Review decisions
Showing 260 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00258
… drugs, for the treatment of certain types of lung and liver cancer. It is also authorized with conditions on the … manufacturer to treat certain types of breast and bladder cancer. Health Canada reviewed the potential risk of … drugs, for the treatment of certain types of lung and liver cancer. Tecentriq is also authorized, with conditions on the …
Issued / Original Publication Date: 2021-02-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00565
… 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have receive endocrine-based therapy and at least … reports based on the metastatic triple-negative breast cancer target population. The submission was reviewed and … locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior …
Product Type: Drug
Control Number: 248753
DIN(s): 02520788
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-01-25
Issued / Original Publication Date: 2021-12-23
Decision / Authorization Date: 2021-09-24
Updated Date: 2024-02-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00562
… to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic …
Product Type: Drug
Control Number: 248435
DIN(s): 02520095, 02552655
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-01-14
Issued / Original Publication Date: 2021-12-07
Decision / Authorization Date: 2021-09-10
Updated Date: 2026-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00744
… for the management of non-muscle invasive bladder cancer (NMIBC). Verity-BCG is an antineoplastic agent for intravesical immunotherapy of superficial bladder cancer. Verity-BCG is composed of a live, attenuated strain … of intermediate and high-risk non-muscle invasive bladder cancer in BCG-naïve patients" is necessary to confirm the …
Product Type: Drug
Control Number: 221579
DIN(s): 02508613
Manufacturer: Verity Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-11-01
Decision / Authorization Date: 2020-12-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00739
… (anaphylaxis) and may increase risk of tumours (both cancerous and non-cancerous) in children and adolescents. Other side effects …
Product Type: Drug
Control Number: 235023
DIN(s): 02509733
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-01-09
Decision / Authorization Date: 2020-12-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00599
… Yescarta, and Carvykti related to T-cell malignancy (cancer that forms in white blood cells called T cells). NC # … disease or confirmation of PET‑positive disease after anticancer therapy for disease control as determined by an … Patients were able to receive bridging chemotherapy (anticancer treatment) while waiting for their cells to be …
Product Type: Drug
Control Number: 247562
DIN(s): 02527138
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-17
Issued / Original Publication Date: 2022-08-16
Decision / Authorization Date: 2022-05-06
Updated Date: 2024-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00252
… products are authorized for sale in Canada to treat ovarian cancer. Health Canada reviewed the risk of Posterior … that are authorized for sale in Canada to treat ovarian cancer. Carboplatin was first marketed in Canada in 1986 …
Issued / Original Publication Date: 2020-12-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00566
… provided the final report for the small cell lung cancer cohort from study B-005 (PM1183-B-005-15). The … adult patients with Stage III or metastatic small cell lung cancer who have progressed on or after platinum-containing … adult patients with Stage III or metastatic small cell lung cancer (SCLC) who have progressed on or after …
Product Type: Drug
Control Number: 247485
DIN(s): 02520834
Manufacturer: Jazz Pharmaceuticals Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-12-16
Issued / Original Publication Date: 2022-01-04
Decision / Authorization Date: 2021-09-29
Updated Date: 2026-02-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00742
… high-risk, non-muscle invasive bladder cancer. The submission was granted advanced consideration in … (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without …
Product Type: Drug
Control Number: 236910
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-03-05
Decision / Authorization Date: 2020-12-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00574
… include relevant caveat statements): Metastatic Colorectal Cancer Aybintio, in combination with fluoropyrimidine-based … 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 Aybintio, in combination with a …
Product Type: Drug
Control Number: 247369, 247724
DIN(s): 02522829, 02522837
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-11
Issued / Original Publication Date: 2022-02-04
Decision / Authorization Date: 2021-11-30
Updated Date: 2024-07-15