Veterinary Medicine Information website

Rominervin 10 mg/ml Solution for Injection for Horses

Authorised
  • Romifidine hydrochloride
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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:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
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:
  • Danish Medicines Agency
Authorisation number:
  • 60008
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0318/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • 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.
Danish (, INJEKTIONSVÆSKE, OPLØSNING 10 MG-ML)
Published on: 29/06/2023
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