Veterinary Medicines

Topimec Injection 10 mg/ml solution for injection

Authorised
  • Ivermectin
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Product identification

Medicine name:
Topimec Injection 10 mg/ml solution for injection
CEVAMECTIN INJECTABLE POUR BOVINS OVINS ET PORCINS
Active substance:
  • Ivermectin
Target species:
  • Cattle
  • Sheep
  • Pig
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Ivermectin
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        49
        day
    • Sheep
      • Meat and offal
        25
        day
    • Pig
      • Meat and offal
        28
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Multidose polyethylene bottle of 50 ml sealed with bromobutyl seal and aluminium overseal.
  • Multidose polyethylene bottle of 250 ml sealed with bromobutyl seal and aluminium overseal.
  • Multidose polyethylene bottle of 500 ml sealed with bromobutyl seal and aluminium overseal.

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/0616621 0/2005
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0163/001
Concerned member states:
  • France

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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French (PDF)
Published on: 4/04/2022
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