Product Dossier
AVSARTAN
Product Dossier for AVSARTAN (hydrochlorothiazide 12.5 mg, irbesartan 300 mg, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes —…
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: hydrochlorothiazide 12.5 mg, irbesartan 300 mg
- Therapeutic area: Cardiology
- Related brand: ABISART
- Same area: ATOZET
- Same area: OPSUMIT
I appreciate your request, but
I must inform you that the provided source document contains only ARTG registration information (product registrations and dates) for AVSARTAN.
To produce a comprehensive Brand Dossier with the required sections, I would need source documents that contain information about: — What the medicine is (active ingredients and therapeutic class) — Approved indications (clinical uses) — Dosing overview (dose recommendations) — Key safety warnings — Contraindications — PBS listing details (item numbers, restrictions, pricing) — Regulatory history beyond ARTG registration dates (PBAC decisions, AusPAR, Black Triangle status)
The current source only confirms that AVSARTAN is registered on the ARTG in six formulations: irbesartan 75 mg, 150 mg, and 300 mg film-coated tablets (first listed 2017-01-10), and combination formulations with hydrochlorothiazide at 150/12.5 mg, 300/25 mg, and 300/12.5 mg strengths (first listed 2017-03-14) .
Please provide additional source documents (such as product information, PBAC submissions, AusPAR reports, or TGA correspondence) to enable completion of a full Brand Dossier.