Veterinary Medicines

Malaseb shampoo for dogs and cats

Authorised
  • Miconazole nitrate
  • Chlorhexidine digluconate solution
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Product identification

Medicine name:
Malaseb shampoo for dogs and cats
Malaseb Shampoo 20 mg/ml Shampoo
Malaseb Shampoo 20 mg/ml Shampoing
Malaseb Shampoo 20 mg/ml Shampoo
Active substance:
  • Miconazole nitrate
  • Chlorhexidine digluconate solution
Target species:
  • Dog
  • Cat
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Miconazole nitrate
    20.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Chlorhexidine digluconate solution
    20.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Shampoo
Withdrawal period by route of administration:
  • Cutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QD01AC52
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • The container is a 250 ml polyethylene bottle with a polypropylene 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:
  • Dechra Veterinary Products A/S
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V365495
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0513/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 20/04/2025
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Dutch (PDF)
Published on: 18/08/2025
Download
French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
Download
French (PDF)
Published on: 18/08/2025
Download
German (PDF)
Published on: 18/08/2025
Download

Combined File of all Documents

English (PDF)
Published on: 20/04/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
Download
French (PDF)
Published on: 18/08/2025
Download
German (PDF)
Published on: 18/08/2025
Download
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