Veterinary Medicines

Noromectin 0.5% w/v Pour-On Solution for Cattle

Authorised
  • Ivermectin
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Product identification

Medicine name:
Noromectin 0.5% w/v Pour-On Solution for Cattle
Noromectin 0,5% w/v áhella, lausn handa nautgripum
Active substance:
  • Ivermectin
Target species:
  • Cattle
Route of administration:
  • Pour-on use

Product details

Active substance and strength:
  • Ivermectin
    0.50
    gram(s)
    /
    100.00
    millilitre(s)
Pharmaceutical form:
  • Pour-on solution
Withdrawal period by route of administration:
  • Pour-on use
    • Cattle
      • 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:
  • Iceland
Available in:
  • Iceland
Package description:
  • Noromectin Pour-On will be supplied in 250 ml twin-neck high density polyethylene dispensers
  • Noromectin Pour-On will be supplied in 1.0L twin-neck high density polyethylene dispensers
  • Noromectin Pour-On will be supplied in 2.5 L low density polyethylene backpacks.
  • Noromectin Pour-On will be supplied in 5 L low density polyethylene backpacks.
  • A 7 L combination pack consisting of 2 x 1.0 L twin-neck high density polyethylene dispensers and 2 x 2.5 L low density polyethylene backpacks with a dosing gun.
  • Noromectin Pour-On will be supplied in 250 L high density polyethylene backpacks.
  • Noromectin Pour-On will be supplied in 1 L high density polyethylene backpacks.
  • Noromectin Pour-On will be supplied in 1.0L squeeze-measure high density polyethylene dispensers
  • Noromectin Pour-On will be supplied in 250 ml squeeze-measure high density polyethylene dispensers
  • Noromectin Pour-On will be supplied in 1.0L single neck high density polyethylene dispensers
  • Noromectin Pour-On will be supplied in 250 ml single neck high density polyethylene dispensers
  • A 7 L combination pack consisting of 2 x 1.0 L squeeze-measure highdensity polyethylene dispensers and 2 x 2.5 L low density polyethylene backpacks with a dosing gun.
  • A 7 L combination pack consisting of 2 x 1.0 L single neck high density polyethylene dispensers and 2 x 2.5 L low density polyethylene backpacks with a dosing gun.

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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Icelandic Medicines Agency
Authorisation number:
  • IS/2/11/012/01
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0105/001
Concerned member states:
  • Germany
  • Iceland
  • Italy
  • Luxembourg
  • Portugal
  • Spain
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