Veterinary Medicine Information website

APSAMIX AMOXICILLIN 200 mg/g

Authorised
  • Amoxicillin trihydrate
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Product identification

Medicine name:
APSAMIX AMOXICILLIN 200 mg/g
Active substance:
  • Amoxicillin trihydrate
Target species:
  • Pig (weaned piglet)
Route of administration:
  • In-feed use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    229.60
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Premix for medicated feeding stuff
Withdrawal period by route of administration:
  • In-feed use
    • Pig (weaned piglet)
      • Meat and offal
        7
        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:
  • Hybrid application (Article 13(3) 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:
  • 4188 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0453/001
Concerned member states:
  • Bulgaria
  • Cyprus
  • Greece
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 19/02/2025
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Spanish (PDF)
Published on: 25/06/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 25/06/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 25/06/2025
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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es-PUAR-4188 esp-np-apsamix-amoxicilina-200-mg-g-premezcla-medicamentosa-para-porcino-es.pdf

Spanish (PDF)
Published on: 15/12/2023
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