Review decisions

Showing 50 results of 73 total
Regulatory Decision Summary for Erleada
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00392
Product Type: Drug
Control Number: 211942
DIN(s): 02478374
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-12-07
Decision / Authorization Date: 2018-07-03
Regulatory Decision Summary for Simponi I.V.
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00350
Product Type: Drug
Control Number: 205724
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-17
Decision / Authorization Date: 2018-04-05
Regulatory Decision Summary for Symtuza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00439
Product Type: Drug
Control Number: 199705
DIN(s): 02473720
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-03-29
Decision / Authorization Date: 2018-03-08
Regulatory Decision Summary for Zytiga
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
Regulatory Decision Summary for Tremfya
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00308
Product Type: Drug
Control Number: 200590
DIN(s): 02469758
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-01-16
Decision / Authorization Date: 2017-11-10
Regulatory Decision Summary for Imbruvica
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00371
Product Type: Drug
Control Number: 204436
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-04-04
Decision / Authorization Date: 2017-10-25
Regulatory Decision Summary for Galexos
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00431
Product Type: Drug
Control Number: 197253
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-08-02
Decision / Authorization Date: 2017-07-20
Regulatory Decision Summary for Darzalex
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00225
Product Type: Drug
Control Number: 198647
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-09-26
Decision / Authorization Date: 2017-04-13
Regulatory Decision Summary for Invokana
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00235
Product Type: Drug
Control Number: 194762
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-05-04
Decision / Authorization Date: 2017-04-13
Regulatory Decision Summary for Imbruvica
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00216
Product Type: Drug
Control Number: 192718
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-02-29
Decision / Authorization Date: 2017-02-01

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