EMEA-002796-PIP01-20-M02 - paediatric investigation plan
acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid) (IB1001)
PIPHuman
Key facts
- Active Substance
- acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid) (IB1001)
- Therapeutic area
- Neurology
- Decision number
- P/0043/2024
- PIP number
- EMEA-002796-PIP01-20-M02
- Pharmaceutical form(s)
- Age-appropriate oral liquid dosage form
- Condition(s) / indication(s)
- Treatment of Niemann-Pick disease, type C
- Route(s) of administration
- Oral use
- Contact for public enquiries
IntraBio Ltd.
E-mail: info@intrabio.com
Tel.: +44 (0)7426 956368- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date