Veterinary Medicines

Robexera 40 mg chewable tablets for dogs

Authorised
  • Robenacoxib
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Product identification

Medicine name:
Robexera 40 mg chewable tablets for dogs
ROBEXERA 40 MG COMPRIMES A CROQUER POUR CHIENS
Active substance:
  • Robenacoxib
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Robenacoxib
    40.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AH91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • OPA/Al/PVC/Aluminium perforated blister containing 10 tablets: 60 x 1 chewable tablet in perforated unit dose blisters, in a cardboard box.
  • OPA/Al/PVC/Aluminium perforated blister containing 10 tablets: 30 x 1 chewable tablet in perforated unit dose blisters, in a cardboard box.
  • OPA/Al/PVC/Aluminium perforated blister containing 10 tablets: 10 x 1 chewable tablet in perforated unit dose blisters, in a cardboard box.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • Krka-Farma d.o.o.
  • TAD Pharma GmbH
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/2166712 9/2023
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0775/004
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 11/12/2024
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