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 vet 5 mg tuggtablett för hund
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AH91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Sweden
Package description:

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:
  • Swedish Medical Products Agency
Authorisation number:
  • 63434
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0775/001
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)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Swedish (PDF)
Published on: 19/09/2023
Updated on: 21/09/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 15/10/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 21/11/2024
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