Review decisions

Showing 770 results of 2304 total
Regulatory Decision Summary for Redesca, Redesca HP
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00743
Product Type: Drug
Control Number: 231767
DIN(s): 02509075, 02509083, 02509091, 02509105, 02509113, 02509121, 02509148, 02509156
Manufacturer: Shenzhen Techdow Pharmaceutical Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-09-23
Decision / Authorization Date: 2020-12-07
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 Basis of Decision for Minjuvi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00560
Product Type: Drug
Control Number: 247025
DIN(s): 02518627
Manufacturer: Incyte Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-04
Issued / Original Publication Date: 2021-11-25
Decision / Authorization Date: 2021-08-19
Updated Date: 2023-07-07
Summary Basis of Decision for Trikafta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00553
Product Type: Drug
Control Number: 246955
DIN(s): 02517140, 02526670, 02542277, 02542285
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-04
Issued / Original Publication Date: 2021-10-16
Decision / Authorization Date: 2021-06-18
Updated Date: 2024-11-28
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 Reblozyl
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00507
Product Type: Drug
Control Number: 236441
DIN(s): 02505541, 02505568
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission
Issued / Original Publication 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
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

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