File downloaded on 2026-04-04
Source URL: https://medicines.health.europa.eu/veterinary/en/600000054821
Authorised

Product identification

Medicine name:
MONZAL 100 mg/ml SOLUCION INYECTABLE
Active substance:
  • Vetrabutine hydrochloride
Target species:
  • Pig (female)
  • Dog (bitch)
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Vetrabutine hydrochloride
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig (female)
      • Meat and offal
        28
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02CA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 656 ESP
Date of authorisation status change:

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 28/11/2023
Download

Summary of Product Characteristics

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Spanish (PDF)
Published on: 28/11/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 28/11/2023
Download