EMEA-000408-PIP01-08-M05

Key facts

Invented name
Firazyr
Active substance
icatibant acetate
Therapeutic area
Other
Decision number
P/0243/2015
PIP number
EMEA-000408-PIP01-08-M05
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of hereditary angioedema (HAE)
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Shire Orphan Therapies GmbH
Switzerland
Tel. +43 1 20100 2471359
E-mail: magdalena.toro-cortes@shire.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000408-PIP01-08-M05
Compliance opinion date
19/08/2016
Compliance outcome
positive

Decision

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