EMEA-000170-PIP01-07-M04

Key facts

Invented name
Revolade
Active substance
Eltrombopag
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0167/2016
PIP number
EMEA-000170-PIP01-07-M04
Pharmaceutical form(s)
  • Powder for oral suspension
  • Film-coated tablet
Condition(s) / indication(s)
Treatment of Idiopathic Thrombocytopenia Purpura (ITP)
Route(s) of administration
Oral use
Contact for public enquiries
Novartis Europharm Limited
United Kingdom
Tel. +41 613241111
E-mail: paediatric.enquiries@novartis.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000170-PIP01-07-M03
Compliance opinion date
14/11/2014
Compliance outcome
positive

Decision

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