Veterinary Medicines

Kelactin 50 µg/ml oral solution

Authorised
  • Cabergoline
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Product identification

Medicine name:
Kelactin 50 µg/ml Oral solution
Veylactin 50 microgrammi/ml soluzione orale per cani e gatti
Kelactin 50 µg/ml oral solution
Active substance:
  • Cabergoline
Target species:
  • Cat
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Cabergoline
    50.00
    microgram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Cat
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02CB03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Available in:
  • Italy
Package description:
  • Kelactin 50 µg/ml or. sol. 24 ml (glass type II)
  • Kelactin 50 µg/ml or. sol. 14 ml (glass type III)
  • Kelactin 50 µg/ml or. sol. 7 ml (glass type III)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Veyx Pharma GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Veyx Pharma GmbH
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 104922
Date of authorisation status change:
Reference member state:
  • Belgium
Procedure number:
  • BE/V/0025/001
Concerned member states:
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Generic of:

Documents

Package Leaflet

English (PDF)
Published on: 16/03/2023
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Dutch (PDF)
Published on: 16/05/2022
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French (PDF)
Published on: 16/05/2022
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German (PDF)
Published on: 16/05/2022
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Summary of Product Characteristics

English (PDF)
Published on: 16/03/2023
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Dutch (PDF)
Published on: 16/05/2022
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French (PDF)
Published on: 16/05/2022
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Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 2/02/2024
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Labelling

English (PDF)
Published on: 16/03/2023
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