Review decisions

Showing 460 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00332
Product Type: Drug
Control Number: 189442
DIN(s): 02458136
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-11-12
Issued / Original Publication Date: 2016-10-31
Decision / Authorization Date: 2016-09-29
Updated Date: 2026-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00180
Product Type: Drug
Control Number: 172616
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-10-27
Updated Date: 2020-10-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00285
Product Type: Drug
Control Number: 165145
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-10-08
Updated Date: 2018-05-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00323
Product Type: Drug
Control Number: 188144
DIN(s): 02455919, 02455927
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-10-01
Issued / Original Publication Date: 2016-08-30
Decision / Authorization Date: 2016-06-21
Updated Date: 2024-11-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00379
Product Type: Drug
Control Number: 188114
DIN(s): 02470373
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-09-30
Issued / Original Publication Date: 2018-02-02
Decision / Authorization Date: 2017-12-01
Updated Date: 2024-02-16
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: 2025-05-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00338
Product Type: Drug
Control Number: 187363
DIN(s): 02458640, 02458659, 02458667
Manufacturer: Daiichi Sankyo, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-09-03
Issued / Original Publication Date: 2016-12-21
Decision / Authorization Date: 2016-11-04
Updated Date: 2026-03-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00179
Product Type: Drug
Control Number: 176810
DIN(s): 02443805
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-08-20
Updated Date: 2022-12-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00341
Product Type: Drug
Control Number: 186333
DIN(s): 02459329
Manufacturer: Guerbet
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-07-31
Issued / Original Publication Date: 2017-01-25
Decision / Authorization Date: 2016-11-25
Updated Date: 2025-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00335
Product Type: Drug
Control Number: 186488
DIN(s): 02456451, 02456478
Manufacturer: Pediapharm Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-07-23
Issued / Original Publication Date: 2016-09-29
Decision / Authorization Date: 2016-07-20
Updated Date: 2023-07-25