Review decisions
Showing 300 results of 768 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/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/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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00481
Product Type: Drug
Control Number: 227315
DIN(s): 02497204, 02497220, 02497247
Manufacturer: ViiV Healthcare ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-04-29
Issued / Original Publication Date: 2020-06-12
Decision / Authorization Date: 2020-03-18
Updated Date: 2025-09-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00493
Product Type: Drug
Control Number: 226941
DIN(s): 02497042, 02497069, 02497077, 02497085
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-04-17
Issued / Original Publication Date: 2020-08-27
Decision / Authorization Date: 2020-03-11
Updated Date: 2025-08-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00488
Product Type: Drug
Control Number: 220445
DIN(s): 02497395
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-04-09
Issued / Original Publication Date: 2020-07-31
Decision / Authorization Date: 0020-04-21
Updated Date: 2024-03-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00425
Product Type: Drug
Control Number: 211732
DIN(s): 02484218
Manufacturer: Bausch and Lomb, Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2019-04-08
Updated Date: 2020-11-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00478
Product Type: Drug
Control Number: 226189
DIN(s): 02496933
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-03-27
Issued / Original Publication Date: 2020-05-27
Decision / Authorization Date: 2020-03-12
Updated Date: 2024-04-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00489
Product Type: Drug
Control Number: 226224
DIN(s): 02496976, 02496984
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-03-27
Issued / Original Publication Date: 2020-08-04
Decision / Authorization Date: 2020-03-12
Updated Date: 2025-06-17