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)
Date: 2020-10-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product








C_2020367EN.01001401.xml










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