№ files_lp_4_process_3_127254
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Ribociclib, in combination with adjuvant endocrine therapy, is a pharmaceutical submission for listing on the Australian PBS for the treatment of early-stage breast cancer at high risk of recurrence, detailing its effectiveness and clinical criteria for inclusion.
Year: 2025
Region / City: Australia
Topic: Pharmaceutical submission
Document Type: Pharmaceutical submission
Organization / Institution: Novartis Pharmaceuticals Australia Pty Limited
Author: Not specified
Target Audience: Medical practitioners
Period of validity: Until March 2025
Approval Date: November 2024
Modification Date: Not specified
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Ribociclib in combination with fulvestrant for HR+/HER2- advanced or metastatic breast cancer: PBAC July 2020 submission and resubmission
Year: 2020
Regulatory body: Pharmaceutical Benefits Advisory Committee (PBAC)
Region: Australia
Drug: Ribociclib (Kisqali)
Combination therapy: Fulvestrant
Indication: Hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer
Population: Non-premenopausal adults
Clinical trials referenced: MONALEESA-2, MONALEESA-3, BOLERO-2
Treatment line: First-line and second-line therapy
Outcome measures: Progression-free survival, overall survival, overall response rate, adverse events, health-related quality of life
Economic analysis: Cost-minimisation (first-line), cost-effectiveness (second-line)
Submission type: Major submission with minor resubmission for economic model adjustment
Approval status: TGA-approved ribociclib (2017, updated 2020), fulvestrant generic approved 2020
Manufacturer: Novartis Pharmaceuticals Australia Pty Ltd / Sandoz
Date of PBAC meeting: July 2020
Erenumab, Solution for subcutaneous injection 70 mg in 1 mL single dose pre-filled pen and 140 mg in 1 mL single dose pre-filled pen, Aimovig®, Novartis Pharmaceuticals Australia Pty. Limited
Year: 2023
Region / City: Australia
Subject: Chronic migraine, medicinal product submission
Document type: Submission for PBS listing
Organization: Novartis Pharmaceuticals Australia Pty. Limited
Author: Not specified
Target audience: Health professionals, pharmaceutical regulatory bodies
Period of validity: Not specified
Date of approval: 2 July 2018
Date of amendments: November 2023
METHYLPHENIDATE Capsule containing methylphenidate hydrochloride 10 mg, 20 mg, 30 mg 40 mg and 60 mg (modified release), Ritalin® LA, Novartis Pharmaceuticals Australia Pty Limited
Year: 2021
Region / City: Australia
Topic: Pharmaceutical submission
Document type: Submission report
Organization: Novartis Pharmaceuticals Australia Pty Limited
Author: Novartis Pharmaceuticals Australia Pty Limited
Target audience: Healthcare professionals, regulatory bodies
Period of validity: Ongoing
Approval date: 21 August 2002
Date of revisions: 18 December 2009, 11 March 2016, 8 July 2021, 16 July 2021, 29 July 2021
Note: Contextual description
ASCIMINIB, Tablet 20 mg, Tablet 40 mg, Scemblix®, Novartis Pharmaceuticals Australia Pty Limited
Year: 2022
Region / City: Australia
Theme: Pharmaceuticals
Document Type: Resubmission
Organization / Institution: Novartis Pharmaceuticals Australia Pty Limited
Author: PBAC
Target Audience: Healthcare professionals, regulatory bodies
Period of Validity: Not specified
Approval Date: 15 July 2022
Date of Changes: July 2022
Topics: Kisqali Ribociclib Novartis