Vibativ

Withdrawn

This medicine's authorisation has been withdrawn

telavancin

Overview

The marketing authorisation for Vibativ has been withdrawn at the request of the marketing authorisation holder.

Vibativ : EPAR - Summary for the public

Reference Number: EMA/425452/2011

Product information

Vibativ : EPAR - Product Information

Latest procedure affecting product information: IAIN/0031

08/09/2017

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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).

Vibativ : EPAR - All Authorised presentations

Vibativ : EPAR - Conditions imposed on member states for safe and effective use

Product details

• Name of medicine:
  Vibativ
• Active substance:
  telavancin
• International non-proprietary name (INN) or common name:
  telavancin
• Therapeutic area (MeSH):
  • Pneumonia, Bacterial
  • Cross Infection
• Anatomical therapeutic chemical (ATC) code:
  J01XA03

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Vibativ is indicated for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA).

Vibativ should be used only in situations where it is known or suspected that other alternatives are not suitable.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Authorisation details

• EMA product number:
  EMEA/H/C/001240
• Marketing authorisation holder:
  Theravance Biopharma Ireland Umited

  Connaught House 1; Burlington Road; Fourth Floor; D04 C5Y6; Dublin 4; Ireland

• Marketing authorisation issued:
  02/09/2011
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

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

Vibativ-H-C-1240-A20-01 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/303395/2012

Initial marketing authorisation documents

Vibativ : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Vibativ

AdoptedReference Number: EMA/CHMP/399709/2011