EMEA-002152-PIP03-19 - paediatric investigation plan
daratumumab
PIPHuman
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Key facts
- Invented name
- Darzalex
- Active substance
- daratumumab
- Therapeutic area
- Oncology
- Decision number
- P/0116/2020
- PIP number
- EMEA-002152-PIP03-19
- Pharmaceutical form(s)
- Concentrate for solution for infusion
- Solution for injection
- Condition(s) / indication(s)
- Treatment of systemic light chain amyloidosis
- Route(s) of administration
- Intravenous use
- Subcutaneous use
- Contact for public enquiries
Janssen-Cilag International N.V.
E-mail: nreymond@its.jnj.com
Tel.: +31 14641125- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date
- Compliance check done
- Nej