Review decisions

Showing 1030 results of 2627 total
Regulatory Decision Summary for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01015
Product Type: Drug
Control Number: 239505
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-05-15
Decision / Authorization Date: 2021-02-05
Summary Safety Review - Ceftriaxone-containing products - Assessing the Potential Risk of Encephalopathy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00257
Issued / Original Publication Date: 2021-02-03
Summary Safety Review - Tecentriq (atezolizumab) - Assessing the Potential Risk of Autoimmune Hemolytic Anemia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00258
Issued / Original Publication Date: 2021-02-03
Regulatory Decision Summary for Emapalumab (*Gamifant)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00776
Product Type: Drug
Control Number: 237121
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-03-09
Decision / Authorization Date: 2021-01-29
Regulatory Decision Summary for Remsima SC
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00755
Product Type: Drug
Control Number: 236086
DIN(s): 02511576, 02511584
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-02-18
Decision / Authorization Date: 2021-01-28
Regulatory Decision Summary for Tivicay
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00785
Product Type: Drug
Control Number: 235583
DIN(s): 02511517
Manufacturer: ViiV Healthcare ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-01-29
Decision / Authorization Date: 2021-01-27
Summary Safety Review - Sofosbuvir-containing products - Assessing the Potential Risk of Severe Cutaneous Adverse Reactions
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00256
Issued / Original Publication Date: 2021-01-27
Regulatory Decision Summary for Reyvow
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00789
Product Type: Drug
Control Number: 236369
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-02-21
Decision / Authorization Date: 2021-01-26
Summary Basis of Decision for Trodelvy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00565
Product Type: Drug
Control Number: 248753
DIN(s): 02520788
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-01-25
Issued / Original Publication Date: 2021-12-23
Decision / Authorization Date: 2021-09-24
Updated Date: 2024-02-26
Regulatory Decision Summary for Kesimpta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00756
Product Type: Drug
Control Number: 237346
DIN(s): 02511355, 02511363
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-03-20
Decision / Authorization Date: 2021-01-22

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