Ecallantide (recombiant inhibitor of human plasma kallikrein)
PIPHuman
Key facts
Active Substance
Ecallantide (recombiant inhibitor of human plasma kallikrein)
Therapeutic area
Pneumology-allergology
Decision number
P/5/2011
PIP number
Ecallantide
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of hereditary angioedema
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Dyax s.a.
ndauteuil@dyax.com United States Phone: +1 6172505773 Fax: +1 6172252501
Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Decision
P/5/2011: EMA decision of 3 January 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ecallantide (Recombinant Inhibitor of Human Plasma Kallikrein), (EMEA-000688-PIP01-09-M01)