№ files_lp_3_process_7_042626
File format: docx Character count: 32497 File size: 80 KB
The document is a pharmaceutical submission requesting the addition of a 70 mg/m2 once-weekly dosing regimen for carfilzomib, along with a change in the restriction level for PBS listings for the treatment of relapsed or refractory multiple myeloma.
Year: 2016
Region / city: Australia
Topic: Pharmaceutical submission
Document Type: Submission request
Organization / institution: Australian Government Department of Health
Author: Amgen Australia Pty Limited
Target audience: Healthcare professionals
Effective period: From 19 December 2016
Approval date: 16 October 2019
Changes date: July 2017
Note: Contextual description
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
TEPROTUMUMAB, Powder for I.V. infusion 500 mg, Tepezza®, AMGEN AUSTRALIA PTY LTD
Year: 2024
Region / city: Australia
Topic: Thyroid eye disease (TED), Medical treatment, Drug submission
Document type: Submission for drug listing approval
Organization: PBAC, TGA
Author: AMGEN AUSTRALIA PTY LTD
Target audience: Medical practitioners, regulatory bodies
Period of validity: Ongoing
Approval date: Not yet decided
Amendment date: December 2024
Clinical criteria: Active, moderate-to-severe thyroid eye disease, CAS ≥ 3, specific treatment criteria
Indication: Active, moderate-to-severe thyroid eye disease
Prescriber type: Medical practitioners
Treatment phase: Initial, Continuing
Category / Program: Section 100, Authority Required (Streamlined)
Product: Teprotumumab (Tepezza)
Comparator: IV methylprednisolone, tocilizumab
Clinical claim: Superior efficacy, non-inferior safety to standard treatments
Outcome measures: Proptosis, diplopia, quality of life, adverse events
Background: Teprotumumab undergoing TGA review, with specific recommendations from the Advisory Committee on Medicines
BLINATUMOMABPOWDER FOR IV INFUSION, 38.5 ΜG, BLINCYTO®, AMGEN
Year: 2015
Region / City: Australia
Topic: Pharmaceutical drug application
Document type: Drug submission
Organization: TGA, PBAC
Author: AMGEN
Target Audience: Pharmaceutical regulators, healthcare professionals
Period of validity: Not specified
Approval date: October 2015
Amendment date: Not specified
Treatment: Relapsed or refractory B-precursor acute lymphoblastic leukaemia (Ph-)
Proposed use: Inpatient hospital setting
Cost: Not specified
Clinical trial: MT103-211
Guideline reference: National Comprehensive Cancer Network (NCCN) Version 2.2014
Indication: Orphan drug designation
Comparator: Standard of care chemotherapy regimens (FLAG, High-dose methotrexate, HiDAC)
Evolocumab Injection 420 mg in 3.5 mL single use pre-filled cartridge, Repatha®, Amgen Australia Pty Ltd
Year: 2026
Region / City: Australia
Topic: Pharmaceutical Submission
Document Type: Application
Institution / Organization: Amgen Australia Pty Ltd
Author: Not specified
Target Audience: Not specified
Period of Effect: Not specified
Approval Date: Not specified
Date of Changes: Not specified
Topics: CARFILZOMIB Kyprolis AMGEN