Review decisions
Showing 160 results of 332 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00799
Product Type: Drug
Control Number: 198822
DIN(s): 02493500
Manufacturer: Endoceutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-10-05
Decision / Authorization Date: 2019-11-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00530
Product Type: Drug
Control Number: 233097
DIN(s): 02505851
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-10-31
Issued / Original Publication Date: 2021-05-17
Decision / Authorization Date: 2020-10-13
Updated Date: 2023-10-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00508
Product Type: Drug
Control Number: 232761
DIN(s): 02505991, 02506009
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-10-25
Issued / Original Publication Date: 2020-12-02
Decision / Authorization Date: 2020-10-02
Updated Date: 2023-08-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00614
Product Type: Drug
Control Number: 215288
DIN(s): 02493012
Manufacturer: Cipher Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-09-20
Decision / Authorization Date: 2019-10-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00526
Product Type: Drug
Control Number: 232078
DIN(s): 02508052, 02508060
Manufacturer: Rigel Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-09-30
Issued / Original Publication Date: 2021-03-31
Decision / Authorization Date: 2020-11-19
Updated Date: 2023-07-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00672
Product Type: Drug
Control Number: 220584
DIN(s): 02492032, 02492040
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-09-28
Decision / Authorization Date: 2019-09-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00757
Product Type: Drug
Control Number: 231286
DIN(s): 02507366, 02507374
Manufacturer: Eisai Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-09-03
Decision / Authorization Date: 2019-09-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00505
Product Type: Drug
Control Number: 228708
DIN(s): 02504855
Manufacturer: Marcan Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-08-07
Issued / Original Publication Date: 2020-11-04
Decision / Authorization Date: 2020-09-14
Updated Date: 2023-07-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00601
Product Type: Drug
Control Number: 218799
DIN(s): 02490714, 02490722
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-08-15
Decision / Authorization Date: 2019-07-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00502
Product Type: Drug
Control Number: 229866
DIN(s): 02502445
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-07-19
Issued / Original Publication Date: 2020-10-22
Decision / Authorization Date: 2020-07-27
Updated Date: 2024-07-17