Review decisions
Showing 260 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00188
… safety review of potential hepatocellular carcinoma (liver cancer), between 2018-12-01 and 2018-12-31. NC # 212116 … early recurrence of hepatocellular carcinoma (liver cancer) in direct-acting antivirals indicated for the … carcinoma (HCC), the most common type of liver cancer. Although asymptomatic liver disease progression can …
Product Type: Drug
Control Number: 165043
DIN(s): 02418355
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2013-05-21
Issued / Original Publication Date: 2014-02-18
Decision / Authorization Date: 2013-12-13
Updated Date: 2025-02-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00230
Product Type: Drug
Control Number: 153806
DIN(s): 02402874, 02402882
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2013-04-30
Updated Date: 2017-04-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00257
… including malignant melanoma, lung, bladder, and breast cancer, and hepatic safety will be monitored as a … and UGT1A9) and transporters p-glycoprotein (P-gp), breast cancer related protein (BCRP), organic anion transporting … risk were noted in the clinical studies. Cases of lung cancer and malignant melanoma were reported more frequently …
Product Type: Drug
Control Number: 162552
DIN(s): 02443937, 02443945
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2013-04-17
Issued / Original Publication Date: 2015-08-27
Decision / Authorization Date: 2015-08-23
Updated Date: 2025-01-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00262
… in Canada due to potential increased risk of skin cancer), containing information on product withdrawal and … skin lesions, due to the potential increased risk of skin cancer), containing information on product safety for the … (Use of the drug Picato may increase the risk of skin cancer), containing information about product safety for the …
Product Type: Drug
Control Number: 153285
Manufacturer: Leo Pharma Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2013-03-11
Updated Date: 2022-11-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00171
… death were: sudden cardiac death, sepsis, shock, and lung cancer. Frequencies of adverse events were comparable …
Product Type: Drug
Control Number: 162761
DIN(s): 02412764, 02412772, 02412799, 02412802, 02412810
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2013-02-25
Issued / Original Publication Date: 2013-12-10
Decision / Authorization Date: 2013-09-19
Updated Date: 2024-07-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00225
… review for Kadcyla related to Tumour Lysis Syndrome (quick cancer cells breakdown severely affecting many organs). NC # … was: the adjuvant treatment of HER2-positive early breast cancer patients who have residual invasive disease following … growth factor receptor 2 (HER2)-positive, metastatic breast cancer who received both prior treatment with Herceptin …
Product Type: Drug
Control Number: 162414
DIN(s): 02412365, 02473224
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2013-02-08
Issued / Original Publication Date: 2013-12-03
Decision / Authorization Date: 2013-09-11
Updated Date: 2023-03-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00219
… was no longer evident, and numerical imbalances in breast cancer cases diminished significantly. However, the non-statistically significant imbalance in bladder cancer cases did not decrease. In light of the lack of a … and the presence of other risk factors in the bladder cancer patients, these imbalances are regarded as a signal …
Product Type: Drug
Control Number: 160877
DIN(s): 02435462, 02435470
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-12-07
Issued / Original Publication Date: 2015-07-06
Decision / Authorization Date: 2014-12-12
Updated Date: 2025-01-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00182
… started a safety review for Duavive related to ovarian cancer in menopausal women (a type of cancer detected in the ovaries). NDS # 160681 2012-12-04 … bleeding. Known, suspected, or past history of breast cancer. Known or suspected estrogen-dependent malignant …
Product Type: Drug
Control Number: 160681
DIN(s): 02432854
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-12-04
Issued / Original Publication Date: 2015-01-21
Decision / Authorization Date: 2014-10-23
Updated Date: 2025-09-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00202
… patients with non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk of … of patients with metastatic castration-sensitive prostate cancer. The submission was reviewed and considered … patients with non-metastatic castration-resistant prostate cancer. The submission was reviewed and considered …
Product Type: Drug
Control Number: 159678
DIN(s): 02407329
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2012-10-26
Issued / Original Publication Date: 2013-07-29
Decision / Authorization Date: 2013-05-29
Updated Date: 2025-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00260
… locally advanced, inflammatory, or early breast cancer (EBC) (either >2 cm in diameter or node positive). … in combination with Perjeta in the authorized early breast cancer and metastatic breast cancer indications. The submission was reviewed and …
Product Type: Drug
Control Number: 158419
DIN(s): 02405016, 02405024
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2012-08-31
Issued / Original Publication Date: 2013-07-10
Decision / Authorization Date: 2013-04-12
Updated Date: 2023-02-23