Review decisions

Showing 760 results of 2304 total
Summary Basis of Decision for HyQvia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00592
Product Type: Drug
Control Number: 247727
DIN(s): 02524368, 02524376, 02524384, 02524392, 02524406
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-18
Issued / Original Publication Date: 2022-06-28
Decision / Authorization Date: 2022-01-14
Updated Date: 2024-02-09
Regulatory Decision Summary for Increlex
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00739
Product Type: Drug
Control Number: 235023
DIN(s): 02509733
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-01-09
Decision / Authorization Date: 2020-12-17
Summary Basis of Decision for Zepzelca
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00566
Product Type: Drug
Control Number: 247485
DIN(s): 02520834
Manufacturer: Jazz Pharmaceuticals Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-12-16
Issued / Original Publication Date: 2022-01-04
Decision / Authorization Date: 2021-09-29
Updated Date: 2023-08-30
Summary Safety Review - Carboplatin-containing products - Assessing the Potential Risk of Posterior Reversible Encephalopathy Syndrome
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00252
Issued / Original Publication Date: 2020-12-16
Regulatory Decision Summary for Zolgensma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00741
Product Type: Drug
Control Number: 239719
DIN(s): 02509695
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-05-21
Decision / Authorization Date: 2020-12-15
Regulatory Decision Summary for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00742
Product Type: Drug
Control Number: 236910
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-03-05
Decision / Authorization Date: 2020-12-14
Summary Basis of Decision for Aybintio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00574
Product Type: Drug
Control Number: 247369, 247724
DIN(s): 02522829, 02522837
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-11
Issued / Original Publication Date: 2022-02-04
Decision / Authorization Date: 2021-11-30
Updated Date: 2024-07-15
Regulatory Decision Summary for Bavencio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00735
Product Type: Drug
Control Number: 240024
Manufacturer: EMD Serono, A division of EMD Inc. Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-05-27
Decision / Authorization Date: 2020-12-10
Regulatory Decision Summary for Pfizer-BioNTech COVID-19 Vaccine
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00730
Product Type: Drug
Control Number: 244906
DIN(s): 02509210
Manufacturer: BioNTech Manufacturing GmbH. Importer: Pfizer Canada ULC.
Submission Type: Application filed under section 3 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-10-09
Decision / Authorization Date: 2020-12-09
Summary Safety Review - Clobazam-containing products - Assessing the Potential Risk of Drug Reaction with Eosinophilia and Systemic Symptoms
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00251
Issued / Original Publication Date: 2020-12-09

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