Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Vibativ   
Auth. number : EU/1/11/705
Active substance : telavancin
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J01 - Antibacterials for systemic use
Pharmacological subgroup: J01X - Other antibacterials
Chemical subgroup: J01XA - Glycopeptide antibacterials
Chemical substance: J01XA03 - Telavancin
(See WHO ATC Index)
Indication: VIBATIV is indicated for the treatment of adults with nosocomial pneumonia (NP) 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.
Marketing Authorisation Holder: Theravance Biopharma Ireland Limited
Fitzwilliam Hall, Fitzwilliam Place, Dublin 2, Ireland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
06/09/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1240 (2011)6340 of 02/09/2011
06/09/2011 Centralised - Authorisation EMEA/H/C/1240 (2011)6341 of 02/09/2011
19/04/2012 Centralised - Variation EMEA/H/C/1240/II/2
Updated with Decision(2013)797 of 08/02/2013
30/05/2012 Referral EMEA/H/C/1240/A-20 (2012)3561 of 25/05/2012
12/02/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1240/T/4 (2013)797 of 08/02/2013
08/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1240/T/4 (2013)2782 of 06/05/2013
05/09/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1240/T/5 (2013)5757 of 03/09/2013
14/03/2014 Centralised - 2-Monthly update EMEA/H/C/1240/II/6 (2014)1732 of 12/03/2014
25/09/2014 Centralised - Variation EMEA/H/C/1240/II/15
Updated with Decision(2015)6819 of 30/09/2015
02/10/2015 Centralised - Yearly update (2015)6819 of 30/09/2015
02/03/2016 Centralised - 2-Monthly update EMEA/H/C/1240/II/23 (2016)1332 of 26/02/2016
28/05/2016 Centralised - Renewal EMEA/H/C/1240/R/25 (2016)3273 of 26/05/2016
07/11/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1240/T/27 (2016)7186 of 03/11/2016
08/09/2017 Centralised - Variation EMEA/H/C/1240/IAin/31