Cayston

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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 03/03/2023

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
20
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

27/02/2023 Cayston - EMEA/H/C/000996 - IB/0093

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

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