EMEA-002205-PIP01-17-M04 - paediatric investigation plan
Isatuximab
PIPHuman
Key facts
- Invented name
- Sarclisa
- Active Substance
- Isatuximab
- Therapeutic area
- Oncology
- Decision number
- P/0144/2023
- PIP number
- EMEA-002205-PIP01-17-M04
- Pharmaceutical form(s)
- Concentrate for solution for infusion
- Condition(s) / indication(s)
- Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
- Route(s) of administration
- Intravenous use
- Contact for public enquiries
Sanofi-Aventis Recherche & Développement
Tel. +33 169745695
E-mail: contact-us@sanofi.com- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance procedure number
- EMEA-C-002205-PIP01-17-M04
- Compliance opinion date
- Compliance outcome
- Positive