Review decisions

Showing 1470 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00493
Product Type: Drug
Control Number: 202772
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-02-10
Decision / Authorization Date: 2019-02-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00584
Product Type: Drug
Control Number: 209210
DIN(s): 02485877, 02485885, 02485893
Manufacturer: Endo Ventures Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-12-19
Decision / Authorization Date: 2019-02-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00486
Product Type: Drug
Control Number: 218389
DIN(s): 02485648
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-08-17
Decision / Authorization Date: 2019-02-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00483
Product Type: Drug
Control Number: 218145
DIN(s): 02485613
Manufacturer: Dompé farmaceutici S.p.A.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2018-07-16
Decision / Authorization Date: 2019-02-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00459
Product Type: Drug
Control Number: 224529
DIN(s): 02493217, 02493225, 02493233, 02493241
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2019-02-08
Issued / Original Publication Date: 2020-01-28
Decision / Authorization Date: 2019-10-25
Updated Date: 2025-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00586
Product Type: Drug
Control Number: 211598
DIN(s): 02485559, 02485567
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-11-28
Decision / Authorization Date: 2019-02-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00577
Product Type: Drug
Control Number: 217033
DIN(s): 02485427, 02485435
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-06-15
Decision / Authorization Date: 2019-02-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00487
Product Type: Drug
Control Number: 224164
DIN(s): 02495724
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-02-06
Issued / Original Publication Date: 2020-07-30
Decision / Authorization Date: 2020-05-04
Updated Date: 2024-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00215
Issued / Original Publication Date: 2019-01-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00605
Product Type: Drug
Control Number: 218044
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2018-07-10
Decision / Authorization Date: 2019-01-25