Review decisions
Showing 10 results of 14 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714051494769
Product Type: Drug
Control Number: 277282
DIN(s): 02407329
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-07-17
Decision / Authorization Date: 2024-01-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706106900025
Product Type: Drug
Control Number: 270698
DIN(s): 02478374, 02540185
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-15
Decision / Authorization Date: 2023-08-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697728420996
Product Type: Drug
Control Number: 265427
DIN(s): 02475200, 02475219
Manufacturer: AstraZeneca Canada Inc
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-06-22
Decision / Authorization Date: 2023-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00989
Product Type: Drug
Control Number: 259417
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-12-09
Decision / Authorization Date: 2022-07-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00594
Product Type: Drug
Control Number: 221824
DIN(s): 02492806
Manufacturer: IRE ELit S.A
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-12-07
Decision / Authorization Date: 2019-11-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00672
Product Type: Drug
Control Number: 220584
DIN(s): 02492032, 02492040
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-09-28
Decision / Authorization Date: 2019-09-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00392
Product Type: Drug
Control Number: 211942
DIN(s): 02478374
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-12-07
Decision / Authorization Date: 2018-07-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00399
Product Type: Drug
Control Number: 210204
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-10-13
Decision / Authorization Date: 2018-05-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00398
Product Type: Drug
Control Number: 205344
DIN(s): 02475200, 02475219
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-05
Decision / Authorization Date: 2018-05-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00400
Product Type: Drug
Control Number: 211942
DIN(s): 02478374, 02540185
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-12-07
Issued / Original Publication Date: 2018-08-27
Decision / Authorization Date: 2018-07-03
Updated Date: 2025-06-13