EMEA-001988-PIP01-16-M02 - paediatric investigation plan
macimorelin
PIPHuman
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Key facts
- Invented name
- Ghryvelin (previously Macimorelin Aeterna Zentaris)
- Active substance
- macimorelin
- Therapeutic area
- Endocrine disorders
- Decision number
- P/0331/2024
- PIP number
- EMEA-001988-PIP01-16-M02
- Pharmaceutical form(s)
- Granules for oral solution
- Condition(s) / indication(s)
- Diagnosis of growth hormone deficiency
- Route(s) of administration
- Oral use
- Contact for public enquiries
Atnahs Pharma Netherlands B.V.
E-mail: nammer@aezsinc.com
Tel.:+49 69426023228- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Ne