Veterinary Medicines

SEDIVET SOLUTION INJECTABLE

Authorised
  • Romifidine hydrochloride
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Product identification

Medicine name:
SEDIVET SOLUTION INJECTABLE
Active substance:
  • Romifidine hydrochloride
Target species:
  • Horse (mare)
  • Horse
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Romifidine hydrochloride
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Horse (mare)
      • Milk
        no withdrawal period
    • Horse
      • Meat and offal
        6
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM93
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Available in:
  • France
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:
  • Boehringer Ingelheim Animal Health France
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/1717685 1/1995
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 21/05/2025
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 15/10/2025
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