Review decisions

Showing 1050 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00483
Product Type: Drug
Control Number: 218145
DIN(s): 02485613
Manufacturer: Dompé farmaceutici S.p.A.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2018-07-16
Decision / Authorization Date: 2019-02-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00586
Product Type: Drug
Control Number: 211598
DIN(s): 02485559, 02485567
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-11-28
Decision / Authorization Date: 2019-02-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00577
Product Type: Drug
Control Number: 217033
DIN(s): 02485427, 02485435
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-06-15
Decision / Authorization Date: 2019-02-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00605
Product Type: Drug
Control Number: 218044
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2018-07-10
Decision / Authorization Date: 2019-01-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00495
Product Type: Drug
Control Number: 213550
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-02-14
Decision / Authorization Date: 2019-01-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00481
Product Type: Drug
Control Number: 213347
Manufacturer: Sandoz Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-02-01
Decision / Authorization Date: 2019-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00578
Product Type: Drug
Control Number: 211854
DIN(s): 02484706
Manufacturer: Pendopharm, Division of Pharmascience Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-03-26
Decision / Authorization Date: 2019-01-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00488
Product Type: Drug
Control Number: 207115
DIN(s): 02484641, 02484668
Manufacturer: Valeo Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-11-08
Decision / Authorization Date: 2019-01-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00580
Product Type: Drug
Control Number: 213188
DIN(s): 02484420, 02484439
Manufacturer: Shire Pharma Canada ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-01-26
Decision / Authorization Date: 2019-01-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00480
Product Type: Drug
Control Number: 217184
DIN(s): 02484552
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-06-11
Decision / Authorization Date: 2019-01-09