Review decisions

Showing 980 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00806
Product Type: Drug
Control Number: 239280
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-05-12
Decision / Authorization Date: 2021-04-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00834
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
Decision / Authorization Date: 2021-04-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00265
Issued / Original Publication Date: 2021-04-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1715971891771
Product Type: Drug
Control Number: 251688
DIN(s): 02542706
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-19
Issued / Original Publication Date: 2024-05-17
Decision / Authorization Date: 2023-11-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00795
Product Type: Drug
Control Number: 237674
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-04-08
Decision / Authorization Date: 2021-04-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00797
Product Type: Drug
Control Number: 242104
DIN(s): 02514400
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-07-27
Decision / Authorization Date: 2021-04-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00852
Product Type: Drug
Control Number: 239083
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-04-30
Decision / Authorization Date: 2021-04-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00596
Product Type: Drug
Control Number: 251687
DIN(s): 02526247, 02526255, 02526263
Manufacturer: BioMarin International Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-14
Issued / Original Publication Date: 2022-07-13
Decision / Authorization Date: 2022-03-30
Updated Date: 2025-08-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00622
Product Type: Drug
Control Number: 251360
DIN(s): 02529602
Manufacturer: Baxter Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-13
Issued / Original Publication Date: 2023-01-26
Decision / Authorization Date: 2022-08-03
Updated Date: 2024-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00791
Product Type: Drug
Control Number: 244119
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-09-18
Decision / Authorization Date: 2021-04-12