EMEA-000876-PIP07-15 - paediatric investigation plan

Eculizumab
PIPHuman

Key facts

Invented name
  • Soliris
  • Soliris
Active Substance
Eculizumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0229/2016
PIP number
EMEA-000876-PIP07-15
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Prevention of delayed graft function after solid organ transplantation
Route(s) of administration
Intravenous use
Contact for public enquiries

Alexion Europe SAS

France
E-mail: pip.enquiries.eu@alxn.com 
Tel. +33 1 47 10 06 06
Fax +33 1 47 10 06 11

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date

Decision

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