Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
LUMYKRAS 120 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Yellow film-coated tablet, oblong-shaped (7 mm × 16 mm), debossed with “AMG” on one side and “120” on the opposite side. |
Each film-coated tablet contains 120 mg of sotorasib.
Excipient with known effect: Each film-coated tablet contains 108 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sotorasib |
Sotorasib is a selective KRAS G12C (Kirsten rat sarcoma viral oncogene homolog) inhibitor, which covalently and irreversibly binds to the unique cysteine of KRAS G12C. Inactivation of KRAS G12C by sotorasib blocks tumour cell signalling and survival, inhibits cell growth, and promotes apoptosis selectively in tumours harbouring KRAS G12C, an oncogenic driver of tumourigenesis. |
| List of Excipients |
|---|
|
Tablet core: Cellulose, microcrystalline (E460(i)) Film-coating: Polyvinyl alcohol (E1203) |
PVC/PE/PVDC blisters with aluminium foil backing containing 8 film-coated tablets. Pack sizes of 240 film-coated tablets (1 carton with 30 blisters) and multipack with 720 (3 × 240) film-coated tablets.
HDPE bottle with a child-resistant polypropylene cap and aluminium foil induction seal liner containing 120 film-coated tablets. Pack size of 240 film-coated tablets (1 carton with 2 bottles).
Not all pack sizes may be marketed.
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
EU/1/21/1603/001
EU/1/21/1603/002
EU/1/21/1603/003
Date of first authorisation: 06 January 2022
| Drug | Countries | |
|---|---|---|
| LUMYKRAS | Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom |
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