Review decisions

Showing 750 results of 2304 total
Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs) - Assessing the Potential Risk of Sexual Dysfunction despite Trea™ent Discontinuation
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00254
Issued / Original Publication Date: 2021-01-06
Regulatory Decision Summary for ONUREG
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01026
Product Type: Drug
Control Number: 240668
DIN(s): 02510197, 02510200
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2020-06-15
Decision / Authorization Date: 2021-01-05
Summary Basis of Decision for Bamlanivimab for Injection
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00512
Product Type: Drug
Control Number: 244947
DIN(s): 02508176
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Issued / Original Publication Date: 2021-01-05
Updated Date: 2023-03-30
Regulatory Decision Summary for Corzyna
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00803
Product Type: Drug
Control Number: 239943
DIN(s): 02510219, 02510227
Manufacturer: Kye Pharmaceuticals Inc., Canada
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-05-27
Decision / Authorization Date: 2020-12-31
Regulatory Decision Summary for Essepna
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00775
Product Type: Drug
Control Number: 231585
DIN(s): 02510324
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-01-16
Decision / Authorization Date: 2020-12-30
Summary Safety Review - Tramadol-containing products - Assessing the Potential Risk of Hallucinations
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00253
Issued / Original Publication Date: 2020-12-29
Regulatory Decision Summary for Verity-BCG
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00744
Product Type: Drug
Control Number: 221579
DIN(s): 02508613
Manufacturer: Verity Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-11-01
Decision / Authorization Date: 2020-12-24
Summary of Cancellation for Elidel
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1701362974599
Product Type: Drug
Control Number: 247851
DIN(s): 02247238
Manufacturer: Bausch Health, Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-24
Decision / Authorization Date: 2023-09-14
Regulatory Decision Summary for Moderna COVID-19 Vaccine
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00736
Product Type: Drug
Control Number: 244946
DIN(s): 02510014
Manufacturer: Moderna Therapeutics Inc.
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: 2020-10-13
Decision / Authorization Date: 2020-12-23
Summary Basis of Decision for Tpoxx
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00578
Product Type: Drug
Control Number: 247561
DIN(s): 02522772
Manufacturer: SIGA Technologies, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-22
Issued / Original Publication Date: 2022-02-21
Decision / Authorization Date: 2021-11-29
Updated Date: 2023-07-14

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