Qualifying notice: Zepzelca

This Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document: Notice of Compliance with Conditions (NOC/c), is to advise you that information submitted in support of the Supplemental New Drug Submission for Zepzelca (lurbinectedin), control number 247485, indicated for the treatment of adults with Stage III or metastatic small cell lung cancer (SCLC) who have progressed on or after platinum-containing therapy, qualifies to be considered for authorization in accordance with the NOC/c Guidance.

Data and Resources

Additional Info

Field Value
Source
Version
Author
Author Email
Maintainer
Maintainer Email
Data Level
Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward
Title (French) Avis d’admissibilité : Zepzelca
Update Frequency as_needed
Geographic Scope []
Criticality Level []
Sensitivity Level unrestricted
Language
Contact Person
Contact Email
Data Dictionary
Open Canada Date Published 2021-10-08 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["avis d'admissibilité", "Zepzelca", "avis de conformité avec conditions", "avis d'adissibilité AC/c-AA"], "en": ["qualifying notice", "Zepzelca", "notice-of-compliance with conditions-qualifying notice", "NOC/c-QN"]}
Open Canada Collection publication
Principal Organization
Reference Data
Official Source