Review decisions

Showing 40 results of 73 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00546
Product Type: Drug
Control Number: 239537
DIN(s): 02515474, 02515482
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-05-15
Issued / Original Publication Date: 2021-08-05
Decision / Authorization Date: 2021-04-28
Updated Date: 2023-07-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00609
Product Type: Drug
Control Number: 224739
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-02-15
Decision / Authorization Date: 2020-01-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00564
Product Type: Drug
Control Number: 226512
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-04-03
Decision / Authorization Date: 2019-10-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00800
Product Type: Drug
Control Number: 224529
DIN(s): 02493217, 02493225, 02493233, 02493241
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-02-08
Decision / Authorization Date: 2019-10-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00516
Product Type: Drug
Control Number: 214952
DIN(s): 02486733, 02486741, 02486768, 02486776
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-04-11
Decision / Authorization Date: 2019-03-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00459
Product Type: Drug
Control Number: 224529
DIN(s): 02493217, 02493225, 02493233, 02493241
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2019-02-08
Issued / Original Publication Date: 2020-01-28
Decision / Authorization Date: 2019-10-25
Updated Date: 2024-07-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00476
Product Type: Drug
Control Number: 212559
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-01-03
Decision / Authorization Date: 2018-11-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00470
Product Type: Drug
Control Number: 210676
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-10-27
Decision / Authorization Date: 2018-10-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00400
Product Type: Drug
Control Number: 211942
DIN(s): 02478374
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2018-08-27
Updated Date: 2019-11-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00426
Product Type: Drug
Control Number: 212632
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2018-01-05
Decision / Authorization Date: 2018-07-24