Review decisions

Showing 800 results of 2304 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00808
Product Type: Drug
Control Number: 227936
DIN(s): 02439360
Manufacturer: Recordati Rare Diseases Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2019-05-17
Decision / Authorization Date: 2020-11-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00720
Product Type: Drug
Control Number: 233914
Manufacturer: Bavarian Nordic AS
Submission Type: Supplement to an Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2019-11-19
Decision / Authorization Date: 2020-11-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00734
Product Type: Drug
Control Number: 233987
DIN(s): 02507501, 02507528, 02507536, 02507544, 02507552, 02507560, 02507579
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-11-26
Decision / Authorization Date: 2020-11-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00715
Product Type: Drug
Control Number: 219453
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-08-23
Decision / Authorization Date: 2020-11-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00714
Product Type: Drug
Control Number: 190433
DIN(s): 02459299, 02459302, 02459310
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-12-11
Decision / Authorization Date: 2020-11-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00716
Product Type: Drug
Control Number: 234183
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-05
Decision / Authorization Date: 2020-11-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00748
Product Type: Drug
Control Number: 217314
DIN(s): 02492156, 02492164
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-10-01
Decision / Authorization Date: 2020-11-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00749
Product Type: Drug
Control Number: 235712
DIN(s): 02505258
Manufacturer: Sandoz Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-02-11
Decision / Authorization Date: 2020-11-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00504
Product Type: Drug
Control Number: 233292
DIN(s): 02501821, 02501848
Manufacturer: Sunovion Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-11-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00712
Product Type: Drug
Control Number: 230637
DIN(s): 02502666, 02502674, 02502682
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-08-19
Decision / Authorization Date: 2020-10-30