Veterinary Medicines

MILBEMAX 2.5 MG/25 MG CHEWABLE TABLETS FOR SMALL DOGS AND PUPPIES

Authorised
  • Milbemycin oxime
  • Praziquantel
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Product identification

Medicine name:
MILBEMAX 2.5 MG/25 MG CHEWABLE TABLETS FOR SMALL DOGS AND PUPPIES
Milbemax kauwtabletten voor kleine honden en puppy’s
Active substance:
  • Milbemycin oxime
  • Praziquantel
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Milbemycin oxime
    2.50
    milligram(s)
    /
    1.00
    Tablet
  • Praziquantel
    25.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable 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:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • 1 box with 1 blister of 2 chewable tablets
  • 1 box with 12 strips, each strip contains 4 chewable tablets
  • 1 box with 12 blisters, each blister contains 4 chewable tablets
  • 1 box with 1 strip of 4 chewable tablets
  • 1 box with 1 strip of 2 chewable tablets
  • 1 box with 1 blister of 4 chewable tablets

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 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 105573
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0135/005
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

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