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||
31/07/2019 Aclasta - EMEA/H/C/000595 - II/0072
- 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
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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