Review decisions
Showing 70 results of 332 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718207489396
Product Type: Drug
Control Number: 268282
DIN(s): 02542943
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-09-29
Issued / Original Publication Date: 2024-06-11
Decision / Authorization Date: 2023-11-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01050
Product Type: Drug
Control Number: 240337
Manufacturer: Kye Pharmaceuticals Inc., Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-05
Decision / Authorization Date: 2022-09-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00992
Product Type: Drug
Control Number: 234562
DIN(s): 02530287, 02530295, 02530309
Manufacturer: Lupin Pharma Canada Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-12-19
Decision / Authorization Date: 2022-08-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1709043672605
Product Type: Drug
Control Number: 267438
DIN(s): 02541599
Manufacturer: Argenx BV
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-29
Issued / Original Publication Date: 2024-02-24
Decision / Authorization Date: 2023-09-19
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/RDS00991
Product Type: Drug
Control Number: 260951
DIN(s): 02530198
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-01-28
Decision / Authorization Date: 2022-08-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1712172719912
Product Type: Drug
Control Number: 267148
DIN(s): 02541742
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-18
Issued / Original Publication Date: 2024-03-28
Decision / Authorization Date: 2023-09-22
Updated Date: 2024-03-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01042
Product Type: Drug
Control Number: 254548
DIN(s): 02532468
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-09-10
Decision / Authorization Date: 2022-08-16
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/RDS01019
Product Type: Drug
Control Number: 240368
Manufacturer: Kye Pharmaceuticals Inc., Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-18
Decision / Authorization Date: 2022-07-14