ARTG Entry
GLYCERYL
ARTG entry for GLYCERYL (glyceryl trinitrate), ARTG 453908 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Phebra
- Active ingredient: glyceryl trinitrate
- Therapeutic area: Cardiology
I cannot write a
Brand Dossier for GLYCERYL as sponsored by Medsurge Pharma based on the provided documents.
The documents contain detailed product information for **NITROSTAT** (a sublingual tablet formulation of glyceryl trinitrate sponsored by Viatris), and ARTG registration records for **GLYCERYL** (concentrated solution for injection sponsored by Medsurge Pharma). These are different products with different formulations, sponsors, and routes of administration.
To produce an accurate Brand Dossier for GLYCERYL as a registered Australian medicine, I would need source documents that specifically cover: — Product information or datasheet for the GLYCERYL injection formulation — PBAC assessment outcomes and dates (if PBS-listed) — AusPAR documentation (if available) — Regulatory history specific to the GLYCERYL brand and its sponsor
The NITROSTAT sublingual tablet information cannot be reliably applied to the GLYCERYL injection product, as the clinical indications, dosing, safety profile, and regulatory pathway may differ significantly between formulations.
Please provide the relevant source documents for the GLYCERYL injection formulation, and I will prepare the Brand Dossier accordingly.