Approval · Notice of Compliance 32336 · 2023
ZEPZELCA: Notice of Compliance 32336
Issued December 11, 2023
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 32336
- Date
- December 11, 2023
- Company
- Jazz Pharmaceuticals Ireland LimitedDublin, Dublin, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfilment of a commitment of the Final Study Report for the SCLC Cohort of Study B-005 as per conditions in the Letter of Undertaking
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZEPZELCA | Not yet assigned | — |
Medicinal ingredients
- LURBINECTEDIN 4 MG per VIAL