This is a summary of the European public assessment report (EPAR) for Sialanar. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Sialanar.
For practical information about using Sialanar, patients should read the package leaflet or contact their doctor or pharmacist.
Sialanar : EPAR - Summary for the public (PDF/75.8 KB)
First published: 29/09/2016
Last updated: 29/09/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Proveca Pharma Limited
|Date of issue of marketing authorisation valid throughout the European Union||
03/10/2019 Sialanar - EMEA/H/C/003883 - IB/0012
- 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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Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.