EMEA-000872-PIP01-10-M03

Key facts

Invented name
HyQvia
Active substance
Human normal immunoglobulin
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0186/2015
PIP number
EMEA-000872-PIP01-10-M03
Pharmaceutical form(s)
Solution for infusion
Condition(s) / indication(s)
Treatment of primary immunodeficiency (PID) as model for replacement therapy
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Baxalta Innovations GmbH
Austria
Tel. +43 1201 000
Fax +43 1201 002 475990
E-mail: europa_biosci_globalra@baxter.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000872-PIP01-10-M03
Compliance opinion date
30/10/2015
Compliance outcome
positive

Decision

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