Review decisions

Showing 870 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1718984960692
Product Type: Drug
Control Number: 257895
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission with flexibilities filed for COVID-19 Drug products (NDS-CV)
Date Filed / Submission Date: 2021-10-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00632
Product Type: Drug
Control Number: 243026
DIN(s): 02532247, 02532255, 02532263, 02532271, 02532298, 02532301, 02532328
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-10-21
Issued / Original Publication Date: 2023-03-28
Decision / Authorization Date: 2022-10-26
Updated Date: 2025-01-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01085
Product Type: Drug
Control Number: 232286
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-04-14
Decision / Authorization Date: 2021-10-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00913
Product Type: Drug
Control Number: 234372
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-11
Decision / Authorization Date: 2021-10-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00995
Product Type: Drug
Control Number: 245848
DIN(s): 02521083
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-10-29
Decision / Authorization Date: 2021-10-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00872
Product Type: Drug
Control Number: 245851
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-10-29
Decision / Authorization Date: 2021-10-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00874
Product Type: Drug
Control Number: 245877
DIN(s): 02521288
Manufacturer: Leo Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-10-30
Decision / Authorization Date: 2021-10-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00876
Product Type: Drug
Control Number: 243229
DIN(s): 02520974, 02520982
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-10-30
Decision / Authorization Date: 2021-10-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00870
Product Type: Drug
Control Number: 220512
DIN(s): 02520990, 02521008
Manufacturer: Tanvex Biopharma USA Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-01-17
Decision / Authorization Date: 2021-10-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00975
Product Type: Drug
Control Number: 245530
DIN(s): 02520893
Manufacturer: Corporation Abbvie
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-10-23
Decision / Authorization Date: 2021-10-06