Actos (pioglitazone)
- Region
- 🇪🇺 EU
- Active substance
- pioglitazone
- Company
- CHEPLAPHARM Arzneimittel GmbH
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- EU approval
- Fri 13 Oct 2000
- Application
- EMEA/H/C/000285
- ATC
- A10BG03
- Official record
- www.ema.europa.eu
Indication
Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: as monotherapy: in 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 patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in 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 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 patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
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
- 🇪🇺 Pioglitazone Teva Withdrawn · Teva B.V.
- 🇪🇺 Glustin Withdrawn · Takeda Pharma A/S
- 🇪🇺 Glubrava Withdrawn · Takeda Pharma A/S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- 🇪🇺 Glidipion (previously Pioglitazone Actavis Group) Withdrawn · Actavis Group PTC ehf
- 🇪🇺 Pioglitazone Teva Pharma Withdrawn · Teva Pharma B.V.
- 🇪🇺 Pioglitazone Krka Withdrawn · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 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.