Veterinary Medicines

FATROSEAL 2.6 g INTRAMAMMARY SUSPENSION FOR DRY COWS

Authorised
  • Bismuth subnitrate, heavy
Download as PDF

Product identification

Medicine name:
FATROSEAL 2.6 g INTRAMAMMARY SUSPENSION FOR DRY COWS
Fatroseal 2,6 g suspensie voor intramammair gebruik voor droogstaande koeien
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:
  • Netherlands
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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 128005
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 11/08/2022
Download

Package Leaflet

English (PDF)
Published on: 1/02/2024
Download

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

English (PDF)
Published on: 1/02/2024
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."