№ files_lp_4_process_2_72405
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The document is a submission to the Pharmaceutical Benefits Advisory Committee (PBAC) regarding the listing of lisdexamfetamine dimesilate for the treatment of ADHD in an expanded age range, with a request for adjusted pricing and regulatory changes for adult patients diagnosed after 18 years of age.
Year:
2019
Region / City:
Australia
Subject:
ADHD Treatment, Medication Listing
Document Type:
Submission to PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
Shire Australia Pty Ltd
Target Audience:
Healthcare professionals, policymakers
Period of Validity:
Ongoing
Approval Date:
22 July 2013 (TGA registration for 30mg, 50mg, and 70mg strengths), 2017 (TGA registration for 20mg, 40mg, and 60mg strengths)
Date of Modification:
2019 (PBAC submission)
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Region:
South Tyneside and Sunderland, UK
Topic:
Adult Attention Deficit Hyperactivity Disorder (ADHD) treatment
Document type:
Clinical guideline / Shared care protocol
Issuing body:
South Tyneside and Sunderland Area Prescribing Committee
References:
NICE Clinical Guideline 87, NICE Quality Standard 39
Target audience:
Healthcare professionals managing adults with ADHD
Medications covered:
Methylphenidate, Dexamfetamine, Lisdexamfetamine, Atomoxetine
Indications:
ADHD in patients aged 18 years and over
Exclusions:
Patients aged 5–17 years, patients under 5 years
Dosage forms:
Tablets, capsules, oral solution
Administration instructions:
Standard and modified-release regimens, including special administration for dysphagia or GI issues
Adverse effects:
Appetite loss, insomnia, mood changes, cardiovascular effects, gastrointestinal effects, rare psychiatric effects
Year:
2025
Region / City:
Arlington, VA
Document Type:
Press Release
Organization:
PBS KIDS
Author:
Genie Deez, Thy Than
Target Audience:
Parents, Preschoolers
Period of Validity:
Fall 2025
Approval Date:
January 22, 2025
Funding Source:
Corporation for Public Broadcasting, U.S. Department of Education
Year:
2025
Region / City:
Cincinnati, OH
Subject:
Documentary
Document Type:
Film
Organization:
PBS
Author:
Yemi Oyediran
Target Audience:
General Public
Effective Date:
October 10, 2025
Date of Approval:
September 18, 2025
Description:
A documentary film about the history and cultural impact of King Records, shedding light on its groundbreaking role in American music.
Year:
2025
Region / city:
Australia
Subject:
Oncology, Pharmaceutical Submission
Document Type:
Pharmaceutical Benefits Scheme (PBS) Submission
Organ / Institution:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
JANSSEN-CILAG PTY LTD
Target Audience:
Medical practitioners, healthcare professionals
Period of validity:
Ongoing
Approval Date:
Pending
Date of modifications:
N/A
Year:
Not specified
Region / City:
Not specified
Theme:
Reproduction, Biology
Document Type:
Worksheet
Author:
Not specified
Target Audience:
Students
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
Not specified
Year:
2000
Region / city:
United States
Theme:
Elections, History, Government
Document type:
Educational Lesson Plan
Author:
Stephanie Schragger
Target audience:
Students, Grades 7-12
Period of validity:
Not specified
Approval date:
Not specified
Date of last modification:
Not specified
Context:
Educational resource aimed at teaching about contested elections in U.S. history, specifically the 2000 and 2020 elections.
Year:
2025
Region / City:
New York City
Topic:
Documentary, Politics, History, Vietnam War
Document Type:
Documentary Film
Organization:
PBS, American Experience
Author:
Marc Levin, Daphne Pinkerson
Target Audience:
General Public, History and Politics Enthusiasts
Period of Action:
May 8, 1970
Approval Date:
N/A
Date of Changes:
N/A
Year:
2025
Region / City:
Australia
Topic:
Pharmaceutical benefits, chemotherapy, PBS
Document Type:
FAQ
Organization:
Pharmaceutical Benefits Scheme
Author:
Pharmaceutical Benefits Advisory Committee (PBAC)
Target Audience:
Healthcare providers, prescribers, patients
Effective Period:
From December 1, 2024
Approval Date:
Not specified
Modification Date:
Not specified
Contextual Description:
FAQ document providing detailed information on the changes in PBS listing for Opdualag and Vyxeos under the EFC Program, including prescription and claiming details.
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
Medicine:
Aciclovir eye ointment 3% (3 mg/g), 4.5 g
Brand name:
Xorox
Sponsor:
Clinect Pty Ltd
ARTG listing date:
6 November 2020
Country:
Australia
Indication:
Herpes simplex keratitis
Regulatory authority:
Therapeutic Goods Administration
Reimbursement scheme:
Pharmaceutical Benefits Scheme
PBAC status:
Not previously considered prior to this submission
Comparator products:
AciVision, Zovirax
Submission type:
Minor submission
Listing type requested:
Restricted benefit, General Schedule
Prescriber types:
Medical practitioners, nurse practitioners, optometrists
Legal framework:
Therapeutic Goods Act 1989, Section 19A
Period discussed:
2014–2021
Source type:
Public Summary Document
Drug name:
Apremilast
Brand name:
Otezla
Dosage form:
Tablet
Strength:
30 mg
Pack composition:
4 tablets of 10 mg, 4 tablets of 20 mg, 19 tablets of 30 mg
Sponsor:
Amgen Australia Pty Ltd
Regulatory status:
TGA registered
TGA registration date:
19 March 2015
Indication:
Severe plaque psoriasis
Previous indication:
Psoriatic arthritis and moderate to severe plaque psoriasis
Application type:
Minor resubmission
Requested listing:
PBS General Schedule, Authority Required (STREAMLINED)
Comparator:
Cyclosporin
Clinical population:
Patients with severe plaque psoriasis intolerant of or contraindicated to methotrexate
Primary outcome:
PASI-75 at 16 weeks
Clinical claim:
Non-inferior comparative efficacy and safety versus cyclosporin
Regulatory body:
Pharmaceutical Benefits Advisory Committee
Submission history period:
2015–2018
Geographic scope:
Australia
Source type:
Public summary document excerpt
Year:
2020
Country:
Australia
Subject:
Osteoporosis pharmacotherapy
Focus medicine:
Denosumab
Other medicines included:
Bisphosphonates, raloxifene, teriparatide, strontium ranelate, calcitriol
Type of document:
Drug utilisation analysis report
Data sources:
Pharmaceutical Benefits Scheme (PBS) data, MedicineInsight data
Committee:
Drug Utilisation Sub-Committee (DUSC)
Study design:
Retrospective cohort analysis
Population:
Patients aged 50 years and over
Study period:
January 2012 – June 2019 (PBS); January 2014 – December 2017 (MedicineInsight cohorts)
Geographic scope:
National
Health system context:
Pharmaceutical Benefits Scheme
Contextual description:
Analytical health policy report examining national prescribing patterns, initiation, discontinuation, and subsequent therapy use of denosumab and other osteoporosis medicines based on linked administrative and general practice data.
Medicine:
Ciclosporin 1 mg/mL (0.1%) eye drops
Brand name:
Ikervis®
Sponsor:
Seqirus (Australia) Pty Ltd
Regulatory authority:
Therapeutic Goods Administration (TGA)
Registration date:
11 December 2020
Program:
Pharmaceutical Benefits Scheme (PBS)
Restriction type:
Authority Required (Streamlined)
Schedule category:
GENERAL – General Schedule (Code GE)
Indication:
Treatment of severe keratitis in adult patients with dry eye disease not improved despite tear substitutes
Population:
Patients aged 18 years or older with severe keratitis and dry eye disease
Comparators:
Best supportive care including preservative free artificial tears
Clinical criteria (initiation):
Corneal fluorescein staining grade 4 (modified Oxford scale or equivalent) and OSDI ≥ 23; failure of optimised preservative free tear substitutes
Clinical criteria (continuation):
Demonstrated adequate response at 6 months
Definition of adequate response:
Improvement in CFS ≥ 3 grades and ≥ 30% improvement in OSDI from baseline
Prescriber restrictions:
Ophthalmologist or optometrist
Economic basis:
Cost-utility analysis versus best supportive care
Proposed treatment phases:
Initiation; continuation; continuation after assessment of response
Note:
Year
Year:
2023
Region / City:
Australia
Subject:
PBS Payload Management
Document Type:
Procedure
Organization / Institution:
PBS Certifier
Author:
Not specified
Target Audience:
Personnel involved in loading and operation of tankers
Period of validity:
Not specified
Approval Date:
Not specified
Date of modifications:
Not specified
Note:
Contextual description
Year:
2022
Region / City:
Arlington, VA
Document Type:
Press Release
Organization:
PBS KIDS, GBH Kids
Author:
PBS KIDS, GBH Kids
Target Audience:
General public, families, fans of the show
Action Period:
2022 and beyond
Approval Date:
January 18, 2022
Date of Changes:
None
Context:
A press release announcing the 25th anniversary celebration of the ARTHUR series, including a marathon, new content, and upcoming media projects.