Review decisions
Showing 10 results of 11 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1716577628323
Product Type: Drug
Control Number: 262892
DIN(s): 02489783, 02530031
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-30
Decision / Authorization Date: 2024-01-12
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/RDS00999
Product Type: Drug
Control Number: 259448
DIN(s): 02530031
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-11-10
Decision / Authorization Date: 2022-08-24
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/RDS00657
Product Type: Drug
Control Number: 216792
DIN(s): 02489783
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-06-04
Decision / Authorization Date: 2019-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00450
Product Type: Drug
Control Number: 216792
DIN(s): 02489783, 02530031
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-06-04
Issued / Original Publication Date: 2019-11-19
Decision / Authorization Date: 2019-06-27
Updated Date: 2025-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00335
Product Type: Drug
Control Number: 207915
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-07-26
Decision / Authorization Date: 2018-02-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00060
Product Type: Drug
Control Number: 177983
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2014-09-15
Decision / Authorization Date: 2015-04-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00202
Product Type: Drug
Control Number: 159678
DIN(s): 02407329
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2012-10-26
Issued / Original Publication Date: 2013-07-29
Decision / Authorization Date: 2013-05-29
Updated Date: 2025-08-20