Veterinary Medicines

APITRAZ 500 mg bee-hive strips for honey bees

Authorised
  • Amitraz
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Product identification

Medicine name:
APITRAZ 500 mg bee-hive strips for honey bees
APITRAZ 500 mg TIRAS PARA COLMENAS PARA ABEJAS
Active substance:
  • Amitraz
Target species:
  • Honey bee
Route of administration:
  • In-hive use

Product details

Active substance and strength:
  • Amitraz
    500.00
    milligram(s)
    /
    1.00
    Strip
Pharmaceutical form:
  • Bee-hive strip
Withdrawal period by route of administration:
  • In-hive use
    • Honey bee
      • Honey
        0
        day
      • Honey
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AD01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:
  • sachet containing 10 bee-hive strips of 250 mm x 48 mm
  • sachet containing 10 bee-hive strips of 300 mm x 40 mm

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 2782 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0197/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Portugal
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/04/2023
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Spanish (PDF)
Published on: 2/02/2024
Download

Package Leaflet

English (PDF)
Published on: 6/04/2023
Download
Spanish (PDF)
Published on: 2/02/2024
Download

Labelling

English (PDF)
Published on: 6/04/2023
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Spanish (PDF)
Published on: 17/03/2023
Download

Combined File of all Documents

English (PDF)
Published on: 21/11/2022
Download
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