Review decisions

Showing 150 results of 809 total
Regulatory Decision Summary for Bevluma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00892
Product Type: Drug
Control Number: 242395
Manufacturer: Centus Biotherapeutics Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-08-20
Decision / Authorization Date: 2021-09-23
Regulatory Decision Summary for Lyumjev
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00863
Product Type: Drug
Control Number: 244611
DIN(s): 02520184, 02520192, 02520206, 02520214, 02520222, 02520230
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-09-30
Decision / Authorization Date: 2021-09-14
Summary Basis of Decision for Wakix
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00550
Product Type: Drug
Control Number: 238175
DIN(s): 02516241, 02516268
Manufacturer: Endo Ventures Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2021-09-14
Regulatory Decision Summary for Lumakras
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00881
Product Type: Drug
Control Number: 248435
DIN(s): 02520095
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-14
Decision / Authorization Date: 2021-09-10
Regulatory Decision Summary for Minjuvi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00849
Product Type: Drug
Control Number: 247025
DIN(s): 02518627
Manufacturer: Incyte Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-04
Decision / Authorization Date: 2021-08-19
Regulatory Decision Summary for Exparel
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00871
Product Type: Drug
Control Number: 231224
Manufacturer: Pacira Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-08-03
Decision / Authorization Date: 2021-08-05
Summary Basis of Decision for Triferic AVNU
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00545
Product Type: Drug
Control Number: 239850
Manufacturer: Rockwell Medical Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2021-07-29
Regulatory Decision Summary for Vablys
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00859
Product Type: Drug
Control Number: 227886
DIN(s): 02518252
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-05-16
Decision / Authorization Date: 2021-07-28
Summary Basis of Decision for Evrysdi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00544
Product Type: Drug
Control Number: 242373
DIN(s): 02514931
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2021-07-27
Summary of Cancellation for Aliqopa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1684433993143
Product Type: Drug
Control Number: 255077
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-26
Decision / Authorization Date: 2021-12-12

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