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 11/05/2023

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
GenericGeneric

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 and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan Pharmaceuticals Limited
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
15/02/2018
Contact address

Mylan Pharmaceuticals Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland

Product information

28/04/2023 Anagrelide Mylan - EMEA/H/C/004585 - IB/0013

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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
  • a history of thrombo-haemorrhagic events.
     

Assessment history

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