C_202504099LV.000101.fmx.xml

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2025. gada 1. jūnijs līdz 2025. gada 30. jūnijs

(publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004 (1) vai Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 5. pants (2))

(C/2025/4099)

— Tirdzniecības atļaujas izsniegšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

2.6.2025

Qoyvolma

ustekinumabum

Celltrion Healthcare Hungary Kft.

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

EU/1/25/1925

Koncentrāts infūziju šķīduma pagatavošanai

Šķīdums injekcijai

L04AC05

13.6.2025

2.6.2025

Ryjunea

atropini sulfas

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/25/1920

Acu pilieni, šķīdums

S01FA01

4.6.2025

6.6.2025

DUVYZAT

givinostat

Italfarmaco S.p.A.

Viale F. Testi, 330, 20126 Milano, Italia

EU/1/25/1930

Suspensija iekšķīgai lietošanai

M09AX14

6.6.2025

11.6.2025

Xoanacyl

dzelzs citrāta kompleksais savienojums

AVEROA SAS

11 Avenue Paul Verlaine, 38100 Grenoble, France

EU/1/25/1923

Apvalkotās tabletes

V03AE08

12.6.2025

19.6.2025

Sephience

sepiapterīns

PTC Therapeutics International Limited

Unit 1, 52-55 Sir John Rogerson's Quay, Dublin 2, D02 NA07, Ireland

EU/1/25/1939

Balts līdz smilškrāsas pulveris iekšķīgai lietošanai attaisāmās kapsulās vai paciņā.

A16AX28

25.6.2025

19.6.2025

TEPEZZA

Teprotumumab

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/25/1941

Pulveris infūziju šķīduma koncentrāta pagatavošanai

L04AG13

22.6.2025

23.6.2025

Junod

denozumabs

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/25/1933

Šķīdums injekcijai

M05BX04

2.7.2025

23.6.2025

Yaxwer

denozumabs

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/25/1934

Šķīdums injekcijai

M05BX04

25.6.2025

Vevzuo

denosumaba

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

EU/1/25/1945

Šķīdums injekcijai

M05BX04

1.7.2025

26.6.2025

Denbrayce

denozumabs

Mabxience Research SL

C/ Manuel Pombo Angulo 28, 28050 Madrid, España

EU/1/25/1936

Šķīdums injekcijai

M05BX04

27.6.2025

26.6.2025

Enwylma

denozumabs

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/25/1944

Šķīdums injekcijai

M05BX04

1.7.2025

26.6.2025

Izamby

denozumabs

Mabxience Research SL

C/ Manuel Pombo Angulo 28, 28050 Madrid, España

EU/1/25/1935

Šķīdums injekcijai

M05BX04

27.6.2025

26.6.2025

ZADENVI

denozumabs

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/25/1937

Šķīdums injekcijai

M05BX04

1.7.2025

27.6.2025

Ziihera

zanidatamab

Jazz Pharmaceuticals Ireland Limited

5th Floor, Waterloo Exchange, Waterloo Road, Dublin 4, D04 E5W7, Ireland

EU/1/25/1931

Pulveris infūziju šķīduma koncentrāta pagatavošanai

L01FD07

30.6.2025

Alyftrek

deitivakaftora (deutivacaftorum)/tezakaftora (tezacaftorum)/ vanzakaftora (vanzacaftorum)

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, Ireland

EU/1/25/1943

Apvalkotās tabletes

R07AX33

1.7.2025

30.6.2025

Dazublys

trastuzumab

CuraTeQ Biologics s.r.o

Trtinova 260/1, Cakovice, 19600 Prague 9, Česká republika

EU/1/25/1949

Pulveris infūziju šķīduma koncentrāta pagatavošanai

L01FD01

1.7.2025

30.6.2025

Evfraxy

denosumaba

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

EU/1/25/1946

Šķīdums injekcijai

M05BX04

1.7.2025

30.6.2025

Oczyesa

oktreotīda

Camurus AB

Rydbergs Torg 4, 224 84 Lund, Sverige

EU/1/25/1938

Ilgstošās darbības šķīdums injekcijai

H01CB02

1.7.2025

— Tirdzniecības atļaujas grozīšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

2.6.2025

ADCETRIS

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/12/794

3.6.2025

2.6.2025

ARIKAYCE liposomal

Insmed Netherlands B.V.

Stadsplateau 7, 3521 AZ Utrecht, Nederland

EU/1/20/1469

3.6.2025

2.6.2025

Bosulif

Pfizer Europe MA EEIG

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

EU/1/13/818

3.6.2025

2.6.2025

Calquence

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/20/1479

3.6.2025

2.6.2025

Evrysdi

Roche Registration GmbH

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

EU/1/21/1531

3.6.2025

2.6.2025

Fasturtec

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/00/170

3.6.2025

2.6.2025

Jivi

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/18/1324

3.6.2025

2.6.2025

Jyseleca

Alfasigma S.p.A.

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

EU/1/20/1480

3.6.2025

2.6.2025

Lytgobi

Taiho Pharma Netherlands B.V.

Barbara Strozzilaan 201, 1083 HN Amsterdam, Noord-Holland, Nederland

EU/1/23/1741

3.6.2025

2.6.2025

Qdenga

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/22/1699

3.6.2025

2.6.2025

RINVOQ

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

3.6.2025

2.6.2025

Rozlytrek

Roche Registration GmbH

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

EU/1/20/1460

3.6.2025

2.6.2025

TALVEY

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/23/1748

3.6.2025

2.6.2025

Ultomiris

Alexion Europe SAS

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

EU/1/19/1371

3.6.2025

2.6.2025

VEGZELMA

Celltrion Healthcare Hungary Kft.

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

EU/1/22/1667

10.6.2025

2.6.2025

VELCADE

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/04/274

3.6.2025

2.6.2025

ZTALMY

Immedica Pharma AB

SE-113 63, Stockholm, Sverige

EU/1/23/1743

16.6.2025

4.6.2025

Tivdak

Genmab A/S

Carl Jacobsens Vej 30, 2500 Valby, Danmark

EU/1/25/1911

5.6.2025

Amvuttra

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/22/1681

6.6.2025

5.6.2025

Aybintio

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/20/1454

9.6.2025

5.6.2025

Bemfola

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/13/909

12.6.2025

5.6.2025

Trodelvy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/21/1592

6.6.2025

Cabazitaxel Accord

Accord Healthcare S.L.U.

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

EU/1/20/1448

10.6.2025

6.6.2025

Cystadrops

Recordati Rare Diseases

Tour Hekla, 52 avenue du Général de Gaulle, F-92800 Puteaux, France

EU/1/15/1049

10.6.2025

6.6.2025

Fingolimod Mylan

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/21/1573

10.6.2025

6.6.2025

Flixabi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/16/1106

11.6.2025

6.6.2025

ORSERDU

Stemline Therapeutics B.V.

Basisweg 10, 1043 AP, Amsterdam, Noord-Holland, Nederland

EU/1/23/1757

10.6.2025

6.6.2025

Pregabalin Viatris Pharma

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/14/916

18.6.2025

6.6.2025

Sugammadex Mylan

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/21/1583

10.6.2025

6.6.2025

Sugammadex Piramal

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland

EU/1/23/1739

15.5.2025

6.6.2025

Sugammadex Piramal

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland

EU/1/23/1739

11.6.2025

6.6.2025

Veklury

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

11.6.2025

6.6.2025

Velsipity

Pfizer Europe MA EEIG

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

EU/1/23/1790

10.6.2025

12.6.2025

Atriance

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57, 1000 Ljubljana, Slovenija

EU/1/07/403

18.6.2025

12.6.2025

Elfabrio

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/23/1724

13.6.2025

12.6.2025

Emtricitabine /Tenofovir disoproxil Krka d.d.

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1182

13.6.2025

12.6.2025

Inflectra

Pfizer Europe MA EEIG

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

EU/1/13/854

13.6.2025

12.6.2025

Oncaspar

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/15/1070

13.6.2025

12.6.2025

Pregabalin Viatris Pharma

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/14/916

16.6.2025

12.6.2025

Xgeva

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703

15.6.2025

12.6.2025

Zoonotic Influenza Vaccine Seqirus

Seqirus S.r.l.

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

EU/1/23/1761

13.6.2025

19.6.2025

Baraclude

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/343

20.6.2025

19.6.2025

BEYONTTRA

Bayer AG

51368 Leverkusen, Deutschland

EU/1/24/1906

25.6.2025

19.6.2025

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

20.6.2025

19.6.2025

Omidria

Rayner Surgical (Ireland) Limited

The Mill Enterprise Hub, Newtown Link Road, Drogheda, A92 CD3D, Co. Louth, Ireland

EU/1/15/1018

7.7.2025

19.6.2025

Talzenna

Pfizer Europe MA EEIG

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

EU/1/19/1377

20.6.2025

19.6.2025

Vyvgart

argenx BV

Industriepark-Zwijnaarde 7, 9052 Gent, België

EU/1/22/1674

20.6.2025

23.6.2025

Adempas

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/907

24.6.2025

23.6.2025

AKEEGA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/23/1722

25.6.2025

23.6.2025

Apremilast Accord

Accord Healthcare S.L.U.

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

EU/1/24/1796

25.6.2025

23.6.2025

Cibinqo

Pfizer Europe MA EEIG

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

EU/1/21/1593

25.6.2025

23.6.2025

Fampridine Accord

Accord Healthcare S.L.U.

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

EU/1/20/1477

25.6.2025

23.6.2025

Irbesartan / Hydrochlorothiazide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/583

26.6.2025

23.6.2025

Leflunomide Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/09/604

27.6.2025

23.6.2025

Pombiliti

Amicus Therapeutics Europe Limited

Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland

EU/1/22/1714

25.6.2025

23.6.2025

Poteligeo

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/18/1335

30.6.2025

23.6.2025

Respreeza

CSL Behring GmbH

Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

EU/1/15/1006

26.7.2025

23.6.2025

Sogroya

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/20/1501

25.6.2025

23.6.2025

Sugammadex Amomed

AOP Orphan Pharmaceuticals GmbH

Leopold-Ungar-Platz 2, 1190 Wien, Österreich

EU/1/22/1708

3.6.2025

23.6.2025

Sugammadex Amomed

AOP Orphan Pharmaceuticals GmbH

Leopold-Ungar-Platz 2, 1190 Wien, Österreich

EU/1/22/1708

25.6.2025

23.6.2025

Tepkinly

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/23/1759

25.6.2025

23.6.2025

Vfend

Pfizer Europe MA EEIG

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

EU/1/02/212

25.6.2025

Amlodipine/Valsartan Mylan

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/16/1092

27.6.2025

25.6.2025

Avamys

GlaxoSmithKline Trading Services Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland

EU/1/07/434

30.6.2025

25.6.2025

Cufence

Univar Solutions B.V.

Schouwburgplein 30, Rotterdam, 3012 CL, Nederland

EU/1/19/1365

1.7.2025

25.6.2025

Eylea

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

26.6.2025

25.6.2025

HyQvia

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/13/840

27.6.2025

25.6.2025

Idefirix

Hansa Biopharma AB

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

EU/1/20/1471

27.6.2025

25.6.2025

Jivi

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/18/1324

26.6.2025

25.6.2025

ProQuad

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/323

27.6.2025

25.6.2025

Raxone

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/15/1020

26.6.2025

25.6.2025

Saxenda

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/15/992

26.6.2025

25.6.2025

Torisel

Pfizer Europe MA EEIG

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

EU/1/07/424

26.6.2025

27.6.2025

Camcevi

Accord Healthcare S.L.U.

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

EU/1/22/1647

30.6.2025

27.6.2025

Hycamtin

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57, 1000 Ljubljana, Slovenija

EU/1/96/027

30.6.2025

27.6.2025

Kapruvia

Vifor Fresenius Medical Care Renal Pharma France

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

EU/1/22/1643

30.6.2025

27.6.2025

Pedmarqsi

Norgine B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/23/1734

1.7.2025

— Tirdzniecības atļaujas izņemšana no aprites (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

19.6.2025

BroPair Spiromax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/21/1534

25.6.2025

19.6.2025

Sixmo

L. Molteni & C. dei F.lli Alitti Società di .Esercizio .S.p.A

Strada Statale 67, Loc. Granatieri, 50018 Scandicci (Firenze), Italia

EU/1/19/1369

30.6.2025

— Tirdzniecības atļaujas izsniegšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004; Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 5. pants): Pieņemtas

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

2.6.2025

Emevet

Maropitantu

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf, Deutschland

EU/2/25/343

Košļājamas tabletes

QA04AD90

4.6.2025

2.6.2025

Nobilis Multriva Gm+REOm

Putnu infekciozās bursālās slimības vīrusa un putnu reovīrusa vakcīna (inaktivēta)

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/25/344

Emulsija injekcijai

QI01AA22

3.6.2025

2.6.2025

Nobilis Multriva IBm+ND

Putnu infekciozā bronhīta un Ņūkāslas slimības vīrusa vakcīna (inaktivēta)

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/25/342

Emulsija injekcijai

QI01AA10

3.6.2025

27.6.2025

Fluralaner Intervet

fluralanērs

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/25/346

Košļājamas tabletes

QP53BE02

9.7.2025

27.6.2025

Nobilis Multriva IBm+ND+Gm+REOm+EDS

Infekciozā bronhīta, Ņūkāslas slimības, putnu infekciozās bursālās slimības vīrusa, putnu reovīrusa un olu dēšanas samazināšanās sindroma vīrusa vakcīna (inaktivēta)

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/25/345

Emulsija injekcijai

QI01AA25

1.7.2025

— Tirdzniecības atļaujas grozīšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004; Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 5. pants): Pieņemtas

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

2.6.2025

Vectormune ND

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/15/188

4.6.2025

27.6.2025

Coxatab

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf, Deutschland

EU/2/22/286

1.7.2025

27.6.2025

DIVENCE PENTA

Laboratorios Hipra, S.A.

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

EU/2/24/307

2.7.2025

27.6.2025

HorStem

EquiCord S.L.

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

EU/2/18/226

2.7.2025

27.6.2025

Melovem

Dopharma Research B.V.

Zalmweg 24, 4941 VX Raamsdonksveer, Nederland

EU/2/09/098

2.7.2025

27.6.2025

Mirataz

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/19/247

4.7.2025

27.6.2025

NexGard Combo

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/267

30.6.2025

27.6.2025

Oncept IL-2

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/13/150

30.6.2025

27.6.2025

Profender

Vetoquinol S.A.

Magny-Vernois, 70200 Lure, France

EU/2/05/054

30.6.2025

27.6.2025

Stronghold Plus

Zoetis Belgium

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

EU/2/16/204

30.6.2025

Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

(1) OV L 136, 30.4.2004, 1. lpp., ELI: https://data.europa.eu/eli/reg/2004/726/oj.

(2) OV L 4, 7.1.2019, 43. lpp., ELI: https://data.europa.eu/eli/reg/2019/6/oj.