Cayston
aztreonam
Table of contents
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.
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List item
Cayston : EPAR - Summary for the public (PDF/63.96 KB)
First published: 19/10/2009
Last updated: 13/09/2012 -
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List item
Cayston : EPAR - Risk-management-plan summary (PDF/73.42 KB)
First published: 04/06/2019
Authorisation details
Product details | |
---|---|
Name |
Cayston
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Agency product number |
EMEA/H/C/000996
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Active substance |
aztreonam lysine
|
International non-proprietary name (INN) or common name |
aztreonam
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J01DF01
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Publication details | |
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Marketing-authorisation holder |
Gilead Sciences Ireland UC
|
Revision |
20
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Date of issue of marketing authorisation valid throughout the European Union |
21/09/2009
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Contact address |
IDA Business & Technology Park |
Product information
27/02/2023 Cayston - EMEA/H/C/000996 - IB/0093
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.