Review decisions

Showing 1910 results of 2627 total
Summary Safety Review - Colorectal Stents Used with AVASTIN (bevacizumab) - Assessing the potential increased risk of bowel rupture (intestinal perforation)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00150
Issued / Original Publication Date: 2017-02-22
Summary Safety Review - Bisphosphonates - Assessing the Potential Risk of Severe Bone Damage (osteonecrosis)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00148
Issued / Original Publication Date: 2017-02-21
Summary Basis of Decision for Veltassa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00418
Product Type: Drug
Control Number: 210368
DIN(s): 02481359, 02481367, 02481375
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-02-20
Issued / Original Publication Date: 2019-02-11
Decision / Authorization Date: 2018-10-03
Updated Date: 2024-08-16
Summary Basis of Decision for Orfadin
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00344
Product Type: Drug
Control Number: 193226
DIN(s): 02459698, 02459701, 02459728, 02459736, 02469693
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-02-17
Updated Date: 2019-04-24
Regulatory Decision Summary for Cuvitru
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00215
Product Type: Drug
Control Number: 190451
DIN(s): 02461692
Manufacturer: Baxalta Canada Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-02-29
Decision / Authorization Date: 2017-02-16
Regulatory Decision Summary for Rexulti
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00222
Product Type: Drug
Control Number: 192684
DIN(s): 02461749, 02461757, 02461765, 02461773, 02461781, 02461803
Manufacturer: Otsuka Pharmaceutical Co. Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-02-26
Decision / Authorization Date: 2017-02-16
Summary Basis of Decision for Imfinzi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00384
Product Type: Drug
Control Number: 202953
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2017-02-16
Issued / Original Publication Date: 2018-02-22
Decision / Authorization Date: 2017-11-03
Updated Date: 2026-04-09
Regulatory Decision Summary for Harvoni
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00228
Product Type: Drug
Control Number: 193140
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-03-09
Decision / Authorization Date: 2017-02-13
Summary Safety Review - Over-the-Counter Topical Pain Relievers Containing Menthol, Methyl Salicylate or Capsaicin - Assessing the Risk of Serious Skin Burns
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00147
Issued / Original Publication Date: 2017-02-13
Regulatory Decision Summary for Replagal
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00217
Product Type: Drug
Control Number: 188407
DIN(s): 02249057
Manufacturer: Shire Human Genetic Therapies, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-02-16
Decision / Authorization Date: 2017-02-10

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