Review decisions

Showing 290 results of 2295 total
Summary Safety Review - Finasteride - Assessing the Potential Risks of Suicide, Suicidal Thoughts (Suicidal Ideation) and Self-injury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00290
Issued / Original Publication Date: 2023-01-19
Summary Safety Review - Third Generation Aromatase Inhibitors (anastrozole, exemestane, letrozole) - Assessing the Potential Risk of Tendon Disorders
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00289
Issued / Original Publication Date: 2023-01-17
Regulatory Decision Summary for Xarelto
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705593803323
Product Type: Drug
Control Number: 234756
DIN(s): 02510162, 02510170
Manufacturer: Bayer Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-24
Decision / Authorization Date: 2021-01-12
Regulatory Decision Summary for Copaxone
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692037182503
Product Type: Drug
Control Number: 234666
DIN(s): 02245619, 02456915, 02512173
Manufacturer: Teva Canada Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-23
Decision / Authorization Date: 2021-02-04
Regulatory Decision Summary for Hydromorphone Hydrochloride Injection USP
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692291386055
Product Type: Drug
Control Number: 237401
DIN(s): 02145901, 02514435
Manufacturer: Sandoz Canada Incorporated
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-03-20
Decision / Authorization Date: 2021-04-09
Regulatory Decision Summary for Ofev
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694610519770
Product Type: Drug
Control Number: 241747
Manufacturer: Boehringer Ingelheim (Canada) Ltd Ltee
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-07-16
Decision / Authorization Date: 2021-06-25
Regulatory Decision Summary for Spikevax
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01052
Product Type: Drug
Control Number: 262408
Manufacturer: ModernaTX, Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-03-16
Decision / Authorization Date: 2023-01-12
Summary Basis of Decision (SBD) for Epkinly
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1709128914848
Product Type: Drug
Control Number: 271331
DIN(s): 02542293, 02542307
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-01-12
Issued / Original Publication Date: 2024-02-27
Decision / Authorization Date: 2023-10-13
Regulatory Decision Summary for Ruzurgi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00737
Product Type: Drug
Control Number: 234655
DIN(s): 02503034
Manufacturer: Medunik Canada
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-12-20
Decision / Authorization Date: 2023-01-10
Regulatory Decision Summary for Enhertu
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01054
Product Type: Drug
Control Number: 265333
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-06-17
Decision / Authorization Date: 2023-01-06

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