EMA — authorised 11 January 2019
- Marketing authorisation holder: AETERNA ZENTARIS GMBH
- Status: approved
🇪🇺 Macrilen in European Union
EMA authorised Macrilen on 11 January 2019
Marketing authorisations
EMA — authorised 11 January 2019
- Application: EMEA/H/C/004660
- Marketing authorisation holder: Atnahs Pharma Netherlands B.V.
- Local brand name: Ghryvelin (previously Macimorelin Aeterna Zentaris)
- Indication: This medicinal product is for diagnostic use only. GHRYVELIN is indicated for the diagnosis of growth hormone deficiency (GHD) in adults.
- Status: approved
Macrilen in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in European Union
Frequently asked questions
Is Macrilen approved in European Union?
Yes. EMA authorised it on 11 January 2019; EMA authorised it on 11 January 2019.
Who is the marketing authorisation holder for Macrilen in European Union?
AETERNA ZENTARIS GMBH holds the EU marketing authorisation.