Review decisions
Showing 56 results of 56 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00257
Product Type: Drug
Control Number: 162552
DIN(s): 02443937, 02443945
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2013-04-17
Issued / Original Publication Date: 2015-08-27
Decision / Authorization Date: 2015-08-23
Updated Date: 2024-06-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00171
Product Type: Drug
Control Number: 162761
DIN(s): 02412764, 02412772, 02412799, 02412802, 02412810
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2013-02-25
Issued / Original Publication Date: 2013-12-10
Decision / Authorization Date: 2013-09-19
Updated Date: 2024-07-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00270
Product Type: Drug
Control Number: 161585
DIN(s): 02418401
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2013-01-10
Issued / Original Publication Date: 2014-02-27
Decision / Authorization Date: 2013-12-23
Updated Date: 2024-06-27
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/SBD00226
Product Type: Drug
Control Number: 155318
DIN(s): 02397412, 02442612, 02442620, 02519364, 02543451
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2012-04-30
Issued / Original Publication Date: 2012-11-24
Decision / Authorization Date: 2012-11-26
Updated Date: 2024-06-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00170
Product Type: Drug
Control Number: 154851
DIN(s): 02401347
Manufacturer: Seattle Genetics, Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2012-04-11
Issued / Original Publication Date: 2013-04-03
Decision / Authorization Date: 2013-02-01
Updated Date: 2024-07-15