Veterinary Medicine Information website

Sputolosin Oral Powder 5 mg/g

Authorised
  • Dembrexine hydrochloride monohydrate
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Product identification

Medicine name:
Sputolosin Oral Powder 5 mg/g
Active substance:
  • Dembrexine hydrochloride monohydrate
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Dembrexine hydrochloride monohydrate
    5.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Oral powder
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QR05CB90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • The product is packaged in a polyethylene container with a push-fit polyethylene capand a measuring spoon (5 g powder). The container is filled with 420 g powder.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Klocke Pharma-Service GmbH
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10454/014/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

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