Veterinary Medicines

Sedivet Vet. injektionsvæske, opløsning 10 mg/ml

Authorised
  • Romifidine hydrochloride
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Product identification

Medicine name:
Sedivet Vet. 10 mg/ml injektionsvæske, opløsning
Sedivet Vet. injektionsvæske, opløsning 10 mg/ml
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
        10
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM93
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
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 Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 14896
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Danish (, INJEKTIONSVÆSKE, OPLØSNING 10 MG-ML)
Published on: 29/06/2023
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