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

(2022/C 331/01)

— 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

1.7.2022.

LIBTAYO

cemiplimaba

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27 Ireland

EU/1/19/1376

Koncentrat za otopinu za infuziju

L01XC33

5.7.2022.

15.7.2022.

Cevenfacta

eptakoga beta (aktiviranog)

Laboratoire français du Fractionnement et des Biotechnologies

Tour W, 102 Terrasse Boieldieu, 19ème Étage, 92800 Puteaux France

EU/1/22/1664

Prašak i otapalo za otopinu za injekciju

B02BD08

22.7.2022.

15.7.2022.

Ertapenem SUN

ertapenema

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH Hoofddorp, Nederland

EU/1/22/1656

Prašak za koncentrat za otopinu za infuziju

J01DH03

22.7.2022.

15.7.2022.

Ganirelix Gedeon Richter

ganireliks

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/22/1658

Otopina za injekciju

H01CC01

19.7.2022.

15.7.2022.

Kinpeygo

budezonid

Calliditas Therapeutics AB

Kungsbron 1, 11122 Stockholm, Sverige

EU/1/22/1657

Kapsula s prilagođenim oslobađanjem, tvrda

A07EA06

18.7.2022.

15.7.2022.

Sugammadex Fresenius Kabi

sugamadeks

Fresenius Kabi Deutschland GmbH

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

EU/1/22/1663

Otopina za injekciju

V03AB35

18.7.2022.

NEXPOVIO

selineksor

Karyopharm Europe GmbH

Franziska-Bilek-Weg 9, 80339 München, Deutschland

EU/1/21/1537

Filmom obložena tableta

L01XX66

19.7.2022.

18.7.2022.

Upstaza

eladokagen eksuparvovek

PTC Therapeutics International Limited

70 Sir John Rogerson's Quay, Dublin 2, Ireland

EU/1/22/1653

Otopina za infuziju

Pending

22.7.2022.

18.7.2022.

Zokinvy

lonafarnib

EigerBio Europe Limited

1 Castlewood Avenue, Rathmines, Dublin 6, D06 H685, Ireland

EU/1/22/1660

Kapsula, tvrda

A16AX20

19.7.2022.

22.7.2022.

Sitagliptin/Metformin hydrochloride Accord

sitagliptin/metforminklorid

Accord Healthcare S.L.U.

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

EU/1/22/1661

Filmom obložena tableta

A10BD07

28.7.2022.

— 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

1.7.2022.

Armisarte

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/15/1063

6.7.2022.

1.7.2022.

Entecavir Accord

Accord Healthcare S.L.U.

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

EU/1/17/1211

4.7.2022.

1.7.2022.

Hetlioz

Vanda Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/15/1008

8.8.2022.

1.7.2022.

Irbesartan / Hydrochlorothiazide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/583

4.7.2022.

1.7.2022.

Kinzalkomb

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/02/214

5.7.2022.

1.7.2022.

Levodopa/Carbidopa/Entacapone Orion

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/706

11.7.2022.

1.7.2022.

Neparvis

Novartis Europharm Limited

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

EU/1/16/1103

7.7.2022.

1.7.2022.

Nuvaxovid

Novavax CZ, a.s.

Bohumil 138, 281 63 Jevany, Česká republika

EU/1/21/1618

1.7.2022.

Orladeyo

Biocryst Ireland Limited

Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland

EU/1/21/1544

5.7.2022.

1.7.2022.

Paxlovid

Pfizer Europe MA EEIG

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

EU/1/22/1625

1.7.2022.

Strensiq

Alexion Europe SAS

103-105 rue Anatole France, 92300 Levallois-Perret, France

EU/1/15/1015

4.7.2022.

1.7.2022.

Viramune

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/055

19.7.2022.

1.7.2022.

Zirabev

Pfizer Europe MA EEIG

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

EU/1/18/1344

4.7.2022.

Prialt

Esteve Pharmaceuticals GmbH

Hohenzollerndamm 150-151, 14199 Berlin, Deutschland

EU/1/04/302

7.7.2022.

8.7.2022.

Amsparity

Pfizer Europe MA EEIG

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

EU/1/19/1415

12.7.2022.

8.7.2022.

AUBAGIO

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/13/838

11.7.2022.

8.7.2022.

Azacitidine Betapharm

betapharm Arzneimittel GmbH

Kobelweg 95, 86156 Augsburg, Deutschland

EU/1/19/1416

12.7.2022.

8.7.2022.

Azacitidine Mylan

Mylan Ireland Limited

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

EU/1/20/1426

12.7.2022.

8.7.2022.

Calquence

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/20/1479

11.7.2022.

8.7.2022.

Dexdor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/718

11.7.2022.

8.7.2022.

EDURANT

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/736

12.7.2022.

8.7.2022.

Efmody

Diurnal Europe B.V.

Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland

EU/1/21/1549

13.7.2022.

8.7.2022.

Eurartesim

Alfasigma S.p.A.

Via Ragazzi del '99, n.5, 40133 Bologna, Italia

EU/1/11/716

12.7.2022.

8.7.2022.

Farydak

Secura Bio Limited

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

EU/1/15/1023

14.7.2022.

8.7.2022.

Fingolimod Accord

Accord Healthcare S.L.U.

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

EU/1/20/1450

11.7.2022.

8.7.2022.

Fortacin

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/13/881

12.7.2022.

8.7.2022.

Giapreza

PAION Deutschland GmbH

Heussstraße 25, 52078 Aachen, Deutschland

EU/1/19/1384

13.7.2022.

8.7.2022.

Grasustek

Juta Pharma GmbH

Gutenbergstr. 13, 24941, Flensburg, Deutschland

EU/1/19/1375

12.7.2022.

8.7.2022.

Herceptin

Roche Registration GmbH

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

EU/1/00/145

11.7.2022.

8.7.2022.

Iclusig

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/13/839

15.7.2022.

8.7.2022.

INCRELEX

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/07/402

12.7.2022.

8.7.2022.

Kadcyla

Roche Registration GmbH

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

EU/1/13/885

11.7.2022.

8.7.2022.

Keppra

UCB Pharma S.A.

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

EU/1/00/146

12.7.2022.

8.7.2022.

Lenalidomide Mylan

Mylan Ireland Limited

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

EU/1/20/1490

11.7.2022.

8.7.2022.

Lutathera

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

EU/1/17/1226

11.7.2022.

8.7.2022.

Mabthera

Roche Registration GmbH

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

EU/1/98/067

11.7.2022.

8.7.2022.

MicardisPlus

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/02/213

13.7.2022.

8.7.2022.

Minjuvi

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/21/1570

11.7.2022.

8.7.2022.

Mvasi

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

EU/1/17/1246

12.7.2022.

8.7.2022.

Orgovyx

Accord Healthcare S.L.U.

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

EU/1/22/1642

11.7.2022.

8.7.2022.

Palforzia

Aimmune Therapeutics Ireland Limited

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

EU/1/20/1495

12.7.2022.

8.7.2022.

Pemetrexed Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1037

12.7.2022.

8.7.2022.

Quinsair

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/973

13.7.2022.

8.7.2022.

Striascan

CIS bio international

RN 306 – Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex, France

EU/1/19/1372

11.7.2022.

8.7.2022.

Tepadina

ADIENNE S.r.l.S.U.

Via Galileo Galilei 19, 20867 Caponago (MB), Italia

EU/1/10/622

12.7.2022.

8.7.2022.

Thiotepa Riemser

Esteve Pharmaceuticals GmbH

Hohenzollerndamm 150-151, 14199 Berlin, Deutschland

EU/1/21/1536

11.7.2022.

8.7.2022.

Tracleer

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/02/220

11.7.2022.

8.7.2022.

Vimpat

UCB Pharma S.A.

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

EU/1/08/470

11.7.2022.

8.7.2022.

Votrient

Novartis Europharm Limited

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

EU/1/10/628

11.7.2022.

8.7.2022.

Xeloda

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/00/163

11.7.2022.

8.7.2022.

Xenleta

Nabriva Therapeutics Ireland DAC

Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland

EU/1/20/1457

13.7.2022.

8.7.2022.

Yondelis

Pharma Mar S.A.

Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España

EU/1/07/417

12.7.2022.

11.7.2022.

Enhertu

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

13.7.2022.

15.7.2022.

Alecensa

Roche Registration GmbH

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

EU/1/16/1169

19.7.2022.

15.7.2022.

AYVAKYT

Blueprint Medicines (Netherlands) B.V.

Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland

EU/1/20/1473

18.7.2022.

15.7.2022.

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

19.7.2022.

15.7.2022.

Elebrato Ellipta

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1237

19.7.2022.

15.7.2022.

Emgality

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/18/1330

19.7.2022.

15.7.2022.

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

19.7.2022.

15.7.2022.

Fotivda

EUSA Pharma (Netherlands) B.V.

Beechavenue 54, 1119PW Schiphol-Rijk, Nederland

EU/1/17/1215

10.8.2022.

15.7.2022.

Galvus

Novartis Europharm Limited

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

EU/1/07/414

18.7.2022.

15.7.2022.

Idefirix

Hansa Biopharma AB

P.O. Box 785, 220 07 Lund, Sverige

EU/1/20/1471

19.7.2022.

15.7.2022.

Jalra

Novartis Europharm Limited

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

EU/1/08/485

18.7.2022.

15.7.2022.

Nitisinone MDK

MendeliKABS Europe Limited

Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23 AT2P, Ireland

EU/1/17/1217

19.7.2022.

15.7.2022.

PecFent

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/10/644

20.7.2022.

15.7.2022.

Posaconazole AHCL

Accord Healthcare S.L.U.

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

EU/1/19/1380

3.8.2022.

15.7.2022.

Raxone

Santhera Pharmaceuticals (Deutschland) GmbH

Marie-Curie Straße 8, 79539 Lörrach, Deutschland

EU/1/15/1020

2.8.2022.

15.7.2022.

Remsima

Celltrion Healthcare Hungary Kft.

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

EU/1/13/853

18.7.2022.

15.7.2022.

Trelegy Ellipta

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1236

19.7.2022.

15.7.2022.

Tremfya

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

19.7.2022.

15.7.2022.

Xiliarx

Novartis Europharm Limited

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

EU/1/08/486

18.7.2022.

Accofil

Accord Healthcare S.L.U.

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

EU/1/14/946

8.8.2022.

18.7.2022.

Bortezomib Fresenius Kabi

Fresenius Kabi Deutschland GmbH

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

EU/1/19/1397

20.7.2022.

18.7.2022.

Cyramza

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/957

22.7.2022.

18.7.2022.

Darunavir Krka d.d.

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1248

20.7.2022.

18.7.2022.

Irbesartan Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/06/376

19.7.2022.

18.7.2022.

Lenalidomide Krka

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/20/1519

22.7.2022.

18.7.2022.

Mayzent

Novartis Europharm Limited

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

EU/1/19/1414

19.7.2022.

18.7.2022.

Suboxone

Indivior Europe Limited

27 Windsor Place, Dublin 2, D02 DK44, Ireland

EU/1/06/359

22.7.2022.

18.7.2022.

Zejula

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1235

20.7.2022.

19.7.2022.

Veklury

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

19.7.2022.

22.7.2022.

Fluad Tetra

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/20/1433

28.7.2022.

22.7.2022.

Imvanex

Bavarian Nordic A/S

Philip Heymans Allé 3, DK-2900 Hellerup, Danmark

EU/1/13/855

25.7.2022.

22.7.2022.

Kirsty

Mylan IRE Healthcare Limited

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

EU/1/20/1506

26.7.2022.

22.7.2022.

Lonquex

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/856

2.8.2022.

22.7.2022.

Miglustat Dipharma

Dipharma B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/18/1346

26.7.2022.

22.7.2022.

Onureg

Bristol-Myers Squibb Pharma EEIG

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

EU/1/21/1556

27.7.2022.

22.7.2022.

Rinvoq

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

25.7.2022.

22.7.2022.

Ryeqo

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/21/1565

27.7.2022.

22.7.2022.

Xevudy

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/21/1562

22.7.2022.

Zavesca

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/02/238

26.7.2022.

25.7.2022.

Braftovi

Pierre Fabre Médicament

Les Cauquillous, 81500 Lavaur, France

EU/1/18/1314

26.7.2022.

25.7.2022.

CRYSVITA

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/17/1262

28.7.2022.

25.7.2022.

Cyramza

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/957

27.7.2022.

25.7.2022.

Zerbaxa

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1032

26.7.2022.

27.7.2022.

BroPair Spiromax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/21/1534

2.8.2022.

27.7.2022.

Flucelvax Tetra

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/18/1326

29.7.2022.

27.7.2022.

Fluenz Tetra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/887

28.7.2022.

27.7.2022.

Phesgo

Roche Registration GmbH

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

EU/1/20/1497

29.7.2022.

27.7.2022.

Rinvoq

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

28.7.2022.

27.7.2022.

Seffalair Spiromax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/21/1533

2.8.2022.

27.7.2022.

Zubsolv

Accord Healthcare S.L.U.

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

EU/1/17/1233

8.8.2022.

28.7.2022.

COVID-19 Vaccine (inactivated, adjuvanted) Valneva

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/21/1624

29.7.2022.

— 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

1.7.2022.

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

5.7.2022.

— 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

27.7.2022.

Cortaderm

Hidrokortizon aceponat

Alfasan Nederland B.V.

Kuipersweg 9, 3449 JA Woerden, Nederland

EU/2/22/287

Sprej za kožu, otopina

QD07AC16

29.7.2022.

27.7.2022.

Evanovo

Živa vakcina protiv kokcidioze kod pilića

Laboratorios Hipra, S.A.

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

EU/2/22/284

Suspenzija i otapalo za suspenziju za injekciju

Pending

28.7.2022.

— 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

4.7.2022.

BTVPUR

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/10/113

5.7.2022.

4.7.2022.

Tulinovet

V.M.D.n.v.

Hoge Mauw 900, 2370 Arendonk, Belgïe

EU/2/20/257

5.7.2022.

11.7.2022.

Coliprotec F4/F18

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/202

12.7.2022.

11.7.2022.

HorStem

EquiCord S.L

103-D Loeches, Polígono. Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España.

EU/2/18/226

12.7.2022.

11.7.2022.

Loxicom

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate, Monaghan, Ireland

EU/2/08/090

14.7.2022.

11.7.2022.

Prevomax

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/17/211

13.7.2022.

11.7.2022.

VEPURED

Laboratorios Hipra, S.A.

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

EU/2/17/214

14.7.2022.

15.7.2022.

Bravecto

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/13/158

19.7.2022.

15.7.2022.

Cerenia

Zoetis Belgium S.A.

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

EU/2/06/062

19.7.2022.

15.7.2022.

GUMBOHATCH

Laboratorios Hipra, S.A.

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

EU/2/19/245

19.7.2022.

15.7.2022.

Nobivac L4

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/12/143

19.7.2022.

15.7.2022.

Suprelorin

VIRBAC S.A.

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

EU/2/07/072

19.7.2022.

15.7.2022.

Suvaxyn PRRS MLV

Zoetis Belgium S.A.

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

EU/2/17/215

22.7.2022.

Comfortis

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/10/115

27.7.2022.

22.7.2022.

FRONTPRO

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/19/240

25.7.2022.

22.7.2022.

GALLIPRANT

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/221

27.7.2022.

22.7.2022.

Onsior

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/08/089

27.7.2022.

22.7.2022.

Vectra Felis

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/14/165

26.7.2022.

22.7.2022.

VEPURED

Laboratorios Hipra, S.A.

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

EU/2/17/214

27.7.2022.

Circovac

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/07/075

29.7.2022.

27.7.2022.

Loxicom

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate, Monaghan, Ireland

EU/2/08/090

29.7.2022.

27.7.2022.

Nobilis IB 4-91

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/98/006

29.7.2022.

— Povlačenje 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)

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

22.7.2022.

Bovilis BTV8

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/10/106

9.8.2022.

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

NETHERLANDS

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

(2) SL L 4, 7.1.2019, str. 43.