Veterinary Medicines

Proin 50 mg chewable tablets for dogs

Authorised
  • Phenylpropanolamine hydrochloride
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Product identification

Medicine name:
Proin 50 mg chewable tablets for dogs
Proin 50 mg kauwtabletten voor honden
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
    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:
  • Netherlands
Package description:
  • White high density polyethylene bottle 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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 118777
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0361/002
Concerned member states:
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 26/01/2022
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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