Veterinary Medicines

Uristop 40 mg/ml syrup for dogs

Authorised
  • Phenylpropanolamine hydrochloride
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Product identification

Medicine name:
Uristop 40 mg/ml syrup for dogs
URIXINE 40,28 MG/ML SIROP POUR CHIENS
Active substance:
  • Phenylpropanolamine hydrochloride
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Phenylpropanolamine hydrochloride
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Syrup
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG04BX91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Box with 1 bottle of 100 ml and 1 syringe of 1,5 ml
  • Box with 1 bottle of 50 ml and 1 syringe of 1,5 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Karizoo S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
  • Laboratorios Karizoo S.A.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/5100093 2/2024
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0288/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Estonia
  • France
  • Germany
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 27/06/2024
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French (PDF)
Published on: 2/07/2024
Download

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: 2/07/2024
Download

eu-PUAR-esv0288001-mrp-uristop-40-mg-ml-syrup-for-dogs-en.pdf

English (PDF)
Published on: 24/07/2024
Download
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