Macimorelin Aeterna Zentaris

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macimorelin

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

Overview

Macimorelin Aeterna Zentaris is a medicine used to test the ability of the body to produce growth hormone. It is used by doctors to diagnose growth hormone deficiency, a condition where the patient does not have enough growth hormone. It is not used to treat patients with the condition.

Macimorelin Aeterna Zentaris contains the active substance macimorelin.

This EPAR was last updated on 26/02/2019

Authorisation details

Product details
Name
Macimorelin Aeterna Zentaris
Agency product number
EMEA/H/C/004660
Active substance
macimorelin acetate
International non-proprietary name (INN) or common name
macimorelin
Therapeutic area (MeSH)
Diagnostic Techniques, Endocrine
Anatomical therapeutic chemical (ATC) code
V04CD06
Additional monitoringAdditional 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
Aeterna Zentaris GmbH
Date of issue of marketing authorisation valid throughout the European Union
11/01/2019
Contact address

Weismullerstrasse 50
60314 Frankfurt am Main
Germany

Product information

Macimorelin Aeterna Zentaris - EMEA/H/C/004660 -

Contents

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Pharmacotherapeutic group

macimorelin

Therapeutic indication

This medicinal product is for diagnostic use only.Macimorelin Aeterna Zentaris is indicated for the diagnosis of growth hormone deficiency (GHD) in adults.

Assessment history

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