Veterinary Medicines

Sedalin 35 mg/ml - Gel zum Eingeben für Hunde und Pferde

Authorised
  • Acepromazine maleate
Download as PDF

Product identification

Medicine name:
Sedalin 35 mg/ml - Gel zum Eingeben für Hunde und Pferde
Active substance:
  • Acepromazine maleate
Target species:
  • Dog
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Acepromazine maleate
    47.50
    milligram(s)
    /
    1.00
    millilitre(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:
  • Austria
Available in:
  • Austria
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Vetoquinol Oesterreich GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetoquinol Biowet Sp. z o.o.
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 8-00167
Date of authorisation status change:

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 11/01/2021
Updated on: 5/05/2024
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 24/01/2019
Updated on: 5/05/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 24/01/2019
Updated on: 5/05/2024
Download