Veterinary Medicines

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

Authorised
  • Xylazine hydrochloride
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Product identification

Medicine name:
Nerfasin vet. 100 mg/ml, solution for injection for cattle and horses
Nerfasin Vet 100 mg/ml Oplossing voor injectie
Nerfasin Vet 100 mg/ml Solution injectable
Nerfasin Vet 100 mg/ml Injektionslösung
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
        no withdrawal period
      • Meat and offal
        1
        day
    • Horse
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
  • Intravenous use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
    • Horse
      • Milk
        no withdrawal period
      • 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:
  • Belgium
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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V435872
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
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Summary of Product Characteristics

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Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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German (PDF)
Published on: 22/03/2022
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108959 - par.pdf

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