Review decisions
Showing 140 results of 332 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692973508042
Product Type: Drug
Control Number: 240071
Manufacturer: Biogen Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-05-29
Decision / Authorization Date: 2023-02-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00546
Product Type: Drug
Control Number: 239537
DIN(s): 02515474, 02515482
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-05-15
Issued / Original Publication Date: 2021-08-05
Decision / Authorization Date: 2021-04-28
Updated Date: 2023-07-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00933
Product Type: Drug
Control Number: 225793
DIN(s): 02498472, 02498480
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-03-15
Decision / Authorization Date: 2020-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00677
Product Type: Drug
Control Number: 224850
DIN(s): 02498049
Manufacturer: Knight Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-02-26
Decision / Authorization Date: 2020-04-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00549
Product Type: Drug
Control Number: 237511
DIN(s): 02515814, 02515822
Manufacturer: Jazz Pharmaceuticals Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-03-30
Issued / Original Publication Date: 2021-09-10
Decision / Authorization Date: 2021-05-13
Updated Date: 2023-02-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00547
Product Type: Drug
Control Number: 237287
DIN(s): 02515067
Manufacturer: Waymade PLC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-03-20
Issued / Original Publication Date: 2021-08-25
Decision / Authorization Date: 2021-04-20
Updated Date: 2023-07-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00533
Product Type: Drug
Control Number: 237410
DIN(s): 02513080
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-03-20
Issued / Original Publication Date: 2021-06-08
Decision / Authorization Date: 2021-03-02
Updated Date: 2023-07-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00646
Product Type: Drug
Control Number: 227315
DIN(s): 02497204, 02497220, 02497247
Manufacturer: ViiV Healthcare ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-04-29
Decision / Authorization Date: 2020-03-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00815
Product Type: Drug
Control Number: 226941
DIN(s): 02497042, 02497069, 02497077, 02497085
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-04-17
Decision / Authorization Date: 2020-03-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00648
Product Type: Drug
Control Number: 223225
DIN(s): 02496429, 02496437
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-12-21
Decision / Authorization Date: 2020-02-20