Review decisions

Showing 820 results of 2304 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00511
Product Type: Drug
Control Number: 244946
DIN(s): 02510014, 02527685
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-10-12
Issued / Original Publication Date: 2021-01-06
Decision / Authorization Date: 2020-12-23
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00707
Product Type: Drug
Control Number: 232775
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-11-14
Decision / Authorization Date: 2020-10-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00828
Product Type: Drug
Control Number: 237194
DIN(s): 02506343
Manufacturer: Alnylam Netherlands B.v.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-03-19
Decision / Authorization Date: 2020-10-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00510
Product Type: Drug
Control Number: 224906
DIN(s): 02509210, 02522454, 02527863, 02530325
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-10-09
Issued / Original Publication Date: 2020-12-16
Decision / Authorization Date: 2020-12-09
Updated Date: 2024-09-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00819
Product Type: Drug
Control Number: 233046
DIN(s): 02505924
Manufacturer: Sterimax Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-10-31
Decision / Authorization Date: 2020-10-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00718
Product Type: Drug
Control Number: 232761
DIN(s): 02505991, 02506009
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-10-25
Decision / Authorization Date: 2020-10-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00498
Product Type: Drug
Control Number: 235295
DIN(s): 02499827, 02499835
Manufacturer: Seattle Genetics Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-10-01
Updated Date: 2022-12-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00519
Product Type: Drug
Control Number: 244627
DIN(s): 02510847, 02511444
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-10-01
Issued / Original Publication Date: 2021-03-05
Decision / Authorization Date: 2021-02-26
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00700
Product Type: Drug
Control Number: 236441
DIN(s): 02505541, 02505568
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-03-05
Decision / Authorization Date: 2020-09-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00704
Product Type: Drug
Control Number: 220233
Manufacturer: Sanofi Pasteur Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-09-18
Decision / Authorization Date: 2020-09-25