GHRYVELIN (previously Macimorelin Aeterna Zentaris)

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macimorelin

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

Overview

GHRYVELIN  (previously 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.

GHRYVELIN contains the active substance macimorelin.

This EPAR was last updated on 25/11/2021

Authorisation details

Product details
Name
GHRYVELIN (previously 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
Consilient Health Limited
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
11/01/2019
Contact address
Consilient Health Limited
5th floor, Beaux Lane House
Mercer Street Lower
Dublin 2
IRELAND

Product information

16/11/2021 GHRYVELIN (previously Macimorelin Aeterna Zentaris) - EMEA/H/C/004660 - IAIN/0016

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

macimorelin

Therapeutic indication

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

Assessment history

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