# Official Journal C 205/2018

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 205 |
| | |
| English edition | Information and Notices | Volume 6114 June 2018 |

ISSN 1977-091X

Official Journal

of the European Union

C 205

English edition

Information and Notices

Volume 6114 June 2018

---

| Contents | page |
| --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2018/C 205/01 | Update of Annex II and of Tables 1 and 2 of Annex IIIb with respect to applicable euro values in accordance with Article 10a of Directive 1999/62/EC of the European Parliament and of the Council, as amended by Directive 2011/76/EU of the European Parliament and of the Council | 1 |

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2018/C 205/01

Update of Annex II and of Tables 1 and 2 of Annex IIIb with respect to applicable euro values in accordance with Article 10a of Directive 1999/62/EC of the European Parliament and of the Council, as amended by Directive 2011/76/EU of the European Parliament and of the Council

1

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| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2018/C 205/02 | Euro exchange rates | 4 |
| | Court of Auditors |
| 2018/C 205/03 | Special Report No 16/2018 — Ex post review of EU legislation: a well-established system, but incomplete | 5 |
| | NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA |
| | EFTA Surveillance Authority |
| 2018/C 205/04 | Communication from the EFTA Surveillance Authority — Termination and appointment of Hearing Officers | 6 |
| | Standing Committee of the EFTA States |
| 2018/C 205/05 | Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2017 | 7 |
| 2018/C 205/06 | Dangerous substances — List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) in the first half of 2017 | 27 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2018/C 205/02

Euro exchange rates

4

Court of Auditors

2018/C 205/03

Special Report No 16/2018 — Ex post review of EU legislation: a well-established system, but incomplete

Ex post

5

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

2018/C 205/04

Communication from the EFTA Surveillance Authority — Termination and appointment of Hearing Officers

6

Standing Committee of the EFTA States

2018/C 205/05

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2017

7

2018/C 205/06

Dangerous substances — List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) in the first half of 2017

27

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| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2018/C 205/07 | Prior notification of a concentration (Case M.8916 — JIC/TAHL/Australia Nature’s Care Biotech) — Candidate case for simplified procedure (
  1) | 31 |
| 2018/C 205/08 | Prior notification of a concentration (Case M.8943 — Intermediate Capital Group/Minimax Viking) — Candidate case for simplified procedure (
  1) | 33 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2018/C 205/07

Prior notification of a concentration (Case M.8916 — JIC/TAHL/Australia Nature’s Care Biotech) — Candidate case for simplified procedure (
  1)

1

31

2018/C 205/08

Prior notification of a concentration (Case M.8943 — Intermediate Capital Group/Minimax Viking) — Candidate case for simplified procedure (
  1)

1

33

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| | |
| --- | --- |
| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | |
| --- | --- |

EN

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II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 14.6.2018 | EN | Official Journal of the European Union | C 205/1 |
| --- | --- | --- | --- |

14.6.2018

EN

Official Journal of the European Union

C 205/1

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Update of Annex II and of Tables 1 and 2 of Annex IIIb with respect to applicable euro values in accordance with Article 10a of Directive 1999/62/EC of the European Parliament and of the Council, as amended by Directive 2011/76/EU of the European Parliament and of the Council

(2018/C 205/01)

Annex II to Directive 1999/62/EC of the European Parliament and of the Council of 17 June 1999 on the charging of heavy goods vehicles for the use of certain infrastructures (1), is updated as follows:

ANNEX II

MAXIMUM AMOUNTS IN EURO OF USER CHARGES, INCLUDING ADMINISTRATIVE COSTS, REFERRED TO IN ARTICLE 7(7)

Annual

| | maximum three axles | minimum four axles |
| --- | --- | --- |
| EURO 0 | 1 428 | 2 394 |
| EURO I | 1 242 | 2 073 |
| EURO II | 1 081 | 1 803 |
| EURO III | 940 | 1 567 |
| EURO IV and less polluting | 855 | 1 425 |

maximum three axles

minimum four axles

EURO 0

1 428

2 394

EURO I

1 242

2 073

EURO II

1 081

1 803

EURO III

940

1 567

EURO IV and less polluting

855

1 425

Monthly and weekly

Maximum monthly and weekly rates are in proportion to the duration of the use made of the infrastructure.

Daily

The daily charge is equal for all vehicle categories and amounts to EUR 12.

Annex IIIb to Directive 1999/62/EC as amended by Directive 2011/76/EU of the European Parliament and of the Council (2), is updated as follows:

2

ANNEX IIIb

MAXIMUM WEIGHTED AVERAGE EXTERNAL-COST CHARGE

This Annex sets out the parameters to be used to calculate the maximum weighted average external-cost charge.

1.   Maximum cost of traffic-based air pollution

Table 1

Maximum chargeable air pollution cost

| cent/vehicle.kilometre | Suburban roads
  (including motorways) | Interurban roads
  (including motorways) |
| --- | --- | --- |
| EURO 0 | 17,2 | 12,9 |
| EURO I | 11,8 | 8,6 |
| EURO II | 9,7 | 7,6 |
| EURO III | 7,6 | 6,5 |
| EURO IV | 4,3 | 3,3 |
| EURO V
  after 31 December 2013 | 0 | 0 |
| 3,3 | 2,2 |
| EURO VI
  after 31 December 2017 | 0 | 0 |
| 2,2 | 1,1 |
| Less polluting than EURO VI | 0 | 0 |

cent/vehicle.kilometre

Suburban roads

(including motorways)

Interurban roads

(including motorways)

EURO 0

17,2

12,9

EURO I

11,8

8,6

EURO II

9,7

7,6

EURO III

7,6

6,5

EURO IV

4,3

3,3

EURO V

after 31 December 2013

0

0

3,3

2,2

EURO VI

after 31 December 2017

0

0

2,2

1,1

Less polluting than EURO VI

0

0

The values of Table 1 may be multiplied by a factor of up to 2 in mountain areas to the extent that it is justified by the gradient of roads, altitude and/or temperature inversions.

2.   Maximum cost of traffic-based noise pollution

Table 2

Maximum chargeable noise cost

| cent/vehicle.kilometre | Day | Night |
| --- | --- | --- |
| Suburban roads
  (including motorways) | 1,18 | 2,15 |
| Interurban roads
  (including motorways) | 0,22 | 0,33 |

cent/vehicle.kilometre

Day

Night

Suburban roads

(including motorways)

1,18

2,15

Interurban roads

(including motorways)

0,22

0,33

The values in Table 2 may be multiplied by a factor of up to 2 in mountain areas to the extent that it is justified by the gradient of roads, temperature inversions and/or amphitheatre effect of valleys.

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(1)  OJ L 187, 20.7.1999, p. 42.

1

(2)  OJ L 269, 14.10.2011, p. 1.

2

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 14.6.2018 | EN | Official Journal of the European Union | C 205/4 |
| --- | --- | --- | --- |

14.6.2018

EN

Official Journal of the European Union

C 205/4

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Euro exchange rates (1)

13 June 2018

(2018/C 205/02)

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,1764 |
| JPY | Japanese yen | 130,03 |
| DKK | Danish krone | 7,4503 |
| GBP | Pound sterling | 0,88210 |
| SEK | Swedish krona | 10,1360 |
| CHF | Swiss franc | 1,1616 |
| ISK | Iceland króna | 125,50 |
| NOK | Norwegian krone | 9,4373 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 25,711 |
| HUF | Hungarian forint | 320,35 |
| PLN | Polish zloty | 4,2766 |
| RON | Romanian leu | 4,6650 |
| TRY | Turkish lira | 5,4603 |
| AUD | Australian dollar | 1,5506 |
| CAD | Canadian dollar | 1,5313 |
| HKD | Hong Kong dollar | 9,2325 |
| NZD | New Zealand dollar | 1,6713 |
| SGD | Singapore dollar | 1,5711 |
| KRW | South Korean won | 1 275,88 |
| ZAR | South African rand | 15,5908 |
| CNY | Chinese yuan renminbi | 7,5293 |
| HRK | Croatian kuna | 7,3800 |
| IDR | Indonesian rupiah | 16 426,44 |
| MYR | Malaysian ringgit | 4,6985 |
| PHP | Philippine peso | 62,616 |
| RUB | Russian rouble | 73,8286 |
| THB | Thai baht | 37,798 |
| BRL | Brazilian real | 4,3587 |
| MXN | Mexican peso | 24,3141 |
| INR | Indian rupee | 79,5340 |

Currency

Exchange rate

USD

US dollar

1,1764

JPY

Japanese yen

130,03

DKK

Danish krone

7,4503

GBP

Pound sterling

0,88210

SEK

Swedish krona

10,1360

CHF

Swiss franc

1,1616

ISK

Iceland króna

125,50

NOK

Norwegian krone

9,4373

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

25,711

HUF

Hungarian forint

320,35

PLN

Polish zloty

4,2766

RON

Romanian leu

4,6650

TRY

Turkish lira

5,4603

AUD

Australian dollar

1,5506

CAD

Canadian dollar

1,5313

HKD

Hong Kong dollar

9,2325

NZD

New Zealand dollar

1,6713

SGD

Singapore dollar

1,5711

KRW

South Korean won

1 275,88

ZAR

South African rand

15,5908

CNY

Chinese yuan renminbi

7,5293

HRK

Croatian kuna

7,3800

IDR

Indonesian rupiah

16 426,44

MYR

Malaysian ringgit

4,6985

PHP

Philippine peso

62,616

RUB

Russian rouble

73,8286

THB

Thai baht

37,798

BRL

Brazilian real

4,3587

MXN

Mexican peso

24,3141

INR

Indian rupee

79,5340

---

(1)  Source: reference exchange rate published by the ECB.

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Court of Auditors

| 14.6.2018 | EN | Official Journal of the European Union | C 205/5 |
| --- | --- | --- | --- |

14.6.2018

EN

Official Journal of the European Union

C 205/5

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Special Report No 16/2018

‘Ex post review of EU legislation: a well-established system, but incomplete’

(2018/C 205/03)

The European Court of Auditors hereby informs you that Special Report No 16/2018 ‘Ex post review of EU legislation: a well-established system, but incomplete’ has just been published.

The report can be accessed for consultation or downloading on the European Court of Auditors' website: http://eca.europa.eu

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NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

| 14.6.2018 | EN | Official Journal of the European Union | C 205/6 |
| --- | --- | --- | --- |

14.6.2018

EN

Official Journal of the European Union

C 205/6

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Communication from the EFTA Surveillance Authority — Termination and appointment of Hearing Officers

(2018/C 205/04)

As of 1 April 2018, the EFTA Surveillance Authority appointed Mr Craig Simpson, official of the EFTA Surveillance Authority, as a Hearing Officer for the purposes of EFTA Surveillance Authority Decision No 442/12/COL of 29 November 2012 on the function and terms of reference of the Hearing Officers in certain competition proceedings (1).

Ms Charlotte Fornø terminated her functions as Hearing Officer, as set out in EFTA Surveillance Authority Decision No 442/12/COL, as of 31 March 2018. Mr Casper Ebrecht remains in post as Hearing Officer at the EFTA Surveillance Authority.

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(1)  OJ L 190, 11.7.2013, p. 93, and EEA Supplement No 40, 11.7.2013, p. 3.

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Standing Committee of the EFTA States

| 14.6.2018 | EN | Official Journal of the European Union | C 205/7 |
| --- | --- | --- | --- |

14.6.2018

EN

Official Journal of the European Union

C 205/7

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Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2017

(2018/C 205/05)

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 2017, at their meeting on 15 December 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

---

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 2017:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/11/699 | Fampyra (Switch to non-conditional) | Liechtenstein | 30.6.2017 |
| EU/1/12/771 | Zoledronsäure Teva | Liechtenstein | 30.6.2017 |
| EU/1/15/1049 | Cystadrops | Liechtenstein | 28.2.2017 |
| EU/1/15/1049 | Cystadrops | Norway | 27.1.2017 |
| EU/1/15/1049 | CYSTADROPS | Iceland | 30.1.2017 |
| EU/1/15/1078 | Natpar | Liechtenstein | 30.4.2017 |
| EU/1/15/1078 | Natpar | Norway | 10.5.2017 |
| EU/1/15/1078 | Natpar | Iceland | 15.5.2017 |
| EU/1/16/1086 | TAGRISSO (Switch to non-conditional) | Liechtenstein | 30.4.2017 |
| EU/1/16/1110 | Chenodeoxycholic acid Leadiant | Norway | 20.4.2017 |
| EU/1/16/1110 | Chenodeoxycholic acid Leadiant | Liechtenstein | 30.6.2017 |
| EU/1/16/1110 | Chenodeoxycholic acid Leadiant | Iceland | 9.5.2017 |
| EU/1/16/1133 | Emtricitabine/Tenofovir disoproxil Mylan | Liechtenstein | 28.2.2017 |
| EU/1/16/1133 | Emtricitabine/Tenofovir disoproxil Mylan | Norway | 16.1.2017 |
| EU/1/16/1133 | Emtricitabine/Tenofovir disoproxil Mylan | Iceland | 5.1.2017 |
| EU/1/16/1139 | OCALIVA | Liechtenstein | 30.4.2017 |
| EU/1/16/1140 | Darunavir Mylan | Liechtenstein | 28.2.2017 |
| EU/1/16/1140 | Darunavir Mylan | Norway | 16.1.2017 |
| EU/1/16/1140 | Darunavir Mylan | Iceland | 11.1.2017 |
| EU/1/16/1150 | Rekovelle | Norway | 6.1.2017 |
| EU/1/16/1150 | REKOVELLE | Iceland | 4.1.2017 |
| EU/1/16/1152 | Roteas | Liechtenstein | 30.4.2017 |
| EU/1/16/1152 | Roteas | Norway | 10.5.2017 |
| EU/1/16/1152 | Roteas | Iceland | 10.5.2017 |
| EU/1/16/1153 | Tadalafil Generics | Liechtenstein | 28.2.2017 |
| EU/1/16/1153 | Tadalafil Generics | Norway | 24.1.2017 |
| EU/1/16/1153 | Tadalafil Generics | Iceland | 13.1.2017 |
| EU/1/16/1154 | Vemlidy | Liechtenstein | 28.2.2017 |
| EU/1/16/1154 | Vemlidy | Norway | 1.2.2017 |
| EU/1/16/1154 | Vemlidy | Iceland | 13.1.2017 |
| EU/1/16/1156 | ZINPLAVA | Liechtenstein | 28.2.2017 |
| EU/1/16/1156 | ZINPLAVA | Norway | 26.1.2017 |
| EU/1/16/1156 | Zinplava | Iceland | 24.1.2017 |
| EU/1/16/1157 | Suliqua | Liechtenstein | 28.2.2017 |
| EU/1/16/1157 | Suliqua | Norway | 25.1.2017 |
| EU/1/16/1157 | Suliqua | Iceland | 24.1.2017 |
| EU/1/16/1158 | AFSTYLA | Liechtenstein | 28.2.2017 |
| EU/1/16/1158 | AFSTYLA | Norway | 11.1.2017 |
| EU/1/16/1158 | Afstyla | Iceland | 11.1.2017 |
| EU/1/16/1159 | Terrosa | Liechtenstein | 28.2.2017 |
| EU/1/16/1159 | Terrosa | Norway | 11.1.2017 |
| EU/1/16/1159 | Terrosa | Iceland | 11.1.2017 |
| EU/1/16/1160 | Fiasp | Liechtenstein | 28.2.2017 |
| EU/1/16/1160 | Fiasp | Norway | 25.1.2017 |
| EU/1/16/1160 | Fiasp | Iceland | 23.1.2017 |
| EU/1/16/1161 | Movymia | Liechtenstein | 28.2.2017 |
| EU/1/16/1161 | Movymia | Norway | 26.1.2017 |
| EU/1/16/1161 | Movymia | Iceland | 24.1.2017 |
| EU/1/16/1162 | Lusduna | Liechtenstein | 28.2.2017 |
| EU/1/16/1162 | Lusduna | Norway | 19.1.2017 |
| EU/1/16/1162 | Lusduna | Iceland | 12.1.2017 |
| EU/1/16/1163 | SOLYMBIC | Liechtenstein | 30.4.2017 |
| EU/1/16/1163 | SOLYMBIC | Norway | 6.4.2017 |
| EU/1/16/1163 | Solymbic | Iceland | 6.4.2017 |
| EU/1/16/1164 | AMGEVITA | Liechtenstein | 30.4.2017 |
| EU/1/16/1164 | AMGEVITA | Norway | 6.4.2017 |
| EU/1/16/1164 | Amgevita | Iceland | 6.4.2017 |
| EU/1/16/1165 | LIFMIOR | Liechtenstein | 28.2.2017 |
| EU/1/16/1165 | LIFMIOR | Norway | 21.2.2017 |
| EU/1/16/1165 | Lifmior | Iceland | 21.2.2017 |
| EU/1/16/1166 | Pregabalin Zentiva k.s | Liechtenstein | 30.4.2017 |
| EU/1/16/1166 | Pregabalin Zentiva k.s. | Norway | 13.3.2017 |
| EU/1/16/1166 | Pregabalin Zentiva k.s. | Iceland | 14.3.2017 |
| EU/1/16/1167 | Truxima | Liechtenstein | 30.4.2017 |
| EU/1/16/1167 | Truxima | Norway | 28.2.2017 |
| EU/1/16/1167 | Truxima | Iceland | 15.3.2017 |
| EU/1/16/1168 | Vihuma | Liechtenstein | 30.4.2017 |
| EU/1/16/1168 | Vihuma | Norway | 17.3.2017 |
| EU/1/16/1168 | Vihuma | Iceland | 10.3.2017 |
| EU/1/16/1169 | Alecensa | Liechtenstein | 28.2.2017 |
| EU/1/16/1169 | Alecensa | Norway | 7.3.2017 |
| EU/1/16/1169 | Alecensa | Iceland | 15.3.2017 |
| EU/1/16/1170 | Olumiant | Liechtenstein | 28.2.2017 |
| EU/1/16/1170 | Olumiant | Norway | 22.2.2017 |
| EU/1/16/1170 | OLUMIANT | Iceland | 21.2.2017 |
| EU/1/16/1171 | Ledaga | Liechtenstein | 30.4.2017 |
| EU/1/16/1171 | Ledaga | Norway | 15.3.2017 |
| EU/1/16/1171 | LEDAGA | Iceland | 14.3.2017 |
| EU/1/17/1172 | Jylamvo | Liechtenstein | 30.4.2017 |
| EU/1/17/1172 | Jylamvo | Norway | 4.4.2017 |
| EU/1/17/1172 | Jylamvo | Iceland | 26.4.2017 |
| EU/1/17/1174 | Rolufta | Liechtenstein | 30.4.2017 |
| EU/1/17/1174 | Rolufta | Norway | 7.4.2017 |
| EU/1/17/1174 | Rolufta | Iceland | 24.3.2017 |
| EU/1/17/1175 | Daptomycin Hospira | Liechtenstein | 30.4.2017 |
| EU/1/17/1175 | Daptomycin Hospira | Norway | 18.4.2017 |
| EU/1/17/1175 | Daptomycin Hospira | Iceland | 7.4.2017 |
| EU/1/17/1176 | Yargesa | Liechtenstein | 30.4.2017 |
| EU/1/17/1176 | Yargesa | Norway | 7.4.2017 |
| EU/1/17/1176 | Yargesa | Iceland | 7.4.2017 |
| EU/1/17/1177 | Tadalafil Lilly | Liechtenstein | 30.4.2017 |
| EU/1/17/1177 | Tadalafil Lilly | Norway | 18.4.2017 |
| EU/1/17/1177 | Tadalafil Lilly | Iceland | 6.4.2017 |
| EU/1/17/1178 | Xeljanz | Liechtenstein | 30.4.2017 |
| EU/1/17/1178 | Xeljanz | Norway | 6.4.2017 |
| EU/1/17/1178 | XELJANZ | Iceland | 6.4.2017 |
| EU/1/17/1180 | Varuby | Liechtenstein | 30.4.2017 |
| EU/1/17/1180 | Varuby | Norway | 10.5.2017 |
| EU/1/17/1180 | Varuby | Iceland | 10.5.2017 |
| EU/1/17/1182 | Emtricitabine/Tenofovir disoproxil Krka d.d. | Liechtenstein | 30.6.2017 |
| EU/1/17/1182 | Emtricitabine/Tenofovir disoproxil Krka d.d. | Norway | 22.5.2017 |
| EU/1/17/1182 | Emtricitabine/Tenofovir disoproxil KrKa d.d. | Iceland | 12.5.2017 |
| EU/1/17/1183 | Pemetrexed Hospira UK Limited | Norway | 9.5.2017 |
| EU/1/17/1183 | Pemetrexed Hospira UK Limited | Iceland | 12.5.2017 |
| EU/1/17/1183 | Pemetrexed Hospira UK Ltd | Liechtenstein | 30.6.2017 |
| EU/1/17/1184 | Riximyo | Liechtenstein | 30.6.2017 |
| EU/1/17/1184 | Riximyo | Norway | 26.6.2017 |
| EU/1/17/1185 | Rixathon | Liechtenstein | 30.6.2017 |
| EU/1/17/1185 | Rixathon | Norway | 23.6.2017 |
| EU/1/17/1186 | Axumin | Liechtenstein | 30.6.2017 |
| EU/1/17/1186 | Axumin | Norway | 31.5.2017 |
| EU/1/17/1186 | Axumin | Iceland | 21.6.2017 |
| EU/1/17/1187 | Trumenba | Liechtenstein | 30.6.2017 |
| EU/1/17/1187 | Trumenba | Norway | 9.6.2017 |
| EU/1/17/1187 | Trumenba | Iceland | 21.6.2017 |
| EU/1/17/1188 | Spinraza | Liechtenstein | 30.6.2017 |
| EU/1/17/1188 | Spinraza | Norway | 8.6.2017 |
| EU/1/17/1188 | Spinraza | Iceland | 30.6.2017 |
| EU/1/17/1189 | Elmiron | Liechtenstein | 30.6.2017 |
| EU/1/17/1189 | Elmiron | Norway | 20.6.2017 |
| EU/1/17/1189 | Elmiron | Iceland | 30.6.2017 |
| EU/1/17/1190 | Ivabradine Accord | Liechtenstein | 30.6.2017 |
| EU/1/17/1190 | Ivabradine Accord | Norway | 12.6.2017 |
| EU/1/17/1190 | Ivabradine Accord | Iceland | 7.6.2017 |
| EU/1/17/1191 | Dinutuximab beta Apeiron | Liechtenstein | 30.6.2017 |
| EU/1/17/1191 | Dinutuximab beta Apeiron | Norway | 12.5.2017 |
| EU/1/17/1191 | Dinutuximab beta Apeiron | Iceland | 23.5.2017 |
| EU/1/17/1192 | Brineura | Liechtenstein | 30.6.2017 |
| EU/1/17/1192 | Brineura | Norway | 6.6.2017 |
| EU/1/17/1192 | Brineura | Iceland | 30.6.2017 |
| EU/1/17/1193 | Refixia | Liechtenstein | 30.6.2017 |
| EU/1/17/1193 | Refixia | Norway | 22.6.2017 |
| EU/1/17/1193 | Refixia | Iceland | 30.6.2017 |
| EU/1/17/1194 | Febuxostat Mylan | Liechtenstein | 30.6.2017 |
| EU/1/17/1194 | Febuxostat Mylan | Norway | 26.6.2017 |
| EU/1/17/1195 | Erelzi | Liechtenstein | 30.6.2017 |
| EU/1/17/1196 | Kevzara | Liechtenstein | 30.6.2017 |
| EU/1/17/1201 | Skilarence | Liechtenstein | 30.6.2017 |
| EU/1/17/1202 | Ucedane | Liechtenstein | 30.6.2017 |
| EU/2/16/200 | Cepedex | Norway | 4.1.2017 |
| EU/2/16/201 | Halagon | Norway | 4.1.2017 |
| EU/2/16/201 | Halagon | Iceland | 4.1.2017 |
| EU/2/16/202 | Coliprotec F4/F18 | Liechtenstein | 28.2.2017 |
| EU/2/16/202 | Coliprotec F4/F18 | Norway | 21.2.2017 |
| EU/2/16/202 | Coliprotec F4/F18 | Iceland | 9.3.2017 |
| EU/2/16/203 | VarroMed | Liechtenstein | 28.2.2017 |
| EU/2/16/203 | VarroMed | Norway | 21.2.2017 |
| EU/2/16/203 | VarroMed | Iceland | 15.2.2017 |
| EU/2/16/204 | Stronghold Plus | Liechtenstein | 28.2.2017 |
| EU/2/16/204 | Stronghold Plus | Norway | 27.2.2017 |
| EU/2/16/204 | Stronghold Plus | Iceland | 15.2.2017 |
| EU/2/17/205 | CYTOPOINT | Liechtenstein | 30.4.2017 |
| EU/2/17/205 | CYTOPOINT | Norway | 23.5.2017 |
| EU/2/17/205 | CYTOPOINT | Iceland | 12.5.2017 |
| EU/2/17/206 | Credelio | Liechtenstein | 30.6.2017 |
| EU/2/17/206 | Credelio | Norway | 23.5.2017 |
| EU/2/17/206 | Credelio | Iceland | 12.5.2017 |
| EU/2/17/207 | Zulvac BTV Ovis | Norway | 18.5.2017 |
| EU/2/17/207 | Zulvac BTV Ovis | Iceland | 12.5.2017 |
| EU/2/17/208 | Ingelvac PCV FLEX | Liechtenstein | 30.6.2017 |
| EU/2/17/208 | Ingelvac PCV FLEX | Norway | 8.6.2017 |
| EU/2/17/208 | Ingelvac PCV FLEX | Iceland | 13.6.2017 |
| EU/2/17/209 | RESPIPORC FLUpan H1N1 | Liechtenstein | 30.6.2017 |
| EU/2/17/209 | RESPIPORC FLUpan H1N1 | Norway | 2.6.2017 |
| EU/2/17/209 | RESPIPORC FLUpan H1N1 | Iceland | 13.6.2017 |
| EU/2/17/210 | Zeleris | Norway | 7.6.2017 |
| EU/2/17/210 | Zeleris | Iceland | 19.5.2017 |

EU Number

Product

Country

Date of authorisation

EU/1/11/699

Fampyra (Switch to non-conditional)

Liechtenstein

30.6.2017

EU/1/12/771

Zoledronsäure Teva

Liechtenstein

30.6.2017

EU/1/15/1049

Cystadrops

Liechtenstein

28.2.2017

EU/1/15/1049

Cystadrops

Norway

27.1.2017

EU/1/15/1049

CYSTADROPS

Iceland

30.1.2017

EU/1/15/1078

Natpar

Liechtenstein

30.4.2017

EU/1/15/1078

Natpar

Norway

10.5.2017

EU/1/15/1078

Natpar

Iceland

15.5.2017

EU/1/16/1086

TAGRISSO (Switch to non-conditional)

Liechtenstein

30.4.2017

EU/1/16/1110

Chenodeoxycholic acid Leadiant

Norway

20.4.2017

EU/1/16/1110

Chenodeoxycholic acid Leadiant

Liechtenstein

30.6.2017

EU/1/16/1110

Chenodeoxycholic acid Leadiant

Iceland

9.5.2017

EU/1/16/1133

Emtricitabine/Tenofovir disoproxil Mylan

Liechtenstein

28.2.2017

EU/1/16/1133

Emtricitabine/Tenofovir disoproxil Mylan

Norway

16.1.2017

EU/1/16/1133

Emtricitabine/Tenofovir disoproxil Mylan

Iceland

5.1.2017

EU/1/16/1139

OCALIVA

Liechtenstein

30.4.2017

EU/1/16/1140

Darunavir Mylan

Liechtenstein

28.2.2017

EU/1/16/1140

Darunavir Mylan

Norway

16.1.2017

EU/1/16/1140

Darunavir Mylan

Iceland

11.1.2017

EU/1/16/1150

Rekovelle

Norway

6.1.2017

EU/1/16/1150

REKOVELLE

Iceland

4.1.2017

EU/1/16/1152

Roteas

Liechtenstein

30.4.2017

EU/1/16/1152

Roteas

Norway

10.5.2017

EU/1/16/1152

Roteas

Iceland

10.5.2017

EU/1/16/1153

Tadalafil Generics

Liechtenstein

28.2.2017

EU/1/16/1153

Tadalafil Generics

Norway

24.1.2017

EU/1/16/1153

Tadalafil Generics

Iceland

13.1.2017

EU/1/16/1154

Vemlidy

Liechtenstein

28.2.2017

EU/1/16/1154

Vemlidy

Norway

1.2.2017

EU/1/16/1154

Vemlidy

Iceland

13.1.2017

EU/1/16/1156

ZINPLAVA

Liechtenstein

28.2.2017

EU/1/16/1156

ZINPLAVA

Norway

26.1.2017

EU/1/16/1156

Zinplava

Iceland

24.1.2017

EU/1/16/1157

Suliqua

Liechtenstein

28.2.2017

EU/1/16/1157

Suliqua

Norway

25.1.2017

EU/1/16/1157

Suliqua

Iceland

24.1.2017

EU/1/16/1158

AFSTYLA

Liechtenstein

28.2.2017

EU/1/16/1158

AFSTYLA

Norway

11.1.2017

EU/1/16/1158

Afstyla

Iceland

11.1.2017

EU/1/16/1159

Terrosa

Liechtenstein

28.2.2017

EU/1/16/1159

Terrosa

Norway

11.1.2017

EU/1/16/1159

Terrosa

Iceland

11.1.2017

EU/1/16/1160

Fiasp

Liechtenstein

28.2.2017

EU/1/16/1160

Fiasp

Norway

25.1.2017

EU/1/16/1160

Fiasp

Iceland

23.1.2017

EU/1/16/1161

Movymia

Liechtenstein

28.2.2017

EU/1/16/1161

Movymia

Norway

26.1.2017

EU/1/16/1161

Movymia

Iceland

24.1.2017

EU/1/16/1162

Lusduna

Liechtenstein

28.2.2017

EU/1/16/1162

Lusduna

Norway

19.1.2017

EU/1/16/1162

Lusduna

Iceland

12.1.2017

EU/1/16/1163

SOLYMBIC

Liechtenstein

30.4.2017

EU/1/16/1163

SOLYMBIC

Norway

6.4.2017

EU/1/16/1163

Solymbic

Iceland

6.4.2017

EU/1/16/1164

AMGEVITA

Liechtenstein

30.4.2017

EU/1/16/1164

AMGEVITA

Norway

6.4.2017

EU/1/16/1164

Amgevita

Iceland

6.4.2017

EU/1/16/1165

LIFMIOR

Liechtenstein

28.2.2017

EU/1/16/1165

LIFMIOR

Norway

21.2.2017

EU/1/16/1165

Lifmior

Iceland

21.2.2017

EU/1/16/1166

Pregabalin Zentiva k.s

Liechtenstein

30.4.2017

EU/1/16/1166

Pregabalin Zentiva k.s.

Norway

13.3.2017

EU/1/16/1166

Pregabalin Zentiva k.s.

Iceland

14.3.2017

EU/1/16/1167

Truxima

Liechtenstein

30.4.2017

EU/1/16/1167

Truxima

Norway

28.2.2017

EU/1/16/1167

Truxima

Iceland

15.3.2017

EU/1/16/1168

Vihuma

Liechtenstein

30.4.2017

EU/1/16/1168

Vihuma

Norway

17.3.2017

EU/1/16/1168

Vihuma

Iceland

10.3.2017

EU/1/16/1169

Alecensa

Liechtenstein

28.2.2017

EU/1/16/1169

Alecensa

Norway

7.3.2017

EU/1/16/1169

Alecensa

Iceland

15.3.2017

EU/1/16/1170

Olumiant

Liechtenstein

28.2.2017

EU/1/16/1170

Olumiant

Norway

22.2.2017

EU/1/16/1170

OLUMIANT

Iceland

21.2.2017

EU/1/16/1171

Ledaga

Liechtenstein

30.4.2017

EU/1/16/1171

Ledaga

Norway

15.3.2017

EU/1/16/1171

LEDAGA

Iceland

14.3.2017

EU/1/17/1172

Jylamvo

Liechtenstein

30.4.2017

EU/1/17/1172

Jylamvo

Norway

4.4.2017

EU/1/17/1172

Jylamvo

Iceland

26.4.2017

EU/1/17/1174

Rolufta

Liechtenstein

30.4.2017

EU/1/17/1174

Rolufta

Norway

7.4.2017

EU/1/17/1174

Rolufta

Iceland

24.3.2017

EU/1/17/1175

Daptomycin Hospira

Liechtenstein

30.4.2017

EU/1/17/1175

Daptomycin Hospira

Norway

18.4.2017

EU/1/17/1175

Daptomycin Hospira

Iceland

7.4.2017

EU/1/17/1176

Yargesa

Liechtenstein

30.4.2017

EU/1/17/1176

Yargesa

Norway

7.4.2017

EU/1/17/1176

Yargesa

Iceland

7.4.2017

EU/1/17/1177

Tadalafil Lilly

Liechtenstein

30.4.2017

EU/1/17/1177

Tadalafil Lilly

Norway

18.4.2017

EU/1/17/1177

Tadalafil Lilly

Iceland

6.4.2017

EU/1/17/1178

Xeljanz

Liechtenstein

30.4.2017

EU/1/17/1178

Xeljanz

Norway

6.4.2017

EU/1/17/1178

XELJANZ

Iceland

6.4.2017

EU/1/17/1180

Varuby

Liechtenstein

30.4.2017

EU/1/17/1180

Varuby

Norway

10.5.2017

EU/1/17/1180

Varuby

Iceland

10.5.2017

EU/1/17/1182

Emtricitabine/Tenofovir disoproxil Krka d.d.

Liechtenstein

30.6.2017

EU/1/17/1182

Emtricitabine/Tenofovir disoproxil Krka d.d.

Norway

22.5.2017

EU/1/17/1182

Emtricitabine/Tenofovir disoproxil KrKa d.d.

Iceland

12.5.2017

EU/1/17/1183

Pemetrexed Hospira UK Limited

Norway

9.5.2017

EU/1/17/1183

Pemetrexed Hospira UK Limited

Iceland

12.5.2017

EU/1/17/1183

Pemetrexed Hospira UK Ltd

Liechtenstein

30.6.2017

EU/1/17/1184

Riximyo

Liechtenstein

30.6.2017

EU/1/17/1184

Riximyo

Norway

26.6.2017

EU/1/17/1185

Rixathon

Liechtenstein

30.6.2017

EU/1/17/1185

Rixathon

Norway

23.6.2017

EU/1/17/1186

Axumin

Liechtenstein

30.6.2017

EU/1/17/1186

Axumin

Norway

31.5.2017

EU/1/17/1186

Axumin

Iceland

21.6.2017

EU/1/17/1187

Trumenba

Liechtenstein

30.6.2017

EU/1/17/1187

Trumenba

Norway

9.6.2017

EU/1/17/1187

Trumenba

Iceland

21.6.2017

EU/1/17/1188

Spinraza

Liechtenstein

30.6.2017

EU/1/17/1188

Spinraza

Norway

8.6.2017

EU/1/17/1188

Spinraza

Iceland

30.6.2017

EU/1/17/1189

Elmiron

Liechtenstein

30.6.2017

EU/1/17/1189

Elmiron

Norway

20.6.2017

EU/1/17/1189

Elmiron

Iceland

30.6.2017

EU/1/17/1190

Ivabradine Accord

Liechtenstein

30.6.2017

EU/1/17/1190

Ivabradine Accord

Norway

12.6.2017

EU/1/17/1190

Ivabradine Accord

Iceland

7.6.2017

EU/1/17/1191

Dinutuximab beta Apeiron

Liechtenstein

30.6.2017

EU/1/17/1191

Dinutuximab beta Apeiron

Norway

12.5.2017

EU/1/17/1191

Dinutuximab beta Apeiron

Iceland

23.5.2017

EU/1/17/1192

Brineura

Liechtenstein

30.6.2017

EU/1/17/1192

Brineura

Norway

6.6.2017

EU/1/17/1192

Brineura

Iceland

30.6.2017

EU/1/17/1193

Refixia

Liechtenstein

30.6.2017

EU/1/17/1193

Refixia

Norway

22.6.2017

EU/1/17/1193

Refixia

Iceland

30.6.2017

EU/1/17/1194

Febuxostat Mylan

Liechtenstein

30.6.2017

EU/1/17/1194

Febuxostat Mylan

Norway

26.6.2017

EU/1/17/1195

Erelzi

Liechtenstein

30.6.2017

EU/1/17/1196

Kevzara

Liechtenstein

30.6.2017

EU/1/17/1201

Skilarence

Liechtenstein

30.6.2017

EU/1/17/1202

Ucedane

Liechtenstein

30.6.2017

EU/2/16/200

Cepedex

Norway

4.1.2017

EU/2/16/201

Halagon

Norway

4.1.2017

EU/2/16/201

Halagon

Iceland

4.1.2017

EU/2/16/202

Coliprotec F4/F18

Liechtenstein

28.2.2017

EU/2/16/202

Coliprotec F4/F18

Norway

21.2.2017

EU/2/16/202

Coliprotec F4/F18

Iceland

9.3.2017

EU/2/16/203

VarroMed

Liechtenstein

28.2.2017

EU/2/16/203

VarroMed

Norway

21.2.2017

EU/2/16/203

VarroMed

Iceland

15.2.2017

EU/2/16/204

Stronghold Plus

Liechtenstein

28.2.2017

EU/2/16/204

Stronghold Plus

Norway

27.2.2017

EU/2/16/204

Stronghold Plus

Iceland

15.2.2017

EU/2/17/205

CYTOPOINT

Liechtenstein

30.4.2017

EU/2/17/205

CYTOPOINT

Norway

23.5.2017

EU/2/17/205

CYTOPOINT

Iceland

12.5.2017

EU/2/17/206

Credelio

Liechtenstein

30.6.2017

EU/2/17/206

Credelio

Norway

23.5.2017

EU/2/17/206

Credelio

Iceland

12.5.2017

EU/2/17/207

Zulvac BTV Ovis

Norway

18.5.2017

EU/2/17/207

Zulvac BTV Ovis

Iceland

12.5.2017

EU/2/17/208

Ingelvac PCV FLEX

Liechtenstein

30.6.2017

EU/2/17/208

Ingelvac PCV FLEX

Norway

8.6.2017

EU/2/17/208

Ingelvac PCV FLEX

Iceland

13.6.2017

EU/2/17/209

RESPIPORC FLUpan H1N1

Liechtenstein

30.6.2017

EU/2/17/209

RESPIPORC FLUpan H1N1

Norway

2.6.2017

EU/2/17/209

RESPIPORC FLUpan H1N1

Iceland

13.6.2017

EU/2/17/210

Zeleris

Norway

7.6.2017

EU/2/17/210

Zeleris

Iceland

19.5.2017

---

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 2017:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/02/226 | InductosOs | Liechtenstein | 30.6.2017 |
| EU/1/06/362 | Byetta | Norway | 24.1.2017 |
| EU/1/06/364 | Adrovance | Norway | 28.3.2017 |
| EU/1/06/365 | Elaprase | Norway | 23.1.2016 |
| EU/1/06/366 | Tandemact | Norway | 27.1.2017 |
| EU/1/07/388 | Sebivo | Liechtenstein | 28.2.2017 |
| EU/1/07/388 | Sebivo | Norway | 16.1.2017 |
| EU/1/07/388 | Sebivo | Iceland | 5.1.2017 |
| EU/1/07/391 | Revlimid | Liechtenstein | 28.2.2017 |
| EU/1/07/391 | Revlimid | Norway | 23.2.2017 |
| EU/1/07/391 | Revlimid | Iceland | 21.2.2017 |
| EU/1/07/396 | Pergoveris | Liechtenstein | 30.6.2017 |
| EU/1/07/396 | Pergoveris | Norway | 23.5.2017 |
| EU/1/07/396 | Pergoveris | Iceland | 23.5.2017 |
| EU/1/07/397 | Siklos | Liechtenstein | 30.4.2017 |
| EU/1/07/397 | Siklos | Norway | 5.5.2017 |
| EU/1/07/397 | Siklos | Iceland | 11.5.2017 |
| EU/1/07/403 | Atriance | Liechtenstein | 30.6.2017 |
| EU/1/07/403 | Atriance | Norway | 26.6.2017 |
| EU/1/07/404 | Flebogamma DIF | Liechtenstein | 30.4.2017 |
| EU/1/07/404 | Flebogamma DIF | Norway | 10.5.2017 |
| EU/1/07/404 | Flebogamma DIF | Iceland | 11.5.2017 |
| EU/1/07/405 | Rasilez | Liechtenstein | 30.6.2017 |
| EU/1/07/405 | Rasilez | Norway | 12.6.2017 |
| EU/1/07/405 | Rasilez | Iceland | 6.6.2017 |
| EU/1/11/699 | Fampyra | Norway | 20.6.2017 |
| EU/1/11/699 | Fampyra | Iceland | 6.6.2017 |
| EU/1/11/749 | Caprelsa | Liechtenstein | 28.2.2017 |
| EU/1/11/749 | Caprelsa | Norway | 2.3.2017 |
| EU/1/11/749 | Caprelsa | Iceland | 24.2.2017 |
| EU/1/12/752 | Vepacel | Liechtenstein | 28.2.2017 |
| EU/1/12/752 | Vepacel | Norway | 19.1.2017 |
| EU/1/12/752 | Vepacel | Iceland | 12.1.2017 |
| EU/1/12/757 | Pioglitazon Teva | Liechtenstein | 30.4.2017 |
| EU/1/12/757 | Pioglitazone Teva | Norway | 21.3.2017 |
| EU/1/12/757 | Pioglitazone Teva | Iceland | 10.3.2017 |
| EU/1/12/758 | Pioglitazon Teva Pharma | Liechtenstein | 30.4.2017 |
| EU/1/12/758 | Pioglitazone Teva Pharma | Norway | 17.3.2017 |
| EU/1/12/758 | Pioglitazone Teva Pharma | Iceland | 10.3.2017 |
| EU/1/12/759 | Zoledronic acid Actavis | Norway | 4.1.2017 |
| EU/1/12/759 | Zoledronic acid Actavis | Iceland | 4.1.2017 |
| EU/1/12/760 | Bronchitol | Liechtenstein | 28.2.2017 |
| EU/1/12/760 | Bronchitol | Norway | 23.1.2017 |
| EU/1/12/760 | Bronchitol | Iceland | 23.1.2017 |
| EU/1/12/761 | Capecitabin Teva | Liechtenstein | 28.2.2017 |
| EU/1/12/761 | Capecitabine Teva | Norway | 25.1.2017 |
| EU/1/12/761 | Capecitabine Teva | Iceland | 23.1.2017 |
| EU/1/12/762 | Capecitabin Accord | Liechtenstein | 28.2.2017 |
| EU/1/12/762 | Capecitabine Accord | Norway | 25.1.2017 |
| EU/1/12/762 | Capecitabine Accord | Iceland | 23.1.2017 |
| EU/1/12/763 | Ecansya | Iceland | 4.1.2017 |
| EU/1/12/764 | Pixuvri | Liechtenstein | 30.4.2017 |
| EU/1/12/764 | Pixuvri | Norway | 29.3.2017 |
| EU/1/12/764 | Pixuvri | Iceland | 6.4.2017 |
| EU/1/12/766 | SANCUSO | Liechtenstein | 28.2.2017 |
| EU/1/12/766 | SANCUSO | Norway | 23.1.2017 |
| EU/1/12/766 | Sancuso | Iceland | 13.1.2017 |
| EU/1/12/767 | Nimenrix | Liechtenstein | 30.4.2017 |
| EU/1/12/767 | Nimenrix | Norway | 14.3.2017 |
| EU/1/12/767 | Nimenrix | Iceland | 14.3.2017 |
| EU/1/12/768 | Riluzol Zentiva | Liechtenstein | 28.2.2017 |
| EU/1/12/768 | Riluzole Zentiva | Norway | 24.1.2017 |
| EU/1/12/768 | Riluzole Zentiva | Iceland | 13.1.2017 |
| EU/1/12/769 | Docetaxel Accord | Norway | 3.3.2017 |
| EU/1/12/769 | Docetaxel Accord | Iceland | 10.3.2017 |
| EU/1/12/770 | Docetaxel Kabi | Liechtenstein | 30.4.2017 |
| EU/1/12/770 | Docetaxel Kabi | Norway | 3.3.2017 |
| EU/1/12/770 | Docetaxel Kabi | Iceland | 10.3.2017 |
| EU/1/12/771 | Zoledronic acid Teva | Norway | 20.6.2017 |
| EU/1/12/771 | Zoledronic Acid Teva | Iceland | 6.6.2017 |
| EU/1/12/772 | Zoledronic acid Teva Pharma | Norway | 20.6.2017 |
| EU/1/12/772 | Zoledronic acid Teva Pharma | Iceland | 6.6.2017 |
| EU/1/12/772 | Zoledronsäure Teva Pharma | Liechtenstein | 30.6.2017 |
| EU/1/12/773 | Jakavi | Liechtenstein | 30.6.2017 |
| EU/1/12/773 | Jakavi | Norway | 12.5.2017 |
| EU/1/12/773 | Jakavi | Iceland | 11.5.2017 |
| EU/1/12/775 | NovoThirteen | Liechtenstein | 30.6.2017 |
| EU/1/12/775 | NovoThirteen | Norway | 15.6.2017 |
| EU/1/12/775 | NovoThirteen | Iceland | 7.6.2017 |
| EU/1/12/776 | Fycompa | Liechtenstein | 30.4.2017 |
| EU/1/12/776 | Fycompa | Norway | 18.4.2017 |
| EU/1/12/776 | Fycompa | Iceland | 24.4.2017 |
| EU/1/12/777 | Inlyta | Liechtenstein | 30.6.2017 |
| EU/1/12/777 | Inlyta | Norway | 14.6.2017 |
| EU/1/12/777 | Inlyta | Iceland | 8.6.2017 |
| EU/1/12/778 | Eklira Genuair | Liechtenstein | 30.4.2017 |
| EU/1/12/778 | Eklira Genuair | Norway | 10.5.2017 |
| EU/1/12/778 | Eklira Genuair | Iceland | 10.5.2017 |
| EU/1/12/779 | Zoledronic acid medac | Iceland | 18.5.2017 |
| EU/1/12/779 | Zoledronsäure medac | Liechtenstein | 30.6.2017 |
| EU/1/12/779 | Zoledronsyre medac | Norway | 22.5.2017 |
| EU/1/12/780 | Jentadueto | Liechtenstein | 30.4.2017 |
| EU/1/12/780 | Jentadueto | Norway | 6.4.2017 |
| EU/1/12/780 | Jentadueto | Iceland | 6.4.2017 |
| EU/1/12/781 | Bretaris Genuair | Liechtenstein | 30.4.2017 |
| EU/1/12/781 | Bretaris Genuair | Norway | 10.5.2017 |
| EU/1/12/781 | Bretaris Genuair | Iceland | 10.5.2017 |
| EU/1/12/782 | Kalydeco | Liechtenstein | 30.6.2017 |
| EU/1/12/782 | Kalydeco | Norway | 19.5.2017 |
| EU/1/12/782 | Kalydeco | Iceland | 11.5.2017 |
| EU/1/12/783 | Zyclara | Liechtenstein | 30.4.2017 |
| EU/1/12/783 | Zyclara | Norway | 6.4.2017 |
| EU/1/12/783 | Zyclara | Iceland | 7.4.2017 |
| EU/1/12/785 | Zinforo | Liechtenstein | 30.6.2017 |
| EU/1/12/785 | Zinforo | Norway | 19.5.2017 |
| EU/1/12/785 | Zinforo | Iceland | 11.5.2017 |
| EU/1/12/786 | Zoledronic acid Mylan | Norway | 26.6.2017 |
| EU/1/12/786 | Zoledronic acid Mylan | Iceland | 7.6.2017 |
| EU/1/12/786 | Zoledronsäure Mylan | Liechtenstein | 30.6.2017 |
| EU/1/12/787 | Revestive | Liechtenstein | 30.6.2017 |
| EU/1/12/792 | Dacogen | Liechtenstein | 30.6.2017 |
| EU/1/12/792 | Dacogen | Norway | 1.6.2017 |
| EU/1/12/792 | Dacogen | Iceland | 6.6.2017 |
| EU/1/12/802 | Capecitabin medac | Liechtenstein | 30.6.2017 |
| EU/1/12/802 | Capecitabine medac | Norway | 26.6.2017 |
| EU/1/13/818 | Bosulif | Liechtenstein | 30.4.2017 |
| EU/1/13/818 | Bosulif | Norway | 5.4.2017 |
| EU/1/13/818 | Bosulif | Iceland | 7.4.2017 |
| EU/1/13/875 | Deltyba | Liechtenstein | 30.4.2017 |
| EU/1/13/875 | Deltyba | Norway | 14.3.2017 |
| EU/1/13/875 | Deltyba | Iceland | 14.3.2017 |
| EU/1/13/890 | Cometriq | Liechtenstein | 28.2.2017 |
| EU/1/13/890 | Cometriq | Iceland | 23.1.2017 |
| EU/1/13/901 | Sirturo | Liechtenstein | 28.2.2017 |
| EU/1/13/901 | Sirturo | Norway | 11.5.2017 |
| EU/1/13/901 | SIRTURO | Iceland | 6.1.2017 |
| EU/1/13/902 | Translarna | Liechtenstein | 28.2.2017 |
| EU/1/13/902 | Translarna | Liechtenstein | 30.6.2017 |
| EU/1/13/902 | Translarna | Norway | 1.2.2017 |
| EU/1/14/987 | Holoclar | Norway | 4.1.2017 |
| EU/1/14/987 | Holoclar | Iceland | 4.1.2017 |
| EU/1/15/999 | Zykadia | Liechtenstein | 30.4.2017 |
| EU/1/15/999 | Zykadia | Norway | 30.5.2017 |
| EU/1/15/999 | Zykadia | Iceland | 21.4.2017 |
| EU/1/16/1086 | Tagrisso | Norway | 2.1.2017 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 MedImmune | Iceland | 10.5.2017 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 MedImmune | Liechtenstein | 30.4.2017 |
| EU/1/16/1089 | Pandemic Influenza Vaccine H5N1 MedImmune | Norway | 29.6.2017 |
| EU/1/16/1101 | Darzalex | Liechtenstein | 30.4.2017 |
| EU/1/16/1101 | Darzalex | Norway | 12.5.2017 |
| EU/1/16/1101 | Darzalex | Iceland | 11.5.2017 |
| EU/2/07/072 | Suprelorin | Liechtenstein | 30.6.2017 |
| EU/2/07/072 | Suprelorin | Norway | 2.6.2017 |
| EU/2/07/072 | Suprelorin | Iceland | 23.5.2017 |
| EU/2/11/137 | Activyl Tick Plus | Iceland | 4.1.2017 |
| EU/2/12/139 | Zulvac 1+8 Bovis | Norway | 3.1.2017 |
| EU/2/12/140 | Poulvac E. coli | Liechtenstein | 30.6.2017 |
| EU/2/12/140 | Poulvac E. Coli | Iceland | 23.5.2017 |
| EU/2/12/140 | Poulvac E.coli | Norway | 23.5.2017 |
| EU/2/12/141 | Porcilis ColiClos | Liechtenstein | 30.4.2017 |
| EU/2/12/141 | Porcilis ColiClos | Norway | 28.4.2017 |
| EU/2/12/141 | Porcilis ColiClos | Iceland | 10.4.2017 |
| EU/2/12/142 | Cardalis | Liechtenstein | 30.6.2017 |
| EU/2/12/142 | Cardalis | Norway | 28.6.2017 |
| EU/2/12/143 | Nobivac L4 | Norway | 20.3.2017 |
| EU/2/12/143 | Nobivac L4 | Liechtenstein | 30.4.2017 |
| EU/2/12/143 | Nobivac L4 | Iceland | 24.3.2017 |

EU Number

Product

Country

Date of authorisation

EU/1/02/226

InductosOs

Liechtenstein

30.6.2017

EU/1/06/362

Byetta

Norway

24.1.2017

EU/1/06/364

Adrovance

Norway

28.3.2017

EU/1/06/365

Elaprase

Norway

23.1.2016

EU/1/06/366

Tandemact

Norway

27.1.2017

EU/1/07/388

Sebivo

Liechtenstein

28.2.2017

EU/1/07/388

Sebivo

Norway

16.1.2017

EU/1/07/388

Sebivo

Iceland

5.1.2017

EU/1/07/391

Revlimid

Liechtenstein

28.2.2017

EU/1/07/391

Revlimid

Norway

23.2.2017

EU/1/07/391

Revlimid

Iceland

21.2.2017

EU/1/07/396

Pergoveris

Liechtenstein

30.6.2017

EU/1/07/396

Pergoveris

Norway

23.5.2017

EU/1/07/396

Pergoveris

Iceland

23.5.2017

EU/1/07/397

Siklos

Liechtenstein

30.4.2017

EU/1/07/397

Siklos

Norway

5.5.2017

EU/1/07/397

Siklos

Iceland

11.5.2017

EU/1/07/403

Atriance

Liechtenstein

30.6.2017

EU/1/07/403

Atriance

Norway

26.6.2017

EU/1/07/404

Flebogamma DIF

Liechtenstein

30.4.2017

EU/1/07/404

Flebogamma DIF

Norway

10.5.2017

EU/1/07/404

Flebogamma DIF

Iceland

11.5.2017

EU/1/07/405

Rasilez

Liechtenstein

30.6.2017

EU/1/07/405

Rasilez

Norway

12.6.2017

EU/1/07/405

Rasilez

Iceland

6.6.2017

EU/1/11/699

Fampyra

Norway

20.6.2017

EU/1/11/699

Fampyra

Iceland

6.6.2017

EU/1/11/749

Caprelsa

Liechtenstein

28.2.2017

EU/1/11/749

Caprelsa

Norway

2.3.2017

EU/1/11/749

Caprelsa

Iceland

24.2.2017

EU/1/12/752

Vepacel

Liechtenstein

28.2.2017

EU/1/12/752

Vepacel

Norway

19.1.2017

EU/1/12/752

Vepacel

Iceland

12.1.2017

EU/1/12/757

Pioglitazon Teva

Liechtenstein

30.4.2017

EU/1/12/757

Pioglitazone Teva

Norway

21.3.2017

EU/1/12/757

Pioglitazone Teva

Iceland

10.3.2017

EU/1/12/758

Pioglitazon Teva Pharma

Liechtenstein

30.4.2017

EU/1/12/758

Pioglitazone Teva Pharma

Norway

17.3.2017

EU/1/12/758

Pioglitazone Teva Pharma

Iceland

10.3.2017

EU/1/12/759

Zoledronic acid Actavis

Norway

4.1.2017

EU/1/12/759

Zoledronic acid Actavis

Iceland

4.1.2017

EU/1/12/760

Bronchitol

Liechtenstein

28.2.2017

EU/1/12/760

Bronchitol

Norway

23.1.2017

EU/1/12/760

Bronchitol

Iceland

23.1.2017

EU/1/12/761

Capecitabin Teva

Liechtenstein

28.2.2017

EU/1/12/761

Capecitabine Teva

Norway

25.1.2017

EU/1/12/761

Capecitabine Teva

Iceland

23.1.2017

EU/1/12/762

Capecitabin Accord

Liechtenstein

28.2.2017

EU/1/12/762

Capecitabine Accord

Norway

25.1.2017

EU/1/12/762

Capecitabine Accord

Iceland

23.1.2017

EU/1/12/763

Ecansya

Iceland

4.1.2017

EU/1/12/764

Pixuvri

Liechtenstein

30.4.2017

EU/1/12/764

Pixuvri

Norway

29.3.2017

EU/1/12/764

Pixuvri

Iceland

6.4.2017

EU/1/12/766

SANCUSO

Liechtenstein

28.2.2017

EU/1/12/766

SANCUSO

Norway

23.1.2017

EU/1/12/766

Sancuso

Iceland

13.1.2017

EU/1/12/767

Nimenrix

Liechtenstein

30.4.2017

EU/1/12/767

Nimenrix

Norway

14.3.2017

EU/1/12/767

Nimenrix

Iceland

14.3.2017

EU/1/12/768

Riluzol Zentiva

Liechtenstein

28.2.2017

EU/1/12/768

Riluzole Zentiva

Norway

24.1.2017

EU/1/12/768

Riluzole Zentiva

Iceland

13.1.2017

EU/1/12/769

Docetaxel Accord

Norway

3.3.2017

EU/1/12/769

Docetaxel Accord

Iceland

10.3.2017

EU/1/12/770

Docetaxel Kabi

Liechtenstein

30.4.2017

EU/1/12/770

Docetaxel Kabi

Norway

3.3.2017

EU/1/12/770

Docetaxel Kabi

Iceland

10.3.2017

EU/1/12/771

Zoledronic acid Teva

Norway

20.6.2017

EU/1/12/771

Zoledronic Acid Teva

Iceland

6.6.2017

EU/1/12/772

Zoledronic acid Teva Pharma

Norway

20.6.2017

EU/1/12/772

Zoledronic acid Teva Pharma

Iceland

6.6.2017

EU/1/12/772

Zoledronsäure Teva Pharma

Liechtenstein

30.6.2017

EU/1/12/773

Jakavi

Liechtenstein

30.6.2017

EU/1/12/773

Jakavi

Norway

12.5.2017

EU/1/12/773

Jakavi

Iceland

11.5.2017

EU/1/12/775

NovoThirteen

Liechtenstein

30.6.2017

EU/1/12/775

NovoThirteen

Norway

15.6.2017

EU/1/12/775

NovoThirteen

Iceland

7.6.2017

EU/1/12/776

Fycompa

Liechtenstein

30.4.2017

EU/1/12/776

Fycompa

Norway

18.4.2017

EU/1/12/776

Fycompa

Iceland

24.4.2017

EU/1/12/777

Inlyta

Liechtenstein

30.6.2017

EU/1/12/777

Inlyta

Norway

14.6.2017

EU/1/12/777

Inlyta

Iceland

8.6.2017

EU/1/12/778

Eklira Genuair

Liechtenstein

30.4.2017

EU/1/12/778

Eklira Genuair

Norway

10.5.2017

EU/1/12/778

Eklira Genuair

Iceland

10.5.2017

EU/1/12/779

Zoledronic acid medac

Iceland

18.5.2017

EU/1/12/779

Zoledronsäure medac

Liechtenstein

30.6.2017

EU/1/12/779

Zoledronsyre medac

Norway

22.5.2017

EU/1/12/780

Jentadueto

Liechtenstein

30.4.2017

EU/1/12/780

Jentadueto

Norway

6.4.2017

EU/1/12/780

Jentadueto

Iceland

6.4.2017

EU/1/12/781

Bretaris Genuair

Liechtenstein

30.4.2017

EU/1/12/781

Bretaris Genuair

Norway

10.5.2017

EU/1/12/781

Bretaris Genuair

Iceland

10.5.2017

EU/1/12/782

Kalydeco

Liechtenstein

30.6.2017

EU/1/12/782

Kalydeco

Norway

19.5.2017

EU/1/12/782

Kalydeco

Iceland

11.5.2017

EU/1/12/783

Zyclara

Liechtenstein

30.4.2017

EU/1/12/783

Zyclara

Norway

6.4.2017

EU/1/12/783

Zyclara

Iceland

7.4.2017

EU/1/12/785

Zinforo

Liechtenstein

30.6.2017

EU/1/12/785

Zinforo

Norway

19.5.2017

EU/1/12/785

Zinforo

Iceland

11.5.2017

EU/1/12/786

Zoledronic acid Mylan

Norway

26.6.2017

EU/1/12/786

Zoledronic acid Mylan

Iceland

7.6.2017

EU/1/12/786

Zoledronsäure Mylan

Liechtenstein

30.6.2017

EU/1/12/787

Revestive

Liechtenstein

30.6.2017

EU/1/12/792

Dacogen

Liechtenstein

30.6.2017

EU/1/12/792

Dacogen

Norway

1.6.2017

EU/1/12/792

Dacogen

Iceland

6.6.2017

EU/1/12/802

Capecitabin medac

Liechtenstein

30.6.2017

EU/1/12/802

Capecitabine medac

Norway

26.6.2017

EU/1/13/818

Bosulif

Liechtenstein

30.4.2017

EU/1/13/818

Bosulif

Norway

5.4.2017

EU/1/13/818

Bosulif

Iceland

7.4.2017

EU/1/13/875

Deltyba

Liechtenstein

30.4.2017

EU/1/13/875

Deltyba

Norway

14.3.2017

EU/1/13/875

Deltyba

Iceland

14.3.2017

EU/1/13/890

Cometriq

Liechtenstein

28.2.2017

EU/1/13/890

Cometriq

Iceland

23.1.2017

EU/1/13/901

Sirturo

Liechtenstein

28.2.2017

EU/1/13/901

Sirturo

Norway

11.5.2017

EU/1/13/901

SIRTURO

Iceland

6.1.2017

EU/1/13/902

Translarna

Liechtenstein

28.2.2017

EU/1/13/902

Translarna

Liechtenstein

30.6.2017

EU/1/13/902

Translarna

Norway

1.2.2017

EU/1/14/987

Holoclar

Norway

4.1.2017

EU/1/14/987

Holoclar

Iceland

4.1.2017

EU/1/15/999

Zykadia

Liechtenstein

30.4.2017

EU/1/15/999

Zykadia

Norway

30.5.2017

EU/1/15/999

Zykadia

Iceland

21.4.2017

EU/1/16/1086

Tagrisso

Norway

2.1.2017

EU/1/16/1089

Pandemic influenza vaccine H5N1 MedImmune

Iceland

10.5.2017

EU/1/16/1089

Pandemic influenza vaccine H5N1 MedImmune

Liechtenstein

30.4.2017

EU/1/16/1089

Pandemic Influenza Vaccine H5N1 MedImmune

Norway

29.6.2017

EU/1/16/1101

Darzalex

Liechtenstein

30.4.2017

EU/1/16/1101

Darzalex

Norway

12.5.2017

EU/1/16/1101

Darzalex

Iceland

11.5.2017

EU/2/07/072

Suprelorin

Liechtenstein

30.6.2017

EU/2/07/072

Suprelorin

Norway

2.6.2017

EU/2/07/072

Suprelorin

Iceland

23.5.2017

EU/2/11/137

Activyl Tick Plus

Iceland

4.1.2017

EU/2/12/139

Zulvac 1+8 Bovis

Norway

3.1.2017

EU/2/12/140

Poulvac E. coli

Liechtenstein

30.6.2017

EU/2/12/140

Poulvac E. Coli

Iceland

23.5.2017

EU/2/12/140

Poulvac E.coli

Norway

23.5.2017

EU/2/12/141

Porcilis ColiClos

Liechtenstein

30.4.2017

EU/2/12/141

Porcilis ColiClos

Norway

28.4.2017

EU/2/12/141

Porcilis ColiClos

Iceland

10.4.2017

EU/2/12/142

Cardalis

Liechtenstein

30.6.2017

EU/2/12/142

Cardalis

Norway

28.6.2017

EU/2/12/143

Nobivac L4

Norway

20.3.2017

EU/2/12/143

Nobivac L4

Liechtenstein

30.4.2017

EU/2/12/143

Nobivac L4

Iceland

24.3.2017

---

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 2017:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/03/256/020 | Humira | Norway | 6.4.2017 |
| EU/1/03/256/020 | Humira | Iceland | 10.4.2017 |
| EU/1/07/396/004-006 | Pergoveris | Norway | 8.5.2017 |
| EU/1/07/396/004-006 | Pergoveris | Iceland | 23.5.2017 |
| EU/1/09/514/021-023 | Zebinix | Iceland | 4.1.2017 |
| EU/1/09/514/024 | Zebinix | Norway | 4.1.2017 |
| EU/1/09/564/004 | Ilaris | Norway | 7.3.2017 |
| EU/1/09/564/004 | Ilaris | Iceland | 14.3.2017 |
| EU/1/10/641/002 | Ruconest | Norway | 26.1.2017 |
| EU/1/10/641/002 | Ruconest | Iceland | 30.1.2017 |
| EU/1/10/655/012-014 | Brilique | Norway | 18.5.2017 |
| EU/1/10/655/012-014 | Brilique | Iceland | 6.6.2017 |
| EU/1/11/667/005-011 | Esbriet | Norway | 9.5.2017 |
| EU/1/11/667/005-011 | Esbriet | Iceland | 11.5.2017 |
| EU/1/13/860/003 | Nexium Control | Norway | 23.6.2017 |
| EU/1/13/892/003-006 | Tivicay | Norway | 2.3.2017 |
| EU/1/13/892/003-006 | Tivicay | Iceland | 13.3.2017 |
| EU/1/15/1016/006-007 | Repatha | Norway | 17.2.2017 |
| EU/1/15/1016/006-007 | Repatha | Iceland | 24.2.2017 |
| EU/1/15/1074/005 | Benepali | Norway | 31.5.2017 |
| EU/1/15/1074/005 | Benepali | Iceland | 7.6.2017 |
| EU/1/97/047/009 | BeneFIX | Norway | 22.3.2017 |
| EU/1/97/047/009 | BeneFIX | Iceland | 7.4.2017 |
| EU/2/04/042/015-018 | Novem | Iceland | 6.6.2017 |
| EU/2/08/083/006-009 | EQUIOXX | Norway | 9.2.2017 |
| EU/2/08/083/006-009 | Equioxx | Iceland | 15.2.2017 |

EU Number

Product

Country

Date of authorisation

EU/1/03/256/020

Humira

Norway

6.4.2017

EU/1/03/256/020

Humira

Iceland

10.4.2017

EU/1/07/396/004-006

Pergoveris

Norway

8.5.2017

EU/1/07/396/004-006

Pergoveris

Iceland

23.5.2017

EU/1/09/514/021-023

Zebinix

Iceland

4.1.2017

EU/1/09/514/024

Zebinix

Norway

4.1.2017

EU/1/09/564/004

Ilaris

Norway

7.3.2017

EU/1/09/564/004

Ilaris

Iceland

14.3.2017

EU/1/10/641/002

Ruconest

Norway

26.1.2017

EU/1/10/641/002

Ruconest

Iceland

30.1.2017

EU/1/10/655/012-014

Brilique

Norway

18.5.2017

EU/1/10/655/012-014

Brilique

Iceland

6.6.2017

EU/1/11/667/005-011

Esbriet

Norway

9.5.2017

EU/1/11/667/005-011

Esbriet

Iceland

11.5.2017

EU/1/13/860/003

Nexium Control

Norway

23.6.2017

EU/1/13/892/003-006

Tivicay

Norway

2.3.2017

EU/1/13/892/003-006

Tivicay

Iceland

13.3.2017

EU/1/15/1016/006-007

Repatha

Norway

17.2.2017

EU/1/15/1016/006-007

Repatha

Iceland

24.2.2017

EU/1/15/1074/005

Benepali

Norway

31.5.2017

EU/1/15/1074/005

Benepali

Iceland

7.6.2017

EU/1/97/047/009

BeneFIX

Norway

22.3.2017

EU/1/97/047/009

BeneFIX

Iceland

7.4.2017

EU/2/04/042/015-018

Novem

Iceland

6.6.2017

EU/2/08/083/006-009

EQUIOXX

Norway

9.2.2017

EU/2/08/083/006-009

Equioxx

Iceland

15.2.2017

---

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 2017:

| EU Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/00/137 | Avandia | Liechtenstein | 28.2.2017 |
| EU/1/03/258 | Avandamet | Liechtenstein | 28.2.2017 |
| EU/1/06/373 | Imprida | Liechtenstein | 30.4.2017 |
| EU/1/06/373 | Imprida | Norway | 19.4.2017 |
| EU/1/06/373 | Imprida | Iceland | 21.4.2017 |
| EU/1/07/385 | Focetria | Liechtenstein | 28.2.2017 |
| EU/1/08/500 | Fablyn | Liechtenstein | 28.2.2017 |
| EU/1/09/512 | Removab | Liechtenstein | 30.6.2017 |
| EU/1/09/512 | Removab | Norway | 23.6.2017 |
| EU/1/09/512 | Removab | Iceland | 12.6.2017 |
| EU/1/09/532 | Clopidogrel Acino | Liechtenstein | 28.2.2017 |
| EU/1/09/532 | Clopidogrel Acino | Norway | 9.2.2017 |
| EU/1/09/532 | Clopidogrel Acino | Iceland | 3.2.2017 |
| EU/1/09/561 | Clopidogrel Teva Pharma | Liechtenstein | 30.6.2017 |
| EU/1/09/561 | Clopidogrel Teva Pharma | Norway | 28.6.2017 |
| EU/1/10/657 | Prepandemic Influenza | Liechtenstein | 28.2.2017 |
| EU/1/11/720 | Incivo | Iceland | 3.2.2017 |
| EU/1/11/721 | Paglitaz | Liechtenstein | 28.2.2017 |
| EU/1/14/942 | Clopidogrel/Acetylsalicylsäure Teva | Liechtenstein | 28.2.2017 |
| EU/1/14/948 | Budesonide/Formoterol Teva | Norway | 19.1.2017 |
| EU/1/14/948 | Budesonide/Formoterol Teva | Iceland | 5.1.2017 |
| EU/1/14/949 | Vylaer Spiromax | Liechtenstein | 28.2.2017 |
| EU/1/14/949 | Vylaer Spiromax | Norway | 19.1.2017 |
| EU/1/14/949 | Vylaer Spiromax | Iceland | 13.1.2017 |
| EU/1/14/950 | Budesonide/Formoterol Teva Pharma B.V. | Norway | 19.1.2017 |
| EU/1/14/950 | Budesonide/Formoterol Teva Pharma B.V. | Iceland | 5.1.2017 |
| EU/1/15/1022 | Unituxin | Norway | 19.4.2017 |
| EU/1/15/1022 | Unituxin | Iceland | 6.4.2017 |
| EU/1/15/995 | DUTREBIS | Liechtenstein | 30.4.2017 |
| EU/1/15/995 | DUTREBIS | Norway | 9.5.2017 |
| EU/1/15/995 | DUTREBIS | Iceland | 11.5.2017 |
| EU/2/11/127 | RECUVYRA | Iceland | 3.2.2017 |

EU Number

Product

Country

Date of withdrawal

EU/1/00/137

Avandia

Liechtenstein

28.2.2017

EU/1/03/258

Avandamet

Liechtenstein

28.2.2017

EU/1/06/373

Imprida

Liechtenstein

30.4.2017

EU/1/06/373

Imprida

Norway

19.4.2017

EU/1/06/373

Imprida

Iceland

21.4.2017

EU/1/07/385

Focetria

Liechtenstein

28.2.2017

EU/1/08/500

Fablyn

Liechtenstein

28.2.2017

EU/1/09/512

Removab

Liechtenstein

30.6.2017

EU/1/09/512

Removab

Norway

23.6.2017

EU/1/09/512

Removab

Iceland

12.6.2017

EU/1/09/532

Clopidogrel Acino

Liechtenstein

28.2.2017

EU/1/09/532

Clopidogrel Acino

Norway

9.2.2017

EU/1/09/532

Clopidogrel Acino

Iceland

3.2.2017

EU/1/09/561

Clopidogrel Teva Pharma

Liechtenstein

30.6.2017

EU/1/09/561

Clopidogrel Teva Pharma

Norway

28.6.2017

EU/1/10/657

Prepandemic Influenza

Liechtenstein

28.2.2017

EU/1/11/720

Incivo

Iceland

3.2.2017

EU/1/11/721

Paglitaz

Liechtenstein

28.2.2017

EU/1/14/942

Clopidogrel/Acetylsalicylsäure Teva

Liechtenstein

28.2.2017

EU/1/14/948

Budesonide/Formoterol Teva

Norway

19.1.2017

EU/1/14/948

Budesonide/Formoterol Teva

Iceland

5.1.2017

EU/1/14/949

Vylaer Spiromax

Liechtenstein

28.2.2017

EU/1/14/949

Vylaer Spiromax

Norway

19.1.2017

EU/1/14/949

Vylaer Spiromax

Iceland

13.1.2017

EU/1/14/950

Budesonide/Formoterol Teva Pharma B.V.

Norway

19.1.2017

EU/1/14/950

Budesonide/Formoterol Teva Pharma B.V.

Iceland

5.1.2017

EU/1/15/1022

Unituxin

Norway

19.4.2017

EU/1/15/1022

Unituxin

Iceland

6.4.2017

EU/1/15/995

DUTREBIS

Liechtenstein

30.4.2017

EU/1/15/995

DUTREBIS

Norway

9.5.2017

EU/1/15/995

DUTREBIS

Iceland

11.5.2017

EU/2/11/127

RECUVYRA

Iceland

3.2.2017

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ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 January-30 June 2017:

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

EU Number

Product

Country

Date of suspension

---

| 14.6.2018 | EN | Official Journal of the European Union | C 205/27 |
| --- | --- | --- | --- |

14.6.2018

EN

Official Journal of the European Union

C 205/27

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Dangerous substances — List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) in the first half of 2017

(2018/C 205/06)

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 25/2008 of 14 March 2008, the EEA Joint Committee is invited to note the following lists concerning authorisation decisions adopted on the basis of Article 64(8) of Regulation (EC) No 1907/2006 (REACH) for the period 1 January – 30 June 2017, at their meeting on 22 September 2017.

---

ANNEX

List of authorisation decisions

The following authorisation decisions in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) have been taken in the EEA EFTA States during the period 1 January – 30 June 2017:

| Substance name | Commission decision under Article 64(8) of Regulation (EC) No 1907/2006 | Country | Date of decision |
| --- | --- | --- | --- |
| Lead sulfochromate yellow & Lead chromate molybdate sulphate red | C(2016) 5644 | Iceland | 30/01/2017 |
| Trichloroethylene | C(2016) 8596 | Iceland | 03/02/2017 |
| Trichloroethylene | C(2016) 8596 | Liechtenstein | 17/02/2017 |
| Trichloroethylene | C(2016) 8596 | Norway | 02/02/2017 |
| Trichloroethylene | C(2017) 69 | Iceland | 03/02/2017 |
| Trichloroethylene | C(2017) 69 | Liechtenstein | 17/02/2017 |
| Trichloroethylene | C(2017) 69 | Norway | 02/02/2017 |
| Trichloroethylene | C(2017) 649 | Iceland | 08/03/2017 |
| Trichloroethylene | C(2017) 649 | Liechtenstein | 25/02/2017 |
| Trichloroethylene | C(2017) 649 | Norway | 10/03/2017 |
| Trichloroethylene | C(2017) 651 | Iceland | 08/03/2017 |
| Trichloroethylene | C(2017) 651 | Liechtenstein | 25/02/2017 |
| Trichloroethylene | C(2017) 651 | Norway | 10/03/2017 |
| Trichloroethylene | C(2017) 658 | Iceland | 08/03/2017 |
| Trichloroethylene | C(2017) 658 | Liechtenstein | 25/02/2017 |
| Trichloroethylene | C(2017) 658 | Norway | 10/03/2017 |
| Trichloroethylene | C(2017) 660 | Iceland | 08/03/2017 |
| Trichloroethylene | C(2017) 660 | Liechtenstein | 25/02/2017 |
| Trichloroethylene | C(2017) 660 | Norway | 10/03/2017 |
| Sodium dichromate | C(2017) 661 | Iceland | 08/03/2017 |
| Sodium dichromate | C(2017) 661 | Liechtenstein | 25/02/2017 |
| Sodium dichromate | C(2017) 661 | Norway | 10/03/2017 |
| Chromium trioxide | C(2017) 663 | Iceland | 08/03/2017 |
| Chromium trioxide | C(2017) 663 | Liechtenstein | 25/02/2017 |
| Chromium trioxide | C(2017) 663 | Norway | 10/03/2017 |
| Sodium chromate | C(2017) 665 | Iceland | 08/03/2017 |
| Sodium chromate | C(2017) 665 | Liechtenstein | 25/02/2017 |
| Sodium chromate | C(2017) 665 | Norway | 10/03/2017 |
| 1,2-dichloroethane | C(2017) 1332 | Iceland | 03/04/2017 |
| 1,2-dichloroethane | C(2017) 1332 | Liechtenstein | 30/03/2017 |
| 1,2-dichloroethane | C(2017) 1332 | Norway | 24/03/2017 |
| Ammonium dichromate | C(2017) 3237 | Liechtenstein | 21/06/2017 |
| Ammonium dichromate | C(2017) 3237 | Norway | 20/06/2017 |
| Chromium trioxide | C(2017) 3439 | Iceland | 09/06/2017 |
| Chromium trioxide | C(2017) 3439 | Liechtenstein | 14/06/2017 |
| Chromium trioxide | C(2017) 3439 | Norway | 20/06/2017 |
| Sodium dichromate | C(2017) 3453 | Liechtenstein | 26/06/2017 |
| Sodium dichromate | C(2017) 3453 | Norway | 20/06/2017 |
| Sodium dichromate | C(2017) 3764 | Liechtenstein | 26/06/2017 |
| Sodium dichromate | C(2017) 3764 | Norway | 20/06/2017 |
| Sodium dichromate | C(2017) 3765 | Liechtenstein | 26/06/2017 |
| Sodium dichromate | C(2017) 3765 | Norway | 20/06/2017 |
| Sodium dichromate | C(2017) 3801 | Liechtenstein | 26/06/2017 |
| Sodium dichromate | C(2017) 3801 | Norway | 20/06/2017 |
| Sodium dichromate | C(2017) 3806 | Liechtenstein | 26/06/2017 |
| Sodium dichromate | C(2017) 3806 | Norway | 20/06/2017 |
| Sodium dichromate | C(2017) 3816 | Liechtenstein | 26/06/2017 |
| Sodium dichromate | C(2017) 3816 | Norway | 20/06/2017 |
| 1,2-dichloroethane | C(2017) 3821 | Liechtenstein | 26/06/2017 |
| 1,2-dichloroethane | C(2017) 3821 | Norway | 20/06/2017 |
| Potassium dichromate | C(2017) 3910 | Liechtenstein | 29/06/2017 |
| Potassium dichromate | C(2017) 3910 | Norway | 20/06/2017 |

Substance name

Commission decision under Article 64(8) of Regulation (EC) No 1907/2006

Country

Date of decision

Lead sulfochromate yellow & Lead chromate molybdate sulphate red

C(2016) 5644

Iceland

30/01/2017

Trichloroethylene

C(2016) 8596

Iceland

03/02/2017

Trichloroethylene

C(2016) 8596

Liechtenstein

17/02/2017

Trichloroethylene

C(2016) 8596

Norway

02/02/2017

Trichloroethylene

C(2017) 69

Iceland

03/02/2017

Trichloroethylene

C(2017) 69

Liechtenstein

17/02/2017

Trichloroethylene

C(2017) 69

Norway

02/02/2017

Trichloroethylene

C(2017) 649

Iceland

08/03/2017

Trichloroethylene

C(2017) 649

Liechtenstein

25/02/2017

Trichloroethylene

C(2017) 649

Norway

10/03/2017

Trichloroethylene

C(2017) 651

Iceland

08/03/2017

Trichloroethylene

C(2017) 651

Liechtenstein

25/02/2017

Trichloroethylene

C(2017) 651

Norway

10/03/2017

Trichloroethylene

C(2017) 658

Iceland

08/03/2017

Trichloroethylene

C(2017) 658

Liechtenstein

25/02/2017

Trichloroethylene

C(2017) 658

Norway

10/03/2017

Trichloroethylene

C(2017) 660

Iceland

08/03/2017

Trichloroethylene

C(2017) 660

Liechtenstein

25/02/2017

Trichloroethylene

C(2017) 660

Norway

10/03/2017

Sodium dichromate

C(2017) 661

Iceland

08/03/2017

Sodium dichromate

C(2017) 661

Liechtenstein

25/02/2017

Sodium dichromate

C(2017) 661

Norway

10/03/2017

Chromium trioxide

C(2017) 663

Iceland

08/03/2017

Chromium trioxide

C(2017) 663

Liechtenstein

25/02/2017

Chromium trioxide

C(2017) 663

Norway

10/03/2017

Sodium chromate

C(2017) 665

Iceland

08/03/2017

Sodium chromate

C(2017) 665

Liechtenstein

25/02/2017

Sodium chromate

C(2017) 665

Norway

10/03/2017

1,2-dichloroethane

C(2017) 1332

Iceland

03/04/2017

1,2-dichloroethane

C(2017) 1332

Liechtenstein

30/03/2017

1,2-dichloroethane

C(2017) 1332

Norway

24/03/2017

Ammonium dichromate

C(2017) 3237

Liechtenstein

21/06/2017

Ammonium dichromate

C(2017) 3237

Norway

20/06/2017

Chromium trioxide

C(2017) 3439

Iceland

09/06/2017

Chromium trioxide

C(2017) 3439

Liechtenstein

14/06/2017

Chromium trioxide

C(2017) 3439

Norway

20/06/2017

Sodium dichromate

C(2017) 3453

Liechtenstein

26/06/2017

Sodium dichromate

C(2017) 3453

Norway

20/06/2017

Sodium dichromate

C(2017) 3764

Liechtenstein

26/06/2017

Sodium dichromate

C(2017) 3764

Norway

20/06/2017

Sodium dichromate

C(2017) 3765

Liechtenstein

26/06/2017

Sodium dichromate

C(2017) 3765

Norway

20/06/2017

Sodium dichromate

C(2017) 3801

Liechtenstein

26/06/2017

Sodium dichromate

C(2017) 3801

Norway

20/06/2017

Sodium dichromate

C(2017) 3806

Liechtenstein

26/06/2017

Sodium dichromate

C(2017) 3806

Norway

20/06/2017

Sodium dichromate

C(2017) 3816

Liechtenstein

26/06/2017

Sodium dichromate

C(2017) 3816

Norway

20/06/2017

1,2-dichloroethane

C(2017) 3821

Liechtenstein

26/06/2017

1,2-dichloroethane

C(2017) 3821

Norway

20/06/2017

Potassium dichromate

C(2017) 3910

Liechtenstein

29/06/2017

Potassium dichromate

C(2017) 3910

Norway

20/06/2017

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V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 14.6.2018 | EN | Official Journal of the European Union | C 205/31 |
| --- | --- | --- | --- |

14.6.2018

EN

Official Journal of the European Union

C 205/31

---

Prior notification of a concentration

(Case M.8916 — JIC/TAHL/Australia Nature’s Care Biotech)

Candidate case for simplified procedure

(Text with EEA relevance)

(2018/C 205/07)

1.

This notification concerns the following undertakings:

| — | China Jianyin Investment Limited (‘JIC’, China), |
| --- | --- |

—

China Jianyin Investment Limited (‘JIC’, China),

| — | Tamar Alliance Health Limited (‘TAHL’, Cayman Islands), |
| --- | --- |

—

Tamar Alliance Health Limited (‘TAHL’, Cayman Islands),

| — | Australia Nature’s Care Biotech Co., Ltd.A (‘ANCB’, Australia) controlled by Alex Wu and Jina Chen. |
| --- | --- |

—

Australia Nature’s Care Biotech Co., Ltd.A (‘ANCB’, Australia) controlled by Alex Wu and Jina Chen.

JIC and TAHL acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of the whole of ANCB.

The concentration is accomplished by way of purchase of shares.

2.

—   for JIC: integrated investment group focused on equity investments, with financial service, industrial manufacturing, culture and consumption and information technology as its four main investment areas,

—   for TAHL: investment vehicle dedicated to investing in consumer and healthcare sectors,

—   for ANCB: one of Australia's leading vitamins and supplements companies, active in manufacturing, marketing, selling, distributing, and exporting vitamins and supplements products and other healthcare products (including, skincare products and baby care products) across Australia, China and Taiwan.

3.

Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

4.

Observations must reach the Commission not later than 10 days following the date of this publication. The following reference should always be specified:

M.8916 — JIC/TAHL/Australia Nature’s Care Biotech

Observations can be sent to the Commission by email, by fax, or by post. Please use the contact details below:

| Email: COMP-MERGER-REGISTRY@ec.europa.eu |
| --- |
| Fax +32 22964301 |
| Postal address: |
| European Commission |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

Email: COMP-MERGER-REGISTRY@ec.europa.eu

Fax +32 22964301

Postal address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

1

(2)  OJ C 366, 14.12.2013, p. 5.

2

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| 14.6.2018 | EN | Official Journal of the European Union | C 205/33 |
| --- | --- | --- | --- |

14.6.2018

EN

Official Journal of the European Union

C 205/33

---

Prior notification of a concentration

(Case M.8943 — Intermediate Capital Group/Minimax Viking)

Candidate case for simplified procedure

(Text with EEA relevance)

(2018/C 205/08)

1.

This notification concerns the following undertakings:

| — | Intermediate Capital Group plc (United Kingdom), |
| --- | --- |

—

Intermediate Capital Group plc (United Kingdom),

| — | MV Holding GmbH, which holds 100 % of the issued share capital of Minimax Viking Group (Germany) |
| --- | --- |

—

MV Holding GmbH, which holds 100 % of the issued share capital of Minimax Viking Group (Germany)

Intermediate Capital Group acquires within the meaning of Article 3(1)(b) of the Merger Regulation sole control of the whole of MV Holding GmbH.

The concentration is accomplished by way of purchase of shares.

2.

—   for Intermediate Capital Group: UK-based investment firm active in the structuring and provision of mezzanine finance, leveraged credit and minority equity and managing assets, with investment porfolios in Europe, Asia Pacific and the US,

—   for Minimax Viking Group: manufacture, supply, and integration of fire suppression and related detection and control systems; manufacture and supply of portable fire exinguishers; and supply and installation of equipment for fire trucks.

3.

Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

4.

Observations must reach the Commission not later than 10 days following the date of this publication. The following reference should always be specified:

M.8943 — Intermediate Capital Group/Minimax Viking

Observations can be sent to the Commission by email, by fax, or by post. Please use the contact details below:

| E-mail: COMP-MERGER-REGISTRY@ec.europa.eu |
| --- |
| Fax +32 22964301 |
| Postal address: |
| European Commission |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

E-mail: COMP-MERGER-REGISTRY@ec.europa.eu

Fax +32 22964301

Postal address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

1

(2)  OJ C 366, 14.12.2013, p. 5.

2

---