Veterinary Medicines

Acomec 5 mg/ml Pour-On Solution for Cattle

Not authorised
  • Ivermectin
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Product identification

Medicine name:
Acomec 5 mg/ml Pour-On Solution for Cattle
Active substance:
  • Ivermectin
Target species:
  • Cattle
Route of administration:
  • Pour-on use

Product details

Active substance and strength:
  • Ivermectin
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Pour-on solution
Withdrawal period by route of administration:
  • Pour-on use
    • Cattle
      • Meat and offal
        31
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Ireland
Package description:
  • 250 ml natural fluorinated high-density polyethylene pour-on container with a 10 ml measuring device
  • 250 ml white non-fluorinated or fluorinated high-density polyethylene bottle with internal graduated calibration chamber
  • 1.0 L white non-fluorinated or fluorinated high-density polyethylene barrel with polypropylene strap
  • 2.5L white non-fluorinated or fluorinated high-density polyethylene barrel with polypropylene strap
  • 5.0 L white non-fluorinated or fluorinated high-density polyethylene back-pack with polypropylene strap and vented cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed consent application (Article 13c of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Eco Animal Health Europe Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Safapac Limited
  • Acme Drugs S.r.l.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA22693/023/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

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