Veterinary Medicine Information website

Osphos 51 mg/ml solution for injection for horses

Authorised
  • Clodronate disodium tetrahydrate
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Product identification

Medicine name:
Osphos 51 mg/ml solution for injection for horses
Active substance:
  • Clodronate disodium tetrahydrate
Target species:
  • Horse
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Clodronate disodium tetrahydrate
    74.98
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Horse
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM05BA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
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:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V477280
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)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 26/01/2025
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Dutch (PDF)
Published on: 13/03/2026
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French (PDF)
Published on: 13/03/2026
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German (PDF)
Published on: 13/03/2026
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 13/03/2026
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German (PDF)
Published on: 13/03/2026
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Dutch (PDF)
Published on: 13/03/2026
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Combined File of all Documents

English (PDF)
Published on: 26/01/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 17/08/2025
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German (PDF)
Published on: 17/08/2025
Download
Dutch (PDF)
Published on: 17/08/2025
Download