Vantobra

Withdrawn

This medicine's authorisation has been withdrawn

tobramycin

Overview

The marketing authorisation for Vantobra has been withdrawn at the request of the marketing authorisation holder.

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

Latest procedure affecting product information: N/0010

21/09/2017

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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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
• 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

AdoptedReference Number: EMA/86872/2015

CHMP summary of positive opinion for Vantobra

AdoptedReference Number: EMA/CHMP/780275/2014