Review decisions

Showing 80 results of 820 total
Summary of Cancellation for Zefylti
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1725902689017
Product Type: Drug
Control Number: 267597
Manufacturer: Curateq Biologics Private Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-09-07
Decision / Authorization Date: 2024-08-01
Regulatory Decision Summary for Rylaze
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01002
Product Type: Drug
Control Number: 257092
DIN(s): 02530406
Manufacturer: Jazz Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-09-27
Decision / Authorization Date: 2022-09-02
Regulatory Decision Summary for Koselugo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01005
Product Type: Drug
Control Number: 243733
DIN(s): 02530139, 02530147
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-09-09
Decision / Authorization Date: 2022-08-31
Summary Basis of Decision for Prevnar 20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00603
Product Type: Drug
Control Number: 253111
DIN(s): 02527049
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-08-31
Summary Basis of Decision for Tabrecta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00602
Product Type: Drug
Control Number: 255972
DIN(s): 02527391, 02527405
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-08-30
Summary Basis of Decision for Semglee
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00600
Product Type: Drug
Control Number: 252068
DIN(s): 02526441
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-08-23
Summary Basis of Decision for Breyanzi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00599
Product Type: Drug
Control Number: 247562
DIN(s): 02527138
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-08-16
Summary Basis of Decision for Byooviz
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00598
Product Type: Drug
Control Number: 251162
DIN(s): 02525852
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-08-12
Regulatory Decision Summary for Myxredlin
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00980
Product Type: Drug
Control Number: 251360
DIN(s): 02529602
Manufacturer: Baxter Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-13
Decision / Authorization Date: 2022-08-03
Summary Basis of Decision (SBD) for Axberi/Axberi HP
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1706623043472
Product Type: Drug
Control Number: 266545
DIN(s): 02539977, 02539985, 02540002, 02540010, 02540029, 02540037, 02540045
Manufacturer: Baxter Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-07-29
Issued / Original Publication Date: 2024-01-26
Decision / Authorization Date: 2023-07-27

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