Table of contents
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||
2 Dublin Landings
01/09/2022 Sialanar - EMEA/H/C/003883 - II/0025/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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 functional gastrointestinal disorders
Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.