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NPLATE (romiplostim), thrombopoietin receptor agonists

HAEMATOLOGY - New indication
Opinions on drugs - Posted on Jun 28 2017

Reason for request

Extension of indication

Minor improvement in chronic autoimmune thrombocytopaenic purpura when usual treatments have failed, in non-splenectomised adults with no contraindication to surgery

  

  • Prior to the extension of the Marketing Authorisation of NPLATE and REVOLADE in non-splenectomised adults with no contraindication to surgery, these medicinal products were a treatment for chronic (idiopathic) autoimmune thrombocytopaenic purpura (ITP) in adults where the usual treatments have failed in refractory splenectomised patients and in non-splenectomised adults in case of contraindication to surgery.
  • Now their use in pre-splenectomy has been validated by Marketing Authorisation. However, they must be used with caution given the uncertainties about long-term safety, as well as in non-splenectomised patients.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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Therapeutic use

-

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