Review decisions

Showing 60 results of 820 total
Summary Basis of Decision for Jubbonti
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1729523262756
Product Type: Drug
Control Number: 271806
DIN(s): 02545411
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Issued / Original Publication Date: 2024-10-17
Decision / Authorization Date: 2024-02-16
Updated Date: 2024-10-17
Regulatory Decision Summary for Prz-Metformin
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01071
Product Type: Drug
Control Number: 263913
DIN(s): 02534673
Manufacturer: Pharmaris Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-05-03
Decision / Authorization Date: 2023-01-24
Summary Basis of Decision for Pluvicto
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00621
Product Type: Drug
Control Number: 260951
DIN(s): 02530198
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2023-01-20
Updated Date: 2023-01-20
Regulatory Decision Summary for Vegzelma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01055
Product Type: Drug
Control Number: 258973
DIN(s): 02534177, 02534185
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-11-24
Decision / Authorization Date: 2023-01-03
Summary Basis of Decision for Welireg
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00616
Product Type: Drug
Control Number: 254495
DIN(s): 02528908
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-12-20
Updated Date: 2022-12-20
Summary Basis of Decision for Cibinqo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00620
Product Type: Drug
Control Number: 245854
DIN(s): 02528363, 02528371, 02528398
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-12-02
Updated Date: 2022-12-02
Summary Basis of Decision for Jamteki
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718291599089
Product Type: Drug
Control Number: 268742
DIN(s): 02543036, 02543044
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-11-24
Issued / Original Publication Date: 2024-06-12
Decision / Authorization Date: 2023-11-09
Summary Basis of Decision for Tezspire
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00613
Product Type: Drug
Control Number: 256188
DIN(s): 02529548, 02529556
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-11-21
Updated Date: 2022-11-21
Regulatory Decision Summary for Slynd
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683208648343
Product Type: Drug
Control Number: 242176
DIN(s): 02522802
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-07-24
Decision / Authorization Date: 2021-11-30
Summary Basis of Decision for Wezlana/Wezlana I.V.
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1721675750511
Product Type: Drug
Control Number: 269097
DIN(s): 02544180, 02544199, 02544202, 02544210
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-11-15
Issued / Original Publication Date: 2024-07-22
Decision / Authorization Date: 2023-12-27

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