EMEA-000876-PIP03-14-M06 - paediatric investigation plan

Eculizumab
PIP Human

Key facts

Invented name
Soliris
Active substance
Eculizumab
Therapeutic area
Neurology
Decision number
P/0124/2023
PIP number
EMEA-000876-PIP03-14-M06
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 147103621

Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date
Compliance check done
No

Decision

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