Review decisions
Showing 720 results of 1550 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00858
Product Type: Drug
Control Number: 240953
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-06-23
Decision / Authorization Date: 2021-05-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00811
Product Type: Drug
Control Number: 240691
Manufacturer: Octapharma Pharmazeutika Produktionsges m.b.H.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-06-16
Decision / Authorization Date: 2021-05-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00820
Product Type: Drug
Control Number: 224036
DIN(s): 02516098
Manufacturer: Sun Pharma Global FZE
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-01-25
Decision / Authorization Date: 2021-05-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00873
Product Type: Drug
Control Number: 240171
DIN(s): 02476991
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-05-29
Decision / Authorization Date: 2021-05-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00867
Product Type: Drug
Control Number: 240101
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-05-28
Decision / Authorization Date: 2021-05-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00802
Product Type: Drug
Control Number: 251730
DIN(s): 02509210
Manufacturer: BioNTech Manufacturing GmbH. Importer: Pfizer Canada ULC.
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: 2021-04-16
Decision / Authorization Date: 2021-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01028
Product Type: Drug
Control Number: 239820
DIN(s): 02515504
Manufacturer: Ibsa Institut Biochimique SA
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-05-22
Decision / Authorization Date: 2021-04-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00952
Product Type: Drug
Control Number: 242743
DIN(s): 02515490
Manufacturer: Jazz Pharmaceuticals Ireland Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-08-21
Decision / Authorization Date: 2021-04-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00838
Product Type: Drug
Control Number: 239537
DIN(s): 02515474, 02515482
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-05-15
Decision / Authorization Date: 2021-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00810
Product Type: Drug
Control Number: 243840
DIN(s): 02515431
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-09-10
Decision / Authorization Date: 2021-04-27