Review decisions

Showing 20 results of 819 total
Regulatory Decision Summary for Steqeyma/Steqeyma IV
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722628438095
Product Type: Drug
Control Number: 274939
DIN(s): 02550245, 02550253, 02550261
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-30
Decision / Authorization Date: 2024-07-30
Regulatory Decision Summary for Okedi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722527517248
Product Type: Drug
Control Number: 264840
DIN(s): 02544601, 02544628
Manufacturer: Laboratorios Farmaceuticos Rovi, S.A.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-06-03
Decision / Authorization Date: 2024-03-21
Regulatory Decision Summary for Combogesic IV
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1730395674104
Product Type: Drug
Control Number: 260262
DIN(s): 02544806
Manufacturer: Biosyent Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-01-11
Decision / Authorization Date: 2024-02-02
Regulatory Decision Summary for Niopeg
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714499567288
Product Type: Drug
Control Number: 262438
DIN(s): 02546973
Manufacturer: Nora Pharma
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-17
Decision / Authorization Date: 2024-04-17
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 Pronextica Liquid
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
Regulatory Decision Summary for Levodexa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708351809911
Product Type: Drug
Control Number: 258157
DIN(s): 02543745
Manufacturer: Xediton Pharmaceuticals
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-10-29
Decision / Authorization Date: 2023-12-12
Regulatory Decision Summary for Epidiolex
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714138409580
Product Type: Drug
Control Number: 268559
DIN(s): 02543079
Manufacturer: GW Research Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-10-07
Decision / Authorization Date: 2023-11-15
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

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