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Eiropas Savienības Oficiālais Vēstnesis, C 350, 2023. gada 29. septembris

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		ISSN 1977-0952
Eiropas Savienības Oficiālais Vēstnesis		C 350

Izdevums latviešu valodā	Informācija un paziņojumi	66. gadagājums 2023. gada 29. septembris

Saturs		Lappuse
	IV Paziņojumi
	EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI
	Eiropas Komisija
2023/C 350/01	Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2023. gada 1. augusta līdz 2023. gada 31. augustam(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu vai Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 5. pantu)	1

IV Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

29.9.2023

Eiropas Savienības Oficiālais Vēstnesis

C 350/1

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2023. gada 1. augusta līdz 2023. gada 31. augustam

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

(2023/C 350/01)

— Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. 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

11.8.2023.

AQUIPTA

atogepants

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/23/1750

Tabletes

N02CD07

14.8.2023.

21.8.2023.

TALVEY

talkvetamabs

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/23/1748

Šķīdums injekcijai

L01FX

22.8.2023.

23.8.2023.

Abrysvo

Respiratori sincitiālā vīrusa vakcīna (bivalenta, rekombinanta)

Pfizer Europe MA EEIG

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

EU/1/23/1752

Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

J07BX05

24.8.2023.

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

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

3.8.2023.

Eladynos

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/22/1706

4.8.2023.

3.8.2023.

Hulio

Biosimilar Collaborations Ireland Limited

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

EU/1/18/1319

4.8.2023.

3.8.2023.

Palforzia

Aimmune Therapeutics Ireland Limited

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

EU/1/20/1495

8.8.2023.

4.8.2023.

Actelsar HCT

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

EU/1/13/817

7.8.2023.

4.8.2023.

Clopidogrel Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/09/568

8.8.2023.

4.8.2023.

Hetlioz

Vanda Pharmaceuticals Netherlands B.V.

Basisweg 10, 1043 AP Amsterdam, Nederland

EU/1/15/1008

9.8.2023.

4.8.2023.

IMJUDO

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/22/1713

7.8.2023.

4.8.2023.

Lacosamide Accord

Accord Healthcare S.L.U.

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

EU/1/17/1230

7.8.2023.

4.8.2023.

Ogivri

Biosimilar Collaborations Ireland Limited

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

EU/1/18/1341

8.8.2023.

4.8.2023.

Pemetrexed Pfizer

Pfizer Europe MA EEIG

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

EU/1/15/1057

7.8.2023.

4.8.2023.

Refixia

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1193

8.8.2023.

4.8.2023.

RotaTeq

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/348

8.8.2023.

4.8.2023.

Rukobia

ViiV Healthcare BV

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

EU/1/20/1518

8.8.2023.

4.8.2023.

Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1127

8.8.2023.

4.8.2023.

Topotecan Hospira

Pfizer Europe MA EEIG

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

EU/1/10/633

7.8.2023.

4.8.2023.

Viramune

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/055

8.8.2023.

4.8.2023.

Ziagen

ViiV Healthcare BV

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

EU/1/99/112

7.8.2023.

8.8.2023.

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

9.8.2023.

Lenalidomide Accord

Accord Healthcare S.L.U.

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

EU/1/18/1316

11.8.2023..

9.8.2023.

Namuscla

Lupin Europe GmbH

Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland

EU/1/18/1325

11.8.2023.

9.8.2023.

Pemetrexed Fresenius Kabi

Fresenius Kabi Deutschland GmbH

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

EU/1/16/1115

14.8.2023.

9.8.2023.

Roteas

Berlin-Chemie AG

Glienicker Weg 125, 12489 Berlin, Deutschland

EU/1/16/1152

10.8.2023.

11.8.2023.

Armisarte

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

EU/1/15/1063

14.8.2023.

11.8.2023.

Dengvaxia

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/18/1338

30.8.2023.

11.8.2023.

Imnovid

Bristol Myers Squibb Pharma EEIG

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

EU/1/13/850

14.8.2023.

11.8.2023.

Invirase

Roche Registration GmbH

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

EU/1/96/026

14.8.2023.

11.8.2023.

Rivaroxaban Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/21/1588

14.8.2023.

11.8.2023.

Spikevax

MODERNA BIOTECH SPAIN, S.L.

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

EU/1/20/1507

21.8.2023.

11.8.2023.

TAKHZYRO

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/18/1340

18.8.2023.

11.8.2023.

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

14.8.2023.

16.8.2023.

Calquence

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/20/1479

17.8.2023.

16.8.2023.

Ervebo

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/19/1392

17.8.2023.

16.8.2023.

Evrysdi

Roche Registration GmbH

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

EU/1/21/1531

17.8.2023.

16.8.2023.

EVUSHELD

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/22/1651

17.8.2023.

16.8.2023.

Foclivia

Seqirus S.r.l.

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

EU/1/09/577

17.8.2023.

16.8.2023.

Mabthera

Roche Registration GmbH

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

EU/1/98/067

17.8.2023.

16.8.2023.

Ovaleap

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/13/871

17.8.2023.

16.8.2023.

Retsevmo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

17.8.2023.

16.8.2023.

Riximyo

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1184

17.8.2023.

16.8.2023.

TECVAYLI

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/22/1675

17.8.2023.

16.8.2023.

Truxima

Celltrion Healthcare Hungary Kft.

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

EU/1/16/1167

22.8.2023.

16.8.2023.

VITRAKVI

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/19/1385

17.8.2023.

21.8.2023.

Duloxetine Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1028

22.8.2023.

21.8.2023.

OPDIVO

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

24.8.2023.

21.8.2023.

Signifor

Recordati Rare Diseases

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

EU/1/12/753

23.8.2023.

Blitzima

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1205

25.8.2023.

23.8.2023.

Celdoxome pegylated liposomal

YES Pharmaceutical Development Services GmbH

Basler Strasse 7, 61352 Bad Homburg, Deutschland

EU/1/22/1666

6.9.2023.

23.8.2023.

Cholib

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/13/866

24.8.2023.

23.8.2023.

Efmody

Diurnal Europe B.V.

Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland

EU/1/21/1549

29.8.2023.

23.8.2023.

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

28.8.2023.

23.8.2023.

Mounjaro

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/22/1685

25.8.2023.

23.8.2023.

Neuraceq

Life Radiopharma Berlin GmbH

Max-Planck-Straße 4, 12489 Berlin, Deutschland

EU/1/13/906

24.8.2023.

23.8.2023.

PecFent

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/10/644

4.9.2023.

23.8.2023.

Rixathon

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1185

24.8.2023.

23.8.2023.

Ruxience

Pfizer Europe MA EEIG

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

EU/1/20/1431

24.8.2023.

23.8.2023.

Symkevi

Vertex Pharmaceuticals (Ireland) Limited

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

EU/1/18/1306

24.8.2023.

23.8.2023.

Tadalafil Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/17/1177

25.8.2023.

23.8.2023.

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

28.8.2023.

23.8.2023.

ZOLSKETIL pegylated liposomal

Accord Healthcare S.L.U.

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

EU/1/22/1629

24.8.2023.

25.8.2023.

Caelyx pegylated liposomal

Baxter Holding B.V.

Kobaltweg 49, 3542 CE Utrecht, Nederland

EU/1/96/011

29.8.2023.

25.8.2023.

Cialis

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/02/237

28.8.2023.

25.8.2023.

Erleada

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/18/1342

28.8.2023.

25.8.2023.

Eurartesim

Alfasigma S.p.A.

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

EU/1/11/716

28.8.2023.

25.8.2023.

Fintepla

UCB Pharma S.A.

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

EU/1/20/1491

29.8.2023.

25.8.2023.

Reyataz

Bristol-Myers Squibb Pharma EEIG

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

EU/1/03/267

1.9.2023.

25.8.2023.

Semglee

Biosimilar Collaborations Ireland Limited

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

EU/1/18/1270

28.8.2023.

29.8.2023.

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

30.8.2023.

29.8.2023.

Spikevax

MODERNA BIOTECH SPAIN, S.L.

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

EU/1/20/1507

30.8.2023.

Abevmy

Biosimilar Collaborations Ireland Limited

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

EU/1/20/1515

4.9.2023.

30.8.2023.

Glyxambi

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/16/1146

1.9.2023.

30.8.2023.

Hulio

Biosimilar Collaborations Ireland Limited

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

EU/1/18/1319

4.9.2023.

30.8.2023.

Kirsty

Biosimilar Collaborations Ireland Limited

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

EU/1/20/1506

4.9.2023.

30.8.2023.

Myclausen

Passauer Pharma GmbH

Eiderstedter Weg 3, 14129 Berlin, Deutschland

EU/1/10/647

4.9.2023.

30.8.2023.

Nepexto

Biosimilar Collaborations Ireland Limited

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

EU/1/20/1436

4.9.2023.

30.8.2023.

Ogivri

Biosimilar Collaborations Ireland Limited

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

EU/1/18/1341

4.9.2023.

30.8.2023.

Renvela

Sanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/09/521

31.8.2023.

30.8.2023.

Synjardy

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1003

1.9.2023.

31.8.2023.

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

1.9.2023.

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

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

16.8.2023.

Invirase

Roche Registration GmbH

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

EU/1/96/026

17.8.2023.

30.8.2023.

Imatinib Koanaa

Koanaa Healthcare GmbH

Fehrgasse 7, 2401 Fischamend, Österreich

EU/1/21/1568

4.9.2023.

30.8.2023.

JETREA

Inceptua AB

Gustavslundsv. 143, 16751 Bromma, Sverige

EU/1/13/819

31.8.2023.

— Tirdzniecības atļaujas atlikšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 20. pants)

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

3.8.2023.

Adakveo

Novartis Europharm Limited

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

EU/1/20/1476

4.8.2023.

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

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

4.8.2023.

CYTOPOINT

Zoetis Belgium

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

EU/2/17/205

7.8.2023.

4.8.2023.

MHYOSPHERE PCV ID

Laboratorios Hipra, S.A.

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

EU/2/20/259

21.8.2023.

4.8.2023.

NASYM

Laboratorios Hipra, S.A.

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

EU/2/19/241

1.9.2023.

8.8.2023.

Easotic

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/08/085

10.8.2023.

8.8.2023.

Versican Plus DHPPi

Zoetis Belgium

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

EU/2/14/169

29.8.2023.

8.8.2023.

Versican Plus DHPPi/L4

Zoetis Belgium

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

EU/2/14/164

29.8.2023.

11.8.2023.

Felpreva

Vetoquinol S.A.

Magny-Vernois, 70200 Lure, France

EU/2/21/277

21.8.2023.

11.8.2023.

SevoFlo

Zoetis Belgium

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

EU/2/02/035

14.8.2023.

24.8.2023.

Apoquel

Zoetis Belgium

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

EU/2/13/154

25.8.2023.

24.8.2023.

Cimalgex

Vétoquinol SA

Magny-Vernois, 70200 Lure, France

EU/2/10/119

25.8.2023.

24.8.2023.

CircoMax Myco

Zoetis Belgium

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

EU/2/20/264

25.8.2023.

24.8.2023.

Dexdomitor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/02/033

25.8.2023.

24.8.2023.

NexGard Combo

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/267

25.8.2023.

24.8.2023.

Panacur AquaSol

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/135

25.8.2023.

24.8.2023.

RenuTend

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/22/282

25.8.2023.

24.8.2023.

Ypozane

VIRBAC S.A.

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

EU/2/06/068

25.8.2023.

24.8.2023.

Zactran

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/08/082

25.8.2023.

24.8.2023.

Zuprevo

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/124

29.8.2023.

25.8.2023.

Bonqat

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/21/273

28.8.2023.

25.8.2023.

Palladia

Zoetis Belgium

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

EU/2/09/100

1.9.2023.

30.8.2023.

Porcilis PCV

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/08/091

31.8.2023.

30.8.2023.

Tessie

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/21/276

31.8.2023.

— Tirdzniecības atļaujas izņemšana no aprites (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants; Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 5. pants)

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

24.8.2023.

Nobivac Myxo-RHD

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/132

28.8.2023.

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.

(2) OV L 4, 7.1.2019., 43. lpp.

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