Dernière mise à jour : 02 septembre 2016
Détails
Generic Name:
Bendamustine hydrochloride
État du projet:
Retiré
Domaine thérapeutique:
Chronic Lymphocytic Leukemia
Fabricant:
Lundbeck Canada Inc.
Brand Name:
Treanda (in combination with rituximab)
Gamme de produits:
Examen en vue du remboursement
Numéro de projet :
PC0040-000
Strength:
25mg/vial and 100mg/vial
Tumour Type:
Leukemia
Indications:
Chronic Lymphocytic Leukemia
Funding Request:
For the first-line treatment of patients with chronic lymphocytic leukemia in combination with rituximab
Review Status:
Retiré
Pre Noc Submission:
Yes
Date NOC Issued:
Sponsor:
Lundbeck Canada Inc.
Submission Date:
Submission Deemed Complete:
Priorisation demandée:
Non demandée
Stakeholder Input Deadline ‡:
Clarification:
Lundbeck Canada Inc. has requested a voluntary withdrawal of the Bendamustine (Treanda) in combination with rituximab for CLL Submission in anticipation of new clinical information and possible resubmission. As per pCODR Procedures B3.1.6.2 b), the pCODR Secretariat has stopped the review. The pCODR Provincial Advisory Group has agreed with the manufacturer's request.
‡ 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