Veterinary Medicines

Urilin 40 mg/ml syrup for dogs

Not authorised
  • Phenylpropanolamine hydrochloride
Download as PDF

Product identification

Medicine name:
Urilin 40 mg/ml syrup for dogs
Urilin, 40.0mg/ml, Sirup
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG04BX91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Czechia
Package description:
  • 50 ml amber type III glass bottle containing 45 ml of syrup,with a low density polyethylene dropper and a polypropylene child resistant screw cap.
  • 100 ml amber type III glass bottle containing 100 ml of syrup,with a low density polyethylene dropper and a polypropylene child resistant screw cap.

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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dales Pharmaceuticals Limited
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/053/10-C
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0510/001

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
Czech (PDF)
Published on: 25/10/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
Download