Review decisions

Showing 1920 results of 2627 total
Regulatory Decision Summary for Lupron Depot
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00218
Product Type: Drug
Control Number: 193372
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-03-16
Decision / Authorization Date: 2017-02-10
Regulatory Decision Summary for Odefsey
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00227
Product Type: Drug
Control Number: 192454
DIN(s): 02461463
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-02-22
Decision / Authorization Date: 2017-02-10
Summary Basis of Decision for Zinbryta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00342
Product Type: Drug
Control Number: 190458
DIN(s): 02459620
Manufacturer: Biogen Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-02-09
Updated Date: 2018-12-12
Summary Safety Review - Low-Molecular-Weight Heparins - Assessing the potential risk of bleeding in or around the spinal cord (Spinal/Epidural Hematoma)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00146
Issued / Original Publication Date: 2017-02-08
Regulatory Decision Summary for Tivicay
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00245
Product Type: Drug
Control Number: 192462
DIN(s): 02461218, 02461226
Manufacturer: ViiV Healthcare ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-02-22
Decision / Authorization Date: 2017-02-03
Regulatory Decision Summary for Imbruvica
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00216
Product Type: Drug
Control Number: 192718
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-02-29
Decision / Authorization Date: 2017-02-01
Regulatory Decision Summary for Viberzi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00244
Product Type: Drug
Control Number: 190162
DIN(s): 02460890, 02460904
Manufacturer: Actavis Specialty Pharmaceuticals Co.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-12-11
Decision / Authorization Date: 2017-01-26
Summary Safety Review - Fluoroquinolones - Assessing the potential risk of persistent and disabling side effects
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00151
Issued / Original Publication Date: 2017-01-23
Summary Basis of Decision for Ozempic
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00388
Product Type: Drug
Control Number: 202059
DIN(s): 02471469, 02471477, 02523930, 02540258
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-01-19
Issued / Original Publication Date: 2018-04-04
Decision / Authorization Date: 2018-01-04
Updated Date: 2025-07-29
Regulatory Decision Summary for Glatect
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00249
Product Type: Drug
Control Number: 191840
DIN(s): 02460661
Manufacturer: Pharmascience Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-02-01
Decision / Authorization Date: 2017-01-17

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