Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sirturo   
Auth. number : EU/1/13/901
Active substance : bedaquiline
Orphan market exclusivity for "Treatment of tuberculosis" (based on designation EU/3/05/314) started on 7/03/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 7/03/2024
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J04 - Antimycobacterials
Pharmacological subgroup: J04A - Drugs for treatment of tuberculosis
Chemical subgroup: J04AK - Other drugs for treatment of tuberculosis
Chemical substance: J04AK05 - simvastatin and fenofibrate
(See WHO ATC Index)
Indication: SIRTURO is indicated for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis (MDR TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
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
7/03/2014 Centralised - Authorisation EMEA/H/C/2614 (2014)1616 of 5/03/2014
27/03/2014 Centralised - Notification EMEA/H/C/2614/N/1
Updated with Decision(2015)282 of 19/01/2015
20/11/2014 Centralised - Variation EMEA/H/C/2614/II/4/G
Updated with Decision(2015)282 of 19/01/2015
18/12/2014 Centralised - Variation EMEA/H/C/2614/II/2/G
Updated with Decision(2016)70 of 07/01/2016
21/01/2015 Centralised - Annual renewal EMEA/H/C/2614/R/3 (2015)282 of 19/01/2015
30/04/2015 Centralised - Variation EMEA/H/C/2614/IB/7/G
Updated with Decision(2016)70 of 07/01/2016
22/10/2015 Centralised - Variation EMEA/H/C/2614/II/8/G
Updated with Decision(2016)70 of 07/01/2016
7/01/2016 Centralised - Variation EMEA/H/C/2614/IB/13
Updated with Decision(2016)9018 of 23/12/2016
11/01/2016 Centralised - Annual renewal EMEA/H/C/2614/R/10 (2016)70 of 7/01/2016
19/02/2016 Centralised - Variation EMEA/H/C/2614/IB/14
Updated with Decision(2016)9018 of 23/12/2016
22/04/2016 Centralised - Notification EMEA/H/C/2614/N/15
Updated with Decision(2016)9018 of 23/12/2016
9/11/2016 Centralised - Variation EMEA/H/C/2614/IB/18
Updated with Decision(2016)9018 of 23/12/2016
4/01/2017 Centralised - Annual renewal EMEA/H/C/2614/R/17 (2016)9018 of 23/12/2016
21/06/2017 PSUSA - Modification EMEA/H/C/PSUSA/10074/201609 (2017)4315 of 16/06/2017
29/06/2017 Centralised - Variation EMEA/H/C/2614/II/21
Updated with Decision(2018)1472 of 05/03/2018
7/03/2018 Centralised - Annual renewal EMEA/H/C/2614/R/24 (2018)1472 of 5/03/2018
12/10/2018 Centralised - Notification EMEA/H/C/2614/N/32
Updated with Decision(2019)204 of 11/01/2019
15/01/2019 Centralised - Annual renewal EMEA/H/C/2614/R/31 (2019)204 of 11/01/2019
14/02/2019 Centralised - Variation EMEA/H/C/2614/II/28