Veterinary Medicines

APITRAZ 500 mg bee-hive strips for honey bees

Authorised
  • Amitraz
Download as PDF

Product identification

Medicine name:
APITRAZ 500 mg bee-hive strips for honey bees
Apitraz, 500 mg, traka za košnicu, za pčele medarice
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:
  • Croatia
Available in:
  • Croatia
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:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/17-01/526
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0197/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Portugal
  • Romania
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/04/2023
Download
Croatian (PDF)
Published on: 20/06/2023
Updated on: 26/06/2023
Download

Package Leaflet

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

Labelling

English (PDF)
Published on: 6/04/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."