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Rituximab (Truxima) for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar - Details

Project Number pCODR 10184
Brand Name Truxima
Generic Name Rituximab
Strength 10 mg/mL
Tumour Type Lymphoma & Leukemia
Indication Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar
Funding Request Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia
Review Status File-Closed Not Submitted
Pre Noc Submission No
NOC Date April 4, 2019
Manufacturer Teva Canada Innovation
Submitter Teva Canada Innovation
Submission Date (Target Date) May 22, 2019
Submission Deemed Complete
Submission Type Biosimilar – New Drug
Stakeholder Input Deadline (target date based on target submission date) ‡ June 5, 2019
Final Biosimilar Summary Dossier Issued (target date)

‡ 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.