EØS-tillegget. NORSK utgave. til Den europeiske unions tidende. Nr. 57 ISSN årgang EØS-ORGANER. 1. EØS-komiteen EFTA-ORGANER

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1 NORSK utgave EØS-tillegget til Den europeiske unions tidende I EØS-ORGANER 1. EØS-komiteen II EFTA-ORGANER 1. EFTA-statenes faste komité ISSN Nr årgang /EØS/57/ /EØS/57/ /EØS/57/03 Underkomité I for fritt varebytte Legemidler Liste over markedsføringstillatelser gitt av EØS-EFTA-statene i andre halvår Underkomité I for fritt varebytte Legemidler Liste over markedsføringstillatelser gitt av EØS-EFTA-statene i første halvår Underkomité I for fritt varebytte Legemidler Liste over markedsføringstillatelser gitt av EØS-EFTA-statene i andre halvår EFTAs overvåkningsorgan 3. EFTA-domstolen III EU-ORGANER 1. Kommisjonen 2014/EØS/57/04 Forhåndsmelding om en foretakssammenslutning (Sak M.7095 SOCAR/DESFA) /EØS/57/05 Forhåndsmelding om en foretakssammenslutning (Sak M.7307 Electricity Supply Board/Vodafone Ireland/JV) /EØS/57/06 Forhåndsmelding om en foretakssammenslutning (Sak M.7333 Alitalia/Etihad) /EØS/57/ /EØS/57/ /EØS/57/09 Forhåndsmelding om en foretakssammenslutning (Sak M.7359 PCCR USA/ Total s CCP Composite Business) Forhåndsmelding om en foretakssammenslutning (Sak M.7418 Bosch/ ZF Lenksysteme) Sak som kan bli behandlet etter forenklet framgangsmåte Forhåndsmelding om en foretakssammenslutning (Sak M.7423 Vinci/Imtech ICT) Sak som kan bli behandlet etter forenklet framgangsmåte /EØS/57/10 Innledning av behandling (Sak M.7265 Zimmer/Biomet)... 40

2 2014/EØS/57/ /EØS/57/ /EØS/57/ /EØS/57/ /EØS/57/ /EØS/57/ /EØS/57/ /EØS/57/18 Vedtak om å ikke gjøre innsigelse mot en meldt foretakssammenslutning (Sak M.7282 Liberty Global/Discovery/All3Media) Vedtak om å ikke gjøre innsigelse mot en meldt foretakssammenslutning (Sak M.7288 Viacom/Channel 5 Broadcasting) Vedtak om å ikke gjøre innsigelse mot en meldt foretakssammenslutning (Sak M.7316 Det norske oljeselskap/marathon Oil Norge) Vedtak om å ikke gjøre innsigelse mot en meldt foretakssammenslutning (Sak M.7354 ADM/WILD Flavors/WDI) Vedtak om å ikke gjøre innsigelse mot en meldt foretakssammenslutning (Sak M.7364 Blackstone/Lombard) Vedtak om å ikke gjøre innsigelse mot en meldt foretakssammenslutning (Sak M.7371 Nordic Capital/Lindorff) Vedtak om å ikke gjøre innsigelse mot en meldt foretakssammenslutning (Sak M.7373 Ortner/Strauss/UBM) Vedtak om å ikke gjøre innsigelse mot en meldt foretakssammenslutning (Sak M.7376 Droege/Weltbild)... 44

3 EØS-tillegget til Den europeiske unions tidende Nr. 57/1 EFTA-ORGANER EFTA-STATENES FASTE KOMITÉ UNDERKOMITÉ I FOR FRITT VAREBYTTE 2014/EØS/57/01 LEGEMIDLER LISTE OVER MARKEDSFØRINGSTILLATELSER GITT AV EØS-EFTA- STATENE I ANDRE HALVÅR 2011 Til underretning for EØS-komiteen Under henvisning til EØS-komiteens beslutning nr. 74/1999 av 28. mai 1999 bes EØS-komiteen, på sitt møte 15. juni 2012, ta til underretning de følgende lister over markeds førings tillatelser for legemidler for tidsrommet 1. juli 31. desember 2011: VEDLEGG I VEDLEGG II VEDLEGG III VEDLEGG IV VEDLEGG V Liste over nye markedsføringstillatelser Liste over fornyede markedsføringstillatelser Liste over utvidede markedsføringstillatelser Liste over tilbakekalte markedsføringstillatelser Liste over suspenderte markedsføringstillatelser

4 Nr. 57/2 EØS-tillegget til Den europeiske unions tidende VEDLEGG I Liste over nye markedsføringstillatelser Følgende markedsføringstillatelser er tildelt i EØS-EFTA-statene i tidsrommet 1. juli 31. desember 2011: EU/1/09/543/ Cayston( 1 ) Liechtenstein EU/1/10/642/ Ibandronic Acid Teva Norge EU/1/10/649/ Clopidogrel Teva Pharma B.V Norge EU/1/10/649/ Clopidogrel Teva Pharma B.V. Liechtenstein EU/1/10/652/ TOBI Podhaler Liechtenstein EU/1/10/652/ TOBI Podhaler Norge EU/1/10/652/ TOBI Podhaler Island EU/1/10/654/ Leflunomide ratiopharm Norge EU/1/10/660/ Potactasol Norge EU/1/10/661/ Fluenz Norge EU/1/11/672/ Xeplion Liechtenstein EU/1/11/683/ Sprimeo HCT Liechtenstein EU/1/11/683/ Sprimeo HCT Norge EU/1/11/683/ Sprimeo HCT Island EU/1/11/685/ Ibandronic acid Sandoz Liechtenstein EU/1/11/685/ Ibandronic acid Sandoz Island EU/1/11/689/ IOA Liechtenstein EU/1/11/689/ IOA Norge EU/1/11/689/ Ioa Island EU/1/11/690/ Zoely Liechtenstein EU/1/11/690/ Zoely Norge EU/1/11/690/ Zoely Island EU/1/11/691/ Eliquis Island EU/1/11/693/ Rivastigmin Actavis Norge EU/1/11/694/ Nulojix Liechtenstein EU/1/11/694/ Nulojix Norge EU/1/11/694/ Nulojix Island EU/1/11/695/ Leganto Liechtenstein EU/1/11/695/ Leganto Norge EU/1/11/695/ Leganto Island EU/1/11/696/ Bydureon Norge EU/1/11/696/ Bydureon Island EU/1/11/696/ Bydureon Liechtenstein EU/1/11/697/ Temozolomide Sun Liechtenstein EU/1/11/697/ Temozolomide SUN Norge EU/1/11/697/ Temozolomide SUN Island

5 EØS-tillegget til Den europeiske unions tidende Nr. 57/3 EU/1/11/698/ Yervoy Liechtenstein EU/1/11/698/ Yervoy Norge EU/1/11/698/ Yervoy Island EU/1/11/699/ Fampyra Liechtenstein EU/1/11/699/ Fampyra Norge EU/1/11/699/ Fampyra Island EU/1/11/700/ Benlysta Liechtenstein EU/1/11/700/ Benlysta Norge EU/1/11/700/ Benlysta Island EU/1/11/701/ Levetiracetam Teva Liechtenstein EU/1/11/701/ Levetiracetam Teva Norge EU/1/11/701/ Levetiracetam Teva Island EU/1/11/702/ Levetiracetam Ratiopharm Liechtenstein EU/1/11/702/ Levetiracetam ratiopharm Norge EU/1/11/702/ Levetiracetam ratiopharm Island EU/1/11/703/ Xgeva Liechtenstein EU/1/11/703/ Xgeva Norge EU/1/11/703/ XGEVA Island EU/1/11/704/001 Victrelis Liechtenstein EU/1/11/704/001 Victrelis Norge EU/1/11/704/001 Victrelis Island EU/1/11/705/ Vibativ Liechtenstein EU/1/11/705/ Vibativ Norge EU/1/11/705/ Vibativ Island EU/1/11/706/ Levodopa/Cardidopa/Entacapone Orion Liechtenstein EU/1/11/706/ Levodopa/Carbidopa/Entacapone Orion Norge EU/1/11/706/ Levodopa/Carbidopa/Entacapone Orion Island EU/1/11/707/ Trajenta Liechtenstein EU/1/11/707/ Trajenta Norge EU/1/11/707/ Trajenta Island EU/1/11/708/ Entacapone Orion Liechtenstein EU/1/11/708/ Entacapone Orion Norge EU/1/11/708/ Entacapone Orion Island EU/1/11/709/ Buccolam Norge EU/1/11/709/ Buccolam Island EU/1/11/710/ Votubia Liechtenstein EU/1/11/710/ Votubia Norge EU/1/11/710/ Votubia Island EU/1/11/711/ Matever Liechtenstein EU/1/11/711/ Matever Island

6 Nr. 57/4 EØS-tillegget til Den europeiske unions tidende EU/1/11/712/ Levetiracetam Accord Liechtenstein EU/1/11/712/ Levetiracetam Accord Island EU/1/11/713/ Levetiracetam Actavis Liechtenstein EU/1/11/713/ Levetiracetam Actavis Island EU/1/11/714/001 Zytiga Liechtenstein EU/1/11/714/001 Zytiga Norge EU/1/11/714/001 Zytiga 250 mg Tafla Island EU/1/11/715/ Plenadren Liechtenstein EU/1/11/715/ Plenadren Norge EU/1/11/716/ Eurartesim Liechtenstein EU/1/11/716/ Eurartesim Norge EU/1/11/716/ Eurartesim Island EU/1/11/717/001 Vyndaqel Liechtenstein EU/1/11/717/001 Vyndaqel Norge EU/1/11/717/001 Vyndaqel Island EU/1/11/718/ Dexdor Liechtenstein EU/1/11/718/ Dexdor Norge EU/1/11/718/ Dexdor Island EU/1/11/719/ Telmisartan Teva Pharma Norge EU/1/11/719/ Telmisartan Teva Pharma Island EU/1/11/720/001 Incivo Liechtenstein EU/1/11/720/001 Incivo Norge EU/1/11/720/001 Incivo 375 mg Filmuhúðuð tafla Island EU/1/11/728/ Pramipexole Accord Liechtenstein EU/1/11/728/ Pramipexole Accord Norge EU/1/11/728/ Pramipexole Accord Island EU/1/11/729/ Onduarp Liechtenstein EU/1/11/729/ Onduarp Island EU/1/11/730/ Rasitrio Norge EU/1/11/731/ Komboglyze Liechtenstein EU/1/11/731/ Komboglyze Norge EU/1/11/731/ Komboglyze Island EU/1/11/732/ Desloratadine Teva Liechtenstein EU/1/11/732/ Desloratadine Teva Norge EU/1/11/732/ Desloratadine Teva Island EU/1/11/733/ Dificlir Liechtenstein EU/1/11/733/ Dificlir Norge EU/1/11/733/ Dificlir Island EU/1/11/734/ Edarbi Liechtenstein EU/1/11/734/ Edarbi Norge

7 EØS-tillegget til Den europeiske unions tidende Nr. 57/5 EU/1/11/734/ Edarbi Island EU/1/11/735/ Ipreziv Liechtenstein EU/1/11/735/ Ipreziv Norge EU/1/11/735/ Ipreziv Island EU/1/11/736/001 Edurant Liechtenstein EU/1/11/736/001 Edurant Norge EU/1/11/736/001 EDURANT Island EU/1/11/737/ Eviplera Liechtenstein EU/1/11/737/ Eviplera Norge EU/1/11/737/ Eviplera Island EU/1/11/738/ Levetiracetam Actavis Group Liechtenstein EU/1/11/738/ Levetiracetam Actavis Group Island EU/1/11/739/ Dasselta Liechtenstein EU/1/11/739/ Dasselta Island EU/1/11/740/001 Ameluz Liechtenstein EU/2/07/078/ Rheumocam Norge EU/2/10/110/ Coxevac Norge EU/2/10/112/ BTVPUR AlSap 1 Norge EU/2/10/113/ BTVPUR AlSap 1-8 Norge EU/2/11/122/ Bluevac BTV8 Island EU/2/11/124/ Zuprevo Norge EU/2/11/125/ Certifect Norge EU/2/11/126/001 MS-H-vaksine Mycoplasma synoviae Norge EU/2/11/127/001 Recuvyra Norge EU/2/11/127/001 RECUVYRA Island EU/2/11/128/ Emdocam Norge EU/2/11/128/ Emdocam Island EU/2/11/129/ Proteq West Nile Norge EU/2/11/129/ Proteq West Nile Island EU/2/11/130/ Zulvac 1 Bovis Norge EU/2/11/130/ Zulvac 1 Bovis Island EU/2/11/131/ Zulvac 1 Ovis Norge EU/2/11/131/ Zulvac 1 Ovis Island EU/2/11/132/ Nobivac Myxo-RHD Norge EU/2/11/132/ Nobivac Myxo-RHD Island EU/2/11/133/ Recocam Norge EU/2/11/133/ Recocam 20 mg/ml Island EU/2/11/134/ Inflacam Island EU/2/11/135/ Panacur AquaSol Island ( 1 ) Fra betinget markedsføringstillatelse med en markedsføringstillatelse som ikke er omfattet av særlige forpliktelser.

8 Nr. 57/6 EØS-tillegget til Den europeiske unions tidende VEDLEGG II Liste over fornyede markedsføringstillatelser Følgende markedsføringstillatelser er fornyet i EØS-EFTA-statene i tidsrommet 1. juli 31. desember 2011: EU/1/01/196/001 EU/1/01/196/003 Cancidas Norge EU/1/01/196/001, 003 Cancidas Island EU/1/01/196/001, 003 Cancidas Liechtenstein EU/1/01/200/ Viread Liechtenstein EU/1/06/336/001 Tygacil Island EU/1/06/340/ Ganfort Liechtenstein EU/1/06/340/ Ganfort Norge EU/1/06/340/ Ganfort Island EU/1/06/342/001 Nexavar Liechtenstein EU/1/06/342/001 Nexavar Norge EU/1/06/342/001 Nexavar Island EU/1/06/343/ Baraclude Norge EU/1/06/346/001 Tysabri Liechtenstein EU/1/06/346/001 Tysabri Norge EU/1/06/35/ Livensa Liechtenstein EU/1/06/350/001 Savene Liechtenstein EU/1/06/350/001 Savene Norge EU/1/06/350/001 Savene Island EU/1/06/351/ Livensa Norge EU/1/06/351/ Livensa Island EU/1/06/352/ Intrinsa Liechtenstein EU/1/06/352/ Intrinsa Norge EU/1/06/352/ Intrinsa Island EU/1/06/355/ ATryn Liechtenstein EU/1/06/355/ ATryn Norge EU/1/06/355/ ATryn Island EU/1/06/356/ Exjade Liechtenstein EU/1/06/356/ Exjade Norge EU/1/06/356/ Exjade Island EU/1/06/357/ , Gardasil Island EU/1/06/357/ EU/1/06/357/ Gardasil Norge EU/1/06/358/ , Silgard Island EU/1/06/358/ Silgard Liechtenstein EU/1/06/358/ Silgard Norge

9 EØS-tillegget til Den europeiske unions tidende Nr. 57/7 EU/1/06/359/ Suboxone Liechtenstein EU/1/06/359/ Suboxone Norge EU/1/06/359/ Suboxone Island EU/1/06/360/ Champix Norge EU/1/06/360/ Champix Island EU/1/06/361/ Luminity Liechtenstein EU/1/06/361/ Luminity Norge EU/1/06/361/ Luminity Island EU/1/06/362/ Byetta Liechtenstein EU/1/06/362/ Byetta Norge EU/1/06/362/ Byetta Island EU/1/06/363/ Sprycel Liechtenstein EU/1/06/363/ Sprycel Norge EU/1/06/363/ Sprycel Island EU/1/06/364/ EU/1/06/364/ Adrovance Norge EU/1/06/364/ , Adrovance Island EU/1/06/364/ Adrovance Liechtenstein EU/1/06/365/ Elaprase Liechtenstein EU/1/06/365/ Elaprase Norge EU/1/06/365/ Elaprase Island EU/1/06/368/ , , , , , , , , Insulin Human Winthrop Liechtenstein EU/1/06/368/ Insulin Human Winthrop Island EU/1/06/370/ Exforge Liechtenstein EU/1/06/372/ Copalia Liechtenstein EU/1/06/372/ Copalia Island EU/1/06/373/ Imprida Liechtenstein EU/1/07/440/ Tyverb Island EU/1/08/468/001 Intelence Liechtenstein EU/1/08/468/001 Intelence Norge EU/1/08/468/001 INTELENCE Island EU/1/09/543/ Cayston Norge EU/1/09/543/ Cayston Island EU/1/10/628/ Votrient Norge EU/1/96/024/ Crixivan Liechtenstein EU/1/96/024/ EU/1/96/024/010 Crixivan Norge EU/1/96/024/ Crixivan Island EU/2/06/059/001 Convenia Norge

10 Nr. 57/8 EØS-tillegget til Den europeiske unions tidende EU/2/06/060/ Poulvac Flufend H5N3 RG Island EU/2/06/061/ Nobilis Influenza H5N2 Norge EU/2/06/061/ Nobilis Influenza H5N2 Island EU/2/06/062/ Cerenia Norge EU/2/06/062/ Cerenia Island EU/2/06/064/ ProMeris Norge EU/2/06/064/ ProMeris Island EU/2/06/065/ ProMeris Duo Island EU/2/06/065/ ProMeris Duo Norge EU/2/06/066/ Prac-Tic Norge EU/2/06/066/ Prac-tic Island EU/2/06/069/001 Cortavance Norge EU/2/06/069/001 Cortavance Island EU/2/99/016/ Porcilis Pesti Norge EU/2/99/016/ Porcilis Pesti Island

11 EØS-tillegget til Den europeiske unions tidende Nr. 57/9 VEDLEGG III Liste over utvidede markedsføringstillatelser Følgende markedsføringstillatelser er utvidet i EØS-EFTA-statene i tidsrommet 1. juli 31. desember 2011: EU/1/00/165/008 Ovitrelle Liechtenstein EU/1/00/165/008 Ovitrelle Norge EU/1/01/176/ Zometa Liechtenstein EU/1/01/176/ Zometa Norge EU/1/01/176/ Zometa Island EU/1/02/221/ Pegasys Liechtenstein EU/1/03/248/ Levitra Liechtenstein EU/1/03/249/ Vivanza Liechtenstein EU/1/03/260/ Stalevo Norge EU/1/03/260/ Stalevo Liechtenstein EU/1/03/260/ Stalevo Island EU/1/03/262/ Emend Liechtenstein EU/1/03/270/ Kentera Liechtenstein EU/1/03/270/ Kentera Norge EU/1/03/270/ Kentera Island EU/1/03/271/ Advate Liechtenstein EU/1/05/322/002 Yttriga Liechtenstein EU/1/06/332/ Omnitrope Norge EU/1/06/378/017 Inovelon Liechtenstein EU/1/06/378/017 Inovelon Norge EU/1/07/392/003 Circadin Liechtenstein EU/1/07/401/016 Alli Liechtenstein EU/1/07/422/ Tasigna Liechtenstein EU/1/07/422/ Tasigna Liechtenstein EU/1/08/442/ Pradaxa Island EU/1/08/442/ Pradaxa Liechtenstein EU/1/08/442/ Pradaxa Norge EU/1/08/468/002 Intelence Liechtenstein EU/1/08/468/002 Intelence Norge EU/1/08/470/ Vimpat Island EU/1/08/472/ Xarelto Liechtenstein EU/1/08/472/ Xarelto Island EU/1/09/508/011 Synflorix Liechtenstein EU/1/09/531/ Instanyl Liechtenstein EU/1/09/531/ Instanyl Norge

12 Nr. 57/10 EØS-tillegget til Den europeiske unions tidende EU/1/09/531/ Instanyl Island EU/1/09/564/003 Ilaris Liechtenstein EU/1/09/564/003 Ilaris Island EU/1/09/564/003 Ilaris Norge EU/1/09/610/ Telmisartan Teva Liechtenstein EU/1/10/614/003 Menveo Liechtenstein EU/1/10/636/ Daxas Liechtenstein EU/1/10/646/ VPRIV Liechtenstein EU/1/10/647/ Myclausen Norge EU/1/10/647/ Myclausen Island EU/1/95/003/ Betaferon Liechtenstein EU/1/97/055/ Viramune Norge EU/1/97/055/ Viramune Island EU/1/98/090/ Micardis Liechtenstein EU/1/99/119/ NovoRapid Liechtenstein EU/1/99/126/022 Enbrel Island EU/2/08/090/ Loxicom Norge EU/2/08/090/ Loxicom Island EU/2/08/090/ Loxicom Norge

13 EØS-tillegget til Den europeiske unions tidende Nr. 57/11 VEDLEGG IV Liste over tilbakekalte markedsføringstillatelser Følgende markedsføringstillatelser er tilbakekalt i EØS-EFTA-statene i tidsrommet 1. juli 31. desember 2011: Tilbakekallingsdato EU/1/02/225/ Xigris Liechtenstein EU/1/03/259/ Onsenal Norge EU/1/05/313/ Ablavar Liechtenstein EU/1/05/313/ Ablavar Norge EU/1/05/313/ Ablavar Island EU/1/08/470/ Vimpat Island EU/1/08/478/001 Prepandemic influenza vaccine (H5N1) Liechtenstein EU/1/08/478/001 Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals Island EU/1/09/547/ Clopidogrel Sandoz Norge EU/1/09/547/ Clopidogrel Sandoz Island EU/1/10/629/001 Humenza Norge EU/2/06/063/ Yarvitan Norge EU/2/06/063/ Yarvitan Island EU/1/06/349/ Avaglim Norge VEDLEGG V Liste over suspenderte markedsføringstillatelser Følgende markedsføringstillatelser er suspendert i EØS-EFTA-statene i tidsrommet 1. juli 31. desember 2011: Suspensjonsdato EU/1/06/361/ Luminity Liechtenstein EU/2/08/088/ Acticam Island

14 Nr. 57/12 EØS-tillegget til Den europeiske unions tidende UNDERKOMITÉ I FOR FRITT VAREBYTTE 2014/EØS/57/02 LEGEMIDLER LISTE OVER MARKEDSFØRINGSTILLATELSER GITT AV EØS-EFTA-STATENE I FØRSTE HALVÅR 2012 Til underretning for EØS-komiteen Under henvisning til EØS-komiteens beslutning nr. 74/1999 av 28. mai 1999 bes EØS-komiteen, på sitt møte 15. juli 2013, ta til underretning følgende lister over markeds førings tillatelser for legemidler for tidsrommet 1. januar 30. juni 2012: VEDLEGG I VEDLEGG II VEDLEGG III VEDLEGG IV VEDLEGG V Liste over nye markedsføringstillatelser Liste over fornyede markedsføringstillatelser Liste over utvidede markedsføringstillatelser Liste over tilbakekalte markedsføringstillatelser Liste over suspenderte markedsføringstillatelser

15 EØS-tillegget til Den europeiske unions tidende Nr. 57/13 VEDLEGG I Liste over nye markedsføringstillatelser Følgende markedsføringstillatelser er tildelt i EØS-EFTA-statene i tidsrommet 1. januar 30. juni 2012: EU/1/11/711/ Matever Norge EU/1/11/712/ Levetiracetam Accord Norge EU/1/11/713/ Levetiracetam Actavis Norge EU/1/11/715/ Plenadren Island EU/1/11/721/ Paglitaz Norge EU/1/11/721/ Paglitaz Island EU/1/11/722/ Pioglitazone Accord Norge EU/1/11/722/ Pioglitazon Accord Liechtenstein EU/1/11/722/ Pioglitazone Accord Island EU/1/11/723/ Pioglitazone Krka Norge EU/1/11/723/ Pioglitazone Krka Island EU/1/11/727/001 Mercatopurine Nova lab. Norge EU/1/11/727/001 Mercaptopurine Nova Laboratories Island EU/1/11/727/001 Mercatopurine Nova Laboratories Liechtenstein EU/1/11/729/ Onduarp Norge EU/1/11/730/ Rasitrio Island EU/1/11/738/ Levetiracetam Actavis Gr. Norge EU/1/11/739/ Dasselta Norge EU/1/11/740/001 Ameluz Island EU/1/11/740/001 Ameluz Norge EU/1/11/741/001 Levetiracetam SUN Norge EU/1/11/741/001 Levetiracetam Sun Island EU/1/11/742/ Efavirenz Teva Norge EU/1/11/742/ Efavirenz Teva Island EU/1/11/742/ Efavirenz Teva Liechtenstein EU/1/11/743/ Repaglinide Accord Norge EU/1/11/743/ Repaglinide Accord Island EU/1/11/743/ Repaglinide Accord Liechtenstein EU/1/11/744/ Topotecan Eagle Island EU/1/11/744/ Topotecan Eagle Liechtenstein EU/1/11/745/ Desloratadine Actavis Island EU/1/11/745/ Desloratadine Actavis Norge EU/1/11/746/ Desloratadine ratiopharm Norge EU/1/11/746/ Desloratadine ratiopharm Island EU/1/11/746/ Desloratadine ratiopharm Liechtenstein EU/1/11/747/001 Colobreathe Island

16 Nr. 57/14 EØS-tillegget til Den europeiske unions tidende EU/1/11/747/001 Colobreathe Liechtenstein EU/1/11/748/ Docetaxel Mylan Island EU/1/11/748/ Docetaxel Mylan Liechtenstein EU/1/11/749/ Caprelsa Liechtenstein EU/1/11/749/ Caprelsa Island EU/1/11/749/ Caprelsa Norge EU/1/12/750/001 Esmya Norge EU/1/12/750/001 Esmya Island EU/1/12/750/001 Esmya Liechtenstein EU/1/12/751/001 Zelboraf Norge EU/1/12/751/001 Zelboraf Island EU/1/12/751/001 Zelboraf Liechtenstein EU/1/12/752/001 Vepacel Norge EU/1/12/752/001 Vepacel Island EU/1/12/752/001 Vepacel Liechtenstein EU/1/12/753/ Signifor Norge EU/1/12/753/ Signifor Island EU/1/12/753/ Signifor Liechtenstein EU/1/12/754/ Sepioglin Norge EU/1/12/754/ Sepioglin Island EU/1/12/754/ Sepioglin Liechtenstein EU/1/12/755/ Pioglitazone Actavis Norge EU/1/12/755/ Pioglitazone Actavis Island EU/1/12/756/ Glidipion (ex Ogliton) Norge EU/1/12/756/ Pioglitazone Actavis Group Island EU/1/12/756/ Pioglitazone Actavis Group Liechtenstein EU/1/12/757/ Pioglitazone Teva Norge EU/1/12/757/ Pioglitazone Teva Island EU/1/12/758/ Pioglitazone Teva Pharma Norge EU/1/12/758/ Pioglitazone Teva Pharma Island EU/1/12/759/ Zoledronic acid Actavis Norge EU/1/12/759/ Zoledronic acid Actavis Island EU/1/12/759/ Zoledronsäure Actavis Liechtenstein EU/1/12/760/ Bronchitol Norge EU/1/12/760/ Bronchitol Island EU/1/12/761/ Capecitabine Teva Norge EU/1/12/761/ Capecitabine Teva Island EU/1/12/761/ Capecitabin Teva Liechtenstein EU/1/12/762/ Capecitabine Accord Island

17 EØS-tillegget til Den europeiske unions tidende Nr. 57/15 EU/1/12/762/ Capecitabin Accord Liechtenstein EU/1/12/763/ Capecitabine Krka Island EU/1/12/763/ Capecitabin Krka Liechtenstein EU/1/12/763/ Capecitabine Krka Norge EU/1/12/764/001 Pixuvri Norge EU/1/12/764/001 Pixuvri Island EU/1/12/764/001 Pixuvri Liechtenstein EU/1/12/765/ Sabervel Island EU/1/12/765/ Sabervel Norge EU/1/12/765/ Sabervel Liechtenstein EU/1/12/766/001 Sancuso Norge EU/1/12/766/001 Sancuso Island EU/1/12/766/001 Sancuso Liechtenstein EU/1/12/767/ Nimenrix Norge EU/1/12/767/ Nimenrix Island EU/1/12/768/001 Riluzole Zentiva Island EU/1/12/768/001 Riluzol Zentiva Liechtenstein EU/1/12/769/ Docetaxel Accord Island EU/1/12/769/ Docetaxel Accord Liechtenstein EU/1/12/770/ Docetaxel Kabi Norge EU/1/12/770/ Docetaxel Kabi Island EU/1/12/770/ Docetaxel Kabi Liechtenstein EU/2/11/134/ Inflacam Norge EU/2/11/135/ Panacur AquaSol Norge EU/2/11/136/001 Truscient Norge EU/2/11/136/001 TruScient Island EU/2/11/137/ Activyl Tick Plus Norge EU/2/11/137/ Activyl Tick Plus Island EU/2/11/137/ Activyl Tick Plus Liechtenstein EU/2/12/138/ RevitaCAM Island EU/2/12/139/ Zulvac 1+8 Bovis Norge EU/2/12/139/ Zulvac 1+8 Bovis Island EU/2/12/139/ Zulvac 1+8 Bovis Liechtenstein

18 Nr. 57/16 EØS-tillegget til Den europeiske unions tidende VEDLEGG II Liste over fornyede markedsføringstillatelser Følgende markedsføringstillatelser er fornyet i EØS-EFTA-statene i tidsrommet 1. januar 30. juni 2012: EU/1/01/197/ Foscan Island EU/1/01/200/ Viread Norge EU/1/01/200/ Viread Island EU/1/02/209/ Dynastat Norge EU/1/02/209/ Dynastat Island EU/1/02/209/ Dynastat Liechtenstein EU/1/02/212/ Vfend Norge EU/1/02/212/ Vfend Island EU/1/02/212/ Vfend Liechtenstein EU/1/02/216/ Invanz Norge EU/1/02/216/ Invanz Island EU/1/02/216/ Invanz Liechtenstein EU/1/02/220/ Tracleer Norge EU/1/02/220/ Tracleer Island EU/1/02/220/ Tracleer Liechtenstein EU/1/02/222/ Tamiflu Norge EU/1/02/222/ Tamiflu Island EU/1/02/222/ Tamiflu Liechtenstein EU/1/06/334/ Evoltra Liechtenstein EU/1/06/347/ Sutent Liechtenstein EU/1/06/366/ Tandemact Norge EU/1/06/366/ Tandemact Island EU/1/06/366/ Tandemact Liechtenstein EU/1/06/367/ Diacomit Norge EU/1/06/367/ Diacomit Island EU/1/06/367/ Diacomit Liechtenstein EU/1/06/370/ Exforge Norge EU/1/06/370/ EXFORGE Island EU/1/06/371/ Dafiro Island EU/1/06/371/ Dafiro Liechtenstein EU/1/06/372/ Copalia Norge EU/1/06/373/ Imprida Norge EU/1/06/373/ Imprida Island EU/1/06/374/001 Lucentis Norge EU/1/06/374/001 Lucentis Island EU/1/06/376/ Irbesartan Zentiva (ex-winthrop) Norge

19 EØS-tillegget til Den europeiske unions tidende Nr. 57/17 EU/1/06/376/ Irbesartan Zentiva Island EU/1/06/376/ Irbesartan Winthrop Liechtenstein EU/1/06/377/ Irbesartan HCT Zentiva (ex-winthrop) Norge EU/1/06/377/ Irbesartan HCT Zentiva Island EU/1/06/377/ Irbesartan HCT Liechtenstein EU/1/06/378/ Inovelon Norge EU/1/06/378/ Inovelon Island EU/1/06/378/ Inovelon Liechtenstein EU/1/06/379/001 Cystadane Island EU/1/06/379/001 Cystadane Liechtenstein EU/1/06/386/ , , , , , ,088102, , Insulin Human Winthrop Norge EU/1/07/382/ Xelevia Norge EU/1/07/382/ Xelevia Island EU/1/07/382/ Xelevia Liechtenstein EU/1/07/383/ Januvia Norge EU/1/07/383/ Januvia Island EU/1/07/383/ Januvia Liechtenstein EU/1/07/384/ Docetaxel Winthrop Norge EU/1/07/384/ Docetaxel Winthrop Island EU/1/07/384/ Docetaxel Winthrop Liechtenstein EU/1/07/386/ Toviaz Norge EU/1/07/386/ Toviaz Island EU/1/07/386/ Toviaz Liechtenstein EU/1/07/387/ Advagraf Norge EU/1/07/387/ Advagraf Island EU/1/07/387/ Advagraf Liechtenstein EU/1/07/388/ Sebivo Norge EU/1/07/388/ Sebivo Island EU/1/07/388/ Sebivo Liechtenstein EU/1/07/389/ Orencia Norge EU/1/07/389/ Orencia Island EU/1/07/389/ Orencia Liechtenstein EU/1/07/390/ Altargo Norge EU/1/07/390/ Altargo Island EU/1/07/390/ Altargo Liechtenstein EU/1/07/391/ Revlimid Norge EU/1/07/391/ Revlimid Island EU/1/07/391/ Revlimid Liechtenstein

20 Nr. 57/18 EØS-tillegget til Den europeiske unions tidende EU/1/07/392/ Circadin Norge EU/1/07/392/ Circadin Island EU/1/07/392/ Circadin Liechtenstein EU/1/07/394/ Optaflu Norge EU/1/07/395/ Invega Liechtenstein EU/1/07/396/ Pergoveris Island EU/1/07/396/ Pergoveris Liechtenstein EU/1/07/398/ Optimark Norge EU/1/07/399/ Aerinaze Norge EU/1/07/399/ Aerinaze Liechtenstein EU/1/07/399/ Aerinaze Island EU/1/07/400/ , Mircera Island EU/1/07/400/ , Mircera Norge EU/1/07/400/ Mircera Liechtenstein EU/1/07/401/ alli Norge EU/1/07/412/ Abseamed Liechtenstein EU/1/07/423/ Vectibix Norge EU/1/07/423/ Vectibix Island EU/1/07/440/ Tyverb Liechtenstein EU/1/07/440/ Tyverb Norge EU/1/07/440/ Tyverb Island EU/1/10/625/001&003 Arzerra Island EU/1/10/625/001&003 Arzerra Norge EU/1/10/628/ Votrient Norge EU/1/10/628/ Votrient Island EU/1/11/699/ Fampyra Norge EU/1/11/699/ Fampyra Island EU/1/11/699/ Fampyra Liechtenstein EU/2/05/053/ Naxcel Norge EU/2/06/068/ Ypozane Norge EU/2/06/068/ Ypozane Island EU/2/06/068/ Ypozane Liechtenstein EU/2/06/070/ Meloxidyl Island EU/2/07/071/ SLENTROL Island EU/2/07/071/ Slentrol Liechtenstein EU/2/07/072/ Suprelorin Island EU/2/07/074/ Prilactone Island EU/2/07/075/ Circovac Liechtenstein EU/2/07/075/ Circovac Island

21 EØS-tillegget til Den europeiske unions tidende Nr. 57/19 VEDLEGG III Liste over utvidede markedsføringstillatelser Følgende markedsføringstillatelser er utvidet i EØS-EFTA-statene i tidsrommet 1. januar 30. juni 2012: EU/1/00/141/002 Myocet Liechtenstein EU/1/02/222/05 Tamiflu Island EU/1/03/262/ Emend Norge EU/1/03/262/ Emend Island EU/1/03/271/ Advate Norge EU/1/03/271/ Advate Island EU/1/05/318/003 Revatio Norge EU/1/05/318/003 Revatio Island EU/1/05/318/003 Revatio Liechtenstein EU/1/06/339/003 Preotact Liechtenstein EU/1/08/465/021 Clopidogrel Zentiva Liechtenstein EU/1/08/468/002 INTELENCE Island EU/1/08/470/ Vimpat Norge EU/1/08/470/ Vimpat Island EU/1/08/470/ Vimpat Liechtenstein EU/1/08/472/ Xarelto Norge EU/1/08/475/ Olanzapin Mylan Liechtenstein EU/1/09/536/ Topotecan Actavis Liechtenstein EU/1/09/551/ Vizarsin Island EU/1/09/551/ Vizarsin Liechtenstein EU/1/09/571/002 Pandemic influenza vaccine H5N1 Baxter Liechtenstein EU/1/11/667/004 Esbriet Liechtenstein EU/1/11/699/ Fampyra Liechtenstein EU/1/11/701/ Levetiracetam Teva Liechtenstein EU/1/11/703/003 Xgeva Liechtenstein EU/1/11/704/002 Victrelis Liechtenstein EU/1/11/720/002 Incivo Liechtenstein EU/1/97/044/009 Tasmar Liechtenstein EU/2/07/078/ Rheumocam Norge EU/2/07/078/ Rheumocam Island EU/2/07/078/ Rheumocam Liechtenstein EU/2/08/085/ Easotic Liechtenstein EU/2/08/090/027 Loxicom Liechtenstein EU/2/10/114/003 Hiprabovis IBR Marker Live Liechtenstein EU/2/97/004/049 Metacam Liechtenstein

22 Nr. 57/20 EØS-tillegget til Den europeiske unions tidende VEDLEGG IV Liste over tilbakekalte markedsføringstillatelser Følgende markedsføringstillatelser er tilbakekalt i EØS-EFTA-statene i tidsrommet 1. januar 30. juni 2012: Tilbakekallingsdato EU/1/02/255/ Xigris Island EU/1/04/272/ PhotoBarr Norge EU/1/04/272/ Photobarr Island EU/1/04/272/ PhotoBarr Liechtenstein EU/1/06/335/001 Valtropin Island EU/1/06/335/001 Valtropin Liechtenstein EU/1/06/351/ Livensa Island EU/1/06/351/ Livensa Liechtenstein EU/1/06/352/ Intrinsa Liechtenstein EU/1/06/352/ Intrinsa Island EU/1/09/534/ Clopidogrel Hexal Island EU/1/09/534/ Clopidgrel Hexal Liechtenstein EU/1/09/548/ Clopidogrel Acino Pharma GmbH Island EU/1/09/548/ Clopidgrel Acino Pharma GmbH Liechtenstein EU/1/09/549/ Clopidogrel Acino Pharma Island EU/1/09/549/ Clopidogrel Acino Pharma Liechtenstein EU/1/10/630/ Docefrez Island EU/1/10/630/ Docefrez Liechtenstein EU/1/97/035/ Refludan Island EU/1/97/035/ Refludan Norge EU/1/97/035/ Refludan Liechtenstein EU/2/00/028/ Zubrin Island EU/2/00/028/ Zubrin Liechtenstein EU/2/03/040/ Gonazon Norge EU/2/03/040/ Gonazon Island EU/2/03/040/ Gonazon Liechtenstein EU/2/06/060/ Poulvac FluFend H5N3 RG Liechtenstein

23 EØS-tillegget til Den europeiske unions tidende Nr. 57/21 VEDLEGG V Liste over suspenderte markedsføringstillatelser Følgende markedsføringstillatelser er suspendert i EØS-EFTA-statene i tidsrommet 1. januar 30. juni 2012: Suspensjonsdato EU/1/06/361/ Luminity Island EU/1/06/361/ Luminity Liechtenstein EU/1/97/037/001 Vistide Liechtenstein EU/1/11/705/001 Vibativ Island

24 Nr. 57/22 EØS-tillegget til Den europeiske unions tidende UNDERKOMITÉ I FOR FRITT VAREBYTTE 2014/EØS/57/03 LEGEMIDLER LISTE OVER MARKEDSFØRINGSTILLATELSER GITT AV EØS-EFTA-STATENE I ANDRE HALVÅR 2012 Til underretning for EØS-komiteen Under henvisning til EØS-komiteens beslutning nr. 74/1999 av 28. mai 1999 bes EØS-komiteen, på sitt møte 8. november 2013, ta til underretning de følgende lister over markeds førings tillatelser for legemidler for tidsrommet 1. juli 31. desember 2012: VEDLEGG I VEDLEGG II VEDLEGG III VEDLEGG IV VEDLEGG V Liste over nye markedsføringstillatelser Liste over fornyede markedsføringstillatelser Liste over utvidede markedsføringstillatelser Liste over tilbakekalte markedsføringstillatelser Liste over suspenderte markedsføringstillatelser

25 EØS-tillegget til Den europeiske unions tidende Nr. 57/23 VEDLEGG I Liste over nye markedsføringstillatelser Følgende markedsføringstillatelser er tildelt i EØS-EFTA-statene i tidsrommet 1. juli 31. desember 2012: EU/1/11/685/ Ibandronic acid Sandoz Norge EU/1/11/719/ Telmisartan Teva Pharma Liechtenstein EU/1/11/744/ Topotecan Eagle Norge EU/1/11/747/001 Colobreathe Norge EU/1/11/748/ Docetaxel Mylan Norge EU/1/12/762/ Capecitabine Accord Norge EU/1/12/768/001 Riluzole Zentiva Norge EU/1/12/769/ Docetaxel Accord Norge EU/1/12/771/ Zoledronic Acid Teva Island EU/1/12/771/ Zoledronic acid Teva Norge EU/1/12/772/ Zoledronic acid Teva Pharma Island EU/1/12/772/ Zoledronic acid Teva Pharma Norge EU/1/12/773/ Jakavi Liechtenstein EU/1/12/773/ Jakavi Norge EU/1/12/773/ Jakavi Island EU/1/12/774/ Rienso Norge EU/1/12/774/ Rienso Island EU/1/12/774/ Rienso Liechtenstein EU/1/12/775/001 NovoThirteen Island EU/1/12/775/001 Novo Thirteen Norge EU/1/12/775/001 Novo Thirteen Liechtenstein EU/1/12/776/ Fycompa Norge EU/1/12/776/ Fycompa Liechtenstein EU/1/12/776/ Fycompa Island EU/1/12/777/ Inlyta Island EU/1/12/777/ Inlyta Norge EU/1/12/777/ Inlyta Liechtenstein EU/1/12/778/ Eklira Genuair Island EU/1/12/778/ Eklira Genuair Norge EU/1/12/778/ Eklira Genuair Liechtenstein EU/1/12/779/ Zoledronic acid medac Norge EU/1/12/779/ Zoledronic acid medac Island EU/1/12/779/ Zoledronic acid medac Liechtenstein EU/1/12/780/ Jentadueto Norge EU/1/12/780/ Jentadueto Liechtenstein EU/1/12/780/ Jentadueto Island

26 Nr. 57/24 EØS-tillegget til Den europeiske unions tidende EU/1/12/781/ Bretaris Genuair Island EU/1/12/781/ Bretaris Genuair Norge EU/1/12/781/ Bretaris Genuair Liechtenstein EU/1/12/782/ Kalydeco Norge EU/1/12/782/ Kalydeco Island EU/1/12/782/ Kalydeco Liechtenstein EU/1/12/783/ Zyclara Liechtenstein EU/1/12/783/ Zyclara Island EU/1/12/783/ Zyclara Norge EU/1/12/784/001 Cuprymina Island EU/1/12/784/001 Cuprymina Norge EU/1/12/784/001 Cuprymina Liechtenstein EU/1/12/785/001 Zinforo Liechtenstein EU/1/12/785/001 Zinforo Island EU/1/12/785/001 Zinforo Norge EU/1/12/786/ Zoledronic acid Mylan Liechtenstein EU/1/12/786/ Zoledronic acid Mylan Island EU/1/12/786/ Zoledronic acid Mylan Norge EU/1/12/787/001 Revestive Island EU/1/12/787/001 Revestive Norge EU/1/12/787/001 Revestive Liechtenstein EU/1/12/788/ Seebri Breezhaler Island EU/1/12/788/ Seebri Breezhaler Norge EU/1/12/789/ Enurev Breezhaler Island EU/1/12/789/ Enurev Breezhaler Norge EU/1/12/790/ Tovanor Breezhaler Island EU/1/12/790/ Tovanor Breezhaler Norge EU/1/12/791/001 Glybera Island EU/1/12/791/001 Glybera Norge EU/1/12/792/001 Dacogen Island EU/1/12/792/001 Dacogen Norge EU/1/12/792/001 Dacogen Liechtenstein EU/1/12/793/ Xalkori Island EU/1/12/793/ Xalkori Norge EU/1/12/793/ Xalkori Liechtenstein EU/1/12/794/001 Adcetris Norge EU/1/12/794/001 Adectris Liechtenstein EU/1/12/795/ Forxiga Norge EU/1/12/795/ Forxiga Island

27 EØS-tillegget til Den europeiske unions tidende Nr. 57/25 EU/1/12/796/ Picato Norge EU/1/12/796/ Picato Island EU/1/12/796/ Picato Liechtenstein EU/1/12/797/ Eylea Norge EU/1/12/797/ Eylea Island EU/1/12/798/ Ibandronic acid Accord Norge EU/1/12/798/ Ibandronic acid Accord Island EU/1/12/798/ Ibandronic acid Accord Liechtenstein EU/1/12/799/ Memantine Merz Island EU/1/12/799/ Memantine Merz Liechtenstein EU/1/12/800/ Zoledronic Acid Hospira Island EU/1/12/800/ Zoledronic acid Hospira Norge EU/1/12/800/ Zoledronic acid Hospira Liechtenstein EU/1/12/801/ Constella Island EU/1/12/801/ Constella Liechtenstein EU/1/12/801/ Constella Norge EU/1/12/802/ Capecitabine medac Norge EU/1/12/802/ Capecitabine medac Island EU/1/12/802/ Capecitabine medac Liechtenstein EU/2/09/099/ Suvaxyn PCV Island EU/2/11/122/ Bluevac BTV8 Norge EU/2/12/138/ RevitaCAM Norge EU/2/12/140/ Poulvac E. Coli Island EU/2/12/141/ Porcilis ColiClos Island EU/2/12/141/ Porcilis ColiClos Norge EU/2/12/141/ Porcilis ColiClos Liechtenstein EU/2/12/142/ Cardalis 2,5/20 mg Island EU/2/12/143/ Nobivac L4 Island EU/2/12/143/ NobivacL4 Norge EU/2/12/143/ Nobivac L4 Liechtenstein

28 Nr. 57/26 EØS-tillegget til Den europeiske unions tidende VEDLEGG II Liste over fornyede markedsføringstillatelser Følgende markedsføringstillatelser er fornyet i EØS-EFTA-statene i tidsrommet 1. juli 31. desember 2012: EU/1/01/187/001 DepoCyte Norge EU/1/01/197/ Foscan Norge EU/1/02/222/ Tamiflu Norge EU/1/02/223/ Evra Island EU/1/02/223/ Evra Norge EU/1/02/223/ Evra Liechtenstein EU/1/02/224/ Ambirix Island EU/1/02/224/ Ambirix Norge EU/1/02/224/ Ambirix Liechtenstein EU/1/02/226/001 InductOs Norge EU/1/02/226/001 InductOs Island EU/1/02/237/ Cialis Norge EU/1/02/237/ Cialis Island EU/1/02/237/ Cialis Liechtenstein EU/1/02/238/001 Zavesca Island EU/1/02/238/001 Zavesca Norge EU/1/02/238/001 Zavesca Liechtenstein EU/1/05/314/001 Kepivance Norge EU/1/06/339/ Preotact Norge EU/1/06/367/ Diacomit Norge EU/1/06/367/ Diacomit Island EU/1/06/367/ Diacomit Liechtenstein EU/1/06/371/ Dafiro Norge EU/1/06/376/ Irbesartan Zentiva Island EU/1/07/393/001 Soliris Island EU/1/07/393/001 Soliris Norge EU/1/07/394/ Optaflu Island EU/1/07/395/ Invega Island EU/1/07/395/ Invega Norge EU/1/07/397/ Siklos Island EU/1/07/397/ Siklos Norge EU/1/07/398/ Optimark Island EU/1/07/398/ Optimark Liechtenstein EU/1/07/401/ alli Island EU/1/07/401/ alli Liechtenstein

29 EØS-tillegget til Den europeiske unions tidende Nr. 57/27 EU/1/07/402/001 Increlex Island EU/1/07/402/001 Increlex Liechtenstein EU/1/07/402/001 Increlex Norge EU/1/07/403/001 Atriance Island EU/1/07/403/001 Atriance Norge EU/1/07/403/001 Atriance Liechtenstein EU/1/07/404/ Flebogamma DIF Island EU/1/07/404/ Flebogamma DIF Norge EU/1/07/405/ Rasilez Liechtenstein EU/1/07/405/ Rasilez Island EU/1/07/405/ Rasilez Norge EU/1/07/409/ Riprazo Island EU/1/07/409/ Riprazo Norge EU/1/07/409/ Riprazo Liechtenstein EU/1/07/410/ Binocrit Norge EU/1/07/410/ Binocrit Island EU/1/07/410/ Binocrit Liechtenstein EU/1/07/411/ Epoetin alfa Hexal Island EU/1/07/411/ Epoetin alfa Hexal Norge EU/1/07/411/ Epoetin alfa Hexal Liechtenstein EU/1/07/412/ Abseamed Island EU/1/07/412/ Abseamed Norge EU/1/07/413/ Gliolan Island EU/1/07/413/ Gliolan Norge EU/1/07/413/ Gliolan Liechtenstein EU/1/07/414/ , 018 Galvus Island EU/1/07/414/ , 018 Galvus Norge EU/1/07/415/ Zalasta Norge EU/1/07/415/ Zalasta Island EU/1/07/415/ Zalasta Liechtenstein EU/1/07/416/002 Ecalta Island EU/1/07/416/002 Ecalta Liechtenstein EU/1/07/416/002 Ecalta Norge EU/1/07/417/ Yondelis Island EU/1/07/417/ Yondelis Liechtenstein EU/1/07/417/ Yondelis Norge EU/1/07/418/ Celsentri Liechtenstein EU/1/07/418/ Celsentri Island EU/1/07/418/ Celsentri Norge

30 Nr. 57/28 EØS-tillegget til Den europeiske unions tidende EU/1/07/419/ Cervarix Island EU/1/07/419/ Cervarix Norge EU/1/07/419/ Cervarix Liechtenstein EU/1/07/420/ Cyanokit Island EU/1/07/420/ Cyanokit Norge EU/1/07/420/ Cyanokit Liechtenstein EU/1/07/421/ Glubrava Island EU/1/07/421/ Glubrava Norge EU/1/07/421/ Glubrava Liechtenstein EU/1/07/422/ Tasigna Norge EU/1/07/422/ Tasigna Liechtenstein EU/1/07/422/ Tasigna Island EU/1/07/424/001 Torisel Island EU/1/07/424/001 Torisel Norge EU/1/07/424/001 Torisel Liechtenstein EU/1/07/425/ Eucreas Norge EU/1/07/425/ Eucreas Island EU/1/07/425/ Eucreas Liechtenstein EU/1/07/426/ Olanzapine Neopharma Island EU/1/07/426/ Olanzapine Neopharma Norge EU/1/07/426/ Olanzapine Neopharma Liechtenstein EU/1/07/427/ Olanzapine Teva Norge EU/1/07/427/ Olanzapine Teva Island EU/1/07/427/ Olanzapine Teva Liechtenstein EU/1/07/430/ Atripla Norge EU/1/07/430/ Atripla Island EU/1/07/431/ Retacrit Island EU/1/07/431/ Retacrit Norge EU/1/07/431/ Retacrit Liechtenstein EU/1/07/432/ Silapo Island EU/1/07/432/ Silapo Norge EU/1/07/432/ Silapo Liechtenstein EU/1/07/433/001 Nevanac Norge EU/1/07/433/001 Nevanac Liechtenstein EU/1/07/435/ Tesavel Island EU/1/07/435/ Tesavel Norge EU/1/07/437/ IVEMEND Island EU/1/07/437/ IVEMEND Norge EU/1/07/437/ IVEMEND Liechtenstein

31 EØS-tillegget til Den europeiske unions tidende Nr. 57/29 EU/1/07/438/ Myfenax Island EU/1/07/438/006 Myfenax Norge EU/1/07/439/ Mycophenolate mofetil Teva Island EU/1/07/439/ Mycophenolate mofetil Teva Norge EU/1/08/468/ INTELENCE Island EU/1/08/468/ INTELENCE Norge EU/1/08/468/ INTELENCE Liechtenstein EU/1/11/710/ Votubia Norge EU/1/11/710/ Votubia Island EU/1/11/710/ Votubia Liechtenstein EU/1/97/047/ BeneFIX Island EU/1/97/047/ BeneFIX Norge EU/1/97/047/ BeneFIX Liechtenstein EU/2/02/032/ Vaxxitek HVT + IBD Island EU/2/02/032/ Vaxxitek HVT + IBD Liechtenstein EU/2/02/034/001 Nobivac Bb Island EU/2/02/034/001 Nobivac Bb Norge EU/2/02/034/001 Nobivac Bb Liechtenstein EU/2/07/072/ Suprelorin Norge EU/2/07/072/ Suprelorin Liechtenstein EU/2/07/074/ Prilactone Liechtenstein EU/2/07/077/ Meloxivet Island EU/2/07/077/ Meloxivet Liechtenstein