Review decisions
Showing 1130 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00426
Product Type: Drug
Control Number: 212632
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2018-01-05
Decision / Authorization Date: 2018-07-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00429
Product Type: Drug
Control Number: 208467
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-08-15
Decision / Authorization Date: 2018-07-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00384
Product Type: Drug
Control Number: 208917
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-09-08
Decision / Authorization Date: 2018-07-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00395
Product Type: Drug
Control Number: 212276
DIN(s): 02478765
Manufacturer: Recordati Rare Diseases Canada Inc.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-12-20
Decision / Authorization Date: 2018-07-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00383
Product Type: Drug
Control Number: 208033
Manufacturer: CSL Behring Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-07-31
Decision / Authorization Date: 2018-07-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00393
Product Type: Drug
Control Number: N/A
Manufacturer: Promethera Biosciences S.A./N.V
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-06-16
Decision / Authorization Date: 2018-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00454
Product Type: Drug
Control Number: 203718
DIN(s): 02478579
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-07-26
Decision / Authorization Date: 2018-07-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00424
Product Type: Drug
Control Number: 205392
DIN(s): 02478498
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-05-09
Decision / Authorization Date: 2018-07-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00382
Product Type: Drug
Control Number: 212067
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-12-13
Decision / Authorization Date: 2018-07-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00406
Product Type: Drug
Control Number: 207006
DIN(s): 02478293
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-06-28
Decision / Authorization Date: 2018-07-06