Veterinary Medicines

SELECTAN 300 mg/ml solution for injection for cattle and swine

Authorised
  • Florfenicol
Download as PDF

Product identification

Medicine name:
SELECTAN 300 mg/ml solution for injection for cattle and swine
SELECTAN
Active substance:
  • Florfenicol
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Florfenicol
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        30
        day
    • Pig
      • Meat and offal
        18
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01BA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • The product is bottled in 50 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.One bottle of 50 ml is available in a cardboard box.
  • The product is bottled in 100 ml colourless Type II glass bottle or 100 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.One bottle of 100 ml is available in a cardboard box.
  • The product is bottled in 250 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.One bottle of 250 ml is available in a cardboard box.
  • The product is bottled in 100 ml colourless Type II glass bottle or 100 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.Clinical pack size:10 x 100 ml
  • The product is bottled in 250 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.Clinical pack size:10 x 250 ml.
  • The product is bottled in 100 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.Clinical pack size: 12 x 100 ml.
  • The product is bottled in 250 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.Clinical pack size: 12 x 250 ml.

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:
  • Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • National Veterinary Medicines Agency
Authorisation number:
  • FR/V/9416206 2/2007
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0189/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 29/08/2023
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."