Betmiga

mirabegron

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This is a summary of the European public assessment report (EPAR) for Betmiga. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Betmiga.

What is Betmiga?

Betmiga is a medicine containing the active substance mirabegron. It is available as prolonged-release tablets (25 mg, 50 mg). ‘Prolonged-release’ means that mirabegron is released slowly from the tablet over a few hours.

What is Betmiga used for?

Betmiga is used in adults with overactive bladder syndrome. It is used to treat certain symptoms of the condition: urgency (sudden urge to urinate), increased urinary frequency (the need to urinate frequently) and urge incontinence (involuntary leakage of urine from the bladder when a sudden strong need to urinate is felt).

The medicine can only be obtained with a prescription.

How is Betmiga used?

The recommended dose of Betmiga is 50 mg once a day. In patients who have reduced kidney or liver function the doctor may need to prescribe a lower dose or avoid the use of Betmiga, especially in patients taking certain other medicines.

For full details, see the package leaflet (also part of the EPAR).

How does Betmiga work?

The active substance in Betmiga, mirabegron, is a beta-3-adrenergic-receptor agonist. It works by attaching to and activating beta-3 receptors that are found in the muscle cells of the bladder. 

Experimental studies have shown that, when activated, beta-3 receptors cause the bladder muscles to relax. This is thought to lead to an increase in the capacity of the bladder and changes in the way the bladder contracts, resulting in fewer bladder contractions and thus fewer unwanted urinations.

How has Betmiga been studied?

The effects of Betmiga were first tested in experimental models before being studied in humans.

Betmiga has been studied in three main studies involving 4,611 patients with overactive bladder syndrome. Patients received Betmiga (25 mg, 50 mg or 100 mg) or placebo (a dummy treatment) every day for three months. The main measure of effectiveness was the change in the number of urinations and incontinence episodes per day after three months of treatment.

What benefit has Betmiga shown during the studies?

Treatment with 50 mg a day of Betmiga was shown to be effective in reducing the number of urination and incontinence episodes. After three months of treatment, on average Betmiga 50 mg reduced the number of urinations by 1.8 per day compared with a reduction of 1.2 per day for placebo. Betmiga 50 mg resulted in a reduction of 1.5 incontinence episodes per day compared with a reduction of 1.1 incontinence episodes per day for placebo.

What is the risk associated with Betmiga?

The most common side effects with Betmiga are tachycardia (rapid heartbeat) seen in just over 1 person in 100, and urinary tract infection (infection of the structures that carry urine) seen in just under 3 people in 100. Serious but uncommon side effects include atrial fibrillation (cardiac rhythm disorder). For the full list of all side effects reported with Betmiga, see the package leaflet.

Betmiga must not be used in people who are hypersensitive (allergic) to mirabegron or any of the other ingredients.

Why has Betmiga been approved?

The CHMP noted that the beneficial effects seen with Betmiga were modest but comparable to the benefits of other medicines authorised for this condition. 

Regarding its safety, most side effects are comparable to those of other medicines used for treating overactive bladder syndrome. The potential risk of hypersensitivity (allergic reactions) and effects on the heart has been adequately addressed in the product information. The CHMP therefore decided that Betmiga’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Betmiga

The European Commission granted a marketing authorisation valid throughout the European Union for Betmiga on 20 December 2012.

Name Language First published Last updated
Betmiga : EPAR - Summary for the public BG = bălgarski 15/01/2013  
Betmiga : EPAR - Summary for the public ES = español 15/01/2013  
Betmiga : EPAR - Summary for the public CS = čeština 15/01/2013  
Betmiga : EPAR - Summary for the public DA = dansk 15/01/2013  
Betmiga : EPAR - Summary for the public DE = Deutsch 15/01/2013  
Betmiga : EPAR - Summary for the public ET = eesti keel 15/01/2013  
Betmiga : EPAR - Summary for the public EL = elliniká 15/01/2013  
Betmiga : EPAR - Summary for the public EN = English 15/01/2013  
Betmiga : EPAR - Summary for the public FR = français 15/01/2013  
Betmiga : EPAR - Summary for the public IT = italiano 15/01/2013  
Betmiga : EPAR - Summary for the public LV = latviešu valoda 15/01/2013  
Betmiga : EPAR - Summary for the public LT = lietuvių kalba 15/01/2013  
Betmiga : EPAR - Summary for the public HU = magyar 15/01/2013  
Betmiga : EPAR - Summary for the public MT = Malti 15/01/2013  
Betmiga : EPAR - Summary for the public NL = Nederlands 15/01/2013  
Betmiga : EPAR - Summary for the public PL = polski 15/01/2013  
Betmiga : EPAR - Summary for the public PT = português 15/01/2013  
Betmiga : EPAR - Summary for the public RO = română 15/01/2013  
Betmiga : EPAR - Summary for the public SK = slovenčina 15/01/2013  
Betmiga : EPAR - Summary for the public SL = slovenščina 15/01/2013  
Betmiga : EPAR - Summary for the public FI = suomi 15/01/2013  
Betmiga : EPAR - Summary for the public SV = svenska 15/01/2013  

This EPAR was last updated on 26/02/2014 .

Authorisation details

Product details

Product details for Betmiga
NameBetmiga
Agency product numberEMEA/H/C/002388
Active substance

mirabegron

International non-proprietary name (INN) or common name

mirabegron

Therapeutic area Urinary Bladder, Overactive
Anatomical therapeutic chemical (ATC) code G04BD12
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Betmiga
Marketing-authorisation holder

Astellas Pharma Europe B.V.

Revision2
Date of issue of marketing authorisation valid throughout the European Union20/12/2012

Contact address:

Astellas Pharma Europe B.V.
Sylviusweg 622333
BE Leiden
The Netherlands

Product information

Product information

05/02/2014  Betmiga -EMEA/H/C/002388 -IA/0010/G

Name Language First published Last updated
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - Product Information SV = svenska 15/01/2013 26/02/2014

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
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014
Betmiga : EPAR - All Authorised presentations SV = svenska 15/01/2013 26/02/2014

Pharmacotherapeutic group

Urologicals

Therapeutic indication

Symptomatic treatment of urgency.

Increased micturition frequency and / or urgency incontinence as may occur in adult patients with overactive-bladder syndrome.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Betmiga : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 28/02/2013 26/02/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Betmiga : EPAR - Public assessment report SV = svenska 15/01/2013  
CHMP summary of positive opinion for Betmiga SV = svenska 19/10/2012  

Authorised

This medicine is approved for use in the European Union