Adrovance

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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 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 19/07/2018

Authorisation details

Product details
Name
Adrovance
Agency product number
EMEA/H/C/000759
Active substance
  • alendronate sodium trihydrate
  • 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
18
Date of issue of marketing authorisation valid throughout the European Union
04/01/2007
Contact address

Waarderweg 39
2031 BN Harlem
The Netherlands

Product information

06/07/2018 Adrovance - EMEA/H/C/000759 - T/0039

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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.

Adrovance reduces the risk of vertebral and hip fractures.

Assessment history

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