Dernière mise à jour : 02 septembre 2016
Détails
FichiersGeneric Name:
Dabrafenib
État du projet:
Terminé
Domaine thérapeutique:
Metastatic Melanoma
Fabricant:
GlaxoSmithKline
Brand Name:
Tafinlar
Gamme de produits:
Examen en vue du remboursement
Numéro de projet :
PC0025-000
Indicateur de rendement:
S. O. – Mesures de rendement prédictives
Strength:
50 mg and 75 mg capsule
Tumour Type:
Peau et mélanome
Indications:
Metastatic Melanoma
Funding Request:
For use as monotherapy for the treatment of patients with unresectable or metastatic melanoma, with a BRAF V600 mutation
Review Status:
Complete
Pre Noc Submission:
Yes
Date NOC Issued:
Sponsor:
GlaxoSmithKline
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:
Clarification:
A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.
Recommandation:
Remboursement sous critères cliniques ou conditions
Clarification:
A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.
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