Veterinary Medicines

Sumex 5 mg/ml Pour on Solution for Cattle

Authorised
  • Ivermectin
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Product identification

Medicine name:
Sumex 5 mg/ml Pour on Solution for Cattle
CHANECTIN POUR ON
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
        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:
  • Italy
Package description:
  • High density polyethylene container (flat bottomed flexi packs) with a 38mm tamper evident closure (1L).The 1L pack will also have a dial a dose dosing cup.Pack sizes: 1L
  • High density polyethylene container (flat bottomed flexi packs) with a 38mm tamper evident closure (2.5L).Pack sizes: 2.5L
  • High density polyethylene container (flat bottomed flexi packs) with a 38mm tamper evident closure (5L).Pack sizes: 5L.
  • High density polyethylene container (flat bottomed flexi packs) with a 38mm tamper evident closure (1L and 5L).The 1L pack will also have a dial a dose dosing cup.Pack sizes: 6L.The 6L pack size consists of a 5L and 1L pack combined in one carton.
  • High density polyethylene squeeze measure pour containers with child resistant closures. Pack sizes: 250ml
  • High density polyethylene squeeze measure pour containers with child resistantclosures. Pack sizes: 500ml
  • High density polyethylene squeeze measure pour containers with child resistant closures. 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:
  • Ministry Of Health
Authorisation number:
  • 103987
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0209/001
Concerned member states:
  • Greece
  • Italy
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Italian (PDF)
Published on: 14/05/2022
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