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This document is a submission for the amendment of the PBS listing and authority requirements for mepolizumab in the treatment of uncontrolled severe asthma and chronic rhinosinusitis with nasal polyps.
Year: 2023
Region / City: Australia
Subject: Pharmaceutical submission
Document Type: Submission for PBS listing amendment
Organization: GlaxoSmithKline Australia Pty Ltd
Author: Not specified
Target Audience: Healthcare professionals, government agencies
Effective Period: Not specified
Approval Date: Not specified
Date of Amendments: Not specified
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
MEPOLIZUMAB, Injection 100 mg in 1 mL single dose pre-filled pen, Nucala®, GlaxoSmithKline Australia Pty Ltd
Year: 2022
Region / City: Australia
Theme: Chronic rhinosinusitis with nasal polyps, Pharmacology
Document Type: Application for PBS listing
Authority / Institution: PBAC, TGA
Author: GlaxoSmithKline Australia Pty Ltd
Target Audience: Healthcare professionals, medical practitioners
Validity Period: Not specified
Approval Date: Not specified
Modification Date: Not specified
MEPOLIZUMAB, Injection 100 mg in 1 mL single dose pre-filled pen, Nucala®, GlaxoSmithKline Australia Pty Ltd
Year: 2022
Region / City: Australia
Theme: Chronic rhinosinusitis with nasal polyps, Pharmacology
Document Type: Application for PBS listing
Authority / Institution: PBAC, TGA
Author: GlaxoSmithKline Australia Pty Ltd
Target Audience: Healthcare professionals, medical practitioners
Validity Period: Not specified
Approval Date: Not specified
Modification Date: Not specified
The efficacy and safety of treatment with mepolizumab in patients with eosinophilic granulomatosis with polyangiitis: a double-blind, randomized, placebo-controlled trial
Year: 2023
Region / City: Multiple international locations
Topic: Clinical trial, treatment for eosinophilic granulomatosis with polyangiitis
Document Type: Research Article
Organization / Institution: GlaxoSmithKline (GSK), National Institutes of Health (NIH), various academic institutions
Author: Michael E. Wechsler, Praveen Akuthota, David Jayne, Paneez Khoury, Amy Klion, Carol A. Langford, Peter A. Merkel, Frank Moosig, Ulrich Specks, Maria C. Cid, Raashid Luqmani, Judith Brown, Stephen Mallett, Richard Philipson, Steve W. Yancey, Jonathan Steinfeld, Peter F. Weller, Gerald J. Gleich
Target Audience: Medical professionals, researchers, healthcare providers
Period of Action: 52 weeks
Approval Date: 2023-01-01
Date of Revisions: None
MOMELOTINIB, Tablet 100 mg (as dihydrochloride monohydrate), Tablet 150 mg (as dihydrochloride monohydrate), Tablet 200 mg (as dihydrochloride monohydrate), Omjjara®, GLAXOSMITHKLINE AUSTRALIA PTY LTD.
Year: 2024
Region / City: Australia
Topic: Medicinal Product Registration
Document Type: Submission Report
Agency: Therapeutic Goods Administration (TGA)
Author: GlaxoSmithKline Australia
Target Audience: Medical Practitioners
Treatment Phase: Initial Treatment
Indication: Myelofibrosis, including primary, post-polycythaemia vera, and post-essential thrombocythaemia myelofibrosis
Approval Status: Pending
Date of Submission: May 2024
Date of Approval: Not yet approved
Background: Momelotinib is currently approved in the UK, US, Japan, and the EU.
Description: Clinical submission for listing momelotinib under the Australian PBS for the treatment of myelofibrosis in patients with moderate to severe anaemia.
GlaxoSmithKline and Microsoft Business Productivity Online Suite Deployment
Year: 2007
Region / city: Global
Industry: Pharmaceuticals
Document Type: Case Study
Organization: GlaxoSmithKline
Author: Not specified
Target audience: Business professionals in the pharmaceutical and IT industries
Period of validity: Not specified
Approval date: Not specified
Modification date: Not specified
RESPIRATORY SYNCYTIAL VIRUS VACCINE, Powder and suspension for injection (0.5 mL), Arexvy®, GlaxoSmithKline Australia Pty Ltd.
Year: 2024
Region / City: Australia
Topic: Vaccine Approval, Respiratory Syncytial Virus
Document Type: Clinical Submission
Organization / Institution: GlaxoSmithKline Australia Pty Ltd
Author: Unknown
Target Audience: Health professionals, Policy makers
Effective Period: Ongoing
Approval Date: January 14, 2024
Change Date: April 2024
VARICELLA ZOSTER VIRUS RECOMBINANT VACCINE, Injection [1 vial] & adjuvant substance diluent [0.5 mL vial], Shingrix®, GlaxoSmithKline Australia Pty Ltd
Year: 2023
Region / city: Australia
Topic: Vaccination, Immunocompromised individuals, Herpes Zoster
Document type: Government recommendation
Organization: PBAC (Pharmaceutical Benefits Advisory Committee)
Author: PBAC
Target audience: Healthcare professionals, Immunocompromised individuals
Period of validity: From November 1, 2023
Approval date: November 1, 2023
Modification date: September 2023
MEPOLIZUMAB, Injection 100 mg in 1 mL single dose pre-filled pen, Nucala®, GlaxoSmithKline Australia Pty Ltd
Year: 2022
Region / City: Australia
Theme: Chronic rhinosinusitis with nasal polyps, Pharmacology
Document Type: Application for PBS listing
Authority / Institution: PBAC, TGA
Author: GlaxoSmithKline Australia Pty Ltd
Target Audience: Healthcare professionals, medical practitioners
Validity Period: Not specified
Approval Date: Not specified
Modification Date: Not specified
Topics: Nucala MEPOLIZUMAB GLAXOSMITHKLINE