Qualifying notice: Zepzelca
Description
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.
Resources
| Name |
Format |
Description |
Link |
| Qualifying notice: Zepzelca |
HTML |
|
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions/qualifying-notice-zepzelca-247485.html |
| Qualifying notice: Zepzelca |
HTML |
|
https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/avis-conformite/conditions/avis-admissibilite-zepzelca-247485.html |