Review decisions

Showing 970 results of 2628 total
Regulatory Decision Summary for Trelegy Ellipta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00867
Product Type: Drug
Control Number: 240101
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-05-28
Decision / Authorization Date: 2021-05-11
Regulatory Decision Summary for Pfizer-BioNTech COVID-19 Vaccine
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00802
Product Type: Drug
Control Number: 251730
DIN(s): 02509210
Manufacturer: BioNTech Manufacturing GmbH. Importer: Pfizer Canada ULC.
Submission Type: Application filed under section 3 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2021-04-16
Decision / Authorization Date: 2021-05-05
Summary safety review - Janssen COVID-19 Vaccine - Assessing the Potential Risk of Thrombosis in combination with Thrombocytopenia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00266
Issued / Original Publication Date: 2021-05-04
Regulatory Decision Summary for Inprosub
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01028
Product Type: Drug
Control Number: 239820
DIN(s): 02515504
Manufacturer: Ibsa Institut Biochimique SA
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-05-22
Decision / Authorization Date: 2021-04-30
Summary Basis of Decision for Orladeyo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00610
Product Type: Drug
Control Number: 252301
DIN(s): 02527693
Manufacturer: BioCryst Pharmaceuticals, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-30
Issued / Original Publication Date: 2022-10-19
Decision / Authorization Date: 2022-06-02
Updated Date: 2025-06-25
Regulatory Decision Summary for Vyxeos
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00952
Product Type: Drug
Control Number: 242743
DIN(s): 02515490
Manufacturer: Jazz Pharmaceuticals Ireland Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-08-21
Decision / Authorization Date: 2021-04-29
Regulatory Decision Summary for Ponvory
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00838
Product Type: Drug
Control Number: 239537
DIN(s): 02515474, 02515482
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-05-15
Decision / Authorization Date: 2021-04-28
Regulatory Decision Summary for Polivy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00810
Product Type: Drug
Control Number: 243840
DIN(s): 02515431
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-09-10
Decision / Authorization Date: 2021-04-27
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
Date Filed / Submission Date: 2021-04-26
Issued / Original Publication Date: 2022-08-23
Decision / Authorization Date: 2022-04-08
Updated Date: 2025-08-19
Regulatory Decision Summary for Zenhale
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00814
Product Type: Drug
Control Number: 239493
Manufacturer: Organon Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-05-14
Decision / Authorization Date: 2021-04-23

Displaying 961 - 970 of 2628 | Page 97 of 263
Date modified: