Bonviva

RSS

ibandronic acid

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

Overview

This is a summary of the European public assessment report (EPAR) for Bonviva. 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 Bonviva.

This EPAR was last updated on 02/08/2022

Authorisation details

Product details
Name
Bonviva
Agency product number
EMEA/H/C/000501
Active substance
ibandronic acid
International non-proprietary name (INN) or common name
ibandronic acid
Therapeutic area (MeSH)
Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code
M05BA06
Publication details
Marketing-authorisation holder
Atnahs Pharma Netherlands B.V.
Revision
29
Date of issue of marketing authorisation valid throughout the European Union
23/02/2004
Contact address

Copenhagen Towers,
Ørestads Boulevard 108, 5.tv
DK-2300 København S
Denmar

Product information

25/07/2022 Bonviva - EMEA/H/C/000501 - PSUSA/00001702/202106

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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 osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

Assessment history

Changes since initial authorisation of medicine

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