Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Vantobra   
Auth. number : EU/1/14/932
Active substance : TOBRAMYCIN
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: Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Authorisation Holder: PARI Pharma GmbH
Moosstraße 3, 82319 Starnberg, Deutschland
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
20/03/2015 Centralised - Authorisation EMEA/H/C/2633 (2015)1977 of 18/03/2015
24/09/2015 Centralised - Variation EMEA/H/C/2633/II/1
Updated with Decision(2016)6432 of 30/09/2016
04/10/2016 Centralised - Yearly update (2016)6432 of 30/09/2016
24/10/2016 Centralised - Notification EMEA/H/C/2633/N/6
21/09/2017 Centralised - Notification EMEA/H/C/2633/N/10