Review decisions

Showing 260 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00465
Product Type: Drug
Control Number: 221824
DIN(s): 02492806
Manufacturer: IRE ELiT S.A.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-03-09
Updated Date: 2022-11-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00464
Product Type: Drug
Control Number: 221945
DIN(s): 02494175
Manufacturer: Galderma Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-03-05
Updated Date: 2022-11-02
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 (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-03-05
Issued / Original Publication Date: 2020-11-30
Decision / Authorization Date: 2020-09-25
Updated Date: 2025-11-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00591
Product Type: Drug
Control Number: 235995
DIN(s): 02524317, 02524325
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-02-27
Issued / Original Publication Date: 2022-06-23
Decision / Authorization Date: 2022-01-28
Updated Date: 2024-06-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00536
Product Type: Drug
Control Number: 236197
DIN(s): 02513218
Manufacturer: Searchlight Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-02-18
Issued / Original Publication Date: 2021-06-16
Decision / Authorization Date: 2021-03-05
Updated Date: 2023-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00531
Product Type: Drug
Control Number: 233288
DIN(s): 02510839, 02542269
Manufacturer: Lundbeck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-02-03
Issued / Original Publication Date: 2021-05-17
Decision / Authorization Date: 2021-01-11
Updated Date: 2024-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00552
Product Type: Drug
Control Number: 235685
DIN(s): 02511045, 02511053, 02511061, 02511088, 02511096
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-01-31
Issued / Original Publication Date: 2021-09-23
Decision / Authorization Date: 2021-01-14
Updated Date: 2023-08-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00528
Product Type: Drug
Control Number: 235672
DIN(s): 02510936
Manufacturer: Sanofi Pasteur Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-01-31
Issued / Original Publication Date: 2021-05-07
Decision / Authorization Date: 2021-01-14
Updated Date: 2025-01-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00458
Product Type: Drug
Control Number: 220584
DIN(s): 02492032, 02492040
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-01-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00514
Product Type: Drug
Control Number: 237194
DIN(s): 02506343
Manufacturer: Alnylam Netherlands B.v.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-01-19
Issued / Original Publication Date: 2021-01-21
Decision / Authorization Date: 2020-10-09
Updated Date: 2025-07-29