Review decisions
Showing 80 results of 332 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01061
Product Type: Drug
Control Number: 254495
DIN(s): 02528908
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-07-09
Decision / Authorization Date: 2022-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01102
Product Type: Drug
Control Number: 245854
DIN(s): 02528363, 02528371, 02528398
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-10-29
Decision / Authorization Date: 2022-06-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1693490140440
Product Type: Drug
Control Number: 265619
DIN(s): 02538881
Manufacturer: Sun Pharmaceutical Industries Limited
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-06-29
Issued / Original Publication Date: 2023-08-30
Decision / Authorization Date: 2023-06-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01060
Product Type: Drug
Control Number: 255700
DIN(s): 02528320, 02528339
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-13
Decision / Authorization Date: 2022-06-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00981
Product Type: Drug
Control Number: 253502
DIN(s): 02527707
Manufacturer: Amylyx Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-06-07
Decision / Authorization Date: 2022-06-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1693591697586
Product Type: Drug
Control Number: 261689
DIN(s): 02538652, 02538660, 02538725, 02538733, 02538741, 02538768, 02538776, 02538784, 02538792, 02538806, 02538814
Manufacturer: Endo Ventures Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-06-09
Issued / Original Publication Date: 2023-08-31
Decision / Authorization Date: 2023-06-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1703192825535
Product Type: Drug
Control Number: 256629
DIN(s): 02541416
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-06-01
Issued / Original Publication Date: 2023-12-21
Decision / Authorization Date: 2023-09-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00961
Product Type: Drug
Control Number: 253904
DIN(s): 02527618
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-06-18
Decision / Authorization Date: 2022-05-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00966
Product Type: Drug
Control Number: 251005
Manufacturer: Biogen Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-03-23
Decision / Authorization Date: 2022-05-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01067
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
Decision / Authorization Date: 2022-05-06