Review decisions

Showing 10 results of 794 total
Regulatory Decision Summary for Kloxxado
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1741871370149
Product Type: Drug
Control Number: 281754
DIN(s): 02555441
Manufacturer: Hikma Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-04
Decision / Authorization Date: 2025-02-12
Regulatory Decision Summary for Vabomere
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1742225785828
Product Type: Drug
Control Number: 280730
DIN(s): 02554151
Manufacturer: Xediton Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-11-03
Decision / Authorization Date: 2024-12-20
Regulatory Decision Summary for Omlyclo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1735063121561
Product Type: Drug
Control Number: 279053
DIN(s): 02553805, 02553813
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-22
Decision / Authorization Date: 2024-12-06
Regulatory Decision Summary for Flucelvax
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1734719825446
Product Type: Drug
Control Number: 289304
DIN(s): 02553708, 02553716
Manufacturer: Seqirus UK Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-08-02
Decision / Authorization Date: 2024-12-03
Regulatory Decision Summary for Voydeya
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1734712189468
Product Type: Drug
Control Number: 274338
DIN(s): 02550040, 02550059
Manufacturer: Alexion Pharma GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-05-31
Decision / Authorization Date: 2024-07-19
Regulatory Decision Summary for Jornay PM
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1741192034006
Product Type: Drug
Control Number: 281510
DIN(s): 02553023, 02553031, 02553058, 02553066, 02553074
Manufacturer: Ironshore Pharmaceuticals & Development Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-11-24
Decision / Authorization Date: 2024-11-13
Regulatory Decision Summary for Tyenne
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1729607296633
Product Type: Drug
Control Number: 280011
DIN(s): 02552450, 02552469, 02552477, 02552485, 02552493
Manufacturer: Fresenius Kabi Canada Ltd
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-17
Decision / Authorization Date: 2024-10-11
Regulatory Decision Summary for Clorotekal
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1733408271619
Product Type: Drug
Control Number: 270862
DIN(s): 02551063
Manufacturer: B. Braun Melsungen AG
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-12-29
Decision / Authorization Date: 2024-08-22
Regulatory Decision Summary for Cabtreo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732553051076
Product Type: Drug
Control Number: 271199
DIN(s): 02550423
Manufacturer: Bausch Heath Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-06
Decision / Authorization Date: 2024-08-14
Regulatory Decision Summary for Plenvu
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732551487982
Product Type: Drug
Control Number: 273065
Manufacturer: Bausch Health Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-03-03
Decision / Authorization Date: 2024-08-16

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