EMEA-001448-PIP01-13-M03

Key facts

Invented name
Spinraza
Active substance
Nusinersen
Therapeutic area
Neurology
Decision number
P/023/2018
PIP number
EMEA-001448-PIP01-13-M03
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of spinal muscular atrophy
Route(s) of administration
Intrathecal use
Contact for public enquiries
Biogen Idec Ltd
Tel. +44 1628501014
E-mail: pip.enquiries@biogenidec.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001448-PIP01-13-M03
Compliance opinion date
29/06/2018
Compliance outcome
positive

Decision

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