EN Official Journal of the European Union C 306/24

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2014

(2015/C 306/09)

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 July–31 December 2014, at their meeting on 20 March 2015:

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Annex II List of renewed marketing authorisations Annex III List of extended marketing authorisations Annex IV List of withdrawn marketing authorisations Annex V List of suspended marketing authorisations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 July – 31 December 2014: EU Number Product Country Date of authorisation EU/1/09/527 Ribavirin Teva Pharma BV Liechtenstein 31.12.2014 EU/1/09/585 Rivastigmine 1A Pharma Liechtenstein 31.10.2014 EU/1/09/591 Multaq Liechtenstein 31.10.2014 EU/1/09/595 Sildenafil Actavis Liechtenstein 31.10.2014 EU/1/09/598 Nevirapine Teva Liechtenstein 31.8.2014 EU/1/09/599 Rivastigmine Sandoz Liechtenstein 31.8.2014 EU/1/09/600 Zutectra Liechtenstein 31.10.2014 EU/1/11/688 Cinryze Liechtenstein 31.12.2014 EU/1/11/705 Vibativ Iceland 27.10.2014 EU/1/12/772 Zoledronsäure Teva Pharma Liechtenstein 31.12.2014 EU/1/13/902 Translarna Iceland 15.8.2014 EU/1/13/902 Translarna Liechtenstein 31.8.2014 EU/1/13/902 Translarna Norway 12.8.2014 EU/1/14/917 Ulunar Breezhaler Iceland 22.7.2014 EU/1/14/931 Mekinist Iceland 21.7.2014 EU/1/14/931 Mekinist Liechtenstein 31.8.2014 EU/1/14/931 Mekinist Norway 14.7.2014 EU/1/14/933 Simbrinza Liechtenstein 31.8.2014 EU/1/14/933 Simbrinza Norway 7.8.2014 EU/1/14/933 Simbrinza Iceland 14.8.2014 EU/1/14/934 Plegridy Iceland 15.8.2014 EU/1/14/934 Plegridy Liechtenstein 31.8.2014 EU/1/14/934 Plegridy Norway 13.8.2014 EU/1/14/935 Envarsus Iceland 14.8.2014 EU/1/14/935 Envarsus Liechtenstein 31.8.2014 EU/1/14/935 Envarsus Norway 13.8.2014 EU/1/14/936 Nuwiq Iceland 10.10.2014 EU/1/14/936 Nuwiq Norway 18.8.2014 EU/1/14/937 Gazyvaro Iceland 14.8.2014 EU/1/14/937 Gazyvaro Liechtenstein 31.8.2014 EU/1/14/937 Gazyvaro Norway 13.8.2014 EU/1/14/938 Zydelig Iceland 25.9.2014 EU/1/14/938 Zydelig Liechtenstein 31.10.2014 EU/1/14/938 Zydelig Norway 2.10.2014 EU/1/14/939 Daklinza Iceland 11.9.2014 EU/1/14/939 Daklinza Liechtenstein 31.8.2014 EU/1/14/939 Daklinza Norway 9.9.2014 EU/1/14/940 Triumeq Iceland 12.9.2014 EU/1/14/940 Triumeq Liechtenstein 31.10.2014 EU/1/14/940 Triumeq Norway 10.9.2014 EU/1/14/941 Vizamyl Iceland 11.9.2014 EU/1/14/941 Vizamyl Liechtenstein 31.8.2014 EU/1/14/941 Vizamyl Norway 12.9.2014 EU/1/14/942 Clopidogrel/Acetylsalicylic acid Teva Iceland 12.9.2014 EU/1/14/942 Clopidogrel/Acetylsalicylic acid Teva Norway 25.9.2014 EU/1/14/942 Clopidogrel/Acetylsalicylsäure Teva Liechtenstein 31.10.2014 EU/1/14/943 Velphoro Iceland 11.9.2014 EU/1/14/943 Velphoro Liechtenstein 31.8.2014 EU/1/14/943 Velphoro Norway 18.9.2014 EU/1/14/944 ABASRIA Iceland 24.9.2014 EU/1/14/944 ABASRIA Liechtenstein 31.10.2014 EU/1/14/944 ABASRIA Norway 24.9.2014 EU/1/14/945 IMBRUVICA Iceland 18.11.2014 EU/1/14/945 IMBRUVICA Liechtenstein 31.10.2014 EU/1/14/945 IMBRUVICA Norway 3.11.2014 EU/1/14/946 Accofil Iceland 26.9.2014 EU/1/14/946 Accofil Liechtenstein 31.10.2014 EU/1/14/946 Accofil Norway 14.10.2014 EU/1/14/947 Xultophy Iceland 25.9.2014 EU/1/14/947 Xultophy Liechtenstein 31.10.2014 EU/1/14/947 Xultophy Norway 25.9.2014 EU/1/14/948 Budesonide/Formoterol Teva Iceland 16.12.2014 EU/1/14/948 Budesonide/Formoterol Teva Liechtenstein 31.12.2014 EU/1/14/948 Budesonide/Formoterol Teva Norway 9.12.2014 EU/1/14/949 Vylaer Spiromax Iceland 12.12.2014 EU/1/14/949 Vylaer Spiromax Liechtenstein 31.12.2014 EU/1/14/949 Vylaer Spiromax Norway 9.12.2014 EU/1/14/950 Budesonide/Formoterol Teva Pharma B.V. Iceland 16.12.2014 EU/1/14/950 Budesonide/Formoterol Teva Pharma B.V. Liechtenstein 31.12.2014 EU/1/14/950 Budesonide/Formoterol Teva Pharma B.V. Norway 9.12.2014 EU/1/14/951 Busulfan Fresenius Kabi Iceland 25.9.2014 EU/1/14/951 Busulfan Fresenius Kabi Liechtenstein 31.10.2014 EU/1/14/951 Busulfan Fresenius Kabi Norway 2.10.2014 EU/1/14/954 Vargatef Iceland 20.12.2014 EU/1/14/954 Vargatef Liechtenstein 31.12.2014 EU/1/14/954 Vargatef Norway 1.12.2014 EU/1/14/955 Lymphoseek Iceland 19.12.2014 EU/1/14/955 Lymphoseek Liechtenstein 31.12.2014 EU/1/14/955 Lymphoseek Norway 10.12.2014 EU/1/14/956 Trulicity Iceland 20.12.2014 EU/1/14/956 Trulicity Liechtenstein 31.12.2014 EU/1/14/956 Trulicity Norway 1.12.2014 EU/1/14/958 Harvoni Iceland 9.12.2014 EU/1/14/958 Harvoni Liechtenstein 31.12.2014 EU/1/14/958 Harvoni Norway 3.12.2014 EU/1/14/959 Lynparza Liechtenstein 31.12.2014 EU/1/14/960 DUAVIVE Liechtenstein 31.12.2014 EU/1/14/961 Tadalafil Mylan Iceland 19.12.2014 EU/1/14/961 Tadalafil Mylan Liechtenstein 31.12.2014 EU/1/14/961 Tadalafil Mylan Norway 9.12.2014 EU/1/14/962 Moventig Iceland 20.12.2014 EU/1/14/962 Moventig Liechtenstein 31.12.2014 EU/1/14/962 Moventig Norway 12.12.2014 EU/1/14/963 Brimica Genuair Iceland 19.12.2014 EU/1/14/963 Brimica Genuair Liechtenstein 31.12.2014 EU/1/14/963 Brimica Genuair Norway 8.12.2014 EU/1/14/964 Duaklir Genuair Iceland 19.12.2014 EU/1/14/964 Duaklir Genuair Liechtenstein 31.12.2014 EU/1/14/964 Duaklir Genuair Norway 8.12.2014 EU/1/14/965 Ketoconazole HRA Norway 8.12.2014 EU/1/14/965 Ketoconazole HRA Iceland 19.12.2014 EU/1/14/965 Ketoconazole HRA Liechtenstein 31.12.2014 EU/1/14/967 REZOLSTA Iceland 17.12.2014 EU/1/14/967 REZOLSTA Liechtenstein 31.12.2014 EU/1/14/967 REZOLSTA Norway 4.12.2014 EU/1/14/969 Scenesse Liechtenstein 31.12.2014 EU/1/14/970 Rixubis Liechtenstein 31.12.2014 EU/1/14/971 Paliperidone Janssen Iceland 5.12.2014 EU/1/14/971 Paliperidone Janssen Liechtenstein 31.12.2014 EU/1/14/971 Paliperidone Janssen Norway 19.12.2014 EU/1/14/972 Duloxetin Lilly Liechtenstein 31.12.2014 EU/1/14/972 Duloxetine Lilly Norway 17.12.2014 EU/2/09/101 Zolvix Liechtenstein 31.12.2014 EU/2/13/150 Oncept IL-2 Norway 26.9.2014 EU/2/14/163 Versican Plus DHPPi/L4R Norway 10.7.2014 EU/2/14/164 Versican Plus DHPPi/L4 Norway 21.7.2014 EU/2/14/165 Vectra Felis Norway 10.7.2014 EU/2/14/166 ERYSENG Iceland 21.7.2014 EU/2/14/166 Eryseng Norway 5.8.2014 EU/2/14/166 ERYSENG Liechtenstein 31.8.2014 EU/2/14/167 ERYSENG PARVO Iceland 12.8.2014 EU/2/14/167 Eryseng Parvo Norway 5.8.2014 EU/2/14/167 ERYSENG PARVO Liechtenstein 31.8.2014 EU/2/14/168 Versican Plus Pi Iceland 21.7.2014 EU/2/14/168 Versican Plus Pi Liechtenstein 31.8.2014 EU/2/14/168 Versican Plus Pi Norway 5.8.2014 EU/2/14/169 Versican Plus DHPPi Iceland 21.7.2014 EU/2/14/169 Versican Plus DHPPi Liechtenstein 31.8.2014 EU/2/14/169 Versican Plus DHPPi Norway 5.8.2014 EU/2/14/170 OSURNIA Iceland 2.9.2014 EU/2/14/170 Osurnia Liechtenstein 31.8.2014 EU/2/14/170 Osurnia Norway 22.9.2014 EU/2/14/171 Versican Plus L4 Iceland 2.9.2014 EU/2/14/171 Versican Plus L4 Liechtenstein 31.8.2014 EU/2/14/171 Versican Plus L4 Norway 11.11.2014 EU/2/14/172 Versican Plus Pi/L4 Iceland 2.9.2014 EU/2/14/172 Versican Plus Pi/L4 Liechtenstein 31.8.2014 EU/2/14/172 Versican Plus Pi/L4 Norway 11.11.2014 EU/2/14/173 Versican Plus Pi/L4R Norway 11.11.2014 EU/2/14/173 Versican Plus Pi/L4R Iceland 31.7.2014 EU/2/14/174 Nobilis IB Primo QX Iceland 24.9.2014 EU/2/14/174 Nobilis IB Primo QX Liechtenstein 31.10.2014 EU/2/14/174 Nobilis IB Primo QX Norway 11.11.2014 EU/2/14/175 Porcilis PCV M Hyo Norway 15.12.2014 EU/2/14/175 Porcilis PCV M Hyo Iceland 4.12.2014 EU/2/14/175 Porcilis PCV M Hyo Liechtenstein 31.12.2014 EU/2/14/176 Bovela Liechtenstein 31.12.2014

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 2014: EU Number Product Country Date of authorisation EU/1/04/287 Osseor Iceland 16.9.2014 EU/1/04/288 Protelos Iceland 16.9.2014 EU/1/04/289 Angiox Iceland 18.7.2014 EU/1/04/289 Angiox Norway 8.7.2014 EU/1/04/295 Xagrid Liechtenstein 31.8.2014 EU/1/04/295 Xagrid Iceland 14.8.2014 EU/1/04/295 Xagrid Norway 7.8.2014 EU/1/04/298 Kivexa Liechtenstein 31.12.2014 EU/1/04/298 Kivexa Iceland 10.12.2014 EU/1/04/298 Kivexa Norway 17.12.2014 EU/1/04/299 Fendrix Liechtenstein 31.12.2014 EU/1/04/299 Fendrix Iceland 9.12.2014 EU/1/04/299 Fendrix Norway 4.12.2014 EU/1/04/300 Avastin Liechtenstein 31.12.2014 EU/1/04/300 Avastin Iceland 12.12.2014 EU/1/04/300 Avastin Norway 28.11.2014 EU/1/04/302 Prialt Liechtenstein 31.10.2014 EU/1/04/302 Prialt Iceland 24.9.2014 EU/1/04/302 Prialt Norway 26.9.2014 EU/1/09/511 Conbriza Iceland 16.9.2014 EU/1/09/530 Repaglinide Teva Iceland 16.7.2014 EU/1/09/530 Repaglinide Teva Norway 1.7.2014 EU/1/09/539 Samsca Iceland 18.7.2014 EU/1/09/539 Samsca Norway 1.7.2014 EU/1/09/545 Onglyza Liechtenstein 31.8.2014 EU/1/09/545 Onglyza Iceland 14.8.2014 EU/1/09/545 Onglyza Norway 25.8.2014 EU/1/09/546 Simponi Iceland 18.7.2014 EU/1/09/546 Simponi Norway 10.7.2014 EU/1/09/550 Javlor Iceland 22.7.2014 EU/1/09/552 Topotecan Teva Iceland 18.7.2014 EU/1/09/552 Topotecan Teva Norway 10.7.2014 EU/1/09/555 Clopidogrel TAD Iceland 22.7.2014 EU/1/09/555 Clopidogrel TAD Norway 1.7.2014 EU/1/09/559 Clopidogrel Mylan Norway 1.7.2014 EU/1/09/560 Clopidogrel DURA Norway 1.7.2014 EU/1/09/562 Clopidogrel Krka d.d. Iceland 22.7.2014 EU/1/09/562 Clopidogrel Krka d.d. Norway 1.7.2014 EU/1/09/563 ChondroCelect Liechtenstein 31.8.2014 EU/1/09/563 ChondroCelect Iceland 9.9.2014 EU/1/09/563 ChondroCelect Norway 10.9.2014 EU/1/09/564 Ilaris Iceland 18.7.2014 EU/1/09/564 Ilaris Norway 10.7.2014 EU/1/09/565 Biopoin Liechtenstein 31.10.2014 EU/1/09/565 Biopoin Iceland 10.9.2014 EU/1/09/565 Biopoin Norway 8.9.2014 EU/1/09/566 Lamivudine Teva Liechtenstein 31.10.2014 EU/1/09/566 Lamivudine Teva Iceland 23.9.2014 EU/1/09/566 Lamivudine Teva Norway 9.10.2014 EU/1/09/568 Clopidogrel Apotex Liechtenstein 31.10.2014 EU/1/09/568 Clopidogrel Apotex Iceland 25.9.2014 EU/1/09/568 Clopidogrel Apotex Norway 29.9.2014 EU/1/09/569 Exforge HCT Liechtenstein 31.8.2014 EU/1/09/569 Exforge HCT Iceland 18.7.2014 EU/1/09/569 Exforge HCT Norway 29.7.2014 EU/1/09/572 Vantavo Liechtenstein 31.10.2014 EU/1/09/572 Vantavo Iceland 25.9.2014 EU/1/09/572 Vantavo Norway 26.9.2014 EU/1/09/573 Eporatio Liechtenstein 31.10.2014 EU/1/09/573 Eporatio Iceland 24.9.2014 EU/1/09/573 Eporatio Norway 29.9.2014 EU/1/09/574 Dafiro HCT Liechtenstein 31.8.2014 EU/1/09/574 Dafiro HCT Iceland 22.7.2014 EU/1/09/574 Dafiro HCT Norway 4.8.2014 EU/1/09/575 Copalia HCT Liechtenstein 31.8.2014 EU/1/09/575 Copalia HCT Iceland 22.7.2014 EU/1/09/575 Copalia HCT Norway 4.8.2014 EU/1/09/576 Irbesartan Teva Liechtenstein 31.8.2014 EU/1/09/576 Irbesartan Teva Iceland 13.8.2014 EU/1/09/576 Irbesartan Teva Norway 4.8.2014 EU/1/09/577 Foclivia Liechtenstein 31.8.2014 EU/1/09/577 Foclivia Iceland 21.7.2014 EU/1/09/577 Foclivia Norway 29.7.2014 EU/1/09/578 Adjupanrix Liechtenstein 31.8.2014 EU/1/09/578 Adjupanrix Iceland 14.8.2014 EU/1/09/578 Adjupanrix Norway 13.8.2014 EU/1/09/579 Repaglinide Krka Liechtenstein 31.10.2014 EU/1/09/579 Repaglinide Krka Iceland 10.9.2014 EU/1/09/579 Repaglinide Krka Norway 9.9.2014 EU/1/09/580 Enyglid Liechtenstein 31.8.2014 EU/1/09/580 Enyglid Iceland 9.9.2014 EU/1/09/580 Enyglid Norway 10.9.2014 EU/1/09/581 Resolor Norway 1.7.2014 EU/1/09/583 Irbesartan/Hydrochlorothiazid Liechtenstein 31.12.2014 EU/1/09/583 Irbesartan/Hydrochlorothiazide Teva Iceland 9.12.2014 EU/1/09/583 Irbesartan/Hydrochlorotiazide Teva Norway 27.11.2014 EU/1/09/584 Sildenafil Teva Liechtenstein 31.10.2014 EU/1/09/584 Sildenafil Teva Iceland 23.9.2014 EU/1/09/584 Sildenafil Teva Norway 2.10.2014 EU/1/09/585 Rivastigmine 1A Pharma Iceland 9.9.2014 EU/1/09/585 Rivastigmine 1A Pharma Norway 10.9.2014 EU/1/09/586 Oslif Breezhaler Liechtenstein 31.10.2014 EU/1/09/586 Oslif Breezhaler Iceland 25.9.2014 EU/1/09/586 Oslif Breezhaler Norway 14.10.2014 EU/1/09/587 Olanzapine Glenmark Liechtenstein 31.8.2014 EU/1/09/587 Olanzapine Glenmark Iceland 9.9.2014 EU/1/09/587 Olanzapine Glenmark Norway 10.9.2014 EU/1/09/588 Olanzapine Glenmark Europe Liechtenstein 31.8.2014 EU/1/09/588 Olanzapine Glenmark Europe Iceland 9.9.2014 EU/1/09/588 Olanzapine Glenmark Europe Norway 10.9.2014 EU/1/09/589 Rivastigmine HEXAL Liechtenstein 31.8.2014 EU/1/09/589 Rivastigmine HEXAL Iceland 13.8.2014 EU/1/09/589 Rivastigmine Hexal Norway 13.8.2014 EU/1/09/590 Prevenar 13 Liechtenstein 31.12.2014 EU/1/09/590 Prevenar 13 Iceland 10.10.2014 EU/1/09/590 Prevenar 13 Norway 15.10.2014 EU/1/09/591 Multaq Norway 29.9.2014 EU/1/09/591 Multaq Iceland 26.9.2014 EU/1/09/592 Olazax Disperzi Liechtenstein 31.8.2014 EU/1/09/592 Olazax Disperzi Iceland 4.9.2014 EU/1/09/592 Olazax Disperzi Norway 27.8.2014 EU/1/09/593 Onbrez Breezhaler Liechtenstein 31.10.2014 EU/1/09/593 Onbrez Breezhaler Iceland 25.9.2014 EU/1/09/593 Onbrez Breezhaler Norway 14.10.2014 EU/1/09/594 Hirobrez Breezhaler Norway 14.10.2014 EU/1/09/594 Hirobriz Breezhaler Liechtenstein 31.10.2014 EU/1/09/594 Hirobriz Breezhaler Iceland 25.9.2014 EU/1/09/595 Sildenafil Actavis Iceland 23.9.2014 EU/1/09/595 Sildenafil Actavis Norway 1.10.2014 EU/1/09/596 Lamivudine Teva Pharma B.V. Liechtenstein 31.10.2014 EU/1/09/596 Lamivudine Teva Pharma B.V. Iceland 23.9.2014 EU/1/09/596 Lamivudine Teva Pharma B.V. Norway 9.10.2014 EU/1/09/597 Olazax Iceland 9.9.2014 EU/1/09/597 Olazax Norway 10.9.2014 EU/1/09/598 Nevirapine Teva Iceland 10.9.2014 EU/1/09/598 Nevirapine Teva Norway 9.9.2014 EU/1/09/599 Rivastigmine Sandoz Iceland 13.8.2014 EU/1/09/599 Rivastigmine Sandoz Norway 13.8.2014 EU/1/09/600 Zutectra Iceland 24.9.2014 EU/1/09/600 Zutectra Norway 15.10.2014 EU/1/09/601 Firdapse Norway 18.12.2014 EU/1/09/602 Scintimun Liechtenstein 31.8.2014 EU/1/09/602 Scintimun Iceland 10.9.2014 EU/1/09/602 Scintimun Norway 18.9.2014 EU/1/09/603 Sildenafil ratiopharm Liechtenstein 31.10.2014 EU/1/09/603 Sildenafil ratiopharm Iceland 23.9.2014 EU/1/09/603 Sildenafil ratiopharm Norway 2.10.2014 EU/1/09/604 Leflunomide Winthrop Liechtenstein 31.12.2014 EU/1/09/604 Leflunomide Winthrop Iceland 12.12.2014 EU/1/09/604 Leflunomide Winthrop Norway 28.11.2014 EU/1/09/605 Temomedac Liechtenstein 31.8.2014 EU/1/09/605 Temomedac Iceland 13.8.2014 EU/1/09/605 Temomedac Norway 7.8.2014 EU/1/09/606 Temozolomide Teva Liechtenstein 31.10.2014 EU/1/09/606 Temozolomide Teva Iceland 10.9.2014 EU/1/09/606 Temozolomide Teva Norway 12.9.2014 EU/1/09/607 Silodyx Liechtenstein 31.10.2014 EU/1/09/607 Silodyx Iceland 25.9.2014 EU/1/09/607 Silodyx Norway 15.10.2014 EU/1/09/608 Urorec Liechtenstein 31.10.2014 EU/1/09/608 Urorec Iceland 25.9.2014 EU/1/09/608 Urorec Norway 15.10.2014 EU/1/09/609 Elonva Liechtenstein 31.8.2014 EU/1/09/609 Elonva Iceland 10.9.2014 EU/1/09/609 Elonva Norway 8.9.2014 EU/1/09/611 Docetaxel Teva Liechtenstein 31.8.2014 EU/1/09/611 Docetaxel Teva Iceland 12.8.2014 EU/1/09/611 Docetaxel Teva Norway 6.8.2014 EU/1/10/614 Menveo Liechtenstein 31.12.2014 EU/1/10/614 Menveo Iceland 20.12.2014 EU/1/10/614 Menveo Norway 12.12.2014 EU/1/10/616 Temozolomide HEXAL Liechtenstein 31.12.2014 EU/1/10/616 Temozolomide Hexal Iceland 12.12.2014 EU/1/10/616 Temozolomide Hexal Norway 26.11.2014 EU/1/10/617 Temozolomid Sandoz Liechtenstein 31.12.2014 EU/1/10/617 Temozolomide Sandoz Iceland 16.12.2014 EU/1/10/617 Temozolomide Sandoz Norway 28.11.2014 EU/1/10/619 DuoPlavin Liechtenstein 31.12.2014 EU/1/10/619 DuoPlavin Iceland 18.12.2014 EU/1/10/619 DuoPlavin Norway 3.12.2014 EU/1/10/620 Ristfor Liechtenstein 31.12.2014 EU/1/10/621 Ristaben Liechtenstein 31.12.2014 EU/1/10/622 Tepadina Liechtenstein 31.12.2014 EU/1/10/622 Tepadina Iceland 10.12.2014 EU/1/10/622 Tepadina Norway 28.11.2014 EU/1/10/623 DuoCover Liechtenstein 31.12.2014 EU/1/10/623 DuoCover Iceland 18.12.2014 EU/1/10/623 DuoCover Norway 3.12.2014 EU/1/11/710 Votubia Liechtenstein 31.8.2014 EU/1/11/710 Votubia Iceland 12.8.2014 EU/1/11/710 Votubia Norway 7.8.2014 EU/1/12/793 XALKORI Liechtenstein 31.8.2014 EU/1/12/793 XALKORI Iceland 10.9.2014 EU/1/12/793 XALKORI Norway 5.9.2014 EU/1/12/794 ADCETRIS Liechtenstein 31.8.2014 EU/1/12/794 ADCETRIS Iceland 10.9.2014 EU/1/12/794 ADCETRIS Norway 5.9.2014 EU/1/13/848 Erivedge Liechtenstein 31.8.2014 EU/1/13/848 Erivedge Iceland 17.7.2014 EU/1/13/848 Erivedge Norway 5.8.2014 EU/1/97/044 Tasmar Liechtenstein 31.8.2014 EU/1/97/044 Tasmar Iceland 13.8.2014 EU/1/97/044 Tasmar Norway 13.8.2014 EU/1/99/114 Zeffix Iceland 18.7.2014 EU/1/99/114 Zeffix Norway 9.7.2014 EU/1/99/123 Renagel Liechtenstein 31.12.2014 EU/1/99/123 Renagel Iceland 17.12.2014 EU/1/99/123 Renagel Norway 10.12.2014 EU/2/04/043 Equilis StrepE Norway 10.7.2014 EU/2/04/044 Aivlosin Liechtenstein 31.10.2014 EU/2/04/044 Aivlosin Iceland 24.9.2014 EU/2/04/044 Aivlosin Norway 11.11.2014 EU/2/08/086 Equip WNV Norway 12.11.2014 EU/2/08/087 Masivet Norway 11.11.2014 EU/2/09/094 BTVPUR AlSap 8 Norway 21.7.2014 EU/2/09/095 Improvac Norway 11.11.2014 EU/2/09/096 Leucogen Norway 9.10.2014 EU/2/09/097 Leucofeligen FeLV/RCP Norway 9.10.2014 EU/2/09/099 Suvaxyn PCV Norway 21.7.2014 EU/2/09/100 Palladia Norway 11.11.2014 EU/2/09/100 Palladia Liechtenstein 31.8.2014 EU/2/09/100 Palladia Iceland 15.8.2014 EU/2/09/101 Zolvix Iceland 4.12.2014 EU/2/09/101 Zolvix Norway 17.12.2014 EU/2/09/102 Gripovac 3 Norway 17.12.2014 EU/2/09/102 Gripovac 3 Liechtenstein 31.12.2014 EU/2/09/102 Gripovac 3 Iceland 20.12.2014 EU/2/09/103 Respiporc Flu3 Liechtenstein 31.12.2014 EU/2/09/103 RESPIPORC FLU3 Iceland 20.12.2014 EU/2/09/104 Zulvac 8 Ovis Liechtenstein 31.12.2014 EU/2/09/104 Zulvac 8 Ovis Iceland 4.12.2014 EU/2/09/105 Zulvac 8 Bovis Norway 15.12.2014 EU/2/09/105 Zulvac 8 Bovis Liechtenstein 31.12.2014 EU/2/09/105 Zulvac 8 Bovis Iceland 4.12.2014

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 2014: EU Number Product Country Date of authorisation EU/1/01/195/028-029 Liprolog KwikPen Norway 20.10.2014 EU/1/03/255/009-010 Ventavis Iceland 14.8.2014 EU/1/03/255/009-010 Ventavis Norway 7.8.2014 EU/1/05/320/004 Noxafil Iceland 10.10.2014 EU/1/05/320/004 Noxafil Norway 15.10.2014 EU/1/07/436/005 Isentress Iceland 11.9.2014 EU/1/07/436/005 Isentress Norway 10.9.2014 EU/1/12/753/013-017 Signifor Iceland 19.12.2014 EU/1/12/753/013-017 Signifor Norway 3.12.2014 EU/1/12/771/007-009 Zoledronic acid Teva Norway 28.10.2014 EU/1/12/773/013-016 Jakavi Iceland 28.10.2014 EU/1/12/773/013-016 Jakavi Norway 15.10.2014 EU/1/96/007/039-042 Humalog KwikPen Norway 20.10.2014 EU/1/99/117/003-004 Synagis Iceland 11.9.2014 EU/1/99/117/003-004 Synagis Norway 11.9.2014 EU/2/03/041/006-008 Draxxin Iceland 12.8.2014 EU/2/03/041/006-008 Draxxin Norway 18.7.2014 EU/2/11/135/002-003 Panacur AquaSol Norway 17.12.2014 EU/2/11/135/002-003 Panacur AquaSol Iceland 15.8.2014

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 2014: EU Number Product Country Date of withdrawal EU/1/06/339 Preotact Iceland 12.8.2014 EU/1/06/339 Preotact Norway 13.8.2014 EU/1/07/426 Olanzapine Cipla Liechtenstein 31.8.2014 EU/1/07/426 Olanzapine Cipla Iceland 22.7.2014 EU/1/08/467 Doribax Liechtenstein 31.8.2014 EU/1/08/467 Doribax Iceland 15.8.2014 EU/1/08/467 Doribax Norway 13.8.2014 EU/1/09/557 Clopidogrel Qualimed Liechtenstein 31.10.2014 EU/1/09/557 Clopidogrel Qualimed Iceland 10.9.2014 EU/1/09/557 Clopidogrel Qualimed Norway 14.10.2014 EU/1/10/649 Clopidogrel Teva Pharma B.V. Liechtenstein 31.10.2014 EU/1/10/649 Clopidogrel Teva Pharma B.V. Iceland 19.11.2014 EU/1/10/661 FLUENZ Liechtenstein 31.12.2014 EU/1/10/661 Fluenz Iceland 18.11.2014 EU/1/10/661 Fluenz Norway 17.12.2014 EU/1/10/662 Docetaxel Teva Pharma Iceland 12.8.2014 EU/1/11/675 Leflunomide Teva Iceland 12.8.2014 EU/1/11/689 IOA Liechtenstein 31.8.2014 EU/1/11/689 Ioa Iceland 2.9.2014 EU/1/11/689 IOA Norway 16.9.2014 EU/1/11/723 Pioglitazon Krka Liechtenstein 31.10.2014 EU/1/11/723 Pioglitazone Krka Iceland 24.9.2014 EU/1/11/735 Ipreziv Liechtenstein 31.12.2014 EU/1/11/735 Ipreziv Iceland 19.11.2014 EU/1/11/735 Ipreziv Norway 17.12.2014 EU/1/11/744 Topotecan Eagle Liechtenstein 31.10.2014 EU/1/11/744 Topotecan Eagle Iceland 27.10.2014 EU/1/11/744 Topotecan Eagle Norway 5.11.2014 EU/1/14/911 Rivastigmine 3M Health Care Ltd. Liechtenstein 31.8.2014 EU/1/14/911 Rivastigmine 3M Health Care Ltd. Iceland 4.9.2014 EU/1/14/911 Rivastigmine 3M Health Care Ltd. Norway 16.9.2014 EU/1/97/037 Vistide Liechtenstein 31.10.2014 EU/1/97/037 Vistide Iceland 10.9.2014 EU/1/97/043 Revasc Liechtenstein 31.8.2014 EU/1/97/043 Revasc Iceland 14.8.2014 EU/1/97/043 Revasc Norway 26.8.2014 EU/2/06/058 Flexicam Iceland 12.8.2014