Review decisions
Showing 330 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00453
Product Type: Drug
Control Number: 218531
DIN(s): 02490064, 02490072, 02490080, 02490099, 02490102
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-07-23
Issued / Original Publication Date: 2019-12-11
Decision / Authorization Date: 2019-07-04
Updated Date: 2023-09-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00442
Product Type: Drug
Control Number: 218389
DIN(s): 02485648
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-07-23
Issued / Original Publication Date: 2019-08-15
Decision / Authorization Date: 2019-02-13
Updated Date: 2026-03-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00467
Product Type: Drug
Control Number: 218346
DIN(s): 02490005
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-07-20
Issued / Original Publication Date: 2020-03-02
Decision / Authorization Date: 2019-07-03
Updated Date: 2024-07-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00461
Product Type: Drug
Control Number: 218224
DIN(s): 02490536
Manufacturer: Puma Biotechnology Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-07-19
Issued / Original Publication Date: 2020-01-29
Decision / Authorization Date: 2019-07-16
Updated Date: 2023-12-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00439
Product Type: Drug
Control Number: 218145
DIN(s): 02485613
Manufacturer: Dompé farmaceutici S.p.A.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-07-16
Issued / Original Publication Date: 2019-07-24
Decision / Authorization Date: 2019-02-08
Updated Date: 2024-12-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00449
Product Type: Drug
Control Number: 218183
DIN(s): 02489430, 02489449
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-07-13
Issued / Original Publication Date: 2019-11-15
Decision / Authorization Date: 2019-06-14
Updated Date: 2024-03-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00452
Product Type: Drug
Control Number: 217663
DIN(s): 02490366
Manufacturer: Otsuka Pharmaceutical Co., Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-06-29
Issued / Original Publication Date: 2019-12-11
Decision / Authorization Date: 2019-07-11
Updated Date: 2025-06-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00543
Product Type: Drug
Control Number: 217524
DIN(s): 02489430, 02489449
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-06-22
Issued / Original Publication Date: 2021-07-21
Decision / Authorization Date: 2021-01-05
Updated Date: 2024-03-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00433
Product Type: Drug
Control Number: 217184
DIN(s): 02484552
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-06-18
Issued / Original Publication Date: 2019-05-29
Decision / Authorization Date: 2019-01-09
Updated Date: 2024-03-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00441
Product Type: Drug
Control Number: 217033
DIN(s): 02485427, 02485435
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-06-15
Issued / Original Publication Date: 2019-08-19
Decision / Authorization Date: 2019-02-06
Updated Date: 2024-06-13