Review decisions

Showing 1330 results of 2627 total
Regulatory Decision Summary for Netildex (with Preservative), Netildex (without Preservative)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00618
Product Type: Drug
Control Number: 212391
DIN(s): 02493187, 02493195
Manufacturer: Knight Therapeutics Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-12-21
Decision / Authorization Date: 2019-10-18
Regulatory Decision Summary for Trulance
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00614
Product Type: Drug
Control Number: 215288
DIN(s): 02493012
Manufacturer: Cipher Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-09-20
Decision / Authorization Date: 2019-10-10
Summary Safety Review - Avalon Fetal Monitor - Assessing the potential risk of inaccurate heart rate tracking of unborn babies (fetuses)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00232
Issued / Original Publication Date: 2019-10-09
Regulatory Decision Summary for Nucala
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00563
Product Type: Drug
Control Number: 221528
DIN(s): 02492989, 02492997
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-11-01
Decision / Authorization Date: 2019-10-08
Summary Basis of Decision for Polivy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00499
Product Type: Drug
Control Number: 232303
DIN(s): 02499614, 02515431
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2019-10-07
Issued / Original Publication Date: 2020-10-08
Decision / Authorization Date: 2020-07-09
Updated Date: 2025-09-19
Regulatory Decision Summary for Dymista
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00600
Product Type: Drug
Control Number: 221498
Manufacturer: BGP Pharma ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-10-30
Decision / Authorization Date: 2019-10-04
Regulatory Decision Summary for Uloric
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00659
Product Type: Drug
Control Number: 228535
DIN(s): 02357380
Manufacturer: Takeda Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-06-11
Decision / Authorization Date: 2019-10-02
Summary Basis of Decision for Tavalisse
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00526
Product Type: Drug
Control Number: 232078
DIN(s): 02508052, 02508060
Manufacturer: Rigel Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-09-30
Issued / Original Publication Date: 2021-03-31
Decision / Authorization Date: 2020-11-19
Updated Date: 2023-07-10
Regulatory Decision Summary for Elidel
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00583
Product Type: Drug
Control Number: 220947
Manufacturer: Valeant Canada LP / Valeant Canada S.E.C.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-10-12
Decision / Authorization Date: 2019-09-26
Regulatory Decision Summary for Dupixent
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00562
Product Type: Drug
Control Number: 221043
DIN(s): 02470365, 02492504
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-10-16
Decision / Authorization Date: 2019-09-25

Displaying 1321 - 1330 of 2627 | Page 133 of 263
Date modified: