26.6.2020   

HR

Službeni list Europske unije

C 213/3


Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. svibnja 2020. do 31. svibnja 2020.

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

(2020/C 213/02)

—   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

18.5.2020.

Zolgensma

onasemnogen abeparvovek

AveXis EU Limited

Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland

EU/1/20/1443

Otopina za infuziju

M09AX09

18.5.2020.

20.5.2020.

Fluad Tetra

Cjepivo protiv influence (površinski antigen) inaktivirano, adjuvantirano

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Netherlands

EU/1/20/1433

Suspenzija za injekciju u napunjenoj štrcaljki (injekcija).

J07BB02

26.5.2020.

20.5.2020.

Nepexto

etanercept

Mylan IRE Healthcare Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 Ireland

EU/1/20/1436

Otopina za injekciju

L04AB01

29.5.2020.

30.5.2020.

Atectura Breezhaler

indakaterol/mometazonfuroat

Novartis Europharm Limited

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

EU/1/20/1439

Prašak inhalata, tvrda kapsula

R03AK14

2.6.2020.

30.5.2020.

Bemrist Breezhaler

indakaterol/mometazonfuroat

Novartis Europharm Limited

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

EU/1/20/1441

Prašak inhalata, tvrda kapsula

R03AK

2.6.2020.

30.5.2020.

Sarclisa

isatuksimab

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Pariz, France

EU/1/20/1435

Koncentrat za otopinu za infuziju

L01XC38

3.6.2020.

—   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

4.5.2020.

Axura

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

EU/1/02/218

8.5.2020.

4.5.2020.

Bortezomib Accord

Accord Healthcare S.L.U.

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

EU/1/15/1019

12.5.2020.

4.5.2020.

Bronchitol

Pharmaxis Europe Limited

108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland

EU/1/12/760

5.5.2020.

4.5.2020.

Clopidogrel Apotex

Apotex Europe B.V.

Archimedesweg 2, 2333 CN Leiden, Nederland

EU/1/09/568

6.5.2020.

4.5.2020.

Clopidogrel Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/09/559

5.5.2020.

4.5.2020.

Clopidogrel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/540

7.5.2020.

4.5.2020.

Cystadrops

Recordati Rare Diseases

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

EU/1/15/1049

6.5.2020.

4.5.2020.

Ferriprox

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/99/108

7.5.2020.

4.5.2020.

Grepid

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535

5.5.2020.

4.5.2020.

Ilumetri

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/18/1323

5.5.2020.

4.5.2020.

Pemetrexed Krka

KRKA, d.d.

Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/18/1283

12.5.2020.

4.5.2020.

Pemetrexed medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/15/1038

12.5.2020.

4.5.2020.

Raxone

Santhera Pharmaceuticals (Deutschland) GmbH

Marie-Curie Straße 8, 79539 Lörrach, Deutschland

EU/1/15/1020

14.5.2020.

4.5.2020.

Tafinlar

Novartis Europharm Limited

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

EU/1/13/865

8.5.2020.

4.5.2020.

Wilzin

Recordati Rare Diseases

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

EU/1/04/286

5.5.2020.

4.5.2020.

Xultophy

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/14/947

6.5.2020.

5.5.2020.

Naglazyme

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork P43 R298, Ireland

EU/1/05/324

6.5.2020.

12.5.2020.

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

19.5.2020.

12.5.2020.

Clopidogrel Krka

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556

13.5.2020.

12.5.2020.

Movymia

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/16/1161

13.5.2020.

12.5.2020.

Pemetrexed Hospira

Pfizer Europe MA EEIG

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

EU/1/15/1057

14.5.2020.

12.5.2020.

Segluromet

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1265

14.5.2020.

12.5.2020.

Steglatro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1267

14.5.2020.

12.5.2020.

Steglujan

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1266

14.5.2020.

12.5.2020.

Vedrop

Recordati Rare Diseases

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

EU/1/09/533

13.5.2020.

14.5.2020.

Clopidogrel Krka d.d.

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

18.5.2020.

14.5.2020.

Firdapse

SERB S.A.

Avenue Louise 480, 1050 Bruxelles, Belgique/Louizalaan 480, 1050 Brussel, België

EU/1/09/601

15.5.2020.

14.5.2020.

Yellox

Bausch Health Ireland Limited

3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

EU/1/11/692

15.5.2020.

18.5.2020.

Signifor

Recordati Rare Diseases

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

EU/1/12/753

19.5.2020.

20.5.2020.

Daxas

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/636

28.5.2020.

20.5.2020.

Ivabradine Anpharm

ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.

ul. Annopol 6B, 03–236 Warszawa, Polska

EU/1/15/1041

25.5.2020.

20.5.2020.

Jorveza

Dr. Falk Pharma GmbH

Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland

EU/1/17/1254

26.5.2020.

20.5.2020.

Lenvima

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/15/1002

26.5.2020.

20.5.2020.

LIBTAYO

Regeneron Ireland Designated Activity Company (DAC)

Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland

EU/1/19/1376

26.5.2020.

20.5.2020.

Nplate

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/08/497

25.5.2020.

20.5.2020.

Odomzo

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/15/1030

28.5.2020.

20.5.2020.

Onpattro

Alnylam Netherlands B.V.

Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland

EU/1/18/1320

25.5.2020.

20.5.2020.

Pregabalin Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1021

25.5.2020.

20.5.2020.

Revestive

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland

EU/1/12/787

11.6.2020.

20.5.2020.

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

25.5.2020.

—   Izmjena 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

20.5.2020.

Emgality

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/18/1330

27.5.2020.

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

18.5.2020.

Lydaxx

tulatromicin

VETOQUINOL S.A.

Magny-Vernois, 70200 Lure, France

EU/2/20/253

Otopina za injekciju

QJ01FA94

19.5.2020.

—   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

4.5.2020.

Apoquel

Zoetis Belgium S.A.

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

EU/2/13/154

7.5.2020.

4.5.2020.

Loxicom

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate, Monaghan, Ireland

EU/2/08/090

7.5.2020.

12.5.2020.

Equilis Prequenza Te

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/057

15.5.2020.

18.5.2020.

Equilis Prequenza

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/056

20.5.2020.

18.5.2020.

Equilis Te

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/055

20.5.2020.

27.5.2020.

CYTOPOINT

Zoetis Belgium S.A.

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

EU/2/17/205

27.5.2020.

27.5.2020.

Porcilis PCV ID

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/187

2.6.2020.

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

NETHERLANDS


(1)  SL L 136, 30.4.2004., str. 1.