Detailed SMPC and OD register data for: Bronchitol
Data as extracted from Orphan Designation Register
Product (OD)
Bronchitol
PL number (OD)
PLGB 27944/0002
OD Designation ID (OD)
OD1
Active substance (OD)
Mannitolum
Data as extracted from SMPC. (PS: More information at bottom of the page)
Product (SMPC)
PL Number (SMPC)
Composition/ Active Substance (SMPC)
Dose form (SMPC)
Marketing Authorisation holder details (SMPC)
AI match to EMA Substance Dictionary
We analysed the SMPC composition text and searched for the closest equivalent in EMA's published substance dictionary. The suggested match and supporting details are shown below.
SMPC composition / active substance
Matched EMA substance
EMA SMS ID
Confidence
Higher confidence means the match is more likely to be correct.
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Further information for:
Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.
OD Indication (OD)
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.
Full Designation Number(OD)
PLGB 27944/0002/OD1
Orphan Condition(OD)
Cystic fibrosis
All Indications (SMPC)
All Contraindications (SMPC)
Warnings/Precautions (SMPC)
Interactions (SMPC)
Pregnancy/Lactation (SMPC)
Driving/Machines (SMPC)
Undesirable effects (SMPC)
Overdose (SMPC)
Shelf life (SMPC)
Storage (SMPC)
Container description (SMPC)
Handling/Disposal (SMPC)
SMPC_URL