alendronic acid / colecalciferol

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Fosavance. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fosavance.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 04/10/2023

Authorisation details

Product details
Agency product number
Active substance
  • alendronic acid
  • colecalciferol
International non-proprietary name (INN) or common name
  • alendronic acid
  • colecalciferol
Therapeutic area (MeSH)
Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
N.V. Organon
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Kloosterstraat 6
5349 AB Oss
The Netherlands

Product information

04/10/2023 Fosavance - EMEA/H/C/000619 - IG1634/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency.

Fosavance reduces the risk of vertebral and hip fractures.

Assessment history

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