Veterinary Medicines

URFAMUCOL INIETTABILE liofilizzato e solvente per soluzione iniettabile per equini

Authorised
  • Acetylcysteine
  • Thiamphenicol glycinate acetylcysteine
Download as PDF

Product identification

Medicine name:
URFAMUCOL INIETTABILE liofilizzato e solvente per soluzione iniettabile per equini
Active substance:
  • Acetylcysteine
  • Thiamphenicol glycinate acetylcysteine
Target species:
  • Horse
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Acetylcysteine
    1.15
    gram(s)
    /
    1.00
    Bottle
  • Thiamphenicol glycinate acetylcysteine
    4.05
    gram(s)
    /
    1.00
    Bottle
Pharmaceutical form:
  • Lyophilisate and solvent for solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Horse
      • Meat and offal
        20
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01BA52
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(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:
  • Ministry Of Health
Authorisation number:
This information is not available for this product.
Date of authorisation status change:

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 20/06/2022
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."