Review decisions

Showing 700 results of 1550 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00902
Product Type: Drug
Control Number: 242357
DIN(s): 02518058
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-07-30
Decision / Authorization Date: 2021-07-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00965
Product Type: Drug
Control Number: 240239
DIN(s): 02517841
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-06-01
Decision / Authorization Date: 2021-07-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00857
Product Type: Drug
Control Number: 236286
DIN(s): 02517868
Manufacturer: Bausch Health, Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-05-06
Decision / Authorization Date: 2021-07-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1691759711587
Product Type: Drug
Control Number: 253850
Manufacturer: Prestige Biopharma Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-05
Decision / Authorization Date: 2023-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00831
Product Type: Drug
Control Number: 247045
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-04
Decision / Authorization Date: 2021-07-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00830
Product Type: Drug
Control Number: 242572
Manufacturer: Sandoz Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-08-07
Decision / Authorization Date: 2021-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01034
Product Type: Drug
Control Number: 244137
DIN(s): 02517361, 02517388
Manufacturer: Medexus Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-09-21
Decision / Authorization Date: 2021-06-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00846
Product Type: Drug
Control Number: 246955
DIN(s): 02517140
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-12-04
Decision / Authorization Date: 2021-06-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00974
Product Type: Drug
Control Number: 225983
Manufacturer: Marcan Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-03-22
Decision / Authorization Date: 2021-06-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00823
Product Type: Drug
Control Number: 249830
DIN(s): 02516691, 02516705
Manufacturer: Hoffmann-La Roche Ltd.
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: 2021-02-24
Decision / Authorization Date: 2021-06-09