# Službeni list C 435/2019

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 435 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 62.27. prosinca 2019. |

ISSN 1977-1088

Službeni list

Europske unije

C 435

Hrvatsko izdanje

Informacije i objave

Godište 62.27. prosinca 2019.

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| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2019/C 435/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenoga 2019. do 30. studenoga 2019. (Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća ) | 1 |

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2019/C 435/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenoga 2019. do 30. studenoga 2019. (Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća )

1

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

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 27.12.2019 | HR | Službeni list Europske unije | C 435/1 |
| --- | --- | --- | --- |

27.12.2019

HR

Službeni list Europske unije

C 435/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenoga 2019. do 30. studenoga 2019.

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

(2019/C 435/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.11.2019 | Ervebo | Cjepivo protiv Zair Ebolavirusa (rVSVΔG-ZEBOV-GP, živo) | Merck Sharp & Dohme B.V. |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

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

11.11.2019

Ervebo

Cjepivo protiv Zair Ebolavirusa (rVSVΔG-ZEBOV-GP, živo)

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/19/1392

Otopina za injekciju

J07BX02

13.11.2019

11.11.2019

Qtrilmet

metforminklorid/ saksagliptin/ dapagliflozin

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/19/1401

Tableta s prilagođenim oslobađanjem

A10BD25

13.11.2019

14.11.2019

Arsenic Trioxide Accord

arsenov trioksid

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/19/1398

Koncentrat za otopinu za infuziju

L01XX27

18.11.2019

14.11.2019

Bortezomib Fresenius Kabi

bortezomib

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/19/1397

Prašak za otopinu za injekciju

L01XX32

18.11.2019

14.11.2019

Ivozall

klofarabin

| ORPHELIA Pharma SAS |
| --- |
| 85 boulevard Saint-Michel, 75005 Paris, France |

ORPHELIA Pharma SAS

85 boulevard Saint-Michel, 75005 Paris, France

EU/1/19/1396

Koncentrat za otopinu za infuziju

L01BB06

18.11.2019

14.11.2019

Senstend

lidokain / prilokain

| Plethora Pharma Solutions Ltd. |
| --- |
| 32 Merrion Street Upper, Dublin 2, Ireland |

Plethora Pharma Solutions Ltd.

32 Merrion Street Upper, Dublin 2, Ireland

EU/1/19/1387

Sprej za kožu, otopina

N01BB20

18.11.2019

19.11.2019

Rhokiinsa

netarsudil

| Aerie Pharmaceuticals Ireland Ltd |
| --- |
| Athlone Business and Technology Park, Dublin Road, Garrycastle, Athlone, Co Westmeath, N37 DW40, IRELAND |

Aerie Pharmaceuticals Ireland Ltd

Athlone Business and Technology Park, Dublin Road, Garrycastle, Athlone, Co Westmeath, N37 DW40, IRELAND

EU/1/19/1400

Kapi za oko, otopina

S01EX05

21.11.2019

| — | 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 |
| --- | --- | --- | --- | --- |
| 4.11.2019 | Efavirenz Teva | Teva B.V. |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

4.11.2019

Efavirenz Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/742

6.11.2019

4.11.2019

Farydak

| Secura Bio Limited |
| --- |
| 32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland |

Secura Bio Limited

32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland

EU/1/15/1023

6.11.2019

4.11.2019

PritorPlus

| Bayer AG |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/02/215

6.11.2019

4.11.2019

Tivicay

| ViiV Healthcare BV |
| --- |
| Huis ter Heideweg 62, 3705 LZ Zeist, Nederland |

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/13/892

6.11.2019

4.11.2019

Tresiba

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/12/807

6.11.2019

4.11.2019

Vosevi

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/17/1223

6.11.2019

7.11.2019

Abseamed

| Medice Arzneimittel Pütter GmbH & Co KG |
| --- |
| Kuhloweg 37, 58638 Iserlohn, Deutschland |

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37, 58638 Iserlohn, Deutschland

EU/1/07/412

11.11.2019

7.11.2019

Comtan

| Orion Corporation |
| --- |
| Orionintie 1, 02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/98/081

11.11.2019

7.11.2019

Intelence

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/468

12.11.2019

7.11.2019

Ketoconazole HRA

| HRA Pharma Rare Diseases |
| --- |
| 200 avenue de Paris, 92 320 Chatillon, France |

HRA Pharma Rare Diseases

200 avenue de Paris, 92 320 Chatillon, France

EU/1/14/965

12.11.2019

7.11.2019

Targretin

| Eisai GmbH |
| --- |
| Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland |

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/01/178

11.11.2019

11.11.2019

Abraxane

| Celgene Europe B.V. |
| --- |
| Winthontlaan 6 N, 3526 KV Utrecht, Nederland |

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/07/428

13.11.2019

11.11.2019

Aprovel

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/97/046

13.11.2019

11.11.2019

Clopidogrel ratiopharm

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/975

13.11.2019

11.11.2019

CoAprovel

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/086

13.11.2019

11.11.2019

DUAVIVE

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

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

EU/1/14/960

13.11.2019

11.11.2019

Erivedge

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

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

EU/1/13/848

13.11.2019

11.11.2019

Esbriet

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

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

EU/1/11/667

13.11.2019

11.11.2019

Inlyta

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

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

EU/1/12/777

13.11.2019

11.11.2019

Pelmeg

| Mundipharma Biologics S.L. |
| --- |
| Calle García Ximénez, no3-1o, 31002 Pamplona (Navarra), España |

Mundipharma Biologics S.L.

Calle García Ximénez, no3-1o, 31002 Pamplona (Navarra), España

EU/1/18/1328

13.11.2019

11.11.2019

Picato

| LEO Laboratories Ltd |
| --- |
| 285 Cashel Road, Crumlin, Dublin 12, Ireland |

LEO Laboratories Ltd

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

13.11.2019

11.11.2019

Sevelamer carbonate Winthrop

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/14/952

13.11.2019

14.11.2019

Actelsar HCT

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland |

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/817

18.11.2019

14.11.2019

Benepali

| Samsung Bioepis NL B.V. |
| --- |
| Olof Palmestraat 10, 2616 LR Delft, Nederland |

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/15/1074

18.11.2019

14.11.2019

Binocrit

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/07/410

18.11.2019

14.11.2019

Cholestagel

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/03/268

25.11.2019

14.11.2019

Cubicin

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/328

18.11.2019

14.11.2019

DuoPlavin

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/10/619

18.11.2019

14.11.2019

Enbrel

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

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

EU/1/99/126

18.11.2019

14.11.2019

Epoetin alfa Hexal

| Hexal AG |
| --- |
| Industriestraße 25, 83607 Holzkirchen, Deutschland |

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/07/411

18.11.2019

14.11.2019

Erelzi

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1195

18.11.2019

14.11.2019

Evoltra

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/06/334

18.11.2019

14.11.2019

EVOTAZ

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/15/1025

18.11.2019

14.11.2019

Kentera

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/03/270

18.11.2019

14.11.2019

KEYTRUDA

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

18.11.2019

14.11.2019

Kyprolis

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

18.11.2019

14.11.2019

Plavix

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/069

18.11.2019

14.11.2019

Ritonavir Mylan

| Mylan S.A.S. |
| --- |
| 117 allée des Parcs, 69800 Saint Priest, France |

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1242

18.11.2019

14.11.2019

Rixubis

| Baxalta Innovations GmbH |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/14/970

18.11.2019

14.11.2019

Stocrin

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/111

18.11.2019

14.11.2019

Tasigna

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/07/422

18.11.2019

14.11.2019

Taxotere

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, 92165 Antony CEDEX, France |

Aventis Pharma S.A.

20 avenue Raymond Aron, 92165 Antony CEDEX, France

EU/1/95/002

18.11.2019

14.11.2019

Tecfidera

| Biogen Netherlands B.V. |
| --- |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/13/837

18.11.2019

14.11.2019

Trevicta

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/971

18.11.2019

14.11.2019

Xenical

| CHEPLAPHARM Arzneimittel GmbH |
| --- |
| Ziegelhof 24, 17489 Greifswald, Deutschland |

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/98/071

18.11.2019

19.11.2019

Alunbrig

| Takeda Pharma A/S |
| --- |
| Dybendal Alle 10, 2630 Taastrup, Danmark |

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/18/1264

21.11.2019

19.11.2019

BeneFIX

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

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

EU/1/97/047

21.11.2019

19.11.2019

Brineura

| BioMarin International Limited |
| --- |
| Shanbally, Ringaskiddy, County Cork, Ireland |

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/17/1192

21.11.2019

19.11.2019

Darzalex

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

21.11.2019

19.11.2019

Efient

| Daiichi Sankyo Europe GmbH |
| --- |
| Zielstattstraße 48, 81379 München, Deutschland |

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/08/503

21.11.2019

19.11.2019

Fulphila

| Mylan S.A.S. |
| --- |
| 117 allée des Parcs, 69800 Saint Priest, France |

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1329

21.11.2019

19.11.2019

Hulio

| Mylan S.A.S. |
| --- |
| 117 allée des Parcs, 69800 Saint Priest, France |

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1319

21.11.2019

19.11.2019

IBRANCE

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

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

EU/1/16/1147

21.11.2019

19.11.2019

Juluca

| ViiV Healthcare BV |
| --- |
| Huis ter Heideweg 62, 3705 LZ Zeist, Nederland |

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/18/1282

21.11.2019

19.11.2019

Prevenar 13

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

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

EU/1/09/590

21.11.2019

19.11.2019

Repatha

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1016

21.11.2019

19.11.2019

SCENESSE

| Clinuvel Europe Limited |
| --- |
| 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland |

Clinuvel Europe Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/14/969

21.11.2019

19.11.2019

Xermelo

| Ipsen Pharma |
| --- |
| 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/17/1224

21.11.2019

19.11.2019

Xgeva

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703

21.11.2019

22.11.2019

Feraccru

| Norgine B.V. |
| --- |
| Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland |

Norgine B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/15/1075

26.11.2019

22.11.2019

Lamivudine Teva Pharma B.V.

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/596

26.11.2019

22.11.2019

Myozyme

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/06/333

26.11.2019

22.11.2019

Neulasta

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/227

26.11.2019

22.11.2019

Olumiant

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

26.11.2019

22.11.2019

Pelgraz

| Accord Healthcare S.L.U. |
| --- |
| Edificio Est Planta 6, Word trade Center, Moll De Barcelona S/N, Edifici Est 6a planta, 08039 Barcelona, Spain |

Accord Healthcare S.L.U.

Edificio Est Planta 6, Word trade Center, Moll De Barcelona S/N, Edifici Est 6a planta, 08039 Barcelona, Spain

EU/1/18/1313

26.11.2019

22.11.2019

Remsima

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/13/853

26.11.2019

22.11.2019

Senshio

| Shionogi B.V. |
| --- |
| Kingsfordweg 151, 1043GR Amsterdam, Nederland |

Shionogi B.V.

Kingsfordweg 151, 1043GR Amsterdam, Nederland

EU/1/14/978

26.11.2019

22.11.2019

Udenyca

| ERA Consulting GmbH |
| --- |
| Lange Straße 70, 29664 Walsrode, Deutschland |

ERA Consulting GmbH

Lange Straße 70, 29664 Walsrode, Deutschland

EU/1/18/1303

26.11.2019

22.11.2019

Vyndaqel

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

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

EU/1/11/717

26.11.2019

28.11.2019

Fabrazyme

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/01/188

2.12.2019

28.11.2019

Foclivia

| Seqirus S.r.l., |
| --- |
| Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia |

Seqirus S.r.l.,

Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia

EU/1/09/577

2.12.2019

28.11.2019

Pemetrexed Pfizer

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

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

EU/1/17/1183

2.12.2019

28.11.2019

Toujeo

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133

2.12.2019

28.11.2019

Xiapex

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| 112 76 Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/11/671

2.12.2019

28.11.2019

Ziextenzo

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1327

2.12.2019

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.11.2019 | GUMBOHATCH | Cjepivo za ptičju zaraznu bursalnu bolest (živo) | Laboratorios Hipra, S.A. |
| Avda. La Selva, 135, 17170 Amer (Girona), España |

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

12.11.2019

GUMBOHATCH

Cjepivo za ptičju zaraznu bursalnu bolest (živo)

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/19/245

Liofilizat i otapalo, suspenzija za injekciju

QI01AD09

14.11.2019

19.11.2019

Nobivac Myxo-RHD PLUS

Cjepivo protiv virusne bolesti miksomatoze i hemoragične bolesti kunića (živo rekombinirano)

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/19/244

Liofilizat i otapalo, suspenzija za injekciju

QI08AD

21.11.2019

| — | 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 |
| --- | --- | --- | --- | --- |
| 11.11.2019 | Bovela | Boehringer Ingelheim Vetmedica GmbH |
| D-55216 Ingelheim am Rhein, Deutschland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

11.11.2019

Bovela

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/14/176

13.11.2019

11.11.2019

Cerenia

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

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

EU/2/06/062

13.11.2019

11.11.2019

NEXGARD SPECTRA

| Merial |
| --- |
| 29 avenue Tony Garnier, 69007 Lyon, France |

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/14/177

13.11.2019

11.11.2019

Suvaxyn CSF Marker

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

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

EU/2/14/179

13.11.2019

12.11.2019

Naxcel

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

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

EU/2/05/053

14.11.2019

12.11.2019

RHINISENG

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, 17170 Amer (Girona), España |

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/10/109

14.11.2019

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 |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| The Netherlands |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

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

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