Glustin

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pioglitazone

Table of contents

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Glustin has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 17/10/2022

Authorisation details

Product details
Name
Glustin
Agency product number
EMEA/H/C/000286
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
28
Date of issue of marketing authorisation valid throughout the European Union
11/10/2000
Contact address

Delta Park 45
2665 Vallensbaek Strand
Denmark

Product information

04/02/2021 Glustin - EMEA/H/C/000286 - WS/1979/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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 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 three to six 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

Initial marketing-authorisation documents

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