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
Sialanar : EPAR - Risk-management-plan summary (PDF/176.17 KB)
First published: 02/06/2020
|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||
30/04/2020 Sialanar - EMEA/H/C/003883 - IB/0014
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Drugs for functional gastrointestinal disorders
Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.