EMEA-003437-PIP01-23 - paediatric investigation plan
modified mRNA encoding human methylmalonyl-coenzyme A mutase containing a polymorphism at position 671 (mRNA-3705)
PIPHuman
Key facts
- Active Substance
- modified mRNA encoding human methylmalonyl-coenzyme A mutase containing a polymorphism at position 671 (mRNA-3705)
- Therapeutic area
- Endocrine disorders
- Decision number
- P/0540/2023
- PIP number
- EMEA-003437-PIP01-23
- Pharmaceutical form(s)
- Dispersion for injection
- Condition(s) / indication(s)
- Treatment of methylmalonic acidaemia
- Route(s) of administration
- Intravenous use
- Contact for public enquiries
Moderna Biotech Spain S.L.
E-mail: medinfo@modernatx.com
Tel: +1 6177146500- Decision type
- P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
- Decision date