Review decisions
Showing 200 results of 768 total
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00567
Product Type: Drug
Control Number: 250213
DIN(s): 02520869
Manufacturer: ViiV Healthcare ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-03-05
Issued / Original Publication Date: 2022-01-11
Decision / Authorization Date: 2021-10-01
Updated Date: 2025-03-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00537
Product Type: Drug
Control Number: 249830
DIN(s): 02516691, 02516705
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2021-02-24
Issued / Original Publication Date: 2021-07-07
Decision / Authorization Date: 2021-06-09
Updated Date: 2024-09-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00601
Product Type: Drug
Control Number: 249774
DIN(s): 02526794, 02526808, 02526816, 02526824
Manufacturer: Allergan Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-02-22
Issued / Original Publication Date: 2022-08-26
Decision / Authorization Date: 2022-04-22
Updated Date: 2025-08-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00565
Product Type: Drug
Control Number: 248753
DIN(s): 02520788
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-01-25
Issued / Original Publication Date: 2021-12-23
Decision / Authorization Date: 2021-09-24
Updated Date: 2024-02-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00606
Product Type: Drug
Control Number: 238499
DIN(s): 02525267, 02525275
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-01-18
Issued / Original Publication Date: 2022-10-03
Decision / Authorization Date: 2022-02-14
Updated Date: 2024-04-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00562
Product Type: Drug
Control Number: 248435
DIN(s): 02520095, 02552655
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-01-14
Issued / Original Publication Date: 2021-12-07
Decision / Authorization Date: 2021-09-10
Updated Date: 2026-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00584
Product Type: Drug
Control Number: 247265
DIN(s): 02523760, 02523779, 02535076, 02535084
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-12
Issued / Original Publication Date: 2022-04-14
Decision / Authorization Date: 2021-12-24
Updated Date: 2024-08-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00585
Product Type: Drug
Control Number: 244990
DIN(s): 02523949, 02523957, 02523965
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-07
Issued / Original Publication Date: 2022-04-14
Decision / Authorization Date: 2022-01-05
Updated Date: 2024-07-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00512
Product Type: Drug
Control Number: 244947
DIN(s): 02508176
Manufacturer: Eli Lilly Canada 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: 2021-01-05
Updated Date: 2023-03-30