# C_2018195EN.01002601.xml

| 7.6.2018 | EN | Official Journal of the European Union | C 195/26 |
| --- | --- | --- | --- |

7.6.2018

EN

Official Journal of the European Union

C 195/26

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Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2016

(2018/C 195/11)

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 2016, at their meeting on 17 March 2017:

| 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| Annex IV | List of withdrawn marketing authorisations |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List of withdrawn marketing authorisations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 2016:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/12/793 | Xalkori (Switch to non-conditional) | Liechtenstein | 31.12.2016 |
| EU/1/13/848 | Erivedge (Switch to non-conditional) | Liechtenstein | 31.12.2016 |
| EU/1/15/1066 | Ongentys | Iceland | 13.7.2016 |
| EU/1/15/1066 | Ongentys | Norway | 4.7.2016 |
| EU/1/16/1091 | Atazanavir Mylan | Iceland | 29.8.2016 |
| EU/1/16/1091 | Atazanavir Mylan | Norway | 2.9.2016 |
| EU/1/16/1091 | Atazanavir Mylan | Liechtenstein | 31.8.2016 |
| EU/1/16/1094 | Ninlaro | Liechtenstein | 31.12.2016 |
| EU/1/16/1094 | Ninlaro | Iceland | 7.12.2016 |
| EU/1/16/1094 | Ninlaro | Norway | 28.11.2016 |
| EU/1/16/1102 | Bortezomib SUN | Iceland | 11.8.2016 |
| EU/1/16/1102 | Bortezomib SUN | Norway | 12.8.2016 |
| EU/1/16/1102 | Bortezomib SUN | Liechtenstein | 31.8.2016 |
| EU/1/16/1103 | Neparvis | Iceland | 4.7.2016 |
| EU/1/16/1105 | EndolucinBeta | Iceland | 25.7.2016 |
| EU/1/16/1105 | EndolucinBeta | Norway | 27.7.2016 |
| EU/1/16/1105 | EndolucinBeta | Liechtenstein | 31.8.2016 |
| EU/1/16/1107 | ZINBRYTA | Iceland | 14.7.2016 |
| EU/1/16/1107 | Zinbryta | Norway | 7.7.2016 |
| EU/1/16/1107 | Zinbryta | Liechtenstein | 31.8.2016 |
| EU/1/16/1108 | Qtern | Iceland | 25.7.2016 |
| EU/1/16/1108 | Qtern | Norway | 4.8.2016 |
| EU/1/16/1108 | Qtern | Liechtenstein | 31.8.2016 |
| EU/1/16/1109 | ZAVICEFTA | Iceland | 12.7.2016 |
| EU/1/16/1109 | Zavicefta | Norway | 1.7.2016 |
| EU/1/16/1112 | Odefsey | Iceland | 12.7.2016 |
| EU/1/16/1113 | Enzepi | Iceland | 14.7.2016 |
| EU/1/16/1113 | Enzepi | Norway | 26.7.2016 |
| EU/1/16/1113 | Enzepi | Liechtenstein | 31.8.2016 |
| EU/1/16/1114 | Bortezomib Hospira | Iceland | 10.8.2016 |
| EU/1/16/1114 | Bortezomib Hospira | Norway | 12.8.2016 |
| EU/1/16/1114 | Bortezomib Hospira | Liechtenstein | 31.8.2016 |
| EU/1/16/1115 | Pemetrexed Fresenius Kabi | Iceland | 16.8.2016 |
| EU/1/16/1115 | Pemetrexed Fresenius Kabi | Norway | 11.8.2016 |
| EU/1/16/1116 | Epclusa | Iceland | 12.7.2016 |
| EU/1/16/1116 | Epclusa | Norway | 11.7.2016 |
| EU/1/16/1116 | Epclusa | Liechtenstein | 31.8.2016 |
| EU/1/16/1119 | Zepatier | Iceland | 11.8.2016 |
| EU/1/16/1119 | Zepatier | Norway | 4.8.2016 |
| EU/1/16/1119 | Zepatier | Liechtenstein | 31.8.2016 |
| EU/1/16/1121 | Zalmoxis | Iceland | 7.9.2016 |
| EU/1/16/1121 | Zalmoxis | Norway | 16.9.2016 |
| EU/1/16/1121 | Zalmoxis | Liechtenstein | 31.10.2016 |
| EU/1/16/1122 | Aerivio Spiromax | Iceland | 2.9.2016 |
| EU/1/16/1122 | Aerivio Spiromax | Norway | 8.9.2016 |
| EU/1/16/1122 | Aerivio Spiromax | Liechtenstein | 31.10.2016 |
| EU/1/16/1123 | Airexar Spiromax | Iceland | 2.9.2016 |
| EU/1/16/1123 | Airexar Spiromax | Norway | 13.9.2016 |
| EU/1/16/1123 | Airexar Spiromax | Liechtenstein | 31.10.2016 |
| EU/1/16/1124 | Nordimet | Iceland | 7.9.2016 |
| EU/1/16/1124 | Nordimet | Norway | 30.8.2016 |
| EU/1/16/1124 | Nordimet | Liechtenstein | 31.8.2016 |
| EU/1/16/1125 | Cinqaero | Iceland | 7.9.2016 |
| EU/1/16/1125 | Cinqaero | Norway | 31.8.2016 |
| EU/1/16/1125 | Cinqaero | Liechtenstein | 31.8.2016 |
| EU/1/16/1126 | Truberzi | Iceland | 7.10.2016 |
| EU/1/16/1126 | Truberzi | Norway | 6.10.2016 |
| EU/1/16/1126 | Truberzi | Liechtenstein | 31.10.2016 |
| EU/1/16/1127 | Tenofovir disoproxil Zentiva | Iceland | 6.10.2016 |
| EU/1/16/1127 | Tenofovir disoproxil Zentiva | Liechtenstein | 31.10.2016 |
| EU/1/16/1127 | Tenofovir disoproxil Zentiva | Norway | 13.10.2016 |
| EU/1/16/1128 | Kisplyx | Iceland | 7.9.2016 |
| EU/1/16/1128 | Kisplyx | Norway | 31.8.2016 |
| EU/1/16/1128 | Kisplyx | Liechtenstein | 31.8.2016 |
| EU/1/16/1129 | Tenofovir disoproxil Mylan | Iceland | 16.12.2016 |
| EU/1/16/1129 | Tenofovir disoproxil Mylan | Norway | 21.12.2016 |
| EU/1/16/1130 | Onivyde | Iceland | 1.11.2016 |
| EU/1/16/1130 | Onivyde | Norway | 4.11.2016 |
| EU/1/16/1130 | Onivyde | Liechtenstein | 31.10.2016 |
| EU/1/16/1131 | Thorinane | Iceland | 6.10.2016 |
| EU/1/16/1131 | Thorinane | Norway | 23.9.2016 |
| EU/1/16/1131 | Thorinane | Liechtenstein | 31.10.2016 |
| EU/1/16/1132 | Inhixa | Iceland | 7.10.2016 |
| EU/1/16/1132 | Inhixa | Norway | 5.10.2016 |
| EU/1/16/1132 | Inhixa | Liechtenstein | 31.10.2016 |
| EU/1/16/1134 | Mysildecard | Iceland | 6.10.2016 |
| EU/1/16/1134 | Mysildecard | Norway | 29.9.2016 |
| EU/1/16/1134 | Mysildecard | Liechtenstein | 31.10.2016 |
| EU/1/16/1135 | Sialanar | Iceland | 7.10.2016 |
| EU/1/16/1135 | Sialanar | Norway | 14.10.2016 |
| EU/1/16/1135 | Sialanar | Liechtenstein | 31.10.2016 |
| EU/1/16/1136 | Cabometyx | Iceland | 6.10.2016 |
| EU/1/16/1136 | CABOMETYX | Norway | 20.9.2016 |
| EU/1/16/1136 | CABOMETYX | Liechtenstein | 31.10.2016 |
| EU/1/16/1137 | Granpidam | Liechtenstein | 31.12.2016 |
| EU/1/16/1137 | Granpidam | Iceland | 6.12.2016 |
| EU/1/16/1137 | Granpidam | Norway | 28.11.2016 |
| EU/1/16/1138 | Venclyxto | Iceland | 8.12.2016 |
| EU/1/16/1138 | Venclyxto | Norway | 13.12.2016 |
| EU/1/16/1139 | Ocaliva | Iceland | 19.12.2016 |
| EU/1/16/1139 | OCALIVA | Norway | 12.12.2016 |
| EU/1/16/1141 | SomaKit TOC | Iceland | 15.12.2016 |
| EU/1/16/1141 | SomaKit TOC | Norway | 15.12.2016 |
| EU/1/16/1142 | Parsabiv | Liechtenstein | 31.12.2016 |
| EU/1/16/1142 | Parsabiv | Iceland | 1.12.2016 |
| EU/1/16/1142 | Parsabiv | Norway | 22.11.2016 |
| EU/1/16/1143 | Lartruvo | Liechtenstein | 31.12.2016 |
| EU/1/16/1143 | Lartruvo | Iceland | 1.12.2016 |
| EU/1/16/1143 | Lartruvo | Norway | 18.11.2016 |
| EU/1/16/1144 | Ivabradine Zentiva | Liechtenstein | 31.12.2016 |
| EU/1/16/1144 | Ivabradine Zentiva | Iceland | 2.12.2016 |
| EU/1/16/1144 | Ivabradine Zentiva | Norway | 28.11.2016 |
| EU/1/16/1145 | Ivabradine JensonR | Liechtenstein | 31.12.2016 |
| EU/1/16/1145 | Ivabradine JensonR | Iceland | 2.12.2016 |
| EU/1/16/1145 | Ivabradine JensonR | Norway | 5.12.2016 |
| EU/1/16/1146 | Glyxambi | Liechtenstein | 31.12.2016 |
| EU/1/16/1146 | Glyxambi | Iceland | 5.12.2016 |
| EU/1/16/1146 | Glyxambi | Norway | 9.12.2016 |
| EU/1/16/1147 | IBRANCE | Liechtenstein | 31.12.2016 |
| EU/1/16/1147 | Ibrance | Iceland | 1.12.2016 |
| EU/1/16/1147 | IBRANCE | Norway | 15.11.2016 |
| EU/1/16/1148 | Emtricitabin/Tenofovir disoproxil Zentiva | Liechtenstein | 31.12.2016 |
| EU/1/16/1148 | Emtricitabine/Tenofovir disoproxil Zentiva | Iceland | 1.12.2016 |
| EU/1/16/1148 | Emtricitabine/Tenofovir disoproxil Zentvia | Norway | 15.11.2016 |
| EU/1/16/1151 | Emtricitabine/Tenofovir disproxil Krka | Norway | 21.12.2016 |
| EU/1/16/1151 | Emtricitabine/Tenofovir disoproxil Krka | Iceland | 14.12.2016 |
| EU/2/16/196 | Sevocalm | Norway | 11.7.2016 |
| EU/2/16/196 | Sevocalm | Liechtenstein | 31.8.2016 |
| EU/2/16/196 | Sevocalm | Iceland | 12.7.2016 |
| EU/2/16/198 | Sedadex | Iceland | 22.8.2016 |
| EU/2/16/198 | Sedadex | Norway | 30.8.2016 |
| EU/2/16/198 | Sedadex | Liechtenstein | 31.8.2016 |
| EU/2/16/199 | Eravac | Iceland | 10.10.2016 |
| EU/2/16/199 | ERAVAC | Norway | 5.10.2016 |
| EU/2/16/199 | ERAVAC | Liechtenstein | 31.10.2016 |
| EU/2/16/200 | Cepedex | Iceland | 19.12.2016 |

EU Number

Product

Country

Date of authorisation

EU/1/12/793

Xalkori (Switch to non-conditional)

Liechtenstein

31.12.2016

EU/1/13/848

Erivedge (Switch to non-conditional)

Liechtenstein

31.12.2016

EU/1/15/1066

Ongentys

Iceland

13.7.2016

EU/1/15/1066

Ongentys

Norway

4.7.2016

EU/1/16/1091

Atazanavir Mylan

Iceland

29.8.2016

EU/1/16/1091

Atazanavir Mylan

Norway

2.9.2016

EU/1/16/1091

Atazanavir Mylan

Liechtenstein

31.8.2016

EU/1/16/1094

Ninlaro

Liechtenstein

31.12.2016

EU/1/16/1094

Ninlaro

Iceland

7.12.2016

EU/1/16/1094

Ninlaro

Norway

28.11.2016

EU/1/16/1102

Bortezomib SUN

Iceland

11.8.2016

EU/1/16/1102

Bortezomib SUN

Norway

12.8.2016

EU/1/16/1102

Bortezomib SUN

Liechtenstein

31.8.2016

EU/1/16/1103

Neparvis

Iceland

4.7.2016

EU/1/16/1105

EndolucinBeta

Iceland

25.7.2016

EU/1/16/1105

EndolucinBeta

Norway

27.7.2016

EU/1/16/1105

EndolucinBeta

Liechtenstein

31.8.2016

EU/1/16/1107

ZINBRYTA

Iceland

14.7.2016

EU/1/16/1107

Zinbryta

Norway

7.7.2016

EU/1/16/1107

Zinbryta

Liechtenstein

31.8.2016

EU/1/16/1108

Qtern

Iceland

25.7.2016

EU/1/16/1108

Qtern

Norway

4.8.2016

EU/1/16/1108

Qtern

Liechtenstein

31.8.2016

EU/1/16/1109

ZAVICEFTA

Iceland

12.7.2016

EU/1/16/1109

Zavicefta

Norway

1.7.2016

EU/1/16/1112

Odefsey

Iceland

12.7.2016

EU/1/16/1113

Enzepi

Iceland

14.7.2016

EU/1/16/1113

Enzepi

Norway

26.7.2016

EU/1/16/1113

Enzepi

Liechtenstein

31.8.2016

EU/1/16/1114

Bortezomib Hospira

Iceland

10.8.2016

EU/1/16/1114

Bortezomib Hospira

Norway

12.8.2016

EU/1/16/1114

Bortezomib Hospira

Liechtenstein

31.8.2016

EU/1/16/1115

Pemetrexed Fresenius Kabi

Iceland

16.8.2016

EU/1/16/1115

Pemetrexed Fresenius Kabi

Norway

11.8.2016

EU/1/16/1116

Epclusa

Iceland

12.7.2016

EU/1/16/1116

Epclusa

Norway

11.7.2016

EU/1/16/1116

Epclusa

Liechtenstein

31.8.2016

EU/1/16/1119

Zepatier

Iceland

11.8.2016

EU/1/16/1119

Zepatier

Norway

4.8.2016

EU/1/16/1119

Zepatier

Liechtenstein

31.8.2016

EU/1/16/1121

Zalmoxis

Iceland

7.9.2016

EU/1/16/1121

Zalmoxis

Norway

16.9.2016

EU/1/16/1121

Zalmoxis

Liechtenstein

31.10.2016

EU/1/16/1122

Aerivio Spiromax

Iceland

2.9.2016

EU/1/16/1122

Aerivio Spiromax

Norway

8.9.2016

EU/1/16/1122

Aerivio Spiromax

Liechtenstein

31.10.2016

EU/1/16/1123

Airexar Spiromax

Iceland

2.9.2016

EU/1/16/1123

Airexar Spiromax

Norway

13.9.2016

EU/1/16/1123

Airexar Spiromax

Liechtenstein

31.10.2016

EU/1/16/1124

Nordimet

Iceland

7.9.2016

EU/1/16/1124

Nordimet

Norway

30.8.2016

EU/1/16/1124

Nordimet

Liechtenstein

31.8.2016

EU/1/16/1125

Cinqaero

Iceland

7.9.2016

EU/1/16/1125

Cinqaero

Norway

31.8.2016

EU/1/16/1125

Cinqaero

Liechtenstein

31.8.2016

EU/1/16/1126

Truberzi

Iceland

7.10.2016

EU/1/16/1126

Truberzi

Norway

6.10.2016

EU/1/16/1126

Truberzi

Liechtenstein

31.10.2016

EU/1/16/1127

Tenofovir disoproxil Zentiva

Iceland

6.10.2016

EU/1/16/1127

Tenofovir disoproxil Zentiva

Liechtenstein

31.10.2016

EU/1/16/1127

Tenofovir disoproxil Zentiva

Norway

13.10.2016

EU/1/16/1128

Kisplyx

Iceland

7.9.2016

EU/1/16/1128

Kisplyx

Norway

31.8.2016

EU/1/16/1128

Kisplyx

Liechtenstein

31.8.2016

EU/1/16/1129

Tenofovir disoproxil Mylan

Iceland

16.12.2016

EU/1/16/1129

Tenofovir disoproxil Mylan

Norway

21.12.2016

EU/1/16/1130

Onivyde

Iceland

1.11.2016

EU/1/16/1130

Onivyde

Norway

4.11.2016

EU/1/16/1130

Onivyde

Liechtenstein

31.10.2016

EU/1/16/1131

Thorinane

Iceland

6.10.2016

EU/1/16/1131

Thorinane

Norway

23.9.2016

EU/1/16/1131

Thorinane

Liechtenstein

31.10.2016

EU/1/16/1132

Inhixa

Iceland

7.10.2016

EU/1/16/1132

Inhixa

Norway

5.10.2016

EU/1/16/1132

Inhixa

Liechtenstein

31.10.2016

EU/1/16/1134

Mysildecard

Iceland

6.10.2016

EU/1/16/1134

Mysildecard

Norway

29.9.2016

EU/1/16/1134

Mysildecard

Liechtenstein

31.10.2016

EU/1/16/1135

Sialanar

Iceland

7.10.2016

EU/1/16/1135

Sialanar

Norway

14.10.2016

EU/1/16/1135

Sialanar

Liechtenstein

31.10.2016

EU/1/16/1136

Cabometyx

Iceland

6.10.2016

EU/1/16/1136

CABOMETYX

Norway

20.9.2016

EU/1/16/1136

CABOMETYX

Liechtenstein

31.10.2016

EU/1/16/1137

Granpidam

Liechtenstein

31.12.2016

EU/1/16/1137

Granpidam

Iceland

6.12.2016

EU/1/16/1137

Granpidam

Norway

28.11.2016

EU/1/16/1138

Venclyxto

Iceland

8.12.2016

EU/1/16/1138

Venclyxto

Norway

13.12.2016

EU/1/16/1139

Ocaliva

Iceland

19.12.2016

EU/1/16/1139

OCALIVA

Norway

12.12.2016

EU/1/16/1141

SomaKit TOC

Iceland

15.12.2016

EU/1/16/1141

SomaKit TOC

Norway

15.12.2016

EU/1/16/1142

Parsabiv

Liechtenstein

31.12.2016

EU/1/16/1142

Parsabiv

Iceland

1.12.2016

EU/1/16/1142

Parsabiv

Norway

22.11.2016

EU/1/16/1143

Lartruvo

Liechtenstein

31.12.2016

EU/1/16/1143

Lartruvo

Iceland

1.12.2016

EU/1/16/1143

Lartruvo

Norway

18.11.2016

EU/1/16/1144

Ivabradine Zentiva

Liechtenstein

31.12.2016

EU/1/16/1144

Ivabradine Zentiva

Iceland

2.12.2016

EU/1/16/1144

Ivabradine Zentiva

Norway

28.11.2016

EU/1/16/1145

Ivabradine JensonR

Liechtenstein

31.12.2016

EU/1/16/1145

Ivabradine JensonR

Iceland

2.12.2016

EU/1/16/1145

Ivabradine JensonR

Norway

5.12.2016

EU/1/16/1146

Glyxambi

Liechtenstein

31.12.2016

EU/1/16/1146

Glyxambi

Iceland

5.12.2016

EU/1/16/1146

Glyxambi

Norway

9.12.2016

EU/1/16/1147

IBRANCE

Liechtenstein

31.12.2016

EU/1/16/1147

Ibrance

Iceland

1.12.2016

EU/1/16/1147

IBRANCE

Norway

15.11.2016

EU/1/16/1148

Emtricitabin/Tenofovir disoproxil Zentiva

Liechtenstein

31.12.2016

EU/1/16/1148

Emtricitabine/Tenofovir disoproxil Zentiva

Iceland

1.12.2016

EU/1/16/1148

Emtricitabine/Tenofovir disoproxil Zentvia

Norway

15.11.2016

EU/1/16/1151

Emtricitabine/Tenofovir disproxil Krka

Norway

21.12.2016

EU/1/16/1151

Emtricitabine/Tenofovir disoproxil Krka

Iceland

14.12.2016

EU/2/16/196

Sevocalm

Norway

11.7.2016

EU/2/16/196

Sevocalm

Liechtenstein

31.8.2016

EU/2/16/196

Sevocalm

Iceland

12.7.2016

EU/2/16/198

Sedadex

Iceland

22.8.2016

EU/2/16/198

Sedadex

Norway

30.8.2016

EU/2/16/198

Sedadex

Liechtenstein

31.8.2016

EU/2/16/199

Eravac

Iceland

10.10.2016

EU/2/16/199

ERAVAC

Norway

5.10.2016

EU/2/16/199

ERAVAC

Liechtenstein

31.10.2016

EU/2/16/200

Cepedex

Iceland

19.12.2016

---

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 2016:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/06/347 | Sutent | Liechtenstein | 31.12.2016 |
| EU/1/06/347 | Sutent | Iceland | 1.12.2016 |
| EU/1/06/347 | Sutent | Norway | 15.11.2016 |
| EU/1/06/355 | ATryn | Iceland | 26.7.2016 |
| EU/1/06/355 | ATryn | Norway | 10.8.2016 |
| EU/1/06/355 | ATryn | Liechtenstein | 31.8.2016 |
| EU/1/06/360 | Champix | Iceland | 13.7.2016 |
| EU/1/06/360 | Champix | Norway | 7.7.2016 |
| EU/1/06/360 | Champix | Liechtenstein | 31.8.2016 |
| EU/1/06/361 | Luminity | Iceland | 26.7.2016 |
| EU/1/06/361 | Luminity | Norway | 6.8.2016 |
| EU/1/06/361 | Luminity | Liechtenstein | 31.8.2016 |
| EU/1/06/362 | Byetta | Iceland | 18.8.2016 |
| EU/1/06/363 | Sprycel | Iceland | 18.8.2016 |
| EU/1/06/363 | Sprycel | Norway | 12.8.2016 |
| EU/1/06/363 | Sprycel | Liechtenstein | 31.8.2016 |
| EU/1/06/364 | Adrovance | Iceland | 16.10.2016 |
| EU/1/06/365 | Elaprase | Iceland | 16.10.2016 |
| EU/1/06/366 | Tandemact | Iceland | 16.10.2016 |
| EU/1/06/374 | Lucentis | Liechtenstein | 31.12.2016 |
| EU/1/06/374 | Lucentis | Iceland | 2.12.2016 |
| EU/1/06/374 | Lucentis | Norway | 22.11.2016 |
| EU/1/06/379 | Cystadane | Iceland | 7.12.2016 |
| EU/1/06/379 | Cystadane | Norway | 29.11.2016 |
| EU/1/11/699 | Fampyra | Norway | 8.7.2016 |
| EU/1/11/701 | Levatiracetam Teva | Norway | 4.8.2016 |
| EU/1/11/701 | Levetiracetam Teva | Iceland | 26.7.2016 |
| EU/1/11/701 | Levetiracetam Teva | Liechtenstein | 31.8.2016 |
| EU/1/11/706 | Levodopa/Carbidopa/Entacapone Orion | Norway | 15.9.2016 |
| EU/1/11/711 | Matever | Iceland | 14.7.2016 |
| EU/1/11/711 | Matever | Norway | 7.7.2016 |
| EU/1/11/711 | Matever | Liechtenstein | 31.8.2016 |
| EU/1/11/712 | Levetiracetam Accord | Iceland | 10.8.2016 |
| EU/1/11/712 | Levetiracetam Accord | Norway | 11.8.2016 |
| EU/1/11/712 | Levetiracetam Accord | Liechtenstein | 31.8.2016 |
| EU/1/11/713 | Levetiracetam Actavis | Iceland | 5.10.2016 |
| EU/1/11/713 | Levetiracetam Actavis | Norway | 30.9.2016 |
| EU/1/11/713 | Levetiracetam Actavis | Liechtenstein | 31.10.2016 |
| EU/1/11/715 | Plenadren | Iceland | 15.8.2016 |
| EU/1/11/715 | Plenadren | Norway | 15.8.2016 |
| EU/1/11/715 | Plenadren | Liechtenstein | 31.8.2016 |
| EU/1/11/716 | Eurartesim | Iceland | 15.9.2016 |
| EU/1/11/716 | Eurartesim | Norway | 15.9.2016 |
| EU/1/11/716 | Eurartesim | Liechtenstein | 31.10.2016 |
| EU/1/11/717 | Vyndaqel | Iceland | 10.8.2016 |
| EU/1/11/717 | Vyndaqel | Norway | 11.8.2016 |
| EU/1/11/717 | Vyndaqel | Liechtenstein | 31.8.2016 |
| EU/1/11/719 | Telmisartan Teva Pharma | Iceland | 12.7.2016 |
| EU/1/11/722 | Pioglitazone Accord | Iceland | 13.12.2016 |
| EU/1/11/722 | Pioglitazone Accord | Norway | 21.12.2016 |
| EU/1/11/727 | Xaluprine | Liechtenstein | 31.12.2016 |
| EU/1/11/727 | Xaluprine | Iceland | 6.12.2016 |
| EU/1/11/727 | Xaluprine | Norway | 5.12.2016 |
| EU/1/11/728 | Pramipexole Accord | Iceland | 26.7.2016 |
| EU/1/11/728 | Pramipexole Accord | Norway | 4.8.2016 |
| EU/1/11/728 | Pramipexole Accord | Liechtenstein | 31.8.2016 |
| EU/1/11/731 | Komboglyze | Iceland | 26.7.2016 |
| EU/1/11/731 | Komboglyze | Norway | 11.8.2016 |
| EU/1/11/731 | Komboglyze | Liechtenstein | 31.8.2016 |
| EU/1/11/732 | Desloratadine Teva | Iceland | 15.8.2016 |
| EU/1/11/732 | Desloratadine Teva | Norway | 22.8.2016 |
| EU/1/11/733 | Dificlir | Iceland | 29.8.2016 |
| EU/1/11/733 | Dificlir | Norway | 30.8.2016 |
| EU/1/11/733 | Dificlir | Liechtenstein | 31.8.2016 |
| EU/1/11/734 | Edarbi | Liechtenstein | 31.12.2016 |
| EU/1/11/734 | Edarbi | Iceland | 2.12.2016 |
| EU/1/11/734 | Edarbi | Norway | 22.11.2016 |
| EU/1/11/736 | EDURANT | Iceland | 10.8.2016 |
| EU/1/11/736 | EDURANT | Norway | 11.8.2016 |
| EU/1/11/736 | EDURANT | Liechtenstein | 31.8.2016 |
| EU/1/11/737 | Eviplera | Iceland | 10.8.2016 |
| EU/1/11/737 | Eviplera | Norway | 11.8.2016 |
| EU/1/11/737 | Eviplera | Liechtenstein | 31.8.2016 |
| EU/1/11/738 | Levetiracetam Actavis Group | Iceland | 15.8.2016 |
| EU/1/11/738 | Levetiracetam Actavis Group | Norway | 2.9.2016 |
| EU/1/11/738 | Levetiracetam Actavis Group | Liechtenstein | 31.8.2016 |
| EU/1/11/739 | Dasselta | Iceland | 22.8.2016 |
| EU/1/11/739 | Dasselta | Norway | 5.9.2016 |
| EU/1/11/739 | Dasselta | Liechtenstein | 31.8.2016 |
| EU/1/11/740 | Ameluz | Liechtenstein | 31.12.2016 |
| EU/1/11/740 | Ameluz | Iceland | 7.12.2016 |
| EU/1/11/740 | Ameluz | Norway | 5.12.2016 |
| EU/1/11/741 | Levetiracetam SUN | Liechtenstein | 31.12.2016 |
| EU/1/11/741 | Levetiracetam Sun | Iceland | 5.12.2016 |
| EU/1/11/741 | Levetiracetam SUN | Norway | 23.11.2016 |
| EU/1/11/742 | Efavirenz Teva | Iceland | 16.10.2016 |
| EU/1/11/742 | Efavirenz Teva | Norway | 21.10.2016 |
| EU/1/11/743 | Repaglinide Accord | Iceland | 14.10.2016 |
| EU/1/11/743 | Repaglinide Accord | Norway | 21.10.2016 |
| EU/1/11/745 | Desloratadin Actavis | Liechtenstein | 31.12.2016 |
| EU/1/11/745 | Desloratadine Actavis | Iceland | 2.12.2016 |
| EU/1/11/745 | Desloratadine Actavis | Norway | 25.11.2016 |
| EU/1/11/746 | Desloratadine ratiopharm | Iceland | 15.8.2016 |
| EU/1/11/746 | Desloratadine ratiopharm | Norway | 22.8.2016 |
| EU/1/11/746 | Desloratadine ratiopharm | Liechtenstein | 31.8.2016 |
| EU/1/11/747 | Colobreathe | Iceland | 10.10.2016 |
| EU/1/11/747 | Colobreathe | Norway | 13.10.2016 |
| EU/1/11/747 | Colobreathe | Liechtenstein | 31.10.2016 |
| EU/1/12/750 | Esmya | Liechtenstein | 31.12.2016 |
| EU/1/12/750 | Esmya | Iceland | 5.12.2016 |
| EU/1/12/750 | Esmya | Norway | 29.11.2016 |
| EU/1/12/751 | Zelboraf | Norway | 6.10.2016 |
| EU/1/12/751 | Zelboraf | Iceland | 10.10.2016 |
| EU/1/12/751 | Zelboraf | Liechtenstein | 31.10.2016 |
| EU/1/12/753 | Signifor | Liechtenstein | 31.12.2016 |
| EU/1/12/753 | Signifor | Iceland | 6.12.2016 |
| EU/1/12/753 | Signifor | Norway | 24.11.2016 |
| EU/1/12/755 | Pioglitazone Actavis | Liechtenstein | 31.12.2016 |
| EU/1/12/755 | Pioglitazone Actavis | Norway | 9.12.2016 |
| EU/1/12/755 | Pioglitazone Actavis | Iceland | 2.12.2016 |
| EU/1/12/756 | Glidipion | Norway | 9.12.2016 |
| EU/1/12/756 | Glidipion | Liechtenstein | 31.12.2016 |
| EU/1/12/756 | Glidipion | Iceland | 2.12.2016 |
| EU/1/12/763 | Ecansya | Norway | 23.12.2016 |
| EU/1/12/793 | XALKORI | Iceland | 10.8.2016 |
| EU/1/12/793 | XALKORI | Norway | 12.8.2016 |
| EU/1/12/793 | XALKORI | Liechtenstein | 31.8.2016 |
| EU/1/12/794 | ADCETRIS | Liechtenstein | 31.10.2016 |
| EU/1/12/794 | ADCETRIS | Iceland | 2.11.2016 |
| EU/1/12/794 | ADCETRIS | Norway | 8.11.2016 |
| EU/1/15/1047 | Blincyto | Iceland | 10.10.2016 |
| EU/1/15/1047 | Blincyto | Norway | 29.9.2016 |
| EU/1/15/1047 | Blincyto | Liechtenstein | 31.10.2016 |
| EU/1/16/1086 | Tagrisso | Iceland | 19.12.2016 |
| EU/2/06/061 | Nobilis Influenza H5N2 | Iceland | 13.7.2016 |
| EU/2/11/128 | Emdocam | Iceland | 13.7.2016 |
| EU/2/11/132 | Nobivac Myxo-RHD | Iceland | 25.8.2016 |
| EU/2/11/132 | Nobivac Myxo-RHD | Norway | 30.8.2016 |
| EU/2/11/132 | Nobivac Myxo-RHD | Liechtenstein | 31.10.2016 |
| EU/2/11/133 | Recocam | Iceland | 17.8.2016 |
| EU/2/11/133 | Recocam | Norway | 25.8.2016 |
| EU/2/11/133 | Recocam | Liechtenstein | 31.8.2016 |
| EU/2/11/134 | Inflacam | Liechtenstein | 31.12.2016 |
| EU/2/11/134 | Inflacam | Iceland | 2.12.2016 |
| EU/2/11/134 | Inflacam | Norway | 25.11.2016 |
| EU/2/11/135 | Panacur AquaSol | Liechtenstein | 31.8.2016 |
| EU/2/11/135 | Panacur AquaSol | Iceland | 2.9.2016 |
| EU/2/11/135 | Panacur AquaSol | Norway | 5.9.2016 |
| EU/2/11/137 | Activyl Tick Plus | Norway | 23.12.2016 |
| EU/2/12/139 | Zulvac 1+8 Bovis | Iceland | 19.12.2016 |

EU Number

Product

Country

Date of authorisation

EU/1/06/347

Sutent

Liechtenstein

31.12.2016

EU/1/06/347

Sutent

Iceland

1.12.2016

EU/1/06/347

Sutent

Norway

15.11.2016

EU/1/06/355

ATryn

Iceland

26.7.2016

EU/1/06/355

ATryn

Norway

10.8.2016

EU/1/06/355

ATryn

Liechtenstein

31.8.2016

EU/1/06/360

Champix

Iceland

13.7.2016

EU/1/06/360

Champix

Norway

7.7.2016

EU/1/06/360

Champix

Liechtenstein

31.8.2016

EU/1/06/361

Luminity

Iceland

26.7.2016

EU/1/06/361

Luminity

Norway

6.8.2016

EU/1/06/361

Luminity

Liechtenstein

31.8.2016

EU/1/06/362

Byetta

Iceland

18.8.2016

EU/1/06/363

Sprycel

Iceland

18.8.2016

EU/1/06/363

Sprycel

Norway

12.8.2016

EU/1/06/363

Sprycel

Liechtenstein

31.8.2016

EU/1/06/364

Adrovance

Iceland

16.10.2016

EU/1/06/365

Elaprase

Iceland

16.10.2016

EU/1/06/366

Tandemact

Iceland

16.10.2016

EU/1/06/374

Lucentis

Liechtenstein

31.12.2016

EU/1/06/374

Lucentis

Iceland

2.12.2016

EU/1/06/374

Lucentis

Norway

22.11.2016

EU/1/06/379

Cystadane

Iceland

7.12.2016

EU/1/06/379

Cystadane

Norway

29.11.2016

EU/1/11/699

Fampyra

Norway

8.7.2016

EU/1/11/701

Levatiracetam Teva

Norway

4.8.2016

EU/1/11/701

Levetiracetam Teva

Iceland

26.7.2016

EU/1/11/701

Levetiracetam Teva

Liechtenstein

31.8.2016

EU/1/11/706

Levodopa/Carbidopa/Entacapone Orion

Norway

15.9.2016

EU/1/11/711

Matever

Iceland

14.7.2016

EU/1/11/711

Matever

Norway

7.7.2016

EU/1/11/711

Matever

Liechtenstein

31.8.2016

EU/1/11/712

Levetiracetam Accord

Iceland

10.8.2016

EU/1/11/712

Levetiracetam Accord

Norway

11.8.2016

EU/1/11/712

Levetiracetam Accord

Liechtenstein

31.8.2016

EU/1/11/713

Levetiracetam Actavis

Iceland

5.10.2016

EU/1/11/713

Levetiracetam Actavis

Norway

30.9.2016

EU/1/11/713

Levetiracetam Actavis

Liechtenstein

31.10.2016

EU/1/11/715

Plenadren

Iceland

15.8.2016

EU/1/11/715

Plenadren

Norway

15.8.2016

EU/1/11/715

Plenadren

Liechtenstein

31.8.2016

EU/1/11/716

Eurartesim

Iceland

15.9.2016

EU/1/11/716

Eurartesim

Norway

15.9.2016

EU/1/11/716

Eurartesim

Liechtenstein

31.10.2016

EU/1/11/717

Vyndaqel

Iceland

10.8.2016

EU/1/11/717

Vyndaqel

Norway

11.8.2016

EU/1/11/717

Vyndaqel

Liechtenstein

31.8.2016

EU/1/11/719

Telmisartan Teva Pharma

Iceland

12.7.2016

EU/1/11/722

Pioglitazone Accord

Iceland

13.12.2016

EU/1/11/722

Pioglitazone Accord

Norway

21.12.2016

EU/1/11/727

Xaluprine

Liechtenstein

31.12.2016

EU/1/11/727

Xaluprine

Iceland

6.12.2016

EU/1/11/727

Xaluprine

Norway

5.12.2016

EU/1/11/728

Pramipexole Accord

Iceland

26.7.2016

EU/1/11/728

Pramipexole Accord

Norway

4.8.2016

EU/1/11/728

Pramipexole Accord

Liechtenstein

31.8.2016

EU/1/11/731

Komboglyze

Iceland

26.7.2016

EU/1/11/731

Komboglyze

Norway

11.8.2016

EU/1/11/731

Komboglyze

Liechtenstein

31.8.2016

EU/1/11/732

Desloratadine Teva

Iceland

15.8.2016

EU/1/11/732

Desloratadine Teva

Norway

22.8.2016

EU/1/11/733

Dificlir

Iceland

29.8.2016

EU/1/11/733

Dificlir

Norway

30.8.2016

EU/1/11/733

Dificlir

Liechtenstein

31.8.2016

EU/1/11/734

Edarbi

Liechtenstein

31.12.2016

EU/1/11/734

Edarbi

Iceland

2.12.2016

EU/1/11/734

Edarbi

Norway

22.11.2016

EU/1/11/736

EDURANT

Iceland

10.8.2016

EU/1/11/736

EDURANT

Norway

11.8.2016

EU/1/11/736

EDURANT

Liechtenstein

31.8.2016

EU/1/11/737

Eviplera

Iceland

10.8.2016

EU/1/11/737

Eviplera

Norway

11.8.2016

EU/1/11/737

Eviplera

Liechtenstein

31.8.2016

EU/1/11/738

Levetiracetam Actavis Group

Iceland

15.8.2016

EU/1/11/738

Levetiracetam Actavis Group

Norway

2.9.2016

EU/1/11/738

Levetiracetam Actavis Group

Liechtenstein

31.8.2016

EU/1/11/739

Dasselta

Iceland

22.8.2016

EU/1/11/739

Dasselta

Norway

5.9.2016

EU/1/11/739

Dasselta

Liechtenstein

31.8.2016

EU/1/11/740

Ameluz

Liechtenstein

31.12.2016

EU/1/11/740

Ameluz

Iceland

7.12.2016

EU/1/11/740

Ameluz

Norway

5.12.2016

EU/1/11/741

Levetiracetam SUN

Liechtenstein

31.12.2016

EU/1/11/741

Levetiracetam Sun

Iceland

5.12.2016

EU/1/11/741

Levetiracetam SUN

Norway

23.11.2016

EU/1/11/742

Efavirenz Teva

Iceland

16.10.2016

EU/1/11/742

Efavirenz Teva

Norway

21.10.2016

EU/1/11/743

Repaglinide Accord

Iceland

14.10.2016

EU/1/11/743

Repaglinide Accord

Norway

21.10.2016

EU/1/11/745

Desloratadin Actavis

Liechtenstein

31.12.2016

EU/1/11/745

Desloratadine Actavis

Iceland

2.12.2016

EU/1/11/745

Desloratadine Actavis

Norway

25.11.2016

EU/1/11/746

Desloratadine ratiopharm

Iceland

15.8.2016

EU/1/11/746

Desloratadine ratiopharm

Norway

22.8.2016

EU/1/11/746

Desloratadine ratiopharm

Liechtenstein

31.8.2016

EU/1/11/747

Colobreathe

Iceland

10.10.2016

EU/1/11/747

Colobreathe

Norway

13.10.2016

EU/1/11/747

Colobreathe

Liechtenstein

31.10.2016

EU/1/12/750

Esmya

Liechtenstein

31.12.2016

EU/1/12/750

Esmya

Iceland

5.12.2016

EU/1/12/750

Esmya

Norway

29.11.2016

EU/1/12/751

Zelboraf

Norway

6.10.2016

EU/1/12/751

Zelboraf

Iceland

10.10.2016

EU/1/12/751

Zelboraf

Liechtenstein

31.10.2016

EU/1/12/753

Signifor

Liechtenstein

31.12.2016

EU/1/12/753

Signifor

Iceland

6.12.2016

EU/1/12/753

Signifor

Norway

24.11.2016

EU/1/12/755

Pioglitazone Actavis

Liechtenstein

31.12.2016

EU/1/12/755

Pioglitazone Actavis

Norway

9.12.2016

EU/1/12/755

Pioglitazone Actavis

Iceland

2.12.2016

EU/1/12/756

Glidipion

Norway

9.12.2016

EU/1/12/756

Glidipion

Liechtenstein

31.12.2016

EU/1/12/756

Glidipion

Iceland

2.12.2016

EU/1/12/763

Ecansya

Norway

23.12.2016

EU/1/12/793

XALKORI

Iceland

10.8.2016

EU/1/12/793

XALKORI

Norway

12.8.2016

EU/1/12/793

XALKORI

Liechtenstein

31.8.2016

EU/1/12/794

ADCETRIS

Liechtenstein

31.10.2016

EU/1/12/794

ADCETRIS

Iceland

2.11.2016

EU/1/12/794

ADCETRIS

Norway

8.11.2016

EU/1/15/1047

Blincyto

Iceland

10.10.2016

EU/1/15/1047

Blincyto

Norway

29.9.2016

EU/1/15/1047

Blincyto

Liechtenstein

31.10.2016

EU/1/16/1086

Tagrisso

Iceland

19.12.2016

EU/2/06/061

Nobilis Influenza H5N2

Iceland

13.7.2016

EU/2/11/128

Emdocam

Iceland

13.7.2016

EU/2/11/132

Nobivac Myxo-RHD

Iceland

25.8.2016

EU/2/11/132

Nobivac Myxo-RHD

Norway

30.8.2016

EU/2/11/132

Nobivac Myxo-RHD

Liechtenstein

31.10.2016

EU/2/11/133

Recocam

Iceland

17.8.2016

EU/2/11/133

Recocam

Norway

25.8.2016

EU/2/11/133

Recocam

Liechtenstein

31.8.2016

EU/2/11/134

Inflacam

Liechtenstein

31.12.2016

EU/2/11/134

Inflacam

Iceland

2.12.2016

EU/2/11/134

Inflacam

Norway

25.11.2016

EU/2/11/135

Panacur AquaSol

Liechtenstein

31.8.2016

EU/2/11/135

Panacur AquaSol

Iceland

2.9.2016

EU/2/11/135

Panacur AquaSol

Norway

5.9.2016

EU/2/11/137

Activyl Tick Plus

Norway

23.12.2016

EU/2/12/139

Zulvac 1+8 Bovis

Iceland

19.12.2016

---

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 2016:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/03/267/012 | Reyataz | Iceland | 13.7.2016 |
| EU/1/08/494/005 | Stelara | Norway | 24.11.2016 |
| EU/1/08/494/005 | Stelara | Iceland | 5.12.2016 |
| EU/1/11/714/002-003 | Zytiga | Iceland | 1.12.2016 |
| EU/1/11/714/003 | Zytiga | Norway | 25.11.2016 |
| EU/1/12/776/024 | Fycompa | Iceland | 11.10.2016 |
| EU/1/12/776/024 | Fycompa | Norway | 10.10.2016 |
| EU/1/14/939/005-006 | Daklinza | Iceland | 13.7.2016 |
| EU/1/14/939/005-006 | Daklinza | Norway | 4.7.2016 |
| EU/1/15/1024/002 | KEYTRUDA | Iceland | 24.8.2016 |
| EU/1/15/1024/002 | KEYTRUDA | Norway | 26.8.2016 |
| EU/2/97/004/050-053 | Metacam | Norway | 29.8.2016 |

EU Number

Product

Country

Date of authorisation

EU/1/03/267/012

Reyataz

Iceland

13.7.2016

EU/1/08/494/005

Stelara

Norway

24.11.2016

EU/1/08/494/005

Stelara

Iceland

5.12.2016

EU/1/11/714/002-003

Zytiga

Iceland

1.12.2016

EU/1/11/714/003

Zytiga

Norway

25.11.2016

EU/1/12/776/024

Fycompa

Iceland

11.10.2016

EU/1/12/776/024

Fycompa

Norway

10.10.2016

EU/1/14/939/005-006

Daklinza

Iceland

13.7.2016

EU/1/14/939/005-006

Daklinza

Norway

4.7.2016

EU/1/15/1024/002

KEYTRUDA

Iceland

24.8.2016

EU/1/15/1024/002

KEYTRUDA

Norway

26.8.2016

EU/2/97/004/050-053

Metacam

Norway

29.8.2016

---

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 2016:

| EU Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/00/137 | Avandia | Iceland | 12.8.2016 |
| EU/1/03/258 | Avandamet | Iceland | 12.8.2016 |
| EU/1/07/385 | Focetria | Iceland | 12.8.2016 |
| EU/1/08/489 | Opgenra | Iceland | 14.7.2016 |
| EU/1/08/489 | Opgenra | Norway | 11.8.2016 |
| EU/1/08/489 | Opgenra | Liechtenstein | 31.8.2016 |
| EU/1/08/500 | Fablyn | Iceland | 12.8.2016 |
| EU/1/08/506 | Celvapan | Iceland | 7.12.2016 |
| EU/1/08/506 | Celvapan | Liechtenstein | 31.12.2016 |
| EU/1/08/506 | Celvapan | Norway | 21.12.2016 |
| EU/1/09/518 | PANTECTA Control | Iceland | 7.10.2016 |
| EU/1/09/518 | PANTECTA Control | Norway | 20.10.2016 |
| EU/1/09/518 | PANTECTA Control | Liechtenstein | 31.10.2016 |
| EU/1/09/563 | ChondroCelect | Liechtenstein | 31.8.2016 |
| EU/1/09/563 | ChondroCelect | Iceland | 15.8.2016 |
| EU/1/09/563 | ChondroCelect | Norway | 11.8.2016 |
| EU/1/10/657 | Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Dia | Iceland | 12.8.2016 |
| EU/1/11/721 | Paglitaz | Iceland | 12.8.2016 |
| EU/1/12/810 | Krystexxa | Iceland | 14.7.2016 |
| EU/1/12/810 | Krystexxa | Norway | 6.7.2016 |
| EU/1/12/810 | Krystexxa | Liechtenstein | 31.8.2016 |
| EU/1/13/831 | Capecitabine SUN | Iceland | 13.7.2016 |
| EU/1/13/831 | Capecitabine SUN | Norway | 6.7.2016 |
| EU/1/13/883 | Vitekta | Iceland | 10.11.2016 |
| EU/1/13/883 | Vitekta | Liechtenstein | 31.12.2016 |
| EU/1/13/883 | Vitekta | Norway | 15.12.2016 |
| EU/1/14/942 | Clopidogrel/Acetylsalicylic acid Teva | Iceland | 26.7.2016 |

EU Number

Product

Country

Date of withdrawal

EU/1/00/137

Avandia

Iceland

12.8.2016

EU/1/03/258

Avandamet

Iceland

12.8.2016

EU/1/07/385

Focetria

Iceland

12.8.2016

EU/1/08/489

Opgenra

Iceland

14.7.2016

EU/1/08/489

Opgenra

Norway

11.8.2016

EU/1/08/489

Opgenra

Liechtenstein

31.8.2016

EU/1/08/500

Fablyn

Iceland

12.8.2016

EU/1/08/506

Celvapan

Iceland

7.12.2016

EU/1/08/506

Celvapan

Liechtenstein

31.12.2016

EU/1/08/506

Celvapan

Norway

21.12.2016

EU/1/09/518

PANTECTA Control

Iceland

7.10.2016

EU/1/09/518

PANTECTA Control

Norway

20.10.2016

EU/1/09/518

PANTECTA Control

Liechtenstein

31.10.2016

EU/1/09/563

ChondroCelect

Liechtenstein

31.8.2016

EU/1/09/563

ChondroCelect

Iceland

15.8.2016

EU/1/09/563

ChondroCelect

Norway

11.8.2016

EU/1/10/657

Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Dia

Iceland

12.8.2016

EU/1/11/721

Paglitaz

Iceland

12.8.2016

EU/1/12/810

Krystexxa

Iceland

14.7.2016

EU/1/12/810

Krystexxa

Norway

6.7.2016

EU/1/12/810

Krystexxa

Liechtenstein

31.8.2016

EU/1/13/831

Capecitabine SUN

Iceland

13.7.2016

EU/1/13/831

Capecitabine SUN

Norway

6.7.2016

EU/1/13/883

Vitekta

Iceland

10.11.2016

EU/1/13/883

Vitekta

Liechtenstein

31.12.2016

EU/1/13/883

Vitekta

Norway

15.12.2016

EU/1/14/942

Clopidogrel/Acetylsalicylic acid Teva

Iceland

26.7.2016

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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 2016:

| EU Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/2/15/192 | Velactis | Iceland | 30.8.2016 |
| EU/2/15/192 | Velactis | Norway | 29.8.2016 |
| EU/2/15/192 | Velactis | Liechtenstein | 31.8.2016 |

EU Number

Product

Country

Date of suspension

EU/2/15/192

Velactis

Iceland

30.8.2016

EU/2/15/192

Velactis

Norway

29.8.2016

EU/2/15/192

Velactis

Liechtenstein

31.8.2016

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