Ghryvelin (previously Macimorelin Aeterna Zentaris) (macimorelin)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- macimorelin
- Company
- Atnahs Pharma Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Diagnostic Techniques, Endocrine
- CHMP opinion
- Thu 15 Nov 2018
- EU approval
- Fri 11 Jan 2019
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004660
- ATC
- V04CD06
- Official record
- www.ema.europa.eu
Indication
This medicinal product is for diagnostic use only. GHRYVELIN is indicated for the diagnosis of growth hormone deficiency (GHD) in adults.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.