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Product No EMEA/H/C/000285
Brand Name Actos
Nonproprietary Name pioglitazone
API pioglitazone hydrochloride
ATC Code A10BG03
Indications 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.
Orphan Drug no
Generics no
Marketing Authorization Holder Takeda Pharma A/S
Status Authorised
Authorization Date 2000-10-13
Version 22
Condition Approval no
Exceptions no
Biosimilar no
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