SEDEDORM 1 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
SEDEDORM 1 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
Authorised
- Medetomidine hydrochloride
Product identification
Medicine name:
SEDEDORM 1 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
Sededorm 1 mg/ml Oplossing voor injectie
Sededorm 1 mg/ml Solution injectable
Sededorm 1 mg/ml Injektionslösung
Active substance:
- Medetomidine hydrochloride
Target species:
-
Dog
-
Cat
Route of administration:
-
Intramuscular use
-
Subcutaneous use
-
Intravenous use
Product details
Active substance and strength:
-
Medetomidine hydrochloride1.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN05CM91
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- Available only in French
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:
- Vetpharma Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
- Industrial Veterinaria S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V334293
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0192/001
Concerned member states:
-
Belgium
-
Germany
-
Hungary
-
Netherlands
-
Poland
-
Portugal
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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Labelling
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