Vantobra
tobramycin
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.
Overview
The marketing authorisation for Vantobra has been withdrawn at the request of the marketing authorisation holder.
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List item
Vantobra : EPAR - Summary for the public (PDF/543.33 KB)
First published: 19/03/2015
Last updated: 29/03/2019
EMA/169512/2015 -
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List item
Vantobra : EPAR - Risk-management-plan summary (PDF/578.05 KB)
First published: 19/03/2015
Last updated: 29/03/2019
EMA/169513/2015
This EPAR was last updated on 29/03/2019
Authorisation details
Product details | |
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Name |
Vantobra
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Agency product number |
EMEA/H/C/002633
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Active substance |
Tobramycin
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International non-proprietary name (INN) or common name |
tobramycin
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
J01GB01
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Publication details | |
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Marketing-authorisation holder |
Pari Pharma GmbH
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Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
18/03/2015
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Contact address |
Product information
21/09/2017 Vantobra - EMEA/H/C/002633 - N/0010
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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
Pharmacotherapeutic group
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Antibacterials for systemic use
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Aminoglycoside antibacterials
Therapeutic indication
Therapeutic 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.