Vantavo (previously Alendronate sodium and colecalciferol, MSD)

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 Vantavo. 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 Vantavo.

This EPAR was last updated on 14/03/2019

Authorisation details

Product details
Name
Vantavo (previously Alendronate sodium and colecalciferol, MSD)
Agency product number
EMEA/H/C/001180
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
13
Date of issue of marketing authorisation valid throughout the European Union
16/10/2009
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

28/11/2018 Vantavo (previously Alendronate sodium and colecalciferol, MSD) - EMEA/H/C/001180 - N/0031

Contents

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Pharmacotherapeutic group

DRUGS FOR TREATMENT OF BONE DISEASES

Therapeutic indication

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

Vantavo reduces the risk of vertebral and hip fractures.

Treatment of postmenopausal osteoporosis in patients who are not receiving vitamin-D supplementation and are at risk of vitamin-D insufficiency.

Vantavo reduces the risk of vertebral and hip fractures.

Assessment history

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