Review decisions

Showing 100 results of 139 total
Regulatory Decision Summary for Rinvoq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1686686460648
Product Type: Drug
Control Number: 264612
DIN(s): 02495155, 02520893
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-27
Decision / Authorization Date: 2023-05-02
Regulatory Decision Summary for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1684156979784
Product Type: Drug
Control Number: 264318
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-16
Decision / Authorization Date: 2023-04-19
Summary Basis of Decision for Xenpozyme
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1725029128529
Product Type: Drug
Control Number: 275236
DIN(s): 02545713, 02545721
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-05-12
Issued / Original Publication Date: 2024-08-30
Decision / Authorization Date: 2024-02-28
Summary of Cancellation for Evenity
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1685724874375
Product Type: Drug
Control Number: 262756
DIN(s): 02489597
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-24
Decision / Authorization Date: 2023-03-21
Regulatory Decision Summary for Dupixent
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683810710858
Product Type: Drug
Control Number: 268311
DIN(s): 02470365, 02492504, 02510049, 02524252, 02526190
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-10-03
Decision / Authorization Date: 2023-05-01
Summary of Cancellation for Molnupiravir (*Lagevrio)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683828447298
Product Type: Drug
Control Number: 255584
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-08-20
Decision / Authorization Date: 2023-04-26
Regulatory Decision Summary for Vyalev
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692038706127
Product Type: Drug
Control Number: 263826
DIN(s): 02537702
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-04-29
Decision / Authorization Date: 2023-05-03
Regulatory Decision Summary for Quviviq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692293386336
Product Type: Drug
Control Number: 255507
DIN(s): 02537435, 02537443
Manufacturer: Idorsia Pharmaceuticals Ltd
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-25
Decision / Authorization Date: 2023-04-28
Regulatory Decision Summary for Beyfortus
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1684952482271
Product Type: Drug
Control Number: 269388
DIN(s): 02537206, 02537214
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-11-03
Decision / Authorization Date: 2023-04-19
Regulatory Decision Summary for Verquvo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705595463519
Product Type: Drug
Control Number: 240862
DIN(s): 02537044, 02537052, 02537060
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-19
Decision / Authorization Date: 2023-04-28

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