Vibativ
Withdrawn
This medicine's authorisation has been withdrawn
telavancin
MedicineHumanWithdrawn
- 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The marketing authorisation for Vibativ has been withdrawn at the request of the marketing authorisation holder.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)
First published: Last updated:
български (BG) (634.53 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
español (ES) (549.37 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
čeština (CS) (617.26 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
dansk (DA) (547.17 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Deutsch (DE) (552 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
eesti keel (ET) (546.46 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
ελληνικά (EL) (639.48 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
français (FR) (550.8 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
hrvatski (HR) (1.06 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
italiano (IT) (548.98 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
latviešu valoda (LV) (616.63 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
lietuvių kalba (LT) (577.48 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
magyar (HU) (610.46 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Malti (MT) (620.67 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Nederlands (NL) (547.6 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
polski (PL) (615.07 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
português (PT) (549.16 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
română (RO) (576.09 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
slovenčina (SK) (617.05 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
slovenščina (SL) (568.91 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Suomi (FI) (547.15 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
svenska (SV) (548.33 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Product information
Vibativ : EPAR - Product Information
English (EN) (989.46 KB - PDF)
First published: Last updated:
български (BG) (1.66 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
español (ES) (972.49 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
čeština (CS) (1.37 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
dansk (DA) (998.7 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Deutsch (DE) (1012.89 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
eesti keel (ET) (990.29 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
ελληνικά (EL) (1.7 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
français (FR) (1.03 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
hrvatski (HR) (1014.8 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
íslenska (IS) (985.54 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
italiano (IT) (1.03 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
latviešu valoda (LV) (1.41 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
lietuvių kalba (LT) (1023.66 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
magyar (HU) (1.37 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Malti (MT) (1.44 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Nederlands (NL) (1016.54 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
norsk (NO) (343.48 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
polski (PL) (1.45 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
português (PT) (1004.82 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
română (RO) (1.06 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
slovenčina (SK) (1.39 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
slovenščina (SL) (1.39 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Suomi (FI) (983.01 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
svenska (SV) (1002.26 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
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
English (EN) (469.33 KB - PDF)
First published: Last updated:
български (BG) (529.08 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
español (ES) (485.69 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
čeština (CS) (529.3 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
dansk (DA) (485.73 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Deutsch (DE) (484.5 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
eesti keel (ET) (485.88 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
ελληνικά (EL) (528.76 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
français (FR) (484.57 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
hrvatski (HR) (492.6 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
íslenska (IS) (484.25 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
italiano (IT) (503.04 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
latviešu valoda (LV) (526.53 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
lietuvių kalba (LT) (502.59 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
magyar (HU) (508.09 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Malti (MT) (522.89 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Nederlands (NL) (485.68 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
norsk (NO) (469.96 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
polski (PL) (523.08 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
português (PT) (485.04 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
română (RO) (509.16 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
slovenčina (SK) (540.33 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
slovenščina (SL) (507.44 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Suomi (FI) (488.95 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
svenska (SV) (485.59 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Vibativ : EPAR - Conditions imposed on member states for safe and effective use
English (EN) (618.72 KB - PDF)
First published: Last updated:
български (BG) (700.28 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
español (ES) (613.31 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
čeština (CS) (1.19 MB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
dansk (DA) (614.54 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Deutsch (DE) (617.65 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
eesti keel (ET) (617.52 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
ελληνικά (EL) (697.34 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
français (FR) (618.22 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
italiano (IT) (619.69 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
latviešu valoda (LV) (660.48 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
lietuvių kalba (LT) (634.24 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
magyar (HU) (647.41 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Malti (MT) (768.5 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Nederlands (NL) (613.46 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
polski (PL) (699.38 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
português (PT) (625.07 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
română (RO) (643.04 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
slovenčina (SK) (679.65 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
slovenščina (SL) (744.22 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
Suomi (FI) (606.41 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
svenska (SV) (612 KB - PDF)
First published: 28/09/2011Last updated: 16/05/2018
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 useTherapeutic 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)
First published: Last updated:
Vibativ-H-C-1240-A20-01 : EPAR - Assessment Report - Article 20
AdoptedReference Number: EMA/303395/2012
English (EN) (750.45 KB - PDF)
First published: Last updated:
News on Vibativ
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)
First published: Last updated:
Final recommendations on 12 centrally authorised medicines manufactured at Ben Venue Laboratories
Reference Number: EMA/106872/2012
English (EN) (188.14 KB - PDF)
First published: Last updated:
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:
More information on Vibativ
This page was last updated on