EMEA-002397-PIP01-18-M01

Table of contents

Key facts

Invented name
Kesimpta
Active substance
ofatumumab
Therapeutic area
Neurology
Decision number
P/0042/2021
PIP number
EMEA-002397-PIP01-18-M01
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of multiple sclerosis
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Novartis Europharm Limited

E-mail: paediatric.enquiries@novartis.com
Tel. +41 613246715

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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