Sedalin Oral Gel 3.5 %w/v
Sedalin Oral Gel 3.5 %w/v
Authorised
- Acepromazine maleate
Product identification
Medicine name:
Sedalin Oral Gel 3.5 %w/v
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
Withdrawal period by route of administration:
-
Oral use
-
Dog
-
Horse (non food-producing)
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN05AA04
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised 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 Ireland Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Vetoquinol Biowet Sp. z o.o.
- Vetoquinol UK Limited
Responsible authority:
- Health Products Regulatory Authority
Authorisation number:
- VPA10983/057/001
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 3/05/2024
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