Key facts

Invented name
Soliris
Active Substance
Eculizumab
Therapeutic area
Neurology
Decision number
P/0514/2020
PIP number
EMEA-000876-PIP03-14-M05
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of neuromyelitis optica spectrum disorders
Route(s) of administration
Intravenous use
Contact for public enquiries

Alexion Europe SAS

E-mail: pip.enquiries.eu@alexion.com
Tel: +33 147100615

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0514/2020 : EMA decision of 22 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for eculizumab (Soliris) (EMEA-000876-PIP03-14-M05)

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