Veterinary Medicines

Octacillin 697 mg/g Powder for use in drinking water

Authorised
  • Amoxicillin trihydrate
Download as PDF

Product identification

Medicine name:
Octacillin 697 mg/g Poeder voor gebruik in drinkwater
Octacillin 697 mg/g Poudre pour administration dans l'eau de boisson
Octacillin 697 mg/g Pulver zum Eingeben über das Trinkwasser
Octacillin 697 mg/g Powder for use in drinking water
Active substance:
  • Amoxicillin trihydrate
Target species:
  • Chicken
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    800.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for use in drinking water
Withdrawal period by route of administration:
  • Oral use
    • Chicken
      • Meat and offal
        1
        day
      • Eggs
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • 1000g: sachet (ALU/PE)
  • 500g: sachet (ALU/PE)
  • 250g: sachet (ALU/PE)
  • 100g: sachet (ALU/PE)
  • 1000g: sachet (ALU/PA/PE)
  • 500g: sachet (ALU/PA/PE)
  • 250g: sachet (ALU/PA/PE)
  • 100g: sachet (ALU/PA/PE)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V279194
Date of authorisation status change:
Reference member state:
  • Belgium
Procedure number:
  • BE/V/0036/001
Concerned member states:
  • Czechia
  • Greece
  • Ireland
  • Italy
  • Poland
  • Portugal
  • Slovakia
  • United Kingdom (Northern Ireland)
Generic of:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 21/12/2021
Download
Dutch (PDF)
Published on: 11/03/2022
Download
French (PDF)
Published on: 11/03/2022
Download

Labelling

English (PDF)
Published on: 21/12/2021
Download

Package Leaflet

English (PDF)
Published on: 22/12/2021
Download
Dutch (PDF)
Published on: 11/03/2022
Download
French (PDF)
Published on: 11/03/2022
Download
German (PDF)
Published on: 11/03/2022
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."