Review decisions

Showing 950 results of 1549 total
Regulatory Decision Summary for Darzalex
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00564
Product Type: Drug
Control Number: 226512
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-04-03
Decision / Authorization Date: 2019-10-25
Regulatory Decision Summary for Balversa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00800
Product Type: Drug
Control Number: 224529
DIN(s): 02493217, 02493225, 02493233, 02493241
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-02-08
Decision / Authorization Date: 2019-10-25
Regulatory Decision Summary for Netildex (with Preservative), Netildex (without Preservative)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00618
Product Type: Drug
Control Number: 212391
DIN(s): 02493187, 02493195
Manufacturer: Knight Therapeutics Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-12-21
Decision / Authorization Date: 2019-10-18
Regulatory Decision Summary for Trulance
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00614
Product Type: Drug
Control Number: 215288
DIN(s): 02493012
Manufacturer: Cipher Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-09-20
Decision / Authorization Date: 2019-10-10
Regulatory Decision Summary for Nucala
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00563
Product Type: Drug
Control Number: 221528
DIN(s): 02492989, 02492997
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-11-01
Decision / Authorization Date: 2019-10-08
Regulatory Decision Summary for Dymista
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00600
Product Type: Drug
Control Number: 221498
Manufacturer: BGP Pharma ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-10-30
Decision / Authorization Date: 2019-10-04
Regulatory Decision Summary for Uloric
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00659
Product Type: Drug
Control Number: 228535
DIN(s): 02357380
Manufacturer: Takeda Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-06-11
Decision / Authorization Date: 2019-10-02
Regulatory Decision Summary for Elidel
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00583
Product Type: Drug
Control Number: 220947
Manufacturer: Valeant Canada LP / Valeant Canada S.E.C.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-10-12
Decision / Authorization Date: 2019-09-26
Regulatory Decision Summary for Dupixent
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00562
Product Type: Drug
Control Number: 221043
DIN(s): 02470365, 02492504
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-10-16
Decision / Authorization Date: 2019-09-25
Regulatory Decision Summary for Symbicort 100 Turbuhaler, Symbicort 200 Turbuhaler, Symbicort Forte Turbuhaler
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00603
Product Type: Drug
Control Number: 220998
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-10-15
Decision / Authorization Date: 2019-09-25

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