Cayston

RSS

aztreonam

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

Overview

This is a summary of the European public assessment report (EPAR) for Cayston. 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 Cayston.

This EPAR was last updated on 06/07/2020

Authorisation details

Product details
Name
Cayston
Agency product number
EMEA/H/C/000996
Active substance
aztreonam lysine
International non-proprietary name (INN) or common name
aztreonam
Therapeutic area (MeSH)
  • Cystic Fibrosis
  • Respiratory Tract Infections
Anatomical therapeutic chemical (ATC) code
J01DF01
Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
21/09/2009
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

12/06/2020 Cayston - EMEA/H/C/000996 - N/0081

Contents

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

Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 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

How useful was this page?

Add your rating