EMA/PE/0000183462 - paediatric investigation plan
autologous regulatory T lymphocytes CD3+ CD4+ CD25+ CD127- FoxP3+, ex-vivo expanded (PolTreg-T1D)
PIPHuman
Romanian is available via eTranslation, the European Commission's machine translation service.
Translate to Romanian | Important information about machine translation
Key facts
- Active substance
- autologous regulatory T lymphocytes CD3+ CD4+ CD25+ CD127- FoxP3+, ex-vivo expanded (PolTreg-T1D)
- Therapeutic area
- Immune system disorders
- Decision number
- EMA/PE/0000183462
- PIP number
- EMA/PE/0000183462
- Pharmaceutical form(s)
- Suspension for injection
- Condition(s) / indication(s)
- Prevention of stage 3 type 1 diabetes mellitus
- Route(s) of administration
- Intravenous use
- Contact for public enquiries
PolTreg SA
E-mail: office@poltreg.tech
Tel.: +48 512532401- Decision type
- P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
- Decision date
- Compliance check done
- Nu