EMEA-002205-PIP02-23 - paediatric investigation plan
Isatuximab
PIPHuman
Key facts
- Invented name
- Sarclisa
- Active Substance
- Isatuximab
- Therapeutic area
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Decision number
- P/0049/2024
- PIP number
- EMEA-002205-PIP02-23
- Pharmaceutical form(s)
- Solution for injection
- Condition(s) / indication(s)
- Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
- Route(s) of administration
- Subcutaneous use
- Contact for public enquiries
Sanofi Winthrop Industrie
E-mail: contact-us@sanofi.com
Tel: +33 1 69 74 56 95- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date