Review decisions
Showing 870 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00695
Product Type: Drug
Control Number: 232923
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2019-10-28
Decision / Authorization Date: 2020-05-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00738
Product Type: Drug
Control Number: 222855
DIN(s): 02499290
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-12-10
Decision / Authorization Date: 2020-05-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00701
Product Type: Drug
Control Number: 232309
DIN(s): 02498731, 02498758, 02498766, 02498774
Manufacturer: Natco Pharma Canada Inc.
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2019-10-04
Decision / Authorization Date: 2020-05-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00691
Product Type: Drug
Control Number: 227987
DIN(s): 02498685, 02498693, 02498707
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-05-23
Decision / Authorization Date: 2020-05-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00905
Product Type: Drug
Control Number: 228159
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-05-31
Decision / Authorization Date: 2020-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00642
Product Type: Drug
Control Number: 224164
DIN(s): 02495724
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-02-06
Decision / Authorization Date: 2020-05-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00647
Product Type: Drug
Control Number: 231976
DIN(s): 02498537, 02498545, 02498553, 02498561, 02498588, 02498596, 02498618, 02498626
Manufacturer: Shire Pharma Canada ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-09-30
Decision / Authorization Date: 2020-05-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00640
Product Type: Drug
Control Number: 229245
DIN(s): 02498235, 02498243
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-06-28
Decision / Authorization Date: 2020-04-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00641
Product Type: Drug
Control Number: 227818
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-05-16
Decision / Authorization Date: 2020-04-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00766
Product Type: Drug
Control Number: 225011
DIN(s): 02498413, 02498421, 02498448, 02498456, 02498464
Manufacturer: Baxter Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-02-27
Decision / Authorization Date: 2020-04-29