Vibativ

telavancin

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The marketing authorisation for Vibativ has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Vibativ : EPAR - Summary for the public BG = bălgarski 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public ES = español 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public CS = čeština 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public DA = dansk 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public DE = Deutsch 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public ET = eesti keel 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public EL = elliniká 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public EN = English 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public FR = français 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public IT = italiano 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public LV = latviešu valoda 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public LT = lietuvių kalba 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public HU = magyar 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public MT = Malti 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public NL = Nederlands 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public PL = polski 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public PT = português 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public RO = română 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public SK = slovenčina 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public SL = slovenščina 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public FI = suomi 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public SV = svenska 2011-09-28 2018-05-16
Vibativ : EPAR - Summary for the public HR = Hrvatski 2011-09-28 2018-05-16

This EPAR was last updated on 16/05/2018 .

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
Additional monitoring

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

Publication details

Publication details for Vibativ
Marketing-authorisation holder

Theravance Biopharma Ireland Umited

Revision10
Date of issue of marketing authorisation valid throughout the European Union02/09/2011

Contact address:

Theravance Biopharma Ireland Umited
Connaught House 1
Burlington Road
Fourth Floor
D04 C5Y6
Dublin 4
Ireland

Product information

Product information

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

Name Language First published Last updated
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Product Information HR = Hrvatski 2011-09-28 2018-05-16

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 HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - All Authorised presentations HR = Hrvatski 2011-09-28 2018-05-16

Name Language First published Last updated
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16
Vibativ : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-09-28 2018-05-16

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Vibativ : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2012-08-21 2018-05-16
Vibativ-H-C-1240-A20-01 : EPAR - Assessment Report - Article 20 HR = Hrvatski 2012-08-21 2018-05-16

Initial marketing-authorisation documents

Name Language First published Last updated
Vibativ : EPAR - Public assessment report HR = Hrvatski 2011-09-28 2018-05-16
CHMP summary of positive opinion for Vibativ HR = Hrvatski 2011-05-19 2018-05-16