Duloxetine Mylan

duloxetine

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This is a summary of the European public assessment report (EPAR) for Duloxetine 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 Duloxetine Mylan.

For practical information about using Duloxetine Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

What is Duloxetine Mylan and what is it used for?

Duloxetine Mylan is used to treat adults with the following diseases:

  • major depression;
  • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
  • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).

Duloxetine Mylan contains the active substance duloxetine and is a ‘generic medicine’. This means that Duloxetine Mylan is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Cymbalta.

How is Duloxetine Mylan used?

Duloxetine Mylan is available as gastroresistant capsules (30 and 60 mg). ‘Gastroresistant’ means that the capsules’ contents pass through the stomach without being broken down until they reach the intestine. This prevents the active substance being destroyed by the acid in the stomach. The medicine can only be obtained with a prescription.

For major depression, the recommended dose of Duloxetine Mylan is 60 mg once a day. A response is usually seen in two to four weeks. In patients who respond to Duloxetine Mylan, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.

For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of 120 mg per day. The response to treatment should be assessed regularly.

For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient’s response. Most patients will need to take 60 mg per day. Patients who also have major depression should start with 60 mg once a day. In patients who respond to Duloxetine Mylan, treatment should continue for several months, to prevent the disorder coming back.

The dose of Duloxetine Mylan should be reduced gradually when stopping treatment.

How does Duloxetine Mylan work?

The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor. It works by preventing the neurotransmitters serotonin (5-hydroxytryptamine) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.

Neurotransmitters are chemicals that allow nerve cells to communicate with one another. By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells. Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.

How has Duloxetine Mylan been studied?

Because Duloxetine Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Cymbalta. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Duloxetine Mylan?

Because Duloxetine Mylan is a generic medicine of Cymbalta, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Duloxetine Mylan approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Duloxetine Mylan has been shown to have comparable quality and to be bioequivalent to Cymbalta. Therefore, the CHMP’s view was that, as for Cymbalta, the benefit outweighs the identified risk. The Committee recommended that Duloxetine Mylan be approved for use in the EU.

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

A risk management plan has been developed to ensure that Duloxetine Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duloxetine Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Duloxetine Mylan

The European Commission granted a marketing authorisation valid throughout the European Union for Duloxetine Mylan on 19 June 2015.

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

Name Language First published Last updated
Duloxetine Mylan : EPAR - Summary for the public BG = bălgarski 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public ES = español 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public CS = čeština 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public DA = dansk 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public DE = Deutsch 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public ET = eesti keel 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public EL = elliniká 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public EN = English 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public FR = français 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public IT = italiano 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public LV = latviešu valoda 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public LT = lietuvių kalba 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public HU = magyar 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public MT = Malti 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public NL = Nederlands 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public PL = polski 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public PT = português 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public RO = română 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public SK = slovenčina 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public SL = slovenščina 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public FI = suomi 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public SV = svenska 2015-06-24  
Duloxetine Mylan : EPAR - Summary for the public HR = Hrvatski 2015-06-24  
Name Language First published Last updated
Duloxetine Mylan : EPAR - Risk-management-plan summary (English only) 2015-06-24  

This EPAR was last updated on 24/10/2016 .

Authorisation details

Product details

Product details for Duloxetine Mylan
NameDuloxetine Mylan
Agency product numberEMEA/H/C/003981
Active substance

duloxetine

International non-proprietary name (INN) or common name

duloxetine

Therapeutic area Depressive Disorder, MajorDiabetic NeuropathiesAnxiety DisordersNeuralgia
Anatomical therapeutic chemical (ATC) code N06AX21
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 Duloxetine Mylan
Marketing-authorisation holder

Generics (UK) Limited

Revision4
Date of issue of marketing authorisation valid throughout the European Union19/06/2015

Contact address:

Generics (UK) Limited
Station Close 
Potters Bar 
Hertfordshire 
EN6 1TL 
United Kingdom

Product information

Product information

21/09/2016  Duloxetine Mylan -EMEA/H/C/003981 -IB/0008

Name Language First published Last updated
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24
Duloxetine Mylan : EPAR - Product Information EN = English 2015-06-24 2016-10-24

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
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21
Duloxetine Mylan : EPAR - All Authorised presentations EN = English 2016-03-22 2016-10-21

Pharmacotherapeutic group

Psychoanaleptics

Therapeutic indication

  • Treatment of major depressive disorder;
  • Treatment of diabetic peripheral neuropathic pain;
  • Treatment of generalised anxiety disorder;
  • Duloxetine Myl++an is indicated in adults.

For further information see section 5.1.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Duloxetine Mylan : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2015-01-12 2016-10-24

Initial marketing-authorisation documents

Name Language First published Last updated
Duloxetine Mylan : EPAR - Public assessment report EN = English 2015-06-24  
CHMP summary of positive opinion for Duloxetine Mylan EN = English 2015-04-24  

Authorised

This medicine is approved for use in the European Union

More information on Duloxetine Mylan