Osphos 51 mg/ml solution for injection for horses
Osphos 51 mg/ml solution for injection for horses
Authorised
- Clodronate disodium tetrahydrate
Product identification
Medicine name:
Osphos 51 mg/ml solution for injection for horses
Osphos 51 mg/ml, injekčný roztok pre kone
Active substance:
- Clodronate disodium tetrahydrate
Target species:
-
Horse
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Clodronate disodium tetrahydrate74.98/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Horse
-
Meat and offal0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM05BA02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Slovakia
Package description:
- Clear glass (type I) vial with siliconized rubber stopper, an aluminium seal and a plastic flip-off cap containing 15 ml of clodronic acid solution.Each cardboard box contains 1 vial
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Eurovet Animal Health B.V.
Responsible authority:
- Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
- 96/046/DC/15-S
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0508/001
Concerned member states:
-
Austria
-
Belgium
-
Czechia
-
Finland
-
France
-
Germany
-
Hungary
-
Iceland
-
Italy
-
Luxembourg
-
Netherlands
-
Poland
-
Portugal
-
Slovakia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
