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Reports

We found 7132 result(s)

elexacaftor/tezacaftor/ivacaftor and ivacaftor (TBC)

Last Updated: January 26, 2021
Result type: Reports
Product Line: Reimbursement Review
Generic Name: elexacaftor/tezacaftor/ivacaftor and ivacaftor
Indications: Triple Combination Therapy (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

  • Brand Name: TBC
  • Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
  • Project Number: SR0673-000
  • Project Status: Received
  • Submission Type: Initial

liraglutide (Saxenda)

Last Updated: December 24, 2020
Result type: Reports
Product Line: Reimbursement Review
Generic Name: liraglutide
Indications: Saxenda® (liraglutide) is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of: 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes, or dyslipidemia) and who have failed a previous weight management intervention.

  • Brand Name: Saxenda
  • Manufacturer: Novo Nordisk Canada Inc.
  • Project Number: SR0668-000
  • Project Status: Active
  • Submission Type: Initial

semaglutide (Rybelsus)

Last Updated: December 24, 2020
Result type: Reports
Product Line: Reimbursement Review
Generic Name: semaglutide
Indications: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; in combination with other medicinal products for the treatment of diabetes

  • Brand Name: Rybelsus
  • Manufacturer: Novo Nordisk Canada Inc.
  • Project Number: SR0637-000
  • Project Status: Active
  • Submission Type: Initial

venetoclax (Venclexta)

Last Updated: January 25, 2021
Result type: Reports
Product Line: Reimbursement Review
Generic Name: Venetoclax
Indications: In combination with azacitidine or low-dose cytarabine is indicated for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

  • Brand Name: Venclexta
  • Manufacturer: AbbVie Corporation
  • Project Number: PC0239-000
  • Project Status: Received
  • Submission Type: Initial

esketamine hydrochloride (Spravato)

Last Updated: December 18, 2020
Result type: Reports
Product Line: Reimbursement Review
Generic Name: esketamine hydrochloride
Indications: Indicated in combination with a SSRI or SNRI, for the treatment of major depressive disorder in adults who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode.

  • Brand Name: Spravato
  • Manufacturer: Janssen Inc.
  • Project Number: SR0621-000
  • Project Status: Active
  • Submission Type: Initial

Venetoclax (Venclexta)

Last Updated: January 25, 2021
Result type: Reports
Product Line: Reimbursement Review
Generic Name: Venetoclax
Indications: Venclexta is indicated, in combination with a hypomethylating agent or in combination with low-dose cytarabine, in adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

  • Brand Name: Venclexta
  • Manufacturer: AbbVie Corporation
  • Project Number: PC0238-000
  • Project Status: Received
  • Submission Type: Initial

vedolizumab (Entyvio)

Last Updated: January 22, 2021
Result type: Reports
Product Line: Reimbursement Review
Generic Name: vedolizumab
Indications: For the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to immunomodulators or a TNFα antagonist; or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids.

  • Brand Name: Entyvio
  • Manufacturer: Takeda Canada Inc.
  • Project Number: SR0647-000
  • Project Status: Active
  • Submission Type: Initial

talazoparib (Talzenna )

Last Updated: January 26, 2021
Result type: Reports
Product Line: Reimbursement Review
Generic Name: talazoparib
Indications: Monotherapy for the treatment of adult patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced (not amenable to curative radiation or surgery) or metastatic breast cancer, who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting, unless patients were inappropriate for these treatments.

  • Brand Name: Talzenna
  • Manufacturer: Pfizer Canada Inc.
  • Project Status: Not filed
  • Submission Type: Non-submission

givosiran (Givlaari)

Last Updated: January 25, 2021
Result type: Reports
Product Line: Reimbursement Review
Generic Name: givosiran
Indications: ​Treatment of acute hepatic porphyria (AHP) in adults

  • Brand Name: Givlaari
  • Manufacturer: Alnylam Netherlands B.V.
  • Project Number: SR0679-000
  • Project Status: Pending
  • Submission Type: Initial