🇪🇺 NPC-15 in European Union

EMA authorised NPC-15 on 20 September 2018

Marketing authorisations

EMA — authorised 20 September 2018

  • Application: EMEA/H/C/004425
  • Marketing authorisation holder: RAD Neurim Pharmaceuticals EEC SARL
  • Local brand name: Slenyto
  • Indication: Slenyto is indicated for: treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient. treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.
  • Status: approved

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EMA — authorised 7 November 2022

  • Application: EMEA/H/C/005603
  • Marketing authorisation holder: RAD Neurim Pharmaceuticals EEC SARL
  • Local brand name: Melatonin Neurim
  • Indication: Melatonin Neurim is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
  • Status: approved

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Other Diabetes approved in European Union

Frequently asked questions

Is NPC-15 approved in European Union?

Yes. EMA authorised it on 20 September 2018; EMA authorised it on 7 November 2022.

Who is the marketing authorisation holder for NPC-15 in European Union?

RAD Neurim Pharmaceuticals EEC SARL holds the EU marketing authorisation.