# Službeni list C 70/23.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 70 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 61.23. veljače 2018. |

ISSN 1977-1088

Službeni list

Europske unije

C 70

Hrvatsko izdanje

Informacije i objave

Godište 61.23. veljače 2018.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2018/C 70/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2018. do 31. siječnja 2018.(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

2018/C 70/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2018. do 31. siječnja 2018.(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

| 23.2.2018 | HR | Službeni list Europske unije | C 70/1 |
| --- | --- | --- | --- |

23.2.2018

HR

Službeni list Europske unije

C 70/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2018. do 31. siječnja 2018.

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

(2018/C 070/01)

| — | 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 (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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1.2018. | ADYNOVI | rurioktokog alfa pegol | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/17/1247 | Prašak i otapalo za otopinu za injekciju | B02BD02 | 10.1.2018. |
| 8.1.2018. | Fasenra | benralizumab | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/17/1252 | Otopina za injekciju | R03DX10 | 10.1.2018. |
| 8.1.2018. | Fulvestrant Mylan | fulvestranta | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1253 | Otopina za injekciju | L02BA03 | 10.1.2018. |
| 8.1.2018. | Intrarosa | prasteron | Endoceutics Ltd.
  Salisbury house, London Wall, London, EC2M 5PS, United Kingdom | EU/1/17/1255 | Pesar | QM01AX92 | 6.2.2018. |
| 8.1.2018. | Jorveza | budezonid | Dr Falk Pharma GmbH
  Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland | EU/1/17/1254 | Raspadljiva tableta za usta | A07EA06 | 10.1.2018. |
| 8.1.2018. | Ocrevus | okrelizumab | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/17/1231 | Koncentrat za otopinu za infuziju | L04AA36 | 10.1.2018. |
| 8.1.2018. | PREVYMIS | letermovir | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/17/1245 | Filmom obložena tableta
  Koncentrat za otopinu za infuziju | J05AX18 | 10.1.2018. |
| 15.1.2018. | Mvasi | bevacizumab | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/17/1246 | Koncentrat za otopinu za infuziju | L01XC07 | 17.1.2018. |
| 18.1.2018. | Darunavir Krka d.d. | darunavir | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1248 | Filmom obložena tableta | J05AE10 | 22.1.2018. |
| 26.1.2018. | Darunavir Krka | darunavir | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1249 | Filmom obložena tableta | J05AE10 | 30.1.2018. |

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

8.1.2018.

ADYNOVI

rurioktokog alfa pegol

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/17/1247

Prašak i otapalo za otopinu za injekciju

B02BD02

10.1.2018.

8.1.2018.

Fasenra

benralizumab

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1252

Otopina za injekciju

R03DX10

10.1.2018.

8.1.2018.

Fulvestrant Mylan

fulvestranta

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1253

Otopina za injekciju

L02BA03

10.1.2018.

8.1.2018.

Intrarosa

prasteron

Endoceutics Ltd.

Salisbury house, London Wall, London, EC2M 5PS, United Kingdom

EU/1/17/1255

Pesar

QM01AX92

6.2.2018.

8.1.2018.

Jorveza

budezonid

Dr Falk Pharma GmbH

Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland

EU/1/17/1254

Raspadljiva tableta za usta

A07EA06

10.1.2018.

8.1.2018.

Ocrevus

okrelizumab

Roche Registration Limited

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

EU/1/17/1231

Koncentrat za otopinu za infuziju

L04AA36

10.1.2018.

8.1.2018.

PREVYMIS

letermovir

Merck Sharp & Dohme Limited

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

EU/1/17/1245

Filmom obložena tableta

Koncentrat za otopinu za infuziju

J05AX18

10.1.2018.

15.1.2018.

Mvasi

bevacizumab

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/17/1246

Koncentrat za otopinu za infuziju

L01XC07

17.1.2018.

18.1.2018.

Darunavir Krka d.d.

darunavir

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1248

Filmom obložena tableta

J05AE10

22.1.2018.

26.1.2018.

Darunavir Krka

darunavir

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1249

Filmom obložena tableta

J05AE10

30.1.2018.

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

—

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

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 8.1.2018. | Onzeald | Nektar Therapeutics UK Limited
  Elizabeth House, 13-19 Queen Street, Leeds LS1 2TW, United Kingdom | — | 10.1.2018. |
| 15.1.2018. | Fanaptum | Vanda Pharmaceuticals Limited
  222 Regent Street, London W1B 5TR, United Kingdom | — | 19.1.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

8.1.2018.

Onzeald

Nektar Therapeutics UK Limited

Elizabeth House, 13-19 Queen Street, Leeds LS1 2TW, United Kingdom

—

10.1.2018.

15.1.2018.

Fanaptum

Vanda Pharmaceuticals Limited

222 Regent Street, London W1B 5TR, United Kingdom

—

19.1.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 8.1.2018. | Bronchitol | Pharmaxis Pharmaceuticals Limited
  25 Moorgate, London, EC2R 6AY, United Kingdom | EU/1/12/760 | 10.1.2018. |
| 8.1.2018. | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 10.1.2018. |
| 8.1.2018. | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/13/890 | 10.1.2018. |
| 8.1.2018. | Comtess | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/98/082 | 10.1.2018. |
| 8.1.2018. | Hexacima | Sanofi Pasteur SA
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/13/828 | 10.1.2018. |
| 8.1.2018. | Hexyon | Sanofi Pasteur Europe
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/13/829 | 10.1.2018. |
| 8.1.2018. | HyQvia | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/13/840 | 10.1.2018. |
| 8.1.2018. | Imatinib Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/13/825 | 10.1.2018. |
| 8.1.2018. | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, 1030 Wien, Österreich | EU/1/08/501 | 10.1.2018. |
| 8.1.2018. | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 10.1.2018. |
| 8.1.2018. | Memantine LEK | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/13/826 | 10.1.2018. |
| 8.1.2018. | Memantine Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/13/827 | 15.1.2018. |
| 8.1.2018. | Nemdatine | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/13/824 | 10.1.2018. |
| 8.1.2018. | Orkambi | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/15/1059 | 10.1.2018. |
| 8.1.2018. | Pradaxa | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/08/442 | 10.1.2018. |
| 8.1.2018. | Stayveer | Marklas Nederland B.V.
  Beneluxlaan 2b, 3446 GR Woerden, Nederland | EU/1/13/832 | 10.1.2018. |
| 8.1.2018. | Synjardy | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | 10.1.2018. |
| 8.1.2018. | Tolucombi | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/821 | 10.1.2018. |
| 8.1.2018. | Votrient | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/628 | 10.1.2018. |
| 8.1.2018. | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 10.1.2018. |
| 8.1.2018. | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 10.1.2018. |
| 8.1.2018. | Zonegran | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/04/307 | 10.1.2018. |
| 11.1.2018. | Carbaglu | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/02/246 | 15.1.2018. |
| 11.1.2018. | Cinacalcet Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1054 | 15.1.2018. |
| 11.1.2018. | Cystadrops | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/15/1049 | 15.1.2018. |
| 11.1.2018. | Cystagon | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/97/039 | 15.1.2018. |
| 11.1.2018. | Lartruvo | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1143 | 15.1.2018. |
| 11.1.2018. | Laventair | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/899 | 15.1.2018. |
| 11.1.2018. | Levetiracetam Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/701 | 15.1.2018. |
| 11.1.2018. | OLYSIO | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/924 | 15.1.2018. |
| 15.1.2018. | Adasuve | Ferrer Internacional S.A.
  Gran Via Carlos III, 94 08028 Barcelona, España | EU/1/13/823 | 17.1.2018. |
| 15.1.2018. | Ciambra | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/15/1055 | 17.1.2018. |
| 15.1.2018. | Prialt | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/04/302 | 17.1.2018. |
| 15.1.2018. | Zostavax | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/341 | 17.1.2018. |
| 18.1.2018. | Bortezomib Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/16/1114 | 22.1.2018. |
| 18.1.2018. | Leganto | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/11/695 | 22.1.2018. |
| 18.1.2018. | Marixino | Consilient Health Ltd
  5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland | EU/1/13/820 | 22.1.2018. |
| 18.1.2018. | Omidria | Omeros London Limited
  Berkeley Square, London, W1J 6BD, United Kingdom | EU/1/15/1018 | 22.1.2018. |
| 18.1.2018. | Taltz | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1085 | 22.1.2018. |
| 18.1.2018. | Tenofovir disoproxil Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1127 | 22.1.2018. |
| 18.1.2018. | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 22.1.2018. |
| 18.1.2018. | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 22.1.2018. |
| 24.1.2018. | Cervarix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/07/419 | 26.1.2018. |
| 24.1.2018. | DUAVIVE | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/14/960 | 26.1.2018. |
| 24.1.2018. | IBRANCE | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/16/1147 | 26.1.2018. |
| 24.1.2018. | LeukoScan | Immunomedics GmbH
  Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland | EU/1/97/032 | 26.1.2018. |
| 25.1.2018. | Matever | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/11/711 | 29.1.2018. |
| 26.1.2018. | Cerdelga | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/14/974 | 30.1.2018. |
| 26.1.2018. | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 30.1.2018. |
| 30.1.2018. | Cialis | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/02/237 | 31.1.2018. |
| 30.1.2018. | Colobreathe | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/747 | 1.2.2018. |
| 30.1.2018. | Copalia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/372 | 1.2.2018. |
| 30.1.2018. | Copalia HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/575 | 1.2.2018. |
| 30.1.2018. | Cresemba | Basilea Medical Ltd
  c/o Cox Costello & Horne Limited, Langwood House, 63-81 High Street, Rickmansworth, Hertfordshire WD3 1EQ, United Kingdom | EU/1/15/1036 | 1.2.2018. |
| 30.1.2018. | Dafiro | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/371 | 1.2.2018. |
| 30.1.2018. | Dafiro HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/574 | 1.2.2018. |
| 30.1.2018. | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1222 | 1.2.2018. |
| 30.1.2018. | Effentora | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/08/441 | 1.2.2018. |
| 30.1.2018. | Exforge HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/569 | 1.2.2018. |
| 30.1.2018. | Fycompa | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/12/776 | 1.2.2018. |
| 30.1.2018. | Granpidam | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/16/1137 | 1.2.2018. |
| 30.1.2018. | Hizentra | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/11/687 | 1.2.2018. |
| 30.1.2018. | Ivemend | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/437 | 1.2.2018. |
| 30.1.2018. | Nplate | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/08/497 | 1.2.2018. |
| 30.1.2018. | Rotarix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/05/330 | 1.2.2018. |
| 30.1.2018. | Stelara | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/08/494 | 2.2.2018. |
| 30.1.2018. | Vectibix | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/07/423 | 1.2.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

8.1.2018.

Bronchitol

Pharmaxis Pharmaceuticals Limited

25 Moorgate, London, EC2R 6AY, United Kingdom

EU/1/12/760

10.1.2018.

8.1.2018.

Cimzia

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/09/544

10.1.2018.

8.1.2018.

Cometriq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

10.1.2018.

8.1.2018.

Comtess

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/98/082

10.1.2018.

8.1.2018.

Hexacima

Sanofi Pasteur SA

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/13/828

10.1.2018.

8.1.2018.

Hexyon

Sanofi Pasteur Europe

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/13/829

10.1.2018.

8.1.2018.

HyQvia

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/13/840

10.1.2018.

8.1.2018.

Imatinib Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/825

10.1.2018.

8.1.2018.

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/08/501

10.1.2018.

8.1.2018.

Jardiance

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/930

10.1.2018.

8.1.2018.

Memantine LEK

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/13/826

10.1.2018.

8.1.2018.

Memantine Mylan

Generics [UK] Limited

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

EU/1/13/827

15.1.2018.

8.1.2018.

Nemdatine

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/824

10.1.2018.

8.1.2018.

Orkambi

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/15/1059

10.1.2018.

8.1.2018.

Pradaxa

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

10.1.2018.

8.1.2018.

Stayveer

Marklas Nederland B.V.

Beneluxlaan 2b, 3446 GR Woerden, Nederland

EU/1/13/832

10.1.2018.

8.1.2018.

Synjardy

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1003

10.1.2018.

8.1.2018.

Tolucombi

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/821

10.1.2018.

8.1.2018.

Votrient

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/628

10.1.2018.

8.1.2018.

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

10.1.2018.

8.1.2018.

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

10.1.2018.

8.1.2018.

Zonegran

Eisai Limited

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

EU/1/04/307

10.1.2018.

11.1.2018.

Carbaglu

Orphan Europe S.A.R.L.

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

EU/1/02/246

15.1.2018.

11.1.2018.

Cinacalcet Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1054

15.1.2018.

11.1.2018.

Cystadrops

Orphan Europe S.A.R.L.

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

EU/1/15/1049

15.1.2018.

11.1.2018.

Cystagon

Orphan Europe S.A.R.L.

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

EU/1/97/039

15.1.2018.

11.1.2018.

Lartruvo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1143

15.1.2018.

11.1.2018.

Laventair

Glaxo Group Ltd

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

EU/1/14/899

15.1.2018.

11.1.2018.

Levetiracetam Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/701

15.1.2018.

11.1.2018.

OLYSIO

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/924

15.1.2018.

15.1.2018.

Adasuve

Ferrer Internacional S.A.

Gran Via Carlos III, 94 08028 Barcelona, España

EU/1/13/823

17.1.2018.

15.1.2018.

Ciambra

Menarini International Operations Luxembourg S.A.

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

EU/1/15/1055

17.1.2018.

15.1.2018.

Prialt

Eisai Limited

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

EU/1/04/302

17.1.2018.

15.1.2018.

Zostavax

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/341

17.1.2018.

18.1.2018.

Bortezomib Hospira

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

EU/1/16/1114

22.1.2018.

18.1.2018.

Leganto

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/11/695

22.1.2018.

18.1.2018.

Marixino

Consilient Health Ltd

5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

EU/1/13/820

22.1.2018.

18.1.2018.

Omidria

Omeros London Limited

Berkeley Square, London, W1J 6BD, United Kingdom

EU/1/15/1018

22.1.2018.

18.1.2018.

Taltz

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1085

22.1.2018.

18.1.2018.

Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1127

22.1.2018.

18.1.2018.

XALKORI

Pfizer Limited

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

EU/1/12/793

22.1.2018.

18.1.2018.

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

22.1.2018.

24.1.2018.

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/07/419

26.1.2018.

24.1.2018.

DUAVIVE

Pfizer Limited

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

EU/1/14/960

26.1.2018.

24.1.2018.

IBRANCE

Pfizer Limited

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

EU/1/16/1147

26.1.2018.

24.1.2018.

LeukoScan

Immunomedics GmbH

Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland

EU/1/97/032

26.1.2018.

25.1.2018.

Matever

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/11/711

29.1.2018.

26.1.2018.

Cerdelga

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/14/974

30.1.2018.

26.1.2018.

Mysimba

Orexigen Therapeutics Ireland Limited

2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/14/988

30.1.2018.

30.1.2018.

Cialis

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/02/237

31.1.2018.

30.1.2018.

Colobreathe

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/747

1.2.2018.

30.1.2018.

Copalia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/372

1.2.2018.

30.1.2018.

Copalia HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/575

1.2.2018.

30.1.2018.

Cresemba

Basilea Medical Ltd

c/o Cox Costello & Horne Limited, Langwood House, 63-81 High Street, Rickmansworth, Hertfordshire WD3 1EQ, United Kingdom

EU/1/15/1036

1.2.2018.

30.1.2018.

Dafiro

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/371

1.2.2018.

30.1.2018.

Dafiro HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/574

1.2.2018.

30.1.2018.

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1222

1.2.2018.

30.1.2018.

Effentora

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/441

1.2.2018.

30.1.2018.

Exforge HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/569

1.2.2018.

30.1.2018.

Fycompa

Eisai Europe Limited

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

EU/1/12/776

1.2.2018.

30.1.2018.

Granpidam

Accord Healthcare Limited

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

EU/1/16/1137

1.2.2018.

30.1.2018.

Hizentra

CSL Behring GmbH

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

EU/1/11/687

1.2.2018.

30.1.2018.

Ivemend

Merck Sharp & Dohme Limited

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

EU/1/07/437

1.2.2018.

30.1.2018.

Nplate

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/08/497

1.2.2018.

30.1.2018.

Rotarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/05/330

1.2.2018.

30.1.2018.

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/494

2.2.2018.

30.1.2018.

Vectibix

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/07/423

1.2.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 11.1.2018. | Daliresp | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/11/668 | 15.1.2018. |
| 11.1.2018. | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/06/368 | 15.1.2018. |
| 11.1.2018. | Libertek | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/11/666 | 15.1.2018. |
| 18.1.2018. | Zoledronic acid Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/772 | 22.1.2018. |
| 30.1.2018. | LeukoScan | Immunomedics GmbH
  Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland | EU/1/97/032 | 1.2.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

11.1.2018.

Daliresp

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/668

15.1.2018.

11.1.2018.

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/06/368

15.1.2018.

11.1.2018.

Libertek

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/666

15.1.2018.

18.1.2018.

Zoledronic acid Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/772

22.1.2018.

30.1.2018.

LeukoScan

Immunomedics GmbH

Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland

EU/1/97/032

1.2.2018.

| — | 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 (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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.1.2018. | GALLIPRANT | grapiprant | Aratana Therapeutics NV
  Ambachtenlaan 1, 3001 Heverlee, België | EU/2/17/221 | Tableta | QM01AX92 | 11.1.2018. |
| 31.1.2018. | MiPet Easecto | sarolaner | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/220 | Tablete za žvakanje | QP53BE03 | 2.2.2018. |

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

9.1.2018.

GALLIPRANT

grapiprant

Aratana Therapeutics NV

Ambachtenlaan 1, 3001 Heverlee, België

EU/2/17/221

Tableta

QM01AX92

11.1.2018.

31.1.2018.

MiPet Easecto

sarolaner

Zoetis Belgium S.A.

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

EU/2/17/220

Tablete za žvakanje

QP53BE03

2.2.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 9.1.2018. | Cortavance | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | EU/2/06/069 | 11.1.2018. |
| 9.1.2018. | Ypozane | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | EU/2/06/068 | 11.1.2018. |
| 12.1.2018. | Aftovaxpur Doe | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/153 | 16.1.2018. |
| 12.1.2018. | Leucofeligen FeLV/RCP | Virbac
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | EU/2/09/097 | 16.1.2018. |
| 12.1.2018. | Virbagen Omega | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | EU/2/01/030 | 16.1.2018. |
| 12.1.2018. | Zactran | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/08/082 | 16.1.2018. |
| 16.1.2018. | Semintra | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/146 | 18.1.2018. |
| 31.1.2018. | Meloxoral | Le Vet B.V.
  Wilgenweg 7, 3421 TV Oudewater, Nederland | EU/2/10/111 | 2.2.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

9.1.2018.

Cortavance

VIRBAC S.A.

1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France

EU/2/06/069

11.1.2018.

9.1.2018.

Ypozane

VIRBAC S.A.

1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France

EU/2/06/068

11.1.2018.

12.1.2018.

Aftovaxpur Doe

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/153

16.1.2018.

12.1.2018.

Leucofeligen FeLV/RCP

Virbac

1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France

EU/2/09/097

16.1.2018.

12.1.2018.

Virbagen Omega

VIRBAC S.A.

1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France

EU/2/01/030

16.1.2018.

12.1.2018.

Zactran

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/08/082

16.1.2018.

16.1.2018.

Semintra

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/146

18.1.2018.

31.1.2018.

Meloxoral

Le Vet B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/10/111

2.2.2018.

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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