Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Mirati Therapeutics B.V., Locatellikade 1, 1076 AZ Amsterdam, Netherlands
KRAZATI 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet. White to off-white, oval shaped, film-coated tablet, approximately 8 × 16 mm, with a stylised “M” on one side and “200” marked on the other side. |
Each film-coated tablet contains 200 mg adagrasib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Adagrasib |
Adagrasib is a selective, irreversible inhibitor of KRAS (Kirsten rat sarcoma viral oncogene homolog) G12C that covalently binds to the mutant cysteine in KRAS G12C and locks the mutant KRAS protein in its inactive, GDP-bound conformation, which prevents KRAS-dependent downstream signalling. Adagrasib inhibits tumour cell growth and viability in cells harbouring KRAS G12C mutations and results in regression in KRAS G12C-positive nonclinical tumour models with minimal off-target activity. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460) Film-coating: Hypromellose |
Each carton contains one white opaque HDPE bottle with a white, child resistant polypropylene closure and an aluminium foil heat induction seal. Each HDPE bottle contains two 1 g of silica gel desiccant containers.
Pack sizes: bottles with 120 and 180 film-coated tablets.
Not all pack sizes may be marketed.
Mirati Therapeutics B.V., Locatellikade 1, 1076 AZ Amsterdam, Netherlands
EU/1/23/1744/001
EU/1/23/1744/002
| Drug | Countries | |
|---|---|---|
| KRAZATI | Austria, Estonia, Croatia, Lithuania, United States |
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