File downloaded on 2026-04-24
Source URL: https://medicines.health.europa.eu/veterinary/en/600000031104
Authorised

Product identification

Medicine name:
GABBROVET 140 MG/ML SOLUTION FOR USE IN DRINKING WATER/MILK FOR PRE-RUMINANT CATTLE AND PIGS
Active substance:
  • Paromomycin sulfate
Target species:
  • Cattle (pre-ruminant)
  • Pig
Route of administration:
  • In drinking water/milk use
  • In drinking water 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/milk
Withdrawal period by route of administration:
  • In drinking water/milk use
    • Cattle (pre-ruminant)
      • Meat and offal
        20
        day
  • In drinking water use
    • 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:
  • Slovenia
Package description:

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 Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0614/001
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

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 24/12/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 24/12/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 24/12/2025
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Combined File of all Documents

English (PDF)
Published on: 1/04/2026
Download

eu-puar-frv0317001-mr-rpe364-en.pdf

English (PDF)
Published on: 13/03/2026
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