Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: TOBI Podhaler   
Auth. number : EU/1/10/652
INN : Tobramycin
Orphan status based on designation EU/3/03/140 added on 25/07/2011
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J01 - Antibacterials for systemic use
Pharmacological subgroup: J01G - Aminoglycoside antibacterials
Chemical subgroup: J01GB - Other aminoglycosides
Chemical substance: J01GB01 - Tobramycin
(See WHO ATC Index)
Indication: 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.
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.


European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/07/2011 Centralised - Authorisation EMEA/H/C/2155 (2011)5394 of 20/07/2011
26/08/2011 Corrigendum
10/10/2011 Centralised - Variation EMEA/H/C/2155/IA/109/G
Updated with Decision(2012)3298 of 14/05/2012
16/05/2012 Centralised - Variation (2012)3298 of 14/05/2012
18/01/2013 Centralised - Variation EMEA/H/C/2155/IAin/12
Updated with Decision(2013)6314 of 24/09/2013
26/09/2013 Centralised - Modification EMEA/H/C/2155/PSUV/15 (2013)6314 of 24/09/2013
18/12/2013 Centralised - Variation EMEA/H/C/2155/II/19
23/01/2014 Centralised - Variation EMEA/H/C/2155/II/20
04/08/2014 Centralised - Variation EMEA/H/C/2155/IAin/24