Review decisions

Showing 1080 results of 2627 total
Summary Basis of Decision for Vaxneuvance
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00579
Product Type: Drug
Control Number: 247042
DIN(s): 02522403
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-04
Issued / Original Publication Date: 2022-02-25
Decision / Authorization Date: 2021-11-16
Updated Date: 2024-08-15
Summary Safety Review - Direct-acting antiviral products containing a Protease Inhibitor - Assessing the Potential Risks of Hepatic Decompensation and Hepatic Failure
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00249
Issued / Original Publication Date: 2020-12-02
Summary Safety Review - Bacitracin for Injection Products - Assessing the Potential Risks of Nephrotoxicity and Anaphylactic Reactions
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00250
Issued / Original Publication Date: 2020-12-02
Regulatory Decision Summary for RiaSTAP
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00751
Product Type: Drug
Control Number: 227551
Manufacturer: CSL Behring Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-05-09
Decision / Authorization Date: 2020-11-30
Summary Basis of Decision for Jcovden (previously the Janssen COVID-19 Vaccine)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00522
Product Type: Drug
Control Number: 246758
DIN(s): 02513153
Manufacturer: Janssen Inc.
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-11-30
Issued / Original Publication Date: 2021-03-19
Decision / Authorization Date: 2021-03-05
Updated Date: 2024-01-19
Summary Basis of Decision for Truseltiq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00561
Product Type: Drug
Control Number: 246904
Manufacturer: QED Therapeutics, Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-11-30
Issued / Original Publication Date: 2021-11-30
Decision / Authorization Date: 2021-09-27
Updated Date: 2025-06-19
Regulatory Decision Summary for Descovy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00770
Product Type: Drug
Control Number: 234525
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-17
Decision / Authorization Date: 2020-11-27
Regulatory Decision Summary for Xarelto
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00781
Product Type: Drug
Control Number: 233166
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-11-01
Decision / Authorization Date: 2020-11-27
Regulatory Decision Summary for Hadlima / Hadlima PushTouch
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00733
Product Type: Drug
Control Number: 234258
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-13
Decision / Authorization Date: 2020-11-26
Regulatory Decision Summary for Sodium Pertechnetate ( 99m Tc) Injection
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00812
Product Type: Drug
Control Number: 231915
DIN(s): 02508230
Manufacturer: BC Cancer, Part of the ProvInc.ial Health Services Authority
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-12-16
Decision / Authorization Date: 2020-11-26

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