Review decisions
Showing 970 results of 1549 total
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/RDS00587
Product Type: Drug
Control Number: 224729
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2019-02-15
Decision / Authorization Date: 2019-08-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1685644161223
Product Type: Drug
Control Number: 231223
Manufacturer: Marcan Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-08-30
Decision / Authorization Date: 2021-06-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00546
Product Type: Drug
Control Number: 220321
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-09-20
Decision / Authorization Date: 2019-08-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00547
Product Type: Drug
Control Number: 217955
DIN(s): 02491559
Manufacturer: Alexion Pharma GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-09-13
Decision / Authorization Date: 2019-08-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00550
Product Type: Drug
Control Number: 222188
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Confirmatory
Date Filed / Submission Date: 2018-11-21
Decision / Authorization Date: 2019-08-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00809
Product Type: Drug
Control Number: 214504
DIN(s): 02491788
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-03-15
Decision / Authorization Date: 2019-08-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00588
Product Type: Drug
Control Number: 220275
DIN(s): 02491753
Manufacturer: ViiV Healthcare ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-09-18
Decision / Authorization Date: 2019-08-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00545
Product Type: Drug
Control Number: 220039
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-09-10
Decision / Authorization Date: 2019-08-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00542
Product Type: Drug
Control Number: 220278
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-09-19
Decision / Authorization Date: 2019-08-15