Vantobra

RSS

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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Vantobra has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 29/03/2019

Authorisation details

Product details
Name
Vantobra
Agency product number
EMEA/H/C/002633
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
Publication details
Marketing-authorisation holder
Pari Pharma GmbH
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
18/03/2015
Contact address

Moosstrasse 3
82319 Starnberg
Germany

Product information

21/09/2017 Vantobra - EMEA/H/C/002633 - N/0010

Contents

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Pharmacotherapeutic group

  • Antibacterials for systemic use

  • AMINOGLYCOSIDE ANTIBACTERIALS

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.

Assessment history

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

More information on Vantobra

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 27 February 2009. Vantobra was withdrawn from the Community register of orphan medicinal products in June 2014 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

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