EMEA-001331-PIP01-12-M02

Table of contents

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
France
E-mail: pip.enquiries.eu@alxn.com 
Tel. +33 1 47 10 06 06
Fax +33 1 47 10 06 11
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

Decision

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