Paglitaz

Lapsed

This medicine's authorisation has lapsed

pioglitazone

Overview

On 27 March 2015, the marketing authorisation of Paglitaz (pioglitazone) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, Krka d.d. Novo mesto, had not marketed Paglitaz in the EU since its initial marketing authorisation in March 2012. 

In accordance with provisions of the sunset clause , the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation. Krka d.d. Novo mesto confirmed that the product had not been marketed due to commercial reasons. 

Paglitaz was granted marketing authorisation in the EU for the treatment of type 2 diabetes mellitus. The marketing authorisation was initially valid for a 5-year period. Paglitaz is a generic medicine of Actos. There are other generic medicinal products of Actos authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Paglitaz is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Paglitaz : EPAR - Summary for the public

Reference Number: EMA/684024/2011

Product information

Paglitaz : EPAR - Product Information

Paglitaz : EPAR - All Authorised presentations

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

Product details

• Name of medicine:
  Paglitaz
• 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 in 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 3 to 6 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/002309
• 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:
  Krka, d.d., Novo mesto

  Šmarješka cesta 6; 8501 Novo mesto; Slovenia

• Marketing authorisation issued:
  21/03/2012
• Lapse of marketing authorisation:
  27/03/2015
• Revision:
  1

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Paglitaz : EPAR - Public assessment report

Reference Number: EMA/183894/2012

CHMP summary of positive opinion for Paglitaz

Adopted Reference Number: EMA/CHMP/423153/2011