№ files_lp_3_process_9_24236
File format: docx Character count: 41395 File size: 100 KB
The document is a submission for PBS listing of adalimumab for the treatment of moderate to severe ulcerative colitis, discussing clinical trial data, pricing proposals, and economic evaluations.
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
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
ADALIMUMAB, Injection 20 mg in 0.2 mL, 40 mg in 0.4 mL, and 80 mg in 0.8 mL for the treatment of non-infectious uveitis
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
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
Topics: mg08 cartridges ADALIMUMAB