Veterinary Medicine Information website

Azasure 500 mg/g Powder for Suspension for Fish Treatment

Not authorised
  • Azamethiphos
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Product identification

Medicine name:
Azasure 500 mg/g Powder for Suspension for Fish Treatment
Active substance:
  • Azamethiphos
Target species:
  • Atlantic salmon
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Azamethiphos
    500.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Powder for suspension for fish treatment
Withdrawal period by route of administration:
  • Cutaneous use
    • Atlantic salmon
      • Meat and offal
        10
        degree day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AF17
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Norway
Package description:
  • 5x100 g: Heat-sealed polyvinylalcohol water soluble bag of product contained in a sealed aluminium/polyethylene sachet
  • 2x20 g: Heat-sealed polyvinylalcohol water soluble bag of product contained in a sealed aluminium/polyethylene sachet
  • 5x20 g: Heat-sealed polyvinylalcohol water soluble bag of product contained in a sealed aluminium/polyethylene sachet
  • 1x100 g: Heat-sealed polyvinylalcohol water soluble bag of product contained in a sealed aluminium/polyethylene sachet

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Ground Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Elara Pharmaservices Europe Limited
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 13-9411
Date of authorisation status change:
Reference member state:
  • Norway
Procedure number:
  • NO/V/0014/001
Generic of:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2022
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Norwegian (PDF)
Published on: 16/06/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 16/06/2022
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