Review decisions

Showing 80 results of 2261 total
Regulatory Decision Summary for Nurtec ODT
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1712323528783
Product Type: Drug
Control Number: 268384
DIN(s): 02543605
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-03
Decision / Authorization Date: 2023-12-01
Regulatory Decision Summary for Beqvez
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1707836185816
Product Type: Drug
Control Number: 275853
DIN(s): 02544156
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-06-01
Decision / Authorization Date: 2023-12-27
Summary Safety Review - Ibrance (palbociclib) - Assessing the Potential Risk of Venous Thromboembolism
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1707157428464
DIN(s): 02453150, 02453169, 02453177, 02493535, 02493543, 02493551
Issued / Original Publication Date: 2024-02-09
Updated Date: 2024-02-09
Regulatory Decision Summary for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1707495404187
Product Type: Drug
Control Number: 272409
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-14
Decision / Authorization Date: 2024-02-06
Regulatory Decision Summary for Mezera
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710793698140
Product Type: Drug
Control Number: 269884
DIN(s): 02524481, 02545012
Manufacturer: Avir Pharma Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-11-18
Decision / Authorization Date: 2024-02-05
Regulatory Decision Summary for Epidiolex
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714138409580
Product Type: Drug
Control Number: 268559
DIN(s): 02543079
Manufacturer: GW Research Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-10-07
Decision / Authorization Date: 2023-11-15
Regulatory Decision Summary for Olumiant
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710876504060
Product Type: Drug
Control Number: 270684
DIN(s): 02480018, 02544768
Manufacturer: Eli Lily Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-15
Decision / Authorization Date: 2024-01-26
Summary Safety Review - Amiodarone - Assessing the Potential Risk of Primary Graft Dysfunction Following Heart Transplantation
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1706035839788
DIN(s): 02239835, 02242325, 02242472, 02243836, 02245248, 02246194, 02246331, 02247217, 02249502, 02292173, 02294508, 02309661, 02364336, 02385465, 02423227, 02427346, 02531844
Issued / Original Publication Date: 2024-02-01
Updated Date: 2024-02-01
Regulatory Decision Summary for Ozempic
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706278116175
Product Type: Drug
Control Number: 271108
DIN(s): 02471469, 02471477, 02523930, 02540258
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-01-04
Decision / Authorization Date: 2023-08-04
Regulatory Decision Summary for Sibboran
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708015333213
Product Type: Drug
Control Number: 259953
DIN(s): 02543338
Manufacturer: Trimedic Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-30
Decision / Authorization Date: 2023-11-20

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