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Document 52020XC0529(04)

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2020. gada 1. aprīļa līdz 2020. gada 30. aprīlim (publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

PUB/2020/383

OJ C 181, 29.5.2020, p. 1–12 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

29.5.2020   

LV

Eiropas Savienības Oficiālais Vēstnesis

C 181/1


Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2020. gada 1. aprīļa līdz 2020. gada 30. aprīlim

(publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004 (1))

(2020/C 181/01)

—   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

1.4.2020.

Arsenic trioxide Mylan

arsenic trioxide

Mylan Ireland Limited

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

EU/1/20/1427

Koncentrāts un šķīdinātājs infūziju šķīduma pagatavošanai

L01XX27

2.4.2020.

1.4.2020.

Nilemdo

bempedoiskā skābe

FGK Representative Service GmbH

Heimeranstraße 35, 80339 München, Deutschland

EU/1/20/1425

Apvalkotās tabletes

C10AX15

2.4.2020.

1.4.2020.

Ruxience

rituksimabs

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique

Pleinlaan 17, 1050 Brussel, België

EU/1/20/1431

Koncentrāts infūziju šķīduma pagatavošanai

L01XC02

6.4.2020.

1.4.2020.

Vaxchora

Holēras vakcīna (rekombinanta, dzīva, perorāla)

Emergent Netherlands B.V.

Strawinskylaan 411, 1077 XX Amsterdam, Nederland

EU/1/20/1423

Putojošs pulveris un pulveris iekšķīgi lietojamas suspensijas pagatavošanai.

J07AE02

15.4.2020.

3.4.2020.

Budesonide/Formoterol Teva Pharma B.V.

budesonidum/Formoteroli fumaras dihydricus

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/19/1403

Inhalācijas pulveris

R03AK07

7.4.2020.

3.4.2020.

Cinacalcet Accordpharma

cinakalceta

Accord Healthcare S.L.U.

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

EU/1/20/1429

Apvalkotās tabletes

H05BX01

7.4.2020.

3.4.2020.

Rybelsus

semaglutīds

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/20/1430

Tabletes

A10BJ06

7.4.2020.

3.4.2020.

Trepulmix

nātrija treprostinils

SciPharm Sàrl

7, Fausermillen, 6689 Mertert, Luxembourg

EU/1/19/1419

Šķīdums infūzijām

B01AC21

7.4.2020.

17.4.2020.

Tigecycline Accord

tigecycline

Accord Healthcare S.L.U.

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

EU/1/19/1394

Pulveris infūziju šķīduma pagatavošanai

J01AA12

20.4.2020.

23.4.2020.

Fetcroja

cefiderokols

Shionogi B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Nederland

EU/1/20/1434

Pulveris infūziju šķīduma koncentrāta pagatavošanai

J01DI04

24.4.2020.

—   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

1.4.2020.

Advate

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/03/271

9.4.2020.

1.4.2020.

Alunbrig

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/18/1264

2.4.2020.

1.4.2020.

Defitelio

Gentium S.r.I.

Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia

EU/1/13/878

6.4.2020.

1.4.2020.

Dovato

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/19/1370

7.4.2020.

1.4.2020.

Dynastat

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique

Pleinlaan 17, 1050 Brussel, België

EU/1/02/209

8.4.2020.

1.4.2020.

Intrarosa

Endoceutics S.A.

Rue Belliard 40, 1040 Brussels, Belgium

EU/1/17/1255

3.4.2020.

1.4.2020.

Isturisa

Recordati Rare Diseases

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

EU/1/19/1407

2.4.2020.

1.4.2020.

Juluca

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/18/1282

7.4.2020.

1.4.2020.

Lonsurf

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/16/1096

2.4.2020.

1.4.2020.

Lutathera

Advanced Accelerator Applications

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

EU/1/17/1226

6.4.2020.

1.4.2020.

Mirvaso

Galderma International

Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France

EU/1/13/904

6.4.2020.

1.4.2020.

Mvasi

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

EU/1/17/1246

3.4.2020.

1.4.2020.

Odefsey

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1112

2.4.2020.

1.4.2020.

Ondexxya

Portola Netherlands B.V.

Prins Bernhardplein 200, 1097 JB, Amsterdam, Netherlands

EU/1/18/1345

10.4.2020.

1.4.2020.

RoActemra

Roche Registration GmbH

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

EU/1/08/492

2.4.2020.

1.4.2020.

Synjardy

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1003

3.4.2020.

1.4.2020.

TAVLESSE

Instituto Grifols, S.A.

Can Guasc, 2, Parets del Vallès, 08150 Barcelona, Espaňa

EU/1/19/1405

3.4.2020.

1.4.2020.

Trecondi

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/18/1351

2.4.2020.

1.4.2020.

Triumeq

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/14/940

7.4.2020.

1.4.2020.

Vemlidy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1154

2.4.2020.

1.4.2020.

Zoledronic acid Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/12/786

3.4.2020.

3.4.2020.

AFSTYLA

CSL Behring GmbH

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

EU/1/16/1158

7.4.2020.

3.4.2020.

Alecensa

Roche Registration GmbH

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

EU/1/16/1169

6.4.2020.

3.4.2020.

Avastin

Roche Registration GmbH

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

EU/1/04/300

6.4.2020.

3.4.2020.

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

6.4.2020.

3.4.2020.

Elmiron

bene-Arzneimittel GmbH

Herterichstraße 1-3, 81479 München, Deutschland

EU/1/17/1189

20.4.2020.

3.4.2020.

Glivec

Novartis Europharm Limited

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

EU/1/01/198

8.4.2020.

3.4.2020.

Jinarc

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland

EU/1/15/1000

7.4.2020.

3.4.2020.

Lorviqua

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique

Pleinlaan 17, 1050 Brussel, België

EU/1/19/1355

8.4.2020.

3.4.2020.

Naglazyme

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork P43 R298, Ireland

EU/1/05/324

6.4.2020.

3.4.2020.

NULOJIX

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/694

6.4.2020.

3.4.2020.

Pregabalin Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/997

7.4.2020.

3.4.2020.

Pregabalin Mylan Pharma

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/998

7.4.2020.

8.4.2020.

Insuman

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030

23.4.2020.

8.4.2020.

Otezla

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/14/981

14.4.2020.

8.4.2020.

Pifeltro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1332

23.4.2020.

8.4.2020.

Pregabalin Accord

Accord Healthcare S.L.U.

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

EU/1/15/1027

14.4.2020.

8.4.2020.

Tamiflu

Roche Registration GmbH

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

EU/1/02/222

14.4.2020.

8.4.2020.

Tivicay

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/13/892

14.4.2020.

8.4.2020.

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

15.4.2020.

8.4.2020.

Vidaza

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/488

14.4.2020.

8.4.2020.

Xaluprine

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland

EU/1/11/727

14.4.2020.

14.4.2020.

Repatha

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1016

16.4.2020.

17.4.2020.

Cystagon

Recordati Rare Diseases

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

EU/1/97/039

23.4.2020.

17.4.2020.

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

20.4.2020.

17.4.2020.

Rubraca

Clovis Oncology Ireland Limited

Regus Dublin Airport, Skybridge House – Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland

EU/1/17/1250

20.4.2020.

17.4.2020.

Zerbaxa

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1032

23.4.2020.

23.4.2020.

Bevespi Aerosphere

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1339

5.5.2020.

23.4.2020.

Bridion

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/466

24.4.2020.

23.4.2020.

Carbaglu

Recordati Rare Diseases

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

EU/1/02/246

5.5.2020.

23.4.2020.

Cresemba

Basilea Pharmaceutica Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Loerrach, Baden-Wuerttemberg, Deutschland

EU/1/15/1036

24.4.2020.

23.4.2020.

Cystadane

Recordati Rare Diseases

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

EU/1/06/379

24.4.2020.

23.4.2020.

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

27.4.2020.

23.4.2020.

Descovy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1099

24.4.2020.

23.4.2020.

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/17/1210

24.4.2020.

23.4.2020.

Kanuma

Alexion Europe SAS

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

EU/1/15/1033

24.4.2020.

23.4.2020.

Lumark

IDB Holland B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

30.4.2020.

23.4.2020.

Onivyde pegylated liposomal

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/16/1130

5.5.2020.

23.4.2020.

OPDIVO

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

24.4.2020.

23.4.2020.

Pedea

Recordati Rare Diseases

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

EU/1/04/284

24.4.2020.

23.4.2020.

Respreeza

CSL Behring GmbH

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

EU/1/15/1006

27.4.2020.

23.4.2020.

Sustiva

Bristol-Myers Squibb Pharma EEIG

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

EU/1/99/110

24.4.2020.

23.4.2020.

Tysabri

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/06/346

24.4.2020.

23.4.2020.

Ultibro Breezhaler

Novartis Europharm Limited

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

EU/1/13/862

24.4.2020.

23.4.2020.

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/714

24.4.2020.

28.4.2020.

Abilify

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland

EU/1/04/276

29.4.2020.

28.4.2020.

ABILIFY MAINTENA

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland

EU/1/13/882

30.4.2020.

28.4.2020.

Aripiprazole Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1029

6.5.2020.

28.4.2020.

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

29.4.2020.

28.4.2020.

Cayston

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/09/543

29.4.2020.

28.4.2020.

Cosentyx

Novartis Europharm Limited

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

EU/1/14/980

30.4.2020.

28.4.2020.

Docetaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/611

29.4.2020.

28.4.2020.

Entyvio

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/923

7.5.2020.

28.4.2020.

Farydak

Secura Bio Limited

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

EU/1/15/1023

30.4.2020.

28.4.2020.

Fycompa

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/12/776

1.5.2020.

28.4.2020.

Humira

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/03/256

29.4.2020.

28.4.2020.

Intelence

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/468

29.4.2020.

28.4.2020.

Kevzara

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1196

30.4.2020.

28.4.2020.

Kineret

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/02/203

30.4.2020.

28.4.2020.

Lokelma

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

5.5.2020.

28.4.2020.

Myalepta

Amryt Pharmaceuticals DAC

90 Harcourt Street, Dublin 2, Ireland

EU/1/18/1276

29.4.2020.

28.4.2020.

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

1.5.2020.

28.4.2020.

OCALIVA

Intercept Pharma International Limited

Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland

EU/1/16/1139

29.4.2020.

28.4.2020.

Ruconest

Pharming Group N.V.

Darwinweg 24, 2333 CR Leiden, Nederland

EU/1/10/641

29.4.2020.

28.4.2020.

Strensiq

Alexion Europe SAS

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

EU/1/15/1015

29.4.2020.

28.4.2020.

Zynteglo

bluebird bio (Netherlands) B.V.

Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland

EU/1/19/1367

30.4.2020.

—   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

14.4.2020.

Osseor

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/04/287

15.4.2020.

14.4.2020.

Protelos

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/04/288

15.4.2020.

—   Tirdzniecības atļaujas izsniegšana (38. 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

24.4.2020.

Tulaven

tulatromicīns

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/20/251

Šķīdums injekcijai

QJ01FA94

27.4.2020.

24.4.2020.

Tulissin

tulatromicīns

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/20/252

Šķīdums injekcijai

QJ01FA94

27.4.2020.

24.4.2020.

Vectormune FP ILT + AE

Putnu baku vīruss, putnu infekciozais laringotraheīts vakcīna (dzīvs, rekombinants) un putnu encefalomielīts vakcīna (dzīvs)

Ceva-Phylaxia Co. Ltd.

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/20/250

Liofilizāts un šķīdinātājs injekciju suspensijas pagatavošanai

Pending

27.4.2020.

—   Tirdzniecības atļaujas grozīšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

1.4.2020.

Comfortis

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/10/115

3.4.2020.

1.4.2020.

Nobivac LeuFel

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/17/217

3.4.2020.

8.4.2020.

Acticam

Ecuphar NV

Legeweg 157-i, 8020 Oostkamp, België

EU/2/08/088

22.4.2020.

8.4.2020.

Fevaxyn Pentofel

Zoetis Belgium S.A.

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

EU/2/96/002

15.4.2020.

8.4.2020.

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/11/134

15.4.2020.

8.4.2020.

MiPet Easecto

Zoetis Belgium S.A.

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

EU/2/17/220

16.4.2020.

8.4.2020.

RESPIPORC FLUpan H1N1

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/209

14.4.2020.

8.4.2020.

Vectra 3D

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/13/156

14.4.2020.

8.4.2020.

Versican Plus DHPPi

Zoetis Belgium S.A.

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

EU/2/14/169

15.4.2020.

8.4.2020.

Versican Plus DHPPi/L4

Zoetis Belgium S.A.

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

EU/2/14/164

15.4.2020.

8.4.2020.

Versican Plus DHPPi/L4R

Zoetis Belgium S.A.

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

EU/2/14/163

15.4.2020.

8.4.2020.

Versican Plus L4

Zoetis Belgium S.A.

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

EU/2/14/171

15.4.2020.

8.4.2020.

Versican Plus Pi

Zoetis Belgium S.A.

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

EU/2/14/168

15.4.2020.

8.4.2020.

Versican Plus Pi/L4

Zoetis Belgium S.A.

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

EU/2/14/172

15.4.2020.

8.4.2020.

Versican Plus Pi/L4R

Zoetis Belgium S.A.

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

EU/2/14/173

15.4.2020.

16.4.2020.

Arti-Cell Forte

Global Stem cell Technology (G.S.T.) NV

Noorwegenstraat 4, 9940 Evergem, België

EU/2/18/228

17.4.2020.

24.4.2020.

Canigen L4

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/183

27.4.2020.

24.4.2020.

Innovax-ILT

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/182

28.4.2020.

24.4.2020.

SevoFlo

Zoetis Belgium S.A.

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

EU/2/02/035

27.4.2020.

24.4.2020.

Sileo

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/15/181

29.4.2020.

—   Tirdzniecības atļaujas izņemšana no aprites (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

8.4.2020.

Suvaxyn PCV

Zoetis Belgium S.A.

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

EU/2/09/099

15.4.2020.

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.


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