# C_2020367EN.01001401.xml

| 30.10.2020 | EN | Official Journal of the European Union | C 367/14 |
| --- | --- | --- | --- |

30.10.2020

EN

Official Journal of the European Union

C 367/14

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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 |

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 |

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

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(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

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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 |

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

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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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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

---