Review decisions
Showing 20 results of 2107 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698843751956
Product Type: Drug
Control Number: 266249
DIN(s): 02482592
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-07-20
Decision / Authorization Date: 2023-07-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698760127896
Product Type: Drug
Control Number: 259843
DIN(s): 02533464
Manufacturer: Aequus Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-12-20
Decision / Authorization Date: 2022-12-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698780442306
Product Type: Drug
Control Number: 264296
DIN(s): 02537532
Manufacturer: Acutis Biotherapeutics, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-05-13
Decision / Authorization Date: 2023-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698761313167
Product Type: Drug
Control Number: 246125
DIN(s): 02536145
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-12-04
Decision / Authorization Date: 2023-05-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698758419366
Product Type: Drug
Control Number: 259397
DIN(s): 02533030
Manufacturer: Bristol-Myers Squibb
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-12-08
Decision / Authorization Date: 2023-11-24
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