Review decisions
Showing 250 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00525
Product Type: Drug
Control Number: 239943
DIN(s): 02510219, 02510227
Manufacturer: KYE Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-05-27
Issued / Original Publication Date: 2021-03-31
Decision / Authorization Date: 2020-12-31
Updated Date: 2023-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00545
Product Type: Drug
Control Number: 239850
Manufacturer: Rockwell Medical Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-05-25
Issued / Original Publication Date: 2021-07-29
Decision / Authorization Date: 2021-04-22
Updated Date: 2025-06-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00521
Product Type: Drug
Control Number: 239719
DIN(s): 02509695
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-05-21
Issued / Original Publication Date: 2021-03-10
Decision / Authorization Date: 2020-12-15
Updated Date: 2025-08-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00546
Product Type: Drug
Control Number: 239537
DIN(s): 02515474, 02515482
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-05-15
Issued / Original Publication Date: 2021-08-05
Decision / Authorization Date: 2021-04-28
Updated Date: 2023-07-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00550
Product Type: Drug
Control Number: 238175
DIN(s): 02516241, 02516268
Manufacturer: Endo Ventures Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-04-06
Issued / Original Publication Date: 2021-09-14
Decision / Authorization Date: 2021-05-25
Updated Date: 2025-07-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00558
Product Type: Drug
Control Number: 237814
DIN(s): 02513447
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-03-30
Issued / Original Publication Date: 2021-11-22
Decision / Authorization Date: 2021-03-11
Updated Date: 2024-11-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00549
Product Type: Drug
Control Number: 237511
DIN(s): 02515814, 02515822
Manufacturer: Jazz Pharmaceuticals Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-03-30
Issued / Original Publication Date: 2021-09-10
Decision / Authorization Date: 2021-05-13
Updated Date: 2025-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00533
Product Type: Drug
Control Number: 237410
DIN(s): 02513080
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-03-20
Issued / Original Publication Date: 2021-06-08
Decision / Authorization Date: 2021-03-02
Updated Date: 2023-07-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00534
Product Type: Drug
Control Number: 237413
DIN(s): 02513099
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-03-20
Issued / Original Publication Date: 2021-06-08
Decision / Authorization Date: 2021-03-02
Updated Date: 2025-01-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00547
Product Type: Drug
Control Number: 237287
DIN(s): 02515067
Manufacturer: Waymade PLC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-03-20
Issued / Original Publication Date: 2021-08-25
Decision / Authorization Date: 2021-04-20
Updated Date: 2025-08-20