Veterinary Medicines

PROPALIN

Authorised
  • Phenylpropanolamine hydrochloride
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Product identification

Medicine name:
PROPALIN
Propalin Syrop 40 mg/ml
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:
  • QG04BX
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • Cardboard box with 1 bottle of 30 ml with a syringe of 1.5 ml
  • Cardboard box with 1 bottle of 100 ml with a syringe of 1.5 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Vetoquinol Biowet Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetoquinol S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1626
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0356/001
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Poland
  • Portugal
  • Slovakia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/12/2023
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Polish (PDF)
Published on: 22/10/2024
Download

Package Leaflet

English (PDF)
Published on: 11/12/2023
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Polish (PDF)
Published on: 22/10/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 8/04/2022
Download
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