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The marketing authorisation for Vibativ has been withdrawn at the request of the marketing authorisation holder.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 |
Connaught House 1
Burlington Road Fourth Floor D04 C5Y6 Dublin 4 Ireland |
Product information
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.
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.