Veterinary Medicines

Amoxicillinum 100 Biofaktor 100 mg/g Proszek do sporządzania roztworu doustnego

Authorised
  • Amoxicillin trihydrate
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Product identification

Medicine name:
Amoxicillinum 100 Biofaktor 100 mg/g Proszek do sporządzania roztworu doustnego
Active substance:
  • Amoxicillin trihydrate
Target species:
  • Chicken (hen)
  • Turkey
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    100.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for oral solution
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken (hen)
      • Meat and offal
        5
        day
    • Turkey
      • Meat and offal
        11
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Available in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Biofaktor Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Biofaktor Sp. z o.o.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 0970
Date of authorisation status change:

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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