Review decisions

Showing 880 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00639
Product Type: Drug
Control Number: 214058
DIN(s): 02498316
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-02-23
Decision / Authorization Date: 2020-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00933
Product Type: Drug
Control Number: 225793
DIN(s): 02498472, 02498480
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-03-15
Decision / Authorization Date: 2020-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00652
Product Type: Drug
Control Number: 231264
DIN(s): 02498251
Manufacturer: CSL Behring Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-09-09
Decision / Authorization Date: 2020-04-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00688
Product Type: Drug
Control Number: 220445
DIN(s): 02497395
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-04-09
Decision / Authorization Date: 2020-04-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00726
Product Type: Drug
Control Number: 199804
DIN(s): 02498146
Manufacturer: Blue-Zone Technologies Ltd.
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2016-10-31
Decision / Authorization Date: 2020-04-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00633
Product Type: Drug
Control Number: 214080
DIN(s): 02485575, 02485583, 02485591, 02485656
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-02-28
Decision / Authorization Date: 2020-04-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00677
Product Type: Drug
Control Number: 224850
DIN(s): 02498049
Manufacturer: Knight Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-02-26
Decision / Authorization Date: 2020-04-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00632
Product Type: Drug
Control Number: 227270
DIN(s): 02498073
Manufacturer: ALK-Abello A/S
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-04-29
Decision / Authorization Date: 2020-04-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00675
Product Type: Drug
Control Number: 220876
DIN(s): 02498057
Manufacturer: Bausch Health, Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-05-01
Decision / Authorization Date: 2020-04-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00627
Product Type: Drug
Control Number: 226828
DIN(s): 02497859
Manufacturer: Teva Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-05-01
Decision / Authorization Date: 2020-04-09