Colobreathe

RSS

colistimethate sodium

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

Overview

This is a summary of the European public assessment report (EPAR) for Colobreathe. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Colobreathe.

This EPAR was last updated on 09/10/2019

Authorisation details

Product details
Name
Colobreathe
Agency product number
EMEA/H/C/001225
Active substance
Colistimethate sodium
International non-proprietary name (INN) or common name
colistimethate sodium
Therapeutic area (MeSH)
Cystic Fibrosis
Anatomical therapeutic chemical (ATC) code
J01XB01
Publication details
Marketing-authorisation holder
Teva B.V.
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
13/02/2012
Contact address
Swensweg 5
2031 Haarlem
Netherlands

Product information

28/08/2019 Colobreathe - EMEA/H/C/001225 - IAIN/0043

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 systemic use

Therapeutic indication

Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged six years and older.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Assessment history

Changes since initial authorisation of medicine

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