Review decisions

Showing 40 results of 820 total
Regulatory Decision Summary for Absorica LD
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694618321621
Product Type: Drug
Control Number: 263460
DIN(s): 02539047, 02539055, 02539063, 02539071
Manufacturer: Sun Pharmaceuticals Industries Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-04-14
Decision / Authorization Date: 2023-06-22
Regulatory Decision Summary for Tecvayli (teclistamab)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1691775757350
Product Type: Drug
Control Number: 269369
DIN(s): 02539756, 02539764
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-11-02
Decision / Authorization Date: 2023-07-26
Regulatory Decision Summary for Axberi / Axberi HP
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1691593234367
Product Type: Drug
Control Number: 266545
DIN(s): 02539977, 02539985, 02540002, 02540010, 02540029, 02540037, 02540045
Manufacturer: Baxter Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-07-29
Decision / Authorization Date: 2023-07-27
Regulatory Decision Summary for Lumblue
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694621051185
Product Type: Drug
Control Number: 219788
Manufacturer: Pendopharm Division of Pharmascience Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-09-17
Decision / Authorization Date: 2021-12-22
Regulatory Decision Summary for Xywav
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1693590059350
Product Type: Drug
Control Number: 262870
DIN(s): 02538237
Manufacturer: Jazz Pharmaceuticals Ireland Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-29
Decision / Authorization Date: 2023-05-25
Regulatory Decision Summary for Vaxchora
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1685545138786
Product Type: Drug
Control Number: 264995
DIN(s): 02538164
Manufacturer: Emergent Travel Health Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-06-08
Decision / Authorization Date: 2023-05-18
Regulatory Decision Summary for Vyalev
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692038706127
Product Type: Drug
Control Number: 263826
DIN(s): 02537702
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-04-29
Decision / Authorization Date: 2023-05-03
Regulatory Decision Summary for Locametz (gallium [68Ga] gozetotide)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683570485222
Product Type: Drug
Control Number: 263638
DIN(s): 02537117
Manufacturer: Advanced Accelerator Application USA, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-04-22
Decision / Authorization Date: 2023-04-05
Summary Basis of Decision for Ubrelvy
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
Summary Basis of Decision for Elonox/Elonox HP
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

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