Zypadhera

RSS

olanzapine

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

Overview

This is a summary of the European public assessment report (EPAR) for Zypadhera. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zypadhera.

This EPAR was last updated on 21/01/2019

Authorisation details

Product details
Name
Zypadhera
Agency product number
EMEA/H/C/000890
Active substance
olanzapine pamoate
International non-proprietary name (INN) or common name
olanzapine
Therapeutic area (MeSH)
Schizophrenia
Anatomical therapeutic chemical (ATC) code
N05AH03
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
19/11/2008
Contact address
Eli Lilly Nederland BV
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

10/12/2018 Zypadhera - EMEA/H/C/000890 - IAIN/0038

Contents

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Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.

Assessment history

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