Review decisions

Showing 70 results of 139 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1691156689629
Product Type: Drug
Control Number: 267314
DIN(s): 02536080, 02536099, 02536102, 02536110
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-26
Decision / Authorization Date: 2023-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1690902285653
Product Type: Drug
Control Number: 270849
DIN(s): 02520788
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-12-20
Decision / Authorization Date: 2023-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694097699416
Product Type: Drug
Control Number: 256961
Manufacturer: Celgene Inc. / Bristol-Myers Squibb
Submission Type: Supplement to a New Drug Submission - Confirmatory
Date Filed / Submission Date: 2021-09-23
Decision / Authorization Date: 2023-06-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694526985734
Product Type: Drug
Control Number: 265223
DIN(s): 02538555, 02538563
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-06-15
Decision / Authorization Date: 2023-06-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697217066787
Product Type: Drug
Control Number: 264963
DIN(s): 02512963
Manufacturer: Beigene Switzerland GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-06-07
Decision / Authorization Date: 2023-05-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697728420996
Product Type: Drug
Control Number: 265427
DIN(s): 02475200, 02475219
Manufacturer: AstraZeneca Canada Inc
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-06-22
Decision / Authorization Date: 2023-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1690554055228
Product Type: Drug
Control Number: 266471
DIN(s): 02539845, 02539853, 02539861
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-07-27
Decision / Authorization Date: 2023-07-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1691593234367
Product Type: Drug
Control Number: 266545
DIN(s): 02539977, 02539985, 02540002, 02540010, 02540029, 02540037, 02540045
Manufacturer: Baxter Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-07-29
Decision / Authorization Date: 2023-07-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692295194036
Product Type: Drug
Control Number: 270922
DIN(s): 02527049
Manufacturer: Pfizer Canada ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-22
Decision / Authorization Date: 2023-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1689349413724
Product Type: Drug
Control Number: 266244
DIN(s): 02522551, 02522578, 02522586, 02522594, 02522608, 02528509, 02528517, 02528525, 02528533, 02528541
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-07-20
Decision / Authorization Date: 2023-06-29