Veterinary Medicines

SEDALIN Gel 350 mg/10 ml peroralni gel za pse in konje

Authorised
  • Acepromazine maleate
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Product identification

Medicine name:
SEDALIN Gel 350 mg/10 ml peroralni gel za pse in konje
Active substance:
  • Acepromazine maleate
Target species:
  • Horse
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Acepromazine maleate
    475.00
    milligram(s)
    /
    10.00
    millilitre(s)
Pharmaceutical form:
  • Oral gel
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        6
        month
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Available in:
  • Slovenia
Package description:

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 Biowet Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetoquinol Biowet Sp. z o.o.
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • NP/V/0311/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Slovenian (PDF)
Published on: 7/12/2021
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Package Leaflet

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Slovenian (PDF)
Published on: 7/12/2021
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 7/12/2021
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