Review decisions

Showing 800 results of 2627 total
Summary Safety Review - Oral, Over-the-counter Diphenhydramine - Containing Products - Assessing the Potential Risk of Serious Side Effects in Children
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00282
Issued / Original Publication Date: 2022-03-01
Regulatory Decision Summary for Covifenz
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00921
Product Type: Drug
Control Number: 254598
Manufacturer: Medicago Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-08-09
Decision / Authorization Date: 2022-02-24
Regulatory Decision Summary for Netvision
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00922
Product Type: Drug
Control Number: 248874
DIN(s): 02525542
Manufacturer: Canadian Molecular Imaging Probe Consortium (CanProbe)
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-03-12
Decision / Authorization Date: 2022-02-24
Regulatory Decision Summary for Favipiravir (*Reeqonus)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00924
Product Type: Drug
Control Number: 256417
Manufacturer: Dr. Reddys Laboratories
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2020-12-18
Decision / Authorization Date: 2022-02-24
Regulatory Decision Summary for Lenvima
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00931
Product Type: Drug
Control Number: 252195
Manufacturer: Eisai Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-05-03
Decision / Authorization Date: 2022-02-24
Regulatory Decision Summary for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00935
Product Type: Drug
Control Number: 252263
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-05-03
Decision / Authorization Date: 2022-02-24
Regulatory Decision Summary for Bamlanivimab
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01088
Product Type: Drug
Control Number: 253646
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-06-11
Decision / Authorization Date: 2022-02-22
Regulatory Decision Summary for Bamlanivimab and Etesevimab
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01089
Product Type: Drug
Control Number: 256653
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-09-20
Decision / Authorization Date: 2022-02-20
Regulatory Decision Summary for Nuvaxovid
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00916
Product Type: Drug
Control Number: 255370
DIN(s): 02525364
Manufacturer: Novavax Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-08-27
Decision / Authorization Date: 2022-02-17
Regulatory Decision Summary for Diacetylmorphine Hydrochloride
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00920
Product Type: Drug
Control Number: 254850
DIN(s): 02524996, 02525003
Manufacturer: Pharmascience Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-20
Decision / Authorization Date: 2022-02-16

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