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Document C:2023:037:FULL

Službeni list Europske unije, C 37, 31. siječnja 2023.


Display all documents published in this Official Journal
 

ISSN 1977-1088

Službeni list

Europske unije

C 37
European flag  

Hrvatsko izdanje

Informacije i objave

Godište 66.
31. siječnja 2023.

Sadržaj

Stranica

 

IV.   Obavijesti

 

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

 

Europska komisija

2023/C 37/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2022. do 31. prosinca 2022.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća ili člankom 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća)

1

HR

 

IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

31.1.2023   

HR

Službeni list Europske unije

C 37/1

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2022. do 31. prosinca 2022.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1) ili člankom 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća (2))

(2023/C 37/01)

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

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

2.12.2022.

Mycapssa

oktreotid

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/22/1690

Želučanootporna tvrda kapsula

H01CB02

5.12.2022.

5.12.2022.

Qdenga

četverovalentno cjepivo protiv denge (živo, atenuirano)

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/22/1699

Prašak i otapalo za otopinu za injekciju

J07BX04

6.12.2022.

9.12.2022.

Livmarli

maraliksibatklorid

Mirum Pharmaceuticals International B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland

EU/1/22/1704

Peroralna otopina

A05AX04

12.12.2022.

9.12.2022.

Locametz

gozetotid

Novartis Europharm Limited

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

EU/1/22/1692

Prašak za otopinu za injekciju

V09IX14

12.12.2022.

9.12.2022.

Pemetreksed Baxter

pemetrekseda

Baxter Holding B.V.

Kobaltweg 49, 3542 CE Utrecht, Nederland

EU/1/22/1705

Prašak za koncentrat za otopinu za infuziju

L01BA04

13.12.2022.

9.12.2022.

Pluvicto

lutecij[177Lu]vipivotidtetraksetan

Novartis Europharm Limited

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

EU/1/22/1703

otopina za injekciju ili infuziju

V10XX05

12.12.2022.

9.12.2022.

Spevigo

spezolimab

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/22/1688

Koncentrat za otopinu za infuziju

L04AC22

12.12.2022.

12.12.2022.

Dimethyl Fumarate Teva

dimetilfumarat

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/22/1702

Želučanootporna tvrda kapsula

L04AX07

3.1.2023.

12.12.2022.

Eladynos

abaloparatid

Radius Health (Ireland) Ltd.

13 Classon House, Dundrum Business Park, Dundrum, Dublin D14 W9Y3, Ireland

EU/1/22/1706

Otopina za injekciju

H05AA04

13.12.2022.

16.12.2022.

Ebvallo

Tabelekleucel

Atara Biotherapeutics Ireland Limited

Arthur Cox Building, 10 Earlsfort Terrace, Dublin 2 D02 T380, Ireland

EU/1/22/1700

Disperzija za injekciju

Pending

16.12.2022.

16.12.2022.

Plerixafor Accord

pleriksafor

Accord Healthcare S.L.U.

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

EU/1/22/1701

Otopina za injekciju

L03AX16

19.12.2022.

20.12.2022.

Zynlonta

lonkastuksimab tesirin

ADC Therapeutics (NL) B.V.

Laarderhoogtweg 25, Amsterdam, Noord-Holland, 1101 EB, Nederland

EU/1/22/1695

Prašak za koncentrat za otopinu za infuziju

L01FX22

22.12.2022.

—   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

2.12.2022.

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

2.12.2022.

2.12.2022.

DuoPlavin

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/10/619

5.12.2022.

2.12.2022.

Kaftrio

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland

EU/1/20/1468

5.12.2022.

2.12.2022.

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland

EU/1/12/782

5.12.2022.

2.12.2022.

QINLOCK

Deciphera Pharmaceuticals (Netherlands) B.V.

Atrium Building Floor 4th, Strawinskylaan 3051, Amsterdam, Noord-Holland, 1077 ZX, Nederland

EU/1/21/1569

8.12.2022.

2.12.2022.

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/050

7.12.2022.

2.12.2022.

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España

EU/1/20/1507

7.12.2022.

2.12.2022.

Trizivir

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/00/156

5.12.2022.

2.12.2022.

Trogarzo

Theratechnologies Europe Limited

4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland

EU/1/19/1359

14.12.2022.

2.12.2022.

Trydonis

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1274

5.12.2022.

2.12.2022.

Zyclara

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/12/783

6.12.2022.

5.12.2022.

Shingrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

6.12.2022.

5.12.2022.

Steglujan

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1266

6.12.2022.

5.12.2022.

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

6.12.2022.

9.12.2022.

Abevmy

Mylan IRE Healthcare Limited

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

EU/1/20/1515

14.12.2022.

9.12.2022.

Atriance

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57, 1000 Ljubljana, Slovenija

EU/1/07/403

12.12.2022.

9.12.2022.

Aybintio

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/20/1454

13.12.2022.

9.12.2022.

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

15.12.2022.

9.12.2022.

Deferiprone Lipomed

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/18/1310

12.12.2022.

9.12.2022.

Duaklir Genuair

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/14/964

12.12.2022.

9.12.2022.

Eklira Genuair

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/12/778

14.12.2022.

9.12.2022.

Erleada

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/18/1342

12.12.2022.

9.12.2022.

Eylea

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

13.12.2022.

9.12.2022.

Herzuma

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1257

14.12.2022.

9.12.2022.

Insulin aspart Sanofi

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1447

13.12.2022.

9.12.2022.

Insulin lispro Sanofi

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1203

13.12.2022.

9.12.2022.

Onbevzi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/20/1499

13.12.2022.

9.12.2022.

Oyavas

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/20/1510

12.12.2022.

9.12.2022.

Qarziba

EUSA Pharma (Netherlands) B.V.

Beechavenue 54, 1119PW Schiphol-Rijk, Nederland

EU/1/17/1191

14.12.2022.

9.12.2022.

Retsevmo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

12.12.2022.

9.12.2022.

Riarify

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1275

12.12.2022.

9.12.2022.

Spravato

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/19/1410

12.12.2022.

9.12.2022.

Suliqua

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/16/1157

13.12.2022.

9.12.2022.

Vaxelis

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden, Nederland

EU/1/15/1079

13.12.2022.

9.12.2022.

Vydura

Pfizer Europe MA EEIG

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

EU/1/22/1645

12.12.2022.

9.12.2022.

Xydalba

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/986

12.12.2022.

9.12.2022.

Zirabev

Pfizer Europe MA EEIG

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

EU/1/18/1344

12.12.2022.

12.12.2022.

Alymsys

Mabxience Research SL

C/ Manuel Pombo Angulo 28 – 3a y 4a Planta, 28050 Madrid, España

EU/1/20/1509

13.12.2022.

12.12.2022.

Cablivi

Ablynx N.V.

Technologiepark 21, 9052 Zwijnaarde, België

EU/1/18/1305

21.12.2022.

12.12.2022.

Dificlir

Tillotts Pharma GmbH

Warmbacher Strasse 80, 79618 Rheinfelden, Deutschland

EU/1/11/733

13.12.2022.

12.12.2022.

DuoPlavin

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/10/619

14.12.2022.

12.12.2022.

Dupixent

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1229

13.12.2022.

12.12.2022.

Enhertu

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

13.12.2022.

12.12.2022.

Karvezide

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/085

13.12.2022.

12.12.2022.

Kisqali

Novartis Europharm Limited

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

EU/1/17/1221

13.12.2022.

12.12.2022.

Refixia

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1193

13.12.2022.

16.12.2022.

Avastin

Roche Registration GmbH

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

EU/1/04/300

19.12.2022.

16.12.2022.

Bretaris Genuair

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/12/781

3.1.2023.

16.12.2022.

Brilique

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/655

19.12.2022.

16.12.2022.

Brimica Genuair

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/14/963

19.12.2022.

16.12.2022.

Caprelsa

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/11/749

19.12.2022.

16.12.2022.

Ceprotin

Baxter AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/01/190

19.12.2022.

16.12.2022.

Combivir

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/98/058

19.12.2022.

16.12.2022.

Corbilta

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/13/859

20.12.2022.

16.12.2022.

DUAVIVE

Pfizer Europe MA EEIG

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

EU/1/14/960

20.12.2022.

16.12.2022.

DuoPlavin

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/10/619

19.12.2022.

16.12.2022.

Dupixent

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1229

19.12.2022.

16.12.2022.

Eptifibatid Accord

Accord Healthcare S.L.U.

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

EU/1/15/1065

19.12.2022.

16.12.2022.

Granpidam

Accord Healthcare S.L.U.

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

EU/1/16/1137

19.12.2022.

16.12.2022.

Imatinib Accord

Accord Healthcare S.L.U.

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

EU/1/13/845

19.12.2022.

16.12.2022.

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

19.12.2022.

16.12.2022.

Inhixa

Techdow Pharma Netherlands B.V.

Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland

EU/1/16/1132

22.12.2022.

16.12.2022.

Intuniv

Takeda Pharmaceuticals International AG Ireland Branch

Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/15/1040

20.12.2022.

16.12.2022.

Iscover

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/070

19.12.2022.

16.12.2022.

Iscover

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/070

19.12.2022.

16.12.2022.

Iscover

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/070

19.12.2022.

16.12.2022.

Karvea

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/97/049

20.12.2022.

16.12.2022.

Levodopa/Carbidopa/Entacapone Orion

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/706

21.12.2022.

16.12.2022.

Lynparza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

19.12.2022.

16.12.2022.

Moventig

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/14/962

21.12.2022.

16.12.2022.

Mvabea

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1445

20.12.2022.

16.12.2022.

Myalepta

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/18/1276

21.12.2022.

16.12.2022.

Neulasta

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/227

20.12.2022.

16.12.2022.

Ocaliva

ADVANZ PHARMA Limited

Suite 17, Northwood House, Northwood Avenue, Santry, Dublin 9, Ireland

EU/1/16/1139

19.12.2022.

16.12.2022.

Ozawade

Bioprojet Pharma

9 rue Rameau, 75002 Paris, France

EU/1/21/1546

19.12.2022.

16.12.2022.

Plavix

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/069

19.12.2022.

16.12.2022.

Plavix

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/069

19.12.2022.

16.12.2022.

Plavix

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/069

19.12.2022.

16.12.2022.

Resolor

Takeda Pharmaceuticals International AG Ireland Branch

Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland

EU/1/09/581

20.12.2022.

16.12.2022.

Rybelsus

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/20/1430

20.12.2022.

16.12.2022.

Sarclisa

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1435

19.12.2022.

16.12.2022.

Saxenda

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/15/992

19.12.2022.

16.12.2022.

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España

EU/1/20/1507

19.12.2022.

16.12.2022.

Trajenta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/11/707

19.12.2022.

16.12.2022.

Tresiba

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/12/807

20.12.2022.

16.12.2022.

Truvelog Mix 30

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/22/1639

19.12.2022.

16.12.2022.

Twynsta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/10/648

3.1.2023.

16.12.2022.

Zoledronic acid Accord

Accord Healthcare S.L.U.

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

EU/1/13/834

19.12.2022.

19.12.2022.

Inrebic

Bristol-Myers Squibb Pharma EEIG

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

EU/1/20/1514

20.12.2022.

20.12.2022.

Ibandronic acid Accord

Accord Healthcare S.L.U.

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

EU/1/12/798

22.12.2022.

20.12.2022.

Mvasi

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

EU/1/17/1246

4.1.2023.

20.12.2022.

Rivaroxaban Accord

Accord Healthcare S.L.U.

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

EU/1/20/1488

22.12.2022.

20.12.2022.

Sarclisa

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1435

21.12.2022.

20.12.2022.

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/901

21.12.2022.

20.12.2022.

Skytrofa

Ascendis Pharma Endocrinology Division A/S

Tuborg Boulevard 12, 2900 Hellerup, Danmark

EU/1/21/1607

21.12.2022.

22.12.2022.

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

22.12.2022.

22.12.2022.

Paxlovid

Pfizer Europe MA EEIG

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

EU/1/22/1625

22.12.2022.

—   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

5.12.2022.

Trogarzo

Theratechnologies Europe Limited

4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland

EU/1/19/1359

5.1.2023.

9.12.2022.

NeuroBloc

Sloan Pharma S.a.r.l.

33 Rue de Puits Romain, 8070 Bertrange, Luxembourg

EU/1/00/166

12.12.2022.

—   Izdavanje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća; Članak 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća): Prihvaćeno

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

20.12.2022.

NEOLEISH

Cjepivo protiv lišmanioze u pasa (plazmid rekombinantne DNK)

CZ Veterinaria, S.A.

La Relva s/n – Torneiros, 36410 Porriño, España

EU/2/22/290

sprej za nos, otopina

Pending

21.12.2022.

—   Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća; članak 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća): Prihvaćeno

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

2.12.2022.

CYTOPOINT

Zoetis Belgium

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

EU/2/17/205

5.12.2022.

2.12.2022.

Fevaxyn Pentofel

Zoetis Belgium

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

EU/2/96/002

6.12.2022.

2.12.2022.

Solensia

Zoetis Belgium SA

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

EU/2/20/269

5.12.2022.

2.12.2022.

Tulissin

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/20/252

6.12.2022.

2.12.2022.

Zenalpha

Vetcare Oy

P.O. Box 99, 24101 Salo, Suomi

EU/2/21/279

7.12.2022.

9.12.2022.

Convenia

Zoetis Belgium

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

EU/2/06/059

14.12.2022.

9.12.2022.

Zeleris

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/210

14.12.2022.

13.12.2022.

Innovax-ND-ILT

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/20/256

14.12.2022.

13.12.2022.

Versican Plus DHPPi/L4R

Zoetis Belgium

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

EU/2/14/163

14.12.2022.

15.12.2022.

Exzolt

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/17/212

20.12.2022.

15.12.2022.

Librela

Zoetis Belgium SA

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

EU/2/20/261

21.12.2022.

15.12.2022.

NEXGARD SPECTRA

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/14/177

16.12.2022.

15.12.2022.

Porcilis PCV M Hyo

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/175

20.12.2022.

15.12.2022.

Simparica Trio

Zoetis Belgium

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

EU/2/19/243

20.12.2022.

15.12.2022.

Simparica Trio

Zoetis Belgium

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

EU/2/19/243

20.12.2022.

15.12.2022.

UBAC

Laboratorios Hipra, S.A.

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

EU/2/18/227

21.12.2022.

15.12.2022.

Versican Plus Pi/L4R

Zoetis Belgium

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

EU/2/14/173

16.12.2022.

16.12.2022.

Equip WNV

Zoetis Belgium

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

EU/2/08/086

20.12.2022.

20.12.2022.

Lydaxx

VETOQUINOL S.A.

Magny-Vernois, 70200 Lure, France

EU/2/20/253

21.12.2022.

20.12.2022.

Novem

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/042

22.12.2022.

20.12.2022.

Onsior

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/08/089

21.12.2022.

20.12.2022.

ProteqFlu

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/03/037

22.12.2022.

20.12.2022.

ProteqFlu-Te

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/03/038

22.12.2022.

20.12.2022.

Rabitec

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/219

21.12.2022.

20.12.2022.

RHINISENG

Laboratorios Hipra, S.A.

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

EU/2/10/109

22.12.2022.

20.12.2022.

Suprelorin

VIRBAC S.A.

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

EU/2/07/072

23.12.2022.

20.12.2022.

Tulaven

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/20/251

21.12.2022.

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

NIZOZEMSKA

(1)  SL L 136, 30.4.2004., str. 1.

(2)  SL L 4, 7.1.2019., str. 43.

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