File downloaded on 2026-04-06
Source URL: https://medicines.health.europa.eu/veterinary/en/600000033582
Not authorised

Product identification

Medicine name:
Rominervin 10 mg/ml Solution for Injection for Horses
Active substance:
  • Romifidine hydrochloride
Target species:
  • Horse
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Romifidine hydrochloride
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Horse
      • Meat and offal
        6
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM93
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Bulgaria
Package description:
  • Multi-pack with 6 boxes each containing 1 vial of 50 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
  • Multi-pack with 6 boxes each containing 1 vial of 20 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
  • Multi-pack with 6 boxes each containing 1 vial of 10 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
  • Multi-pack with 10 boxes each containing 1 vial of 10 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
  • Box with 1 vial of 50 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
  • Box with 1 vial of 20 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
  • Box with 1 vial 10 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
  • Multi-pack with 10 boxes each containing 1 vial of 50 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
  • Multi-pack with 10 boxes each containing 1 vial of 20 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.

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:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2864
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0318/001

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 4/04/2022
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 4/04/2022
Download