Veterinary Medicines

Nerfasin vet. 100 mg/ml, solution for injection for cattle and horses

Authorised
  • Xylazine hydrochloride
Download as PDF

Product identification

Medicine name:
Nerfasin vet. 100 mg/ml, solution for injection for cattle and horses
Nerfasin, 100mg/ml, Injekční roztok
Active substance:
  • Xylazine hydrochloride
Target species:
  • Cattle
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Xylazine hydrochloride
    116.55
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        1
        day
    • Horse
      • Milk
        0
        hour
      • Meat and offal
        1
        day
  • Intravenous use
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        1
        day
    • Horse
      • Milk
        0
        hour
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM92
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • 50 ml product in a 50 ml clear type II glass vials closed with a bromobutyl rubber stopper and aluminium cap in a carton box.
  • 25 ml product in a 30 ml clear type II glass vials closed with a bromobutyl rubber stopper and aluminium cap in a carton box.
  • 10 ml product in a 10 ml clear type II glass vials closed with a bromobutyl rubber stopper and aluminium cap in a carton box.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) 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:
  • Institute For State Control Of Veterinary Biologicals And Medicines
Authorisation number:
  • 96/082/12-C
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0157/002
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 21/06/2022
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
Download

108959 - par.pdf

English (PDF)
Published on: 21/06/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."