Paxneury (guanfacine)
- Region
- 🇪🇺 EU
- Active substance
- guanfacine
- Company
- Neuraxpharm Pharmaceuticals S.L.
- Status
- Authorised
- Therapeutic area
- Attention Deficit Disorder with Hyperactivity
- CHMP opinion
- Thu 12 Dec 2024
- EU approval
- Wed 26 Feb 2025
- Designations
- Generic
- Application
- EMEA/H/C/006312
- ATC
- C02AC02
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Intuniv Authorised · Takeda Pharmaceuticals International AG Ireland
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.