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
|
Route(s) of administration |
Subcutaneous use
|
Contact for public enquiries |
Shire Orphan Therapies GmbH
|
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
|