Review decisions

Showing 1490 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00499
Product Type: Drug
Control Number: 211732
DIN(s): 02484218
Manufacturer: Bausch and Lomb, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-01-24
Decision / Authorization Date: 2018-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00501
Product Type: Drug
Control Number: 215813
DIN(s): 02484137
Manufacturer: Santen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-05-09
Decision / Authorization Date: 2018-12-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00559
Product Type: Drug
Control Number: 200807
DIN(s): 02484153
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-01-19
Decision / Authorization Date: 2018-12-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00473
Product Type: Drug
Control Number: 213996
Manufacturer: Seattle Genetics Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-02-28
Decision / Authorization Date: 2018-12-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00471
Product Type: Drug
Control Number: 223225
DIN(s): 02496429, 02496437, 02543370
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-12-21
Issued / Original Publication Date: 2020-04-29
Decision / Authorization Date: 2020-02-20
Updated Date: 2025-03-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00467
Product Type: Drug
Control Number: 216539
DIN(s): 02484013
Manufacturer: BioMarin International Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-05-23
Decision / Authorization Date: 2018-12-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00503
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
Decision / Authorization Date: 2018-12-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00484
Product Type: Drug
Control Number: 223091
DIN(s): 02494388
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-12-17
Issued / Original Publication Date: 2020-07-10
Decision / Authorization Date: 2019-11-28
Updated Date: 2024-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00468
Product Type: Drug
Control Number: 212387
Manufacturer: Emergent BioDefense Operations Lansing LLC
Submission Type: Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2017-12-29
Decision / Authorization Date: 2018-12-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00485
Product Type: Drug
Control Number: 213303
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-04-10
Decision / Authorization Date: 2018-12-11