Vibativ

RSS
Withdrawn

This medicine's authorisation has been withdrawn

telavancin
Medicine Human Withdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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The marketing authorisation for Vibativ has been withdrawn at the request of the marketing authorisation holder.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

English (EN) (553.83 KB - PDF)

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български (BG) (634.53 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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español (ES) (549.37 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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čeština (CS) (617.26 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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dansk (DA) (547.17 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Deutsch (DE) (552 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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eesti keel (ET) (546.46 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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ελληνικά (EL) (639.48 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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français (FR) (550.8 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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hrvatski (HR) (1.06 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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italiano (IT) (548.98 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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latviešu valoda (LV) (616.63 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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lietuvių kalba (LT) (577.48 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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magyar (HU) (610.46 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Malti (MT) (620.67 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Nederlands (NL) (547.6 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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polski (PL) (615.07 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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português (PT) (549.16 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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română (RO) (576.09 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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slovenčina (SK) (617.05 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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slovenščina (SL) (568.91 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Suomi (FI) (547.15 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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svenska (SV) (548.33 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Product information

Vibativ : EPAR - Product Information

English (EN) (989.46 KB - PDF)

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български (BG) (1.66 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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español (ES) (972.49 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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čeština (CS) (1.37 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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dansk (DA) (998.7 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Deutsch (DE) (1012.89 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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eesti keel (ET) (990.29 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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ελληνικά (EL) (1.7 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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français (FR) (1.03 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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hrvatski (HR) (1014.8 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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íslenska (IS) (985.54 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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italiano (IT) (1.03 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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latviešu valoda (LV) (1.41 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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lietuvių kalba (LT) (1023.66 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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magyar (HU) (1.37 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Malti (MT) (1.44 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Nederlands (NL) (1016.54 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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norsk (NO) (343.48 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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polski (PL) (1.45 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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português (PT) (1004.82 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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română (RO) (1.06 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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slovenčina (SK) (1.39 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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slovenščina (SL) (1.39 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Suomi (FI) (983.01 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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svenska (SV) (1002.26 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Latest procedure affecting product information:IAIN/0031
08/09/2017
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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

English (EN) (469.33 KB - PDF)

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български (BG) (529.08 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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español (ES) (485.69 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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čeština (CS) (529.3 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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dansk (DA) (485.73 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Deutsch (DE) (484.5 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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eesti keel (ET) (485.88 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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ελληνικά (EL) (528.76 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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français (FR) (484.57 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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hrvatski (HR) (492.6 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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íslenska (IS) (484.25 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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italiano (IT) (503.04 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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latviešu valoda (LV) (526.53 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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lietuvių kalba (LT) (502.59 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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magyar (HU) (508.09 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Malti (MT) (522.89 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Nederlands (NL) (485.68 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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norsk (NO) (469.96 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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polski (PL) (523.08 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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português (PT) (485.04 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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română (RO) (509.16 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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slovenčina (SK) (540.33 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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slovenščina (SL) (507.44 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Suomi (FI) (488.95 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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svenska (SV) (485.59 KB - PDF)

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

English (EN) (618.72 KB - PDF)

First published: Last updated:
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български (BG) (700.28 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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español (ES) (613.31 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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čeština (CS) (1.19 MB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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dansk (DA) (614.54 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Deutsch (DE) (617.65 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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eesti keel (ET) (617.52 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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ελληνικά (EL) (697.34 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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français (FR) (618.22 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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italiano (IT) (619.69 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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latviešu valoda (LV) (660.48 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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lietuvių kalba (LT) (634.24 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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magyar (HU) (647.41 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Malti (MT) (768.5 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Nederlands (NL) (613.46 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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polski (PL) (699.38 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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português (PT) (625.07 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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română (RO) (643.04 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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slovenčina (SK) (679.65 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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slovenščina (SL) (744.22 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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Suomi (FI) (606.41 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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svenska (SV) (612 KB - PDF)

First published: 28/09/2011 Last updated: 16/05/2018
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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

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

English (EN) (621.87 KB - PDF)

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

Adopted Reference Number: EMA/303395/2012

English (EN) (750.45 KB - PDF)

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Vibativ : EPAR - Public assessment report

Adopted

English (EN) (3.42 MB - PDF)

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CHMP summary of positive opinion for Vibativ

Adopted Reference Number: EMA/CHMP/399709/2011

English (EN) (649.04 KB - PDF)

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More information on Vibativ

Public statement on Vibativ: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/198910/2018

English (EN) (65.8 KB - PDF)

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Final recommendations on 12 centrally authorised medicines manufactured at Ben Venue Laboratories

Reference Number: EMA/106872/2012

English (EN) (188.14 KB - PDF)

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Questions and answers on shortcomings in quality assurance at Ben Venue Laboratories

Reference Number: EMA/946321/2011

English (EN) (71.91 KB - PDF)

First published: Last updated:
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