EMEA-001918-PIP01-15-M02

Key facts

Active substance
Balovaptan
Therapeutic area
Neurology
Decision number
P/0247/2019
PIP number
EMEA-001918-PIP01-15-M02
Pharmaceutical form(s)
Dispersible tablet
Condition(s) / indication(s)
Treatment of autism spectrum disorder
Route(s) of administration
Oral use
Contact for public enquiries
Roche Registration GmbH

Tel. +41 616879411
E-mail: info.paediatrics@roche.com

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

Decision

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