Review decisions
Showing 10 results of 12 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714051494769
Product Type: Drug
Control Number: 277282
DIN(s): 02407329
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-07-17
Decision / Authorization Date: 2024-01-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697728420996
Product Type: Drug
Control Number: 265427
DIN(s): 02475200, 02475219
Manufacturer: AstraZeneca Canada Inc
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-06-22
Decision / Authorization Date: 2023-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00989
Product Type: Drug
Control Number: 259417
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-12-09
Decision / Authorization Date: 2022-07-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1687370834165
Product Type: Drug
Control Number: 263638
DIN(s): 02537117
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-04-22
Issued / Original Publication Date: 2023-06-21
Decision / Authorization Date: 2023-04-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00922
Product Type: Drug
Control Number: 248874
DIN(s): 02525542
Manufacturer: Canadian Molecular Imaging Probe Consortium (CanProbe)
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-03-12
Decision / Authorization Date: 2022-02-24
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00399
Product Type: Drug
Control Number: 210204
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-10-13
Decision / Authorization Date: 2018-05-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00398
Product Type: Drug
Control Number: 205344
DIN(s): 02475200, 02475219
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-05
Decision / Authorization Date: 2018-05-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00130
Product Type: Drug
Control Number: 182823
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-03-16
Decision / Authorization Date: 2016-04-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00060
Product Type: Drug
Control Number: 177983
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2014-09-15
Decision / Authorization Date: 2015-04-15