Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Secura Bio Limited, 32 Molesworth Street, Dublin 2, Ireland
Copiktra 15 mg hard capsules.
Copiktra 25 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Copiktra 15 mg hard capsules: Opaque, pink, size no. 2, hard gelatin capsules marked “duv 15 mg” in black ink. Dimensions: approx. 18 mm x 6 mm (length and diameter). Copiktra 25 mg hard capsules: Opaque, white to off-white and orange, size no. 2, hard gelatin capsules marked “duv 25 mg” in black ink. Dimensions: approx. 18 mm x 6 mm (length and diameter). |
Copiktra 15 mg hard capsules: Each hard capsule contains 15 mg duvelisib (as monohydrate).
Copiktra 25 mg hard capsules: Each hard capsule contains 25 mg duvelisib (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Duvelisib |
Duvelisib is a dual inhibitor of phosphatidylinositol 3-kinase p110δ (PI3K-δ) and PI3K-γ. PI3K-δ inhibition directly reduces proliferation and survival of malignant B-cell lines and primary CLL tumour cells, while PI3K-γ inhibition reduces the activity of CD4+ T cells and macrophages in the tumor microenvironment to support the malignant B cells. |
| List of Excipients |
|---|
|
Capsule content: Colloidal silicon dioxide Capsule shell: Gelatin Printing black ink: Shellac glaze |
Copiktra 15 mg hard capsules:
Child-resistant PVC-PE-PCTFE/Aluminium blisters.
Pack size: 28 days carton containing 56 capsules (2 blisters with 28 capsules each).
Copiktra 25 mg hard capsules:
Child-resistant PVC-PE-PCTFE/Aluminium blisters.
Pack size: 28 days carton containing 56 capsules (2 blisters with 28 capsules each).
Secura Bio Limited, 32 Molesworth Street, Dublin 2, Ireland
EU/1/21/1542/001
EU/1/21/1542/002
Date of first authorisation: 19 May 2021
| Drug | Countries | |
|---|---|---|
| COPIKTRA | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United States |
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