This is a summary of the European public assessment report (EPAR) for Bronchitol. 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 Bronchitol.
Therapeutic Indication
### Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
R05CB16
ATC Item
mannitol
Pharmacotherapeutic Group
Cough and cold preparations
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| mannitol | N/A | 甘露醇 |
EMA Name
Bronchitol
Medicine Name
Bronchitol
Aliases
N/ANo risk management plan link.