Review decisions

Showing 1670 results of 2627 total
Regulatory Decision Summary for Besponsa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00349
Product Type: Drug
Control Number: 204077
DIN(s): 02473909
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-05-16
Decision / Authorization Date: 2018-03-15
Summary Basis of Decision for Calquence
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00457
Product Type: Drug
Control Number: 214504
DIN(s): 02491788, 02535696
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2018-03-15
Issued / Original Publication Date: 2020-01-13
Decision / Authorization Date: 2019-08-23
Updated Date: 2025-05-06
Regulatory Decision Summary for Jaydess
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00351
Product Type: Drug
Control Number: 204355
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-03-31
Decision / Authorization Date: 2018-03-14
Regulatory Decision Summary for Mar-Cidofovir
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00441
Product Type: Drug
Control Number: 200865
DIN(s): 02473925
Manufacturer: Marcan Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-12-02
Decision / Authorization Date: 2018-03-14
Summary Safety Review - Halaven (eribulin mesylate) - Assessing the potential Risk of severe skin side effects
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00194
Issued / Original Publication Date: 2018-03-12
Regulatory Decision Summary for Dysport Therapeutic
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00347
Product Type: Drug
Control Number: 204299
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-03-30
Decision / Authorization Date: 2018-03-09
Regulatory Decision Summary for APO-Perindopril Arginine
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00418
Product Type: Drug
Control Number: 201189
DIN(s): 02473062, 02473070, 02473089
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-01-04
Decision / Authorization Date: 2018-03-09
Summary Safety Review - Clozapine - Assessing the effectiveness of monitoring for low numbers of white blood cells
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00192
Issued / Original Publication Date: 2018-03-09
Updated Date: 2018-07-26
Summary Safety Review - SurgiWrap Adhesion Barrier Film - Assessing the potential risk of foreign body reactions that mimic local re-appearance of cancer
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00193
Issued / Original Publication Date: 2018-03-09
Summary Basis of Decision for Radicava
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00417
Product Type: Drug
Control Number: 214391
DIN(s): 02475472
Manufacturer: Mitsubishi Tanabe Pharma Corporation
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-03-09
Issued / Original Publication Date: 2019-02-07
Decision / Authorization Date: 2018-10-03
Updated Date: 2025-07-08

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