Milbenin 12.5 mg/125 mg chewable tablets for dogs
Milbenin 12.5 mg/125 mg chewable tablets for dogs
Authorised
- Milbemycin oxime
- Praziquantel
Product identification
Medicine name:
Milbenin 12.5 mg/125 mg chewable tablets for dogs
Active substance:
- Milbemycin oxime
- Praziquantel
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Milbemycin oxime12.50/milligram(s)1.00Tablet
-
Praziquantel125.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Chewable tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP54AB51
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Romania
Package description:
- 2 or 4 tablets in OPA-Al-PVC/AL blisters. 12 blisters of 4 chewable tablets introduced in carton box.
- 2 or 4 tablets in OPA-Al-PVC/AL blisters. 1 blister of 4 chewable tablets introduced in carton box.
- 2 or 4 tablets in OPA-Al-PVC/AL blisters. 1 blister of 2 chewable tablets introduced in carton box.
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:
- Pharma VIM Kft.
Marketing authorisation date:
Manufacturing sites for batch release:
- Vim Spectrum S.R.L.
Responsible authority:
- Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
- 230059
Date of authorisation status change:
Reference member state:
-
Hungary
Procedure number:
- HU/V/0146/002
Concerned member states:
-
Belgium
-
France
-
Germany
-
Greece
-
Italy
-
Luxembourg
-
Netherlands
-
Portugal
-
Romania
-
Spain
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
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Romanian (PDF)
Published on: 17/12/2025
