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.
Tobi Podhaler : EPAR - Summary for the public (PDF/79.81 KB)
First published: 25/08/2011
Last updated: 22/03/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Mylan IRE Healthcare Limited
|Date of issue of marketing authorisation valid throughout the European Union||
14/08/2019 Tobi Podhaler - EMEA/H/C/002155 - IAIN/0042
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Antibacterials for systemic use
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.