Review decisions

Showing 120 results of 820 total
Regulatory Decision Summary for Simlandi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00908
Product Type: Drug
Control Number: 244990
DIN(s): 02523949, 02523957, 02523965
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-07
Decision / Authorization Date: 2022-01-05
Summary Basis of Decision for Vegzelma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684869579695
Product Type: Drug
Control Number: 258973
DIN(s): 02534177, 02534185
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-12-29
Issued / Original Publication Date: 2023-05-02
Decision / Authorization Date: 2023-01-03
Regulatory Decision Summary for Yuflyma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00906
Product Type: Drug
Control Number: 247265
DIN(s): 02523760, 02523779
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-12
Decision / Authorization Date: 2021-12-24
Regulatory Decision Summary for Ixifi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00901
Product Type: Drug
Control Number: 248134
DIN(s): 02523191
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-08
Decision / Authorization Date: 2021-12-21
Summary Basis of Decision for Tecartus
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00563
Product Type: Drug
Control Number: 246355
DIN(s): 02516667
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2021-12-06
Regulatory Decision Summary for Saphnelo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00897
Product Type: Drug
Control Number: 246187
DIN(s): 02522845
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-09
Decision / Authorization Date: 2021-11-30
Regulatory Decision Summary for Aybintio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00900
Product Type: Drug
Control Number: 247369
DIN(s): 02522829, 02522837
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-12
Decision / Authorization Date: 2021-11-30
Summary Basis of Decision for Truseltiq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00561
Product Type: Drug
Control Number: 246904
Manufacturer: QED Therapeutics, Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2021-11-30
Summary Basis of Decision for Gavreto
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00559
Product Type: Drug
Control Number: 243731
DIN(s): 02517590
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2021-11-26
Regulatory Decision Summary for Wegovy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00896
Product Type: Drug
Control Number: 247235
DIN(s): 02522551, 02522578, 02522586, 02522594, 02522608
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-08
Decision / Authorization Date: 2021-11-23

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