Review decisions

Showing 140 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1700081467048
Product Type: Drug
Control Number: 266464
DIN(s): 02538539
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-07-29
Issued / Original Publication Date: 2023-11-09
Decision / Authorization Date: 2023-06-16
Updated Date: 2024-11-20
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/SBD1715956069651
Product Type: Drug
Control Number: 266189
DIN(s): 02532018
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-07-25
Issued / Original Publication Date: 2022-12-19
Decision / Authorization Date: 2022-10-21
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00594
Product Type: Drug
Control Number: 254440
DIN(s): 02526182
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00609
Product Type: Drug
Control Number: 265656
DIN(s): 02530252
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-06-30
Issued / Original Publication Date: 2022-10-27
Decision / Authorization Date: 2022-09-01
Updated Date: 2024-05-17
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
Updated Date: 2025-01-28
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
Updated Date: 2025-01-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1693591697586
Product Type: Drug
Control Number: 261689
DIN(s): 02538652, 02538660, 02538725, 02538733, 02538741, 02538768, 02538776, 02538784, 02538792, 02538806, 02538814
Manufacturer: Endo Ventures Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-06-09
Issued / Original Publication Date: 2023-08-31
Decision / Authorization Date: 2023-06-12
Updated Date: 2025-08-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1703192825535
Product Type: Drug
Control Number: 256629
DIN(s): 02541416
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-06-01
Issued / Original Publication Date: 2023-12-21
Decision / Authorization Date: 2023-09-13
Updated Date: 2025-02-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1687370834165
Product Type: Drug
Control Number: 263638
DIN(s): 02537117
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-04-22
Issued / Original Publication Date: 2023-06-21
Decision / Authorization Date: 2023-04-05
Updated Date: 2025-10-23