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.
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
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
---|---|
Marketing-authorisation holder |
Otsuka Pharmaceutical Netherlands B.V.
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
26/07/2018
|
Contact address |
Herikerbergweg 292 |
Product information
17/11/2021 Rxulti - EMEA/H/C/003841 - IB/0013/G
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.