Review decisions

Showing 670 results of 1550 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00863
Product Type: Drug
Control Number: 244611
DIN(s): 02520184, 02520192, 02520206, 02520214, 02520222, 02520230
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-09-30
Decision / Authorization Date: 2021-09-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00861
Product Type: Drug
Control Number: 244472
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-10-07
Decision / Authorization Date: 2021-09-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00860
Product Type: Drug
Control Number: 244601
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-10-01
Decision / Authorization Date: 2021-09-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00881
Product Type: Drug
Control Number: 248435
DIN(s): 02520095
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-14
Decision / Authorization Date: 2021-09-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00893
Product Type: Drug
Control Number: 244618
Manufacturer: Sandoz Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-10-01
Decision / Authorization Date: 2021-09-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00895
Product Type: Drug
Control Number: 244338
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-09-23
Decision / Authorization Date: 2021-09-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00854
Product Type: Drug
Control Number: 253630
Manufacturer: SaNOtize Research & Development Corp.
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2021-06-11
Decision / Authorization Date: 2021-09-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00844
Product Type: Drug
Control Number: 253430
DIN(s): 02510014
Manufacturer: ModernaTX, Inc.
Submission Type: Application filed under section 3 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2021-06-04
Decision / Authorization Date: 2021-08-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00970
Product Type: Drug
Control Number: 247481
DIN(s): 02519364
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2020-12-18
Decision / Authorization Date: 2021-08-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01075
Product Type: Drug
Control Number: 248423
DIN(s): 02519380
Manufacturer: Pendopharm, Division of Pharmascience Inc.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2021-01-15
Decision / Authorization Date: 2021-08-23