Sepioglin

Withdrawn

This medicine's authorisation has been withdrawn

pioglitazone

Overview

On 9 March 2012, the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Sepioglin, (pioglitazone), which had been approved for treatment of type 2 diabetes mellitus. The marketing authorisation holder (MAH) responsible for Sepioglin was Vaia S.A.. 

On 6 June 2013, the European Commission issued a decision to withdraw the marketing authorisation for Sepioglin, following its receipt of a letter dated 22 May 2013 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for commercial reasons. Sepioglin has not been marketed in any European country. 

Pursuant to this decision, the European public assessment report for Sepioglin is updated to reflect that the marketing authorisation is no longer valid.

Sepioglin : EPAR - Summary for the public

Product information

Sepioglin : EPAR - Product Information

Sepioglin : EPAR - All Authorised presentations

Sepioglin : EPAR - Conditions imposed on member states for safe and effective use

Product details

• Name of medicine:
  Sepioglin
• 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 (see section 4.4).

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 (see section 4.4).

Authorisation details

• EMA product number:
  EMEA/H/C/002021
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Vaia S.A.

  1, 28 Octovriou Str.; Ag. Varvara; EL-12351 Athens; Greece

• Marketing authorisation issued:
  09/03/2012
• Withdrawal of marketing authorisation:
  06/06/2013
• Revision:
  1

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Sepioglin : EPAR - Public assessment report

Reference Number: EMA/207581/2012

CHMP summary of positive opinion for Sepioglin

Adopted Reference Number: EMA/CHMP/644013/2011