Review decisions

Showing 1380 results of 2627 total
Regulatory Decision Summary for Lokelma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00601
Product Type: Drug
Control Number: 218799
DIN(s): 02490714, 02490722
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-08-15
Decision / Authorization Date: 2019-07-25
Summary Basis of Decision for Cablivi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00477
Product Type: Drug
Control Number: 230001
DIN(s): 02496194
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-07-22
Issued / Original Publication Date: 2020-05-29
Decision / Authorization Date: 2020-02-28
Updated Date: 2025-07-14
Regulatory Decision Summary for Genvoya
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00624
Product Type: Drug
Control Number: 219784
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-09-04
Decision / Authorization Date: 2019-07-19
Summary Basis of Decision for Inrebic
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00502
Product Type: Drug
Control Number: 229866
DIN(s): 02502445
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-07-19
Issued / Original Publication Date: 2020-10-22
Decision / Authorization Date: 2020-07-27
Updated Date: 2024-07-17
Summary Safety Review - U by Kotex Sleek and U by Kotex Click Tampons - Assessing the risk of tampons coming apart during removal and potential adverse reactions (side effects)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00228
Issued / Original Publication Date: 2019-07-18
Regulatory Decision Summary for Nerlynx
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00658
Product Type: Drug
Control Number: 218224
DIN(s): 02490536
Manufacturer: Puma Biotechnology Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-07-19
Decision / Authorization Date: 2019-07-16
Summary Safety Review - Propofol-containing products - Assessing the potential risk of prolonged erection of the penis (priapism)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00227
Issued / Original Publication Date: 2019-07-12
Regulatory Decision Summary for Pdp-Levetiracetam
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00611
Product Type: Drug
Control Number: 213656
DIN(s): 02490439, 02490447
Manufacturer: Pendopharm, Division of Pharmascience Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-07-20
Decision / Authorization Date: 2019-07-11
Regulatory Decision Summary for Dacogen
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00763
Product Type: Drug
Control Number: 217663
DIN(s): 02490366
Manufacturer: Otsuka Pharmaceutical Co. Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-06-29
Decision / Authorization Date: 2019-07-11
Regulatory Decision Summary for Vitrakvi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00673
Product Type: Drug
Control Number: 219998
DIN(s): 02490315, 02490323, 02490331
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-09-18
Decision / Authorization Date: 2019-07-10

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