Review decisions

Showing 430 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1684952482271
Product Type: Drug
Control Number: 269388
DIN(s): 02537206, 02537214
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-11-03
Decision / Authorization Date: 2023-04-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705595463519
Product Type: Drug
Control Number: 240862
DIN(s): 02537044, 02537052, 02537060
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-19
Decision / Authorization Date: 2023-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692372982357
Product Type: Drug
Control Number: 264825
DIN(s): 02451379, 02463040, 02483831, 02483858, 02537087
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-06-06
Decision / Authorization Date: 2023-04-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1685721892425
Product Type: Drug
Control Number: 263700
DIN(s): 02487144, 02487152
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-04-26
Decision / Authorization Date: 2023-04-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1684435400131
Product Type: Drug
Control Number: 267878
DIN(s): 02347113, 02347121, 02347148, 02365669, 02417103, 02417111, 02417138, 02417146
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-09-14
Decision / Authorization Date: 2023-03-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683570485222
Product Type: Drug
Control Number: 263638
DIN(s): 02537117
Manufacturer: Advanced Accelerator Application USA, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-04-22
Decision / Authorization Date: 2023-04-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683571472631
Product Type: Drug
Control Number: 266965
DIN(s): 02490315, 02490323, 02490331
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-08-12
Decision / Authorization Date: 2023-03-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683639670276
Product Type: Drug
Control Number: 261912
DIN(s): 02436523, 02436531, 02436558, 02536579
Manufacturer: Chiesi Canada Corp.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-01
Decision / Authorization Date: 2023-03-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01109
Product Type: Drug
Control Number: 267448
Manufacturer: Medicago Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-08-30
Decision / Authorization Date: 2023-03-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1755266323193
Product Type: Drug
Control Number: 262121
Manufacturer: Pharma Stullin Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-03-29