Veterinary Medicines

Robexera 20 mg/ml solution for injection for cats and dogs

Authorised
  • Robenacoxib
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Product identification

Medicine name:
Robexera 20 mg/ml solution for injection for cats and dogs
Robexera 20 mg/ml инжекционен разтвор за котки и кучета
Active substance:
  • Robenacoxib
Target species:
  • Dog
  • Cat
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Robenacoxib
    20.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AH91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Package description:
  • A cardboard box containing one amber type I glass vial of 20 ml, closed with a type I bromobutyl rubber stopper and an aluminium seal with plastic tear-off tab.

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:
  • TAD Pharma GmbH
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-3319
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0627/001/DC
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Generic of:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/08/2025
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Bulgarian (PDF)
Published on: 27/08/2025
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Combined File of all Documents

English (PDF)
Published on: 24/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 27/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 27/08/2025
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ie-puar-mr-iev0627001dc-robexera-20-mgml-solution-for-injection-for-cats-a-en.pdf

English (PDF)
Published on: 24/08/2025
Download