Veterinary Medicines

Bimacox 2.5 mg/ml Oral Suspension for Lambs and Calves

Authorised
  • Diclazuril
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Product identification

Medicine name:
Bimacox 2.5 mg/ml Oral Suspension for Sheep and Cattle
Bimacox 2.5 mg/ml Oral Suspension for Lambs and Calves
Active substance:
  • Diclazuril
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Diclazuril
    2.50
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Cattle
      • Meat and offal
        0
        day
    • Sheep
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP51BC03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Package description:
  • 1 litre high density polyethylene container with polypropylene tamper-evident cap with an aluminium seal.
  • 2.5 litre high density polyethylene container with polypropylene tamper-evident cap with an aluminium seal.
  • 5 litre high density polyethylene container with polypropylene tamper-evident cap with an aluminium seal.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Bimeda Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bimeda Animal Health Limited
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • Vm 50146/3004
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0784/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Estonia
  • France
  • Germany
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)
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