Veterinary Medicines

Api-Bioxal 44.2 mg/ml bee-hive solution

Authorised
  • Oxalic acid
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Product identification

Medicine name:
Api-Bioxal 44.2 mg/ml bee-hive solution
API-BIOXAL 62 mg/ml SOLUCION PARA COLMENAS
Active substance:
  • Oxalic acid
Target species:
  • Honey bee
Route of administration:
  • In-hive use

Product details

Active substance and strength:
  • Oxalic acid
    44.20
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Bee-hive solution
Withdrawal period by route of administration:
  • In-hive use
    • Honey bee
      • Honey
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AG03
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:
  • 5 Lt bag-in-box container: opaque low-density polyethylene container in a cardboard box, bag-in-box (Ecopack) with screw cap (HDPE) and tamper-evident seal
  • 5 Lt container: white opaque high-density polyethylene cans, with screw cap (HDPE) and tamper-evident seal
  • 500 ml bottle: white opaque high-density polyethylene bottles with child – resistant screw cap (HDPE) and tamper-evident seal

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Complete application (stand-alone) - Directive No 2001/82/EC
Marketing authorisation holder:
  • Chemicals Laif S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chemifarma - S.p.A.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 4045 ESP
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0132/002
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Ireland
  • Norway
  • Portugal
  • Romania
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 11/11/2024
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