EMEA-000876-PIP02-11-M01
Key facts
| Invented name |
Soliris
|
| Active substance |
Eculizumab
|
| Therapeutic area |
Immunology-Rheumatology-Transplantation
|
| Decision number |
P/0306/2012
|
| PIP number |
EMEA-000876-PIP02-11-M01
|
| Pharmaceutical form(s) |
Concentrate for solution for infusion
|
| Condition(s) / indication(s) |
Treatment of Shiga-toxin-producing Escherichia coli haemolytic uraemic syndrome
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Alexion Europe SAS
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-000876-PIP01-10-M01
|
| Compliance opinion date |
02/06/2015
|
| Compliance outcome |
positive
|