EMEA-000019-PIP02-07-M05

Key facts

Invented name
Votubia
Active substance
everolimus
Therapeutic area
Neurology
Decision number
P/0003/2014
PIP number
EMEA-000019-PIP02-07-M05
Pharmaceutical form(s)
  • Tablet
  • dispersible tablet
Condition(s) / indication(s)
  • Treatment of subependymal giant-cell astrocytoma
  • Treatment of angiomyolipoma
Route(s) of administration
Oral use
Contact for public enquiries
Novartis Europharm Ltd
United Kingdom
E-mail: paediatric.enquiries@novartis.com
Tel. +41 61 324 1111
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000019-PIP02-07-M05
Compliance opinion date
29/01/2016
Compliance outcome
positive

Decision

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