Niapelf (paliperidone)
- Region
- 🇪🇺 EU
- Active substance
- paliperidone
- Company
- Neuraxpharm Pharmaceuticals S.L.
- Status
- Authorised
- Therapeutic area
- Schizophrenia
- CHMP opinion
- Wed 25 Jan 2023
- EU approval
- Sun 31 Mar 2024
- Designations
- Generic
- Application
- EMEA/H/C/006185
- ATC
- N05AX13
- Official record
- www.ema.europa.eu
Indication
indicated for maintenance treatment of schizophrenia in adult patients stabilised withpaliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Niapelf may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Byannli (previously Paliperidone Janssen-Cilag International) Authorised ·
- 🇪🇺 Xeplion Authorised · Janssen-Cilag International
- 🇪🇺 Invega Authorised · Janssen-Cilag International NV
- 🇪🇺 Trevicta (previously Paliperidone Janssen) Authorised · Janssen-Cilag International NV
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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.