Veterinary Medicines

Alpramil 12.5 mg/125 mg tablets for dogs weighing at least 5 kg

Authorised
  • Praziquantel
  • Milbemycin oxime
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Product identification

Medicine name:
Alpramil 12.5 mg/125 mg tablets for dogs weighing at least 5 kg
Alpramil 12,5 mg/125 mg таблетки за кучета с тегло най-малко 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
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AB51
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Package description:
  • Box with 10 OPA/Aluminium/PVC-Aluminium blisters each containing 1 tablet.
  • Box with 1 OPA/Aluminium/PVC-Aluminium blister containing 4 tablets.
  • Box with 25 OPA/Aluminium/PVC-Aluminium blisters each containing 4 tablets.
  • Box with 25 OPA/Aluminium/PVC-Aluminium blisters each containing 2 tablets.
  • Box with 25 OPA/Aluminium/PVC-Aluminium blisters each containing 1 tablet.
  • Box with 10 OPA/Aluminium/PVC-Aluminium blisters each containing 4 tablets.
  • Box with 10 OPA/Aluminium/PVC-Aluminium blisters each containing 2 tablets.
  • Box with 1 OPA/Aluminium/PVC-Aluminium blister containing 2 tablets
  • Box with 1 OPA/Aluminium/PVC-Aluminium blister containing 1 tablet

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:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfasan Nederland B.V.
  • Lelypharma B.V.
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-3150
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0364/005
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 4/05/2022
Updated on: 5/05/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 15/07/2024
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NL_V_0364_004-006_DC Milpramax tablets for dogs-Final PuAR.pdf

English (PDF)
Published on: 29/02/2024
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