Review decisions
Showing 40 results of 139 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706278116175
Product Type: Drug
Control Number: 271108
DIN(s): 02471469, 02471477, 02523930, 02540258
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-01-04
Decision / Authorization Date: 2023-08-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706712320386
Product Type: Drug
Control Number: 266710
DIN(s): 02434407, 02486733, 02486741, 02486768, 02486776, 02540215
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-08-04
Decision / Authorization Date: 2023-08-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706026709659
Product Type: Drug
Control Number: 273908
DIN(s): 02544555, 02544563, 02544571
Manufacturer: Amryt Pharmaceuticals DAC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Decision / Authorization Date: 2024-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705502911003
Product Type: Drug
Control Number: 274717
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2023-04-26
Decision / Authorization Date: 2023-10-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705507252665
Product Type: Drug
Control Number: 273313
Manufacturer: Novavax Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2023-03-15
Decision / Authorization Date: 2023-11-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1713201445261
Product Type: Drug
Control Number: 273575
DIN(s): 02397412, 02442612, 02442620, 02519364, 02543451
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-03-24
Decision / Authorization Date: 2023-11-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1703188857510
Product Type: Drug
Control Number: 264439
DIN(s): 02470365, 02492504, 02510049, 02524252
Manufacturer: Sanofi-aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-20
Decision / Authorization Date: 2023-04-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1704984251239
Product Type: Drug
Control Number: 271030
DIN(s): 02539888
Manufacturer: Mirum Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-12-28
Decision / Authorization Date: 2023-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706106900025
Product Type: Drug
Control Number: 270698
DIN(s): 02478374, 02540185
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-15
Decision / Authorization Date: 2023-08-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706285264505
Product Type: Drug
Control Number: 270386
DIN(s): 02409623, 02409658, 02539993
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-12-05
Decision / Authorization Date: 2023-07-24