GHRYVELIN (previously Macimorelin Aeterna Zentaris)
macimorelin
Table of contents
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.
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List item
GHRYVELIN (previously Macimorelin Aeterna Zentaris) : EPAR - Medicine overview (PDF/89.65 KB)
Adopted
First published: 26/02/2019
EMA/820056/2018 -
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List item
GHRYVELIN (previously Macimorelin Aeterna Zentaris) : EPAR - Risk-management-plan summary (PDF/56.95 KB)
First published: 26/02/2019
Authorisation details
Product details | |
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Name |
GHRYVELIN (previously Macimorelin Aeterna Zentaris)
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Agency product number |
EMEA/H/C/004660
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Active substance |
macimorelin acetate
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International non-proprietary name (INN) or common name |
macimorelin
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Therapeutic area (MeSH) |
Diagnostic Techniques, Endocrine
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Anatomical therapeutic chemical (ATC) code |
V04CD06
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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 | |
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Marketing-authorisation holder |
Consilient Health Limited
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Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
11/01/2019
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Contact address |
Consilient Health Limited
5th floor, Beaux Lane House Mercer Street Lower Dublin 2 IRELAND |
Product information
11/09/2023 GHRYVELIN (previously Macimorelin Aeterna Zentaris) - EMEA/H/C/004660 - T/0021
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
Therapeutic indication
This medicinal product is for diagnostic use only. GHRYVELIN is indicated for the diagnosis of growth hormone deficiency (GHD) in adults.