Basic Information
Sialanar
Regulatory Information
EMEA/H/C/003883
Authorised
September 15, 2016
12
April 11, 2025
Company Information
Ireland
2 Dublin Landings North Wall Quay Dublin 1
Proveca Pharma Ltd.
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
Overview Summary
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.