Review decisions

Showing 2010 results of 2627 total
Summary Basis of Decision for Tagrisso
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00328
Product Type: Drug
Control Number: 188171
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-09-22
Updated Date: 2022-10-20
Regulatory Decision Summary for ZEMAIRA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00158
Product Type: Drug
Control Number: 188216
DIN(s): 02457911
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-09-30
Decision / Authorization Date: 2016-09-21
Regulatory Decision Summary for MDK-NITISINONE
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00160
Product Type: Drug
Control Number: 190564
DIN(s): 02457717, 02457725, 02457733
Manufacturer: Mendelikabs Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-12-16
Decision / Authorization Date: 2016-09-20
Regulatory Decision Summary for SOMAVERT
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00159
Product Type: Drug
Control Number: 188597
Manufacturer: Pfizer Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-10-19
Decision / Authorization Date: 2016-09-16
Summary Basis of Decision for Ocrevus
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00366
Product Type: Drug
Control Number: 198094
DIN(s): 02467224
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-09-16
Issued / Original Publication Date: 2017-10-19
Decision / Authorization Date: 2017-08-14
Updated Date: 2024-02-23
Summary Safety Review - Gabapentin - Assessing the Potential Risk of Serious Breathing Problems
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00103
Issued / Original Publication Date: 2016-09-16
Summary Safety Review - SOLIRIS (eculizumab) and BEXSERO (Multicomponent Meningococcal B Vaccine [recombinant, adsorbed]) - Assessing the Potential Risk of Hemolysis and Low Hemoglobin in Patients Treated with Soliris and Vaccinated with Bexsero
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00104
Issued / Original Publication Date: 2016-09-16
Summary Basis of Decision for Ocaliva
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00357
Product Type: Drug
Control Number: 198418
DIN(s): 02463121, 02463148
Manufacturer: Intercept Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2016-09-16
Issued / Original Publication Date: 2017-06-21
Decision / Authorization Date: 2017-05-24
Updated Date: 2025-05-28
Regulatory Decision Summary for ENSTILAR
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00155
Product Type: Drug
Control Number: 182839
DIN(s): 02457393
Manufacturer: Leo Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-07-09
Decision / Authorization Date: 2016-09-13
Summary Basis of Decision for Tresiba
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00369
Product Type: Drug
Control Number: 198124
DIN(s): 02467860, 02467879, 02467887
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-09-13
Issued / Original Publication Date: 2017-11-28
Decision / Authorization Date: 2017-08-25
Updated Date: 2024-02-23

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