ISSN 1977-1088

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Europske unije

C 350
European flag  

Hrvatsko izdanje

Informacije i objave

Godište 66.
29 rujna 2023.

Sadržaj

Stranica

 

IV.   Obavijesti

 

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

 

Europska komisija

2023/C 350/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. kolovoza 2023. do 31. kolovoza 2023.(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

29.9.2023   

HR

Službeni list Europske unije

C 350/1

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. kolovoza 2023. do 31. kolovoza 2023.

(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 350/01)

—   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

11.8.2023.

AQUIPTA

atogepant

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/23/1750

Tableta

N02CD07

14.8.2023.

21.8.2023.

TALVEY

talkvetamab

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/23/1748

Otopina za injekciju

L01FX

22.8.2023.

23.8.2023.

Abrysvo

Cjepivo protiv respiratornog sincicijskog virusa (dvovalentno, rekombinantno)

Pfizer Europe MA EEIG

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

EU/1/23/1752

Prašak i otapalo za otopinu za injekciju

J07BX05

24.8.2023.

—   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

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.

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.

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.

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.

—   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

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.

—   Obustava odobrenja za stavljanje u promet (članak 20 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

3.8.2023.

Adakveo

Novartis Europharm Limited

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

EU/1/20/1476

4.8.2023.

—   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

4.8.2023.

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.

—   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

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.

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.