Veterinary Medicines

Flukiver Combi 50 mg/ml + 75 mg/ml oral suspension

Authorised
  • Closantel sodium dihydrate
  • Mebendazole
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Product identification

Medicine name:
Flukiver Combi 50 mg/ml + 75 mg/ml oral suspension
Flukiver Combi vet. 50/75 mg/ml Mixtúra, lausn handa sauðfé og lömbum
Active substance:
  • Closantel sodium dihydrate
  • Mebendazole
Target species:
  • Sheep
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Closantel sodium dihydrate
    54.37
    milligram(s)
    /
    1.00
    millilitre(s)
  • Mebendazole
    75.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Sheep
      • Meat and offal
        65
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52A
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Iceland
Package description:
  • Container: High density polyethylene bottles of 5 litresClosure: High density polyethylene screw cap
  • Container: High density polyethylene bottles of 2.5 litresClosure: High density polyethylene screw cap
  • Container: High density polyethylene bottles of 1 litre Closure: High density polyethylene screw cap

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:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lusomedicamenta Sociedade Tecnica Farmaceutica S.A.
Responsible authority:
  • Icelandic Medicines Agency
Authorisation number:
  • IS/2/009/006/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0222/001
Concerned member states:
  • Austria
  • Belgium
  • France
  • Germany
  • Iceland
  • Italy
  • Netherlands

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Icelandic (PDF)
Published on: 16/01/2025
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