Review decisions
Showing 980 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00556
Product Type: Drug
Control Number: 212140
DIN(s): 02483467, 02483475
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-12-15
Decision / Authorization Date: 2019-08-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00543
Product Type: Drug
Control Number: 223862
Manufacturer: Shire Pharmaceuticals Ireland Ltd.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2019-01-18
Decision / Authorization Date: 2019-08-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00539
Product Type: Drug
Control Number: 211993
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-12-11
Decision / Authorization Date: 2019-08-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00540
Product Type: Drug
Control Number: 219716
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-08-29
Decision / Authorization Date: 2019-08-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00541
Product Type: Drug
Control Number: 223753
DIN(s): 02462990
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2019-01-16
Decision / Authorization Date: 2019-08-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00548
Product Type: Drug
Control Number: 195082
DIN(s): 02486423
Manufacturer: Teva Canada Ltd.
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2016-05-13
Decision / Authorization Date: 2019-08-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00560
Product Type: Drug
Control Number: 212016
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-12-15
Decision / Authorization Date: 2019-08-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00576
Product Type: Drug
Control Number: 219500
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-08-24
Decision / Authorization Date: 2019-08-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00537
Product Type: Drug
Control Number: 219669
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-08-30
Decision / Authorization Date: 2019-07-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00538
Product Type: Drug
Control Number: 219521
DIN(s): 02491060, 02491087
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-08-21
Decision / Authorization Date: 2019-07-30