Review decisions
Showing 1760 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00423
Product Type: Drug
Control Number: 210935
DIN(s): 02481758, 02481766, 02481774, 02481782, 02481790
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-11-03
Issued / Original Publication Date: 2019-03-15
Decision / Authorization Date: 2018-10-18
Updated Date: 2023-10-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00415
Product Type: Drug
Control Number: 200292
DIN(s): 02420864, 02420872, 02445018, 02445026
Manufacturer: Otsuka Pharmaceutical Co. Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-11-16
Decision / Authorization Date: 2017-11-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00327
Product Type: Drug
Control Number: 189577
DIN(s): 02469359
Manufacturer: Teva Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-07-11
Decision / Authorization Date: 2017-11-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00342
Product Type: Drug
Control Number: 204165
DIN(s): 02469367, 02469375, 02469383, 02469405
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-04-10
Decision / Authorization Date: 2017-11-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00414
Product Type: Drug
Control Number: 208730
DIN(s): 02481553
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-11-01
Issued / Original Publication Date: 2019-01-25
Decision / Authorization Date: 2018-10-10
Updated Date: 2025-03-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00343
Product Type: Drug
Control Number: 197038
DIN(s): 02469332
Manufacturer: Pediapharm Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-08-03
Decision / Authorization Date: 2017-10-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00303
Product Type: Drug
Control Number: 204251
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-03-30
Decision / Authorization Date: 2017-10-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00424
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
Issued / Original Publication Date: 2019-04-08
Decision / Authorization Date: 2018-12-19
Updated Date: 2025-06-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00371
Product Type: Drug
Control Number: 204436
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-04-04
Decision / Authorization Date: 2017-10-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00473
Product Type: Drug
Control Number: 210238
DIN(s): 02480794, 02506211
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-10-24
Issued / Original Publication Date: 2020-04-29
Decision / Authorization Date: 2019-09-03
Updated Date: 2024-02-08