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
|