# Službeni list C 433/30.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 433 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 61.30. studenoga 2018. |

ISSN 1977-1088

Službeni list

Europske unije

C 433

Hrvatsko izdanje

Informacije i objave

Godište 61.30. studenoga 2018.

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| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2018/C 433/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja do 2018. do 30. rujna 2018.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2018/C 433/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2018. do 31. listopada 2018.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 6 |

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2018/C 433/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja do 2018. do 30. rujna 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

2018/C 433/02

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

6

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| HR | |
| --- | --- |

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 30.11.2018 | HR | Službeni list Europske unije | C 433/1 |
| --- | --- | --- | --- |

30.11.2018

HR

Službeni list Europske unije

C 433/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja do 2018. do 30. rujna 2018.

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

(2018/C 433/01)

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

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 19.7.2018. | Carmustine Obvius | karmustin | Obvius Investment B.V.
  De Cuserstraat 93, 1081 CN Amsterdam, Nederland | EU/1/18/1278 | | L01AD01 | 23.7.2018. |

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

19.7.2018.

Carmustine Obvius

karmustin

Obvius Investment B.V.

De Cuserstraat 93, 1081 CN Amsterdam, Nederland

EU/1/18/1278

L01AD01

23.7.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 20.9.2018. | Dexxience | Portola Pharma UK Limited
  209 Tower Bridge Business Centre, 46-48 East Smithfield, London E1 W 1AW, United Kingdom | — | 16.10.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

20.9.2018.

Dexxience

Portola Pharma UK Limited

209 Tower Bridge Business Centre, 46-48 East Smithfield, London E1 W 1AW, United Kingdom

—

16.10.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 30.1.2018. | Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1133 | 1.2.2018. |
| 8.5.2018. | Riluzole Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/12/768 | 15.5.2018. |
| 19.7.2018. | Taxespira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/15/1017 | 23.7.2018. |
| 26.7.2018. | Defitelio | Gentium S.r.I.
  Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia | EU/1/13/878 | 30.7.2018. |
| 26.7.2018. | Mycamine | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/08/448 | 30.7.2018. |
| 26.7.2018. | Roteas | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/16/1152 | 30.9.2018. |
| 26.7.2018. | Xeljanz | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1178 | 30.7.2018. |
| 30.7.2018. | Arava | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/99/118 | 9.8.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

30.1.2018.

Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1133

1.2.2018.

8.5.2018.

Riluzole Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/12/768

15.5.2018.

19.7.2018.

Taxespira

Hospira UK Limited

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

EU/1/15/1017

23.7.2018.

26.7.2018.

Defitelio

Gentium S.r.I.

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

EU/1/13/878

30.7.2018.

26.7.2018.

Mycamine

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/08/448

30.7.2018.

26.7.2018.

Roteas

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/16/1152

30.9.2018.

26.7.2018.

Xeljanz

Pfizer Limited

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

EU/1/17/1178

30.7.2018.

30.7.2018.

Arava

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/99/118

9.8.2018.

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.2.2018. | Oxybee | dihidrat oksalne kiseline | Dany Bienenwohl GmbH
  Geyerspergerstraße 27, 80689 München, Deutschland | EU/2/17/216 | Prah i otopina za disperziju za košnice | QP53AG03 | 5.2.2018. |

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

1.2.2018.

Oxybee

dihidrat oksalne kiseline

Dany Bienenwohl GmbH

Geyerspergerstraße 27, 80689 München, Deutschland

EU/2/17/216

Prah i otopina za disperziju za košnice

QP53AG03

5.2.2018.

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.

---

| 30.11.2018 | HR | Službeni list Europske unije | C 433/6 |
| --- | --- | --- | --- |

30.11.2018

HR

Službeni list Europske unije

C 433/6

---

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

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

(2018/C 433/02)

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

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 31.10.2018. | Symkevi | tezakaftor/ivakaftor | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/18/1306 | Filmom obložena tableta | R07AX31 | 6.11.2018. |

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

31.10.2018.

Symkevi

tezakaftor/ivakaftor

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/18/1306

Filmom obložena tableta

R07AX31

6.11.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 4.10.2018. | Exviera | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/983 | 8.10.2018. |
| 4.10.2018. | Grastofil | Apotex Europe B.V.
  Archimedesweg 2, 2333 CN Leiden, Nederland | EU/1/13/877 | 8.10.2018. |
| 4.10.2018. | Palonosetron Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/16/1100 | 8.10.2018. |
| 10.10.2018. | Irbesartan Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/06/376 | 12.10.2018. |
| 10.10.2018. | Kalydeco | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/12/782 | 12.10.2018. |
| 11.10.2018. | Riximyo | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/17/1184 | 15.10.2018. |
| 16.10.2018. | ABILIFY MAINTENA | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Nederland | EU/1/13/882 | 18.10.2018. |
| 16.10.2018. | Kivexa | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/04/298 | 18.10.2018. |
| 16.10.2018. | Leflunomide Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/09/604 | 18.10.2018. |
| 16.10.2018. | Rapamune | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/01/171 | 18.10.2018. |
| 16.10.2018. | Sutent | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/06/347 | 18.10.2018. |
| 18.10.2018. | Evoltra | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/06/334 | 22.10.2018. |
| 18.10.2018. | Forsteo | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/03/247 | 22.10.2018. |
| 18.10.2018. | Irbesartan/Hydrochlorothiazide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/583 | 22.10.2018. |
| 18.10.2018. | Pemetrexed Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/15/1057 | 22.10.2018. |
| 18.10.2018. | Velphoro | Vifor Fresenius Medical Care Renal Pharma France
  100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Pariz la Défense Cedex, France | EU/1/14/943 | 22.10.2018. |
| 23.10.2018. | Cosentyx | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/980 | 25.10.2018. |
| 23.10.2018. | Micardis | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/98/090 | 25.10.2018. |
| 23.10.2018. | XALKORI | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/793 | 25.10.2018. |
| 23.10.2018. | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/13/846 | 25.10.2018. |
| 23.10.2018. | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 25.10.2018. |
| 25.10.2018. | Clopidogrel/Acetylsalicylic acid Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Pariz, France | EU/1/10/623 | 29.10.2018. |
| 25.10.2018. | Clopidogrel Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/08/465 | 29.10.2018. |
| 25.10.2018. | Cyltezo | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/17/1240 | 29.10.2018. |
| 25.10.2018. | DuoPlavin | Sanofi Clir SNC
  54 rue La Boétie, 75008 Pariz, France | EU/1/10/619 | 29.10.2018. |
| 25.10.2018. | Iscover | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Pariz, France | EU/1/98/070 | 29.10.2018. |
| 25.10.2018. | Plavix | Sanofi Clir SNC
  54 rue La Boétie, 75008 Pariz, France | EU/1/98/069 | 29.10.2018. |
| 25.10.2018. | Replagal | Shire Human Genetic Therapies AB
  Vasagatan 7, 111 20 Stockholm, Sverige | EU/1/01/189 | 29.10.2018. |
| 25.10.2018. | Sustiva | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/99/110 | 29.10.2018. |
| 25.10.2018. | Synflorix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/09/508 | 29.10.2018. |
| 29.10.2018. | AMGEVITA | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1164 | 31.10.2018. |
| 29.10.2018. | Evista | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/98/073 | 31.10.2018. |
| 29.10.2018. | Imraldi | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/17/1216 | 31.10.2018. |
| 29.10.2018. | Integrilin | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/99/109 | 31.10.2018. |
| 29.10.2018. | Protopic | Leo Pharma A/S
  Industriparken 55, 2750 Ballerup, Danmark | EU/1/02/201 | 1.11.2018. |
| 29.10.2018. | RoActemra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/08/492 | 31.10.2018. |
| 29.10.2018. | Taxespira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/15/1017 | 31.10.2018. |
| 29.10.2018. | Venclyxto | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/16/1138 | 31.10.2018. |
| 29.10.2018. | Volibris | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/08/451 | 31.10.2018. |
| 31.10.2018. | Arzerra | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/625 | 6.11.2018. |
| 31.10.2018. | Elebrato Ellipta | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1237 | 6.11.2018. |
| 31.10.2018. | Neulasta | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/02/227 | 6.11.2018. |
| 31.10.2018. | Samsca | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Nederland | EU/1/09/539 | 6.11.2018. |
| 31.10.2018. | Trelegy Ellipta | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1236 | 6.11.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

4.10.2018.

Exviera

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

8.10.2018.

4.10.2018.

Grastofil

Apotex Europe B.V.

Archimedesweg 2, 2333 CN Leiden, Nederland

EU/1/13/877

8.10.2018.

4.10.2018.

Palonosetron Hospira

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/16/1100

8.10.2018.

10.10.2018.

Irbesartan Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/06/376

12.10.2018.

10.10.2018.

Kalydeco

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/12/782

12.10.2018.

11.10.2018.

Riximyo

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1184

15.10.2018.

16.10.2018.

ABILIFY MAINTENA

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/13/882

18.10.2018.

16.10.2018.

Kivexa

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/04/298

18.10.2018.

16.10.2018.

Leflunomide Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/09/604

18.10.2018.

16.10.2018.

Rapamune

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/01/171

18.10.2018.

16.10.2018.

Sutent

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/06/347

18.10.2018.

18.10.2018.

Evoltra

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/06/334

22.10.2018.

18.10.2018.

Forsteo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/03/247

22.10.2018.

18.10.2018.

Irbesartan/Hydrochlorothiazide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/583

22.10.2018.

18.10.2018.

Pemetrexed Hospira

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/15/1057

22.10.2018.

18.10.2018.

Velphoro

Vifor Fresenius Medical Care Renal Pharma France

100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Pariz la Défense Cedex, France

EU/1/14/943

22.10.2018.

23.10.2018.

Cosentyx

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/14/980

25.10.2018.

23.10.2018.

Micardis

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/98/090

25.10.2018.

23.10.2018.

XALKORI

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/12/793

25.10.2018.

23.10.2018.

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/13/846

25.10.2018.

23.10.2018.

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

25.10.2018.

25.10.2018.

Clopidogrel/Acetylsalicylic acid Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Pariz, France

EU/1/10/623

29.10.2018.

25.10.2018.

Clopidogrel Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/08/465

29.10.2018.

25.10.2018.

Cyltezo

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/17/1240

29.10.2018.

25.10.2018.

DuoPlavin

Sanofi Clir SNC

54 rue La Boétie, 75008 Pariz, France

EU/1/10/619

29.10.2018.

25.10.2018.

Iscover

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Pariz, France

EU/1/98/070

29.10.2018.

25.10.2018.

Plavix

Sanofi Clir SNC

54 rue La Boétie, 75008 Pariz, France

EU/1/98/069

29.10.2018.

25.10.2018.

Replagal

Shire Human Genetic Therapies AB

Vasagatan 7, 111 20 Stockholm, Sverige

EU/1/01/189

29.10.2018.

25.10.2018.

Sustiva

Bristol-Myers Squibb Pharma EEIG

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

EU/1/99/110

29.10.2018.

25.10.2018.

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/09/508

29.10.2018.

29.10.2018.

AMGEVITA

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1164

31.10.2018.

29.10.2018.

Evista

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/98/073

31.10.2018.

29.10.2018.

Imraldi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1216

31.10.2018.

29.10.2018.

Integrilin

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/99/109

31.10.2018.

29.10.2018.

Protopic

Leo Pharma A/S

Industriparken 55, 2750 Ballerup, Danmark

EU/1/02/201

1.11.2018.

29.10.2018.

RoActemra

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/08/492

31.10.2018.

29.10.2018.

Taxespira

Hospira UK Limited

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

EU/1/15/1017

31.10.2018.

29.10.2018.

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

31.10.2018.

29.10.2018.

Volibris

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/08/451

31.10.2018.

31.10.2018.

Arzerra

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/10/625

6.11.2018.

31.10.2018.

Elebrato Ellipta

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1237

6.11.2018.

31.10.2018.

Neulasta

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/227

6.11.2018.

31.10.2018.

Samsca

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/09/539

6.11.2018.

31.10.2018.

Trelegy Ellipta

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1236

6.11.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 29.10.2018. | Lusduna | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1162 | 31.10.2018. |
| 30.10.2018. | Taxespira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/15/1017 | 1.11.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

29.10.2018.

Lusduna

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1162

31.10.2018.

30.10.2018.

Taxespira

Hospira UK Limited

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

EU/1/15/1017

1.11.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 17.10.2018. | Recocam | Bimeda Animal Health Limited
  2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland | EU/2/11/133 | 19.10.2018. |
| 18.10.2018. | NexGard | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/159 | 22.10.2018. |
| 18.10.2018. | NEXGARD SPECTRA | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/14/177 | 22.10.2018. |
| 23.10.2018. | Canigen L4 | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/15/183 | 25.10.2018. |
| 30.10.2018. | Dexdomitor | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/2/02/033 | 1.11.2018. |
| 30.10.2018. | Improvac | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/095 | 5.11.2018. |
| 30.10.2018. | Zolvix | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/09/101 | 1.11.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

17.10.2018.

Recocam

Bimeda Animal Health Limited

2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland

EU/2/11/133

19.10.2018.

18.10.2018.

NexGard

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/159

22.10.2018.

18.10.2018.

NEXGARD SPECTRA

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/14/177

22.10.2018.

23.10.2018.

Canigen L4

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/183

25.10.2018.

30.10.2018.

Dexdomitor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/02/033

1.11.2018.

30.10.2018.

Improvac

Zoetis Belgium S.A.

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

EU/2/09/095

5.11.2018.

30.10.2018.

Zolvix

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/09/101

1.11.2018.

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

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

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