Vantobra

Withdrawn

This medicine's authorisation has been withdrawn

tobramycin

Overview

On 18 February 2019, the European Commission withdrew the marketing authorisation for Vantobra (tobramycin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, PARI Pharma GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Vantobra was granted marketing authorisation in the EU on 18 March 2015 for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis. The marketing authorisation was initially valid for a 5-year period. Vantobra is an identical product to Tobramycin PARI, which is authorised in the EU for the same condition. 

The European Public Assessment Report (EPAR) for Vantobra is updated to reflect the fact that the marketing authorisation is no longer valid.

Vantobra : EPAR - Summary for the public

Reference Number: EMA/169512/2015

Vantobra : EPAR - Risk-management-plan summary

Reference Number: EMA/169513/2015

Product information

Vantobra : EPAR - Product Information

Vantobra : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Vantobra
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002633
• Marketing authorisation holder:
  Pari Pharma GmbH

  Moosstrasse 3; 82319 Starnberg; Germany

• Marketing authorisation issued:
  18/03/2015
• Withdrawal of marketing authorisation:
  18/02/2019
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Vantobra : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Vantobra : EPAR - Public assessment report

Adopted Reference Number: EMA/86872/2015

CHMP summary of positive opinion for Vantobra

Adopted Reference Number: EMA/CHMP/780275/2014