EMEA-002198-PIP01-21-M01 - paediatric investigation plan
Alisitol
Retinyl Palmitate
zinc gluconate
PIPHuman
Key facts
- Active Substance
- Alisitol
- Retinyl Palmitate
- zinc gluconate
- Therapeutic area
- Gastrointestinal disorders
- Decision number
- P/0511/2023
- PIP number
- EMEA-002198-PIP01-21-M01
- Pharmaceutical form(s)
- Age-appropriate oral liquid dosage form
- Condition(s) / indication(s)
- Treatment of microvillus inclusion disease
- Route(s) of administration
- Oral use
- Contact for public enquiries
Vanessa Research Magyarorszag Kft/Vanessa Research Hungary ltd
Email: vrregulatory@vanessaresearch.com
Tel. +1 2038368424 x 114- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date