№ lp_2_1_23727
File format: docx Character count: 27939 File size: 65 KB
Public Summary Document detailing the PBAC evaluation of a resubmission for PBS listing of midazolam oromucosal solution for the treatment of generalised convulsive status epilepticus, including considerations of restriction criteria, pricing, financial impact, and risk sharing.
Medicine: Midazolam oromucosal solution in pre-filled syringe
Brand name: Zyamis®
Sponsor: Clinect Pty Ltd
Dosage forms: 2.5 mg/0.25 mL; 5 mg/0.5 mL; 7.5 mg/0.75 mL; 10 mg/1 mL
Indication: Treatment of generalised convulsive status epilepticus (GCSE) in patients over 6 months of age
Regulatory authority: Therapeutic Goods Administration (TGA)
ARTG listing date: 22 April 2022
Advisory body: Pharmaceutical Benefits Advisory Committee (PBAC)
Submission type: Early re-entry resubmission
Requested listing: Section 85 Authority Required (telephone/online)
Additional request: Prescriber Bag Schedule listing for Medical Practitioners
Comparative medicine: Midazolam hydrochloride injection 5 mg/mL
Proposed maximum quantity: 2 pre-filled syringes per prescription
Estimated financial impact: $20 million to < $30 million over six years
Previous consideration: July 2022 PBAC meeting
Source: Public Summary Document (PSD), July 2022
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
ETANERCEPT, Injections 50 mg in 1 mL single use pre-filled syringes, 4, Nepexto®, Maxx Pharma Pty Ltd
Year: 2020
Region / city: Australia
Topic: Biosimilar medicine submission
Document type: Pharmaceutical submission
Organization / institution: Pharmaceutical Benefits Advisory Committee (PBAC)
Author: Maxx Pharma Pty Ltd
Target audience: Healthcare professionals, regulatory bodies
Period of validity: Ongoing
Approval date: November 2022
Modification date: November 2022
ADALIMUMAB 40 mg/0.8 mL injection, 2 x 0.8 mL cartridges, 2 x 0.8 mL syringes, 6 x 0.8 mL cartridges, 6 x 0.8 mL syringes - Purpose of Application
Year: 2013
Region / City: Australia
Theme: Pharmaceutical
Document Type: Pharmaceutical Submission
Agency / Institution: PBAC
Author: AbbVie Pty Ltd
Target Audience: Medical Professionals, Pharmacists
Effective Period: Ongoing
Approval Date: 23 July 2013
Date of Changes: Not specified
Topics: Oromucosal Midazolam syringes