Review decisions

Showing 1160 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00364
Product Type: Drug
Control Number: 194071
DIN(s): 02475561, 02475588, 02475618, 02475626
Manufacturer: Grifols Biologicals LLC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-05-06
Decision / Authorization Date: 2018-05-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00404
Product Type: Drug
Control Number: 204724
DIN(s): 02475510, 02475529
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-04-13
Decision / Authorization Date: 2018-05-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00386
Product Type: Drug
Control Number: 203250 & 203292
DIN(s): 02473097, 02473100
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-03-02
Decision / Authorization Date: 2018-05-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00399
Product Type: Drug
Control Number: 210204
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-10-13
Decision / Authorization Date: 2018-05-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00362
Product Type: Drug
Control Number: 208742
DIN(s): 02469723
Manufacturer: EMD Serono, A Division of EMD Inc., Canada
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-08-24
Decision / Authorization Date: 2018-05-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00366
Product Type: Drug
Control Number: 208834
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-08-29
Decision / Authorization Date: 2018-05-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00398
Product Type: Drug
Control Number: 205344
DIN(s): 02475200, 02475219
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-05
Decision / Authorization Date: 2018-05-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00368
Product Type: Drug
Control Number: 201427
DIN(s): 02470748, 02470756
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-12-29
Decision / Authorization Date: 2018-04-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00358
Product Type: Drug
Control Number: 205985
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-26
Decision / Authorization Date: 2018-04-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00363
Product Type: Drug
Control Number: 206921
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-08-10
Decision / Authorization Date: 2018-04-24