Vibativ
telavancin
Table of contents
Overview
The marketing authorisation for Vibativ has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Vibativ
|
| Agency product number |
EMEA/H/C/001240
|
| Active substance |
telavancin
|
| International non-proprietary name (INN) or common name |
telavancin
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
J01XA03
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Theravance Biopharma Ireland Umited
|
| Revision |
10
|
| Date of issue of marketing authorisation valid throughout the European Union |
02/09/2011
|
| Contact address | |
Product information
08/09/2017 Vibativ - EMEA/H/C/001240 - IAIN/0031
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
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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.