Product Dossier
APX-CITALOPRAM
Product Dossier for APX-CITALOPRAM (citalopram, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: citalopram
- Therapeutic area: Psychiatry
- Related brand: CELAPRAM
- Related brand: AURO-CITALOPRAM
- Related brand: IPC
- Same area: REXULTI
- Same area: NICORETTE
I appreciate your request, but
I must inform you that the provided source document contains insufficient information to write a comprehensive Brand Dossier as specified.
The single document provided contains only ARTG registration details—specifically, that APX-CITALOPRAM is a citalopram 20 mg tablet formulation (as hydrobromide) sponsored by Arrotex Pharmaceuticals, with two ARTG entries first listed on 2020-06-23 .
To complete a Brand Dossier with the required sections, I would need source documents containing information on: — What the medicine is (therapeutic class, mechanism of action) — Approved indications — Dosing overview and recommendations — Key safety warnings — Contraindications — PBS listing details (strength, item number, restriction type, price) — Regulatory history (PBAC outcomes, AusPAR, Black Triangle status)
I recommend obtaining:
1. The product information sheet or SmPC (Summary of Product Characteristics) for APX-CITALOPRAM 2. PBAC documentation and outcomes 3. Any available AusPAR (Australian Public Assessment Report) 4. PBS schedule entries for this medicine 5. TGA / ARTG regulatory documentation
Once these sources are provided, I will be able to prepare a complete, properly cited Brand Dossier in the format and style you have specified.