Review decisions

Showing 1580 results of 2627 total
Regulatory Decision Summary for Imbruvica
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00426
Product Type: Drug
Control Number: 212632
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2018-01-05
Decision / Authorization Date: 2018-07-24
Summary Basis of Decision for Esperoct
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00453
Product Type: Drug
Control Number: 218531
DIN(s): 02490064, 02490072, 02490080, 02490099, 02490102
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-07-23
Issued / Original Publication Date: 2019-12-11
Decision / Authorization Date: 2019-07-04
Updated Date: 2023-09-15
Summary Safety Review - REMICADE (infliximab) - Assessing the potential risk of a blistering skin condition known as linear IgA bullous dermatosis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00205
Issued / Original Publication Date: 2018-07-23
Summary Basis of Decision for Yescarta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00442
Product Type: Drug
Control Number: 218389
DIN(s): 02485648
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-07-23
Issued / Original Publication Date: 2019-08-15
Decision / Authorization Date: 2019-02-13
Updated Date: 2026-03-16
Summary Basis of Decision for Netspot
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00467
Product Type: Drug
Control Number: 218346
DIN(s): 02490005
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-07-20
Issued / Original Publication Date: 2020-03-02
Decision / Authorization Date: 2019-07-03
Updated Date: 2024-07-25
Summary Safety Review - Sodium/glucose cotransporter 2 (SGLT2) inhibitors - Assessing the potential risk of inflammation of the pancreas (acute and chronic pancreatitis)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00204
Issued / Original Publication Date: 2018-07-20
Summary Basis of Decision for Nerlynx
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00461
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
Issued / Original Publication Date: 2020-01-29
Decision / Authorization Date: 2019-07-16
Updated Date: 2023-12-07
Regulatory Decision Summary for Nucala
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00429
Product Type: Drug
Control Number: 208467
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-08-15
Decision / Authorization Date: 2018-07-17
Regulatory Decision Summary for Tresiba
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00384
Product Type: Drug
Control Number: 208917
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-09-08
Decision / Authorization Date: 2018-07-17
Summary Basis of Decision for Oxervate
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00439
Product Type: Drug
Control Number: 218145
DIN(s): 02485613
Manufacturer: Dompé farmaceutici S.p.A.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-07-16
Issued / Original Publication Date: 2019-07-24
Decision / Authorization Date: 2019-02-08
Updated Date: 2024-12-16

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