Product Dossier
Fosamax Plus
Product Dossier for Fosamax Plus (alendronic acid, colecalciferol, Organon Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Organon Pharma
- Active ingredient: alendronic acid, colecalciferol
- Therapeutic area: Musculoskeletal
- Related brand: ALENDROBELL
- Related brand: APO-ALENDRONATE
- Related brand: FONAT
- Same area: NAPROSYN
- Same area: PROXEN
What it is
FOSAMAX PLUS is a combination tablet containing alendronic acid and colecalciferol. Two strengths are registered: FOSAMAX PLUS ONCE WEEKLY containing alendronic acid 70 mg and colecalciferol 70 micrograms, and FOSAMAX PLUS 70 mg/140 ug containing alendronic acid 70 mg and colecalciferol 140 micrograms.
Regulatory history
FOSAMAX PLUS ONCE WEEKLY (ARTG 113482) was first listed on 8 March 2006. FOSAMAX PLUS 70 mg/140 ug (ARTG 136846) was first listed on 14 May 2008.