Review decisions

Showing 1000 results of 2631 total
Summary Basis of Decision for Poteligeo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00611
Product Type: Drug
Control Number: 251277
DIN(s): 02527715
Manufacturer: Kyowa Kirin, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-03-31
Issued / Original Publication Date: 2022-10-25
Decision / Authorization Date: 2022-06-02
Updated Date: 2025-06-27
Regulatory Decision Summary for Taltz
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00790
Product Type: Drug
Control Number: 238580
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-04-17
Decision / Authorization Date: 2021-03-29
Summary Basis of Decision for Byooviz
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00598
Product Type: Drug
Control Number: 251162
DIN(s): 02525852
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-03-29
Issued / Original Publication Date: 2022-08-12
Decision / Authorization Date: 2022-03-08
Updated Date: 2025-07-14
Summary Basis of Decision for Jemperli
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00580
Product Type: Drug
Control Number: 251105
DIN(s): 02523434
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-03-26
Issued / Original Publication Date: 2022-03-09
Decision / Authorization Date: 2021-12-23
Updated Date: 2024-07-26
Regulatory Decision Summary for Vistaseal
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00796
Product Type: Drug
Control Number: 239016
DIN(s): 02514222, 02514230, 02514249, 02514257
Manufacturer: Instituto Grifols, S.A.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-05-04
Decision / Authorization Date: 2021-03-25
Summary Safety Review - Artemisia annua -containing Products - Assessing the Potential Risk of Liver Injury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00262
Issued / Original Publication Date: 2021-03-24
Summary Safety Review - Diuretics, Including Acetazolamide - Assessing the Potential Risk of Certain Eye Disorders
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00261
Issued / Original Publication Date: 2021-03-19
Summary safety review - Remicade (infliximab), Humira (adalimumab), Enbrel (etanercept) and Erelzi (biosimilar etanercept) - Assessing the Potential Risk of Mycosis Fungoides
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00260
Issued / Original Publication Date: 2021-03-18
Summary Basis of Decision for NETVision
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00588
Product Type: Drug
Control Number: 248874
DIN(s): 02525542
Manufacturer: Canadian Molecular Imaging Probe Consortium (CanProbe)
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-03-12
Issued / Original Publication Date: 2022-05-26
Decision / Authorization Date: 2022-02-24
Updated Date: 2024-06-18
Summary Basis of Decision for Covishield
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00520
Product Type: Drug
Control Number: 248651
DIN(s): 02512947
Manufacturer: Verity Pharmaceuticals Inc.
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Issued / Original Publication Date: 2021-03-12
Updated Date: 2022-01-21

Displaying 991 - 1000 of 2631 | Page 100 of 264
Date modified: