Review decisions
Showing 1590 results of 2627 total
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/SBD00449
Product Type: Drug
Control Number: 218183
DIN(s): 02489430, 02489449
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-07-13
Issued / Original Publication Date: 2019-11-15
Decision / Authorization Date: 2019-06-14
Updated Date: 2024-03-08
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00385
Product Type: Drug
Control Number: 208089
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-08-01
Decision / Authorization Date: 2018-07-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00428
Product Type: Drug
Control Number: 208034
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-07-31
Decision / Authorization Date: 2018-07-04