Review decisions
Showing 200 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00344
… 20 (71%) underwent liver transplantation, for cirrhosis or cancer (13 patients), acute hepatic failure (2) or …
Product Type: Drug
Control Number: 193226
DIN(s): 02459698, 02459701, 02459728, 02459736, 02469693
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-02-17
Updated Date: 2019-04-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00384
… Stage II, IIIA, or IIIB (T3-4 N2) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor … of patients with resectable muscle invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin … of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor …
Product Type: Drug
Control Number: 202953
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2017-02-16
Issued / Original Publication Date: 2018-02-22
Decision / Authorization Date: 2017-11-03
Updated Date: 2026-04-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00342
Product Type: Drug
Control Number: 190458
DIN(s): 02459620
Manufacturer: Biogen Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-02-09
Updated Date: 2018-12-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00388
… there did not appear to be an increased risk for individual cancer types, including thyroid neoplasms. However, the …
Product Type: Drug
Control Number: 202059
DIN(s): 02471469, 02471477, 02523930, 02540258
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-01-19
Issued / Original Publication Date: 2018-04-04
Decision / Authorization Date: 2018-01-04
Updated Date: 2025-07-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00404
… epithelial ovarian, fallopian tube and primary peritoneal cancer. The submission was reviewed and considered … epithelial ovarian, fallopian tube and primary peritoneal cancer. The submission was reviewed and considered … authorized for Avastin, including: Metastatic Colorectal Cancer, Locally Advanced, Metastatic or Recurrent Non-small …
Product Type: Drug
Control Number: 201427
DIN(s): 02470748, 02470756
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-12-21
Issued / Original Publication Date: 2018-10-17
Decision / Authorization Date: 2018-04-30
Updated Date: 2025-06-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00432
… (MDS) and Acute Myeloid Leukemia (AML) in breast and lung cancer patients when used in conjunction with chemotherapy … biologic drug, in patients with Stage II/III breast cancer receiving myelosuppressive chemotherapy in the … were evaluated in 194 patients with Stage II/III breast cancer receiving six cycles of a chemotherapy regimen of …
Product Type: Drug
Control Number: 200807
DIN(s): 02484153
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-12-05
Issued / Original Publication Date: 2019-05-29
Decision / Authorization Date: 2018-12-24
Updated Date: 2024-04-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00387
… include sunburn, photo-aging, and an increased risk of skin cancer (particularly with PUVA). Several pharmaceutical …
Product Type: Drug
Control Number: 200590
DIN(s): 02469758, 02487314
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-11-25
Issued / Original Publication Date: 2018-03-23
Decision / Authorization Date: 2017-11-10
Updated Date: 2024-08-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00336
… 28 (71%) underwent liver transplantation, for cirrhosis or cancer (13 patients), acute hepatic failure (2) or …
Product Type: Drug
Control Number: 190564
DIN(s): 02457717, 02457725, 02457733, 02470055
Manufacturer: Mendelikabs Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-11-18
Updated Date: 2020-10-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00466
… is contraindicated in women with a known history of breast cancer. Therefore, the Warnings and Precautions section of … has not been studied in women with a history of breast cancer and recommends regular breast exams. A Risk … is contraindicated in women with a known history of breast cancer. Therefore, the Warnings and Precautions section of …
Product Type: Drug
Control Number: 198822
DIN(s): 02493500
Manufacturer: Endoceutics, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-10-05
Issued / Original Publication Date: 2020-03-10
Decision / Authorization Date: 2019-11-01
Updated Date: 2025-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00375
… nausea and vomiting associated with highly emetogenic cancer chemotherapy Prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-hydroxytryptamine … nausea and vomiting associated with highly emetogenic cancer chemotherapy Prevention of acute nausea and vomiting …
Product Type: Drug
Control Number: 196495
DIN(s): 02468735
Manufacturer: Purdue Pharma
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-10-03
Issued / Original Publication Date: 2018-01-10
Decision / Authorization Date: 2017-09-28
Updated Date: 2024-06-24