Authorised

Product identification

Medicine name:
Narcostart (Sedastart) 1 mg/ml solution for injection for cats and dogs
Narcostart 1 mg/ml Injektionslösung für Hund und Katze
Active substance:
  • Medetomidine hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Medetomidine hydrochloride
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
    • Cat
  • Intravenous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM91
Legal status of supply:
  • Medicinal product on medical prescription for non-renewable delivery
Authorisation status:
  • Valid
Authorised in:
  • Austria
Package description:
  • 1 x 1 glass vial with 10 ml. Glass (type I) vials closed with bromobutyl rubber closures secured with aluminium crimp caps.
  • 5 x 1 glass vial with 10 ml. Glass (type I) vials closed with bromobutyl rubber closures secured with aluminium crimp caps.

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. B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 8-00867
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0138/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Luxembourg
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 21/08/2015
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 21/08/2015
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 21/08/2015
Download

Combined File of all Documents

English (PDF)
Published on: 14/06/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000037128