Review decisions

Showing 1900 results of 2627 total
Regulatory Decision Summary for Enbrel
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00220
Product Type: Drug
Control Number: 193787
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-03-30
Decision / Authorization Date: 2017-03-14
Regulatory Decision Summary for Brinavess
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00237
Product Type: Drug
Control Number: 190817
DIN(s): 02462400
Manufacturer: Cardiome UK Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-01-04
Decision / Authorization Date: 2017-03-13
Regulatory Decision Summary for Revolade
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00223
Product Type: Drug
Control Number: 188969
DIN(s): 02461382
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-10-29
Decision / Authorization Date: 2017-03-07
Summary Basis of Decision for Rapivab
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00349
Product Type: Drug
Control Number: 191280
DIN(s): 02460319
Manufacturer: BioCryst Pharmaceuticals, Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-03-07
Updated Date: 2018-11-29
Summary Basis of Decision for Lancora
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00348
Product Type: Drug
Control Number: 166949
DIN(s): 02459973, 02459981
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-03-06
Updated Date: 2019-03-25
Summary Safety Review - Zydelig (idelalisib) - Assessing the potential risk of serious infections
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00152
Issued / Original Publication Date: 2017-03-03
Summary Basis of Decision for Hadlima / Hadlima PushTouch
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00398
Product Type: Drug
Control Number: 203250, 203292
DIN(s): 02473097, 02473100, 02533472, 02533480
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-03-02
Issued / Original Publication Date: 2018-08-20
Decision / Authorization Date: 2018-05-08
Updated Date: 2024-07-05
Regulatory Decision Summary for Vimpat
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00221
Product Type: Drug
Control Number: 193732
Manufacturer: UCB Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-03-29
Decision / Authorization Date: 2017-02-28
Regulatory Decision Summary for Oncaspar
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00219
Product Type: Drug
Control Number: 189795
DIN(s): 02461900
Manufacturer: Baxalta Canada Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-03-14
Decision / Authorization Date: 2017-02-24
Summary Safety Review - Tramadol-containing Products - Assessing the Potential Risk of Serious Breathing Problems (Respiratory Depression) in Children and Adolescents
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00149
Issued / Original Publication Date: 2017-02-22

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