Review decisions
Showing 210 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00328
… in patients with stage IB-IIIA non-small cell lung cancer whose tumours have epidermal growth factor receptor … with locally advanced or metastatic non-small cell lung cancer whose tumours have epidermal growth factor receptor …
Product Type: Drug
Control Number: 188171
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-09-22
Updated Date: 2022-10-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00366
… female patients who received Ocrevus developed breast cancer, whereas no breast cancer was reported in the Rebif group. This information has … include but are not limited to: malignancies (e.g., breast cancer), serious/opportunistic infections, hepatitis B virus …
Product Type: Drug
Control Number: 198094
DIN(s): 02467224
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-09-16
Issued / Original Publication Date: 2017-10-19
Decision / Authorization Date: 2017-08-14
Updated Date: 2024-02-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00356
… First-line treatment of extensive-stage small cell lung cancer (ES-SCLC) First-line treatment of non-small cell lung cancer (NSCLC) First-line treatment of hepatocellular … of locally advanced or metastatic triple-negative breast cancer (TNBC) In addition, the submission was filed for …
Product Type: Drug
Control Number: 196843
DIN(s): 02462990
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2016-07-18
Issued / Original Publication Date: 2017-05-30
Decision / Authorization Date: 2017-04-12
Updated Date: 2025-06-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00329
… (Assessing the potential risk of new or returning liver cancer named hepatocellular carcinoma). Summary Safety … for Epclusa related to hepatocellular carcinoma (liver cancer). NC # 212690 2018-01-10 Issued NOL 2018-04-16 … antivirals posted (Assessing the potential risk of liver cancer recurrence). Information Update Not applicable Posted …
Product Type: Drug
Control Number: 190521
DIN(s): 02456370
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-07-11
Updated Date: 2022-10-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00297
Product Type: Drug
Control Number: 172617
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-04-25
Updated Date: 2020-10-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00360
… review for Erelzi related to mycosis fungoides (a type of cancer that begins in white blood cells called T cells, …
Product Type: Drug
Control Number: 193864
DIN(s): 02462850, 02462869, 02462877
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-04-18
Issued / Original Publication Date: 2017-08-03
Decision / Authorization Date: 2017-04-06
Updated Date: 2024-04-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00345
… 28 (71%) underwent liver transplantation, for cirrhosis or cancer (13 patients), acute hepatic failure (2) or …
Product Type: Drug
Control Number: 193770
DIN(s): 02458616, 02458624, 02458632
Manufacturer: Cycle Pharmaceuticals Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2016-04-05
Issued / Original Publication Date: 2017-02-17
Decision / Authorization Date: 2016-11-04
Updated Date: 2025-07-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00354
… locally advanced or metastatic squamous non-small cell lung cancer who have not received prior chemotherapy for this … locally advanced or metastatic squamous non-small cell lung cancer who have not received prior chemotherapy for this … locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy for …
Product Type: Drug
Control Number: 193689
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-03-29
Issued / Original Publication Date: 2017-05-16
Decision / Authorization Date: 2017-03-16
Updated Date: 2024-06-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00410
… of serious heart-related problems, fatal blood clots and cancer ) for the general public and health professionals. … risks of serious heart-related problems, blood clots, cancer and death ). SNDS # 260967 2022-02-02 Issued NOC … events (MACE, serious heart-related problems), malignancy (cancer), and thrombosis (blood clots). Application # 252683 …
Product Type: Drug
Control Number: 193687
DIN(s): 02480018, 02544768
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-03-29
Issued / Original Publication Date: 2018-12-17
Decision / Authorization Date: 2018-08-17
Updated Date: 2025-01-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00318
… (Assessing the potential risk of new or returning liver cancer named hepatocellular carcinoma). Summary Safety … for Zepatier related to hepatocellular carcinoma (liver cancer). NC # 204225 2017-03-29 Issued NOL 2017-06-29 … to early recurrence of hepatocellular carcinoma (liver cancer) and hepatitis B reactivation. NC # 193658 2016-03-22 …
Product Type: Drug
Control Number: 185866
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-03-15
Updated Date: 2022-11-14