Review decisions

Showing 100 results of 820 total
Regulatory Decision Summary for Tavneos
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00996
Product Type: Drug
Control Number: 248255
DIN(s): 02526662
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-12
Decision / Authorization Date: 2022-04-14
Summary Basis of Decision for Yuflyma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00584
Product Type: Drug
Control Number: 247265
DIN(s): 02523760, 02523779
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-04-14
Regulatory Decision Summary for Semglee
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01066
Product Type: Drug
Control Number: 252068
DIN(s): 02526441
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-26
Decision / Authorization Date: 2022-04-08
Summary Basis of Decision for Ixifi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00583
Product Type: Drug
Control Number: 248134
DIN(s): 02523191
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-04-06
Regulatory Decision Summary for Palynziq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00937
Product Type: Drug
Control Number: 251687
DIN(s): 02526247, 02526255, 02526263
Manufacturer: BioMarin International Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-14
Decision / Authorization Date: 2022-03-30
Regulatory Decision Summary for Rybrevant
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00941
Product Type: Drug
Control Number: 254440
DIN(s): 02526182
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-05
Decision / Authorization Date: 2022-03-30
Summary Basis of Decision for Niopeg
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1730903762975
Product Type: Drug
Control Number: 262438
DIN(s): 02546973
Manufacturer: Nora Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-23
Issued / Original Publication Date: 2024-11-07
Decision / Authorization Date: 2024-04-17
Regulatory Decision Summary for Zynrelef
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01091
Product Type: Drug
Control Number: 233561
DIN(s): 02525968, 02526018, 02526026, 02526034
Manufacturer: Heron Therapeutics, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-11-18
Decision / Authorization Date: 2022-03-16
Regulatory Decision Summary for Byooviz (ranibizumab)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00930
Product Type: Drug
Control Number: 251162
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-03-29
Decision / Authorization Date: 2022-03-08
Regulatory Decision Summary for Netvision
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00922
Product Type: Drug
Control Number: 248874
DIN(s): 02525542
Manufacturer: Canadian Molecular Imaging Probe Consortium (CanProbe)
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-03-12
Decision / Authorization Date: 2022-02-24

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