Okedi

RSS

risperidone

Authorised
This medicine is authorised for use in the European Union.

Overview

Okedi is a medicine used to treat schizophrenia in adults. It contains the active substance risperidone and is intended for use in patients in whom medicines containing risperidone have been effective and have not produced unacceptable side effects when given by mouth.

Okedi is a type of medicine called a ‘hybrid medicine’. This means that it is similar to a reference medicine containing the same active substance, but it is presented in a different way. While the reference medicine for Okedi, Risperdal tablets, is taken daily by mouth, Okedi is provided as a monthly injection.

This EPAR was last updated on 01/08/2022

Authorisation details

Product details
Name
Okedi
Agency product number
EMEA/H/C/005406
Active substance
Risperidone
International non-proprietary name (INN) or common name
risperidone
Therapeutic area (MeSH)
Schizophrenia
Anatomical therapeutic chemical (ATC) code
N05AX08
Publication details
Marketing-authorisation holder
Laboratorios Farmacéuticos Rovi, S.A.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
14/02/2022
Contact address

Julián Camarillo, 35
28037 Madrid
Spain

Product information

23/07/2022 Okedi - EMEA/H/C/005406 - IB/0003/G

Product information documents contain:

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 in adults for whom tolerability and effectiveness has been established with oral risperidone.

Assessment history

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