Veterinary Medicines

Milquantel 12.5mg/125.0mg Tablets for Dogs

Authorised
  • Praziquantel
  • Milbemycin oxime
Download as PDF

Product identification

Medicine name:
Milquantel 12.5mg/125.0mg Tablets for Dogs
Milquantel 12,5 mg/125 mg compresse per cani che pesano almeno 5 kg
Active substance:
  • Praziquantel
  • Milbemycin oxime
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Praziquantel
    125.00
    milligram(s)
    /
    1.00
    Tablet
  • Milbemycin oxime
    12.50
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AB51
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • Blister packs consisting of cold formed OPA_Al_PVC foil and aluminium foil. Box with 1 blister of 4 tablets
  • Blister packs consisting of cold formed OPA_Al_PVC foil and aluminium foil. Box with 1 blister of 2 tablets
  • Blister packs consisting of cold formed OPA_Al_PVC foil and aluminium foil. Box with 12 blisters of 4 tablets

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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 105104
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0259/002
Concerned member states:
  • France
  • Italy
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 4/04/2024
Download
Italian (PDF)
Published on: 14/03/2022
Download