# Službeni list C 61/24.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 61 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 60.24. veljače 2017. |

ISSN 1977-1088

Službeni list

Europske unije

C 61

Hrvatsko izdanje

Informacije i objave

Godište 60.24. veljače 2017.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2017/C 61/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2017. do 31. siječnja 2017.(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

2017/C 61/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2017. do 31. siječnja 2017.(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

| 24.2.2017 | HR | Službeni list Europske unije | C 61/1 |
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24.2.2017

HR

Službeni list Europske unije

C 61/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2017. do 31. siječnja 2017.

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

(2017/C 061/01)

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

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

| Datum odluke | Naziv lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1.2017. | AFSTYLA | lonoktokog alfa | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/16/1158 | Prašak i otapalo za otopinu za injekciju | B02BD02 | 6.1.2017. |
| 4.1.2017. | Darunavir Mylan | darunavir | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1140 | Filmom obložena tableta | J05AE10 | 6.1.2017. |
| 4.1.2017. | Lusduna | inzulin glargin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/16/1162 | Otopina za injekciju | A10AE04 | 6.1.2017. |
| 4.1.2017. | Terrosa | teriparatid | Gedeon Richter Plc.
  Gyömrői út 19-21., H-1103 Budapest, Magyarország | EU/1/16/1159 | Otopina za injekciju | H05AA02 | 6.1.2017. |
| 9.1.2017. | Fiasp | aspart inzulin | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/16/1160 | Otopina za injekciju | A10AB05 | 11.1.2017. |
| 9.1.2017. | Tadalafil Generics | tadalafil | Mylan S.A.S.
  117 Allée des Parcs, 69800 Saint-Priest, France | EU/1/16/1153 | Filmom obložena tableta | G04BE08 | 11.1.2017. |
| 9.1.2017. | Vemlidy | tenofoviralafenamid | Gilead Sciences International Ltd.
  Cambridge, CB21 6GT, United Kingdom | EU/1/16/1154 | Filmom obložena tableta | J05AF13 | 11.1.2017. |
| 11.1.2017. | Movymia | teriparatid | STADA Arzneimittel AG
  Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland | EU/1/16/1161 | Otopina za injekciju | H05AA02 | 13.1.2017. |
| 11.1.2017. | Suliqua | inzulin glargin/liksisenatid | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/16/1157 | Otopina za injekciju | A10AE54 | 13.1.2017. |
| 18.1.2017. | ZINPLAVA | bezlotoksumab | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/16/1156 | Koncentrat za otopinu za infuziju | J06BB21 | 20.1.2017. |
| 19.1.2017. | Cystadrops | merkaptamin | Orphan Europe SARL
  Immeuble „Le Wilson”, 70, Avenue du Général de Gaulle, 92800 Puteaux, France | EU/1/15/1049 | Kapi za oko, otopina | S01XA21 | 23.1.2017. |

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

4.1.2017.

AFSTYLA

lonoktokog alfa

CSL Behring GmbH

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

EU/1/16/1158

Prašak i otapalo za otopinu za injekciju

B02BD02

6.1.2017.

4.1.2017.

Darunavir Mylan

darunavir

Mylan S.A.S

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

EU/1/16/1140

Filmom obložena tableta

J05AE10

6.1.2017.

4.1.2017.

Lusduna

inzulin glargin

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/16/1162

Otopina za injekciju

A10AE04

6.1.2017.

4.1.2017.

Terrosa

teriparatid

Gedeon Richter Plc.

Gyömrői út 19-21., H-1103 Budapest, Magyarország

EU/1/16/1159

Otopina za injekciju

H05AA02

6.1.2017.

9.1.2017.

Fiasp

aspart inzulin

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/16/1160

Otopina za injekciju

A10AB05

11.1.2017.

9.1.2017.

Tadalafil Generics

tadalafil

Mylan S.A.S.

117 Allée des Parcs, 69800 Saint-Priest, France

EU/1/16/1153

Filmom obložena tableta

G04BE08

11.1.2017.

9.1.2017.

Vemlidy

tenofoviralafenamid

Gilead Sciences International Ltd.

Cambridge, CB21 6GT, United Kingdom

EU/1/16/1154

Filmom obložena tableta

J05AF13

11.1.2017.

11.1.2017.

Movymia

teriparatid

STADA Arzneimittel AG

Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland

EU/1/16/1161

Otopina za injekciju

H05AA02

13.1.2017.

11.1.2017.

Suliqua

inzulin glargin/liksisenatid

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/16/1157

Otopina za injekciju

A10AE54

13.1.2017.

18.1.2017.

ZINPLAVA

bezlotoksumab

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/16/1156

Koncentrat za otopinu za infuziju

J06BB21

20.1.2017.

19.1.2017.

Cystadrops

merkaptamin

Orphan Europe SARL

Immeuble „Le Wilson”, 70, Avenue du Général de Gaulle, 92800 Puteaux, France

EU/1/15/1049

Kapi za oko, otopina

S01XA21

23.1.2017.

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

—

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 |
| --- | --- | --- | --- | --- |
| 4.1.2017. | Emadine | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/98/095 | 6.1.2017. |
| 4.1.2017. | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/845 | 6.1.2017. |
| 4.1.2017. | Incruse | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/922 | 6.1.2017. |
| 4.1.2017. | Kolbam | Retrophin Europe Limited
  Palmerstown House, Fenian Street, Dublin 2, Ireland | EU/1/13/895 | 6.1.2017. |
| 4.1.2017. | Vepacel | Nanotherapeutics Bohumil, s.r.o.
  Bohumil 138, 28163 Jevany, Česká republika | EU/1/12/752 | 6.1.2017. |
| 4.1.2017. | Zonegran | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/04/307 | 6.1.2017. |
| 9.1.2017. | Capecitabine Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/762 | 11.1.2017. |
| 9.1.2017. | Capecitabine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/761 | 11.1.2017. |
| 9.1.2017. | DaTSCAN | GE Healthcare Limited
  Little Chalfont, Bucks HP7 9NA, United Kingdom | EU/1/00/135 | 11.1.2017. |
| 9.1.2017. | Foclivia | Novartis Vaccines Influenza S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/09/577 | 11.1.2017. |
| 9.1.2017. | Naglazyme | BioMarin Europe Ltd.
  10 Bloomsbury Way, London WC1A 2SL, United Kingdom | EU/1/05/324 | 13.1.2017. |
| 9.1.2017. | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 11.1.2017. |
| 9.1.2017. | Relistor | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Česká republika | EU/1/08/463 | 11.1.2017. |
| 9.1.2017. | Riluzole Zentiva | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/12/768 | 11.1.2017. |
| 9.1.2017. | SANCUSO | Kyowa Kirin Limited
  Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | EU/1/12/766 | 11.1.2017. |
| 9.1.2017. | Translarna | PTC Therapeutics International Limited
  77 Sir John Rogerson’s Quay, Dublin 2, Ireland | EU/1/13/902 | 11.1.2017. |
| 9.1.2017. | Viagra | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/98/077 | 11.1.2017. |
| 9.1.2017. | Viramune | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/055 | 11.1.2017. |
| 9.1.2017. | Xultophy | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/14/947 | 11.1.2017. |
| 11.1.2017. | Adenuric | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/447 | 13.1.2017. |
| 11.1.2017. | Brintellix | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/13/891 | 13.1.2017. |
| 11.1.2017. | Bronchitol | Pharmaxis Pharmaceuticals Limited
  25 Moorgate, London, EC2R 6AY, United Kingdom. | EU/1/12/760 | 13.1.2017. |
| 11.1.2017. | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/13/890 | 13.1.2017. |
| 11.1.2017. | Defitelio | Gentium S.r.l
  Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia | EU/1/13/878 | 16.1.2017. |
| 11.1.2017. | Entresto | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1058 | 13.1.2017. |
| 11.1.2017. | Herceptin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/145 | 13.1.2017. |
| 11.1.2017. | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/845 | 13.1.2017. |
| 11.1.2017. | Inovelon | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/06/378 | 13.1.2017. |
| 11.1.2017. | Invanz | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/02/216 | 13.1.2017. |
| 11.1.2017. | Ivemend | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/437 | 13.1.2017. |
| 11.1.2017. | Kuvan | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/08/481 | 13.1.2017. |
| 11.1.2017. | Pregabalin Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/997 | 13.1.2017. |
| 11.1.2017. | Pregabalin Mylan Pharma | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/998 | 13.1.2017. |
| 11.1.2017. | Ruconest | Pharming Group N.V.
  Darwinweg 24, NL-2333 CR Leiden, Nederland | EU/1/10/641 | 13.1.2017. |
| 11.1.2017. | Vimizim | BioMarin Europe Ltd.
  10 Bloomsbury Way, London WC1A 2SL, United Kingdom | EU/1/14/914 | 13.1.2017. |
| 11.1.2017. | Xadago | Zambon S.p.A.
  Via Lillo del Duca 10, 20 091 Bresso (MI), Italia | EU/1/14/984 | 13.1.2017. |
| 19.1.2017. | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 23.1.2017. |
| 23.1.2017. | Lymphoseek | Norgine B.V.
  Hogehilweg 7, 1101CA Amsterdam, Nederland | EU/1/14/955 | 25.1.2017. |
| 23.1.2017. | Remsima | Celltrion Healthcare Hungary Kft.
  Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország | EU/1/13/853 | 25.1.2017. |
| 26.1.2017. | Cinryze | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/688 | 30.1.2017. |
| 26.1.2017. | Iclusig | Incyte Biosciences UK Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 30.1.2017. |
| 26.1.2017. | NovoSeven | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/96/006 | 30.1.2017. |
| 26.1.2017. | Orfadin | Swedish Orphan Biovitrum International AB
  SE-112 76 Stockholm, Sverige | EU/1/04/303 | 30.1.2017. |
| 26.1.2017. | Picato | LEO Laboratories Ltd.
  285 Cashel Road, Crumlin, Dublin 12, Ireland | EU/1/12/796 | 30.1.2017. |
| 26.1.2017. | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/967 | 30.1.2017. |
| 26.1.2017. | Vorikonazol Hikma | Hikma Farmacêutica (Portugal), S.A.
  Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal | EU/1/15/1004 | 30.1.2017. |
| 27.1.2017. | Ameluz | Biofrontera Bioscience GmbH
  Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland | EU/1/11/740 | 31.1.2017. |
| 27.1.2017. | Benepali | Samsung Bioepis UK Limited
  3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom | EU/1/15/1074 | 31.1.2017. |
| 27.1.2017. | Docetaxel Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/769 | 31.1.2017. |
| 27.1.2017. | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 31.1.2017. |
| 27.1.2017. | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 31.1.2017. |
| 27.1.2017. | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 31.1.2017. |
| 27.1.2017. | Stivarga | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/13/858 | 31.1.2017. |
| 27.1.2017. | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 31.1.2017. |
| 27.1.2017. | Vaxelis | MCM Vaccine B.V.
  Robert Boyleweg 4, 2333 CG Leiden, Nederland | EU/1/15/1079 | 31.1.2017. |
| 27.1.2017. | Votubia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/710 | 31.1.2017. |
| 27.1.2017. | Xydalba | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/14/986 | 31.1.2017. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

4.1.2017.

Emadine

Alcon Laboratories (UK) Ltd

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/98/095

6.1.2017.

4.1.2017.

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

6.1.2017.

4.1.2017.

Incruse

Glaxo Group Ltd

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

EU/1/14/922

6.1.2017.

4.1.2017.

Kolbam

Retrophin Europe Limited

Palmerstown House, Fenian Street, Dublin 2, Ireland

EU/1/13/895

6.1.2017.

4.1.2017.

Vepacel

Nanotherapeutics Bohumil, s.r.o.

Bohumil 138, 28163 Jevany, Česká republika

EU/1/12/752

6.1.2017.

4.1.2017.

Zonegran

Eisai Limited

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

EU/1/04/307

6.1.2017.

9.1.2017.

Capecitabine Accord

Accord Healthcare Limited

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

EU/1/12/762

11.1.2017.

9.1.2017.

Capecitabine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/761

11.1.2017.

9.1.2017.

DaTSCAN

GE Healthcare Limited

Little Chalfont, Bucks HP7 9NA, United Kingdom

EU/1/00/135

11.1.2017.

9.1.2017.

Foclivia

Novartis Vaccines Influenza S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/09/577

11.1.2017.

9.1.2017.

Naglazyme

BioMarin Europe Ltd.

10 Bloomsbury Way, London WC1A 2SL, United Kingdom

EU/1/05/324

13.1.2017.

9.1.2017.

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

11.1.2017.

9.1.2017.

Relistor

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Česká republika

EU/1/08/463

11.1.2017.

9.1.2017.

Riluzole Zentiva

Aventis Pharma S.A.

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

EU/1/12/768

11.1.2017.

9.1.2017.

SANCUSO

Kyowa Kirin Limited

Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

EU/1/12/766

11.1.2017.

9.1.2017.

Translarna

PTC Therapeutics International Limited

77 Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/13/902

11.1.2017.

9.1.2017.

Viagra

Pfizer Limited

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

EU/1/98/077

11.1.2017.

9.1.2017.

Viramune

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/055

11.1.2017.

9.1.2017.

Xultophy

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/14/947

11.1.2017.

11.1.2017.

Adenuric

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/08/447

13.1.2017.

11.1.2017.

Brintellix

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/13/891

13.1.2017.

11.1.2017.

Bronchitol

Pharmaxis Pharmaceuticals Limited

25 Moorgate, London, EC2R 6AY, United Kingdom.

EU/1/12/760

13.1.2017.

11.1.2017.

Cometriq

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/13/890

13.1.2017.

11.1.2017.

Defitelio

Gentium S.r.l

Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia

EU/1/13/878

16.1.2017.

11.1.2017.

Entresto

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1058

13.1.2017.

11.1.2017.

Herceptin

Roche Registration Limited

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

EU/1/00/145

13.1.2017.

11.1.2017.

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

13.1.2017.

11.1.2017.

Inovelon

Eisai Limited

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

EU/1/06/378

13.1.2017.

11.1.2017.

Invanz

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/02/216

13.1.2017.

11.1.2017.

Ivemend

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/437

13.1.2017.

11.1.2017.

Kuvan

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/08/481

13.1.2017.

11.1.2017.

Pregabalin Mylan

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/15/997

13.1.2017.

11.1.2017.

Pregabalin Mylan Pharma

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/15/998

13.1.2017.

11.1.2017.

Ruconest

Pharming Group N.V.

Darwinweg 24, NL-2333 CR Leiden, Nederland

EU/1/10/641

13.1.2017.

11.1.2017.

Vimizim

BioMarin Europe Ltd.

10 Bloomsbury Way, London WC1A 2SL, United Kingdom

EU/1/14/914

13.1.2017.

11.1.2017.

Xadago

Zambon S.p.A.

Via Lillo del Duca 10, 20 091 Bresso (MI), Italia

EU/1/14/984

13.1.2017.

19.1.2017.

Jardiance

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/14/930

23.1.2017.

23.1.2017.

Lymphoseek

Norgine B.V.

Hogehilweg 7, 1101CA Amsterdam, Nederland

EU/1/14/955

25.1.2017.

23.1.2017.

Remsima

Celltrion Healthcare Hungary Kft.

Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország

EU/1/13/853

25.1.2017.

26.1.2017.

Cinryze

Shire Services BVBA

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

EU/1/11/688

30.1.2017.

26.1.2017.

Iclusig

Incyte Biosciences UK Ltd

Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom

EU/1/13/839

30.1.2017.

26.1.2017.

NovoSeven

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/96/006

30.1.2017.

26.1.2017.

Orfadin

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sverige

EU/1/04/303

30.1.2017.

26.1.2017.

Picato

LEO Laboratories Ltd.

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

30.1.2017.

26.1.2017.

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/967

30.1.2017.

26.1.2017.

Vorikonazol Hikma

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal

EU/1/15/1004

30.1.2017.

27.1.2017.

Ameluz

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland

EU/1/11/740

31.1.2017.

27.1.2017.

Benepali

Samsung Bioepis UK Limited

3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom

EU/1/15/1074

31.1.2017.

27.1.2017.

Docetaxel Accord

Accord Healthcare Limited

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

EU/1/12/769

31.1.2017.

27.1.2017.

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

31.1.2017.

27.1.2017.

KEYTRUDA

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/15/1024

31.1.2017.

27.1.2017.

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

31.1.2017.

27.1.2017.

Stivarga

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/858

31.1.2017.

27.1.2017.

Trajenta

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/11/707

31.1.2017.

27.1.2017.

Vaxelis

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden, Nederland

EU/1/15/1079

31.1.2017.

27.1.2017.

Votubia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/710

31.1.2017.

27.1.2017.

Xydalba

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/14/986

31.1.2017.

| — | Povlačenje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) |
| --- | --- |

—

Povlačenje odobrenja za stavljanje u promet (članak 13 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 |
| --- | --- | --- | --- | --- |
| 9.1.2017. | Vylaer Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/949 | 11.1.2017. |
| 18.1.2017. | Clopidogrel Acino | Acino AG
  Am Windfeld 35, 83714 D-Miesbach, Deutschland | EU/1/09/532 | 20.1.2017. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

9.1.2017.

Vylaer Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/949

11.1.2017.

18.1.2017.

Clopidogrel Acino

Acino AG

Am Windfeld 35, 83714 D-Miesbach, Deutschland

EU/1/09/532

20.1.2017.

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

—

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

| Datum odluke | Naziv lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.1.2017. | Coliprotec F4/F18 | Cjepivo protiv proljeva nakon odbića u svinja (živo) | Prevtec Microbia GmbH
  Geyerspergerstr 27, 80689 München, Deutschland | EU/2/16/202 | Liofilizat za oralnu suspenziju | QI09AE03 | 11.1.2017. |

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

9.1.2017.

Coliprotec F4/F18

Cjepivo protiv proljeva nakon odbića u svinja (živo)

Prevtec Microbia GmbH

Geyerspergerstr 27, 80689 München, Deutschland

EU/2/16/202

Liofilizat za oralnu suspenziju

QI09AE03

11.1.2017.

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

—

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 |
| --- | --- | --- | --- | --- |
| 9.1.2017. | Novaquin | Le Vet Beheer B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/15/186 | 11.1.2017. |
| 18.1.2017. | Nobilis IB 4-91 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/98/006 | 20.1.2017. |
| 18.1.2017. | Simparica | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/15/191 | 20.1.2017. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

9.1.2017.

Novaquin

Le Vet Beheer B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/15/186

11.1.2017.

18.1.2017.

Nobilis IB 4-91

Intervet International B.V.

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

EU/2/98/006

20.1.2017.

18.1.2017.

Simparica

Zoetis Belgium S.A.

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

EU/2/15/191

20.1.2017.

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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