This is a summary of the European public assessment report (EPAR) for Savene. 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 Savene.
Savene : EPAR - Summary for the public (PDF/57.75 KB)
First published: 05/09/2006
Last updated: 16/08/2011
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Extravasation of Diagnostic and Therapeutic Materials
|Anatomical therapeutic chemical (ATC) code||
Clinigen Healthcare B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
11/01/2019 Savene - EMEA/H/C/000682 - T/0038
- 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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Savene is indicated for the treatment of anthracycline extravasation.