015 |
| EU/2/97/003 | Dicural | Norway | 1.12.2015 |

EU Number

Product

Country

Date of authorisation

EU/1/01/179

Osigraft

Liechtenstein

31.12.2015

EU/1/08/450

Biograstim

Iceland

22.10.2015

EU/1/08/450

Biograstim

Liechtenstein

31.10.2015

EU/1/08/450

Biograstim

Norway

7.10.2015

EU/1/08/452

Pandemrix

Iceland

17.11.2015

EU/1/11/686

Rasilamlo

Iceland

23.7.2015

EU/1/11/686

Rasilamlo

Norway

18.8.2015

EU/1/14/912

Zoledronic acid Teva Generics

Iceland

12.8.2015

EU/1/14/912

Zoledronic acid Teva Generics

Norway

25.9.2015

EU/1/15/1026

Nivolumab BMS

Iceland

28.12.2015

EU/1/15/1026

Nivolumab BMS

Norway

9.12.2015

EU/1/15/1026

Nivolumab BMS

Liechtenstein

31.12.2015

EU/1/99/102

Sonata

Iceland

6.8.2015

EU/1/99/102

Sonata

Liechtenstein

31.8.2015

EU/1/99/102

Sonata

Norway

18.8.2015

EU/2/06/064

ProMeris

Iceland

7.8.2015

EU/2/06/064

ProMeris

Liechtenstein

31.8.2015

EU/2/06/064

ProMeris

Norway

18.8.2015

EU/2/06/065

ProMeris Duo

Iceland

7.8.2015

EU/2/06/065

ProMeris Duo

Liechtenstein

31.8.2015

EU/2/06/065

ProMeris Duo

Norway

26.8.2015

EU/2/97/003

Dicural

Iceland

6.11.2015

EU/2/97/003

Dicural

Liechtenstein

31.10.2015

EU/2/97/003

Dicural

Norway

1.12.2015

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ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 July-31 December 2015:

| EU Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/02/226 | InductOs | Iceland | 17.12.2015 |
| EU/1/02/226 | InductOs | Norway | 1.12.2015 |
| EU/1/02/226 | InductOs | Liechtenstein | 31.12.2015 |

EU Number

Product

Country

Date of suspension

EU/1/02/226

InductOs

Iceland

17.12.2015

EU/1/02/226

InductOs

Norway

1.12.2015

EU/1/02/226

InductOs

Liechtenstein

31.12.2015

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