Review decisions
Showing 300 results of 338 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00326
Product Type: Drug
Control Number: 182114
DIN(s): 02451158, 02451166, 02451174, 02451182, 02451190, 02451204, 02451212, 02451220
Manufacturer: Actelion Pharmaceuticals Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-02-13
Issued / Original Publication Date: 2016-03-03
Decision / Authorization Date: 2016-01-20
Updated Date: 2024-03-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00288
Product Type: Drug
Control Number: 180793
DIN(s): 02451336, 02451344, 02451352, 02451360, 02489627
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-02-09
Issued / Original Publication Date: 2016-03-09
Decision / Authorization Date: 2016-01-26
Updated Date: 2023-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00267
Product Type: Drug
Control Number: 180223
DIN(s): 02445727
Manufacturer: NPS Pharma Holdings Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-12-09
Issued / Original Publication Date: 2015-11-09
Decision / Authorization Date: 2015-09-04
Updated Date: 2023-04-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00279
Product Type: Drug
Control Number: 179850
DIN(s): 02449781, 02492989, 02492997, 02530821
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-11-19
Issued / Original Publication Date: 2016-03-01
Decision / Authorization Date: 2015-12-03
Updated Date: 2023-08-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00337
Product Type: Drug
Control Number: 179333
Manufacturer: Sucampo Pharma Americas, LLC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-10-31
Issued / Original Publication Date: 2015-12-24
Decision / Authorization Date: 2015-10-14
Updated Date: 2023-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00190
Product Type: Drug
Control Number: 179340
DIN(s): 02444607, 02444615, 02444623, 02444631, 02444658
Manufacturer: Alexion Pharma International Sarl
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-10-30
Issued / Original Publication Date: 2015-10-21
Decision / Authorization Date: 2015-08-14
Updated Date: 2023-09-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00247
Product Type: Drug
Control Number: 178006
DIN(s): 02446901
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-09-15
Issued / Original Publication Date: 2015-11-30
Decision / Authorization Date: 2015-09-30
Updated Date: 2023-03-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00245
Product Type: Drug
Control Number: 177359
DIN(s): 02444267
Manufacturer: Provensis Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-08-20
Issued / Original Publication Date: 2015-09-18
Decision / Authorization Date: 2015-08-04
Updated Date: 2023-01-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00240
Product Type: Drug
Control Number: 177290
DIN(s): 02447401
Manufacturer: Baxalta Canada Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-08-15
Issued / Original Publication Date: 2015-12-03
Decision / Authorization Date: 2015-10-14
Updated Date: 2024-02-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00246
Product Type: Drug
Control Number: 176820
DIN(s): 02443732, 02443740, 02443759
Manufacturer: Forest Laboratories Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-07-29
Issued / Original Publication Date: 2015-09-30
Decision / Authorization Date: 2015-07-16
Updated Date: 2024-03-04