52023XC0131(03)

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Document 52023XC0131(03)

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2022 m. gruodžio 1 d. iki 2022 m. gruodžio 31 d. (Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį arba Europos Parlamento ir Tarybos reglamento (ES) 2019/6 5 straipsnį)

PUB/2023/87

OL C 37, 2023 1 31, pp. 1–12 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

HTML

PDF

Official Journal

2023 1 31

Europos Sąjungos oficialusis leidinys

C 37/1

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2022 m. gruodžio 1 d. iki 2022 m. gruodžio 31 d.

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 (1) 13 straipsnį arba 38 straipsnį arba Europos Parlamento ir Tarybos reglamento (ES) 2019/6 5 straipsnį (2))

(2023/C 37/01)

— Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

2022 12 2

Mycapssa

oktreotidas

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/22/1690

Skrandyje neirios kapsulės, kietos

H01CB02

2022 12 5

Qdenga

denge karštligės keturvalentė vakcina (gyvoji, susilpninta)

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/22/1699

Milteliai ir tirpiklis injekciniam tirpalui

J07BX04

2022 12 6

2022 12 9

Livmarli

maraliksibato chlorido

Mirum Pharmaceuticals International B.V.

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

EU/1/22/1704

Geriamasis tirpalas

A05AX04

2022 12 12

2022 12 9

Locametz

gozetotidas

Novartis Europharm Limited

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

EU/1/22/1692

Milteliai injekciniam tirpalui

V09IX14

2022 12 12

2022 12 9

Pemetrexed Baxter

pemetreksedo

Baxter Holding B.V.

Kobaltweg 49, 3542 CE Utrecht, Nederland

EU/1/22/1705

Milteliai koncentratui infuziniam tirpalui

L01BA04

2022 12 13

2022 12 9

Pluvicto

liutecis (177Lu) vipivotidas tetraksetanas

Novartis Europharm Limited

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

EU/1/22/1703

Injekcinis arba infuzinis tirpalas

V10XX05

2022 12 12

2022 12 9

Spevigo

spesolimabas

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/22/1688

Koncentratas infuziniam tirpalui

L04AC22

2022 12 12

Dimethyl Fumarate Teva

dimethyl fumarate

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/22/1702

Skrandyje neirios kapsulės, kietos

L04AX07

2023 1 3

2022 12 12

Eladynos

abaloparatidas

Radius Health (Ireland) Ltd.

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

EU/1/22/1706

Injekcinis tirpalas

H05AA04

2022 12 13

2022 12 16

Ebvallo

tabelekleucelas

Atara Biotherapeutics Ireland Limited

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

EU/1/22/1700

Injekcinė dispersija

Pending

2022 12 16

Plerixafor Accord

pleriksaforas

Accord Healthcare S.L.U.

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

EU/1/22/1701

Injekcinis tirpalas

L03AX16

2022 12 19

2022 12 20

Zynlonta

lonkastuksimabas tesirinas

ADC Therapeutics (NL) B.V.

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

EU/1/22/1695

Milteliai koncentratui infuziniam tirpalui

L01FX22

2022 12 22

— Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2022 12 2

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

2022 12 2

DuoPlavin

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/10/619

2022 12 5

2022 12 2

Kaftrio

Vertex Pharmaceuticals (Ireland) Limited

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

EU/1/20/1468

2022 12 5

2022 12 2

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

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

EU/1/12/782

2022 12 5

2022 12 2

QINLOCK

Deciphera Pharmaceuticals (Netherlands) B.V.

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

EU/1/21/1569

2022 12 8

2022 12 2

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/050

2022 12 7

2022 12 2

Spikevax

MODERNA BIOTECH SPAIN, S.L.

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

EU/1/20/1507

2022 12 7

2022 12 2

Trizivir

ViiV Healthcare BV

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

EU/1/00/156

2022 12 5

2022 12 2

Trogarzo

Theratechnologies Europe Limited

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

EU/1/19/1359

2022 12 14

2022 12 2

Trydonis

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1274

2022 12 5

2022 12 2

Zyclara

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/12/783

2022 12 6

2022 12 5

Shingrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

2022 12 6

2022 12 5

Steglujan

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1266

2022 12 6

2022 12 5

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

2022 12 6

2022 12 9

Abevmy

Mylan IRE Healthcare Limited

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

EU/1/20/1515

2022 12 14

2022 12 9

Atriance

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57, 1000 Ljubljana, Slovenija

EU/1/07/403

2022 12 12

2022 12 9

Aybintio

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/20/1454

2022 12 13

2022 12 9

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

2022 12 15

2022 12 9

Deferiprone Lipomed

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/18/1310

2022 12 12

2022 12 9

Duaklir Genuair

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/14/964

2022 12 12

2022 12 9

Eklira Genuair

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/12/778

2022 12 14

2022 12 9

Erleada

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/18/1342

2022 12 12

2022 12 9

Eylea

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

2022 12 13

2022 12 9

Herzuma

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1257

2022 12 14

2022 12 9

Insulin aspart Sanofi

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1447

2022 12 13

2022 12 9

Insulin lispro Sanofi

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1203

2022 12 13

2022 12 9

Onbevzi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/20/1499

2022 12 13

2022 12 9

Oyavas

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/20/1510

2022 12 12

2022 12 9

Qarziba

EUSA Pharma (Netherlands) B.V.

Beechavenue 54, 1119PW Schiphol-Rijk, Nederland

EU/1/17/1191

2022 12 14

2022 12 9

Retsevmo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

2022 12 12

2022 12 9

Riarify

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1275

2022 12 12

2022 12 9

Spravato

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/19/1410

2022 12 12

2022 12 9

Suliqua

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/16/1157

2022 12 13

2022 12 9

Vaxelis

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden, Nederland

EU/1/15/1079

2022 12 13

2022 12 9

Vydura

Pfizer Europe MA EEIG

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

EU/1/22/1645

2022 12 12

2022 12 9

Xydalba

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/986

2022 12 12

2022 12 9

Zirabev

Pfizer Europe MA EEIG

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

EU/1/18/1344

2022 12 12

Alymsys

Mabxience Research SL

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

EU/1/20/1509

2022 12 13

2022 12 12

Cablivi

Ablynx N.V.

Technologiepark 21, 9052 Zwijnaarde, België

EU/1/18/1305

2022 12 21

2022 12 12

Dificlir

Tillotts Pharma GmbH

Warmbacher Strasse 80, 79618 Rheinfelden, Deutschland

EU/1/11/733

2022 12 13

2022 12 12

DuoPlavin

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/10/619

2022 12 14

2022 12 12

Dupixent

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1229

2022 12 13

2022 12 12

Enhertu

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

2022 12 13

2022 12 12

Karvezide

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/085

2022 12 13

2022 12 12

Kisqali

Novartis Europharm Limited

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

EU/1/17/1221

2022 12 13

2022 12 12

Refixia

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1193

2022 12 13

2022 12 16

Avastin

Roche Registration GmbH

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

EU/1/04/300

2022 12 19

2022 12 16

Bretaris Genuair

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/12/781

2023 1 3

2022 12 16

Brilique

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/655

2022 12 19

2022 12 16

Brimica Genuair

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/14/963

2022 12 19

2022 12 16

Caprelsa

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/11/749

2022 12 19

2022 12 16

Ceprotin

Baxter AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/01/190

2022 12 19

2022 12 16

Combivir

ViiV Healthcare BV

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

EU/1/98/058

2022 12 19

2022 12 16

Corbilta

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/13/859

2022 12 20

2022 12 16

DUAVIVE

Pfizer Europe MA EEIG

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

EU/1/14/960

2022 12 20

2022 12 16

DuoPlavin

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/10/619

2022 12 19

2022 12 16

Dupixent

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1229

2022 12 19

2022 12 16

Eptifibatide 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

2022 12 19

2022 12 16

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

2022 12 19

2022 12 16

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

2022 12 19

2022 12 16

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

2022 12 19

2022 12 16

Inhixa

Techdow Pharma Netherlands B.V.

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

EU/1/16/1132

2022 12 22

2022 12 16

Intuniv

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/15/1040

2022 12 20

2022 12 16

Iscover

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/070

2022 12 19

2022 12 16

Iscover

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/070

2022 12 19

2022 12 16

Iscover

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/070

2022 12 19

2022 12 16

Karvea

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/97/049

2022 12 20

2022 12 16

Levodopa/Carbidopa/Entacapone Orion

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/706

2022 12 21

2022 12 16

Lynparza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

2022 12 19

2022 12 16

Moventig

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/14/962

2022 12 21

2022 12 16

Mvabea

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1445

2022 12 20

2022 12 16

Myalepta

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/18/1276

2022 12 21

2022 12 16

Neulasta

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/227

2022 12 20

2022 12 16

Ocaliva

ADVANZ PHARMA Limited

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

EU/1/16/1139

2022 12 19

2022 12 16

Ozawade

Bioprojet Pharma

9 rue Rameau, 75002 Paris, France

EU/1/21/1546

2022 12 19

2022 12 16

Plavix

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/069

2022 12 19

2022 12 16

Plavix

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/069

2022 12 19

2022 12 16

Plavix

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/069

2022 12 19

2022 12 16

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

2022 12 20

2022 12 16

Rybelsus

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/20/1430

2022 12 20

2022 12 16

Sarclisa

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1435

2022 12 19

2022 12 16

Saxenda

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/15/992

2022 12 19

2022 12 16

Spikevax

MODERNA BIOTECH SPAIN, S.L.

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

EU/1/20/1507

2022 12 19

2022 12 16

Trajenta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/11/707

2022 12 19

2022 12 16

Tresiba

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/12/807

2022 12 20

2022 12 16

Truvelog Mix 30

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/22/1639

2022 12 19

2022 12 16

Twynsta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/10/648

2023 1 3

2022 12 16

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

2022 12 19

Inrebic

Bristol-Myers Squibb Pharma EEIG

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

EU/1/20/1514

2022 12 20

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

2022 12 22

2022 12 20

Mvasi

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

EU/1/17/1246

2023 1 4

2022 12 20

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

2022 12 22

2022 12 20

Sarclisa

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1435

2022 12 21

2022 12 20

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/901

2022 12 21

2022 12 20

Skytrofa

Ascendis Pharma Endocrinology Division A/S

Tuborg Boulevard 12, 2900 Hellerup, Danmark

EU/1/21/1607

2022 12 21

2022 12 22

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

2022 12 22

Paxlovid

Pfizer Europe MA EEIG

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

EU/1/22/1625

2022 12 22

— Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis)

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2022 12 5

Trogarzo

Theratechnologies Europe Limited

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

EU/1/19/1359

2023 1 5

2022 12 9

NeuroBloc

Sloan Pharma S.a.r.l.

33 Rue de Puits Romain, 8070 Bertrange, Luxembourg

EU/1/00/166

2022 12 12

— Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis; Europos Parlamento ir Tarybos reglamento (ES) 2019/6 5 straipsnis): Priimta

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

2022 12 20

NEOLEISH

Šunų vakcina nuo leišmaniozės (rekombinantinės DNR plazmidės)

CZ Veterinaria, S.A.

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

EU/2/22/290

Nosies purškalas, tirpalas

Pending

2022 12 21

— Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis; Europos Parlamento ir Tarybos reglamento (ES) 2019/6 5 straipsnis): Priimta

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2022 12 2

CYTOPOINT

Zoetis Belgium

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

EU/2/17/205

2022 12 5

2022 12 2

Fevaxyn Pentofel

Zoetis Belgium

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

EU/2/96/002

2022 12 6

2022 12 2

Solensia

Zoetis Belgium SA

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

EU/2/20/269

2022 12 5

2022 12 2

Tulissin

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/20/252

2022 12 6

2022 12 2

Zenalpha

Vetcare Oy

P.O. Box 99, 24101 Salo, Suomi

EU/2/21/279

2022 12 7

2022 12 9

Convenia

Zoetis Belgium

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

EU/2/06/059

2022 12 14

2022 12 9

Zeleris

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/210

2022 12 14

2022 12 13

Innovax-ND-ILT

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/20/256

2022 12 14

2022 12 13

Versican Plus DHPPi/L4R

Zoetis Belgium

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

EU/2/14/163

2022 12 14

2022 12 15

Exzolt

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/17/212

2022 12 20

2022 12 15

Librela

Zoetis Belgium SA

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

EU/2/20/261

2022 12 21

2022 12 15

NEXGARD SPECTRA

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/14/177

2022 12 16

2022 12 15

Porcilis PCV M Hyo

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/175

2022 12 20

2022 12 15

Simparica Trio

Zoetis Belgium

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

EU/2/19/243

2022 12 20

2022 12 15

Simparica Trio

Zoetis Belgium

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

EU/2/19/243

2022 12 20

2022 12 15

UBAC

Laboratorios Hipra, S.A.

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

EU/2/18/227

2022 12 21

2022 12 15

Versican Plus Pi/L4R

Zoetis Belgium

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

EU/2/14/173

2022 12 16

Equip WNV

Zoetis Belgium

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

EU/2/08/086

2022 12 20

Lydaxx

VETOQUINOL S.A.

Magny-Vernois, 70200 Lure, France

EU/2/20/253

2022 12 21

2022 12 20

Novem

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/042

2022 12 22

2022 12 20

Onsior

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/08/089

2022 12 21

2022 12 20

ProteqFlu

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/03/037

2022 12 22

2022 12 20

ProteqFlu-Te

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/03/038

2022 12 22

2022 12 20

Rabitec

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/219

2022 12 21

2022 12 20

RHINISENG

Laboratorios Hipra, S.A.

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

EU/2/10/109

2022 12 22

2022 12 20

Suprelorin

VIRBAC S.A.

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

EU/2/07/072

2022 12 23

2022 12 20

Tulaven

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/20/251

2022 12 21

Norintieji susipažinti su nagrinėjamųjų vaistų vieša vertinimo ataskaita ir su ja susijusiais sprendimais, gali kreiptis į:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

(1) OL L 136, 2004 4 30, p. 1.

(2) OL L 4, 2019 1 7, p. 43.

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