EMEA-000311-PIP03-11-M07 - paediatric investigation plan
ustekinumab
PIPHuman
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Key facts
- Invented name
- Stelara
- Active substance
- ustekinumab
- Therapeutic area
- Musculoskeletal and connective tissue disorders
- Decision number
- P/0370/2024
- PIP number
- EMEA-000311-PIP03-11-M07
- Pharmaceutical form(s)
- Solution for injection
- Concentrate for solution for infusion
- Condition(s) / indication(s)
- Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis)
- Route(s) of administration
- Subcutaneous use
- Intravenous use
- Contact for public enquiries
Janssen-Cilag International NV
E-mail: contact@janssen-emea.com
Tel.: +32 14602111- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Non