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EMA Product

Anagrelide Viatris (previously Anagrelide Mylan)

Product approved by European Medicines Agency (EU)

Basic Information

Anagrelide Viatris (previously Anagrelide Mylan)

Regulatory Information

EMEA/H/C/004585

Authorised

February 15, 2018

December 14, 2017

11

May 13, 2024

Company Information

Ireland

Damastown Industrial Park Mulhuddart Dublin 15

VIATRIS PHARMA LIMITED

Drug Classification

Generic Medicine

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Anagrelide Viatris is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy. An at-risk patient An at-risk essential thrombocythaemia patient is defined by one or more of the following features: • >60 years of age or • a platelet count >1,000 x 10⁹/l or • a history of thrombo-haemorrhagic events.

Overview Summary

This is a summary of the European public assessment report (EPAR) for Anagrelide Viatris (previously Anagrelide Mylan). It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Anagrelide Viatris. For practical information about using Anagrelide Viatris, patients should read the package leaflet or contact their doctor or pharmacist.

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