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Regulatory Decision Summary for Talzenna

https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00672

Product Type: Drug

Control Number: 220584

DIN(s): 02492032, 02492040

Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH

Submission Type: New Drug Submission (New Active Substance)

Date Filed / Submission Date: 2018-09-28

Decision / Authorization Date: 2019-09-06

Date modified:: 2026-04-20

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