№ lp_1_32870
File format: docx Character count: 15521 File size: 49 KB
Year: 2018
Region / City: Australia
Theme: Pharmaceutical application
Document Type: Authority Required listing submission
Agency / Organization: PBAC (Pharmaceutical Benefits Advisory Committee)
Author: Orphan Australia Pty Ltd
Target Audience: Healthcare professionals, regulatory authorities
Effective Period: Not specified
Approval Date: 12 June 2012
Amendment Date: Not specified
Price: 8 / 10 USD
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Budesonide 4 mg suppository listing submission for ulcerative proctitis, July 2024
Year: 2024
Region / Country: Australia
Therapeutic Area: Gastroenterology
Type of Document: Regulatory submission / PBAC evaluation
Product: Budesonide 4 mg suppository (Budenofalk®)
Comparator: Budesonide 2 mg foam (Budenofalk®), prednisolone suppositories and enemas, hydrocortisone acetate enemas
Regulatory Authority: TGA (Therapeutic Goods Administration)
Intended Use: Short-term treatment of mild to moderate ulcerative colitis limited to the rectum
Prescriber Type: Medical practitioners, Nurse practitioners
PBS Benefit Type: Unrestricted
Maximum Quantity: 1 pack, 30 units
Treatment Duration: up to 8 weeks per script
Clinical Evidence: Phase 3, randomized, double-blind, double-dummy, non-inferiority trial (BUS-4/UCA)
BUDESONIDE, Tablet (orally disintegrating) 1 mg, Jorveza®, Dr Falk Pharma Australia
Year: 2020
Region / city: Australia
Theme: Medical treatment
Document type: Regulatory submission
Organization / institution: Dr Falk Pharma Australia
Author: Dr Falk Pharma Australia
Target audience: Medical professionals, regulatory bodies
Treatment phase: Induction of remission
Date of approval: 15 September 2020
Date of amendments: N/A
Registration status: TGA registered
Regulatory agencies involved: TGA, EMA, Switzerland, Canada, Israel
Requested listing: PBS listing
Indication: Eosinophilic oesophagitis
Dosage: 1 mg orally disintegrating tablet, BID
Safety: Inferior compared to placebo
Efficacy: Superior compared to placebo
Comparator: Placebo
Clinical claim: Efficacy superiority, safety inferiority
Date of evaluation phase completion: 31 August 2021
End of evaluation period: 14 January 2022
Type of product: Orally disintegrating tablet (BOT)
Purpose: Treatment of eosinophilic oesophagitis
Medical criteria: Eosinophilic infiltration of the oesophagus confirmed by biopsy
Treatment criteria: Must be treated by a gastroenterologist
Administrative requirements: Applications within XX weeks of biopsy
National Institute for Health and Care Excellence Guidance: Targeted-release budesonide for treating primary IgA nephropathy (review of TA937) [ID6485] Consultation date: 22 January – 29 January 2026
Year: 2026
Region / city: United Kingdom
Topic: Healthcare, Nephrology
Document Type: Guidance
Organisation / Institution: National Institute for Health and Care Excellence (NICE)
Author: Unknown
Target Audience: Healthcare professionals, policymakers
Approval Date: Unknown
Date of Changes: Unknown
Note: Contextual description
Enhanced typhoid and paratyphoid (enteric fever) surveillance questionnaire
Note: Year
OzFoodNet Enteric Disease Surveillance Report 1st Quarter 2019
Year: 2019
Region / city: Western Australia
Topic: Enteric Disease Surveillance
Document Type: Report
Organization: OzFoodNet WA, Western Australian Department of Health
Author: OzFoodNet WA
Target Audience: Public health professionals, researchers, local government health officials
Period of validity: 1st Quarter 2019
Approval Date: 2019
Date of changes: Not specified
Key trends: Enteric disease notifications, outbreaks, and disease trends in 1Q19
Most common diseases: Salmonella Typhimurium, Shigellosis, Hepatitis A, Cryptosporidiosis
Travel-associated infections: Yes
Outbreak details: Provided in Appendices
Investigations: PCR testing and surveillance data
Laboratory tests: Polymerase chain reaction (PCR) testing
Date of outbreak report: 1st Quarter 2019
Date of last report: Previous quarters not specified
Investigating seasonal patterns in enteric infections: a systematic review of time series methods
Year: 2021
Region / City: Boston, MA, USA; Basel, Switzerland
Subject: Epidemiology of enteric infections
Document Type: Supplemental material for a scientific review
Institution / Organization: Tufts University Friedman School of Nutrition Science and Policy; Swiss Tropical and Public Health Institute; University of Basel
Author: Ryan B. Simpson, Alexandra V. Kulinkina, Elena N. Naumova
Corresponding Author: Elena N. Naumova
Word Count: 6312
Data Source: Published research articles on human gastrointestinal infections
Coverage Period: Various (based on cited studies)
Methodology: Systematic review of time series methods
Focus: Seasonal patterns, infection surveillance, epidemiological trends
Topics: Budenofalk Budesonide Enteric