Veterinary Medicines

Norofol 10 mg/ml Emulsion for Injection for Cats and Dogs

Authorised
  • Propofol
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Product identification

Medicine name:
Vetofol 10mg/ml Emulsion for Injection for cats and dogs
Norofol 10 mg/ml Emulsion for Injection for Cats and Dogs
Active substance:
  • Propofol
Target species:
  • Dog
  • Cat
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Propofol
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN01AX10
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Package description:
  • (ID2) 50 millilitre(s): unspecified outer container with 1 Vial (Glass) with 50 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID1) 20 millilitre(s): unspecified outer container with 1 Vial (Glass) with 20 millilitre(s), closed with Stopper (bromobutyl rubber`)

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:
  • Norbrook Laboratories Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories (Ireland) Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • VM 02000/4275
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0317/001
Concerned member states:
  • Austria
  • Bulgaria
  • Cyprus
  • Czechia
  • Estonia
  • Finland
  • Latvia
  • Lithuania
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 14/02/2022
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