Review decisions
Showing 190 results of 2299 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692107292830
Product Type: Drug
Control Number: 269021
DIN(s): 02540207
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-25
Decision / Authorization Date: 2023-08-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1693422463164
Product Type: Drug
Control Number: 267443
DIN(s): 02539934, 02539942, 02539950
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-29
Decision / Authorization Date: 2023-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694618321621
Product Type: Drug
Control Number: 263460
DIN(s): 02539047, 02539055, 02539063, 02539071
Manufacturer: Sun Pharmaceuticals Industries Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-04-14
Decision / Authorization Date: 2023-06-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1691775757350
Product Type: Drug
Control Number: 269369
DIN(s): 02539756, 02539764
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-11-02
Decision / Authorization Date: 2023-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1691154193657
Product Type: Drug
Control Number: 267120
DIN(s): 02536080, 02536099, 02536102, 02536110
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-19
Decision / Authorization Date: 2023-03-10
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