Veterinary Medicines

Sputolysin - poeder 5 mg/g poeder voor oraal gebruik voor paarden

Authorised
  • Dembrexine hydrochloride
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Product identification

Medicine name:
Sputolysin - poeder 5 mg/g poeder voor oraal gebruik voor paarden
Active substance:
  • Dembrexine hydrochloride
Target species:
  • Horse
Route of administration:
  • Top-dressing use

Product details

Active substance and strength:
  • Dembrexine hydrochloride
    5.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Oral powder
Withdrawal period by route of administration:
  • Top-dressing use
    • Horse
      • Meat and offal
        6
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QR05CB90
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Klocke Pharma-Service GmbH
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 2635
Date of authorisation status change:

Documents

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Dutch (PDF)
Published on: 11/03/2025
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