Review decisions

Showing 60 results of 72 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00201
Product Type: Drug
Control Number: 190665
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission - Confirmatory
Date Filed / Submission Date: 2015-12-23
Decision / Authorization Date: 2016-11-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00387
Product Type: Drug
Control Number: 200590
DIN(s): 02469758, 02487314
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-11-25
Issued / Original Publication Date: 2018-03-23
Decision / Authorization Date: 2017-11-10
Updated Date: 2024-08-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00151
Product Type: Drug
Control Number: 190730
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2015-12-21
Decision / Authorization Date: 2016-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00143
Product Type: Drug
Control Number: 187648
DIN(s): 02455951, 02455978
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-09-14
Decision / Authorization Date: 2016-06-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00134
Product Type: Drug
Control Number: 185908
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-06-25
Decision / Authorization Date: 2016-06-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00126
Product Type: Drug
Control Number: 185929
DIN(s): 02455943, 02455986, 02455994, 02456001
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-07-10
Decision / Authorization Date: 2016-06-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00127
Product Type: Drug
Control Number: 185383
DIN(s): 02455404, 02455420, 02455439, 02455455
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-06-11
Decision / Authorization Date: 2016-06-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00118
Product Type: Drug
Control Number: 185031
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-06-02
Decision / Authorization Date: 2016-05-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00085
Product Type: Drug
Control Number: 183766
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-04-16
Decision / Authorization Date: 2016-03-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00046
Product Type: Drug
Control Number: 180654
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-12-15
Decision / Authorization Date: 2015-12-10