Review decisions

Showing 1230 results of 2627 total
Regulatory Decision Summary for Itulatek
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00632
Product Type: Drug
Control Number: 227270
DIN(s): 02498073
Manufacturer: ALK-Abello A/S
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-04-29
Decision / Authorization Date: 2020-04-15
Regulatory Decision Summary for Uceris
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00675
Product Type: Drug
Control Number: 220876
DIN(s): 02498057
Manufacturer: Bausch Health, Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-05-01
Decision / Authorization Date: 2020-04-15
Regulatory Decision Summary for Ajovy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00627
Product Type: Drug
Control Number: 226828
DIN(s): 02497859
Manufacturer: Teva Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-05-01
Decision / Authorization Date: 2020-04-09
Regulatory Decision Summary for Entyvio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00654
Product Type: Drug
Control Number: 226874
DIN(s): 02497867, 02497875
Manufacturer: Takeda Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-04-23
Decision / Authorization Date: 2020-04-07
Summary Basis of Decision for Wakix
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00550
Product Type: Drug
Control Number: 238175
DIN(s): 02516241, 02516268
Manufacturer: Endo Ventures Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-04-06
Issued / Original Publication Date: 2021-09-14
Decision / Authorization Date: 2021-05-25
Updated Date: 2025-07-02
Summary Safety Review - Propyl-Thyracil (propylthiouracil): Assessing the Potential Risk of Birth Defects
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00235
Issued / Original Publication Date: 2020-04-03
Regulatory Decision Summary for Tecentriq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00649
Product Type: Drug
Control Number: 226905
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-04-16
Decision / Authorization Date: 2020-04-02
Regulatory Decision Summary for Vlexio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00666
Product Type: Drug
Control Number: 216257
Manufacturer: Pendopharm, Division of Pharmascience Inc.
Submission Type: New Drug Submission
Decision / Authorization Date: 2020-04-02
Summary Safety Review - Direct-Acting Antivirals - Assessing the Potential Risk of New or Returning Liver Cancer named Hepatocellular Carcinoma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00236
Issued / Original Publication Date: 2020-04-02
Regulatory Decision Summary for Addnutriv
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00676
Product Type: Drug
Control Number: 223801
DIN(s): 02497697
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-04-09
Decision / Authorization Date: 2020-04-01

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