Review decisions

Showing 820 results of 2627 total
Regulatory Decision Summary for Paxlovid
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00904
Product Type: Drug
Control Number: 259186
DIN(s): 02524031
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-12-01
Decision / Authorization Date: 2022-01-17
Regulatory Decision Summary for Tecentriq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00911
Product Type: Drug
Control Number: 254361
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-30
Decision / Authorization Date: 2022-01-14
Regulatory Decision Summary for HyQvia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01080
Product Type: Drug
Control Number: 247727
DIN(s): 02524368, 02524376, 02524384, 02524392, 02524406
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-18
Decision / Authorization Date: 2022-01-14
Regulatory Decision Summary for Benvyon
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01083
Product Type: Drug
Control Number: 248962
DIN(s): 02524309
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-29
Decision / Authorization Date: 2022-01-14
Regulatory Decision Summary for Xofluza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00953
Product Type: Drug
Control Number: 253245
DIN(s): 02524163
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-01-13
Decision / Authorization Date: 2022-01-13
Summary Safety Review - Esophageal Stents - Assessing the Potential Risk of Bilateral Vocal Cord Paralysis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00279
Issued / Original Publication Date: 2022-01-13
Summary Safety Review - Xeljanz/Xeljanz XR (tofacitinib) - Assessing the Potential Risks of Serious Heart-related Problems and Cancer
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00278
Issued / Original Publication Date: 2022-01-12
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
Regulatory Decision Summary for Phesgo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00912
Product Type: Drug
Control Number: 254251
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-28
Decision / Authorization Date: 2022-01-05
Regulatory Decision Summary for Ozempic
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01068
Product Type: Drug
Control Number: 248754
DIN(s): 02523930
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-01-25
Decision / Authorization Date: 2022-01-04

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