Review decisions

Showing 360 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00462
Product Type: Drug
Control Number: 212140
DIN(s): 02483467, 02483475
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-12-15
Issued / Original Publication Date: 2020-02-04
Decision / Authorization Date: 2019-08-15
Updated Date: 2024-08-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00428
Product Type: Drug
Control Number: 212066
DIN(s): 02483076
Manufacturer: United Therapeutics Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-12-14
Issued / Original Publication Date: 2019-05-06
Decision / Authorization Date: 2018-11-28
Updated Date: 2024-03-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00371
Product Type: Drug
Control Number: 202233
DIN(s): 02467550, 02522470
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-12-07
Updated Date: 2022-11-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00400
Product Type: Drug
Control Number: 211942
DIN(s): 02478374, 02540185
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-12-07
Issued / Original Publication Date: 2018-08-27
Decision / Authorization Date: 2018-07-03
Updated Date: 2025-06-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00402
Product Type: Drug
Control Number: 211292
DIN(s): 02478080
Manufacturer: Vertex Pharmaceuticals Inc.orporated
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-11-17
Issued / Original Publication Date: 2018-09-06
Decision / Authorization Date: 2018-06-27
Updated Date: 2025-03-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00421
Product Type: Drug
Control Number: 211293
DIN(s): 02481545
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-11-17
Issued / Original Publication Date: 2019-03-11
Decision / Authorization Date: 2018-10-12
Updated Date: 2025-09-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00437
Product Type: Drug
Control Number: 207115
DIN(s): 02484641, 02484668
Manufacturer: Valeo Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-11-08
Issued / Original Publication Date: 2019-07-03
Decision / Authorization Date: 2019-01-10
Updated Date: 2025-07-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00423
Product Type: Drug
Control Number: 210935
DIN(s): 02481758, 02481766, 02481774, 02481782, 02481790
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-11-03
Issued / Original Publication Date: 2019-03-15
Decision / Authorization Date: 2018-10-18
Updated Date: 2023-10-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00414
Product Type: Drug
Control Number: 208730
DIN(s): 02481553
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-11-01
Issued / Original Publication Date: 2019-01-25
Decision / Authorization Date: 2018-10-10
Updated Date: 2025-03-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00424
Product Type: Drug
Control Number: 208919
DIN(s): 02483971, 02483998
Manufacturer: Avir Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-10-26
Issued / Original Publication Date: 2019-04-08
Decision / Authorization Date: 2018-12-19
Updated Date: 2025-06-17