EMEA-001794-PIP02-16-M09 - paediatric investigation plan
vamorolone
PIPHuman
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Key facts
- Invented name
- Agamree
- Active substance
- vamorolone
- Therapeutic area
- Congenital, familial and genetic disorders
- Decision number
- P/0355/2024
- PIP number
- EMEA-001794-PIP02-16-M09
- Pharmaceutical form(s)
- Oral suspension
- Condition(s) / indication(s)
- Treatment of Duchenne muscular dystrophy
- Route(s) of administration
- Oral use
- Contact for public enquiries
Santhera Pharmaceuticals (Deutschland) GmbH
E-mail: office@santhera.com
Tel.: +49 76211690200- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Nej