Review decisions
Showing 160 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00621
Product Type: Drug
Control Number: 260951
DIN(s): 02530198
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-01-28
Issued / Original Publication Date: 2023-01-20
Decision / Authorization Date: 2022-08-25
Updated Date: 2025-11-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1719939219034
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
Issued / Original Publication Date: 2024-07-02
Decision / Authorization Date: 2023-11-20
Updated Date: 2025-01-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684869579695
Product Type: Drug
Control Number: 258973
DIN(s): 02534177, 02534185
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-12-29
Issued / Original Publication Date: 2023-05-02
Decision / Authorization Date: 2023-01-03
Updated Date: 2025-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00625
Product Type: Drug
Control Number: 259676
DIN(s): 02530740
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-16
Issued / Original Publication Date: 2023-02-17
Decision / Authorization Date: 2022-09-15
Updated Date: 2024-11-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00628
Product Type: Drug
Control Number: 259397
DIN(s): 02533030
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-08
Issued / Original Publication Date: 2023-03-10
Decision / Authorization Date: 2022-11-24
Updated Date: 2024-06-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00577
Product Type: Drug
Control Number: 259186
DIN(s): 02524031, 02527804
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-12-01
Issued / Original Publication Date: 2022-02-28
Decision / Authorization Date: 2022-01-17
Updated Date: 2025-05-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00629
Product Type: Drug
Control Number: 259103
DIN(s): 02532891, 02532905, 02532913, 02532921, 02532948, 02532956, 02541041, 02541068, 02541076, 02541084, 02541092, 02541106, 02551950, 02551969, 02551977, 02551985, 02552000
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-11-29
Issued / Original Publication Date: 2023-03-17
Decision / Authorization Date: 2022-11-24
Updated Date: 2025-10-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00605
Product Type: Drug
Control Number: 258717
DIN(s): 02527588
Manufacturer: Immunocore Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-11-19
Issued / Original Publication Date: 2022-10-03
Decision / Authorization Date: 2022-06-07
Updated Date: 2023-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684173887386
Product Type: Drug
Control Number: 258772
DIN(s): 02532549, 02532557, 02532565, 02532573
Manufacturer: Bristol Myers Squibb Pharma
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-11-18
Issued / Original Publication Date: 2023-04-12
Decision / Authorization Date: 2022-11-08
Updated Date: 2025-05-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00589
Product Type: Drug
Control Number: 258295
DIN(s): 02526271
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-11-03
Issued / Original Publication Date: 2022-06-15
Decision / Authorization Date: 2022-04-14
Updated Date: 2024-05-17