File downloaded on 2026-01-26
Source URL: https://medicines.health.europa.eu/veterinary/en/600000097284
Not authorised

Product identification

Medicine name:
Acalma comprimidos para cães e gatos
Active substance:
  • Hydroxyzine hydrochloride
  • Chlorphenamine maleate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Hydroxyzine hydrochloride
    25.00
    milligram(s)
    /
    1.00
    Tablet
  • Chlorphenamine maleate
    1.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QR06AB54
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Revoked
Authorised in:
  • Portugal
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • ARRIGONI Patrice Antoine Gaston
Marketing authorisation date:
Manufacturing sites for batch release:
  • ARRIGONI Patrice Antoine Gaston
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 756/01/14NFVPT
Date of authorisation status change:

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 26/06/2023
Updated on: 27/06/2023
Download