Zypadhera
olanzapine
Table of contents
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.
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 |
21
|
Date of issue of marketing authorisation valid throughout the European Union |
19/11/2008
|
Contact address |
Eli Lilly Nederland BV |
Product information
22/12/2021 Zypadhera - EMEA/H/C/000890 - N/0047
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
Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.