Review decisions

Showing 10 results of 665 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1707315192044
Product Type: Drug
Control Number: 278519
DIN(s): 02543656
Manufacturer: Novavax Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-09-01
Issued / Original Publication Date: 2024-02-09
Decision / Authorization Date: 2023-12-05
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1688740135719
Product Type: Drug
Control Number: 259302
DIN(s): 02533286
Manufacturer: VBI Vaccines Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-07-08
Issued / Original Publication Date: 2023-07-06
Decision / Authorization Date: 2022-12-06
Updated Date: 2023-07-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1700495075939
Product Type: Drug
Control Number: 276302
DIN(s): 02541823, 02541831, 02541858, 02541866
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Issued / Original Publication Date: 2023-11-22
Decision / Authorization Date: 2023-09-28
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1698862620995
Product Type: Drug
Control Number: 275936
DIN(s): 02541270
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Issued / Original Publication Date: 2023-10-31
Decision / Authorization Date: 2023-09-12
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00631
Product Type: Drug
Control Number: 256191
DIN(s): 02532530, 02532581
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission
Issued / Original Publication Date: 2023-03-30
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
Issued / Original Publication Date: 2023-03-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1713457878482
Product Type: Drug
Control Number: 273741
DIN(s): 02542641, 02542676, 02542684, 02542692
Manufacturer: Medison Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-03-28
Issued / Original Publication Date: 2024-04-17
Decision / Authorization Date: 2023-10-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1715173505610
Product Type: Drug
Control Number: 273721
DIN(s): 02542560
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-03-27
Issued / Original Publication Date: 2024-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00630
Product Type: Drug
Control Number: 256568
DIN(s): 02532603
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2023-03-24
Updated Date: 2023-03-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00629
Product Type: Drug
Control Number: 259103
DIN(s): 02532891, 02532905, 02532913, 02532921, 02532948, 02532956
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2023-03-17