Review decisions

Showing 1840 results of 2627 total
Regulatory Decision Summary for Iron Dextran Injection USP
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00292
Product Type: Drug
Control Number: 189897
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-12-21
Decision / Authorization Date: 2017-06-08
Regulatory Decision Summary for FIBRYGA (formerly FIBRYNA)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00254
Product Type: Drug
Control Number: 195870
DIN(s): 02464616
Manufacturer: Octapharma Pharmazeutika Produktionsges m.b.H.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-06-20
Decision / Authorization Date: 2017-06-07
Summary Basis of Decision for Cabometyx
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00419
Product Type: Drug
Control Number: 206230
DIN(s): 02480824, 02480832, 02480840
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-06-06
Issued / Original Publication Date: 2019-02-12
Decision / Authorization Date: 2018-09-14
Updated Date: 2025-07-10
Summary Safety Review - Mefloquine - Assessing the potential risk of rare long-lasting and permanent adverse events related to the brain and nervous system (neurological) and mental health (psychiatric)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00161
Issued / Original Publication Date: 2017-06-01
Summary Basis of Decision for Tibella
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00456
Product Type: Drug
Control Number: 206099
DIN(s): 02488361
Manufacturer: Biosyent Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-06-01
Issued / Original Publication Date: 2020-01-07
Decision / Authorization Date: 2019-05-10
Updated Date: 2025-03-25
Summary Basis of Decision for Lonsurf
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00389
Product Type: Drug
Control Number: 205852
DIN(s): 02472104, 02472112
Manufacturer: Taiho Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-05-30
Issued / Original Publication Date: 2018-04-06
Decision / Authorization Date: 2018-01-25
Updated Date: 2023-08-14
Regulatory Decision Summary for Adlyxine
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00259
Product Type: Drug
Control Number: 193862
DIN(s): 02464276, 02464284, 02464349
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-04-26
Decision / Authorization Date: 2017-05-25
Regulatory Decision Summary for Harvoni
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00397
Product Type: Drug
Control Number: 199607
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2016-10-27
Decision / Authorization Date: 2017-05-24
Regulatory Decision Summary for Ibrance
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00261
Product Type: Drug
Control Number: 195948
Manufacturer: Pfizer Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-06-14
Decision / Authorization Date: 2017-05-19
Regulatory Decision Summary for EYLEA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00252
Product Type: Drug
Control Number: 186851
DIN(s): 02415992
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-08-11
Decision / Authorization Date: 2017-05-19

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