Review decisions

Showing 490 results of 2627 total
Regulatory Decision Summary for Imjudo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694525571508
Product Type: Drug
Control Number: 262740
DIN(s): 02541009
Manufacturer: AstraZeneca Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-03-24
Decision / Authorization Date: 2023-08-31
Summary Basis of Decision (SBD) for Nuvaxovid (previously Nuvaxovid XBB.1.5)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1707315192044
Product Type: Drug
Control Number: 278519
DIN(s): 02543656
Manufacturer: Novavax Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-09-01
Issued / Original Publication Date: 2024-02-09
Decision / Authorization Date: 2023-12-05
Updated Date: 2025-03-21
Regulatory Decision Summary for Comirnaty Original & Omicron BA.4/BA.5
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1693487564948
Product Type: Drug
Control Number: 275559
DIN(s): 02541025
Manufacturer: Pfizer Canada ULC, on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2023-05-24
Decision / Authorization Date: 2023-08-31
Summary Safety Review - Domperidone - Assessing the Potential Risk of Psychiatric Withdrawal Events when Used for Lactation Stimulation
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1691692252806
DIN(s): 01912070, 02103613, 02236466, 02236857, 02238341, 02268078, 02350440, 02369206, 02403218, 02403870, 02408937, 02445034, 02462834
Issued / Original Publication Date: 2023-08-30
Updated Date: 2023-08-30
Summary Basis of Decision for Pavblu
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1757691075272
Product Type: Drug
Control Number: 276955
DIN(s): 02550628, 02550636
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-08-24
Issued / Original Publication Date: 2025-09-12
Decision / Authorization Date: 2023-08-24
Updated Date: 2025-07-08
Summary Basis of Decision for Pyzchiva and Pyzchiva I.V.
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1739909145014
Product Type: Drug
Control Number: 278712
DIN(s): 02550520, 02550539, 02550547
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-08-22
Issued / Original Publication Date: 2025-02-18
Decision / Authorization Date: 2024-08-07
Regulatory Decision Summary for Livtencity
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1701379593048
Product Type: Drug
Control Number: 259676
DIN(s): 02530740
Manufacturer: Takeda Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-03
Decision / Authorization Date: 2023-05-08
Regulatory Decision Summary for Vocabria and Cabenuva
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694624462535
Product Type: Drug
Control Number: 254233
DIN(s): 02497220, 02497247
Manufacturer: ViiV Healthcare ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-28
Decision / Authorization Date: 2022-06-15
Regulatory Decision Summary for Pifeltro
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694626834389
Product Type: Drug
Control Number: 264733
DIN(s): 02481545
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-31
Decision / Authorization Date: 2023-05-30
Regulatory Decision Summary for Eraxis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697738098405
Product Type: Drug
Control Number: 262044
DIN(s): 02330695
Manufacturer: Pfizer Canada ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-03
Decision / Authorization Date: 2023-05-08

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