Regulatory PathRegulatory requirements compared

Active substances

Alendronic acid + Colecalciferol

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
FOSAMAX PLUS DEQ 70MG BASE;2,800 IU; EQ 70MG BASE;5,600 IUtablet · oralORGANON LLCPrescription7 Apr 2005

EMA European Union — centrally authorised medicines

Fosavance Organon N.V. · Authorised · authorised 24 Aug 2005 · ATC M05BB03

Therapeutic indication (EMA)

Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency. Fosavance reduces the risk of vertebral and hip fractures.

Adrovance Organon N.V. · Authorised · authorised 4 Jan 2007 · ATC M05BB03

Therapeutic indication (EMA)

Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency. Adrovance reduces the risk of vertebral and hip fractures.

Vantavo (previously Alendronate sodium and colecalciferol, MSD) Organon N.V. · Authorised · authorised 16 Oct 2009 · ATC M05BB03

Therapeutic indication (EMA)

Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency. Vantavo reduces the risk of vertebral and hip fractures. Treatment of postmenopausal osteoporosis in patients who are not receiving vitamin-D supplementation and are at risk of vitamin-D insufficiency. Vantavo reduces the risk of vertebral and hip fractures.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFOSAMAX PLUS D 70 MG-2800 UNIT$52.5645per EA23 Sep 2026
US NADACFOSAMAX PLUS D 70 MG-5600 UNIT$52.51292per EA23 Sep 2026
NHS Drug TariffAlendronic acid 70mg / Colecalciferol 70microgram tablets£22.804 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.