EMEA-000876-PIP05-15-M05 - paediatric investigation plan

Eculizumab
PIPHuman

Key facts

Invented name
  • Soliris
  • Soliris
Active Substance
Eculizumab
Therapeutic area
Neurology
Decision number
P/0074/2022
PIP number
EMEA-000876-PIP05-15-M05
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of myasthenia gravis
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
Compliance procedure number
EMEA-C-000876-PIP05-15-M05
Compliance opinion date
Compliance outcome
Positive

Decision

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