Review decisions

Showing 2100 results of 2304 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00213
Product Type: Drug
Control Number: 153849
DIN(s): 02393751, 02464489, 02464500
Manufacturer: InterMune International AG
Submission Type: New Drug Submission
Issued / Original Publication Date: 2012-11-21
Updated Date: 2022-10-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00330
Product Type: Drug
Control Number: 160195
DIN(s): 02419483, 02511576, 02511584
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2012-11-14
Issued / Original Publication Date: 2014-04-01
Decision / Authorization Date: 2014-01-15
Updated Date: 2023-09-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00239
Product Type: Drug
Control Number: 160063
DIN(s): 02444038
Manufacturer: Linepharma International Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-11-14
Issued / Original Publication Date: 2016-01-08
Decision / Authorization Date: 2015-07-29
Updated Date: 2023-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00253
Product Type: Drug
Control Number: 159493
DIN(s): 02419475
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2012-11-14
Issued / Original Publication Date: 2014-03-04
Decision / Authorization Date: 2014-01-15
Updated Date: 2024-09-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00259
Product Type: Drug
Control Number: 159416
DIN(s): 02413388
Manufacturer: Valeant Canada LP
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-10-19
Issued / Original Publication Date: 2013-12-05
Decision / Authorization Date: 2013-10-02
Updated Date: 2023-04-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00196
Product Type: Drug
Control Number: 161084
DIN(s): 02414945, 02461218, 02461226, 02511517
Manufacturer: ViiV Healthcare ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2012-10-09
Issued / Original Publication Date: 2014-02-13
Decision / Authorization Date: 2013-10-31
Updated Date: 2024-06-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00231
Product Type: Drug
Control Number: 159020
DIN(s): 02412683
Manufacturer: Biomarin Pharmaceutical Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-09-28
Issued / Original Publication Date: 2013-12-10
Decision / Authorization Date: 2013-09-16
Updated Date: 2023-04-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00260
Product Type: Drug
Control Number: 158419
DIN(s): 02405016, 02405024
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2012-08-31
Issued / Original Publication Date: 2013-07-10
Decision / Authorization Date: 2013-04-12
Updated Date: 2023-02-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00189
Product Type: Drug
Control Number: 157970
DIN(s): 02403390
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2012-08-15
Issued / Original Publication Date: 2013-05-07
Decision / Authorization Date: 2013-03-11
Updated Date: 2023-04-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00228
Product Type: Drug
Control Number: 157665
DIN(s): 02409623, 02409658
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-08-03
Issued / Original Publication Date: 2014-02-13
Decision / Authorization Date: 2013-07-18
Updated Date: 2023-04-05