Review decisions

Showing 50 results of 1257 total
Regulatory Decision Summary for Uplizna
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
Regulatory Decision Summary for Yervoy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706819201300
Product Type: Drug
Control Number: 270801
DIN(s): 02379384
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-19
Decision / Authorization Date: 2023-12-07
Regulatory Decision Summary for Kalydeco
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1713201445261
Product Type: Drug
Control Number: 273575
DIN(s): 02397412, 02442612, 02442620, 02519364, 02543451
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-03-24
Decision / Authorization Date: 2023-11-28
Regulatory Decision Summary for Noyada
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714578062319
Product Type: Drug
Control Number: 248574
DIN(s): 02543907, 02543915
Manufacturer: Ethypharm Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-20
Decision / Authorization Date: 2023-12-18
Regulatory Decision Summary for Doptelet
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
Regulatory Decision Summary for Abrysvo (Respiratory Syncytial Virus Stabilized Prefusion F Subunit Vaccine)
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
Regulatory Decision Summary for Wezlana/Wezlana I.V.
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705591073125
Product Type: Drug
Control Number: 269097
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-10-27
Decision / Authorization Date: 2023-12-27
Regulatory Decision Summary for Trikafta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1709225685625
Product Type: Drug
Control Number: 271750
DIN(s): 02517140, 02526670, 02542277, 02542285
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-01-26
Decision / Authorization Date: 2023-10-16
Regulatory Decision Summary for Tembexa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710785654782
Product Type: Drug
Control Number: 262030
DIN(s): 02543842, 02543850
Manufacturer: Emergent BioDefense Operations Lansing LLC
Submission Type: Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2022-03-08
Decision / Authorization Date: 2023-12-11
Regulatory Decision Summary for Amvuttra
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

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