Paglitaz

pioglitazone

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About

The marketing authorisation for Paglitaz has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

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

This EPAR was last updated on 10/03/2016 .

Authorisation details

Product details

Product details for Paglitaz
NamePaglitaz
Agency product numberEMEA/H/C/002309
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 Paglitaz
Marketing-authorisation holder

Krka, d.d., Novo mesto

Revision1
Date of issue of marketing authorisation valid throughout the European Union21/03/2012

Contact address:

Krka, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

Product information

15/01/2014  Paglitaz -EMEA/H/C/002309 -IB/0002

Name Language First published Last updated
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14
Paglitaz : EPAR - Product Information SV = svenska 2012-04-26 2014-07-14

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
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  
Paglitaz : EPAR - All Authorised presentations SV = svenska 2012-04-26  

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

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;

as dual oral therapy in combination with

  • metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;
  • a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;

as triple oral therapy in combination with

  • metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.

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

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. 

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Paglitaz : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2014-07-14  

Initial marketing-authorisation documents

Name Language First published Last updated
Paglitaz : EPAR - Public assessment report SV = svenska 2012-04-26  
CHMP summary of positive opinion for Paglitaz SV = svenska 2012-01-20  

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Paglitaz