This is a summary of the European public assessment report (EPAR) for Aclasta. 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 Aclasta.
Aclasta : EPAR - Summary for the public (PDF/85.67 KB)
First published: 08/07/2009
Last updated: 28/07/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
29/09/2021 Aclasta - EMEA/H/C/000595 - N/0077
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Drugs for treatment of bone diseases
Treatment of osteoporosis:
- in post-menopausal women;
- in men;
at increased risk of fracture, including those with a recent low-trauma hip fracture.
Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture.
Treatment of Paget's disease of the bone.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 February 201217/02/2012