№ lp_1_2_20761
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This document is a submission detailing the request for PBS listing of adalimumab for non-infectious uveitis treatment, including clinical data and concerns regarding ocular complications, paediatric considerations, and the efficacy comparison with corticosteroids.
Year: 2017
Region / City: Australia
Subject: Medical treatment, pharmaceutical submission
Document Type: Submission for Pharmaceutical Benefits Scheme (PBS) consideration
Organization: Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory Committee (PBAC)
Author: AbbVie Pty Ltd.
Target Audience: Medical professionals, regulatory authorities
Effective Period: 2017–2024
Approval Date: October 26, 2016
Amendment 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.
Hyrimoz® adalimumab biosimilar submission for PBS listing
Year: 2024
Region / city: Australia
Topic: Biosimilars, pharmaceutical regulation
Document type: Submission report
Organ / institution: Australian Government, Pharmaceutical Benefits Advisory Committee (PBAC)
Author: Sandoz Pty Ltd
Target audience: Regulatory bodies, pharmaceutical industry professionals
Period of validity: 2024–2025
Approval date: 15 May 2024
Date of changes: March 2024
ADALIMUMAB 40 mg/0.8 mL injection, 2 x 0.8 mL cartridges, 2 x 0.8 mL syringes, 6 x 0.8 mL cartridges, 6 x 0.8 mL syringes - Purpose of Application
Year: 2013
Region / City: Australia
Theme: Pharmaceutical
Document Type: Pharmaceutical Submission
Agency / Institution: PBAC
Author: AbbVie Pty Ltd
Target Audience: Medical Professionals, Pharmacists
Effective Period: Ongoing
Approval Date: 23 July 2013
Date of Changes: Not specified
Topics: non-infectious uveitis ADALIMUMAB