№ files_lp_3_process_9_41158
File format: docx Character count: 31526 File size: 65 KB
Regulatory evaluation summary outlining PBAC recommendations, clinical criteria, cost-minimisation considerations, and listing conditions for fluocinolone acetonide intravitreal implant for diabetic macular oedema in Australia.
Year: 2020
Country: Australia
Therapeutic Area: Ophthalmology
Indication: Diabetic macular oedema (DMO)
Active Substance: Fluocinolone acetonide 190 microgram intravitreal implant
Brand Name: Iluvien®
Sponsor: Specialised Therapeutics Alim Pty Ltd
Regulatory Authority: Pharmaceutical Benefits Advisory Committee (PBAC)
Registration Status: TGA registered on 29 July 2019
Type of Submission: Minor resubmission
Type of Analysis: Cost-minimisation analysis (CMA)
Comparator: Dexamethasone intravitreal implant
Restriction Level: Authority Required – In Writing Only
Treatment Phase: Initial treatment
Prescriber Type: Medical practitioners, nurse practitioners, optometrists, midwives, dental practitioners
Program Category: General Schedule (Code GE)
Clinical Criteria: Visual impairment due to DMO with specified visual acuity range and prior corticosteroid treatment without significant intraocular pressure rise
Population Criteria: Patients post-cataract surgery or scheduled for cataract surgery in the treated eye
Document Type: Public Summary Document extract
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

Don’t have cryptocurrency yet?

You can still complete your purchase in a few minutes:
  1. Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
  2. In the app, tap Send.
  3. Select network, paste our wallet address.
  4. Send the exact amount shown above.
After sending, paste your TXID (transaction ID) and your email to receive the download link. Need help? Contact support and we’ll guide you step by step.

The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Intraocular Triamcinolone Acetonide (KenalogTM or TriesenceTM)
Year: 2020
Region / city: USA
Theme: Ophthalmology, Medical Risk Management
Document type: Risk Management Recommendations
Organization: OMIC
Author: Anne M. Menke, RN, PhD
Target audience: Ophthalmologists
Effective period: Ongoing
Approval date: 8/4/20
Date of changes: None specified
Section 790.6570 Neomycin Sulfate; Triamcinolone Acetonide (Repealed)
Year: 1992
Region / City: Illinois
Topic: Pharmaceutical Regulations
Document Type: Legal Regulation
Organization: State of Illinois
Author: Illinois General Assembly
Target Audience: Legal professionals, regulatory bodies
Effective Date: August 10, 1992
Date of Repeal: Not specified
Context Description: Legal document regarding the repeal of regulations for neomycin sulfate and triamcinolone acetonide in Illinois.
Topics: Fluocinolone Iluvien Acetonide