Review decisions

Showing 860 results of 1553 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00794
Product Type: Drug
Control Number: 230307
DIN(s): 02501775
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-08-01
Decision / Authorization Date: 2020-07-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00693
Product Type: Drug
Control Number: 228353
DIN(s): 02501244
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-07-22
Decision / Authorization Date: 2020-07-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00687
Product Type: Drug
Control Number: 226954
Manufacturer: EMD Serono, A Division of EMD Inc., Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-04-18
Decision / Authorization Date: 2020-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00682
Product Type: Drug
Control Number: 234304
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2019-12-10
Decision / Authorization Date: 2020-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00689
Product Type: Drug
Control Number: 229726
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-07-15
Decision / Authorization Date: 2020-06-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00879
Product Type: Drug
Control Number: 234688
DIN(s): 02500833
Manufacturer: Deciphera Pharmaceuticals, LLC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-12-23
Decision / Authorization Date: 2020-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00664
Product Type: Drug
Control Number: 229313
Manufacturer: Kyowa Kirin, Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-07-10
Decision / Authorization Date: 2020-06-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00665
Product Type: Drug
Control Number: 230279
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-07-31
Decision / Authorization Date: 2020-06-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00746
Product Type: Drug
Control Number: 217320
DIN(s): 02500264, 02500272, 02500280, 02500299, 02500302
Manufacturer: Sunovion Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-06-15
Decision / Authorization Date: 2020-06-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00907
Product Type: Drug
Control Number: 229407
DIN(s): 02500337
Manufacturer: Sun Pharma Global FZE
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-07-04
Decision / Authorization Date: 2020-06-12