Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2020 to 31 October 2020 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2020-11-27
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_2020409EN.01000801.xml










27.11.2020   


EN


Official Journal of the European Union


C 409/8






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2020 to 31 October 2020
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2020/C 409/02)
—   Issuing, maintenance or modification of a national marketing authorization











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




15.10.2020


Ibuprofen Kabi 400 mg Infusionslösung and associated names


ibuprofen


See Annex I


See Annex I


16.10.2020




12.10.2020


Betamox LA 150 mg/ml suspension for injection and associated names, and generic products thereof


Amoxicillin trihydrate


See Annex II


See Annex II


12.10.2020




12.10.2020


Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof


azaperone


See Annex III


See Annex III


12.10.2020






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.




ANNEX I
List of medicinal products and presentations











Member State EU/EEA


Applicant


Invented Name


Strength


Pharmaceutical form


Route of administration


Content
(concentration)




Austria







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




Bad Homburg v.d.H. 61352




Germany






Ibuprofen Kabi 400 mg Infusionslösung


400 mg


Solution for infusion


Intravenous use


4 mg/ml




Belgium







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




Bad Homburg v.d.H. 61352




Germany






Ibuprofen Fresenius Kabi 400 mg oplossing voor infusie
Ibuprofen Fresenius Kabi 400 mg solution pour perfusion
Ibuprofen Fresenius Kabi 400 mg Infusionslösung


400 mg


Solution for infusion


Intravenous use


4 mg/ml




Czech Republic







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




Bad Homburg v.d.H. 61352




Germany






Ibuprofen Kabi


400 mg


Solution for infusion


Intravenous use


4 mg/ml




Germany







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




Bad Homburg v.d.H. 61352




Germany






Ibuprofen Kabi 400 mg Infusionslösung


400 mg


Solution for infusion


Intravenous use


4 mg/ml




Hungary







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




Bad Homburg v.d.H. 61352




Germany






Ibuprofen Kabi 400 mg oldatos infúzió


400 mg


Solution for infusion


Intravenous use


4 mg/ml




The Netherlands







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




Bad Homburg v.d.H. 61352




Germany






Ibuprofen Fresenius Kabi 400 mg oplossing voor infusie


400 mg


Solution for infusion


Intravenous use


4 mg/ml




Poland







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




Bad Homburg v.d.H. 61352




Germany






Ibuprofen Kabi


400 mg


Solution for infusion


Intravenous use


4 mg/ml




Portugal







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




Bad Homburg v.d.H. 61352




Germany






Ibuprofeno Kabi


400 mg


Solution for infusion


Intravenous use


4 mg/ml




Romania







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




Bad Homburg v.d.H. 61352




Germany






Ibuprofen Kabi 400 mg soluţie perfuzabilă


400 mg


Solution for infusion


Intravenous use


4 mg/ml




Slovak Republic







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




Bad Homburg v.d.H. 61352




Germany






Ibuprofen Kabi 400 mg


400 mg


Solution for infusion


Intravenous use


4 mg/ml




Slovenia







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




Bad Homburg v.d.H. 61352




Germany






Ibuprofen Kabi 400 mg raztopina za infundiranje


400 mg


Solution for infusion


Intravenous use


4 mg/ml




Spain







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




Bad Homburg v.d.H. 61352




Germany






Ibuprofeno Kabi 400 mg solución para perfusión


400 mg


Solution for infusion


Intravenous use


4 mg/ml




United Kingdom







Fresenius Kabi Deutschland GmbH




Else-Kröner-Str. 1




Bad Homburg v.d.H. 61352




Germany






Ibuprofen Kabi 400 mg Solution for Infusion


400 mg


Solution for infusion


Intravenous use


4 mg/ml









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












Member State EU/EEA


Marketing authorisation holder


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




Austria







Norbrook Laboratories (Ireland) Limited




Rossmore Industrial Estate




H18 W620 Monaghan




Ireland






Betamox long acting-Injektionssuspension für Tiere


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Austria







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml Injektionssuspension für Rinder, Schafe, Schweine, Hunde, Katzen


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Belgium







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Bulgaria







Asklep-Farma OOD




j.k. Lyulin 7,




bl. 711A, shop 3




Sofia




Bulgaria






Betamox LA Injection


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Bulgaria







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml suspension for injection for cattle, sheep, pigs, dogs and cats


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Croatia







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA, 150 mg/mL, suspenzija za injekciju, za goveda, ovce, svinje, pse i mačke


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Croatia







GENERA d.d.




Svetonedeljska cesta 2




Kalinovica




10436 Rakov Potok




Croatia






Simivet retard, 150 mg/mL, suspenzija za injekciju, za goveda, ovce, svinje, pse i mačke


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Cyprus







Stavrinides Spyros Chemicals Ltd




28A Stasinou Ave




Nicosia




Cyprus






Betamox LA Injection, 150 mg/ml Ενέσιμο Εναιώρημα


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Cyprus







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml Ενέσιμο εναιώρημα για
βοοειδή, πρόβατα, χοίρους, σκύλους, γάτες


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Czech Republic







Norbrook Laboratories (Ireland) Limited




Rossmore Industrial Estate




Monaghan




Ireland






Betamox LA 150 mg/ml injekční suspenze


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Denmark







ScanVet Animal Health A/S




Kongevejen 66




3480 Fredensborg




Denmark






Betamox Vet.


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Denmark







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Estonia







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Finland







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry, Co. Down BT35 6JP




Northern Ireland




United Kingdom






Betamox vet


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Finland







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox vet


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




France







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml Suspension for Injection for Cattle, Sheep, Pigs, Dogs, Cats


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Germany







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml suspension for injection


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Greece







Hellafarm A.E




Fleming 15




15123, Marousi




Greece






Betamox L.A


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Greece







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox L.A


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Hungary







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry, Co. Down




BT35 6JP




Northern Ireland




United Kingdom






Betamox LA 150 mg/ml szuszpenziós injekció A.U.V.


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs


Intramuscular and/or subcutaneous use




Hungary







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml suspension for injection


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Hungary







Bayer Hungária Kft.




1123 Budapest




Alkotás u. 50.




Hungary






Amoxysol LA 150 mg/ml szuszpenziós injekció szarvasmarhák, sertések és juhok részére A.U.V.


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular and/or subcutaneous use




Ireland







Norbrook Laboratories (Ireland) Limited




Rossmore Industrial Estate




Monaghan




Ireland






Betamox LA 150 mg/ml Suspension for Injection


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Ireland







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml suspension for injection


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Italy







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry, Co. Down




BT35 6JP




Northern Ireland




United Kingdom






Betamox LA, 150 mg/ml sospensione iniettabile per bovini, suini, cani e gatti


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Italy







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trimox LA 150 mg/ml, sospensione iniettabile per bovini, ovini, suini, cani e gatti


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Latvia







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml suspensija injekcijām liellopiem, aitām, cūkām, suņiem, kaķiem


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Latvia







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry, Co. Down




BT35 6JP




Northern Ireland




United Kingdom






Betamox LA 150 mg/ml suspensija injekcijām liellopiem, aitām, cūkām, suņiem, kaķiem


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Lithuania







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry, Co. Down




BT35 6JP




Northern Ireland




United Kingdom






Betamox LA, 150 mg/ml, injekcinė suspensija galvijams, kiaulėms, avims, šunims ir katėms


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Lithuania







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml Suspension for Injection for Cattle, Sheep, Pigs, Dogs, Cats


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Norway







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox Vet


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




The Netherlands







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml suspensie voor injectie voor runderen, schapen, varkens, honden, katten


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Poland







Scanvet Poland Sp. z o.o.




ul. Kiszkowska 9




Gniezno 62-200




Poland






Betamox L.A.


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Poland







Nordpharm Poland Sp. z o.o.




Al. Jerozolimskie 99 lok. 39




02-001 Warszawa




Poland






Amoxyvet LA


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Poland







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Portugal







Norbrook Laboratories (Ireland) Limited




Rossmore Industrial Estate




Monaghan




Ireland






Betamox LA 150 mg/ml Suspension for Injection


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Portugal







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml suspension for injection


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Romania







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry, Co. Down




BT35 6JP




Northern Ireland




United Kingdom






Betamox LA, 150 mg/ml


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Romania







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Slovak Republic







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry, Co. Down




BT35 6JP




Northern Ireland




United Kingdom






Betamox LA 150 mg/ml injekčná suspenzia


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Slovak Republic







Zoetis Česká republika, s.r.o




námestí 14. října 642/17




150 00 Prague 5




Czech Republic






Duphamox LA 150 mg/ml injekčná suspenzia


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Slovak Republic







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml Suspension for Injection for Cattle, Sheep, Pigs, Dogs, Cats


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Slovenia







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml suspension for injection for cattle, sheep, pigs, dogs and cats


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Slovenia







GENERA SI d.o.o.




Parmova ulica 53




1000 Ljubljana




Slovenia






Simivet retard 150 mg/ml suspenzija za injiciranje


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




Spain







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry, Co. Down




BT35 6JP




Northern Ireland




United Kingdom






Betamox LA


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs


Intramuscular and/or subcutaneous use




Sweden







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox vet


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




United Kingdom







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry, Co. Down




BT35 6JP




Northern Ireland




United Kingdom






Betamox LA 150 mg/ml Suspension for Injection


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs


Intramuscular and/or subcutaneous use




United Kingdom







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry, Co. Down




BT35 6JP




Northern Ireland




United Kingdom






Amoxycare LA Suspension for Injection 15 % w/v


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use




United Kingdom







Univet Ltd




Tullyvin




Cootehill




Co. Cavan




Ireland






Trymox LA 150 mg/ml Suspension for Injection for Cattle, Sheep, Pigs, Dogs, Cats


Amoxicillin trihydrate


150 mg/ml


Suspension for injection


Cattle, sheep, pigs, dogs, cats


Intramuscular and/or subcutaneous use









ANNEX III
List of the names, pharmaceutical form, strength 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







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Separon 40 mg/ml Injektionslösung für Schweine


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Austria







Serumwerk Bernburg AG




Hallesche Landstrasse 105 b




06406 Bernburg/Saale




Germany






Azaporc 40 mg/ml Injektionslösung für Schweine


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Austria







Elanco GmbH




Heinz-Lohmann-Straße 4




27472 Cuxhaven




Germany






Stresnil 40 mg/ml Injektionslösung für Schweine


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Belgium







Elanco GmbH




Heinz-Lohmann-Straβe 4




27472 Cuxhaven




Duitsland






Stresnil 40 mg/ml


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Bulgaria







Elanco GmbH




Heinz-Lohmann-Straβe 4




27472 Cuxhaven




Germany






Stresnil 40 mg/ml injectable solution


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Bulgaria







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Croatia







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Cyprus







Elanco GmbH




Heinz-Lohmann-Str. 4




27472 Cuxhaven




Germany






Stresnil, 40 mg/mL ενέσιμο διάλυμα για χοίρους


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Czech Republic







Elanco GmbH Heinz




Lohmann Str. 4




27472 Cuxhaven




Germany






Stresnil 40 mg/ml injekční roztok pro prasata


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Czech Republic







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml injekční roztok pro prasata


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Denmark







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Separon vet.


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Estonia







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Finland







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Separon vet.


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




France







Elanco GmbH




Heinz-Lohmann-Strasse 4




27472 Cuxhaven




Germany






Stresnil


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Germany







Serumwerk Bernburg AG




Hallesche Landstr. 105b




06406 Bernburg




Germany






Azaporc 40 mg/ml Injektionslösung für Schweine


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Germany







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Germany







Elanco GmbH




Heinz-Lohmann-Straße 4




27472 Cuxhaven




Germany






Stresnil


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Greece







Elanco GmbH




Heinz-Lohmann-Str.4




27472 Cuxhaven




Germany






Stresnil ενέσιμο διάλυμα 40 mg/ml


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Greece







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Separon 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Hungary







Elanco GmbH




Heinz-Lohmann-Straße 4




27472 Cuxhaven




Germany






Stresnil 40 mg/ml oldatos injekció sertéseknek A.U.V.


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Hungary







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Iceland







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Separon vet.


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Ireland







Elanco GmbH




Heinz-Lohmann-Straβe 4




27472 Cuxhaven




Germany






Stresnil 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Ireland







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Italy







Eli Lilly Italia S.P.A.




Via Gramsci, 731-733




50019 Sesto Fiorentino (FI)




Italy






Stresnil 40 mg/ml soluzione iniettabile per suini


Azaperone


40 mg/ml


Solution for injections


Pigs


Intramuscular use




Italy







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Latvia







Elanco GmbH




Heinz-Lohmann Str. 4




27472 Cuxhaven




Germany






Stresnil


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Latvia







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Lithuania







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Lithuania







Elanco GmbH




Heinz-Lohmann Str. 4




27472 Cuxhaven




Germany






Stresnil 40 mg/ml injekcinis tirpalas kiaulėms


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




The Netherlands







Elanco GmbH




Heinz-Lohmann-Strasse 4 27472 Cuxhaven




Germany






Stresnil 40 mg/ml oplossing voor injectie voor varkens


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




The Netherlands







Kernfarm B.V.




De Corridor 14D




3621 ZB Breukelen




The Netherlands






Stresnil 40 mg/ml oplossing voor injectie voor varkens


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Norway







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Separon vet. 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Poland







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Poland







Elanco GmbH




Heinz-Lohmann-Strasse 4 27472 Cuxhaven




Germany






Stresnil


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Portugal







Ecuphar Veterinaria S.L.U




Avenida Río de Janeiro, 60-66, planta 13




08016 Barcelona




Spain






Stresnil 40 mg/ml solução injetável para suínos


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Portugal







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml solução injetável para suínos


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Romania







Elanco GmbH




Heinz-Lohmann-Strasse 4 27472 Cuxhaven




Germany






Stresnil 40 mg/ml


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Romania







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Slovakia







Elanco GmbH




Heinz-Lohmann-Str. 4




27472 Cuxhaven




Germany






Stresnil 40 mg/ml injekčný roztok pre ošípané


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Slovakia







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml injekčný roztok pre ošípané


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Slovenia







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Spain







Ecuphar Veterinaria S.L.U.




Avda. Rio de Janeiro, 60-66




planta 13




08016 Barcelona




Spain






Stresnil 40 mg/ml solución inyectable para porcino


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




Sweden







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Separon vet.


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




United Kingdom







Eli Lilly and Company Limited




Elanco Animal Health




Lilly House




Priestley Road




Basingstoke RG24 9NL




United Kingdom






Stresnil 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use




United Kingdom







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Sedanol 40 mg/ml solution for injection for pigs


Azaperone


40 mg/ml


Solution for injection


Pigs


Intramuscular use