Review decisions

Showing 450 results of 2299 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00968
Product Type: Drug
Control Number: 253256
Manufacturer: Octapharma Pharmazeutika Produktionsges m.b.H.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-08
Decision / Authorization Date: 2022-05-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01103
Product Type: Drug
Control Number: 254371
Manufacturer: BGP Pharma ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-30
Decision / Authorization Date: 2022-05-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00947
Product Type: Drug
Control Number: 259715
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-17
Decision / Authorization Date: 2022-05-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00948
Product Type: Drug
Control Number: 253111
DIN(s): 02527049
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-05-21
Decision / Authorization Date: 2022-05-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01067
Product Type: Drug
Control Number: 247562
DIN(s): 02527138
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-17
Decision / Authorization Date: 2022-05-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01062
Product Type: Drug
Control Number: 253057
Manufacturer: Eisai Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-05-25
Decision / Authorization Date: 2022-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00949
Product Type: Drug
Control Number: 253060
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-05-25
Decision / Authorization Date: 2022-05-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00946
Product Type: Drug
Control Number: 259606
Manufacturer: Canadian Blood Services
Submission Type: Application for an Authorization Amendment
Date Filed / Submission Date: 2021-12-15
Decision / Authorization Date: 2022-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00942
Product Type: Drug
Control Number: 250151
DIN(s): 02502143
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2021-03-05
Decision / Authorization Date: 2022-04-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01084
Product Type: Drug
Control Number: 249774
DIN(s): 02526794, 02526808, 02526816, 02526824
Manufacturer: Allergan Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-02-22
Decision / Authorization Date: 2022-04-22