Review decisions

Showing 1620 results of 2627 total
Regulatory Decision Summary for AVASTIN
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00381
Product Type: Drug
Control Number: N/A
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission - Confirmatory
Decision / Authorization Date: 2018-05-23
Regulatory Decision Summary for Steglujan
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00373
Product Type: Drug
Control Number: 201006
DIN(s): 02475901, 02475928
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-13
Decision / Authorization Date: 2018-05-22
Regulatory Decision Summary for Tivicay
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00432
Product Type: Drug
Control Number: 207076
Manufacturer: ViiV Healthcare ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-06-29
Decision / Authorization Date: 2018-05-22
Regulatory Decision Summary for Tafinlar
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00377
Product Type: Drug
Control Number: 210753
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-10-30
Decision / Authorization Date: 2018-05-18
Regulatory Decision Summary for Mekinist
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00378
Product Type: Drug
Control Number: 210760
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-10-30
Decision / Authorization Date: 2018-05-18
Regulatory Decision Summary for Juluca
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00438
Product Type: Drug
Control Number: 206402
DIN(s): 02475774
Manufacturer: ViiV Healthcare ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-06-12
Decision / Authorization Date: 2018-05-18
Summary Basis of Decision for Crysvita
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00429
Product Type: Drug
Control Number: 216239
DIN(s): 02483629, 02483637, 02483645
Manufacturer: Kyowa Kirin, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-05-16
Issued / Original Publication Date: 2019-05-06
Decision / Authorization Date: 2018-12-05
Updated Date: 2026-03-12
Regulatory Decision Summary for Alphanate
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00364
Product Type: Drug
Control Number: 194071
DIN(s): 02475561, 02475588, 02475618, 02475626
Manufacturer: Grifols Biologicals LLC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-05-06
Decision / Authorization Date: 2018-05-11
Summary Safety Review - Isoniazid - Assessing the potential risk of inflammation of the pancreas (pancreatitis)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00201
Issued / Original Publication Date: 2018-05-10
Regulatory Decision Summary for Steglatro
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00404
Product Type: Drug
Control Number: 204724
DIN(s): 02475510, 02475529
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-04-13
Decision / Authorization Date: 2018-05-09

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