Review decisions

Showing 290 results of 2299 total
Regulatory Decision Summary for VidPrevtyn Beta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01087
Product Type: Drug
Control Number: 269939
Manufacturer: Sanofi Pasteur Ltd.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-12-16
Decision / Authorization Date: 2023-01-25
Regulatory Decision Summary for Prz-Metformin
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01071
Product Type: Drug
Control Number: 263913
DIN(s): 02534673
Manufacturer: Pharmaris Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-05-03
Decision / Authorization Date: 2023-01-24
Summary Safety Review - Cephalosporins - Assessing the Potential Risk of Seizures
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00291
Issued / Original Publication Date: 2023-01-23
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
Issued / Original Publication Date: 2023-01-20
Updated Date: 2023-01-20
Summary Safety Review - Finasteride - Assessing the Potential Risks of Suicide, Suicidal Thoughts (Suicidal Ideation) and Self-injury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00290
Issued / Original Publication Date: 2023-01-19
Summary Safety Review - Third Generation Aromatase Inhibitors (anastrozole, exemestane, letrozole) - Assessing the Potential Risk of Tendon Disorders
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00289
Issued / Original Publication Date: 2023-01-17
Regulatory Decision Summary for Xarelto
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705593803323
Product Type: Drug
Control Number: 234756
DIN(s): 02510162, 02510170
Manufacturer: Bayer Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-24
Decision / Authorization Date: 2021-01-12
Regulatory Decision Summary for Copaxone
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692037182503
Product Type: Drug
Control Number: 234666
DIN(s): 02245619, 02456915, 02512173
Manufacturer: Teva Canada Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-23
Decision / Authorization Date: 2021-02-04
Regulatory Decision Summary for Hydromorphone Hydrochloride Injection USP
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692291386055
Product Type: Drug
Control Number: 237401
DIN(s): 02145901, 02514435
Manufacturer: Sandoz Canada Incorporated
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-03-20
Decision / Authorization Date: 2021-04-09
Regulatory Decision Summary for Ofev
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694610519770
Product Type: Drug
Control Number: 241747
Manufacturer: Boehringer Ingelheim (Canada) Ltd Ltee
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-07-16
Decision / Authorization Date: 2021-06-25

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