Fosavance

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alendronic acid / colecalciferol

Authorised
This medicine is authorised for use in the European Union.

Overview

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 24/05/2019

Authorisation details

Product details
Name
Fosavance
Agency product number
EMEA/H/C/000619
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
M05BB03
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
24/08/2005
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

05/04/2019 Fosavance - EMEA/H/C/000619 - N/0043

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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