Veterinary Medicines

TILDREN 5 MG/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION FOR HORSES

Authorised
  • Tiludronate disodium hemihydrate
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Product identification

Medicine name:
TILDREN 5 MG/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION FOR HORSES
TILDREN®
Active substance:
  • Tiludronate disodium hemihydrate
Target species:
  • Horse
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Tiludronate disodium hemihydrate
    5.83
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Powder and solvent for solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Horse
      • Meat and offal
        0
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM05BA05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Audevard
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 02-1588
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0134/001
Concerned member states:
  • Austria
  • Greece
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Spain

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 10/10/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 10/10/2024
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