Review decisions

Showing 1420 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00485
Product Type: Drug
Control Number: 227517
DIN(s): 02495007, 02495015
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2019-05-08
Issued / Original Publication Date: 2020-07-16
Decision / Authorization Date: 2020-02-10
Updated Date: 2025-06-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00521
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
Decision / Authorization Date: 2019-05-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00222
Issued / Original Publication Date: 2019-05-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00544
Product Type: Drug
Control Number: 216513
Manufacturer: Seattle Genetics Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-05-24
Decision / Authorization Date: 2019-05-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00572
Product Type: Drug
Control Number: 223245
Manufacturer: Sandoz Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2018-12-20
Decision / Authorization Date: 2019-05-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00585
Product Type: Drug
Control Number: 219662
DIN(s): 02488078, 02488086, 02488094
Manufacturer: Verity Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-08-30
Decision / Authorization Date: 2019-05-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00479
Product Type: Drug
Control Number: 226828
DIN(s): 02497859, 02509474
Manufacturer: Teva Canada Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-05-01
Issued / Original Publication Date: 2020-06-15
Decision / Authorization Date: 2020-04-09
Updated Date: 2024-02-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00518
Product Type: Drug
Control Number: 223202, 223227
Submission Type: Application for an Authorization Amendment
Date Filed / Submission Date: 2018-12-20
Decision / Authorization Date: 2019-04-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00475
Product Type: Drug
Control Number: 227361
DIN(s): 02496364, 02496372, 02524163
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-04-30
Issued / Original Publication Date: 2020-05-05
Decision / Authorization Date: 2020-02-19
Updated Date: 2023-08-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00472
Product Type: Drug
Control Number: 227235
DIN(s): 02495244
Manufacturer: HLS Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-04-29
Issued / Original Publication Date: 2020-04-27
Decision / Authorization Date: 2019-12-30
Updated Date: 2024-10-15