Veterinary Medicines

APSASOL AMOXICILINA 500 mg/g

Authorised
  • Amoxicillin trihydrate
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Product identification

Medicine name:
APSASOL AMOXICILINA 500 mg/g
APSASOL AMOXICILINA 500 mg/g POLVO PARA ADMINISTRACION EN AGUA DE BEBIDA PARA PORCINO, POLLOS, PAVOS Y PATOS
Active substance:
  • Amoxicillin trihydrate
Target species:
  • Pig
  • Chicken (broiler)
  • Turkey (for meat production)
  • Duck (broiler)
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    500.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Pig
      • Meat and offal
        6
        day
    • Chicken (broiler)
      • Meat and offal
        1
        day
    • Turkey (for meat production)
      • Meat and offal
        5
        day
    • Duck (broiler)
      • Meat and offal
        9
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Andres Pintaluba S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Andres Pintaluba S.A.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 3071 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0276/001
Concerned member states:
  • Bulgaria
  • Croatia
  • Cyprus
  • Greece
  • Hungary
  • Italy
  • Poland
  • Portugal
  • Romania

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/04/2023
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Spanish (PDF)
Published on: 17/03/2023
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Package Leaflet

English (PDF)
Published on: 11/04/2023
Download
Spanish (PDF)
Published on: 17/03/2023
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023
Download

eu-PUAR-apsasol-amoxicilina-500-mg-g-powder-for-use-in-drinking-water-for-pigs--chickens--ducks-and-turkeys-en.pdf

English (PDF)
Published on: 11/04/2023
Download

es-puar-apsasol-amoxicilina-500-mg-g-powder-for-use-in-drinking-water-for-pigs--chickens--ducks-and-turkeys-es.pdf

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