Dernière mise à jour : 02 septembre 2016
Détails
FichiersGeneric Name:
Obinutuzumab
État du projet:
Terminé
Domaine thérapeutique:
Chronic Lymphocytic Leukemia
Fabricant:
Hoffmann-La Roche Limited
Brand Name:
Gazyva
Gamme de produits:
Examen en vue du remboursement
Numéro de projet :
PC0041-000
Strength:
1000 mg/ vial
Tumour Type:
Leukemia
Indications:
Chronic Lymphocytic Leukemia
Funding Request:
In combination with chlorambucil for previously untreated chronic lymphocytic leukemia where fludarabine-based therapy is considered inappropriate
Review Status:
Complete
Pre Noc Submission:
Yes
Date NOC Issued:
Sponsor:
Hoffmann-La Roche Limited
Submission Date:
Submission Deemed Complete:
Priorisation demandée:
Demandée et accordée
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommandation:
Couvrir le remboursement
Clarification:
The Manufacturer had advised that Category 2 submission requirements for a pre-NOC submission will not be available to complete the submission for a November pERC meeting date. An updated target date for the pERC meeting had been set by pCODR, based on the anticipated timing of the manufacturer being able to provide these outstanding submission requirements. A confirmed pERC meeting date is posted as all pre-NOC submission requirements have been met.
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