№ files_lp_3_process_9_35573
File format: docx Character count: 34083 File size: 84 KB
Year: 2015
Region / City: Australia
Topic: Pharmaceutical submission
Document Type: Submission for Authority Required Listing
Institution: Medical Services Advisory Committee (MSAC)
Author: Allergan Australia Pty Limited
Target Audience: Healthcare professionals, Medical Services Advisory Committee, Pharmaceutical Regulators
Period of Validity: Indefinite
Approval Date: Not specified
Modification Date: Not specified
Treatment: Diabetic Macular Oedema (DME)
Indication: Visual impairment due to centre-involving DME
Restriction: Authority Required (streamlined)
Clinical Criteria: Diabetic Macular Oedema, Reduced Visual Acuity ≤ 6/12 Snellen
Population Criteria: Adults, pseudophakic or cataract surgery scheduled
Price: Special pricing arrangements
Limitations: Discontinuation of treatment if ≥ 15 letter decrease in best corrected visual acuity (BCVA)
Formulation: 700 µg dexamethasone in a solid polymer drug delivery system
Comparator: Ranibizumab, Bevacizumab
Context: Submission for PBS listing of dexamethasone implant for treating diabetic macular oedema in patients with pseudophakic eyes or those scheduled for cataract surgery.
Price: 8 / 10 USD
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CARMELLOSE WITH GLYCEROL AND HYALURONIC ACID, Eye drops containing carmellose sodium 5 mg per mL with glycerol 9 mg per mL and sodium hyaluronate 1 mg per mL, 10 mL, Optive Fusion®, Allergan Australia Pty Ltd
Year: 2019
Region / city: Australia
Topic: Medical device, eye care
Document type: Public Summary Document
Organ / institution: Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory Committee (PBAC)
Author: Allergan Australia Pty Ltd
Target audience: Healthcare professionals, medical practitioners
Period of validity: Not specified
Approval date: 13 March 2019
Date of amendments: Not specified
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCESINGLE TECHNOLOGY APPRAISALAPPEAL HEARINGAdvice on isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma [ID4067]: Decision of the panel.
Year: 2024
Region / city: United Kingdom
Topic: Health technology assessment
Document type: Appeal hearing report
Organization: National Institute for Health and Care Excellence (NICE)
Author: NICE
Target audience: Healthcare professionals, industry representatives, public
Period of validity: Not specified
Approval date: 23 September 2024
Date of changes: Not specified
Decision: Paddy Lee – Australian Harness Racing Rule 190(1) – Dexamethasone Positive in Keayang Xena
Date: 1 March 2024
Region/City: Melton, Australia
Subject: Horse Racing, Doping Violation
Document Type: Legal Decision
Authority/Institution: Harness Racing Victoria, Victorian Racing Tribunal
Author: Mark Howard, Registrar, Victorian Racing Tribunal
Target Audience: Horse Racing Professionals, Legal Experts
Period of Validity: 3 February 2023
Date of Approval: 1 March 2024
Possible Side Effects of Velcade, Revlimid, Dexamethasone (Table Version Date: December 23, 2022)
Year: 2022
Region / City: Not specified
Topic: Health / Medication Side Effects
Document Type: Medical Information
Organ / Institution: Not specified
Author: Not specified
Target Audience: Healthcare professionals, patients
Effective Period: Not specified
Approval Date: Not specified
Date of Changes: Not specified
Context: A medical source providing information on the potential side effects of Velcade, Revlimid, and Dexamethasone, organized by frequency and severity.
IXAZOMIB in combination with lenalidomide and dexamethasone for the treatment of relapsed and/or refractory multiple myeloma
Year: 2016
Region / city: Australia
Topic: Multiple myeloma treatment
Document type: Submission for listing consideration
Organ / institution: PBAC (Pharmaceutical Benefits Advisory Committee)
Author: Takeda Pharmaceuticals Australia Pty Ltd
Target audience: PBAC, healthcare professionals
Period of validity: Ongoing treatment
Approval date: 15 November 2016
Date of changes: N/A
Quality by Design Based Pharmaceutical Development Report of Cost-Effective Dexamethasone Tablets 20 mg for Regulatory Submission
Year: Not specified
Region / Market context: United States, European Union, India
Field: Pharmaceutical development
Document type: Pharmaceutical development report
Drug product: Dexamethasone Tablets 20 mg
Therapeutic area: Oncology and anti-inflammatory therapy
Indication mentioned: Multiple myeloma adjunct therapy
Development approach: Quality by Design (QbD)
Reference product: HEMADY™ (Dexamethasone) Tablets 20 mg
Reference product manufacturer: Dexcel Pharma Technologies Ltd, Israel
Reference product distributor: Acrotech Biopharma Inc, USA
Active pharmaceutical ingredient: Dexamethasone (micronized API)
Key excipients: Lactose Monohydrate, Corn Starch, Povidone, Sodium Starch Glycollate Type A, Magnesium Stearate
Manufacturing process: Direct blending and compression
Critical Material Attribute (CMA): API particle size distribution below 10 microns
Critical Process Parameter (CPP): Blending time (15 minutes pre-lubrication, 5 minutes lubrication)
Critical Quality Attributes (CQA): Blend flow, hardness, dissolution
Stability testing conditions: 40°C ± 2°C / 75% RH ± 5% RH for 6 months
Packaging evaluated: Bottle and blister pack
Regulatory framework referenced: ICH Q8 (R2), ICH stability guidelines
Supporting regulatory sources: US DMF, CEP, USP, BP, Ph.Eur
Related patent referenced: US10,537,585 B2 (21 January 2020)
Primary objective: Development of a cost-effective bioequivalent dexamethasone tablet formulation
Topics: OZURDEX Allergan dexamethasone