Review decisions
Showing 330 results of 359 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/SBD1721675750511
Product Type: Drug
Control Number: 269097
DIN(s): 02544180, 02544199, 02544202, 02544210
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-11-15
Issued / Original Publication Date: 2024-07-22
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1708102173051
Product Type: Drug
Control Number: 269372
DIN(s): 02542137
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-11-03
Issued / Original Publication Date: 2024-02-16
Decision / Authorization Date: 2023-10-10
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: 2024-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1695302358644
Product Type: Drug
Control Number: 269369
DIN(s): 02539756, 02539764
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-11-02
Issued / Original Publication Date: 2023-09-20
Decision / Authorization Date: 2023-07-26
Updated Date: 2025-05-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1712065211631
Product Type: Drug
Control Number: 267923
DIN(s): 02542420
Manufacturer: Alnylam Netherlands B.v.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-31
Issued / Original Publication Date: 2024-03-28
Decision / Authorization Date: 2023-10-18
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
Updated Date: 2024-11-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1719417006477
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
Issued / Original Publication Date: 2024-06-26
Decision / Authorization Date: 2023-12-01
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
Updated Date: 2025-04-03