Veterinary Medicines

Dectomax 5 mg/ml Pour-On Solution for Cattle

Authorised
  • Doramectin
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Product identification

Medicine name:
Dectomax 5 mg/ml Pour-On Solution for Cattle
Dectomax 5 mg/ml påhellingsvæske, oppløsning til storfe
Active substance:
  • Doramectin
Target species:
  • Cattle
Route of administration:
  • Pour-on use

Product details

Active substance and strength:
  • Doramectin
    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
        35
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Available in:
  • Norway
Package description:
  • .The product will be supplied in:-5 L multi-dose high-density polyethylene bottles with screw-top lidsand draw-off adaptor in a carton box.
  • The product will be supplied in:-3 L multi-dose high-density polyethylene bottles with screw-top lidsand draw-off adaptor in a carton box.
  • The product will be supplied in:- 2.5 L multi-dose high-density polyethylene bottles with screw-top lidsand draw-off adaptor in a carton box.
  • The product will be supplied in:- 1 L multi-dose high-density polyethylene bottles with screw-top lidsand dosing cups in a carton box
  • The product will be supplied in:- 250 ml multi-dose high-density polyethylene bottles with screw-top lidsand dosing cups in a carton box

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:
  • Zoetis Animal Health ApS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 10-7389
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0260/002
Concerned member states:
  • Austria
  • Denmark
  • France
  • Netherlands
  • Norway
  • Portugal
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Norwegian (PDF)
Published on: 30/01/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 30/01/2024
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