EMEA-000822-PIP01-09-M01

Key facts

Active substance
bucelipase alfa
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0092/2013
PIP number
EMEA-000822-PIP01-09-M01
Pharmaceutical form(s)
Powder for oral solution
Condition(s) / indication(s)
Prevention of growth retardation due to lack of bile-salt-stimulated lipase in enteral nutrition
Route(s) of administration
Oral use
Contact for public enquiries
Swedish Orphan Biovitrum AB
E-mail: communication@sobi.com
Country: Sweden
Tel. +46 86972000
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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