Product Dossier

PROPRANOLOL-WGR

Product Dossier for PROPRANOLOL-WGR (propranolol hydrochloride, GM Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

I appreciate the detailed instructions, but

I must respectfully note a significant issue with this request.

The source documents provided relate to **Hemangiol** (propranolol 3.75 mg/mL oral solution for infantile haemangioma, sponsored by Pierre Fabre Australia), while you have asked me to write a Brand Dossier for **PROPRANOLOL-WGR** (propranolol tablets 10 mg and 40 mg, sponsored by GM Pharma).

These are distinct registered products: — Hemangiol is a paediatric oral solution for a specific indication (proliferating infantile haemangioma) — PROPRANOLOL-WGR consists of tablet formulations with different strengths and a different sponsor

The ARTG document (Document 2) provides only registration dates and licence categories for PROPRANOLOL-WGR but contains no clinical, safety, dosing, or other substantive information about those products.

**I cannot ethically write a Brand Dossier for PROPRANOLOL-WGR using only information from the Hemangiol product information document**, as this would misrepresent the clinical profile, indications, dosing, and safety data of a different medicine to a different audience.

To proceed, I would need: — Product information or other authoritative source documents specific to PROPRANOLOL-WGR tablets, or — Clarification that you wish me to write the dossier for Hemangiol instead

Which would you prefer?