Authorised

Product identification

Medicine name:
FATROSEAL 2.6 g INTRAMAMMARY SUSPENSION FOR DRY COWS
FATROSEAL 2,6 g Suspension zur intramammären Anwendung für trockenstehende Milchkühe
Active substance:
  • Bismuth subnitrate, heavy
Target species:
  • Cattle (dairy cow at drying-off)
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Bismuth subnitrate, heavy
    26.00
    gram(s)
    /
    4.00
    gram(s)
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle (dairy cow at drying-off)
      • Meat and offal
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG52X
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
Available in:
  • Austria
Package description:
  • Cardboard box with 120 syringes of 4 g + 120 cleaning wipes
  • Cardboard box with 60 syringes of 4 g + 60 cleaning wipes
  • Cardboard box with 24 syringes of 4 g + 24 cleaning wipes
  • Cardboard box with 120 syringes
  • Cardboard box with 60 syringes
  • Cardboard box with 24 syringes of 4 g

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:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 841219
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0407/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

English (PDF)
Published on: 1/02/2024
Download
German (PDF)
Published on: 8/06/2022
Updated on: 2/10/2024
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 8/06/2022
Updated on: 2/10/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 3/05/2024
Updated on: 2/10/2024
Download

eu-PUAR-esv0407001-dcp-fatroseal-2.6-g-en.pdf

English (PDF)
Published on: 1/02/2024
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000092720