Review decisions
Showing 1070 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00741
Product Type: Drug
Control Number: 239719
DIN(s): 02509695
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-05-21
Decision / Authorization Date: 2020-12-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00742
Product Type: Drug
Control Number: 236910
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-03-05
Decision / Authorization Date: 2020-12-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00574
Product Type: Drug
Control Number: 247369, 247724
DIN(s): 02522829, 02522837
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-11
Issued / Original Publication Date: 2022-02-04
Decision / Authorization Date: 2021-11-30
Updated Date: 2024-07-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00735
Product Type: Drug
Control Number: 240024
Manufacturer: EMD Serono, A division of EMD Inc. Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-05-27
Decision / Authorization Date: 2020-12-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00730
Product Type: Drug
Control Number: 244906
DIN(s): 02509210
Manufacturer: BioNTech Manufacturing GmbH. Importer: Pfizer Canada ULC.
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: 2020-10-09
Decision / Authorization Date: 2020-12-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00251
Issued / Original Publication Date: 2020-12-09
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00624
Product Type: Drug
Control Number: 242332
DIN(s): 02531836
Manufacturer: Telix Pharmaceuticals (US), Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-06
Issued / Original Publication Date: 2023-02-03
Decision / Authorization Date: 2022-10-13
Updated Date: 2025-02-05
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
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) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-12-04
Issued / Original Publication Date: 2021-11-25
Decision / Authorization Date: 2021-08-19
Updated Date: 2025-05-28