Product Dossier
AMLO
Product Dossier for AMLO (amlodipine, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: amlodipine
- Therapeutic area: Cardiology
- Related brand: NORVASC
- Related brand: CADIVAST
- Related brand: TWYNSTA
- Same area: ATOZET
- Same area: OPSUMIT
I appreciate your request, but
I need to flag a significant inconsistency in your materials.
The product information document you've provided (Document 1) describes **amlodipine/valsartan/hydrochlorothiazide** — a triple-combination antihypertensive medicine made by Novartis.
However, the ARTG registration document (Document 2) shows that the brand **AMLO** is registered for **amlodipine monotherapy only** (5 mg and 10 mg tablets) sponsored by Arrotex Pharmaceuticals.
These are two completely different medicines: — Different manufacturers (Novartis vs Arrotex) — Different active ingredients (triple combination vs monotherapy) — Different indications and dosing
**I cannot write a Brand Dossier that reconciles these conflicting sources.** The product information document does not match the registered AMLO brand on the ARTG.
To proceed, I would need: 1. Clarification of which medicine the dossier should describe, or 2. The correct product information document that matches the AMLO brand registered by Arrotex Pharmaceuticals
Could you please confirm which medicine requires the Brand Dossier, or provide the appropriate source documents?