Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Zydelig 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Orange, oval-shaped, film-coated tablet of dimensions 9.7 mm by 6.0 mm, debossed on one side with “GSI” and “100” on the other side. |
Each film-coated tablet contains 100 mg of idelalisib.
Excipient with known effect: Each tablet contains 0.1 mg sunset yellow FCF (E110) (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Idelalisib |
Idelalisib inhibits phosphatidylinositol 3-kinase p110δ (PI3Kδ), which is hyperactive in B-cell malignancies and is central to multiple signalling pathways that drive proliferation, survival, homing, and retention of malignant cells in lymphoid tissues and bone marrow. Idelalisib induces apoptosis and inhibits proliferation in cell lines derived from malignant B-cells and in primary tumour cells. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film-coating: Polyvinyl alcohol (E1203) |
High density polyethylene (HDPE) bottle, capped with a polypropylene child-resistant closure, containing 60 film-coated tablets and a polyester coil.
Each carton contains 1 bottle.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/14/938/001
Date of first authorisation: 18 September 2014
Date of latest renewal: 30 April 2019
| Drug | Countries | |
|---|---|---|
| ZYDELIG | Austria, Australia, Canada, Cyprus, Estonia, Spain, France, Ireland, Lithuania, Netherlands, New Zealand, Poland, United Kingdom, United States |
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