Kisqali (ribociclib)

Numéro de dossier de l’APP: 23515
État des négociations:
Négociation envisagée
Indication(s):
in combination with an aromatase inhibitor for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II-III early breast cancer at high risk of recurrence• In pre- or perimenopausal women, or men, the aromatase inhibitor should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
Promoteur/fabricant:
Novartis Pharmaceuticals Canada Inc.
Numéro de projet de l’AMC:
PC0395-000
Lettre d’entente de l’APP:
Sans objet
Conclusion du processus de négociation:
Sans objet