Review decisions

Showing 180 results of 2299 total
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
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
Regulatory Decision Summary for Jardiance
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705090544554
Product Type: Drug
Control Number: 261909
DIN(s): 02443937, 02443945
Manufacturer: Boehringer Ingelheim (Canada) Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-02-28
Decision / Authorization Date: 2023-05-29
Regulatory Decision Summary for Perseris
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1693494435256
Product Type: Drug
Control Number: 253442
DIN(s): 02507838, 02507846
Manufacturer: HLS Therapeutics Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-08
Decision / Authorization Date: 2023-05-25
Summary Safety Review - Keytruda (pembrolizumab) and Tecentriq (atezolizumab) - Assessing the Potential Risk of Aplastic Anemia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1691503886633
DIN(s): 02456869, 02462990, 02468816, 02469723, 02487144, 02487152, 02492393, 02523434
Issued / Original Publication Date: 2023-08-17
Updated Date: 2023-08-17
Summary Basis of Decision for Talvey
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1732553847408
Product Type: Drug
Control Number: 278277
DIN(s): 02547392, 02547406
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-08-15
Issued / Original Publication Date: 2024-11-23

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