Review decisions

Showing 460 results of 633 total
Regulatory Decision Summary for Invokana
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00470
Product Type: Drug
Control Number: 210676
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-10-27
Decision / Authorization Date: 2018-10-15
Regulatory Decision Summary for Trajenta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00471
Product Type: Drug
Control Number: 194075
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-04-11
Decision / Authorization Date: 2018-10-11
Regulatory Decision Summary for Xeljanz
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00449
Product Type: Drug
Control Number: 209643
Manufacturer: Pfizer Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-09-26
Decision / Authorization Date: 2018-10-04
Regulatory Decision Summary for Rydapt
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00451
Product Type: Drug
Control Number: 210496
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-10-25
Decision / Authorization Date: 2018-10-03
Regulatory Decision Summary for Mekinist
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00435
Product Type: Drug
Control Number: 213580
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-02-09
Decision / Authorization Date: 2018-09-21
Regulatory Decision Summary for Tafinlar
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00436
Product Type: Drug
Control Number: 213581
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-02-09
Decision / Authorization Date: 2018-09-21
Regulatory Decision Summary for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00427
Product Type: Drug
Control Number: 212388
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-01-02
Decision / Authorization Date: 2018-09-21
Regulatory Decision Summary for Xarelto
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00574
Product Type: Drug
Control Number: 211611
DIN(s): 02480808
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-11-27
Decision / Authorization Date: 2018-09-14
Regulatory Decision Summary for Duavive
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00444
Product Type: Drug
Control Number: 210469
Manufacturer: Pfizer Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-10-20
Decision / Authorization Date: 2018-09-14
Regulatory Decision Summary for Aptiom
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00484
Product Type: Drug
Control Number: 209753
Manufacturer: Sunovion Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-09-28
Decision / Authorization Date: 2018-09-12

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