Byannli (previously Paliperidone Janssen-Cilag International) (paliperidone)
- Region
- 🇪🇺 EU
- Active substance
- paliperidone
- Status
- Authorised
- Therapeutic area
- Schizophrenia
- CHMP opinion
- Thu 30 Apr 2020
- EU approval
- Thu 18 Jun 2020
- Application
- EMEA/H/C/005486
- ATC
- N05AX13
- Official record
- www.ema.europa.eu
Indication
Byannli (previously Paliperidone Janssen-Cilag International) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Xeplion Authorised · Janssen-Cilag International
- 🇪🇺 Invega Authorised · Janssen-Cilag International NV
- 🇪🇺 Trevicta (previously Paliperidone Janssen) Authorised · Janssen-Cilag International NV
- 🇪🇺 Niapelf Authorised · Neuraxpharm Pharmaceuticals S.L.
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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.