Veterinary Medicines

Unomec 5 mg/ml Pour-on Solution for beef and dairy cattle

Authorised
  • Eprinomectin
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Product identification

Medicine name:
Unomec 5 mg/ml Pour-on Solution for beef and dairy cattle
Zepromec 5 mg/ml pour-on, opløsning
Active substance:
  • Eprinomectin
Target species:
  • Cattle
Route of administration:
  • Topical use

Product details

Active substance and strength:
  • Eprinomectin
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Pour-on solution
Withdrawal period by route of administration:
  • Topical use
    • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • High density polyethylene container with a polypropylene tamper evident screw cap which consists of the following: 5L 'Flexi' packs. Pack sizes 5 L.
  • High density polyethylene container with a polypropylene tamper evident screw cap which consists of the following: 3L 'Flexi' packs. Pack sizes 3L.
  • High density polyethylene container with a polypropylene tamper evident screw cap which consists of the following: 2.5 L 'Flexi' packs. Pack sizes 2.5L.
  • High density polyethylene container with a polypropylene tamper evident screw cap which consists of the following: 1L 'Squeeze pour' packs. Pack sizes 1L.

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:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 56356
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0354/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
Download
Danish (PDF)
Published on: 19/01/2024
Download
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