Review decisions

Showing 10 results of 18 total
Regulatory Decision Summary for Keytruda (pembrolizumab)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1713542168989
Product Type: Drug
Control Number: 275053
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-05
Decision / Authorization Date: 2024-04-12
Regulatory Decision Summary for Xtandi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714051494769
Product Type: Drug
Control Number: 277282
DIN(s): 02407329
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-07-17
Decision / Authorization Date: 2024-01-05
Regulatory Decision Summary for Bimzelx
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1712149040145
Product Type: Drug
Control Number: 273663
DIN(s): 02525267, 02525275
Manufacturer: UBC Canada Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-27
Decision / Authorization Date: 2024-03-11
Regulatory Decision Summary for Awiqli
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1711383693011
Product Type: Drug
Control Number: 273850
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Decision / Authorization Date: 2024-03-12
Regulatory Decision Summary for Tecentriq / Tecentriq SC
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1711121589642
Product Type: Drug
Control Number: 273807
DIN(s): 02462990, 02492393, 02546310
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-29
Decision / Authorization Date: 2024-03-13
Regulatory Decision Summary for Wyost
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710769045419
Product Type: Drug
Control Number: 267788
DIN(s): 02545764
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Decision / Authorization Date: 2024-03-01
Regulatory Decision Summary for Jubbonti
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710165579186
Product Type: Drug
Control Number: 271806
DIN(s): 02545411
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Decision / Authorization Date: 2024-02-16
Regulatory Decision Summary for Bimzelx
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1709215072174
Product Type: Drug
Control Number: 273184
DIN(s): 02525267, 02525275
Manufacturer: UCB Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-09
Decision / Authorization Date: 2024-02-23
Regulatory Decision Summary for Velsipity
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710775270976
Product Type: Drug
Control Number: 271038
DIN(s): 02544903
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-12-28
Decision / Authorization Date: 2024-01-31
Regulatory Decision Summary for Remsima SC
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708630999500
Product Type: Drug
Control Number: 272981
DIN(s): 02511576, 02511584
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-02
Decision / Authorization Date: 2024-02-15

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