Sedan, 35mg/ml, Oral gel
Sedan, 35mg/ml, Oral gel
Authorised
- Acepromazine
Product identification
Medicine name:
SEDAN 35 mg/ml belsőleges gél lovak és kutyák számára
Sedan, 35mg/ml, Oral gel
Active substance:
- Acepromazine
Target species:
-
Horse
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Acepromazine35.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Oral gel
Withdrawal period by route of administration:
-
Oral use
- Horse
-
Meat and offalno withdrawal periodThe treatment must be recorded into the horse's passport.,
-
Milkno withdrawal periodThe treatment must be recorded into the horse's passport.,
-
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN05AA04
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Hungary
Package description:
- Plastic Applicator 1 x 10.0 millilitre(s)
- Plastic Applicator 1 x 1.0 millilitre(s)
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:
- Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
- Bioveta a.s.
Responsible authority:
- Directorate Of Veterinary Medicinal Products
Authorisation number:
- 4336/X/2022 NÉBIH ÁTI
Date of authorisation status change:
Reference member state:
-
Czechia
Procedure number:
- CZ/V/0174/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Denmark
-
Estonia
-
France
-
Germany
-
Greece
-
Hungary
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Spain
-
Sweden
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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