Macimorelin Aeterna Zentaris
macimorelin
Table of contents
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.
-
List item
Macimorelin Aeterna Zentaris : EPAR - Medicine overview (PDF/89.65 KB)
Adopted
First published: 26/02/2019
EMA/820056/2018 -
-
List item
Macimorelin Aeterna Zentaris : EPAR - Risk-management-plan summary (PDF/56.95 KB)
First published: 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 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
|
Revision |
1
|
Date of issue of marketing authorisation valid throughout the European Union |
11/01/2019
|
Contact address |
Product information
Macimorelin Aeterna Zentaris - EMEA/H/C/004660 -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
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.