EMEA-001331-PIP01-12-M02
Key facts
| Active substance |
sebelipase alfa
|
| Therapeutic area |
Gastroentology-Hepatology
|
| Decision number |
P/0173/2015
|
| PIP number |
EMEA-001331-PIP01-12-M02
|
| Pharmaceutical form(s) |
Concentrate for solution for infusion
|
| Condition(s) / indication(s) |
Treatment of lysosomal acid-lipase deficiency
|
| 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-C-001331-PIP01-12-M02
|
| Compliance opinion date |
01/03/2019
|
| Compliance outcome |
positive
|