EMEA-000876-PIP05-15-M05
Key facts
| Invented name |
Soliris
|
| Active substance |
Eculizumab
|
| Therapeutic area |
Neurology
|
| Decision number |
P/0074/2022
|
| PIP number |
EMEA-000876-PIP05-15-M05
|
| Pharmaceutical form(s) |
Concentrate for solution for infusion
|
| Condition(s) / indication(s) |
Treatment of myasthenia gravis
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Alexion Europe SAS
Tel. +33 147100615 E-mail: pip.enquiries.eu@alexion.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000876-PIP05-15-M05
|
| Compliance opinion date |
14/10/2022
|
| Compliance outcome |
positive
|