Review decisions
Showing 1510 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00002
Product Type: Drug
Control Number: 178110
Manufacturer: Otsuka Pharmaceutical Co. Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-09-30
Decision / Authorization Date: 2015-09-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00043
Product Type: Drug
Control Number: 178234
DIN(s): 02446057
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-09-19
Decision / Authorization Date: 2015-09-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00028
Product Type: Drug
Control Number: 178245
Manufacturer: Shire Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-09-23
Decision / Authorization Date: 2015-09-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00044
Product Type: Drug
Control Number: 180223
DIN(s): 02445727
Manufacturer: NPS Pharma Holdings Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2014-12-01
Decision / Authorization Date: 2015-09-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00009
Product Type: Drug
Control Number: 177405
DIN(s): 02444844, 02444852
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-08-29
Decision / Authorization Date: 2015-09-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00056
Product Type: Drug
Control Number: 166626
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2013-07-17
Decision / Authorization Date: 2015-08-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00038
Product Type: Drug
Control Number: 175468
DIN(s): 02445301
Manufacturer: EMD Serono, A division of EMD Inc. Canada
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-06-09
Decision / Authorization Date: 2015-08-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00213
Product Type: Drug
Control Number: 178389
DIN(s): 02348497
Manufacturer: Omrix Biopharmaceuticals Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-09-29
Decision / Authorization Date: 2015-08-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00182
Product Type: Drug
Control Number: 186992
Manufacturer: PTC Therapeutics
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-08-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00050
Product Type: Drug
Control Number: 179340
DIN(s): 02444607, 02444615, 02444623, 02444631, 02444658
Manufacturer: Alexion Pharma International Sarl
Submission Type: New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2014-10-30
Decision / Authorization Date: 2015-08-14