This is a summary of the European public assessment report (EPAR) for 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 Mylan.
For practical information about using Anagrelide Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Anagrelide Mylan : EPAR - Summary for the public (PDF/92.78 KB)
First published: 27/02/2018
Last updated: 27/02/2018
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic medicines.
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15/02/2018 Anagrelide Mylan - EMEA/H/C/004585 - -
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Anagrelide 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 an history of thrombo-haemorrhagic events.