Fosavance (alendronic acid;colecalciferol)
- Region
- 🇪🇺 EU
- Active substance
- alendronic acid;colecalciferol
- Company
- Organon N.V.
- Status
- Authorised
- Therapeutic area
- Osteoporosis, Postmenopausal
- CHMP opinion
- Thu 26 May 2005
- EU approval
- Wed 24 Aug 2005
- Application
- EMEA/H/C/000619
- ATC
- M05BB03
- Official record
- www.ema.europa.eu
Indication
Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency. Fosavance reduces the risk of vertebral and hip fractures.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Vantavo (previously Alendronate sodium and colecalciferol, MSD) Authorised · Organon N.V.
- 🇪🇺 Adrovance Authorised · Organon N.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.