Dernière mise à jour : 02 septembre 2016
Détails
FichiersGeneric Name:
Ibrutinib
État du projet:
Terminé
Domaine thérapeutique:
Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma
Fabricant:
Janssen Inc.
Brand Name:
Imbruvica
Gamme de produits:
Examen en vue du remboursement
Numéro de projet :
PC0043-000
Indicateur de rendement:
S. O. – Mesures de rendement prédictives
Strength:
140 mg capsule
Tumour Type:
Leukemia
Indications:
Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (previously treated)
Funding Request:
For the treatment of patients with CLL/SLL with or without deletion 17p who have received at least one prior therapy and are not considered appropriate for treatment or re-treatment with a purine analog (e.g., fludarabine)
Review Status:
Complete
Pre Noc Submission:
Yes
Date NOC Issued:
Sponsor:
Janssen Inc.
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:
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