Veterinary Medicines

Acticarp 50 mg/ml, Solution for Injection

Authorised
  • Carprofen
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Product identification

Medicine name:
Acticarp 50 mg/ml, Solution for Injection
Acticarp Cattle 50 mg/ml Oplossing voor injectie voor runderen
Active substance:
  • Carprofen
Target species:
  • Cattle
Route of administration:
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Carprofen
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        21
        day
  • Subcutaneous use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        21
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AE91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • 50 ml amber glass (Type I) vial closed with Flurotec (coated chlorobutyl) rubber stopper and aluminium flip off. One vial in a carton box.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Accord Healthcare B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fundacio Privada Dau
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 109311
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0156/001
Concerned member states:
  • Austria
  • Belgium
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 12/09/2024
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Dutch (PDF)
Published on: 13/12/2023
Download
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