Overview

The marketing authorisation for Pioglitazone Krka has been withdrawn at the request of the marketing-authorisation holder.

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Product information

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Latest procedure affecting product information: IB/0001

16/09/2014

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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).

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Product details

Name of medicine
Pioglitazone Krka
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

- 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;

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/002453

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
Revision
2

Assessment history

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