Bronchitol (mannitol)
- Region
- 🇪🇺 EU
- Active substance
- mannitol
- Company
- Pharmaxis Europe Limited
- Status
- Authorised
- Therapeutic area
- Cystic Fibrosis
- EU approval
- Fri 13 Apr 2012
- Application
- EMEA/H/C/001252
- ATC
- R05CB16
- Official record
- www.ema.europa.eu
Indication
Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.
Regulatory milestones
Fri 14 Nov 2025🇪🇺 EU shortage
Bronchitol: shortage ongoing
Inhalation powder; Alternatives available: Yes · source
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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.