EMEA-000019-PIP08-12-M03

Key facts

Invented name
Votubia
Active substance
everolimus
Therapeutic area
Neurology
Decision number
P/0316/2017
PIP number
EMEA-000019-PIP08-12-M03
Pharmaceutical form(s)
  • Tablet
  • Dispersible tablet
Condition(s) / indication(s)
Treatment of tuberous sclerosis complex
Route(s) of administration
Oral use
Contact for public enquiries
Novartis Europharm Limited

Tel. +41 6132 41111
E-mail: paediatric.enquiries@novartis.com

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000019-PIP08-12-M03
Compliance opinion date
01/06/2018
Compliance outcome
positive

Decision

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