Veterinary Medicine Information website

Topimec Super Solution for Injection

Authorised
  • Ivermectin
  • Clorsulon
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Product identification

Medicine name:
Topimec Super Solution for Injection
Active substance:
  • Ivermectin
  • Clorsulon
Target species:
  • Cattle
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Ivermectin
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Clorsulon
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        66
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA51
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Package description:
  • Container material: High density polyethyleneContainer closure: Siliconised grey bromobutyl rubber stopperContainer volume: 50 ml
  • Container material: High density polyethyleneContainer closure: Siliconised grey bromobutyl rubber stopperContainer volume: 250 ml
  • Container material: High density polyethyleneContainer closure: Siliconised grey bromobutyl rubber stopperContainer volume: 500 ml

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:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 360/01/11RFVPT
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0286/001
Concerned member states:
  • Czechia
  • France
  • Greece
  • Poland
  • Portugal
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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