Review decisions

Showing 30 results of 820 total
Regulatory Decision Summary for Panenza (Haemagglutinin-Strain A (H1N1))
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1701354245768
Product Type: Drug
Control Number: 267444
DIN(s): 02542714
Manufacturer: Sanofi Pasteur Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-08-29
Decision / Authorization Date: 2023-10-27
Regulatory Decision Summary for Jamteki
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1702060641808
Product Type: Drug
Control Number: 268742
DIN(s): 02543036, 02543044
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-12-01
Decision / Authorization Date: 2023-11-09
Regulatory Decision Summary for Asparlas
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1707229586312
Product Type: Drug
Control Number: 268282
DIN(s): 02542943
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-09-29
Decision / Authorization Date: 2023-11-08
Regulatory Decision Summary for Ranopto
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697811489202
Product Type: Drug
Control Number: 268288
DIN(s): 02542250
Manufacturer: Teva Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-10-04
Decision / Authorization Date: 2023-10-11
Regulatory Decision Summary for Zimed PF
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698760127896
Product Type: Drug
Control Number: 259843
DIN(s): 02533464
Manufacturer: Aequus Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-12-20
Decision / Authorization Date: 2022-12-14
Regulatory Decision Summary for Micro+ TE Pediatric
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698761313167
Product Type: Drug
Control Number: 246125
DIN(s): 02536145
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-12-04
Decision / Authorization Date: 2023-05-15
Regulatory Decision Summary for Zoryve
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698780442306
Product Type: Drug
Control Number: 264296
DIN(s): 02537532
Manufacturer: Acutis Biotherapeutics, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-05-13
Decision / Authorization Date: 2023-04-28
Regulatory Decision Summary for Winlevi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1701375559096
Product Type: Drug
Control Number: 265619
DIN(s): 02538881
Manufacturer: Sun Pharmaceutical Industries Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-06-29
Decision / Authorization Date: 2023-06-15
Regulatory Decision Summary for Sotyktu
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698758419366
Product Type: Drug
Control Number: 259397
DIN(s): 02533030
Manufacturer: Bristol-Myers Squibb
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-12-08
Decision / Authorization Date: 2023-11-24
Regulatory Decision Summary for Quillivant ER chewable tablets and Quillivant ER oral suspension
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697216175270
Product Type: Drug
Control Number: 243224
DIN(s): 02541602, 02541610, 02541629, 02541637
Manufacturer: KYE Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-20
Decision / Authorization Date: 2023-09-21

Displaying 21 - 30 of 820 | Page 3 of 82
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