Propodine 10 mg/ml Emulsion for Injection/Infusion for Dogs and Cats
Propodine 10 mg/ml Emulsion for Injection/Infusion for Dogs and Cats
Authorised
- Propofol
Product identification
Medicine name:
Propodine 10 mg/ml emulsão injetável/para perfusão para cães e gatos
Propodine 10 mg/ml Emulsion for Injection/Infusion for Dogs and Cats
Active substance:
- Propofol
Target species:
-
Dog
-
Cat
Route of administration:
-
Intravenous use
Product details
Active substance and strength:
-
Propofol10.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Emulsion for injection/infusion
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:
-
Portugal
Package description:
- Colourless type I glass vials of 100 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
- Colourless type I glass vials of 20 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
- Colourless type I glass vials of 50 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
- Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Corden Pharma S.p.A.
Responsible authority:
- Directorate General For Food And Veterinary
Authorisation number:
- 1257/01/19DFVPT
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0319/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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