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Questions & Answers

On 9 November 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Nplate. The marketing authorisation holder for this medicinal product is Amgen Europe B.V.

The CHMP adopted an extension to the existing indication as follows1:

"Nplate is indicated for adult  chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1)."

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission. 

1 New text in bold

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Nplate (English only) 2017-11-10  

Key facts

Product details for Nplate
INN or common name


Therapeutic area Purpura, Thrombocytopenic, Idiopathic
Active substance


Date opinion adopted09/11/2017
Company name

Amgen Europe B.V.

Application typePost authorisation