Adrovance

RSS

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 Adrovance. 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 Adrovance.

This EPAR was last updated on 09/09/2021

Authorisation details

Product details
Name
Adrovance
Agency product number
EMEA/H/C/000759
Active substance
  • colecalciferol
  • alendronic acid (as sodium trihydrate)
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
N.V. Organon
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
04/01/2007
Contact address

Kloosterstraat 6
5349 AB, Oss
Netherlands

Product information

21/04/2021 Adrovance - EMEA/H/C/000759 - T/0047

Contents

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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.

Adrovance reduces the risk of vertebral and hip fractures.

Assessment history

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