Veterinary Medicines

Vulketan 2.5 mg/g gel for horses

Authorised
  • Ketanserin tartrate
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Product identification

Medicine name:
Vulketan 2.5 mg/g gel for horses
Vulketan 2,5 mg/g gel voor paarden
Active substance:
  • Ketanserin tartrate
Target species:
  • Horse
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Ketanserin tartrate
    3.45
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Gel
Withdrawal period by route of administration:
  • Cutaneous use
    • Horse
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QD03AX90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • The product is packed in 75 g aluminum tubes with HDPE screw cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Audevard
Marketing authorisation date:
Manufacturing sites for batch release:
  • Sanochemia Pharmazeutika AG
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 108178
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0265/001
Concerned member states:
  • Austria
  • Denmark
  • Finland
  • France
  • Germany
  • Iceland
  • Italy
  • Luxembourg
  • Netherlands
  • Portugal
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 26/01/2022
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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