Anagrelide Mylan
anagrelide
Table of contents
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.
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List item
Anagrelide Mylan : EPAR - Summary for the public (PDF/92.78 KB)
First published: 27/02/2018
Last updated: 27/02/2018
EMA/8115/2018 -
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Anagrelide Mylan : EPAR - Risk management plan summary (PDF/97.06 KB)
First published: 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
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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 and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
Mylan Pharmaceuticals Limited
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Revision |
8
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Date of issue of marketing authorisation valid throughout the European Union |
15/02/2018
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Contact address |
Mylan Pharmaceuticals Limited |
Product information
28/04/2023 Anagrelide Mylan - EMEA/H/C/004585 - IB/0013
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.