Review decisions

Showing 1860 results of 2627 total
Regulatory Decision Summary for Revolade
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00242
Product Type: Drug
Control Number: 195798
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-06-16
Decision / Authorization Date: 2017-05-01
Summary Safety Review - Direct-Acting Antivirals - Assessing the Potential Risk of Liver Cancer Recurrence
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00157
Issued / Original Publication Date: 2017-04-27
Summary Safety Review - Dipeptidylpeptidase-4 (DPP-4) inhibitors - Assessing the risk of joint pain (arthralgia)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00158
Issued / Original Publication Date: 2017-04-27
Summary Safety Review - Iodinated Contrast Medium - Assessing the Potential Risk of Decreased Thyroid Hormone Production (Hypothyroidism)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00156
Issued / Original Publication Date: 2017-04-24
Regulatory Decision Summary for Cerdelga
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00238
Product Type: Drug
Control Number: 183050
DIN(s): 02463261
Manufacturer: Sanofi Genzyme, A Division of Sanofi-aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-03-19
Decision / Authorization Date: 2017-04-21
Summary Basis of Decision for Lapelga
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00396
Product Type: Drug
Control Number: 204841
DIN(s): 02474565, 02529343
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-21
Issued / Original Publication Date: 2018-07-06
Decision / Authorization Date: 2018-04-05
Updated Date: 2025-02-25
Regulatory Decision Summary for Banzel
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00412
Product Type: Drug
Control Number: 194343
DIN(s): 02369613, 02369621, 02369648, 02388685
Manufacturer: Eisai Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-05-05
Decision / Authorization Date: 2017-04-20
Summary Basis of Decision for Probuphine
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00397
Product Type: Drug
Control Number: 204746
DIN(s): 02474921
Manufacturer: Knight Therapeutics Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-20
Issued / Original Publication Date: 2018-07-06
Decision / Authorization Date: 2018-04-18
Updated Date: 2024-11-18
Regulatory Decision Summary for Orkambi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00250
Product Type: Drug
Control Number: 198036
DIN(s): 02463040
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-09-12
Decision / Authorization Date: 2017-04-18
Summary Basis of Decision for NeuraCeq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00352
Product Type: Drug
Control Number: 193105
DIN(s): 02461927
Manufacturer: IsoLogic Innovative Radiopharmaceuticals Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-04-18
Updated Date: 2019-03-19

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