The marketing authorisation for Vibativ has been withdrawn at the request of the marketing authorisation holder.
Vibativ : EPAR - Summary for the public (PDF/553.83 KB)
First published: 28/09/2011
Last updated: 16/05/2018
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Theravance Biopharma Ireland Umited
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Connaught House 1
08/09/2017 Vibativ - EMEA/H/C/001240 - IAIN/0031
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Antibacterials for systemic use
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 February 201217/02/2012
European Medicines Agency gives final recommendations for 12 centrally authorised medicines manufactured at Ben Venue Laboratories16/02/2012
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European Medicines Agency gives further interim recommendations on dealing with shortcomings in quality assurance at Ben Venue Laboratories09/12/2011
European Medicines Agency gives interim recommendations to deal with shortcomings in quality assurance at Ben Venue Laboratories22/11/2011