Review decisions

Showing 30 results of 2107 total
Regulatory Decision Summary for Spikevax XBB.1.5
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694116967823
Product Type: Drug
Control Number: 275936
DIN(s): 02541270
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Decision / Authorization Date: 2023-09-12
Regulatory Decision Summary for Esperoct
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1696002316689
Product Type: Drug
Control Number: 268221
DIN(s): 02490064, 02490072, 02490080, 02490099, 02490102
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-09-27
Decision / Authorization Date: 2023-09-11
Regulatory Decision Summary for Tagrisso
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698937127708
Product Type: Drug
Control Number: 243288
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2020-08-27
Decision / Authorization Date: 2021-01-18
Regulatory Decision Summary for Tagrisso
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1696430838362
Product Type: Drug
Control Number: 211762
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-02-13
Decision / Authorization Date: 2018-07-10
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
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
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
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
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 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

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