Tobi Podhaler
tobramycin
Table of contents
Overview
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.
Authorisation details
Product details | |
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Name |
Tobi Podhaler
|
Agency product number |
EMEA/H/C/002155
|
Active substance |
Tobramycin
|
International non-proprietary name (INN) or common name |
tobramycin
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J01GB01
|
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Mylan Ireland Limited
|
Revision |
19
|
Date of issue of marketing authorisation valid throughout the European Union |
20/07/2011
|
Contact address |
Unit 35/36 Grange Parade |
Product information
13/05/2022 Tobi Podhaler - EMEA/H/C/002155 - N/0052
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antibacterials for systemic use
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.