Review decisions

Showing 40 results of 2223 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1711550170651
Product Type: Drug
Control Number: 257284
DIN(s): 02495155, 02520893, 02539721
Manufacturer: AbbVie corp.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-10-05
Decision / Authorization Date: 2023-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1709049767533
Product Type: Drug
Control Number: 251521
DIN(s): 02324032, 02371081
Manufacturer: Merz Pharmaceuticals GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-04-08
Decision / Authorization Date: 2022-03-15
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1709660755239
Product Type: Drug
Control Number: 273683
DIN(s): 02543028
Manufacturer: Grifols Therapeutics LLC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-03-24
Decision / Authorization Date: 2023-11-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1709310383688
Product Type: Drug
Control Number: 261864
DIN(s): 02491559
Manufacturer: Alexion Pharma Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-02-25
Decision / Authorization Date: 2023-01-06
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1712086340348
Product Type: Drug
Control Number: 269372
DIN(s): 02542137
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-11-03
Decision / Authorization Date: 2023-10-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1712843981486
Product Type: Drug
Control Number: 268111
DIN(s): 02541742
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-09-23
Decision / Authorization Date: 2023-10-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708530494939
Product Type: Drug
Control Number: 272504
DIN(s): 02446626, 02446634
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-15
Decision / Authorization Date: 2023-12-29
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