Product Dossier
DERALIN
Product Dossier for DERALIN (propranolol hydrochloride, Alphapharm). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Alphapharm
- Active ingredient: propranolol hydrochloride
- Therapeutic area: Cardiology
- Related brand: APO-Propranolol
- Related brand: INDERAL
- Related brand: PROPRANOLOL-WGR
- Same area: ATOZET
- Same area: OPSUMIT
I appreciate the detailed instructions, but
I need to flag an issue with the source documents provided.
The documents contain information about **Hemangiol** (propranolol oral solution for infantile haemangioma) and ARTG registration details for **DERALIN** tablets (propranolol 10 mg, 40 mg, and 160 mg). These are different pharmaceutical products with different indications, formulations, and patient populations.
The ARTG records show DERALIN tablets were first registered in 1991, but the product information document is entirely about Hemangiol oral solution for paediatric use in infantile haemangioma—a completely different indication and formulation.
**To write an accurate Brand Dossier for DERALIN, I would need:** — Product information or SmPC (Summary of Product Characteristics) specific to DERALIN tablets — Current PBS listing information for DERALIN (if PBS-listed) — PBAC meeting outcomes and dates relating to DERALIN — Regulatory history specific to DERALIN's tablet formulations — Safety and efficacy data for DERALIN's actual indications (likely hypertension, angina, arrhythmias, etc.)
The Hemangiol document, while detailed, cannot be used to create a dossier for DERALIN without creating significant clinical and safety errors, as the two medicines have entirely different approved indications and patient populations.
Would you be able to provide source documents specific to DERALIN tablets?