Veterinary Medicines

Kelactin 50 µg/ml oral solution

Authorised
  • Cabergoline
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Product identification

Medicine name:
Kelactin 50 µg/ml oral solution
Kelactin vet 50 mikrogram/ml Oral lösning
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:
  • Sweden
Package description:

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:
  • Swedish Medical Products Agency
Authorisation number:
  • 46010
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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Swedish (PDF)
Published on: 16/08/2023
Download

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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Swedish (PDF)
Published on: 15/08/2023
Download

Labelling

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