Veterinary Medicines

FATROSEAL 2.6 g INTRAMAMMARY SUSPENSION FOR DRY COWS

Authorised
  • Bismuth subnitrate, heavy
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Product identification

Medicine name:
FATROSEAL 2.6 g INTRAMAMMARY SUSPENSION FOR DRY COWS
FATROSEAL 2,6 g SUSPENSION INTRAMAMARIA PARA VACAS EN SECADO
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:
  • Spain
Available 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:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 4071 ESP
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

Summary of Product Characteristics

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

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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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