Anagrelide Mylan

anagrelide

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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.

What is Anagrelide Mylan and what is it used for?

Anagrelide Mylan is a medicine used to reduce the number of platelets (components that help the blood to clot) in patients with essential thrombocythaemia (a disease in which there are too many platelets circulating in the blood). ‘Essential’ means that the disease has no obvious cause.

Anagrelide Mylan is used when the patient’s current treatment does not work well enough or has unacceptable side effects, and when they are ‘at risk’ because of their age (over 60 years), very high platelet counts or previous clotting problems.

Anagrelide Mylan contains the active substance anagrelide and is a ‘generic medicine’. This means that Anagrelide Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Xagrid. Anagrelide Mylan is also a ‘hybrid medicine’ because it is available in an additional strength.

How is Anagrelide Mylan used?

Anagrelide Mylan can only be obtained with a prescription. Treatment should only be started by a doctor who has experience in treating essential thrombocythaemia.

Anagrelide Mylan is available as capsules (0.5  and 1 mg). The recommended starting dose is one
0.5 mg capsule twice a day. After a week, the dose is increased every week by 0.5 mg a day, until the platelet count is below 600 million platelets per millilitre, and ideally between 150 and 400 million/ml (the level usually seen in healthy people). Results are normally seen within 2 or 3 weeks of starting treatment.

The maximum recommended dose of Anagrelide Mylan is 2.5 mg at a time.

How does Anagrelide Mylan work?

Essential thrombocythaemia is a disease in which the bone marrow produces too many platelets. This puts the patient at risk of developing blood clots or bleeding problems. The active substance in Anagrelide Mylan, anagrelide, blocks the development and growth of cells in the bone marrow called ‘megakaryocytes’, which produce platelets. This reduces the platelet count, helping to improve symptoms in patients with the disease.

How has Anagrelide Mylan been studied?

Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Xagrid, and do not need to be repeated for Anagrelide Mylan.

As for every medicine, the company provided studies on the quality of Anagrelide Mylan. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Anagrelide Mylan?

Because Anagrelide Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Anagrelide Mylan approved?

The European Medicines Agency concluded that, in accordance with EU requirements, Anagrelide Mylan has been shown to have comparable quality and to be bioequivalent to Xagrid. Therefore, the Agency’s view was that, as for Xagrid, the benefit outweighs the identified risk. The Agency recommended that Anagrelide Mylan be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Anagrelide Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Anagrelide Mylan have been included in the summary of product characteristics and the package leaflet.

Other information about Anagrelide Mylan

The European Commission granted a marketing authorisation valid throughout the European Union for Anagrelide Mylan on 15 February 2018.

For more information about treatment with Anagrelide Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Anagrelide Mylan : EPAR - Summary for the public BG = bălgarski 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public ES = español 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public CS = čeština 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public DA = dansk 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public DE = Deutsch 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public ET = eesti keel 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public EL = elliniká 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public EN = English 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public FR = français 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public IT = italiano 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public LV = latviešu valoda 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public LT = lietuvių kalba 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public HU = magyar 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public MT = Malti 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public NL = Nederlands 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public PL = polski 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public PT = português 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public RO = română 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public SK = slovenčina 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public SL = slovenščina 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public FI = suomi 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public SV = svenska 2018-02-27  
Anagrelide Mylan : EPAR - Summary for the public HR = Hrvatski 2018-02-27  

This EPAR was last updated on 27/02/2018 .

Authorisation details

Product details

Product details for Anagrelide Mylan
NameAnagrelide Mylan
Agency product numberEMEA/H/C/004585
Active substance

anagrelide hydrochloride

International non-proprietary name (INN) or common name

anagrelide

Therapeutic area Thrombocythemia, Essential
Anatomical therapeutic chemical (ATC) code L01XX35
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Anagrelide Mylan
Marketing-authorisation holder

Mylan S.A.S.

Revision0
Date of issue of marketing authorisation valid throughout the European Union15/02/2018

Contact address:

Mylan S.A.S.
117 Allee des Parcs
69800 Saint-Priest
France

Product information

Product information

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

Name Language First published Last updated
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - Product Information HR = Hrvatski 2018-02-27  

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.


Name Language First published Last updated
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  
Anagrelide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-27  

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

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Anagrelide Mylan : EPAR - Public assessment report HR = Hrvatski 2018-02-27  
CHMP summary of positive opinion for Anagrelide Mylan HR = Hrvatski 2017-12-15  

Authorised

This medicine is approved for use in the European Union

More information on Anagrelide Mylan