Review decisions

Showing 1050 results of 2627 total
Summary of Cancellation for Casirivimab and Imdevimab (Ronapreve)*
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724855581143
Product Type: Drug
Control Number: 256264
Manufacturer: Hoffman-La Roche Limited
Submission Type: New Drug Submission with flexibilities filed for COVID-19 Drug products (NDS-CV)
Date Filed / Submission Date: 2021-01-09
Decision / Authorization Date: 2024-06-21
Regulatory Decision Summary for Retin-A
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00771
Product Type: Drug
Control Number: 235656
DIN(s): 02510243
Manufacturer: Bausch Health, Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-01-30
Decision / Authorization Date: 2021-01-08
Summary Safety Review - Tamiflu (oseltamivir) and generics - Assessing the Potential Risk of Haemorrhages
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00255
Issued / Original Publication Date: 2021-01-08
Regulatory Decision Summary for Foclivia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00752
Product Type: Drug
Control Number: 235556
DIN(s): 02510561, 02510588
Manufacturer: Seqirus UK Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-01-28
Decision / Authorization Date: 2021-01-07
Summary Basis of Decision for Simlandi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00585
Product Type: Drug
Control Number: 244990
DIN(s): 02523949, 02523957, 02523965
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-07
Issued / Original Publication Date: 2022-04-14
Decision / Authorization Date: 2022-01-05
Updated Date: 2024-07-29
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

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