Review decisions

Showing 310 results of 633 total
Regulatory Decision Summary for Kanjinti
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00852
Product Type: Drug
Control Number: 239083
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-04-30
Decision / Authorization Date: 2021-04-14
Regulatory Decision Summary for Darzalex SC
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00791
Product Type: Drug
Control Number: 244119
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-09-18
Decision / Authorization Date: 2021-04-12
Regulatory Decision Summary for Taltz
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00790
Product Type: Drug
Control Number: 238580
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-04-17
Decision / Authorization Date: 2021-03-29
Regulatory Decision Summary for Botox
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00792
Product Type: Drug
Control Number: 237685
Manufacturer: Allergan Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-03-27
Decision / Authorization Date: 2021-03-11
Regulatory Decision Summary for Alunbrig
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00829
Product Type: Drug
Control Number: 237680
DIN(s): 02479206, 02479214, 02479222, 02479230
Manufacturer: Takeda Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-03-27
Decision / Authorization Date: 2021-03-03
Regulatory Decision Summary for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01016
Product Type: Drug
Control Number: 240864
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-06-19
Decision / Authorization Date: 2021-03-03
Regulatory Decision Summary for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01016
Product Type: Drug
Control Number: 240864
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-06-19
Decision / Authorization Date: 2021-03-03
Regulatory Decision Summary for Tecentriq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00783
Product Type: Drug
Control Number: 237371
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-03-20
Decision / Authorization Date: 2021-03-01
Regulatory Decision Summary for Perjeta and Perjeta - Herceptin
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00782
Product Type: Drug
Control Number: 230602
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-08-09
Decision / Authorization Date: 2021-02-25
Regulatory Decision Summary for Saxenda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00784
Product Type: Drug
Control Number: 237880
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-03-31
Decision / Authorization Date: 2021-02-25

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