Revolade

eltrombopag

Opinion

After re-examining its initial opinion, the European Medicines Agency has confirmed its recommendation to refuse a change to the marketing authorisation for the medicine Revolade. The change concerned an extension of indication to add treatment of previously untreated patients with severe aplastic anaemia from 12 years of age who cannot have stem cell transplantation (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor).

The Agency issued this opinion on 17 October 2019, after concluding the re-examination. The Agency had issued its initial opinion on 27 June 2019. The company that applied for the change to the authorisation was Novartis Europharm Limited.

Key facts

Name
Revolade
Agency product number
EMEA/H/C/001110
International non-proprietary name (INN) or common name
  • eltrombopag
Active substance
  • Eltrombopag olamine
Therapeutic area
Purpura, Thrombocytopenic, Idiopathic
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
17/10/2019
Company name
Novartis Europharm Limited
Status
Negative
Application type
Post-authorisation

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