Review decisions

Showing 1570 results of 2627 total
Regulatory Decision Summary for Bexsero
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00400
Product Type: Drug
Control Number: 209413
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-09-15
Decision / Authorization Date: 2018-08-14
Regulatory Decision Summary for Repatha
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00401
Product Type: Drug
Control Number: 208904
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-08-30
Decision / Authorization Date: 2018-08-10
Summary Safety Review - Oral prednisone and prednisolone (glucocorticoids) - Assessing the potential risk of a serious complication called scleroderma renal crisis in patients with systemic sclerosis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00208
Issued / Original Publication Date: 2018-08-07
Summary Safety Review - METHADOSE and METADOL-D - Assessing the potential risk of serious harm in children exposed to methadone through breast milk
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00207
Issued / Original Publication Date: 2018-08-03
Regulatory Decision Summary for Hemlibra
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00396
Product Type: Drug
Control Number: 212635
DIN(s): 02479621, 02479648, 02479656, 02479664
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-01-08
Decision / Authorization Date: 2018-08-02
Regulatory Decision Summary for Aimovig
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00394
Product Type: Drug
Control Number: 208607
DIN(s): 02479605, 02479613
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-10-05
Decision / Authorization Date: 2018-08-01
Regulatory Decision Summary for Oxycodone (*XTAMPZA ER)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00465
Product Type: Drug
Control Number: 198865
Manufacturer: Collegium Pharmaceutical, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-09-30
Decision / Authorization Date: 2018-07-27
Summary Basis of Decision for Libtayo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00443
Product Type: Drug
Control Number: 218718
DIN(s): 02487144, 02487152
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2018-07-27
Issued / Original Publication Date: 2019-08-27
Decision / Authorization Date: 2019-04-10
Updated Date: 2024-12-06
Regulatory Decision Summary for Alunbrig
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00434
Product Type: Drug
Control Number: 210369
DIN(s): 02479206, 02479214, 02479222, 02479230
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-10-24
Decision / Authorization Date: 2018-07-26
Summary Safety Review - IMBRUVICA (ibrutinib) - Assessing the potential risk of a serious and life-threatening abnormal heart rhythm (ventricular tachyarrhythmia)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00206
Issued / Original Publication Date: 2018-07-26

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