Rxulti
brexpiprazole
Table of contents
Overview
Rxulti is an antipsychotic medicine used to treat schizophrenia in adults. Schizophrenia is a mental illness with symptoms such as delusions, disorganised thinking and speech, suspiciousness and hallucinations (seeing, hearing or feeling things that are not there).
Rxulti contains the active substance brexpiprazole.
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List item
Rxulti : EPAR - Medicine overview (PDF/83.48 KB)
First published: 26/11/2018
EMA/393168/2018 -
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List item
Rxulti : EPAR - Risk-management-plan summary (PDF/35.45 KB)
Adopted
First published: 14/06/2023
Authorisation details
Product details | |
---|---|
Name |
Rxulti
|
Agency product number |
EMEA/H/C/003841
|
Active substance |
brexpiprazole
|
International non-proprietary name (INN) or common name |
brexpiprazole
|
Therapeutic area (MeSH) |
Schizophrenia
|
Anatomical therapeutic chemical (ATC) code |
N05AX16
|
Publication details | |
---|---|
Marketing-authorisation holder |
Otsuka Pharmaceutical Netherlands B.V.
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
26/07/2018
|
Contact address |
Herikerbergweg 292 |
Product information
26/05/2023 Rxulti - EMEA/H/C/003841 - R/0014
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Psycholeptics
Therapeutic indication
Treatment of schizophrenia.