Review decisions
Showing 20 results of 332 total
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/RDS1712323528783
Product Type: Drug
Control Number: 268384
DIN(s): 02543605
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-03
Decision / Authorization Date: 2023-12-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708015333213
Product Type: Drug
Control Number: 259953
DIN(s): 02543338
Manufacturer: Trimedic Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-30
Decision / Authorization Date: 2023-11-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710259036712
Product Type: Drug
Control Number: 267148
DIN(s): 02541742
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-18
Decision / Authorization Date: 2023-09-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706026709659
Product Type: Drug
Control Number: 273908
DIN(s): 02544555, 02544563, 02544571
Manufacturer: Amryt Pharmaceuticals DAC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Decision / Authorization Date: 2024-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706812807082
Product Type: Drug
Control Number: 271065
DIN(s): 02543931
Manufacturer: Horizon Therapeutics Ireland DAC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-12-30
Decision / Authorization Date: 2023-12-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714574957940
Product Type: Drug
Control Number: 251688
DIN(s): 02542706
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-19
Decision / Authorization Date: 2023-11-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705588381487
Product Type: Drug
Control Number: 272785
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-02-27
Decision / Authorization Date: 2023-12-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1713896533366
Product Type: Drug
Control Number: 267923
DIN(s): 02542420
Manufacturer: Alnylam Netherlands B.v.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-31
Decision / Authorization Date: 2023-10-18