Pirsue

RSS

pirlimycin

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 18/01/2019

Authorisation details

Product details
Name
Pirsue
Agency product number
EMEA/V/C/000054
Active substance
pirlimycin
International non-proprietary name (INN) or common name
pirlimycin
Species
Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QJ51FF90
Publication details
Marketing-authorisation holder
Zoetis Belgium SA
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
29/01/2001
Contact address

Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium

Product information

19/12/2018 Pirsue - EMEA/V/C/000054 - IAIN/0024/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTIBACTERIALS FOR INTRAMAMMARY USE

Therapeutic indication

For the treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as Staphylococcus aureus, both penicillinase-positive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including Streptococcus agalactiae, Streptococcus dysgalactiae and Streptococcus uberis.

Assessment history

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