EMEA-001110-PIP01-10-M01

Key facts

Active substance
Human normal immunoglobulin
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0138/2012
PIP number
EMEA-001110-PIP01-10-M01
Pharmaceutical form(s)
Solution for infusion
Condition(s) / indication(s)
  • Treatment of chronic inflammatory demyelinating polyradiculo-neuropathy
  • Treatment of idiopathic thrombocytopenic purpura as a model for immunomodulation
  • Treatment of primary immunodeficiency (PID) as model for replacement therapy
Route(s) of administration
Intravenous use
Contact for public enquiries
Octapharma Pharmazeutika Produktionsges.m.b.H
wolfgang.frenzel@octapharma.com
Austria
+ 43 1610321201 
+ 43 1610329249
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001110-PIP01-10-M01
Compliance opinion date
11/10/2013
Compliance outcome
positive

Decision

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