Veterinary Medicines

Sedivet 10 mg/ml Solution for Injection for horses

Authorised
  • Romifidine hydrochloride
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Product identification

Medicine name:
Sedivet 10 mg/ml Solution for Injection for horses
Active substance:
  • Romifidine hydrochloride
Target species:
  • 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
      • 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:
  • Ireland
Package description:
  • 20 ml clear Type I PhEur glass vial with grey bromobutyl stopper containing a clearcolourless aqueous solution.

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:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • LABIANA LIFE SCIENCES, S.A.-TERRASSA
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10454/013/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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