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TALZENNA DIN 02555069

Status: Approved
Holder: PFIZER CANADA ULC
Molecule: TALAZOPARIB (TALAZOPARIB TOSYLATE)

Health Canada record

Active ingredient(s)TALAZOPARIB (TALAZOPARIB TOSYLATE) 0.35 MG
Dosage formCapsule
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCL01XK04 TALAZOPARIB
Original market date
Current status date30-Jan-2025
SourceHealth 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)

DINProductCompanyFormStrengthStatus
02492032TALZENNAPFIZER CANADA ULCCapsuleTALAZOPARIB (TALAZOPARIB TOSYLATE) 0.25 MGMarketed
02492040TALZENNAPFIZER CANADA ULCCapsuleTALAZOPARIB (TALAZOPARIB TOSYLATE) 1 MGApproved
02555050TALZENNAPFIZER CANADA ULCCapsuleTALAZOPARIB (TALAZOPARIB TOSYLATE) 0.1 MGMarketed
02555077TALZENNAPFIZER CANADA ULCCapsuleTALAZOPARIB (TALAZOPARIB TOSYLATE) 0.5 MGApproved

Notices of Compliance

NOCDateSubmissionReason
347632025-01-30Supplement 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
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