# Službeni list C 229/24.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 229 |
| | |
| Hrvatsko izdanje | Informacije i objave | Svezak 59.24. lipnja 2016. |

ISSN 1977-1088

Službeni list

Europske unije

C 229

Hrvatsko izdanje

Informacije i objave

Svezak 59.24. lipnja 2016.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2016/C 229/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. svibnja 2016. do 31. svibnja 2016.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |

Obavijest br.

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2016/C 229/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. svibnja 2016. do 31. svibnja 2016.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

1

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| HR | |
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HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 24.6.2016 | HR | Službeni list Europske unije | C 229/1 |
| --- | --- | --- | --- |

24.6.2016

HR

Službeni list Europske unije

C 229/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. svibnja 2016. do 31. svibnja 2016.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))

(2016/C 229/01)

—   Izdavanje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.5.2016. | Empliciti | elotuzumab | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/16/1088 | Prašak za koncentrat za otopinu za infuziju | 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 | Prašak i otapalo za otopinu za injekciju | B02BD04 | 13.5.2016. |
| 12.5.2016. | ALPROLIX | eftrenonakoga alfa (eftrenonacog alfa) | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1098 | Prašak i otapalo za otopinu za injekciju | 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 | Filmom obložena tableta | B01AC27 | 19.5.2016. |
| 20.5.2016. | Darzalex | Daratumumab | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/16/1101 | Koncentrat za otopinu za infuziju | L01XC24 | 24.5.2016. |
| 20.5.2016. | Pandemijsko cjepivo protiv influence H5N1 MedImmune | Pandemijsko cjepivo protiv influence (H5N1) (živo, atenuirano, za nos) | MedImmune, LLC
  Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland | EU/1/16/1089 | Sprej za nos, suspenzija | J07BB03 | 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, tvrda | 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 | Filmom obložena tableta | 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 | Otopina za injekciju | A04AA05 | 31.5.2016. |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

11.5.2016.

Empliciti

elotuzumab

Bristol-Myers Squibb Pharma EEIG

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

EU/1/16/1088

Prašak za koncentrat za otopinu za infuziju

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

Prašak i otapalo za otopinu za injekciju

B02BD04

13.5.2016.

12.5.2016.

ALPROLIX

eftrenonakoga alfa (eftrenonacog alfa)

Biogen Idec Limited

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

EU/1/16/1098

Prašak i otapalo za otopinu za injekciju

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

Filmom obložena tableta

B01AC27

19.5.2016.

20.5.2016.

Darzalex

Daratumumab

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/16/1101

Koncentrat za otopinu za infuziju

L01XC24

24.5.2016.

20.5.2016.

Pandemijsko cjepivo protiv influence H5N1 MedImmune

Pandemijsko cjepivo protiv influence (H5N1) (živo, atenuirano, za nos)

MedImmune, LLC

Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland

EU/1/16/1089

Sprej za nos, suspenzija

J07BB03

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, tvrda

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

Filmom obložena tableta

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

Otopina za injekciju

A04AA05

31.5.2016.

—   Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 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. | Desloratadine Actavis | 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. | Desloratadine 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. | Capecitabine medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/12/802 | 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. | Klopidogrel/acetilsalicilatna kiselina 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 odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

Desloratadine Actavis

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.

Desloratadine 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.

Capecitabine medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/802

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.

Klopidogrel/acetilsalicilatna kiselina 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.

—   Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 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. | MS-H vaccine | 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 odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

MS-H vaccine

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.

—   Povlačenje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 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 odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

26.5.2016.

RevitaCAM

Zoetis Belgium S.A.

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

EU/2/12/138

30.5.2016.

Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:

| 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)  SL L 136, 30.4.2004, str. 1.

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