Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Piqray 50 mg film-coated tablets.
Piqray 150 mg film-coated tablets.
Piqray 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Piqray 50 mg film-coated tablets: Light pink, round, curved film-coated tablet with bevelled edges, imprinted with “L7” on one side and “NVR” on the other side. Approximate diameter: 7.2 mm. Piqray 150 mg film-coated tablets: Pale red, ovaloid, curved film-coated tablet with bevelled edges, imprinted with “UL7” on one side and “NVR” on the other side. Approximate size: 14.2 mm (length); 5.7 mm (width). Piqray 200 mg film-coated tablets: Light red, ovaloid, curved film-coated tablet with bevelled edges, imprinted with “YL7” on one side and “NVR” on the other side. Approximate size: 16.2 mm (length); 6.5 mm (width). |
Piqray 50 mg film-coated tablets: Each film-coated tablet contains 50 mg of alpelisib.
Piqray 150 mg film-coated tablets: Each film-coated tablet contains 150 mg of alpelisib.
Piqray 200 mg film-coated tablets: Each film-coated tablet contains 200 mg of alpelisib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Alpelisib |
Alpelisib is an α-specific class I phosphatidylinositol3kinase (PI3Kα) inhibitor. Gain-of-function mutations in the gene encoding the catalytic α-subunit of PI3K (PIK3CA) lead to activation of PI3Kα and AKT-signalling, cellular transformation and the generation of tumours in in vitro and in vivo models. |
| List of Excipients |
|---|
|
Tablet core: Cellulose microcrystalline Film coating: Hypromellose |
PVC/PCTFE/alu (polyvinylchloride/polychlorotrifluoroethylene/aluminium) blister sealed into a blister card containing 14 film-coated tablets.
Piqray 50 mg and 200 mg film-coated tablets:
Packs containing 28 film-coated tablets (14 of 50 mg and 14 of 200 mg) or 56 film-coated tablets (28 of 50 mg and 28 of 200 mg).
Multipacks containing 168 film-coated tablets (3x 56, each comprising 28 tablets of 50 mg and 28 tablets of 200 mg).
Piqray 150 mg film-coated tablets:
Packs containing 28 or 56 film-coated tablets.
Multipacks containing 168 (3x 56) film-coated tablets.
Piqray 200 mg film-coated tablets:
Packs containing 14 or 28 film-coated tablets.
Multipacks containing 84 (3x 28) film-coated tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/20/1455/001-009
27 July 2020
| Drug | Countries | |
|---|---|---|
| PIQRAY | Austria, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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