Authorised

Product identification

Medicine name:
Octacillin 800 mg/g powder for use in drinking water for pigs, amoxicillin trihydrate
OCTACILLIN 800 mg/g POLVO PARA ADMINISTRACION EN AGUA DE BEBIDA PARA PORCINO
Active substance:
  • Amoxicillin trihydrate
Target species:
  • Pig
Route of administration:
  • In drinking water 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:
  • In drinking water use
    • Pig
      • Meat and offal
        2
        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:
  • 500 g multilayer sachet consisting of the following materials: on the outside a white layer, inside different transparent layers, a sub-layer of aluminium and an inner layer of polyethylene
  • 250 g multilayer sachet consisting of the following materials: on the outside a white layer, inside different transparent layers, a sub-layer of aluminium and an inner layer of polyethylene
  • 100 g multilayer sachet consisting of the following materials: on the outside a white layer, inside different transparent layers, a sub-layer of aluminium and an inner layer of polyethylene
  • 1 kg multilayer sachet consisting of the following materials: on the outside a polyester layer, inside layers of aluminium and polyamide and an inner layer of polyethylene
  • 250 g multilayer sachet consisting of the following materials: on the outside a polyester layer, inside layers of aluminium and polyamide and an inner layer of polyethylene
  • 500 g multilayer sachet consisting of the following materials: on the outside a polyester layer, inside layers of aluminium and polyamide and an inner layer of polyethylene
  • 100 g multilayer sachet consisting of the following materials: on the outside a polyester layer, inside layers of aluminium and polyamide and an inner layer of polyethylene
  • 1 kg multilayer sachet consisting of the following materials: on the outside a white layer, inside different transparent layers, a sub-layer of aluminium and an inner layer of polyethylene

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:
  • Eurovet Animal Health B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
Responsible authority:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2249 ESP
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0367/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/02/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/02/2023
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 15/03/2023
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000034224