# Uradni list C 229/24.

| | ISSN 1977-1045 |
| --- | --- |
| Uradni list
  Evropske unije | C 229 |
| | |
| Slovenska izdaja | Informacije in objave | Zvezek 5924. junij 2016 |

ISSN 1977-1045

Uradni list

Evropske unije

C 229

Slovenska izdaja

Informacije in objave

Zvezek 5924. junij 2016

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| Obvestilo št. | Vsebina | Stran |
| --- | --- | --- |
| | IV   Informacije |
| | INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
| | Evropska komisija |
| 2016/C 229/01 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. maja 2016 do 31. maja 2016(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta) | 1 |

Obvestilo št.

Vsebina

Stran

IV   Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

2016/C 229/01

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. maja 2016 do 31. maja 2016(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

1

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| SL | |
| --- | --- |

SL

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IV Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

| 24.6.2016 | SL | Uradni list Evropske unije | C 229/1 |
| --- | --- | --- | --- |

24.6.2016

SL

Uradni list Evropske unije

C 229/1

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Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. maja 2016 do 31. maja 2016

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (1))

(2016/C 229/01)

—   Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.5.2016 | Empliciti | elotuzumab | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/16/1088 | Prašek za koncentrat za raztopino za infundiranje | L01XC23 | 13.5.2016 |
| 11.5.2016 | IDELVION | albutrepenonakog alfa | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/16/1095 | Prašek in vehikel za raztopino za injiciranje | B02BD04 | 13.5.2016 |
| 12.5.2016 | ALPROLIX | eftrenonakog alfa (eftrenonacogum alfa) | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1098 | Prašek in vehikel za raztopino za injiciranje | B02BD04 | 13.5.2016 |
| 12.5.2016 | Uptravi | seleksipag | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/15/1083 | Filmsko obložene tablete | B01AC27 | 19.5.2016 |
| 20.5.2016 | Cepivo proti pandemski gripi H5N1 MedImmune | cepivo proti pandemski gripi (H5N1) (živo, oslabljeno, nazalno) | MedImmune, LLC
  Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland | EU/1/16/1089 | Pršilo za nos, suspenzija | J07BB03 | 24.5.2016 |
| 20.5.2016 | Darzalex | Daratumumab | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/16/1101 | Koncentrat za raztopino za infundiranje | L01XC24 | 24.5.2016 |
| 26.5.2016 | Galafold | migalastat | Amicus Therapeutics UK Ltd
  Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom | EU/1/15/1082 | Kapsula, trda | Pending | 31.5.2016 |
| 26.5.2016 | Neparvis | sakubitril/valsartan | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/16/1103 | Filmsko obložene tablete | C09DX04 | 30.5.2016 |
| 26.5.2016 | Palonosetron Accord | palonosetron | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/16/1104 | Rztopina za injiciranje | A04AA05 | 31.5.2016 |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

11.5.2016

Empliciti

elotuzumab

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/16/1088

Prašek za koncentrat za raztopino za infundiranje

L01XC23

13.5.2016

11.5.2016

IDELVION

albutrepenonakog alfa

CSL Behring GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/16/1095

Prašek in vehikel za raztopino za injiciranje

B02BD04

13.5.2016

12.5.2016

ALPROLIX

eftrenonakog alfa (eftrenonacogum alfa)

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/16/1098

Prašek in vehikel za raztopino za injiciranje

B02BD04

13.5.2016

12.5.2016

Uptravi

seleksipag

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/15/1083

Filmsko obložene tablete

B01AC27

19.5.2016

20.5.2016

Cepivo proti pandemski gripi H5N1 MedImmune

cepivo proti pandemski gripi (H5N1) (živo, oslabljeno, nazalno)

MedImmune, LLC

Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland

EU/1/16/1089

Pršilo za nos, suspenzija

J07BB03

24.5.2016

20.5.2016

Darzalex

Daratumumab

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/16/1101

Koncentrat za raztopino za infundiranje

L01XC24

24.5.2016

26.5.2016

Galafold

migalastat

Amicus Therapeutics UK Ltd

Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom

EU/1/15/1082

Kapsula, trda

Pending

31.5.2016

26.5.2016

Neparvis

sakubitril/valsartan

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/16/1103

Filmsko obložene tablete

C09DX04

30.5.2016

26.5.2016

Palonosetron Accord

palonosetron

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/16/1104

Rztopina za injiciranje

A04AA05

31.5.2016

—   Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 2.5.2016 | Bortezomib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1019 | 4.5.2016 |
| 2.5.2016 | Combivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/98/058 | 4.5.2016 |
| 2.5.2016 | Ebilfumin | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/14/915 | 4.5.2016 |
| 2.5.2016 | ellaOne | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/09/522 | 4.5.2016 |
| 2.5.2016 | HALAVEN | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/11/678 | 4.5.2016 |
| 2.5.2016 | Harvoni | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/958 | 4.5.2016 |
| 2.5.2016 | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, A-1030 Wien, Österreich | EU/1/08/501 | 4.5.2016 |
| 2.5.2016 | Lyxumia | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/12/811 | 4.5.2016 |
| 2.5.2016 | Norvir | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/96/016 | 4.5.2016 |
| 2.5.2016 | Quadramet | CIS bio international
  Boite Postale 32, F-91192 Gif-sur-Yvette, France | EU/1/97/057 | 4.5.2016 |
| 2.5.2016 | Synflorix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/09/508 | 4.5.2016 |
| 2.5.2016 | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 4.5.2016 |
| 11.5.2016 | Desloratadin Actavis 5 mg filmsko obložene tablete | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/11/745 | 13.5.2016 |
| 11.5.2016 | Humalog | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/96/007 | 13.5.2016 |
| 11.5.2016 | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/03/256 | 13.5.2016 |
| 11.5.2016 | Imatinib Medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/13/876 | 13.5.2016 |
| 11.5.2016 | Inlyta | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/777 | 13.5.2016 |
| 11.5.2016 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 13.5.2016 |
| 11.5.2016 | Plenadren | ViroPharma SPRL-BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/715 | 13.5.2016 |
| 11.5.2016 | Zerit | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/96/009 | 13.5.2016 |
| 12.5.2016 | Brimica Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/963 | 16.5.2016 |
| 12.5.2016 | Clopidogrel Mylan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/09/559 | 17.5.2016 |
| 12.5.2016 | Desloratadin Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/732 | 17.5.2016 |
| 12.5.2016 | Docetaxel Winthrop | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/07/384 | 17.5.2016 |
| 12.5.2016 | Enurev Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/789 | 16.5.2016 |
| 12.5.2016 | Glybera | uniQure biopharma B.V.
  Meibergdreef 61, NL-1105 BA Amsterdam, Nederland | EU/1/12/791 | 17.5.2016 |
| 12.5.2016 | Integrilin | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/99/109 | 16.5.2016 |
| 12.5.2016 | NovoEight | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/13/888 | 17.5.2016 |
| 12.5.2016 | Seebri Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/788 | 16.5.2016 |
| 12.5.2016 | Tepadina | ADIENNE S.r.l.
  Via Galileo Galilei 19, 20867 Caponago (MB), Italia | EU/1/10/622 | 16.5.2016 |
| 12.5.2016 | Tovanor Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/790 | 16.5.2016 |
| 13.5.2016 | Hexacima | Sanofi Pasteur SA
  2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/13/828 | 24.5.2016 |
| 17.5.2016 | Capecitabine SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/13/831 | 19.5.2016 |
| 17.5.2016 | Champix | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/360 | 19.5.2016 |
| 17.5.2016 | Epivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/96/015 | 19.5.2016 |
| 17.5.2016 | Imatinib Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/808 | 19.5.2016 |
| 17.5.2016 | Wilzin | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | EU/1/04/286 | 19.5.2016 |
| 20.5.2016 | Ceprotin | Baxter AG
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/01/190 | 24.5.2016 |
| 20.5.2016 | Clopidogrel Krka d.d. | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/562 | 24.5.2016 |
| 20.5.2016 | Gazyvaro | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/14/937 | 24.5.2016 |
| 20.5.2016 | Hexyon | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/13/829 | 24.5.2016 |
| 26.5.2016 | Actos | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/00/150 | 30.5.2016 |
| 26.5.2016 | Afinitor | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/538 | 30.5.2016 |
| 26.5.2016 | Buccolam | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/709 | 30.5.2016 |
| 26.5.2016 | Cayston | Gilead Sciences International Limited
  Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | EU/1/09/543 | 31.5.2016 |
| 26.5.2016 | Cinryze | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/688 | 30.5.2016 |
| 26.5.2016 | Clopidogrel HCS | HCS bvba
  H. Kennisstraat 53, B-2650 Edegem, België | EU/1/10/651 | 30.5.2016 |
| 26.5.2016 | Clopidogrel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/540 | 30.5.2016 |
| 26.5.2016 | Competact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/354 | 30.5.2016 |
| 26.5.2016 | Conbriza | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/09/511 | 31.5.2016 |
| 26.5.2016 | Constella | Allergan Pharmaceuticals International Ltd.
  Clonshaugh Business and Technology Park Coolock Dublin D17 E400, Ireland | EU/1/12/801 | 30.5.2016 |
| 26.5.2016 | DepoCyte | Pacira Limited
  Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom | EU/1/01/187 | 28.5.2016 |
| 26.5.2016 | Dexdor | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/718 | 30.5.2016 |
| 26.5.2016 | Duaklir Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/964 | 30.5.2016 |
| 26.5.2016 | Ferriprox | Apotex Europe B.V.
  Darwinweg 20, NL- 2333 CR Leiden, Nederland | EU/1/99/108 | 30.5.2016 |
| 26.5.2016 | Firazyr | Shire Orphan Therapies GmbH
  Friedrichstraße 149, D-10117 Berlin, Deutschland | EU/1/08/461 | 30.5.2016 |
| 26.5.2016 | Glubrava | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/07/421 | 30.5.2016 |
| 26.5.2016 | Glustin | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/00/151 | 30.5.2016 |
| 26.5.2016 | HyQvia | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/13/840 | 30.5.2016 |
| 26.5.2016 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/945 | 30.5.2016 |
| 26.5.2016 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 31.5.2016 |
| 26.5.2016 | Kapecitabin medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/12/802 | 30.5.2016 |
| 26.5.2016 | Klopidogrel/acetilsalicilna kislina Teva | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/942 | 30.5.2016 |
| 26.5.2016 | Levodopa/Carbidopa/Entacapone Orion | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/706 | 30.5.2016 |
| 26.5.2016 | Liprolog | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/01/195 | 30.5.2016 |
| 26.5.2016 | Mabthera | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/98/067 | 31.5.2016 |
| 26.5.2016 | Neulasta | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/02/227 | 30.5.2016 |
| 26.5.2016 | Nexium Control | Pfizer Consumer Healthcare Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/13/860 | 31.5.2016 |
| 26.5.2016 | Rixubis | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/14/970 | 30.5.2016 |
| 26.5.2016 | Strimvelis | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/16/1097 | 30.5.2016 |
| 26.5.2016 | Tandemact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/366 | 30.5.2016 |
| 26.5.2016 | Taxotere | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/95/002 | 30.5.2016 |
| 26.5.2016 | Trevicta | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/971 | 30.5.2016 |
| 26.5.2016 | Vibativ | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | EU/1/11/705 | 28.5.2016 |
| 26.5.2016 | Victoza | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/09/529 | 30.5.2016 |
| 26.5.2016 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 31.5.2016 |
| 26.5.2016 | Ytracis | CIS bio international
  Boite Postale 32, F-91192 Gif-sur-Yvette, France | EU/1/03/250 | 30.5.2016 |
| 26.5.2016 | Zytiga | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/714 | 30.5.2016 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

2.5.2016

Bortezomib Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/15/1019

4.5.2016

2.5.2016

Combivir

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/98/058

4.5.2016

2.5.2016

Ebilfumin

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/14/915

4.5.2016

2.5.2016

ellaOne

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/09/522

4.5.2016

2.5.2016

HALAVEN

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

EU/1/11/678

4.5.2016

2.5.2016

Harvoni

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/958

4.5.2016

2.5.2016

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, A-1030 Wien, Österreich

EU/1/08/501

4.5.2016

2.5.2016

Lyxumia

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/811

4.5.2016

2.5.2016

Norvir

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/96/016

4.5.2016

2.5.2016

Quadramet

CIS bio international

Boite Postale 32, F-91192 Gif-sur-Yvette, France

EU/1/97/057

4.5.2016

2.5.2016

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/508

4.5.2016

2.5.2016

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/865

4.5.2016

11.5.2016

Desloratadin Actavis 5 mg filmsko obložene tablete

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/11/745

13.5.2016

11.5.2016

Humalog

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/96/007

13.5.2016

11.5.2016

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/03/256

13.5.2016

11.5.2016

Imatinib Medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/13/876

13.5.2016

11.5.2016

Inlyta

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/12/777

13.5.2016

11.5.2016

Opdivo

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/15/1014

13.5.2016

11.5.2016

Plenadren

ViroPharma SPRL-BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België

EU/1/11/715

13.5.2016

11.5.2016

Zerit

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/96/009

13.5.2016

12.5.2016

Brimica Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/963

16.5.2016

12.5.2016

Clopidogrel Mylan

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/09/559

17.5.2016

12.5.2016

Desloratadin Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/732

17.5.2016

12.5.2016

Docetaxel Winthrop

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92165 Antony CEDEX, France

EU/1/07/384

17.5.2016

12.5.2016

Enurev Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/789

16.5.2016

12.5.2016

Glybera

uniQure biopharma B.V.

Meibergdreef 61, NL-1105 BA Amsterdam, Nederland

EU/1/12/791

17.5.2016

12.5.2016

Integrilin

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/99/109

16.5.2016

12.5.2016

NovoEight

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/13/888

17.5.2016

12.5.2016

Seebri Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/788

16.5.2016

12.5.2016

Tepadina

ADIENNE S.r.l.

Via Galileo Galilei 19, 20867 Caponago (MB), Italia

EU/1/10/622

16.5.2016

12.5.2016

Tovanor Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/790

16.5.2016

13.5.2016

Hexacima

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/13/828

24.5.2016

17.5.2016

Capecitabine SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/13/831

19.5.2016

17.5.2016

Champix

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/06/360

19.5.2016

17.5.2016

Epivir

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/96/015

19.5.2016

17.5.2016

Imatinib Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/808

19.5.2016

17.5.2016

Wilzin

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France

EU/1/04/286

19.5.2016

20.5.2016

Ceprotin

Baxter AG

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/01/190

24.5.2016

20.5.2016

Clopidogrel Krka d.d.

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

24.5.2016

20.5.2016

Gazyvaro

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/14/937

24.5.2016

20.5.2016

Hexyon

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/13/829

24.5.2016

26.5.2016

Actos

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/150

30.5.2016

26.5.2016

Afinitor

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/538

30.5.2016

26.5.2016

Buccolam

Shire Services BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België

EU/1/11/709

30.5.2016

26.5.2016

Cayston

Gilead Sciences International Limited

Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543

31.5.2016

26.5.2016

Cinryze

Shire Services BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België

EU/1/11/688

30.5.2016

26.5.2016

Clopidogrel HCS

HCS bvba

H. Kennisstraat 53, B-2650 Edegem, België

EU/1/10/651

30.5.2016

26.5.2016

Clopidogrel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/540

30.5.2016

26.5.2016

Competact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/354

30.5.2016

26.5.2016

Conbriza

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/09/511

31.5.2016

26.5.2016

Constella

Allergan Pharmaceuticals International Ltd.

Clonshaugh Business and Technology Park Coolock Dublin D17 E400, Ireland

EU/1/12/801

30.5.2016

26.5.2016

DepoCyte

Pacira Limited

Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom

EU/1/01/187

28.5.2016

26.5.2016

Dexdor

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/718

30.5.2016

26.5.2016

Duaklir Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/964

30.5.2016

26.5.2016

Ferriprox

Apotex Europe B.V.

Darwinweg 20, NL- 2333 CR Leiden, Nederland

EU/1/99/108

30.5.2016

26.5.2016

Firazyr

Shire Orphan Therapies GmbH

Friedrichstraße 149, D-10117 Berlin, Deutschland

EU/1/08/461

30.5.2016

26.5.2016

Glubrava

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/07/421

30.5.2016

26.5.2016

Glustin

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/151

30.5.2016

26.5.2016

HyQvia

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/13/840

30.5.2016

26.5.2016

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/945

30.5.2016

26.5.2016

Imnovid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/13/850

31.5.2016

26.5.2016

Kapecitabin medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/802

30.5.2016

26.5.2016

Klopidogrel/acetilsalicilna kislina Teva

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/942

30.5.2016

26.5.2016

Levodopa/Carbidopa/Entacapone Orion

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/706

30.5.2016

26.5.2016

Liprolog

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/01/195

30.5.2016

26.5.2016

Mabthera

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/98/067

31.5.2016

26.5.2016

Neulasta

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/02/227

30.5.2016

26.5.2016

Nexium Control

Pfizer Consumer Healthcare Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/13/860

31.5.2016

26.5.2016

Rixubis

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/14/970

30.5.2016

26.5.2016

Strimvelis

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/16/1097

30.5.2016

26.5.2016

Tandemact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/366

30.5.2016

26.5.2016

Taxotere

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92165 Antony CEDEX, France

EU/1/95/002

30.5.2016

26.5.2016

Trevicta

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/971

30.5.2016

26.5.2016

Vibativ

Clinigen Healthcare Limited

Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom

EU/1/11/705

28.5.2016

26.5.2016

Victoza

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/09/529

30.5.2016

26.5.2016

XALKORI

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/12/793

31.5.2016

26.5.2016

Ytracis

CIS bio international

Boite Postale 32, F-91192 Gif-sur-Yvette, France

EU/1/03/250

30.5.2016

26.5.2016

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/714

30.5.2016

—   Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 3.5.2016 | Suvaxyn PCV | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/099 | 20.5.2016 |
| 17.5.2016 | Apoquel | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/13/154 | 19.5.2016 |
| 17.5.2016 | Bravecto | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/13/158 | 19.5.2016 |
| 17.5.2016 | Cepivo MS-H | Pharmsure International Ltd
  Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom | EU/2/11/126 | 19.5.2016 |
| 17.5.2016 | Proteq West Nile | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/11/129 | 19.5.2016 |
| 26.5.2016 | Aivlosin | ECO Animal Health Ltd
  78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom | EU/2/04/044 | 31.5.2016 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

3.5.2016

Suvaxyn PCV

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/09/099

20.5.2016

17.5.2016

Apoquel

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/13/154

19.5.2016

17.5.2016

Bravecto

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/13/158

19.5.2016

17.5.2016

Cepivo MS-H

Pharmsure International Ltd

Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom

EU/2/11/126

19.5.2016

17.5.2016

Proteq West Nile

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/11/129

19.5.2016

26.5.2016

Aivlosin

ECO Animal Health Ltd

78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom

EU/2/04/044

31.5.2016

—   Ukinitev dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 26.5.2016 | RevitaCAM | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/138 | 30.5.2016 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

26.5.2016

RevitaCAM

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/12/138

30.5.2016

Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih sklepih o zdravilih, se lahko obrne na naslov:

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

(1)  UL L 136, 30.4.2004, str. 1.

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