Review decisions

Showing 760 results of 1550 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01015
Product Type: Drug
Control Number: 239505
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-05-15
Decision / Authorization Date: 2021-02-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00776
Product Type: Drug
Control Number: 237121
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-03-09
Decision / Authorization Date: 2021-01-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00755
Product Type: Drug
Control Number: 236086
DIN(s): 02511576, 02511584
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-02-18
Decision / Authorization Date: 2021-01-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00785
Product Type: Drug
Control Number: 235583
DIN(s): 02511517
Manufacturer: ViiV Healthcare ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-01-29
Decision / Authorization Date: 2021-01-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00789
Product Type: Drug
Control Number: 236369
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-02-21
Decision / Authorization Date: 2021-01-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00756
Product Type: Drug
Control Number: 237346
DIN(s): 02511355, 02511363
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-03-20
Decision / Authorization Date: 2021-01-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00788
Product Type: Drug
Control Number: 235705
Manufacturer: Kye Pharmaceuticals Inc., Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-01-31
Decision / Authorization Date: 2021-01-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00762
Product Type: Drug
Control Number: 235994
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-02-11
Decision / Authorization Date: 2021-01-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00753
Product Type: Drug
Control Number: 231019
DIN(s): 02510987
Manufacturer: Apotex Inc.
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2019-08-23
Decision / Authorization Date: 2021-01-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00754
Product Type: Drug
Control Number: 235672
DIN(s): 02510936
Manufacturer: Sanofi Pasteur Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-01-31
Decision / Authorization Date: 2021-01-14