🇪🇺 Sialanar in European Union

EMA authorised Sialanar on 15 September 2016

Marketing authorisation

EMA — authorised 15 September 2016

  • Application: EMEA/H/C/003883
  • Marketing authorisation holder: Proveca Pharma Limited
  • Local brand name: Sialanar
  • Indication: Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
  • Status: approved

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Sialanar in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Respiratory approved in European Union

Frequently asked questions

Is Sialanar approved in European Union?

Yes. EMA authorised it on 15 September 2016.

Who is the marketing authorisation holder for Sialanar in European Union?

Proveca Pharma Limited holds the EU marketing authorisation.