Review decisions

Showing 2060 results of 2632 total
Summary Basis of Decision for Epclusa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00329
Product Type: Drug
Control Number: 190521
DIN(s): 02456370
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-07-11
Updated Date: 2022-10-28
Regulatory Decision Summary for ELOCTATE
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00144
Product Type: Drug
Control Number: 186957
Manufacturer: Biogen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-08-18
Decision / Authorization Date: 2016-07-08
Regulatory Decision Summary for MONOPROST
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00179
Product Type: Drug
Control Number: 173577
DIN(s): 02456230
Manufacturer: Laboratoires Thea
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-04-25
Decision / Authorization Date: 2016-07-07
Regulatory Decision Summary for RIXUBIS
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00133
Product Type: Drug
Control Number: 186641
Manufacturer: Baxalta Canada Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-07-31
Decision / Authorization Date: 2016-07-05
Regulatory Decision Summary for TAGRISSO
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00135
Product Type: Drug
Control Number: 188171
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-10-01
Decision / Authorization Date: 2016-07-05
Regulatory Decision Summary for SMOFKABIVEN PERIPHERAL
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00149
Product Type: Drug
Control Number: 177540
DIN(s): 02456206
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-07-23
Decision / Authorization Date: 2016-07-05
Summary Basis of Decision for Belsomra
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00431
Product Type: Drug
Control Number: 196367
DIN(s): 02483505
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-07-05
Issued / Original Publication Date: 2019-05-16
Decision / Authorization Date: 2018-11-29
Updated Date: 2023-02-28
Summary Safety Review - Alpha Lipoic Acid - Assessing the Potential Risk of Low Blood Sugar (Hypoglycemic Episodes)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00089
Issued / Original Publication Date: 2016-06-30
Summary Safety Review - AVONEX (interferon beta-1a) - Assessing the Potential Risk of Kidney Damage (nephrotic syndrome)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00090
Issued / Original Publication Date: 2016-06-30
Regulatory Decision Summary for DARZALEX
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00143
Product Type: Drug
Control Number: 187648
DIN(s): 02455951, 02455978
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-09-14
Decision / Authorization Date: 2016-06-29

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