Glustin

Withdrawn

This medicine's authorisation has been withdrawn

pioglitazone

Overview

The marketing authorisation for Glustin has been withdrawn at the request of the marketing-authorisation holder.

Glustin : EPAR - Summary for the public

Glustin : EPAR - Risk-management-plan summary

Product information

Glustin : EPAR - Product Information

Latest procedure affecting product information: WS/1979/G

04/02/2021

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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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

AdoptedReference 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

AdoptedReference 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