Review decisions

Showing 1060 results of 2627 total
Summary Safety Review - Tramadol-containing products - Assessing the Potential Risk of Hallucinations
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00253
Issued / Original Publication Date: 2020-12-29
Regulatory Decision Summary for Verity-BCG
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00744
Product Type: Drug
Control Number: 221579
DIN(s): 02508613
Manufacturer: Verity Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-11-01
Decision / Authorization Date: 2020-12-24
Summary of Cancellation for Elidel
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1701362974599
Product Type: Drug
Control Number: 247851
DIN(s): 02247238
Manufacturer: Bausch Health, Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-24
Decision / Authorization Date: 2023-09-14
Regulatory Decision Summary for Moderna COVID-19 Vaccine
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00736
Product Type: Drug
Control Number: 244946
DIN(s): 02510014
Manufacturer: Moderna Therapeutics Inc.
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: 2020-10-13
Decision / Authorization Date: 2020-12-23
Summary Basis of Decision for Tpoxx
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00578
Product Type: Drug
Control Number: 247561
DIN(s): 02522772
Manufacturer: SIGA Technologies, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-22
Issued / Original Publication Date: 2022-02-21
Decision / Authorization Date: 2021-11-29
Updated Date: 2025-09-18
Summary Basis of Decision for HyQvia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00592
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
Issued / Original Publication Date: 2022-06-28
Decision / Authorization Date: 2022-01-14
Updated Date: 2024-02-09
Regulatory Decision Summary for Increlex
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00739
Product Type: Drug
Control Number: 235023
DIN(s): 02509733
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-01-09
Decision / Authorization Date: 2020-12-17
Summary Basis of Decision for Breyanzi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00599
Product Type: Drug
Control Number: 247562
DIN(s): 02527138
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-17
Issued / Original Publication Date: 2022-08-16
Decision / Authorization Date: 2022-05-06
Updated Date: 2024-12-23
Summary Safety Review - Carboplatin-containing products - Assessing the Potential Risk of Posterior Reversible Encephalopathy Syndrome
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00252
Issued / Original Publication Date: 2020-12-16
Summary Basis of Decision for Zepzelca
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00566
Product Type: Drug
Control Number: 247485
DIN(s): 02520834
Manufacturer: Jazz Pharmaceuticals Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-12-16
Issued / Original Publication Date: 2022-01-04
Decision / Authorization Date: 2021-09-29
Updated Date: 2026-02-02

Displaying 1051 - 1060 of 2627 | Page 106 of 263
Date modified: