Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
TRUQAP 160 mg film-coated tablets.
TRUQAP 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets (tablet). TRUQAP 160 mg film-coated tablets: Round, biconvex, beige film-coated tablets debossed with ‘CAV’ above ‘160’ on one side and plain on the reverse. Approximate diameter: 10 mm. TRUQAP 200 mg film-coated tablets: Capsule-shaped, biconvex, beige film-coated tablets debossed with ‘CAV 200’ on one side and plain on the reverse. Approximate size: 14.5 mm (length), 7.25 mm (width). |
TRUQAP 160 mg film-coated tablets: Each film-coated tablet contains 160 mg of capivasertib.
TRUQAP 200 mg film-coated tablets: Each film-coated tablet contains 200 mg of capivasertib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Capivasertib |
Capivasertib is a potent, selective inhibitor of the kinase activity of all 3 isoforms of serine/threonine kinase AKT (AKT1, AKT2 and AKT3). AKT activation in tumours is a result of upstream activation from other signalling pathways, mutations of AKT1, loss of Phosphatase and Tensin Homolog (PTEN) function and mutations in the catalytic subunit of PI3K (PIK3CA). Capivasertib reduces growth of cell lines derived from solid tumours and haematological disease, including breast cancer cell lines with and without PIK3CA or AKT1 mutations, or PTEN alterations. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460i) Film coating: Hypromellose |
Aluminium/Aluminium blister containing 16 film-coated tablets. Pack of 64 tablets (4 blisters).
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/24/1820/001 160 mg tablets
EU/1/24/1820/002 200 mg tablets
| Drug | Countries | |
|---|---|---|
| TRUQAP | Austria, Estonia, France, Lithuania, Romania, United Kingdom, United States |
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