Tobi Podhaler

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tobramycin

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 13/05/2022

Authorisation details

Product details
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)
  • Cystic Fibrosis
  • Respiratory Tract Infections
Anatomical therapeutic chemical (ATC) code
J01GB01
OrphanOrphan

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
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
Baldoyle Industrial Estate
Dublin 13
Ireland

Product information

13/05/2022 Tobi Podhaler - EMEA/H/C/002155 - N/0052

Other EU languages available icon 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:

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.

Assessment history

Changes since initial authorisation of medicine

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