Review decisions

Showing 810 results of 2627 total
Regulatory Decision Summary for Bimzelx
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00918
Product Type: Drug
Control Number: 238499
DIN(s): 02525267, 02525275
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-18
Decision / Authorization Date: 2022-02-14
Summary Safety Review - Methadone - Assessing the Potential Risk of Hypoglycemia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00281
Issued / Original Publication Date: 2022-02-09
Regulatory Decision Summary for Nordapro
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00925
Product Type: Drug
Control Number: 247924
Manufacturer: Nordic Group B.V.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-04
Decision / Authorization Date: 2022-02-01
Regulatory Decision Summary for Ontruzant
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00914
Product Type: Drug
Control Number: 235995
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-02-27
Decision / Authorization Date: 2022-01-28
Regulatory Decision Summary for Olumiant
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00972
Product Type: Drug
Control Number: 245874
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-10-30
Decision / Authorization Date: 2022-01-28
Summary Basis of Decision for Pluvicto
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00621
Product Type: Drug
Control Number: 260951
DIN(s): 02530198
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-01-28
Issued / Original Publication Date: 2023-01-20
Decision / Authorization Date: 2022-08-25
Updated Date: 2025-11-13
Summary Safety Review - Airvo 2 Humidifier - Assessing the Potential Risk of Breathing Problems Associated with Undetected, Accidental Disconnection of Nasal Cannula
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00280
Issued / Original Publication Date: 2022-01-25
Regulatory Decision Summary for Veklury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00954
Product Type: Drug
Control Number: 248928
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission - Confirmatory
Date Filed / Submission Date: 2021-01-29
Decision / Authorization Date: 2022-01-24
Regulatory Decision Summary for Darzalex SC
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00915
Product Type: Drug
Control Number: 249815
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-02-23
Decision / Authorization Date: 2022-01-21
Regulatory Decision Summary for Mezera
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00956
Product Type: Drug
Control Number: 247241
DIN(s): 02524481
Manufacturer: Avir Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-08
Decision / Authorization Date: 2022-01-18

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