Overview

The marketing authorisation for Glidipion has been withdrawn at the request of the marketing-authorisation holder.

Glidipion : EPAR - Summary for the public

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polski (PL) (773.96 KB - PDF)
português (PT) (699 KB - PDF)
română (RO) (664.4 KB - PDF)
slovenčina (SK) (752.96 KB - PDF)
slovenščina (SL) (766.92 KB - PDF)
Suomi (FI) (695.99 KB - PDF)
svenska (SV) (697.07 KB - PDF)

Glidipion : EPAR - Risk-management-plan summary

Product information

Glidipion : EPAR - Product Information

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español (ES) (1.17 MB - PDF)
čeština (CS) (1.97 MB - PDF)
dansk (DA) (1.19 MB - PDF)
Deutsch (DE) (1.14 MB - PDF)
eesti keel (ET) (1.04 MB - PDF)
ελληνικά (EL) (2.19 MB - PDF)
français (FR) (1.16 MB - PDF)
hrvatski (HR) (1.22 MB - PDF)
íslenska (IS) (1.17 MB - PDF)
italiano (IT) (1.22 MB - PDF)
latviešu valoda (LV) (1.85 MB - PDF)
lietuvių kalba (LT) (1.29 MB - PDF)
magyar (HU) (1.65 MB - PDF)
Malti (MT) (1.89 MB - PDF)
Nederlands (NL) (996.51 KB - PDF)
norsk (NO) (1.22 MB - PDF)
polski (PL) (1.93 MB - PDF)
português (PT) (1.25 MB - PDF)
română (RO) (1.33 MB - PDF)
slovenčina (SK) (1.87 MB - PDF)
slovenščina (SL) (1.76 MB - PDF)
Suomi (FI) (1.16 MB - PDF)
svenska (SV) (1.15 MB - PDF)

Latest procedure affecting product information: WS/1791

11/06/2020

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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).

Glidipion : EPAR - All Authorised presentations

български (BG) (631.49 KB - PDF)
español (ES) (604.7 KB - PDF)
dansk (DA) (609.94 KB - PDF)
Deutsch (DE) (610.16 KB - PDF)
eesti keel (ET) (606.62 KB - PDF)
ελληνικά (EL) (647.33 KB - PDF)
français (FR) (610.62 KB - PDF)
íslenska (IS) (606.77 KB - PDF)
italiano (IT) (607.2 KB - PDF)
latviešu valoda (LV) (659.29 KB - PDF)
lietuvių kalba (LT) (626.79 KB - PDF)
magyar (HU) (647.52 KB - PDF)
Malti (MT) (656.82 KB - PDF)
Nederlands (NL) (611.38 KB - PDF)
norsk (NO) (606.82 KB - PDF)
polski (PL) (630.09 KB - PDF)
português (PT) (612.19 KB - PDF)
română (RO) (620.54 KB - PDF)
slovenčina (SK) (659.39 KB - PDF)
slovenščina (SL) (622.77 KB - PDF)
Suomi (FI) (610.62 KB - PDF)
svenska (SV) (610.36 KB - PDF)

Pioglitazone Actavis Group : EPAR - Conditions imposed on member states for safe and effective use

български (BG) (664.7 KB - PDF)
español (ES) (586.53 KB - PDF)
čeština (CS) (635.8 KB - PDF)
dansk (DA) (585.16 KB - PDF)
Deutsch (DE) (585.72 KB - PDF)
eesti keel (ET) (584.74 KB - PDF)
ελληνικά (EL) (662.54 KB - PDF)
français (FR) (585.71 KB - PDF)
íslenska (IS) (585.42 KB - PDF)
italiano (IT) (585.91 KB - PDF)
latviešu valoda (LV) (639.73 KB - PDF)
lietuvių kalba (LT) (604.15 KB - PDF)
magyar (HU) (631.59 KB - PDF)
Malti (MT) (631 KB - PDF)
Nederlands (NL) (579.74 KB - PDF)
norsk (NO) (579.95 KB - PDF)
polski (PL) (632.76 KB - PDF)
português (PT) (577.88 KB - PDF)
română (RO) (595.84 KB - PDF)
slovenčina (SK) (636.53 KB - PDF)
slovenščina (SL) (624.91 KB - PDF)
Suomi (FI) (584.39 KB - PDF)
svenska (SV) (576.87 KB - PDF)

Product details

Name of medicine
Glidipion (previously Pioglitazone Actavis Group)
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 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/002558

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
Actavis Group PTC ehf   

Actavis Group PTC ehf
Reykjavíkurvegur 76 - 78
IS-220 Hafnarfjörður
Iceland

Marketing authorisation issued
15/03/2012
Revision
8

Assessment history

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

Pioglitazone Actavis Group : EPAR - Public assessment report

CHMP summary of positive opinion for Pioglitazone Actavis Group

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