Veterinary Medicines

Milbetab 12.5 mg/125 mg Tablets for Dogs

Authorised
  • Milbemycin oxime
  • Praziquantel
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Product identification

Medicine name:
Milbetab 12.5 mg/125 mg Tablets for Dogs
Milbetab, 12,5 mg/125 mg, tableta za pse
Active substance:
  • Milbemycin oxime
  • Praziquantel
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Milbemycin oxime
    12.50
    milligram(s)
    /
    1.00
    Tablet
  • Praziquantel
    125.00
    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:
  • Croatia
Package description:
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil. Multipack of 10 individual packs of 50 tablets.
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil. Multipack of 10 individual packs of 20 tablets.
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil. Multipack of 10 individual packs of 2 tablets.
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 500 tablets (50 blister strips of 10).
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 200 (20 blister strips of 10)
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 100 (10 blister strips of 10)
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 50 (5 blister strips of 10)
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 30 (3 blister strips of 10)
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 20 (2 blister strips of 10)
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 20 (10 blister strips of 2)
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 10 (1 blister strip of 10)
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 8 (4 blister strips of 2)
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 8 (2 blister strips of 4)
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 8 (1 blister strip of 8)
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 4 (2 blister strips of 2)
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 4 (1 blister strip of 4)
  • Blister packs made up of a cold form laminate of OPA/ALU/PVC and a 20µm hard temper aluminium foil.Cardboard box with 2 (1 blister strip of 2)

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:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/17-01/541
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0399/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 16/01/2026
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Croatian (PDF)
Published on: 30/10/2025
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Combined File of all Documents

English (PDF)
Published on: 28/09/2025
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