Product Dossier
APO-AZITHROMYCIN
Product Dossier for APO-AZITHROMYCIN (azithromycin, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: azithromycin
- Therapeutic area: Infectious Disease
- Related brand: ZITHROMAX
- Related brand: AZITH
- Related brand: AZITHROMYCIN-AFT
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
I cannot provide a
Brand Dossier for APO-AZITHROMYCIN as requested because the source documents do not contain consistent information about this brand.
Document 1 describes a product called "AZITHROMYCIN MEDSURGE" (sponsored by Medsurge Pharma Pty Ltd), which is an intravenous powder for injection indicated for community acquired pneumonia.
Document 2 lists ARTG registrations for "APO-AZITHROMYCIN" (sponsored by Arrotex Pharmaceuticals) as oral tablets, first listed in 2012.
These appear to be different products from different sponsors with different formulations and indications. The detailed product information in Document 1 does not apply to the APO-AZITHROMYCIN tablets registered in Document 2.
To prepare an accurate Brand Dossier for APO-AZITHROMYCIN tablets, I would need source documents that specifically describe the oral tablet formulation, its approved indications, dosing, safety profile, and PBS listing status.