Aderexa 12.5 mg/125 mg chewable tablets for dogs weighing at least 5 kg
  • Milbémycine oxime
  • Prazikvantels
  • Valid
Authorised in these countries:
  • United Kingdom (Northern Ireland)
Export to PDF

Product identification

Medicine name:
Aderexa 12.5 mg/125 mg chewable tablets for dogs weighing at least 5 kg
Active substance and strength:
  • Milbémycine oxime
    12.50
    milligram(s)
    /
    1.00
    Tablet
  • Prazikvantels
    125.00
    milligram(s)
    /
    1.00
    Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AB51
Authorisation number:
  • VM 24745/4024
Product identification number:
  • 690ee20d-0b31-463c-bccd-46d4c4e4db97
Permanent identification number:
  • 600000046608

Product details

Legal status of supply:
This information is not available for this product.
Pharmaceutical form:
  • Chewable tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog

Availability

Package description:
  • Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil. Cardboard box with 1 blister of 2 tablets.
  • Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil. Cardboard box with 1 blister of 4 tablets.
  • Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil. Cardboard box with 12 blisters, each blister contains 4 tablets (total 48 tablets).
Manufacturing sites for batch release:
  • TAD Pharma GmbH
  • KRKA tovarna zdravil d.d. Novo mesto
Source wholesaler:
This information is not available for this product.
Destination wholesaler:
This information is not available for this product.

Authorisation details

Authorisation status:
  • Valid
Authorisation procedure type:
  • Marketing Authorisation
Procedure number:
  • IE/V/0528/002
Date of authorisation status change:
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Authorisation country:
  • United Kingdom (Northern Ireland)
Responsible authority:
  • VMD
Marketing authorisation holder:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation issued:
Reference member state:
  • Ireland
Concerned member states:
  • United Kingdom (Northern Ireland)
Reference product identifier:
This information is not available for this product.
Source product identifier:
This information is not available for this product.

Additional information

To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet

Documents

Summary of Product Characteristics (PDF)
First published:
Last updated:
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."