Actos

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pioglitazone

Authorised
This medicine is authorised for use in the European Union.

Overview

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

This EPAR was last updated on 07/06/2016

Authorisation details

Product details
Name
Actos
Agency product number
EMEA/H/C/000285
Active substance
pioglitazone hydrochloride
International non-proprietary name (INN) or common name
pioglitazone
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BG03
Publication details
Marketing-authorisation holder
Takeda Pharma A/S
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
13/10/2000
Contact address
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

26/05/2016 Actos - EMEA/H/C/000285 - PSUSA/2417/201507

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.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Pioglitazone is indicated in the treatment of type-2 diabetes mellitus:

  • as monotherapy:
    • in 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 patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;
    • a sulphonylurea, only in 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 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 patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.

Assessment history

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