Review decisions
Showing 600 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00211
… 620 (0.5%) patients treated with Entyvio, including colon cancer [patient number (n) = 2] and transitional cell … long-term extension study included B-cell lymphoma, breast cancer, colon cancer, hepatic neoplasm malignant, lung neoplasm malignant, …
Product Type: Drug
Control Number: 169414
DIN(s): 02436841, 02497867, 02497875
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2013-10-29
Issued / Original Publication Date: 2015-04-28
Decision / Authorization Date: 2015-01-29
Updated Date: 2024-06-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00223
… chronic lymphocytic leukemia (B-CLL) according to National Cancer Institute (NCI) criteria, previously untreated CLL … due to cerebrovascular accident, hemorrhagic stroke, colon cancer, squamous cell carcinoma and subdural hematoma. …
Product Type: Drug
Control Number: 168227
DIN(s): 02434806
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2013-10-16
Issued / Original Publication Date: 2015-02-16
Decision / Authorization Date: 2014-11-25
Updated Date: 2023-03-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00229
… constipation (OIC) in adult patients with non-cancer pain who have had an inadequate response to … constipation (OIC) in adult patients with non-cancer pain who have had an inadequate response to … constipation (OIC) in adult patients with non-cancer pain who have had an inadequate response to …
Product Type: Drug
Control Number: 167790
DIN(s): 02442167, 02442175
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2013-08-30
Issued / Original Publication Date: 2015-08-13
Decision / Authorization Date: 2015-06-02
Updated Date: 2025-06-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00217
Product Type: Drug
Control Number: 156861
DIN(s): 02408163
Manufacturer: Watson Laboratories Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2013-07-29
Updated Date: 2022-10-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00263
… its action in the bone marrow to slow down the growth of cancerous myeloma cells. In in vitro cellular assays, …
Product Type: Drug
Control Number: 165891
DIN(s): 02419580, 02419599, 02419602, 02419610
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2013-06-20
Issued / Original Publication Date: 2014-03-10
Decision / Authorization Date: 2014-01-20
Updated Date: 2025-02-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00251
… acts by targeting several proteins on the surface of cancer cells, as well as targets within the cell. By …
Product Type: Drug
Control Number: 165121
DIN(s): 02437333, 02437341
Manufacturer: ARIAD Pharmaceuticals, Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2013-05-23
Issued / Original Publication Date: 2015-07-02
Decision / Authorization Date: 2015-04-02
Updated Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00188
… safety review of potential hepatocellular carcinoma (liver cancer), between 2018-12-01 and 2018-12-31. NC # 212116 … early recurrence of hepatocellular carcinoma (liver cancer) in direct-acting antivirals indicated for the … carcinoma (HCC), the most common type of liver cancer. Although asymptomatic liver disease progression can …
Product Type: Drug
Control Number: 165043
DIN(s): 02418355
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2013-05-21
Issued / Original Publication Date: 2014-02-18
Decision / Authorization Date: 2013-12-13
Updated Date: 2025-02-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00230
Product Type: Drug
Control Number: 153806
DIN(s): 02402874, 02402882
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2013-04-30
Updated Date: 2017-04-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00257
… including malignant melanoma, lung, bladder, and breast cancer, and hepatic safety will be monitored as a … and UGT1A9) and transporters p-glycoprotein (P-gp), breast cancer related protein (BCRP), organic anion transporting … risk were noted in the clinical studies. Cases of lung cancer and malignant melanoma were reported more frequently …
Product Type: Drug
Control Number: 162552
DIN(s): 02443937, 02443945
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2013-04-17
Issued / Original Publication Date: 2015-08-27
Decision / Authorization Date: 2015-08-23
Updated Date: 2025-01-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00262
… in Canada due to potential increased risk of skin cancer), containing information on product withdrawal and … skin lesions, due to the potential increased risk of skin cancer), containing information on product safety for the … (Use of the drug Picato may increase the risk of skin cancer), containing information about product safety for the …
Product Type: Drug
Control Number: 153285
Manufacturer: Leo Pharma Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2013-03-11
Updated Date: 2022-11-16