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.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
N/AATC Code
J01XB01
ATC Item
colistin
Pharmacotherapeutic Group
Antibacterials for systemic use
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| Colistimethate sodium | N/A | Colistimethate |
EMA Name
Colobreathe
Medicine Name
Colobreathe
Aliases
N/ANo risk management plan link.
