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Document 52020XC1030(08)

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2020 to 30 September 2020 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

PUB/2020/815

OJ C 367, 30.10.2020, p. 14–32 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

30.10.2020   

EN

Official Journal of the European Union

C 367/14


Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2020 to 30 September 2020

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

(2020/C 367/03)

—   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

16.9.2020

Dinolytic 12,5  mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof

Dinoprost

See Annex II

See Annex II

18.9.2020

—   Suspension 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

24.9.2020

medicinal products for human use which have been authorised or are pending approval based on clinical trials performed at Panexcell Clinical Laboratories Priv. Ltd

medicinal products for human use which have been authorised or are pending approval based on clinical trials performed at Panexcell Clinical Laboratories Priv. Ltd

See Annex I

See Annex I

25.9.2020


(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

List of nationally authorised medicinal products

Member State in EEA

Marketing authorisaton holder

Applicant

Product name

INN

Strength

Pharmaceutical form

Route of administration

Denmark

 

Laurus Generics GmBH

Atazanavir Laurus

Atazanavir

150 mg

Capsule, hard

Oral use

Denmark

 

Laurus Generics GmBH

Atazanavir Laurus

Atazanavir

200 mg

Capsule, hard

Oral use

Denmark

 

Laurus Generics GmBH

Atazanavir Laurus

Atazanavir

300 mg

Capsule, hard

Oral use

Finland

 

Laurus Generics GmbH

Atazanavir Laurus

Atazanavirsulfat

150 mg

Capsule, hard

Oral use

Finland

 

Laurus Generics GmbH

Atazanavir Laurus

Atazanavirsulfat

200 mg

Capsule, hard

Oral use

Finland

 

Laurus Generics GmbH

Atazanavir Laurus

Atazanavirsulfat

300 mg

Capsule, hard

Oral use

France

ALMUS FRANCE

 

Amoxicilline Almus Pharma 500 mg gélule

AMOXICILLIN TRIHYDRATE

500 mg

Capsule, hard

Oral use

France

Baxter Holding B.V.

 

FER BAXTER 20 mg/mL, solution pour injection/perfusion

IRON SUCROSE

20 mg/mL

solution for injection/infusion

Intravenous use

Germany

 

Laurus Generics GmbH

Atazanavir Laurus 150 mg Hartkapseln

Atazanavir sulphate

150 mg

Capsule, hard

Oral use

Germany

 

Laurus Generics GmbH

Atazanavir Laurus 200 mg Hartkapseln

Atazanavir sulphate

200 mg

Capsule, hard

Oral use

Germany

 

Laurus Generics GmbH

Atazanavir Laurus 300 mg Hartkapseln

Atazanavir sulphate

300 mg

Capsule, hard

Oral use

Germany

Baxter Holding B.V.

 

Eisen Sucrose Baxter 20 mg/ml Injektions-/Infusionslösung

iron sucrose

20 mg/ml

solution for injection/infusion

Intravenous use

Malta

NEXCAPE PHARMACEUTICALS LIMITED

 

AMOXICILLIN 250MG CAPSULES

AMOXICILLIN TRIHYDRATE

250 mg

Capsule, hard

Oral use

Malta

NEXCAPE PHARMACEUTICALS LIMITED

 

AMOXICILLIN 500MG CAPSULES

AMOXICILLIN TRIHYDRATE

500 mg

Capsule, hard

Oral use

The Netherlands

 

Laurus Generics GmbH

Atazanavir Laurus 150 mg, hard capsules

atazanavir

150 mg

Capsule, hard

Oral use

The Netherlands

 

Laurus Generics GmbH

Atazanavir Laurus 200 mg, hard capsules

atazanavir

200 mg

Capsule, hard

Oral use

The Netherlands

 

Laurus Generics GmbH

Atazanavir Laurus 300 mg, hard capsules

atazanavir

300 mg

Capsule, hard

Oral use

Spain

ALMUS FARMACEUTICA, S.A.

 

AMOXICILINA ALMUS 500 mg cápsulas duras EFG

AMOXICILLIN

500 mg

Capsule, hard

Oral use

Sweden

 

Laurus Generics GmbH

Atazanavir Laurus

Atazanavir sulfate

150 mg

Capsule, hard

Oral use

Sweden

 

Laurus Generics GmbH

Atazanavir Laurus

Atazanavir sulfate

200 mg

Capsule, hard

Oral use

Sweden

 

Laurus Generics GmbH

Atazanavir Laurus

Atazanavir sulfate

300 mg

Capsule, hard

Oral use

United Kingdom

MANX HEALTHCARE LIMITED

 

AZITHROMYCIN 250MG CAPSULES

AZITHROMYCIN DIHYDRATE

250 mg

Capsule, hard

Oral use

United Kingdom

MANX HEALTHCARE LIMITED

 

CARBOCISTEINE 375MG CAPSULE HARD

CARBOCISTEINE

375 mg

Capsule, hard

Oral use

United Kingdom

 

STRANDHAVEN LIMITED

CARBOCISTEINE 375 MG CAPSULES, HARD

CARBOCISTEINE

375MG

Capsule, hard

Oral use

United Kingdom

 

DAWA LIMITED

AMOXICILLIN 250 MG CAPSULES

AMOXICILLIN TRIHYDRATE

250MG

Capsule, hard

Oral use

United Kingdom

 

DAWA LIMITED

AMOXICILLIN 500 MG CAPSULE

AMOXICILLIN TRIHYDRATE

500MG

Capsule, hard

Oral use

United Kingdom

 

SPECIAL CONCEPT DEVELOPMENT (UK) LIMITED

TRIMETHOPRIM 100MG TABLETS

TRIMETHOPRIM

100MG

tablet

Oral use

United Kingdom

 

SPECIAL CONCEPT DEVELOPMENT (UK) LIMITED

TRIMETHOPRIM 200MG TABLETS

TRIMETHOPRIM

200MG

tablet

Oral use

United Kingdom

BAXTER HEALTHCARE LIMITED

 

IRON SUCROSE 20 MG IRON/ML, SOLUTION FOR INJECTION /INFUSION

IRON SUCROSE

20MG/ML

Concentrate for solution for injection/infusion

Intravenous use

United Kingdom

 

LAURUS GENERICS GMBH

ATAZANAVIR LAURUS 150 MG CAPSULES, HARD

ATAZANAVIR SULFATE

150MG

Capsule, hard

Oral use

United Kingdom

 

LAURUS GENERICS GMBH

ATAZANAVIR LAURUS 200 MG, CAPSULES, HARD

ATAZANAVIR SULFATE

200MG

Capsule, hard

Oral use

United Kingdom

 

LAURUS GENERICS GMBH

ATAZANAVIR LAURUS 300 MG, CAPSULES, HARD

ATAZANAVIR SULFATE

300MG

Capsule, hard

Oral use

United Kingdom

NEXCAPE PHARMACEUTICALS LIMITED

 

AMOXICILLIN 250MG CAPSULES

AMOXICILLIN TRIHYDRATE

250 mg

Capsule, hard

Oral use

United Kingdom

NEXCAPE PHARMACEUTICALS LIMITED

 

AMOXICILLIN 500MG CAPSULES

AMOXICILLIN TRIHYDRATE

500 mg

Capsule, hard

Oral use


ANNEX II

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

Member State EU/EEA

Marketing authorisation holders

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Ceva Santé Animale

10 Avenue de la Ballastiere

33500 Libourne

France

Enzaprost Bovis 12.5 mg/ml Injektionslösung für Rinder

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Austria

Zoetis Österreich GmbH

Floridsdorfer Hauptstraße 1

1210 Vienna

Austria

Dinolytic 5 mg/ml — Injektionslösung für Tiere

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Austria

Ceva Santé Animale

10 Avenue de la Ballastiere

33500 Libourne

France

ENZAPROST T 5 mg/ml Injektionslösung für Rinder und Schweine

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Belgium

Ceva Santé

10 Avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost Bovis

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Belgium

Zoetis Belgium s.a.

Rue Laid Burniat, 1

B-1348 Louvain-La-Neuve

Belgium

Dinolytic, 5 mg-ml

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Belgium

Ceva Santé Animale N.V.

Metrologielaan 6

1130 Brussel

Belgium

Enzaprost

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Bulgaria

Ceva Animal Health Bulgaria Ltd

str. Elemag 26Б, app. 1, fl. 1

1113 Sofia

Bulgaria

Enzaprost bovis 12.5 mg/ml solution for injection for cattle

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Bulgaria

Ceva Animal Health Bulgaria Ltd

str. Elemag 26Б, app. 1, fl. 1

1113 Sofia

Bulgaria

ENZAPROST T 5 mg/ml solution for injection for cattle and pig

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Croatia

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost Bovis, 12,5  mg/mL, otopina za injekciju, za goveda

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Croatia

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost, 5 mg/mL, otopina za injekciju, za goveda i svinje

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Croatia

Zoetis B.V.,

Podružnica Zagreb za promidžbu

Petra Hektorovića 2

10000 Zagreb

Croatia

DINOLYTIC, 5 mg/mL, otopina za injekciju, za goveda, konje i svinje

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Cyprus

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne

Gironde, 33500

France

Enzaprost Bovis 12.5 mg/ml solution for injection for cattle

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Czech Republic

Ceva Santé Animale,

10 avenue de la Ballastiere

33500 Libourne Cedex

France

Enzaprost Bovis 12.5 mg/ injekční roztok pro skot

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Czech Republic

Zoetis Česká republika s. r. o.

Náměstí 14. října 642/17

150 00 Praha 5

Czech Republic

Dinolytic 5 mg/ml injekční roztok

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Czech Republic

Ceva Animal Health Slovakia s.r.o.,

Račianska 153

Bratislava, 831 53

Slovakia

ENZAPROST T 5 mg/ml injekční roztok

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Denmark

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Denmark

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost Bovis

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Estonia

Zoetis Belgium S.A.

Rue Laid Burniat 1,

1348 Louvain-la-Neuve,

Belgium

Dinolytic 12.5 mg

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Estonia

Zoetis Belgium S.A.

Rue Laid Burniat 1,

1348 Louvain-la-Neuve,

Belgium

Dinolytic

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Estonia

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost Bovis

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Finland

Ceva Santé Animale

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Finland

Ceva Santé Animale

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost Bovis

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Finland

Zoetis Finland Oy

Tietokuja 4

00330 Helsinki

Finland

Dinolytic vet.

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Finland

Zoetis Finland Oy

Tietokuja 4

00330 Helsinki

Finland

Dinolytic vet.

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

France

Zoetis France

10 Rue Raymond David

92240 Malakoff

France

DINOLYTIC 12,5 MG/ML Solution Injectable pour bovins

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

France

Ceva Sante Animale

10 Avenue de la Ballastiere

33500 Libourne

France

ENZAPROST BOVIS 12,5  mg/ml Solution injectable pour bovins

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

France

Zoetis France

10 Rue Raymond David

92240 Malakoff

France

DINOLYTIC

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

France

Ceva Sante Animale

10 Avenue de la Ballastiere

33500 Libourne

France

ENZAPROST T

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Germany

Ceva Sante Animale

10 avenue de la Ballastiere

F-33500 Libourne

France

Enzaprost Bovis 12,5  mg/ml solution for injection for cattle

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Germany

Zoetis Deutschland GmbH

Schellingstr. 1

D-10785 Berlin

Germany

Dinolytic Forte 12,5  mg/ml

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Germany

Zoetis Deutschland GmbH

Schellingstr. 1

D-10785 Berlin

Germany

Dinolytic

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Germany

Ceva Tiergesundheit GmbH

Kanzlerstr. 4

D-40472 Düsseldorf

Germany

Enzaprost T

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Greece

Ceva Hellas LLC,

15, Agiou Nikolaou str.

Alimos, 17455

Greece

Enzaprost Bovis inj. Sol 12,5  mg/ml

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Greece

Ceva Hellas LLC,

15, Agiou Nikolaou str.

Alimos, 17455

Greece

Cevaprost 5 mg/ml

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Greece

Zoetis Hellas S.A.

Frangokklisias 7

151 25, Maroussi Attica

Greece

Dinolytic Inj. Sol 5 mg/ml

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Hungary

Zoetis Hungary Kft.

1123. Budapest

Alkotás u. 53.

Hungary

Dinolytic injekció A.U.V.

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Hungary

Ceva-Phylaxia Zrt.,

1107 Budapest

Szállás u. 5.

Hungary

Enzaprost T 5 mg/ml oldatos injekció szarvasmarhák és sertések részére A.U.V.

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Hungary

Ceva-Phylaxia Zrt.,

1107 Budapest

Szállás u. 5.

Hungary

Enzaprost Bovis 12,5  mg/ml oldatos injekció szarvasmarhák részére A.U.V.

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Iceland

Ceva Santé Animale,

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost Bovis

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Ireland

Zoetis Belgium S.A.

2nd Floor, Building 10

Cherrywood Business Park, Loughlinstown

Co Dublin

Ireland

Lutalyse

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Ireland

Ceva Santé Animale

10 avenue de la Ballastiere

33500 Libourne,

France

Enzaprost 5 mg/ml Solution for injection for cattle and pig

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Ireland

Ceva Santé Animale

10 avenue de la Ballastiere

33500 Libourne,

France

Enzaprost Bovis 12.5 mg/ml Solution for Injection for Cattle

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Ireland

Zoetis Belgium S.A.

2nd Floor, Building 10, Cherrywood Business Park, Loughlinstown, Co Dublin, Ireland

Lutalyse High Concentration 12.5 mg/ml solution for injection for cattle

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Italy

Zoetis Italia S.r.l.

Via Andrea Doria, 41 M

00192 Roma

Italy

DINOLYTIC

5 mg/ml soluzione iniettabile per bovini, equini e suini

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Italy

Zoetis Italia S.r.l.

Via Andrea Doria, 41 M

00192 Roma

Italy

DINOLYTIC 12,5  mg/ml soluzione iniettabile per bovini

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Italy

Ceva Salute Animale S.p.A.

Viale Bartolomeo Colleoni 15

20864 Agrate Brianza (MB)

Italia

Enzaprost 5 mg/ml Soluzione iniettabile per bovini e suini

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Italy

Ceva Salute Animale S.p.A.

Viale Bartolomeo Colleoni 15

20864 Agrate Brianza (MB)

Italia

Enzaprost Bovis 12,5  mg/ml soluzione iniettabile per bovini

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Latvia

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

Dinolytic 12,5  mg/ml šķīdums injekcijām

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Latvia

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

Dinolytic 5 mg/ml šķīdums injekcijām

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Latvia

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde, 33500

France

Enzaprost Bovis 12,5  mg/ml šķīdums injekcijām

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Latvia

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde, 33500

France

Enzaprost 5 mg/ml šķīdums injekcijām

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Lithuania

Zoetis Belgium S.A.,

Rue Laid Burniat 1,

1348 Louvain-la-Neuve

Belgium

DINOLYTIC 12,5  mg/ml injekcinis tirpalas galvijams

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Lithuania

Zoetis Belgium S.A.,

Rue Laid Burniat 1,

1348 Louvain-la-Neuve

Belgium

DINOLYTIC, 5 mg/ml injekcinis tirpalas galvijams, arkliams ir kiaulėms

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Lithuania

Ceva Sante Animale,

10 avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost Bovis 12.5 mg/ml solution for injection for cattle

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Lithuania

Ceva Sante Animale Z.I.

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost 5 mg/ml injekcinis tirpalas galvijams ir kiaulėms

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Luxembourg

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost Bovis

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Luxembourg

Zoetis Belgium s.a.

Rue Laid Burniat, 1

B-1348 Louvain-La-Neuve

Belgium

Dinolytic, 5 mg-ml

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Luxembourg

Ceva Santé Animale N.V.

Metrologielaan 6

1130 Brussel

Belgium

Enzaprost

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Norway

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne 33500

France

Enzaprost

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Norway

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne 33500

France

Enzaprost Bovis

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Poland

Ceva Animal Health Polska Sp. z o.o.,

Okrzei Street 1A

03-715 Warsaw

Poland

Enzaprost Bovis 12,5  mg/ml roztwór do wstrzykiwań dla bydła

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Poland

Zoetis Polska Sp. z o.o.

ul. Postępu 17B

02-676 Warsaw

Poland

Dinolytic Forte

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Poland

Ceva Animal Health Polska Sp. z o.o.,

Okrzei Street 1A

03-715 Warsaw

Poland

ENZAPROST 5 mg/ml, roztór do wstrzykiwań dla bydła i świń

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Poland

Zoetis Polska Sp. z o.o.

ul. Postępu 17B

02-676 Warsaw

Poland

Dinolytic

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Portugal

Ceva Saúde Animal

Rua Dr. António Loureiro Borges, 9/9A — 9oA,

Miraflores, 1495-131 Algés –

Portugal

ENZAPROST T 5 mg/ml Solução injectável para bovinos e suínos

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Portugal

Ceva Saúde Animal

Rua Dr. António Loureiro Borges, 9/9A — 9oA,

Miraflores, 1495-131 Algés –

Portugal

Enzaprost Bovis 12.5 mg/ml Solution for Injection for Cattle

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Portugal

Zoetis Portugal Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

DINOLYTIC 5 mg/ml Solução injectável para bovinos, siunos e equinos

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Romania

Ceva Sante Animale

10 Avenue De La Ballastiere, 33500 Libourne Gironde,

France

Enzaprost Bovis 12,5  mg/ml

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Romania

Ceva Sante Animale,

10 Avenue De La Ballastiere 33500 Libourne Gironde

France

Enzaprost T 5 mg/ml

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Romania

Zoetis Belgium SA,

Rue Laid Burniat 1,

1348 Louvain-la-Neuve,

Belgium

Dinolytic 5 mg/ml

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Slovak Republic

Zoetis Česká republika, s.r.o., náměstí 14. října 642/17,

150 00 Praha 5

Česká republika

Dinolytic 5 mg/ml injekčný roztok

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Slovak Republic

Ceva Animal Health Slovakia s.r.o.,

Račianska 153

Bratislava, 831 53

Slovakia

Enzaprost T 5 mg/ml injekčný roztok

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Slovak Republic

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

Bratislava, 831 53

Slovakia

Enzaprost Bovis 12.5 mg/ml Solution for Injection for Cattle

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Slovenia

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde, 33500

France

Enzaprost Bovis 12.5 mg/ml solution for injection for cattle

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Slovenia

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde, 33500, France

Enzaprost 5 mg/ml raztopina za injiciranje za govedo in prašiče

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Slovenia

Zoetis Belgium SA,

Rue Laid Burniat 1,

1348 Louvain-la-Neuve,

Belgium

Dinolytic 5 mg/ml raztopina za injiciranje za govedo, konje in prašiče

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Spain

Zoetis Spain, SL

Avda. de Europa 20-B

Parque Empresarial la Moraleja

28108 Alcobendas (Madrid)

Spain

Dinolytic 12,5  mg/ml solución inyectable para bovino

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Spain

Ceva Salud Animal, S.A.

Avda. Diagonal 609-615

Barcelona 08028

Spain

Enzaprost Bovis 12.5 mg/ml solution for injection for cattle

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Spain

Zoetis Spain, SL

Avda. de Europa 20-B

Parque Empresarial la Moraleja

28108 Alcobendas (Madrid)

Spain

DINOLYTIC 5 mg/ml solución inyectable para bovino, porcino y caballos

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Spain

Ceva Salud Animal, S.A.

Avda. Diagonal 609-615 Barcelona 08028

Spain

Enzaprost T

5 mg/ml solución inyectable para bovino y porcino

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Sweden

Zoetis Finland Oy

Tietokuja 4

00330 Helsingfors

Finland

Dinolytic vet.

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Sweden

Ceva Santé Animale

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost Bovis

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

Sweden

Zoetis Finland Oy

Tietokuja 4

00330 Helsingfors

Finland

Dinolytic® vet.

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

Sweden

Ceva Santé Animale

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

The Netherlands

Zoetis B.V.

Rivium Westlaan 74,

2909 LD Capelle a/d Ijssel,

The Netherlands

Dinolytic hoge conenctratie 12,5  mg/ml oplossing voor injectie voor runderen

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

The Netherlands

Ceva Santé

10 avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost Bovis 12,5  mg/ml oplossing voor injectie voor runderen

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

The Netherlands

Zoetis B.V.

Rivium Westlaan 74,

2909 LD Capelle a/d Ijssel,

The Netherlands

Dinolytic 5 mg/ml oplossing voor injectie voor runderen, varkens en paarden

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

The Netherlands

Ceva Santé Animjale B.V

Tiendweg 8c,

2671 SB, Naaldwijk,

The Netherlands

Enzaprost 5 mg/ml Solution for injection for cattle and pig

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

United Kingdom

Ceva Animal Health Ltd,

Unit 3, Anglo Office Park, White Lion Road, Amersham, Buckinghamshire, HP7 9FB, United Kingdom

Enzaprost Bovis 12.5 mg/ml Solution for Injection for Cattle

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

United Kingdom

Zoetis UK Limited,

5th Floor, 6 St. Andrew Street,

London, EC4A 3AE,

United Kingdom

Lutalyse 12.5 mg/ml Solution for Injection for Cattle

Dinoprost

12.5 mg/ml

Solution for injection

Cattle

Intramuscular

United Kingdom

Ceva Animal Health Ltd,

Unit 3, Anglo Office Park, White Lion Road, Amersham, Buckinghamshire, HP7 9FB, United Kingdom

Enzaprost 5 mg/ml Solution for Injection for Cattle and Pig

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular

United Kingdom

Zoetis UK Limited,

5th Floor, 6 St. Andrew Street,

London, EC4A 3AE,

United Kingdom

Lutalyse 5 mg/ml Solution for Injection

Dinoprost

5 mg/ml

Solution for injection

Cattle

Intramuscular


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