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
|