Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sivextro   
Auth. number : EU/1/15/991
Active substance : tedizolid phosphate
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J01 - Antibacterials for systemic use
Pharmacological subgroup: J01X - Other antibacterials
Chemical subgroup: J01XX - Other antibacterials
Chemical substance: J01XX11 - tedizolid
(See WHO ATC Index)
Indication: Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Authorisation Holder: Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland
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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/03/2015 Centralised - Authorisation EMEA/H/C/2846 (2015)2115 of 23/03/2015
13/05/2015 Centralised - Variation EMEA/H/C/2846/IAIN/1
Updated with Decision(2016)144 of 11/01/2016
21/10/2015 Centralised - Variation EMEA/H/C/2846/IB/4/G
Updated with Decision(2016)144 of 11/01/2016
13/01/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2846/T/7 (2016)144 of 11/01/2016
22/07/2016 Centralised - Variation EMEA/H/C/2846/IA/13
Updated with Decision(2017)4307 of 16/06/2017
26/10/2016 Centralised - Variation EMEA/H/C/2846/IA/16
Updated with Decision(2017)4307 of 16/06/2017
10/11/2016 Centralised - Variation EMEA/H/C/2846/II/9
Updated with Decision(2017)4307 of 16/06/2017
21/03/2017 Centralised - Variation EMEA/H/C/2846/IA/18
Updated with Decision(2017)4307 of 16/06/2017
20/06/2017 Centralised - Yearly update (2017)4307 of 16/06/2017
30/11/2017 Centralised - Variation EMEA/H/C/2846/II/19
Updated with Decision(2018)5522 of 08/08/2018
28/05/2018 Centralised - Variation EMEA/H/C/2846/IB/26
Updated with Decision(2018)5522 of 08/08/2018
10/08/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2846/T/28 (2018)5522 of 8/08/2018
11/10/2018 Centralised - Variation EMEA/H/C/2846/IAIN/30/G