Dernière mise à jour : 02 septembre 2016
Détails
FichiersGeneric Name:
Dabrafenib & Trametinib in combo
État du projet:
Terminé
Domaine thérapeutique:
Metastatic Melanoma
Fabricant:
GlaxoSmithKline Inc.
Brand Name:
Tafinlar & Mekinist in combo
Gamme de produits:
Examen en vue du remboursement
Numéro de projet :
PC0053-000
Strength:
Dabrafenib: 50mg and 75mg capsules;Trametinib: 0.5mg and 2.0mg tablets
Tumour Type:
Peau et mélanome
Indications:
Metastatic Melanoma
Funding Request:
Dabrafenib and trametinib in combination for the treatment of patients with unresectable or metastatic melanoma with a BRAF 600 mutation.
Review Status:
Complete
Pre Noc Submission:
Yes
Date NOC Issued:
Sponsor:
GlaxoSmithKline Inc.
Submission Date:
Submission Deemed Complete:
Priorisation demandée:
Non demandée
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommandation:
Remboursement sous critères cliniques ou conditions
pERC Meeting:
Final Recommendation Issued:
Fichiers
‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.
Dernière mise à jour : 02 septembre 2016