This is a summary of the European public assessment report (EPAR) for Tobi Podhaler. 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 Tobi Podhaler.
Therapeutic Indication
### Therapeutic indication Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Therapeutic Area (MeSH)
ATC Code
J01GB01
ATC Item
tobramycin
Pharmacotherapeutic Group
Antibacterials for systemic use
Active Substance (Summary)
INN / Common Names
EMA Name
Tobi Podhaler
Medicine Name
Tobi Podhaler
Aliases
N/ANo risk management plan link.
