№ files_lp_4_process_3_096950
File format: docx Character count: 5952 File size: 39 KB
This document pertains to the submission for the modification of the evolocumab injection product, specifically the switch from a 9-minute automated mini-doser (AMD) to a 5-minute version, with no changes to the drug itself.
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
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

Don’t have cryptocurrency yet?

You can still complete your purchase in a few minutes:
  1. Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
  2. In the app, tap Send.
  3. Select network, paste our wallet address.
  4. Send the exact amount shown above.
After sending, paste your TXID (transaction ID) and your email to receive the download link. Need help? Contact support and we’ll guide you step by step.

The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
PCSK9 injections: Alirocumab 75/150mg and Evolocumab 140mg fortnightly
Note: Year
Topic: Lipid disorders, Cardiovascular Risk
Document Type: Medical guideline
Target Audience: Medical professionals, healthcare providers
Evolocumab 140 mg in 1 mL pre-filled pen and 420 mg in 3.5 mL pre-filled cartridge for the treatment of hypercholesterolemia
Year: 2015
Region / city: Australia
Theme: Hypercholesterolemia treatment
Document type: Pharmaceutical submission
Organization / institution: Amgen Australia Pty Limited
Author: Amgen Australia Pty Limited
Target audience: Healthcare professionals
Period of validity: Ongoing
Approval date: 4 December 2015
Date of amendments: December 2022
Context: Submission to modify existing PBS listings for evolocumab for the treatment of different types of hypercholesterolemia, including changes to prescription requirements and treatment duration.
Analysis of evolocumab utilisation for hypercholesterolaemia, February 2023
Year: 2023
Region: Australia
Topic: Hypercholesterolaemia treatment
Document type: Drug utilisation analysis
Organization: Department of Health and Aged Care; Services Australia
Author: Drug Utilisation Sub-Committee (DUSC)
Target audience: Healthcare policymakers, clinicians
PBS listing date: 1 December 2016
Data sources: PBS and Authorities databases
Indications: Homozygous familial hypercholesterolaemia, heterozygous familial hypercholesterolaemia, non-familial hypercholesterolaemia
Number of patients treated (2021): 6,119
Number of prescriptions supplied (2021): 48,483
Therapeutic class: PCSK9 inhibitor
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
CARFILZOMIB, Powder for injection 10 mg, 30 mg and 60 mg, Kyprolis®, Amgen Australia Pty Limited
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
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)
Topics: Repatha Evolocumab AMGEN