№ files_lp_4_process_2_56109
File format: docx Character count: 68207 File size: 145 KB
Year: 2020
Region: Australia
Subject: Asthma treatment; inhaled corticosteroids; combination therapy
Document type: Regulatory submission summary
Organization: Pharmaceutical Benefits Advisory Committee (PBAC)
Company: Chiesi Australia Pty Ltd
Drug: Fostair® (Beclometasone dipropionate 100 µg + Formoterol fumarate 6 µg)
Population: Adults with asthma requiring ICS/LABA therapy
Comparator: Budesonide/Formoterol (BUD/FOR 200/6) and other ICS/LABA formulations
Approval status: TGA approved 12 February 2020
Therapy type: Maintenance and reliever therapy (MART)
Clinical claim: Non-inferior efficacy and safety compared to BUD/FOR 200/6 MART
Endpoints: Time to first severe exacerbation, exacerbation rate, FEV1, ACQ score, reliever use
Submission type: Category 2, Authority Required (Streamlined) listing
Context: Regulatory source detailing clinical efficacy, safety, and PBS listing considerations for BEC/FOR 100/6 as a combined maintenance and reliever asthma therapy.
Price: 8 / 10 USD
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What should I do if I need to use my reliever inhaler often for my asthma?
Note: Year
Topic: Asthma Management
Document Type: Health Advice
Target Audience: Individuals with asthma
Context: A health advisory document providing guidance on the proper use of reliever and preventer inhalers for asthma patients.
BECLOMETASONE with FORMOTEROL and GLYCOPYRRONIUM Pressurised inhalation containing beclometasone dipropionate 100 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses, TRIMBOW®, Chiesi Australia Pty Ltd
Year: 2020
Region / city: Australia
Topic: Medical Submission for Pharmaceutical Product
Document Type: Submission
Organization / Institution: Chiesi Australia Pty Ltd
Author: Chiesi Australia Pty Ltd
Target Audience: Medical professionals, regulatory authorities
Period of validity: Not specified
Approval Date: June 24, 2020
Date of changes: Not specified
BECLOMETASONE with FORMOTEROL and GLYCOPYRRONIUM Pressurised inhalation containing beclometasone dipropionate 100 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses, TRIMBOW®, Chiesi Australia Pty Ltd
Year: 2020
Region / city: Australia
Topic: Medical Submission for Pharmaceutical Product
Document Type: Submission
Organization / Institution: Chiesi Australia Pty Ltd
Author: Chiesi Australia Pty Ltd
Target Audience: Medical professionals, regulatory authorities
Period of validity: Not specified
Approval Date: June 24, 2020
Date of changes: Not specified
Topics: RELIEVER BECLOMETASONE FORMOTEROL