Review decisions
Showing 320 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00536
… implied that estetrol acts as a P-glycoprotein and Breast Cancer Resistance Protein (BCRP) substrate. Since estetrol …
Product Type: Drug
Control Number: 236197
DIN(s): 02513218
Manufacturer: Searchlight Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-02-18
Issued / Original Publication Date: 2021-06-16
Decision / Authorization Date: 2021-03-05
Updated Date: 2023-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00234
… serious scarring of the liver (cirrhosis), or liver cancer (hepatocellular carcinoma). Health Canada reviewed … serious scarring of the liver (cirrhosis), or liver cancer (hepatocellular carcinoma). This review included the …
Issued / Original Publication Date: 2020-02-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00832
… decision issued? Tropomyosin receptor kinase (TRK) fusion cancer is a genetically defined cancer occurring in a histologically diverse group of … types, with low frequency expression in some common adult cancers and either common or up to 100% expression in some …
Product Type: Drug
Control Number: 227517
DIN(s): 02495007, 02495015
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2019-05-08
Decision / Authorization Date: 2020-02-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00458
Product Type: Drug
Control Number: 220584
DIN(s): 02492032, 02492040
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-01-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00524
… in 2 patients (2%, unrelated). A case of papillary thyroid cancer was detected in the EU registry study. In the …
Product Type: Drug
Control Number: 235023
DIN(s): 02509733
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-01-09
Issued / Original Publication Date: 2021-03-25
Decision / Authorization Date: 2020-12-17
Updated Date: 2023-10-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00662
… in Canada it is the second most common cause of death after cancer, despite major advances in treatment and prevention …
Product Type: Drug
Control Number: 227235
DIN(s): 02495244
Manufacturer: HLS Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-04-29
Decision / Authorization Date: 2019-12-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00760
… indicated that malignancies (other than nonmelanoma skin cancer) and adjudicated VTEs were reported at comparable …
Product Type: Drug
Control Number: 223734
DIN(s): 02495155
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-01-16
Decision / Authorization Date: 2019-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00807
… the intended use of gilteritinib in patients with advanced cancer, no nonclinical toxicological issues were identified …
Product Type: Drug
Control Number: 227918
DIN(s): 02495058
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-05-22
Decision / Authorization Date: 2019-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00497
… care professional who is experienced in the use of anticancer medicinal products. 1 What was approved? Qinlock, … care professional who is experienced in the use of anticancer medicinal products. No data are available to Health … care professional who is experienced in the use of anticancer medicinal products. Gastrointestinal stromal tumours …
Product Type: Drug
Control Number: 234688
DIN(s): 02500833
Manufacturer: Deciphera Pharmaceuticals, LLC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-12-23
Issued / Original Publication Date: 2020-09-22
Decision / Authorization Date: 2020-06-19
Updated Date: 2025-10-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00501
… as an autoimmune disorder or develop due to an underlying cancer (paraneoplastic type). In the autoimmune type, …
Product Type: Drug
Control Number: 234655
DIN(s): 02503034
Manufacturer: Medunik Canada
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-12-20
Issued / Original Publication Date: 2020-10-22
Decision / Authorization Date: 2023-01-10
Updated Date: 2024-11-18