Veterinary Medicine Information website

SEDALIN gel, 35mg/ml, Perorální gel

Authorised
  • Acepromazine
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Product identification

Medicine name:
SEDALIN gel, 35mg/ml, Perorální gel
Active substance:
  • Acepromazine
Target species:
  • Dog
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Acepromazine
    35.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral gel
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Available in:
  • Czechia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Vetoquinol s.r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetoquinol Biowet Sp. z o.o.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/1341/97-C
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Czech (PDF)
Published on: 26/10/2022
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Package Leaflet

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Czech (PDF)
Published on: 26/10/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 26/10/2022
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