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 für Pferde
Active substance:
  • Ketanserin tartrate
Target species:
  • Horse
Route of administration:
  • Topical 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:
  • Topical 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:
  • Germany
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:
  • BVL
Authorisation number:
  • 401487.00.00
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

Summary of Product Characteristics

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