Review decisions

Showing 70 results of 73 total
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00125
Product Type: Drug
Control Number: 180916
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-12-23
Decision / Authorization Date: 2015-11-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00024
Product Type: Drug
Control Number: 179386
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-11-03
Decision / Authorization Date: 2015-10-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00321
Product Type: Drug
Control Number: 187648
DIN(s): 02455951, 02455978, 02502712
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-09-14
Issued / Original Publication Date: 2016-09-08
Decision / Authorization Date: 2016-06-29
Updated Date: 2023-06-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00150
Product Type: Drug
Control Number: 179136
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-10-24
Decision / Authorization Date: 2015-07-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00193
Product Type: Drug
Control Number: 174291
DIN(s): 02435128, 02435136
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2014-04-28
Issued / Original Publication Date: 2015-05-15
Decision / Authorization Date: 2014-12-03
Updated Date: 2022-11-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00252
Product Type: Drug
Control Number: 174029
DIN(s): 02434407, 02486733, 02486741, 02486768, 02486776
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2014-04-17
Issued / Original Publication Date: 2015-03-18
Decision / Authorization Date: 2014-11-17
Updated Date: 2022-11-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00221
Product Type: Drug
Control Number: 164021
DIN(s): 02416441
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2014-01-28
Updated Date: 2020-10-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00255
Product Type: Drug
Control Number: 157505
DIN(s): 02425483, 02425491
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-07-27
Issued / Original Publication Date: 2014-08-26
Decision / Authorization Date: 2014-05-23
Updated Date: 2022-12-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00169
Product Type: Drug
Control Number: 138343
DIN(s): 02371065
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2010-12-23
Issued / Original Publication Date: 2012-02-21
Updated Date: 2011-07-27