Veterinary Medicines

Proin 15 mg chewable tablets for dogs

Authorised
  • Phenylpropanolamine hydrochloride
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Product identification

Medicine name:
Proin 15 mg chewable tablets for dogs
PROIN 15 mg COMPRIMIDOS MASTICABLES PARA PERROS
Active substance:
  • Phenylpropanolamine hydrochloride
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Phenylpropanolamine hydrochloride
    15.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
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:
  • Spain
Package description:
  • White high density polyethylene bottles containing a 5 gram desiccant pack and cotton, sealed with a child resistant, foil lined heat sealed white polypropylene cap. Pack size: 60 tablets.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Pegasus Laboratories Ireland Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Tairgi Tread-Lia Baile Na Sceilge Teoranta
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 3761 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0361/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Spanish (PDF)
Published on: 16/03/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/03/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/03/2023
Download
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