Vibativ

telavancin

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The marketing authorisation for Vibativ has been suspended at the recommendation of the Agency’s Committee for Medicinal Products for Human Use (CHMP).

Name Language First published Last updated
Vibativ : EPAR - Summary for the public BG = bălgarski 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public ES = español 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public CS = čeština 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public DA = dansk 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public DE = Deutsch 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public ET = eesti keel 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public EL = elliniká 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public EN = English 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public FR = français 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public IT = italiano 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public LV = latviešu valoda 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public LT = lietuvių kalba 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public HU = magyar 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public MT = Malti 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public NL = Nederlands 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public PL = polski 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public PT = português 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public RO = română 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public SK = slovenčina 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public SL = slovenščina 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public FI = suomi 29/09/2011 22/08/2012
Vibativ : EPAR - Summary for the public SV = svenska 29/09/2011 22/08/2012

This EPAR was last updated on 18/04/2013 .

More detail is available in the summary of product characteristics

Authorisation details

Product details

Product details for Vibativ
NameVibativ
Agency product numberEMEA/H/C/001240
Active substance

telavancin

International non-proprietary name (INN) or common name

telavancin

Therapeutic area Cross InfectionPneumonia, Bacterial
Anatomical therapeutic chemical (ATC) code J01XA03

Publication details

Publication details for Vibativ
Marketing-authorisation holder

Theravance UK Limited

Revision2
Date of issue of marketing authorisation valid throughout the European Union02/09/2011

Contact address:

Theravance UK Limited
90 Fetter Lane
London
EC4A 1EQ
United Kingdom

Product information

Product information

08/02/2013  Vibativ -EMEA/H/C/001240 -T/0004

Name Language First published Last updated
Vibativ : EPAR - Product Information BG = bălgarski 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information ES = español 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information CS = čeština 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information DA = dansk 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information DE = Deutsch 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information ET = eesti keel 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information EL = elliniká 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information EN = English 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information FR = français 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information IT = italiano 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information LV = latviešu valoda 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information LT = lietuvių kalba 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information HU = magyar 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information MT = Malti 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information NL = Nederlands 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information PL = polski 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information PT = português 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information RO = română 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information SK = slovenčina 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information SL = slovenščina 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information FI = suomi 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information SV = svenska 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information IS = Islenska 29/09/2011 18/04/2013
Vibativ : EPAR - Product Information NO = Norsk 29/09/2011 18/04/2013

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.

Name Language First published Last updated
Vibativ : EPAR - All Authorised presentations BG = bălgarski 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations ES = español 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations CS = čeština 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations DA = dansk 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations DE = Deutsch 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations ET = eesti keel 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations EL = elliniká 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations EN = English 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations FR = français 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations IT = italiano 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations LV = latviešu valoda 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations LT = lietuvių kalba 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations HU = magyar 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations MT = Malti 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations NL = Nederlands 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations PL = polski 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations PT = português 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations RO = română 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations SK = slovenčina 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations SL = slovenščina 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations FI = suomi 29/09/2011 22/08/2012
Vibativ : EPAR - All Authorised presentations SV = svenska 29/09/2011 22/08/2012
Name Language First published Last updated
Vibativ : EPAR - Conditions imposed on member states for safe and effective use BG = bălgarski 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use ES = español 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use CS = čeština 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use DA = dansk 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use DE = Deutsch 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use ET = eesti keel 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use EL = elliniká 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use EN = English 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use FR = français 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use IT = italiano 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use LV = latviešu valoda 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use LT = lietuvių kalba 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HU = magyar 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use MT = Malti 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use NL = Nederlands 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use PL = polski 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use PT = português 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use RO = română 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SK = slovenčina 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SL = slovenščina 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use FI = suomi 29/09/2011 22/08/2012
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 29/09/2011 22/08/2012

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 (see sections 4.3, 4.4, 4.8 and 5.1).

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

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Vibativ : EPAR - Procedural steps taken and scientific information after authorisation (English only) 22/08/2012 18/04/2013
Vibativ-H-C-1240-A20-01 : EPAR - Assessment Report - Article 20 (English only) 22/08/2012  

Initial marketing-authorisation documents

Name Language First published Last updated
Vibativ : EPAR - Public assessment report (English only) 29/09/2011 22/08/2012
CHMP summary of positive opinion for Vibativ (English only) 20/05/2011 22/08/2012

Suspended

This medicine is currently suspended for use in the European Union

Patient safety


More information on Vibativ