TALZENNA DIN 02555050
Status: Marketed
Holder: PFIZER CANADA ULC
Molecule: TALAZOPARIB (TALAZOPARIB TOSYLATE)
Available to quote
Health Canada record
| Active ingredient(s) | TALAZOPARIB (TALAZOPARIB TOSYLATE) 0.1 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01XK04 TALAZOPARIB |
| Original market date | 16-May-2025 |
| Current status date | 16-May-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Pfizer Canada ULC — licence 100255, currently licensed, last inspection rating C (2023-08-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing TALAZOPARIB (TALAZOPARIB TOSYLATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02492032 | TALZENNA | PFIZER CANADA ULC | Capsule | TALAZOPARIB (TALAZOPARIB TOSYLATE) 0.25 MG | Marketed |
| 02492040 | TALZENNA | PFIZER CANADA ULC | Capsule | TALAZOPARIB (TALAZOPARIB TOSYLATE) 1 MG | Approved |
| 02555069 | TALZENNA | PFIZER CANADA ULC | Capsule | TALAZOPARIB (TALAZOPARIB TOSYLATE) 0.35 MG | Approved |
| 02555077 | TALZENNA | PFIZER CANADA ULC | Capsule | TALAZOPARIB (TALAZOPARIB TOSYLATE) 0.5 MG | Approved |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 34763 | 2025-01-30 | Supplement to a New Drug Submission (SNDS) | Addition of new indication: TALZENNA is indicated in combination with enzalutamide for the treatment of adul t patients with homologous recombination repair (HRR) gene mutated metastatic castration-resistant prostate cancer (mCRPC). Addition of new strength: 0.1 mg, 0.35 mg and 0.5 mg |