Tobi Podhaler

RSS

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 04/09/2018

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
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
Marketing-authorisation holder
Novartis Europharm Limited
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
20/07/2011
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

23/04/2018 Tobi Podhaler - EMEA/H/C/002155 - T/0036

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

How useful was this page?

Add your rating