Colobreathe (colistimethate sodium)
- Region
- 🇪🇺 EU
- Active substance
- colistimethate sodium
- Company
- Essential Pharma Limited
- Status
- Authorised
- Therapeutic area
- Cystic Fibrosis
- EU approval
- Mon 13 Feb 2012
- Application
- EMEA/H/C/001225
- ATC
- J01XB01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.