Review decisions
Showing 270 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00524
Product Type: Drug
Control Number: 235023
DIN(s): 02509733
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-01-09
Issued / Original Publication Date: 2021-03-25
Decision / Authorization Date: 2020-12-17
Updated Date: 2023-10-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00496
Product Type: Drug
Control Number: 234610
DIN(s): 02501600
Manufacturer: Otsuka Pharmaceutical Co., Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-12-31
Issued / Original Publication Date: 2020-09-21
Decision / Authorization Date: 2020-07-07
Updated Date: 2024-09-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00497
Product Type: Drug
Control Number: 234688
DIN(s): 02500833
Manufacturer: Deciphera Pharmaceuticals, LLC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-12-23
Issued / Original Publication Date: 2020-09-22
Decision / Authorization Date: 2020-06-19
Updated Date: 2025-10-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00501
Product Type: Drug
Control Number: 234655
DIN(s): 02503034
Manufacturer: Medunik Canada
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-12-20
Issued / Original Publication Date: 2020-10-22
Decision / Authorization Date: 2023-01-10
Updated Date: 2024-11-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00623
Product Type: Drug
Control Number: 234562
DIN(s): 02530287, 02530295, 02530309
Manufacturer: Lupin Pharma Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-12-19
Issued / Original Publication Date: 2023-02-03
Decision / Authorization Date: 2022-08-31
Updated Date: 2026-01-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00517
Product Type: Drug
Control Number: 233987
DIN(s): 02507501, 02507528, 02507536, 02507544, 02507552, 02507560, 02507579
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-11-26
Issued / Original Publication Date: 2021-02-08
Decision / Authorization Date: 2020-11-05
Updated Date: 2024-08-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00495
Product Type: Drug
Control Number: 233642
DIN(s): 02499681
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-11-18
Issued / Original Publication Date: 2020-09-08
Decision / Authorization Date: 2020-06-01
Updated Date: 2025-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00523
Product Type: Drug
Control Number: 233373
DIN(s): 02506238
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-11-12
Issued / Original Publication Date: 2021-03-22
Decision / Authorization Date: 2020-10-28
Updated Date: 2024-07-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00532
Product Type: Drug
Control Number: 232449
DIN(s): 02510995
Manufacturer: Dutch Ophthalmic Research Center International BV
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-11-07
Issued / Original Publication Date: 2021-06-02
Decision / Authorization Date: 2021-01-15
Updated Date: 2024-06-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00504
Product Type: Drug
Control Number: 233292
DIN(s): 02501821, 02501848
Manufacturer: Sunovion Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-11-07
Issued / Original Publication Date: 2020-11-02
Decision / Authorization Date: 2020-07-10
Updated Date: 2025-01-28