Review decisions

Showing 80 results of 819 total
Regulatory Decision Summary for Susvimo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01000
Product Type: Drug
Control Number: 254848
DIN(s): 02530589
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-14
Decision / Authorization Date: 2022-09-14
Regulatory Decision Summary for Eyezirgan
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01040
Product Type: Drug
Control Number: 221456
DIN(s): 02530546
Manufacturer: Laboratoires Thea
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-11-16
Decision / Authorization Date: 2022-09-08
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 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

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