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Document C:2021:033:FULL

Official Journal of the European Union, C 33, 29 January 2021


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ISSN 1977-091X

Official Journal

of the European Union

C 33

European flag  

English edition

Information and Notices

Volume 64
29 January 2021


Contents

page

 

IV   Notices

 

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

 

European Commission

2021/C 33/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2020 to 31 December 2020(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2021/C 33/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2020 to 31 December 2020(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

11


EN

 


IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

29.1.2021   

EN

Official Journal of the European Union

C 33/1


Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2020 to 31 December 2020

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2021/C 33/01)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

9.12.2020

Leqvio

inclisiran

Novartis Europharm Limited

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

EU/1/20/1494

Solution for injection

C10AX16

10.12.2020

9.12.2020

TRIXEO AEROSPHERE

Formoterol / glycopyrronium bromide / budesonide

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/20/1498

Pressurised inhalation, suspension

R03AL11

10.12.2020

14.12.2020

Tecartus

autologous anti-CD19-transduced CD3+ cells

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

EU/1/20/1492

Dispersion for infusion

L01X

15.12.2020

17.12.2020

Libmeldy

autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene

Orchard Therapeutics (Netherlands) B.V.

Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland

EU/1/20/1493

Dispersion for infusion

Pending

18.12.2020

17.12.2020

REKAMBYS

rilpivirine

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1482

Prolonged release suspension for injection

J05AG05

21.12.2020

17.12.2020

Vocabria

cabotegravir

ViiV Healthcare BV

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

EU/1/20/1481

Film-coated tablet

Prolonged release suspension for injection

J05AJ04

21.12.2020

18.12.2020

Fintepla

fenfluramine

Zogenix ROI Limited

Trinity House, Charleston Road, Ranelagh, Dublin 6, D06 C8X4, Ireland

EU/1/20/1491

Oral solution

N03AX

21.12.2020

18.12.2020

Lenalidomide Mylan

lenalidomide

Mylan Ireland Limited

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

EU/1/20/1490

Capsule, hard

L04AX04

21.12.2020

21.12.2020

Phesgo

pertuzumab / trastuzumab

Roche Registration GmbH

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

EU/1/20/1497

Solution for injection

L01XY02

22.12.2020

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

1.12.2020

Vimpat

UCB Pharma S.A.

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

EU/1/08/470

2.12.2020

1.12.2020

Zonisamide Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1093

4.12.2020

9.12.2020

Aldara

Meda AB

Pipers väg 2A, 170 73 Solna, Sverige

EU/1/98/080

11.12.2020

9.12.2020

Caspofungin Accord

Accord Healthcare S.L.U.

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

EU/1/15/1081

11.12.2020

9.12.2020

Epidyolex

GW Pharma (International) B.V.

Databankweg 26, 3821AL Amersfoort, Nederland

EU/1/19/1389

11.12.2020

9.12.2020

Inlyta

Pfizer Europe MA EEIG

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

EU/1/12/777

11.12.2020

9.12.2020

Kadcyla

Roche Registration GmbH

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

EU/1/13/885

10.12.2020

9.12.2020

Lucentis

Novartis Europharm Limited

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

EU/1/06/374

10.12.2020

9.12.2020

MAVENCLAD

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1212

11.1.2021

9.12.2020

Miglustat Dipharma

Dipharma B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/18/1346

10.12.2020

9.12.2020

Neofordex

Laboratoires CTRS

63 rue de l'Est, 92100 Boulogne-Billancourt, France

EU/1/15/1053

11.12.2020

9.12.2020

Olazax Disperzi

Glenmark Pharmaceuticals s.r.o.

Hvězdova 1716/2b, 14078 Praha 4, Česká republika

EU/1/09/592

11.12.2020

9.12.2020

Onbrez Breezhaler

Novartis Europharm Limited

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

EU/1/09/593

10.12.2020

9.12.2020

Orbactiv

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/15/989

10.12.2020

9.12.2020

Orencia

Bristol-Myers Squibb Pharma EEIG

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

EU/1/07/389

10.12.2020

9.12.2020

Polivy

Roche Registration GmbH

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

EU/1/19/1388

10.12.2020

9.12.2020

SCENESSE

Clinuvel Europe Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/14/969

10.12.2020

9.12.2020

Seebri Breezhaler

Novartis Europharm Limited

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

EU/1/12/788

10.12.2020

9.12.2020

Tovanor Breezhaler

Novartis Europharm Limited

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

EU/1/12/790

6.1.2021

14.12.2020

ADCETRIS

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/12/794

15.12.2020

14.12.2020

Bosulif

Pfizer Europe MA EEIG

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

EU/1/13/818

15.12.2020

14.12.2020

Gilenya

Novartis Europharm Limited

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

EU/1/11/677

15.12.2020

14.12.2020

Hirobriz Breezhaler

Novartis Europharm Limited

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

EU/1/09/594

17.12.2020

14.12.2020

Jakavi

Novartis Europharm Limited

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

EU/1/12/773

17.12.2020

14.12.2020

JEVTANA

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/11/676

17.12.2020

14.12.2020

Lonsurf

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/16/1096

15.12.2020

14.12.2020

Plegridy

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/14/934

15.12.2020

14.12.2020

Revatio

Upjohn EESV

Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland

EU/1/05/318

21.12.2020

14.12.2020

Uptravi

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/15/1083

16.12.2020

14.12.2020

Zyclara

Meda AB

Pipers väg 2A, 170 73 Solna, Sverige

EU/1/12/783

17.12.2020

17.12.2020

Empliciti

Bristol-Myers Squibb Pharma EEIG

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

EU/1/16/1088

19.12.2020

17.12.2020

Halimatoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1288

7.1.2021

17.12.2020

Keppra

UCB Pharma S.A.

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

EU/1/00/146

21.12.2020

17.12.2020

Kyprolis

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

18.12.2020

17.12.2020

Lorviqua

Pfizer Europe MA EEIG

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

EU/1/19/1355

18.12.2020

17.12.2020

Rubraca

Clovis Oncology Ireland Limited

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

EU/1/17/1250

21.12.2020

17.12.2020

Taltz

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1085

22.12.2020

17.12.2020

Truberzi

Allergan Pharmaceuticals International Limited

Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland

EU/1/16/1126

30.12.2020

17.12.2020

Verzenios

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/18/1307

22.12.2020

17.12.2020

Votrient

Novartis Europharm Limited

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

EU/1/10/628

20.12.2020

17.12.2020

Wakix

Bioprojet Pharma

9 rue Rameau, 75002 Paris, France

EU/1/15/1068

6.1.2021

17.12.2020

Xyrem

UCB Pharma S.A.

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

EU/1/05/312

18.12.2020

17.12.2020

Ziextenzo

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1327

7.1.2021

18.12.2020

Cerezyme

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/97/053

21.12.2020

18.12.2020

Galvus

Novartis Europharm Limited

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

EU/1/07/414

6.1.2021

18.12.2020

Jalra

Novartis Europharm Limited

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

EU/1/08/485

6.1.2021

18.12.2020

Jivi

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/18/1324

22.12.2020

18.12.2020

Pixuvri

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/12/764

22.12.2020

18.12.2020

Rixubis

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/14/970

22.12.2020

18.12.2020

Veklury

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

21.12.2020

18.12.2020

Xiliarx

Novartis Europharm Limited

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

EU/1/08/486

6.1.2021

21.12.2020

Veklury

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

22.12.2020

22.12.2020

BLINCYTO

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

25.12.2020

22.12.2020

Zirabev

Pfizer Europe MA EEIG

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

EU/1/18/1344

23.12.2020

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

17.12.2020

Prepandrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/08/453

4.1.2021

18.12.2020

Halimatoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1288

8.1.2021

18.12.2020

Truberzi

Allergan Pharmaceuticals International Limited

Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland

EU/1/16/1126

5.1.2021

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

3.12.2020

REXXOLIDE

tulathromycin

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/20/263

Solution for injection

QJ01FA94

9.12.2020

9.12.2020

CircoMax Myco

Porcine circovirus vaccine (inactivated, recombinant) and Mycoplasma hyopneumoniae vaccine (inactivated)

Zoetis Belgium S.A.

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

EU/2/20/264

Emulsion for injection

QI09AL08

11.12.2020

9.12.2020

Enteroporc Coli AC

Neonatal piglet colibacillosis (recombinant, inactivated) and Clostridium perfringens vaccine (inactivated)

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/20/262

Lyophilisate and suspension for suspension for injection

Pending

10.12.2020

9.12.2020

Nobivac DP Plus

Canine distemper vaccine (live) and canine parvovirus vaccine (live, recombinant)

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/20/265

Lyophilisate and solvent for suspension for injection

QI07AD03

10.12.2020

9.12.2020

Vectormune FP ILT

Fowlpox, avian infectious laryngotracheitis vaccine (live, recombinant)

Ceva-Phylaxia Co. Ltd.

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/20/266

Lyophilisate and solvent for suspension for injection

Pending

10.12.2020

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.12.2020

Bravecto Plus

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/18/224

4.12.2020

3.12.2020

Exzolt

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/17/212

4.12.2020

9.12.2020

Bravecto

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/13/158

10.12.2020

9.12.2020

Circovac

Ceva-Phylaxia Zrt.

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/07/075

11.12.2020

9.12.2020

Zulvac SBV

Zoetis Belgium S.A.

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

EU/2/14/178

11.12.2020

11.12.2020

Onsior

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/08/089

14.12.2020

17.12.2020

Nobilis IB 4-91

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/98/006

21.12.2020

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS


(1)  OJ L 136, 30.4.2004, p. 1.


29.1.2021   

EN

Official Journal of the European Union

C 33/11


Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2020 to 31 December 2020

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2021/C 33/02)

—   Issuing, maintenance or modification of a national marketing authorization

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

9.12.2020

Tiamulin

Tiamiulin

See Annex

See Annex

10.12.2020


(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX

List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, marketing authorisation holders in the Member States

Member State EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Denagard 100 mg/g — Arzneimittelvormischung zur Herstellung von Fütterungsarzneimitteln für Schweine, Geflügel und Kaninchen

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, chickens, rabbits

Oral

Austria

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Denagard 20 mg/g — Arzneimittelvormischung zur Herstellung von Fütterungsarzneimitteln für Schweine, Geflügel und Kaninchen

Tiamulin (as hydrogen fumarate)

20 mg/g

Premix for medicated feeding stuff

Pigs, chickens, rabbits

Oral

Austria

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 100 g/kg Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine, Hühner, Puten und Kaninchen

Tiamulin (as hydrogen fumarate)

100 g/kg

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Belgium

V.M.D. n.v.

Hoge Mauw 900

B-2370 Arendonk

Belgium

Tiamutin 10 %

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Belgium

V.M.D. n.v.

Hoge Mauw 900

B-2370 Arendonk

Belgium

Tiamutin 10 % Pulvis

Tiamulin (as hydrogen fumarate)

100 mg/g

Oral powder

Pigs

Oral

Belgium

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 20 g/kg Premix

Tiamulin (as hydrogen fumarate)

20 g/kg

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Belgium

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 100 g/kg

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Bulgaria

Huvepharma NV Uitbreidingstraat 80

2600 Antwerpen

Belgium

Ветмулин 20 g/kg премикс за медикаментозен фураж

Tiamulin (as hydrogen fumarate)

20 g/kg

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Bulgaria

Farma SIS Ltd.,

ul.‘San Stefano’ №6b, et.1, of. 3,

Dobrich

Bulgaria

НЕУМУТИЛ 10 % ПРЕМИКС

Tiamulin (as hydrogen fumarate)

100 g/1 000  g

Premix for medicated feeding stuff

Pigs, chickens

Oral

Bulgaria

Huvepharma NV Uitbreidingstraat 80

2600 Antwerpen

Belgium

Ветмулин 100 g/kg премикс за медикаментозен фураж

Tiamulin (as hydrogen fumarate)

100 g/kg

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Cyprus

Vitatrace Nutrition LTD

Οδός Προποντίδος 17,

Βιομηχανική Περιοχή Στροβόλου,

2033 Nicosia

Cyprus

CM2609 ΦΟΥΜΑΡΙΚΗ ΤΙΑΜΟΥΛΙΝΗ 10 %, φαρμακούχο πρόμιγμα για χοίρους

Tiamulin (as hydrogen fumarate)

100 g/kg

Medicated premix

Pigs

Oral

Cyprus

Dox-al Italia S.p.A.

Piazzale Cadorna 10

20123 Milano

Italy

COLINDOX 100, 100 mg/g — premix for medicated feed for swine

Tiamulin (as hydrogen fumarate)

100 mg/g

Medicated premix

Pigs

Oral

Cyprus

Elanco GmbH

Heinz-Lohmann-Str. 4

27472 Cuxhaven Germany

DENAGARD Πρόμιγμα για φαρμακούχο τροφή για χοίρους, όρνιθες, ινδόρνιθες και κουνέλια

Tiamulin (as hydrogen fumarate)

100 mg/g

Medicated premix

Pigs, chickens, turkeys, rabbits

Oral

Czech Republic

Elanco GmbH

Heinz-Lohmann-Str. 4

27472 Cuxhaven Germany

Denagard 100 mg/g perorální prášek

Tiamulin (as hydrogen fumarate)

100 mg/g

Oral powder

Pigs, chickens, turkeys

Oral

Czech Republic

Elanco GmbH

Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany

Denagard 100 mg/g premix pro medikaci krmiva pro prasata, drůbež a králíky

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Czech Republic

Ceva Animal Health Slovakia, s.r.o., Prievozská 5434/6A,

821 09 Bratislava — mestská časť Ružinov, Slovak Republic

TIAMVET 100 mg/g premix pro medikaci krmiva pro prasata

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs

Oral

Czech Republic

Univit s.r.o.,

Na Vlčinci 16/3,

779 00 Olomouc

Czech Republic

UNI-TIAMULIN 10 % perorální prášek

Tiamulin (as hydrogen fumarate)

100 mg/g

Oral powder for use in medicated feeding stuff

Pigs, chickens, turkeys

Oral

Czech Republic

Univit s.r.o.,

Na Vlčinci 16/3,

779 00 Olomouc

Czech Republic

UNI-TIAMULIN 2 % premix pro medikaci krmiva

Tiamulin (as hydrogen fumarate)

20 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys

Oral

Czech Republic

Huvepharma NV Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 100 g/kg premix pro medikaci krmiva pro prasata, kura domácího, krůty a králíky

Tiamulin (as hydrogen fumarate)

100 g/kg

Premix for medicated feeding stuff

Pigs, chickens, turkeys,

rabbits

Oral

Denmark

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys,

rabbits

Oral

Finland

Elanco GmbH

Heinz-Lohmann-Str. 4

27472 Cuxhaven Germany

Denagard vet 20 mg/g jauhe, sioille

Tiamulin (as hydrogen fumarate)

20 mg/g

Oral powder

Pigs

Oral

France

Ceva Sante Animale

10 Avenue de la Ballastiere,

Libourne 33500

France

Tiamuval premelange medicamenteux Tiamuline 6,5 enterite porc enterocolite lapin

Tiamulin (as hydrogen fumarate)

6,5  mg/g

Premix for medicated feeding stuff

Pigs, rabbits

Oral

France

Huvepharma SA

34 Rue Jean Monnet, Zone Industrielle D'etriche, Segre,

Segre-en-Anjou Bleu

49500

France

Tiamuline 6,5 enterite porc enterocolite lapin franvet

Tiamulin (as hydrogen fumarate)

6,5  mg/g

Premix for medicated feeding stuff

Pigs, rabbits

Oral

France

Huvepharma

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 16,2  mg/g premelange medicamenteux pour porcs, poulets, dindes et lapins

Tiamulin (as hydrogen fumarate)

16,2  mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

France

Huvepharma

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 81 mg/g premelange medicamenteux pour porcs, poulets, dindes et lapins

Tiamulin (as hydrogen fumarate)

81 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Germany

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Denagard 10 % oral, Pulver zum Eingeben über das Futter für Schweine

Tiamulin (as hydrogen fumarate)

100 mg/g

Powder

Pigs

Oral

Germany

Serumwerk Bernburg AG

Hallesche Landstr. 105b

06406 Bernburg

Germany

Ursomutin 25 % Granulat

Tiamulin (as hydrogen fumarate)

250 mg/g

Granules

Pigs, chickens, turkeys

Oral

Germany

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Denagard 10 % AMV

Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine, Geflügel und Kaninchen

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feed

Pigs, chickens, turkeys, rabbits

Oral

Greece

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 10 % PREMIX, Πρόμιγμα υπό μορφής σκόνης για φαρμακούχο τροφή 10 %

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feed

Pigs, chickens, turkeys, rabbits

Oral

Greece

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Denagard Πρόμιγμα για φαρμακούχο τροφή 10 %

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feed

Pigs, chickens, turkeys, rabbits

Oral

Hungary

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 100 g/kg gyógypremix sertések számára A.U.V.

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Ireland

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 100 g/kg premix for medicated feeding stuff for pigs, chickens, turkeys and rabbits

Tiamulin (as hydrogen fumarate)

100 g/kg

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Ireland

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 20 g/kg premix for medicated feeding stuff for pigs, chickens, turkeys and rabbits

Tiamulin (as hydrogen fumarate)

20 g/kg

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Italy

Elanco GmbH

Heinz-Lohmann-Str. 4

27472 Cuxhaven

Germany

Denagard 10 % premix plus

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Italy

Ceva Salute Animale S.p.A.

Viale Colleoni 15

20864 Agrate Brianza Italy

Tiamvet Plus

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, rabbits

Oral

Italy

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 100 g/kg

Tiamulin (as hydrogen fumarate)

100 g/kg

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Malta

Andres Pintaluba S.A.

Poligono Industrial Agro-Reus

C/ Prudenci Bertrana No 5

43206- Reus (Tarragona)

Spain

Apsamix Tiamulina 100 mg/g

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs

Oral

The Netherlands

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 100 mg/g premix voor gemedicineerd voer voor varkens, kippen, kalkoenen en konijnen

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Poland

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 100 g/kg premiks do sporządzania paszy leczniczej dla świń, kur, indyków i królików

Tiamulin (as hydrogen fumarate)

100 g/kg

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Poland

Elanco GmbH

Heinz-Lohmann Str. 4

27472 Cuxhaven

Germany

Denagard, 100 mg/g, premiks do sporządzania paszy leczniczej dla świń, kur, indyków i królików

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Portugal

Andres Pintaluba S.A.

Poligono Industrial Agro-Reus

C/ Prudenci Bertrana No 5

43206- Reus (Tarragona)

Spain

Apsamix Tiamulina 100 mg/g Pré-mistura medicamentosa para suínos (porcos de engorda)

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs

Oral

Portugal

Calier Portugal, S.A.

Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro

Estrada de Albarraque

2710 — 335 Sintra

Portugal

Caliermutin, 100 mg/g, pré-mistura para alimento medicamentoso para suínos

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff as granulated powder

Pigs

Oral

Portugal

Calier Portugal, S.A.

Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro

Estrada de Albarraque

2710 — 335 Sintra

Portugal

Caliermutin, 20 mg/g, pré-mistura para alimento medicamentoso para suínos e coelhos.

Tiamulin (as hydrogen fumarate)

20 mg/g

Premix for medicated feeding stuff as granulated powder

Pigs, rabbits

Oral

Portugal

Calier Portugal, S.A.

Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro

Estrada de Albarraque

2710 — 335 Sintra

Portugal

Caliermutin, 800 mg/g, pré-mistura medicamentosa para alimento medicamentoso para suínos

Tiamulin (as hydrogen fumarate)

800 mg/g

Premix for medicated feeding stuff as granulated powder

Pigs

Oral

Portugal

Representagro — Representaςoes LDA,

Estrada da Lapa no 1

2665-540 Venda do Pinheiro

Portugal

Nemutin 10 % Premix — P 100 mg/g pré-mistura medicamentosa para alimento medicamentoso para suínos

Tiamulin (as hydrogen fumarate)

100 mg/g

Medicated premix for medicated food

Pigs

Oral

Portugal

Zoopan — Produtos Pecuários, S.A.

Rua da Liberdade, 77

2050-023 Aveiras de Baixo

Portugal

Tiamuloxi

Tiamulin (as hydrogen fumarate)

100 mg/g

Medicated premix for medicated food

Pigs

Oral

Portugal

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 100 g/kg Pré-mistura para alimento medicamentoso para suínos, galinhas, perus e coelhos

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Portugal

Vetlima — SOC. Distribuidora de prod. Agro-pecuarios, SA Centro Empresarial da Rainha, Lote 27

2050-501 Vila Nova da Rainha

Portugal

Vetamulin 100 g/kg pré-mistura medicamentosa para alimento medicamentoso para suínos de engorda e frangos de carne

Tiamulin (as hydrogen fumarate)

100 g/kg

Medicated premix for medicated food

Pigs, chickens

Oral

Portugal

Elanco GmbH

Heinz-Lohmann Str.4,

27472 Cuxhaven

Germany

Denagard 100 g/kg pré-mistura medicamentosa para alimento medicamentoso para suínos, galinhas, perus e coelhos

Tiamulin (as hydrogen fumarate)

100 g/kg

Medicated premix for medicated food

Pigs, chickens, turkeys, rabbits

Oral

Romania

Lavet Phamaceuticals Ltd.

Otto u 14

1161 Budapest

Hungary

Lamulin 10 %

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs

Oral

Romania

Pasteur — Filiala Filipestii de Padure SRL

Str. Principala nr. 944, Filipestii de Padure, Jud. Prahova,

Romania

Tiamulin FP 80 %

Tiamulin (as hydrogen fumarate)

800 mg/g

Premix

Pigs, chickens

Oral

Romania

Huvepharma NV Uitbreidingstraat 80 2600 Antwerp

Belgium

Vetmulin 100 g/kg

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Romania

Praxis Trading SRL str. Iancu Capitanu nr. 38, sector 2,

Bucuresti

Romania

Biomulin 800 mg/g

Tiamulin (as hydrogen fumarate)

800 mg/g

Premix

Pigs

Oral

Romania

Elanco GmbH

Heinz-Lohmann-Str. 4,

27472 Cuxhaven Germany

Denagard 80 % coated

Tiamulin (as hydrogen fumarate)

800 mg/g

Premix

Pigs, chickens, turkeys

Oral

Slovak Republic

Farmavet s.r.o., Sklabinská 20

036 01 Martin

Slovak Republic

Tiafarm 20 mg/g premix na medikáciu krmiva

Tiamulin (as hydrogen fumarate)

20 mg/g

Premix for medicated feeding stuff

Pigs, chickens

Oral

Slovak Republic

Ceva Animal Health Slovakia, s.r.o., Račianska 153,

831 53 Bratislava

Slovak republic

Tiamvet 100 mg/g premix na medikáciu krmiva pre ošípané

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs

Oral

Spain

Andres Pintaluba S.A.

Poligono Industrial Agro-Reus

C/ Prudenci Bertrana 5

43206- Reus (Tarragona)

Spain

Tiamumix 20 mg/g premezcla medicamentosa para porcino y conejos

Tiamulin (as hydrogen fumarate)

20 mg/g

Premix for medicated feeding stuff

Pigs, rabbits

Oral

Spain

Andres Pintaluba S.A.

Poligono Industrial Agro-Reus

C/ Prudenci Bertrana 5

43206- Reus (Tarragona)

Spain

Apsamix Tiamulina 20 mg/g

Tiamulin (as hydrogen fumarate)

20 mg/g

Premix for medicated feeding stuff

Pigs

Oral

Spain

Laboratorios Calier S.A;

Barcelones 26. Pla del Ramassa

0852 — Les Franqueses del Valles (Barcelona)

Spain

Tiamulina Calier 100 mg/g Premezcla medicamentosa para cerdos

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs

Oral

Spain

Reidesen Pharma Services S.L.

C/ Bruc 64 baixos local 3

08009 Barcelona

Spain

Z-Mulin 20 g/kg Premezcla medicamentosa

Tiamulin (as hydrogen fumarate)

20 g/kg

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Spain

Laboratorios Calier S.A;

Barcelones 26. Pla del Ramassa

0852 — Les Franqueses del Valles (Barcelona)

Spain

Caliermutin 20 mg/g Premezcla

Tiamulin (as hydrogen fumarate)

20 mg/g

Premix for medicated feeding stuff as granulated powder

Pigs, rabbits

Oral

Spain

Andres Pintaluba S.A.

Poligono Industrial Agro-Reus

C/ Prudenci Bertrana 5

43206- Reus (Tarragona)

Spain

Tiamumix 100 mg/g Premezcla medicamentosa para porcino y conejos

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff as fine white powder

Pigs, rabbits

Oral

Spain

Andres Pintaluba S.A.

Poligono Industrial Agro-Reus

C/ Prudenci Bertrana 5

43206- Reus (Tarragona)

Spain

Apsamix Tiamulina 100 mg/g

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs

Oral

Spain

Elanco Spain SLU

Avda. de Bruselas, 13

28108, Alcobendas

Spain

Denagard 100 mg/g Premezcla medicamentosa

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Spain

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 100 g/kg Premezcla medicamentosa para porcino, pollos, pavos y conejos

Tiamulin (as hydrogen fumarate)

100 g/kg

Premix for medicated feeding stuff as granulated powder

Pigs, chickens, turkeys, rabbits

Oral

Spain

S.P. Veterinaria, S. A.;

Ctra. Reus — Vinyols, Km. 4,1

43330 Riudoms (Tarragona)

Spain

Nemutin 100 mg/g Premix

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs

Oral

Spain

Laboratorios Calier S.A;

Barcelones 26. Pla del Ramassa

0852 — Les Franqueses del Valles (Barcelona)

Spain

Caliermutin 100 mg/g Premezcla medicamentosa para cerdos

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff as granulated powder

Pigs

Oral

Spain

Elanco Spain SLU

Avda. de Bruselas, 13

28108, Alcobendas

Spain

Denagard 20 mg/g Premezcla medicamentosa

Tiamulin (as hydrogen fumarate)

20 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

Spain

Laboratorios Calier S.A;

Barcelones 26. Pla del Ramassa

0852 — Les Franqueses del Valles (Barcelona)

Spain

Caliermutin 800 mg/g Premezcla para porcino

Tiamulin (as hydrogen fumarate)

800 mg/g

Premix for medicated feeding stuff as granulated powder

Pigs

Oral

Spain

Cenavisa, S.L.

Camí Pedra Estela s/n

43205 Reus

Spain

Cenamutin 100 mg/g Premix

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs

Oral

United Kingdom

Elanco Europe Ltd

Lilly House

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Denagard 10 % w/w premix for medicated feeding stuff for pigs, chickens, turkeys and rabbits

Tiamulin (as hydrogen fumarate)

100 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

United Kingdom

Elanco Europe Ltd

Lilly House

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Denagard 2 % w/w premix for medicated feed for pigs, chickens, turkeys and rabbits

Tiamulin (as hydrogen fumarate)

20 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral

United Kingdom

Elanco Europe Ltd

Lilly House

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Denagard 80 % w/w premix for medicated feed for pigs, chickens and turkeys

Tiamulin (as hydrogen fumarate)

800 mg/g

Premix for medicated feeding stuff

Pigs, chickens, turkeys

Oral

United Kingdom

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Vetmulin 100 g/kg premix for medicated feeding stuff for pigs, chickens, turkeys and rabbits

Tiamulin (as hydrogen fumarate)

100 g/kg

Premix for medicated feeding stuff

Pigs, chickens, turkeys, rabbits

Oral


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