Vibativ

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telavancin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Vibativ has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 16/05/2018

Authorisation details

Product details
Name
Vibativ
Agency product number
EMEA/H/C/001240
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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Theravance Biopharma Ireland Umited
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
02/09/2011
Contact address
Connaught House 1
Burlington Road
Fourth Floor
D04 C5Y6
Dublin 4
Ireland

Product information

08/09/2017 Vibativ - EMEA/H/C/001240 - IAIN/0031

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

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.

Assessment history

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