EMA — authorised 17 September 2015
- Marketing authorisation holder: Takeda Pharmaceuticals International AG Ireland Branch
- Status: approved
🇪🇺 Tenex in European Union
EMA authorised Tenex on 17 September 2015
Marketing authorisations
EMA — authorised 26 February 2025
- Application: EMEA/H/C/006312
- Marketing authorisation holder: Neuraxpharm Pharmaceuticals S.L.
- Local brand name: Paxneury
- Indication: Paxneury is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6‑17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. Paxneury must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.
- Status: approved
The European Medicines Agency (EMA) approved Paxneury (Tenex) for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6-17 years. This approval is for patients who are not suitable, cannot tolerate, or have shown no response to stimulants. Paxneury must be used as part of a comprehensive ADHD treatment programme, including psychological, educational, and social measures.
Tenex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in European Union
Frequently asked questions
Is Tenex approved in European Union?
Yes. EMA authorised it on 17 September 2015; EMA authorised it on 26 February 2025.
Who is the marketing authorisation holder for Tenex in European Union?
Takeda Pharmaceuticals International AG Ireland Branch holds the EU marketing authorisation.