EMEA-000876-PIP02-11-M01

Key facts

Invented name
Soliris
Active substance
Eculizumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0306/2012
PIP number
EMEA-000876-PIP02-11-M01
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of Shiga-toxin-producing Escherichia coli haemolytic uraemic syndrome
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
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-000876-PIP01-10-M01
Compliance opinion date
02/06/2015
Compliance outcome
positive

Decision

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