Review decisions
Showing 10 results of 11 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1716577628323
Product Type: Drug
Control Number: 262892
DIN(s): 02489783, 02530031
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-30
Decision / Authorization Date: 2024-01-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706106900025
Product Type: Drug
Control Number: 270698
DIN(s): 02478374, 02540185
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-15
Decision / Authorization Date: 2023-08-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00999
Product Type: Drug
Control Number: 259448
DIN(s): 02530031
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-11-10
Decision / Authorization Date: 2022-08-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00813
Product Type: Drug
Control Number: 227804
DIN(s): 02503603
Manufacturer: Eckert & Ziegler Radiopharma GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-05-15
Decision / Authorization Date: 2020-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00465
Product Type: Drug
Control Number: 221824
DIN(s): 02492806
Manufacturer: IRE ELiT S.A.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-03-09
Updated Date: 2022-11-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00657
Product Type: Drug
Control Number: 216792
DIN(s): 02489783
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-06-04
Decision / Authorization Date: 2019-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00506
Product Type: Drug
Control Number: 227804
DIN(s): 02503603
Manufacturer: Eckert & Ziegler Radiopharma GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-05-15
Issued / Original Publication Date: 2020-11-25
Decision / Authorization Date: 2020-08-19
Updated Date: 2024-11-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00392
Product Type: Drug
Control Number: 211942
DIN(s): 02478374
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-12-07
Decision / Authorization Date: 2018-07-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00450
Product Type: Drug
Control Number: 216792
DIN(s): 02489783, 02530031
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-06-04
Issued / Original Publication Date: 2019-11-19
Decision / Authorization Date: 2019-06-27
Updated Date: 2025-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00400
Product Type: Drug
Control Number: 211942
DIN(s): 02478374, 02540185
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-12-07
Issued / Original Publication Date: 2018-08-27
Decision / Authorization Date: 2018-07-03
Updated Date: 2025-06-13