Sedalin 35 mg/ml oral gel
Sedalin 35 mg/ml oral gel
Authorised
- Acepromazine maleate
Product identification
Medicine name:
Sedalin 35 mg/ml oral gel
Active substance:
- Acepromazine maleate
Target species:
-
Dog
-
Horse (non-food-producing)
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Acepromazine maleate4.74/gram(s)100.00millilitre(s)
Pharmaceutical form:
-
Oral gel
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN05AA04
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Ireland
Available in:
-
Ireland
Package description:
- Graduated 10 ml white linear medium density polyethylene oral doser syringe with a linear medium density polyethyleneplunger and closed with a low density polyethylene cap.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Vetoquinol S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Vetoquinol Biowet Sp. z o.o.
Responsible authority:
- Health Products Regulatory Authority
Authorisation number:
- VPA10521/034/001
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
