Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Zydelig   
Auth. number : EU/1/14/938
Active substance : idelalisib
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX47 - Idelalisib
(See WHO ATC Index)
Indication: Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
• who have received at least one prior therapy, or
• as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.
Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
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
19/09/2014 Centralised - Authorisation EMEA/H/C/3843 (2014)6796 of 18/09/2014
26/03/2015 Centralised - Variation EMEA/H/C/3843/IG/251
Updated with Decision(2016)938 of 11/02/2016
26/03/2015 Centralised - Variation EMEA/H/C/3843/II/6
Updated with Decision(2016)938 of 11/02/2016
06/07/2015 Centralised - Variation EMEA/H/C/3843/IB/10
Updated with Decision(2016)938 of 11/02/2016
14/01/2016 Centralised - Variation EMEA/H/C/3843/IB/19/G
Updated with Decision(2016)938 of 11/02/2016
15/02/2016 Centralised - Yearly update (2016)938 of 11/02/2016
25/02/2016 Centralised - Variation EMEA/H/C/3843/II/17
Updated with Decision(2016)5959 of 15/09/2016
29/03/2016 Corrigendum (2016)1932 of 23/03/2016
30/03/2016 Referral EMEA/H/C/3843/A-20 (2016)1932 of 23/03/2016
28/04/2016 Centralised - Variation EMEA/H/C/3843/II/18
Updated with Decision(2016)5959 of 15/09/2016
19/09/2016 Referral : EMEA/H/A-20/1439/C/3843/0023 (2016)5959 of 15/09/2016
21/09/2016 Centralised - 2-Monthly update EMEA/H/C/3843/II/11 (2016)6081 of 19/09/2016
10/11/2016 Centralised - Variation EMEA/H/C/3843/II/25
16/11/2016 Centralised - Variation EMEA/H/C/3843/IB/30
30/01/2017 Centralised - Variation EMEA/H/C/3843/IB/31
31/07/2017 Centralised - Variation EMEA/H/C/3843/IB/36