Sialanar

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glycopyrronium

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 15/09/2022

Authorisation details

Product details
Name
Sialanar
Agency product number
EMEA/H/C/003883
Active substance
glycopyrronium bromide
International non-proprietary name (INN) or common name
glycopyrronium
Therapeutic area (MeSH)
Sialorrhea
Anatomical therapeutic chemical (ATC) code
A03AB02
Publication details
Marketing-authorisation holder
Proveca Pharma Limited
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
15/09/2016
Contact address

2 Dublin Landings
North Wall Quay
Dublin 1
Ireland

Product information

01/09/2022 Sialanar - EMEA/H/C/003883 - II/0025/G

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Product information documents contain:

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.

Pharmacotherapeutic group

Drugs for functional gastrointestinal disorders

Therapeutic indication

Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.

Assessment history

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