Review decisions

Showing 1050 results of 2631 total
Summary Basis of Decision for Lumakras
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00562
Product Type: Drug
Control Number: 248435
DIN(s): 02520095, 02552655
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-01-14
Issued / Original Publication Date: 2021-12-07
Decision / Authorization Date: 2021-09-10
Updated Date: 2026-02-09
Summary of Cancellation for Dronabinol (*Reduvo)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692978760470
Product Type: Drug
Control Number: 240372
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-13
Decision / Authorization Date: 2023-05-01
Summary Basis of Decision for Yuflyma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00584
Product Type: Drug
Control Number: 247265
DIN(s): 02523760, 02523779, 02535076, 02535084
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-12
Issued / Original Publication Date: 2022-04-14
Decision / Authorization Date: 2021-12-24
Updated Date: 2024-08-21
Regulatory Decision Summary for Vyepti
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00745
Product Type: Drug
Control Number: 233288
DIN(s): 02510839
Manufacturer: Lundbeck Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-02-03
Decision / Authorization Date: 2021-01-11
Summary of Cancellation for Casirivimab and Imdevimab (Ronapreve)*
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724855581143
Product Type: Drug
Control Number: 256264
Manufacturer: Hoffman-La Roche Limited
Submission Type: New Drug Submission with flexibilities filed for COVID-19 Drug products (NDS-CV)
Date Filed / Submission Date: 2021-01-09
Decision / Authorization Date: 2024-06-21
Regulatory Decision Summary for Retin-A
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00771
Product Type: Drug
Control Number: 235656
DIN(s): 02510243
Manufacturer: Bausch Health, Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-01-30
Decision / Authorization Date: 2021-01-08
Summary Safety Review - Tamiflu (oseltamivir) and generics - Assessing the Potential Risk of Haemorrhages
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00255
Issued / Original Publication Date: 2021-01-08
Regulatory Decision Summary for Foclivia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00752
Product Type: Drug
Control Number: 235556
DIN(s): 02510561, 02510588
Manufacturer: Seqirus UK Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-01-28
Decision / Authorization Date: 2021-01-07
Summary Basis of Decision for Simlandi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00585
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
Issued / Original Publication Date: 2022-04-14
Decision / Authorization Date: 2022-01-05
Updated Date: 2024-07-29
Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs) - Assessing the Potential Risk of Sexual Dysfunction despite Trea™ent Discontinuation
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00254
Issued / Original Publication Date: 2021-01-06

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