File downloaded on 2026-01-01
Source URL: https://medicines.health.europa.eu/veterinary/en/600000031096
Authorised

Product identification

Medicine name:
GABBROVET 140 MG/ML SOLUTION FOR USE IN DRINKING WATER, MILK OR MILK REPLACER FOR PRE-RUMINANT CATTLE AND PIGS
AMMINOFARMA BS 140 MG/ML
Active substance:
  • Paromomycin sulfate
Target species:
  • Cattle
  • Pig
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Paromomycin sulfate
    200.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for use in drinking water
Withdrawal period by route of administration:
  • Oral use
    • Cattle
      • Meat and offal
        20
        day
    • Pig
      • Meat and offal
        3
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA07AA06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • Box of 1 vial of 125 mL
  • Vial of 1000 mL
  • Vial of 500 mL
  • Vial of 250 mL
  • Vial of 125 mL
  • Box of 1 vial of 1000 mL
  • Box of 1 vial of 500 mL
  • Box of 1 vial of 250 mL

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Salute Animale S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 105112
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0317/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 11/12/2024
Download
Italian (PDF)
Published on: 27/09/2023
Download