Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: OLYSIO   
Auth. number : EU/1/14/924
Active substance : simeprevir
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AE - Protease inhibitors
Chemical substance: J05AE14 - Simeprevir
(See WHO ATC Index)
Indication: OLYSIO is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.
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 Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
16/05/2014 Centralised - Authorisation EMEA/H/C/2777 (2014)3368 of 14/05/2014
18/12/2014 Centralised - Variation EMEA/H/C/2777/II/1
Updated with Decision(2015)5965 of 20/08/2015
22/01/2015 Centralised - Variation EMEA/H/C/2777/II/2
Updated with Decision(2015)5965 of 20/08/2015
26/02/2015 Centralised - Variation EMEA/H/C/2777/II/3
Updated with Decision(2015)5965 of 20/08/2015
25/06/2015 Centralised - Variation EMEA/H/C/2777/II/7/G
Updated with Decision(2015)5965 of 20/08/2015
25/06/2015 Centralised - Variation EMEA/H/C/2777/II/12
Updated with Decision(2015)5965 of 20/08/2015
23/07/2015 Centralised - Variation EMEA/H/C/2777/II/8
Updated with Decision(2016)4243 of 30/06/2016
23/07/2015 Centralised - Variation EMEA/H/C/2777/II/11
Updated with Decision(2016)4243 of 30/06/2016
24/08/2015 PSUSA - Modification EMEA/H/C/PSUSA/10255/201411 (2015)5965 of 20/08/2015
28/01/2016 Centralised - Variation EMEA/H/C/2777/II/17
Updated with Decision(2016)4243 of 30/06/2016
04/07/2016 Centralised - 2-Monthly update EMEA/H/C/2777/II/15 (2016)4243 of 30/06/2016
22/08/2016 PSUSA - Modification EMEA/H/C/PSUSA/10255/201511 (2016)5444 of 18/08/2016
19/10/2016 Centralised - Variation EMEA/H/C/2777/IB/25/G
Updated with Decision(2017)1402 of 23/02/2017
09/12/2016 Centralised - Variation EMEA/H/C/2777/IB/28
Updated with Decision(2017)1402 of 23/02/2017
09/12/2016 Centralised - Notification EMEA/H/C/2777/N/26
Updated with Decision(2017)1402 of 23/02/2017
19/01/2017 Centralised - Variation EMEA/H/C/2777/II/27/G
27/02/2017 Referral EMEA/H/A-20/1438/C/2777/19 (2017)1402 of 23/02/2017
24/03/2017 Centralised - Notification EMEA/H/C/2777/N/32
20/07/2017 Centralised - Variation EMEA/H/C/2777/II/31