Veterinary Medicines

MILBEMAX 12.5 MG/125 MG TABLETS FOR DOGS

Authorised
  • Milbemycin oxime
  • Praziquantel
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Product identification

Medicine name:
MILBEMAX 12.5 MG/125 MG TABLETS FOR DOGS
Milbemax tabletten voor honden
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 not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • Box of 1 PVC/PE/PVdC/aluminium blister of 2 tablets
  • Box of 10 PVC/PE/PVdC/aluminium blister of 10 tablets
  • Box of 5 PVC/PE/PVdC/aluminium blister of 10 tablets
  • Box of 2 PVC/PE/PVdC/aluminium blister of 10 tablets
  • Box of 1 PVC/PE/PVdC/aluminium blister of 10 tablets
  • Box of 1 PVC/PE/PVdC/aluminium blister of 4 tablets

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Elanco France S.A.S.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 10091
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0135/002
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 7/04/2022
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