Review decisions

Showing 1700 results of 2627 total
Regulatory Decision Summary for Contrave
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00417
Product Type: Drug
Control Number: 202774
DIN(s): 02472945
Manufacturer: Valeant Canada LP / Valeant Canada S.E.C.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-02-13
Decision / Authorization Date: 2018-02-13
Summary Basis of Decision for Lartruvo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00380
Product Type: Drug
Control Number: 203478
DIN(s): 02469227
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2018-02-09
Updated Date: 2021-11-12
Summary Basis of Decision for Kymriah
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00416
Product Type: Drug
Control Number: 213547
DIN(s): 02480514
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-02-09
Issued / Original Publication Date: 2019-02-08
Decision / Authorization Date: 2018-09-05
Updated Date: 2025-02-28
Summary Safety Review - SGLT2 inhibitors - Assessing the potential risk of a rare brain condition (posterior reversible encephalopathy syndrome) in patients who have developed high levels of acids in the blood (diabetic ketoacidosis)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00189
Issued / Original Publication Date: 2018-02-08
Regulatory Decision Summary for Somatuline Autogel
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00331
Product Type: Drug
Control Number: 203094
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-02-21
Decision / Authorization Date: 2018-02-02
Regulatory Decision Summary for Lorcaserin hydrochloride (*Belviq)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00370
Product Type: Drug
Control Number: 198689
Manufacturer: Eisai Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-09-27
Decision / Authorization Date: 2018-02-02
Summary Basis of Decision for Vonvendi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00434
Product Type: Drug
Control Number: 213188
DIN(s): 02484420, 02484439
Manufacturer: Shire Pharma Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-01-26
Issued / Original Publication Date: 2019-06-18
Decision / Authorization Date: 2019-01-10
Updated Date: 2025-09-26
Regulatory Decision Summary for Lonsurf
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00325
Product Type: Drug
Control Number: 205852
DIN(s): 02472104, 02472112
Manufacturer: Taiho Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-05-30
Decision / Authorization Date: 2018-01-25
Summary Safety Review - Dipeptidylpeptidase-4 inhibitors - Assessing the potential risk of a skin reaction (bullous pemphigoid)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00188
Issued / Original Publication Date: 2018-01-25
Regulatory Decision Summary for Opdivo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00336
Product Type: Drug
Control Number: 203593
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-03-09
Decision / Authorization Date: 2018-01-19

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