Review decisions

Showing 1150 results of 1549 total
Regulatory Decision Summary for Ibrance
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00388
Product Type: Drug
Control Number: 207909
Manufacturer: Pfizer Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-07-26
Decision / Authorization Date: 2018-06-06
Regulatory Decision Summary for REPATHA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00447
Product Type: Drug
Control Number: 207038
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-06-28
Decision / Authorization Date: 2018-06-05
Regulatory Decision Summary for Restasis Multidose
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00456
Product Type: Drug
Control Number: 210440
DIN(s): 02476835
Manufacturer: Allergan Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-10-20
Decision / Authorization Date: 2018-06-01
Regulatory Decision Summary for Segluromet
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00372
Product Type: Drug
Control Number: 201005
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-13
Decision / Authorization Date: 2018-05-30
Regulatory Decision Summary for AVASTIN
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00381
Product Type: Drug
Control Number: N/A
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission - Confirmatory
Decision / Authorization Date: 2018-05-23
Regulatory Decision Summary for Steglujan
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00373
Product Type: Drug
Control Number: 201006
DIN(s): 02475901, 02475928
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-13
Decision / Authorization Date: 2018-05-22
Regulatory Decision Summary for Tivicay
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00432
Product Type: Drug
Control Number: 207076
Manufacturer: ViiV Healthcare ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-06-29
Decision / Authorization Date: 2018-05-22
Regulatory Decision Summary for Tafinlar
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00377
Product Type: Drug
Control Number: 210753
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-10-30
Decision / Authorization Date: 2018-05-18
Regulatory Decision Summary for Mekinist
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00378
Product Type: Drug
Control Number: 210760
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-10-30
Decision / Authorization Date: 2018-05-18
Regulatory Decision Summary for Juluca
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00438
Product Type: Drug
Control Number: 206402
DIN(s): 02475774
Manufacturer: ViiV Healthcare ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-06-12
Decision / Authorization Date: 2018-05-18

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