Glustin

Withdrawn

This medicine's authorisation has been withdrawn

pioglitazone

Overview

On 30 November 2021, the European Commission withdrew the marketing authorisation for Glustin (pioglitazone) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Takeda Pharma A/S, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Glustin was granted marketing authorisation in the EU on 11 October 2000 for the treatment of type 2 diabetes. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2005. It was then granted unlimited validity in 2010. The product had not been marketed in the EU since 2019. Glustin was a duplicate application to Actos, which is marketed in several EU countries. 

The European Public Assessment Report (EPAR) for Glustin is updated to indicate that the marketing authorisation is no longer valid.

Glustin : EPAR - Summary for the public

Glustin : EPAR - Risk-management-plan summary

Product information

Glustin : EPAR - Product Information

Glustin : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Glustin
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000286
• Marketing authorisation holder:
  Takeda Pharma A/S

  Delta Park 45; 2665 Vallensbaek Strand; Denmark

• Marketing authorisation issued:
  11/10/2000
• Revision:
  28

Assessment history

Changes since initial authorisation of medicine

Glustin : EPAR - Procedural steps taken and scientific information after authorisation

Glustin-H-C-PSUSA-00002417-201807 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/241767/2019

Glustin-H-C-286-PSUV-0056 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/566874/2013

Glustin-H-C-286-A20-0044 : EPAR - Assessment Report - Article 20

Adopted Reference Number: EMA/CHMP/940059/2011

Glustin-H-C-286-II-25 : EPAR - Scientific Discussion - Variation

Adopted

Glustin-H-C-286-II-26 : EPAR - Scientific Discussion - Variation

Adopted

Glustin : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Glustin : EPAR - Scientific Discussion

Glustin : EPAR - Procedural steps taken before authorisation