Review decisions
Showing 90 results of 1257 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1701377700366
Product Type: Drug
Control Number: 258574
DIN(s): 02497220, 02497247
Manufacturer: ViiV Healthcare ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-11-12
Decision / Authorization Date: 2022-12-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1696010036746
Product Type: Drug
Control Number: 272688
DIN(s): 02541769
Manufacturer: Ultragenyx Pharmaceutical Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-02-24
Decision / Authorization Date: 2023-09-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1695648310158
Product Type: Drug
Control Number: 256629
DIN(s): 02541416
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-06-01
Decision / Authorization Date: 2023-09-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1695999988500
Product Type: Drug
Control Number: 267438
Manufacturer: Argenx BV
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-19
Decision / Authorization Date: 2023-09-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697216175270
Product Type: Drug
Control Number: 243224
DIN(s): 02541602, 02541610, 02541629, 02541637
Manufacturer: KYE Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-20
Decision / Authorization Date: 2023-09-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1695846822831
Product Type: Drug
Control Number: 276302
Manufacturer: Pfizer Canada ULC (on behalf of BioNTech Manufacturing GmbH)
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Decision / Authorization Date: 2023-09-28
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
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
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
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