Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sovaldi   
Auth. number : EU/1/13/894
Active substance : sofosbuvir
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: J05AX - Other antivirals
Chemical substance: J05AX15 - Sofosbuvir
(See WHO ATC Index)
Indication: Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
Marketing Authorisation Holder: Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom
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
17/01/2014 Centralised - Authorisation EMEA/H/C/2798 (2014)319 of 16/01/2014
26/06/2014 Centralised - Variation EMEA/H/C/2798/II/2/G
Updated with Decision(2015)3661 of 27/05/2015
20/11/2014 Centralised - Variation EMEA/H/C/2798/II/6
Updated with Decision(2015)3661 of 27/05/2015
25/02/2015 Centralised - Variation EMEA/H/C/2798/IA/13
Updated with Decision(2015)3661 of 27/05/2015
26/02/2015 Centralised - Variation EMEA/H/C/2798/IG/521
Updated with Decision(2015)3661 of 27/05/2015
29/05/2015 Centralised - Yearly update (2015)3661 of 27/05/2015
22/06/2015 Centralised - Variation EMEA/H/C/2798/IB/19
Updated with Decision(2016)637 of 28/01/2016
14/08/2015 Centralised - Variation EMEA/H/C/2798/IB/21
Updated with Decision(2016)637 of 28/01/2016
22/10/2015 Centralised - Variation EMEA/H/C/2798/II/15
Updated with Decision(2016)637 of 28/01/2016
05/02/2016 Centralised - 2-Monthly update EMEA/H/C/2798/II/18 (2016)637 of 28/01/2016