Veterinary Medicines

Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle

Authorised
  • Ivermectin
  • Closantel sodium
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Product identification

Medicine name:
Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle
Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle
Active substance:
  • Ivermectin
  • Closantel sodium
Target species:
  • Cattle
Route of administration:
  • Pour-on use

Product details

Active substance and strength:
  • Ivermectin
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Closantel sodium
    206.94
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Pour-on solution
Withdrawal period by route of administration:
  • Pour-on use
    • Cattle
      • Meat and offal
        58
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA51
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • Translucent 1L HDPE containers with white HDPE caps and integrated measuring device, packaged incartons.
  • 4L combination pack containing 1 x 1L container or back pack, 1 x 2.5L HDPE back pack and a 1 x 500mlHDPE container with dosing gun.
  • White 5L HDPE backpacks with white polypropylene screw caps, packaged in cartons.
  • White 2.5L HDPE backpacks with white polypropylene screw caps, packaged in cartons.
  • White 1L HDPE backpacks with white polypropylene screw caps, packaged in cartons.
  • Translucent 500 ml HDPE containers with white HDPE caps and integrated measuring device, packaged incartons.
  • Translucent 250 ml HDPE containers with white HDPE caps and integrated measuring device, packaged in cartons.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Laboratories (Ireland) Limited
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA22664/088/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0611/001
Concerned member states:
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 16/02/2025
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Combined File of all Documents

English (PDF)
Published on: 16/02/2025
Download