Review decisions

Showing 1640 results of 2627 total
Regulatory Decision Summary for Norditropin NordiFlex
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00358
Product Type: Drug
Control Number: 205985
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-26
Decision / Authorization Date: 2018-04-25
Regulatory Decision Summary for Dysport Aesthetic
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00363
Product Type: Drug
Control Number: 206921
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-08-10
Decision / Authorization Date: 2018-04-24
Regulatory Decision Summary for Dotarem
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00440
Product Type: Drug
Control Number: 205610
Manufacturer: Guerbet
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-12
Decision / Authorization Date: 2018-04-24
Regulatory Decision Summary for Glyxambi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00360
Product Type: Drug
Control Number: 204589
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-04-07
Decision / Authorization Date: 2018-04-20
Regulatory Decision Summary for Latuda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00369
Product Type: Drug
Control Number: 205325
Manufacturer: Sunovion Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-05
Decision / Authorization Date: 2018-04-19
Regulatory Decision Summary for Probuphine
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00375
Product Type: Drug
Control Number: 204746
DIN(s): 02474921
Manufacturer: Knight Therapeutics Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-20
Decision / Authorization Date: 2018-04-18
Summary Safety Review - Percutaneous radiofrequency ablation catheters - Assessing the potential risk of an abnormal connection between the heart and digestive tract (atrioesophageal fistula)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00199
Issued / Original Publication Date: 2018-04-16
Summary Basis of Decision for Verzenio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00445
Product Type: Drug
Control Number: 215268
DIN(s): 02487098, 02487101, 02487128, 02487136
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-04-16
Issued / Original Publication Date: 2019-09-26
Decision / Authorization Date: 2019-04-05
Updated Date: 2024-11-18
Summary Basis of Decision for Osnuvo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00470
Product Type: Drug
Control Number: 215409
DIN(s): 02495589
Manufacturer: Avir Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-04-16
Issued / Original Publication Date: 2020-04-24
Decision / Authorization Date: 2020-01-13
Updated Date: 2025-03-04
Regulatory Decision Summary for Ikervis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00379
Product Type: Drug
Control Number: 194580
Manufacturer: Santen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-05-04
Decision / Authorization Date: 2018-04-13

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