Review decisions
Showing 130 results of 139 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1690897580182
Product Type: Drug
Control Number: 270055
Manufacturer: Veru Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-11-24
Decision / Authorization Date: 2023-06-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1686249847840
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
Issued / Original Publication Date: 2023-06-07
Decision / Authorization Date: 2023-04-19
Updated Date: 2024-06-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1701180125532
Product Type: Drug
Control Number: 269021
DIN(s): 02540207
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-25
Issued / Original Publication Date: 2023-11-18
Decision / Authorization Date: 2023-08-04
Updated Date: 2024-06-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1688741986480
Product Type: Drug
Control Number: 268412
DIN(s): 02537745
Manufacturer: Rhythm Pharmaceuticals, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-10-04
Issued / Original Publication Date: 2023-07-07
Decision / Authorization Date: 2023-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1700071951489
Product Type: Drug
Control Number: 267443
DIN(s): 02539934, 02539942, 02539950
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-29
Issued / Original Publication Date: 2023-11-15
Decision / Authorization Date: 2023-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1687438952638
Product Type: Drug
Control Number: 267362
DIN(s): 02536455
Manufacturer: Boehringer Ingelheim (Canada) Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-08-26
Issued / Original Publication Date: 2023-06-21
Decision / Authorization Date: 2023-03-22
Updated Date: 2023-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1706623043472
Product Type: Drug
Control Number: 266545
DIN(s): 02539977, 02539985, 02540002, 02540010, 02540029, 02540037, 02540045
Manufacturer: Baxter Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-07-29
Issued / Original Publication Date: 2024-01-26
Decision / Authorization Date: 2023-07-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1695821197450
Product Type: Drug
Control Number: 266471
DIN(s): 02539845, 02539853, 02539861
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-07-27
Issued / Original Publication Date: 2023-09-25
Decision / Authorization Date: 2023-07-20
Updated Date: 2024-06-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1693490140440
Product Type: Drug
Control Number: 265619
DIN(s): 02538881
Manufacturer: Sun Pharmaceutical Industries Limited
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-06-29
Issued / Original Publication Date: 2023-08-30
Decision / Authorization Date: 2023-06-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1685634038615
Product Type: Drug
Control Number: 265517
DIN(s): 02536552, 02536560
Manufacturer: Hoffmann-La Roche Limited
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-06-23
Issued / Original Publication Date: 2023-05-31
Decision / Authorization Date: 2023-03-24