Review decisions

Showing 380 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00419
Product Type: Drug
Control Number: 206230
DIN(s): 02480824, 02480832, 02480840
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-06-06
Issued / Original Publication Date: 2019-02-12
Decision / Authorization Date: 2018-09-14
Updated Date: 2025-07-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00456
Product Type: Drug
Control Number: 206099
DIN(s): 02488361
Manufacturer: Biosyent Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-06-01
Issued / Original Publication Date: 2020-01-07
Decision / Authorization Date: 2019-05-10
Updated Date: 2025-03-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00389
Product Type: Drug
Control Number: 205852
DIN(s): 02472104, 02472112
Manufacturer: Taiho Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-05-30
Issued / Original Publication Date: 2018-04-06
Decision / Authorization Date: 2018-01-25
Updated Date: 2023-08-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00355
Product Type: Drug
Control Number: 190817
DIN(s): 02462400
Manufacturer: Cardiome UK Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-05-17
Updated Date: 2020-11-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00409
Product Type: Drug
Control Number: 205392
DIN(s): 02478498
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-05-09
Issued / Original Publication Date: 2018-11-27
Decision / Authorization Date: 2018-07-10
Updated Date: 2024-06-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00396
Product Type: Drug
Control Number: 204841
DIN(s): 02474565, 02529343
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-21
Issued / Original Publication Date: 2018-07-06
Decision / Authorization Date: 2018-04-05
Updated Date: 2025-02-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00397
Product Type: Drug
Control Number: 204746
DIN(s): 02474921
Manufacturer: Knight Therapeutics Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-20
Issued / Original Publication Date: 2018-07-06
Decision / Authorization Date: 2018-04-18
Updated Date: 2024-11-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00352
Product Type: Drug
Control Number: 193105
DIN(s): 02461927
Manufacturer: IsoLogic Innovative Radiopharmaceuticals Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-04-18
Updated Date: 2019-03-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00448
Product Type: Drug
Control Number: 204579
DIN(s): 02474425, 02474433
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-18
Issued / Original Publication Date: 2019-10-23
Decision / Authorization Date: 2019-05-03
Updated Date: 2024-02-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00403
Product Type: Drug
Control Number: 204724
DIN(s): 02475510, 02475529
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-04-13
Issued / Original Publication Date: 2018-10-01
Decision / Authorization Date: 2018-05-09
Updated Date: 2023-07-28