Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: TOBI Podhaler   
Auth. number : EU/1/10/652
Active substance : Tobramycin
Orphan market exclusivity for "Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis" (based on designation EU/3/03/140) started on 25/07/2011
   10 years of market exclusivity
   2 additional years of market exclusivity as paediatric reward granted on 19/01/2015
   This orphan market exclusivity will expire on 25/07/2023
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: 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.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, 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 EMEA/H/C/2155 (2011)5394 cor of 24/08/2011
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 PSUSA - Modification EMEA/H/C/2155/PSUV/15 (2013)6314 of 24/09/2013
18/12/2013 Centralised - Variation EMEA/H/C/2155/II/19
Updated with Decision(2015)215 of 15/01/2015
23/01/2014 Centralised - Variation EMEA/H/C/2155/II/20
Updated with Decision(2015)215 of 15/01/2015
04/08/2014 Centralised - Variation EMEA/H/C/2155/IAin/24
Updated with Decision(2015)215 of 15/01/2015
20/11/2014 Centralised - Variation EMEA/H/C/2155/II/27
Updated with Decision(2015)215 of 15/01/2015
19/01/2015 Centralised - Yearly update (2015)215 of 15/01/2015
13/02/2015 Rectificative Decision (2015)876 of 11/02/2015
29/10/2015 Centralised - Variation EMEA/H/C/2155/II/30
Updated with Decision(2016)1144 of 18/02/2016
22/02/2016 Centralised - Renewal EMEA/H/C/2155/R/34 (2016)1144 of 18/02/2016