EMEA-001362-PIP01-12-M03

Key facts

Active substance
cerliponase alfa
Therapeutic area
Neurology
Decision number
P/0248/2016
PIP number
EMEA-001362-PIP01-12-M03
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of Neuronal Ceroid Lipofuscinosis type 2
Route(s) of administration
Intracerebral use
Contact for public enquiries
BioMarin International Limited
Ireland
Tel. +44 2074200800
Fax +44 2074200829
E-mail: biomarin-europe@bmrn.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001362-PIP01-12-M03
Compliance opinion date
26/02/2021
Compliance outcome
positive

Decision

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