Review decisions

Showing 990 results of 2628 total
Regulatory Decision Summary for Darzalex SC
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
Summary Basis of Decision for Tavneos
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1745405201062
Product Type: Drug
Control Number: 248255
DIN(s): 02526662
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-12
Issued / Original Publication Date: 2022-07-28
Decision / Authorization Date: 2022-04-14
Updated Date: 2025-04-22
Summary Safety Review - Veklury (remdesivir) - Assessing the Potential Risks of Acute Kidney Injury (AKI) and Acute Renal Failure (ARF)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00264
Issued / Original Publication Date: 2021-04-09
Summary Basis of Decision for Padcev
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00573
Product Type: Drug
Control Number: 251438
DIN(s): 02521903, 02521911
Manufacturer: Seagen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-04-06
Issued / Original Publication Date: 2022-02-04
Decision / Authorization Date: 2021-10-29
Updated Date: 2025-06-18
Summary Basis of Decision for Sotrovimab
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00548
Product Type: Drug
Control Number: 251285
DIN(s): 02518341
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-01
Issued / Original Publication Date: 2021-09-10
Decision / Authorization Date: 2021-07-30
Updated Date: 2024-07-19
Regulatory Decision Summary for Braftovi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01025
Product Type: Drug
Control Number: 238571
DIN(s): 02513099
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-04-17
Decision / Authorization Date: 2021-03-30
Summary safety review - Dental Amalgam - Assessing the Potential Risk of Negative Health Effects from Mercury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00263
Issued / Original Publication Date: 2021-03-31
Summary Basis of Decision for Poteligeo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00611
Product Type: Drug
Control Number: 251277
DIN(s): 02527715
Manufacturer: Kyowa Kirin, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-03-31
Issued / Original Publication Date: 2022-10-25
Decision / Authorization Date: 2022-06-02
Updated Date: 2025-06-27
Regulatory Decision Summary for Taltz
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00790
Product Type: Drug
Control Number: 238580
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-04-17
Decision / Authorization Date: 2021-03-29
Summary Basis of Decision for Byooviz
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00598
Product Type: Drug
Control Number: 251162
DIN(s): 02525852
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-03-29
Issued / Original Publication Date: 2022-08-12
Decision / Authorization Date: 2022-03-08
Updated Date: 2025-07-14

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