Review decisions
Showing 250 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00201
Product Type: Drug
Control Number: 161312
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2014-03-04
Updated Date: 2020-10-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00222
… 33, 45, 52 and 58 and oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58. … to add an indication for prevention of anal dysplasia and cancer caused by human papillomavirus (HPV) types contained … included in the vaccine: Cervical, vulvar, and vaginal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 …
Product Type: Drug
Control Number: 170006
DIN(s): 02437058
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-02-13
Issued / Original Publication Date: 2015-08-11
Decision / Authorization Date: 2015-02-05
Updated Date: 2025-10-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00244
… submission was the potential risk of developing thyroid cancer with the use of Trulicity. Thyroid C‑cell tumors have … no evidence of adverse effects to the pancreas, pancreatic cancers must be considered a potential safety risk, as is … receptor agonists (e.g. liraglutide). The risk of thyroid cancer is captured in the Warnings and Precautions box and …
Product Type: Drug
Control Number: 168671
DIN(s): 02448572, 02448580, 02448599, 02448602, 02530163, 02530171
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-02-10
Issued / Original Publication Date: 2016-02-05
Decision / Authorization Date: 2015-11-10
Updated Date: 2025-06-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00221
Product Type: Drug
Control Number: 164021
DIN(s): 02416441
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2014-01-28
Updated Date: 2020-10-08
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