Review decisions
Showing 80 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1716577628323
… (2LM) therapy in patients with recurrent ovarian cancer regardless of breast cancer gene (BRCA) mutation status. However, the OS results … for patients with platinum-sensitive recurrent ovarian cancer who responded to platinum-based chemotherapy. A total …
Product Type: Drug
Control Number: 262892
DIN(s): 02489783, 02530031
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-30
Decision / Authorization Date: 2024-01-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714499567288
… assessor-blinded, parallel-group phase 3 trial in breast cancer patients undergoing adjuvant myelosuppressive … chemotherapy therapy after surgical dissection of breast cancer. The primary efficacy analysis showed that the 95% CI … observed in healthy subjects or in patients with breast cancer. No new safety signal was detected. The …
Product Type: Drug
Control Number: 262438
DIN(s): 02546973
Manufacturer: Nora Pharma
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-17
Decision / Authorization Date: 2024-04-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1713542168989
… Mediastinal B-cell Lymphoma, urothelial carcinoma, bladder cancer, colorectal cancer, endometrial cancer, melanoma, non-small cell lung carcinoma, renal cell …
Product Type: Drug
Control Number: 275053
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-05
Decision / Authorization Date: 2024-04-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714051494769
… patients with non-metastatic castration sensitive prostate cancer (nmCSPC) with high-risk biochemical recurrence … patients with non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk of … enrolled adult non-metastatic castration sensitive prostate cancer (nm-CSPC) subjects with biochemical recurrence at …
Product Type: Drug
Control Number: 277282
DIN(s): 02407329
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-07-17
Decision / Authorization Date: 2024-01-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714680266149
… (ET) for the treatment of adult patients with early breast cancer (EBC) who are hormone receptor (HR) positive (HR+), … of Verzenio as maintenance therapy in Early Breast Cancer (EBC) with the removal of the Ki-67 score as a …
Product Type: Drug
Control Number: 270898
DIN(s): 02487098, 02487101, 02487128, 02487136
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-21
Decision / Authorization Date: 2023-12-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1760535633085
… multidrug resistance protein 1 (P‑glycoprotein) and breast cancer resistance protein, and inhibited bile salt export …
Product Type: Drug
Control Number: 285622
DIN(s): 02559056
Manufacturer: Amivas Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-04-03
Issued / Original Publication Date: 2025-10-10
Decision / Authorization Date: 2025-07-04
Updated Date: 2025-07-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1751980281334
… tract hemorrhage, myocardial infarction, colorectal cancer, COVID-19, COVID-19 pneumonia, and pneumonia … tract hemorrhage, myocardial infarction, colorectal cancer, COVID-19, COVID-19 pneumonia, and pneumonia …
Product Type: Drug
Control Number: 285444
DIN(s): 02558262
Manufacturer: Hoffmann-La Roche Limited
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-28
Issued / Original Publication Date: 2025-07-07
Decision / Authorization Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732299832627
… cystoscopy in the management of non-muscle invasive bladder cancer, including carcinoma in situ (CIS), in patients with known or suspected bladder cancer to increase tumor detection and reduce recurrence … the diagnosis and follow-up of non-muscle invasive bladder cancer, including carcinoma in situ (CIS), in patients with …
Product Type: Drug
Control Number: 273436
DIN(s): 02436639
Manufacturer: Photocure ASA
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-10-05
Decision / Authorization Date: 2023-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1711121589642
… authorised indications: 1L Extensive-Stage Small Cell Lung Cancer (ES-SCLC), 1L Non-Small Cell Lung Cancer (NSCLC) and 1L Hepatocellular Carcinoma (HCC) and Locally Advanced or Metastatic Triple-Negative Breast Cancer (TNBC). To include additional dosage regimens of …
Product Type: Drug
Control Number: 273807
DIN(s): 02462990, 02492393, 02546310
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-29
Decision / Authorization Date: 2024-03-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1748529563500
… to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) …
Product Type: Drug
Control Number: 285014
DIN(s): 02555964, 02555972
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-15
Issued / Original Publication Date: 2025-05-28
Decision / Authorization Date: 2025-03-06