Review decisions
Showing 359 results of 359 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692287802053
Product Type: Drug
Control Number: 255132
Manufacturer: Porton Biopharma Ltd.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2021-07-27
Decision / Authorization Date: 2023-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684935203980
Product Type: Drug
Control Number: 255032
DIN(s): 02534622
Manufacturer: Chiesi Farmaceutici S.p.a.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-07-22
Issued / Original Publication Date: 2023-05-23
Decision / Authorization Date: 2023-01-20
Updated Date: 2024-11-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1691759711587
Product Type: Drug
Control Number: 253850
Manufacturer: Prestige Biopharma Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-05
Decision / Authorization Date: 2023-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1715971891771
Product Type: Drug
Control Number: 251688
DIN(s): 02542706
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-19
Issued / Original Publication Date: 2024-05-17
Decision / Authorization Date: 2023-11-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692978760470
Product Type: Drug
Control Number: 240372
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-13
Decision / Authorization Date: 2023-05-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1701362974599
Product Type: Drug
Control Number: 247851
DIN(s): 02247238
Manufacturer: Bausch Health, Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-24
Decision / Authorization Date: 2023-09-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1692890357153
Product Type: Drug
Control Number: 240862
DIN(s): 02537044, 02537052, 02537060
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-19
Issued / Original Publication Date: 2023-08-22
Decision / Authorization Date: 2023-04-28
Updated Date: 2025-10-02
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/SBD00501
Product Type: Drug
Control Number: 234655
DIN(s): 02503034
Manufacturer: Medunik Canada
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-12-20
Issued / Original Publication Date: 2020-10-22
Decision / Authorization Date: 2023-01-10
Updated Date: 2024-11-18