- Current languageen
Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/14/938|
|ATC:||Anatomical main group: L - Antineoplastic and immunomodulating agents|
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
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 unsuitable for chemo-immunotherapy.
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|
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.
|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|