🇪🇺 Memantine Oral Tablet in European Union

EMA authorised Memantine Oral Tablet on 11 October 2000

Marketing authorisations

EMA — authorised 11 October 2000

• Application: EMEA/H/C/000286
• Marketing authorisation holder: Takeda Pharma A/S
• Local brand name: Glustin
• 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 me
• Status: withdrawn

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EMA — authorised 28 July 2006

• Application: EMEA/H/C/000655
• Marketing authorisation holder: CHEPLAPHARM Arzneimittel GmbH
• Local brand name: Competact
• Indication: Competact is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
• Status: approved

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EMA — authorised 8 January 2007

• Application: EMEA/H/C/000680
• Marketing authorisation holder: CHEPLAPHARM Arzneimittel GmbH
• Local brand name: Tandemact
• Indication: Tandemact is indicated for the treatment of patients with type-2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
• Status: approved

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EMA — authorised 11 December 2007

• Application: EMEA/H/C/000893
• Marketing authorisation holder: Takeda Pharma A/S
• Local brand name: Glubrava
• Indication: Glubrava is indicated as second line treatment of type-2-diabetes-mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone. After initiation of therapy with pioglitazone, patients should be reviewed after three to six 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
• Status: withdrawn

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EMA — authorised 22 July 2011

• Application: EMEA/H/C/002370
• Marketing authorisation holder: Ratiopharm GmbH
• Local brand name: Pioglitazone ratio
• Status: withdrawn

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EMA — authorised 22 July 2011

• Application: EMEA/H/C/002369
• Marketing authorisation holder: Ratiopharm GmbH
• Local brand name: Pioglitazone ratiopharm GmbH
• Status: withdrawn

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EMA — authorised 22 July 2011

• Application: EMEA/H/C/002260
• Marketing authorisation holder: Ratiopharm GmbH
• Local brand name: Pioglitazone ratiopharm
• Status: withdrawn

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EMA — authorised 23 September 2011

• Application: EMEA/H/C/002448
• Marketing authorisation holder: Teva Pharma B.V.
• Local brand name: Pioglitazone Teva Generics
• Indication: Treatment of type 2 diabetes mellitus
• Status: withdrawn

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EMA — authorised 9 March 2012

• Application: EMEA/H/C/002021
• Marketing authorisation holder: Vaia S.A.
• Local brand name: Sepioglin
• 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 met
• Status: withdrawn

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EMA — authorised 15 March 2012

• Application: EMEA/H/C/002558
• Marketing authorisation holder: Actavis Group PTC ehf
• Local brand name: Glidipion (previously Pioglitazone Actavis Group)
• 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 me
• Status: withdrawn

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EMA — authorised 15 March 2012

• Application: EMEA/H/C/002324
• Marketing authorisation holder: Actavis Group PTC ehf
• Local brand name: Pioglitazone Actavis
• 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 metfor
• Status: approved

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EMA — authorised 21 March 2012

• Application: EMEA/H/C/002309
• Marketing authorisation holder: Krka, d.d., Novo mesto
• Local brand name: Paglitaz
• 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 metfor
• Status: withdrawn

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EMA — authorised 21 March 2012

• Application: EMEA/H/C/002453
• Marketing authorisation holder: Krka, d.d., Novo mesto
• Local brand name: Pioglitazone Krka
• 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
• Status: withdrawn

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EMA — authorised 21 March 2012

• Application: EMEA/H/C/002277
• Marketing authorisation holder: Accord Healthcare S.L.U.
• Local brand name: Pioglitazone Accord
• Indication: Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: as monotherapy in adult patients (particularly overweight patients) inadequately controlled by diet and exercise 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
• Status: approved

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EMA — authorised 26 March 2012

• Application: EMEA/H/C/002410
• Marketing authorisation holder: Teva Pharma B.V.
• Local brand name: Pioglitazone Teva Pharma
• Indication: Pioglitazone is indicated in the treatment of type-2 diabetes mellitus as monotherapy: in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. 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 ass
• Status: withdrawn

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EMA — authorised 26 March 2012

• Application: EMEA/H/C/002297
• Marketing authorisation holder: Teva B.V.
• Local brand name: Pioglitazone Teva
• Indication: Pioglitazone is indicated in the treatment of type 2 diabetes mellitus: 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 insuffic
• Status: withdrawn

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Frequently asked questions

Is Memantine Oral Tablet approved in European Union?

Yes. EMA authorised it on 11 October 2000; EMA authorised it on 28 July 2006; EMA authorised it on 8 January 2007.

Who is the marketing authorisation holder for Memantine Oral Tablet in European Union?

Takeda Pharma A/S holds the EU marketing authorisation.