Review decisions

Showing 370 results of 2299 total
Summary Safety Review - Xeljanz/Xeljanz XR (tofacinitib), Olumiant (baricitinib) and Rinvoq (upadacitinib) - Janus Kinase (JAK) Inhibitors - Assessing the Potential Risks of Serious Heart-related Problems, Blood Clots, Cancer and Death
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00287
Issued / Original Publication Date: 2022-09-16
Regulatory Decision Summary for Spikevax
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01014
Product Type: Drug
Control Number: 262952
Manufacturer: ModernaTX, Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-04-01
Decision / Authorization Date: 2022-09-15
Regulatory Decision Summary for Susvimo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01000
Product Type: Drug
Control Number: 254848
DIN(s): 02530589
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-14
Decision / Authorization Date: 2022-09-14
Regulatory Decision Summary for Sholyne
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01050
Product Type: Drug
Control Number: 240337
Manufacturer: Kye Pharmaceuticals Inc., Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-05
Decision / Authorization Date: 2022-09-12
Summary Basis of Decision for Spikevax Bivalent (Original / Omicron BA.4/5)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00617
Product Type: Drug
Control Number: 267589
DIN(s): 02532352
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-09-12
Issued / Original Publication Date: 2023-01-05
Decision / Authorization Date: 2022-11-03
Updated Date: 2024-05-17
Regulatory Decision Summary for Comirnaty
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00993
Product Type: Drug
Control Number: 265483
DIN(s): 02530325
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-06-23
Decision / Authorization Date: 2022-09-09
Regulatory Decision Summary for Amgevita
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01072
Product Type: Drug
Control Number: 256159
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-08-26
Decision / Authorization Date: 2022-09-09
Regulatory Decision Summary for Eyezirgan
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01040
Product Type: Drug
Control Number: 221456
DIN(s): 02530546
Manufacturer: Laboratoires Thea
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-11-16
Decision / Authorization Date: 2022-09-08
Summary of Cancellation for Zefylti
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1725902689017
Product Type: Drug
Control Number: 267597
Manufacturer: Curateq Biologics Private Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-09-07
Decision / Authorization Date: 2024-08-01
Regulatory Decision Summary for Transitioning toward a gender-neutral questionnaire focusing on at-risk behaviour for all donation types
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00986
Product Type: Drug
Control Number: 266773
Manufacturer: Héma-Québec
Submission Type: Application for an Authorization Amendment
Date Filed / Submission Date: 2022-08-08
Decision / Authorization Date: 2022-09-06

Displaying 361 - 370 of 2299 | Page 37 of 230
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