Anagrelide Mylan

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anagrelide

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 27/02/2018

Authorisation details

Product details
Name
Anagrelide Mylan
Agency product number
EMEA/H/C/004585
Active substance
Anagrelide hydrochloride
International non-proprietary name (INN) or common name
anagrelide
Therapeutic area (MeSH)
Thrombocythemia, Essential
Anatomical therapeutic chemical (ATC) code
L01XX35
Generic

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.

Publication details
Marketing-authorisation holder
Mylan S.A.S.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
15/02/2018
Contact address
117 Allee des Parcs
69800 Saint-Priest
France

Product information

15/02/2018 Anagrelide Mylan - EMEA/H/C/004585 - -

Contents

  • 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.

Pharmacotherapeutic group

ANTINEOPLASTIC AGENTS

Therapeutic indication

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.

Assessment history

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