Veterinary Medicines

Tildren 500 mg Lyophilisate for Solution for Infusion for Horses

Authorised
  • Tiludronate disodium hemihydrate
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Product identification

Medicine name:
TILDREN 500 mg Lyophilisat zur Herstellung einer Infusionslösung für Pferde
Tildren 500 mg Lyophilisate for Solution for Infusion for Horses
Active substance:
  • Tiludronate disodium hemihydrate
Target species:
  • Horse
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Tiludronate disodium hemihydrate
    569.00
    milligram(s)
    /
    1.00
    Vial
Pharmaceutical form:
  • Lyophilisate for solution for infusion
Withdrawal period by route of administration:
  • Intravenous use
    • Horse
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM05BA05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Package description:
  • A clear glass (type II) vial with chlorobutyl rubber closure secured by aluminium overseal with plastic flip-off cap within cardboard carton.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Audevard
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • Vm 44684/3000
Date of authorisation status change:
Reference member state:
  • Austria
Procedure number:
  • AT/V/0026/001
Concerned member states:
  • United Kingdom (Northern Ireland)