Review decisions
Showing 60 results of 139 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1693487564948
Product Type: Drug
Control Number: 275559
DIN(s): 02541025
Manufacturer: Pfizer Canada ULC, on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2023-05-24
Decision / Authorization Date: 2023-08-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1701379593048
Product Type: Drug
Control Number: 259676
DIN(s): 02530740
Manufacturer: Takeda Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-03
Decision / Authorization Date: 2023-05-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694626834389
Product Type: Drug
Control Number: 264733
DIN(s): 02481545
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-31
Decision / Authorization Date: 2023-05-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697738098405
Product Type: Drug
Control Number: 262044
DIN(s): 02330695
Manufacturer: Pfizer Canada ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-03
Decision / Authorization Date: 2023-05-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705090544554
Product Type: Drug
Control Number: 261909
DIN(s): 02443937, 02443945
Manufacturer: Boehringer Ingelheim (Canada) Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-02-28
Decision / Authorization Date: 2023-05-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1693494435256
Product Type: Drug
Control Number: 253442
DIN(s): 02507838, 02507846
Manufacturer: HLS Therapeutics Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-08
Decision / Authorization Date: 2023-05-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692107292830
Product Type: Drug
Control Number: 269021
DIN(s): 02540207
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-25
Decision / Authorization Date: 2023-08-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1693422463164
Product Type: Drug
Control Number: 267443
DIN(s): 02539934, 02539942, 02539950
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-29
Decision / Authorization Date: 2023-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694618321621
Product Type: Drug
Control Number: 263460
DIN(s): 02539047, 02539055, 02539063, 02539071
Manufacturer: Sun Pharmaceuticals Industries Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-04-14
Decision / Authorization Date: 2023-06-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1691775757350
Product Type: Drug
Control Number: 269369
DIN(s): 02539756, 02539764
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-11-02
Decision / Authorization Date: 2023-07-26