Veterinary Medicines

Robexera 5 mg chewable tablets for dogs

Authorised
  • Robenacoxib
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Product identification

Medicine name:
Robexera 5 mg chewable tablets for dogs
Robexera 5 mg žuvacie tablety pre psy
Active substance:
  • Robenacoxib
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Robenacoxib
    5.00
    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:
  • Slovakia
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 d.d. Novo Mesto
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/015/DC/23-S
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0775/001
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovak (PDF)
Published on: 11/10/2023
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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