Pioglitazone Krka (pioglitazone)
- Region
- 🇪🇺 EU
- Active substance
- pioglitazone
- Company
- KRKA tovarna zdravil d.d. Novo mesto
- Status
- Withdrawn
- Therapeutic area
- Diabetes Mellitus, Type 2
- EU approval
- Wed 21 Mar 2012
- Designations
- Generic
- Application
- EMEA/H/C/002453
- ATC
- A10BG03
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Competact Authorised · CHEPLAPHARM Arzneimittel GmbH
- 🇪🇺 Pioglitazone Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Tandemact Authorised · CHEPLAPHARM Arzneimittel GmbH
- 🇪🇺 Pioglitazone Actavis Authorised · Actavis Group PTC ehf
- 🇪🇺 Actos Authorised · CHEPLAPHARM Arzneimittel GmbH
- 🇪🇺 Pioglitazone Teva Withdrawn · Teva B.V.
- 🇪🇺 Glustin Withdrawn · Takeda Pharma A/S
- 🇪🇺 Glubrava Withdrawn · Takeda Pharma A/S
- 🇪🇺 Incresync Authorised · Takeda Pharma A/S
- 🇪🇺 Glidipion (previously Pioglitazone Actavis Group) Withdrawn · Actavis Group PTC ehf
- 🇪🇺 Pioglitazone Teva Pharma Withdrawn · Teva Pharma B.V.
- 🇪🇺 Paglitaz Lapsed · KRKA tovarna zdravil d.d. Novo mesto
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.