Pioglitazone Actavis

pioglitazone

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This is a summary of the European public assessment report (EPAR) for Pioglitazone Actavis. 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 Pioglitazone Actavis.

What is Pioglitazone Actavis?

Pioglitazone Actavis is a medicine that contains the active substance pioglitazone. It is available as tablets (15, 30 and 45 mg).

Pioglitazone Actavis is a ‘generic medicine’. This means that Pioglitazone Actavis is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Actos.

What is Pioglitazone Actavis used for?

Pioglitazone Actavis is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight. It is used in addition to diet and exercise.

Pioglitazone Actavis is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.

Pioglitazone Actavis can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.

The medicine can only be obtained with a prescription.

How is Pioglitazone Actavis used?

The recommended starting dose of Pioglitazone Actavis is 15 or 30 mg once a day. This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed. Pioglitazone Actavis should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).

Treatment with Pioglitazone Actavis should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit. At subsequent reviews prescribers should confirm that benefits to patients are maintained.

How does Pioglitazone Actavis work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Pioglitazone Actavis, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.
Treatment with Pioglitazone Actavis should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit. At subsequent reviews prescribers should confirm that benefits to patients are maintained.

How has Pioglitazone Actavis been studied?

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

What is the risk associated with Pioglitazone Actavis?

Because Pioglitazone Actavis 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 has Pioglitazone Actavis been approved?

The CHMP concluded that, in accordance with EU requirements, Pioglitazone Actavis has been shown to have comparable quality and to be bioequivalent to Actos. Therefore, the CHMP’s view was that, as for Actos, the benefit outweighs the identified risk. The Committee recommended that Pioglitazone Actavis be given marketing authorisation.

Other information about Pioglitazone Actavis

The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Actavis on 15 March 2012.

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

Name Language First published Last updated
Pioglitazone Actavis : EPAR - Summary for the public BG = bălgarski 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public ES = español 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public CS = čeština 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public DA = dansk 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public DE = Deutsch 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public ET = eesti keel 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public EL = elliniká 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public EN = English 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public FR = français 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public IT = italiano 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public LV = latviešu valoda 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public LT = lietuvių kalba 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public HU = magyar 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public MT = Malti 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public NL = Nederlands 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public PL = polski 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public PT = português 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public RO = română 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public SK = slovenčina 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public SL = slovenščina 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public FI = suomi 26/04/2012  
Pioglitazone Actavis : EPAR - Summary for the public SV = svenska 26/04/2012  

This EPAR was last updated on 07/03/2016 .

Authorisation details

Product details

Product details for Pioglitazone Actavis
NamePioglitazone Actavis
Agency product numberEMEA/H/C/002324
Active substance

pioglitazone hydrochloride

International non-proprietary name (INN) or common name

pioglitazone

Therapeutic area Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code A10BG03
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 Pioglitazone Actavis
Marketing-authorisation holder

Actavis Group PTC ehf  

Revision3
Date of issue of marketing authorisation valid throughout the European Union15/03/2012

Contact address:

Actavis Group PTC ehf 
Reykjavíkurvegur 76 - 78
IS-220 Hafnarfjörður
Iceland

Product information

Product information

11/12/2015  Pioglitazone Actavis -EMEA/H/C/002324 -N/0006

Name Language First published Last updated
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016
Pioglitazone Actavis : EPAR - Product Information SV = svenska 26/04/2012 07/03/2016

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
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - All Authorised presentations SV = svenska 26/04/2012  

Name Language First published Last updated
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  
Pioglitazone Actavis : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 26/04/2012  

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:

as monotherapy

  • in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.

Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).

After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Pioglitazone Actavis : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 18/02/2014 07/03/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Pioglitazone Actavis : EPAR - Public assessment report SV = svenska 26/04/2012  
CHMP summary of positive opinion for Pioglitazone Actavis SV = svenska 23/09/2011 20/01/2012

Authorised

This medicine is approved for use in the European Union

More information on Pioglitazone Actavis