EMEA-000645-PIP01-09-M09 - paediatric investigation plan
vedolizumab
PIPHuman
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Key facts
- Invented name
- Entyvio
- Active substance
- vedolizumab
- Therapeutic area
- Gastrointestinal disorders
- Decision number
- P/0244/2024
- PIP number
- EMEA-000645-PIP01-09-M09
- Pharmaceutical form(s)
- Powder for concentrate for solution for infusion
- Solution for injection
- Condition(s) / indication(s)
- Treatment of Crohn's disease
- Treatment of ulcerative colitis
- Route(s) of administration
- Intravenous use
- Subcutaneous use
- Contact for public enquiries
Takeda Pharma A/S
Tel. +44 2031168000
E-mail: paediatrics@tgrd.com- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Não