Review decisions

Showing 1890 results of 2627 total
Regulatory Decision Summary for Alvimopan (*Entereg)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00231
Product Type: Drug
Control Number: 189825
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-11-23
Decision / Authorization Date: 2017-03-29
Regulatory Decision Summary for Tarceva
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00240
Product Type: Drug
Control Number: 194018
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-04-06
Decision / Authorization Date: 2017-03-29
Summary Safety Review - Esophageal Stents - Assessing the potential risk of damage to the esophagus and nearby major blood vessels
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00153
Issued / Original Publication Date: 2017-03-29
Summary Basis of Decision for Kanuma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00382
Product Type: Drug
Control Number: 204085
DIN(s): 02469596
Manufacturer: Alexion Pharma GmbH
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2017-03-23
Issued / Original Publication Date: 2018-02-09
Decision / Authorization Date: 2017-12-15
Updated Date: 2023-11-29
Summary Basis of Decision for Bavencio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00385
Product Type: Drug
Control Number: 204052
DIN(s): 02469723
Manufacturer: EMD Serono, A division of EMD Inc. Canada
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2017-03-23
Issued / Original Publication Date: 2018-03-09
Decision / Authorization Date: 2017-12-08
Updated Date: 2025-06-04
Regulatory Decision Summary for Lotus Valve System
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00408
Product Type: Drug
Manufacturer: Boston Scientific Corporation
Date Filed / Submission Date: 2016-06-30
Decision / Authorization Date: 2017-03-22
Summary Basis of Decision for Fasenra
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00390
Product Type: Drug
Control Number: 204008
DIN(s): 02473232, 02496135
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-03-21
Issued / Original Publication Date: 2018-04-30
Decision / Authorization Date: 2018-02-22
Updated Date: 2023-09-21
Summary Basis of Decision for Kisqali
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00395
Product Type: Drug
Control Number: 203884
DIN(s): 02473569
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-03-17
Issued / Original Publication Date: 2018-06-18
Decision / Authorization Date: 2018-03-02
Updated Date: 2024-12-20
Regulatory Decision Summary for Portrazza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00232
Product Type: Drug
Control Number: 193689
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-03-22
Decision / Authorization Date: 2017-03-16
Regulatory Decision Summary for Primaquine
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00229
Product Type: Drug
Control Number: 196046
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-06-23
Decision / Authorization Date: 2017-03-15

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