Review decisions
Showing 200 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00935
… choice in participants with advanced endometrial cancer. In addition, summary of results in endometrial cancer patients from the following supportive studies were … 2 study of lenvatinib in subjects with advanced endometrial cancer and disease progression following first-line …
Product Type: Drug
Control Number: 252263
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-05-03
Decision / Authorization Date: 2022-02-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00914
… held by Herceptin in Canada: HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. Why was the decision issued? To support the …
Product Type: Drug
Control Number: 235995
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-02-27
Decision / Authorization Date: 2022-01-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00972
… heart-related events such as heart attack or stroke, cancer, blood clots, and death. Following discussions with …
Product Type: Drug
Control Number: 245874
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-10-30
Decision / Authorization Date: 2022-01-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00621
… (PSMA)‑positive metastatic castration‑resistant prostate cancer (mCRPC) who have received at least one androgen … (PSMA)‑positive metastatic castration-resistant prostate cancer (mCRPC) who have received at least one androgen … (PSMA)‑positive metastatic castration-resistant prostate cancer (mCRPC) who have received at least one androgen …
Product Type: Drug
Control Number: 260951
DIN(s): 02530198
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-01-28
Issued / Original Publication Date: 2023-01-20
Decision / Authorization Date: 2022-08-25
Updated Date: 2025-11-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00904
… sickle cell disease, neurodevelopmental disorders, active cancer, medically-related technological dependence, or were …
Product Type: Drug
Control Number: 259186
DIN(s): 02524031
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-12-01
Decision / Authorization Date: 2022-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00911
… for adjuvant treatment for early stage non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥1% of …
Product Type: Drug
Control Number: 254361
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-30
Decision / Authorization Date: 2022-01-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00279
… to keep open an area that has become narrow due to cancer or scarring, or to seal off leaks in the esophagus. … the esophagus to widen areas that have become narrow due to cancer or scarring, or to seal off leaks in the esophagus. …
Issued / Original Publication Date: 2022-01-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00278
… problems (heart attack, stroke or cardiovascular death) and cancer (malignancies) Key Messages Xeljanz/Xeljanz XR … problems (heart attack, stroke or cardiovascular death) and cancer (malignancies) with the use of Xeljanz/Xeljanz XR … Xeljanz/Xeljanz XR included warnings and precautions for cancer and information on heart attacks. The purpose of this …
Issued / Original Publication Date: 2022-01-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00912
… locally advanced, inflammatory, or early stage breast cancer (either > 2 cm in diameter or node positive). Phesgo … in female patients with HER2-positive early breast cancer which demonstrated that exposures to pertuzumab and … across all the authorised pertuzumab HER2-postive breast cancer indications. Study MO40628 provided safety related …
Product Type: Drug
Control Number: 254251
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-28
Decision / Authorization Date: 2022-01-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684869579695
… for the following indications: Metastatic Colorectal Cancer (mCRC) Vegzelma in combination with … given to current standard of care guidelines for colorectal cancer. See the Drug-Drug Interactions section of the … Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) Vegzelma, in combination with a …
Product Type: Drug
Control Number: 258973
DIN(s): 02534177, 02534185
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-12-29
Issued / Original Publication Date: 2023-05-02
Decision / Authorization Date: 2023-01-03
Updated Date: 2025-08-19