🇪🇺 Tekturna in European Union

EMA authorised Tekturna on 22 August 2007

Marketing authorisations

Application: EMEA/H/C/000964
Marketing authorisation holder: Noden Pharma DAC
Local brand name: Rasilez HCT
Indication: Treatment of essential hypertension in adults. Rasilez HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone. Rasilez HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.
Status: withdrawn

Application: EMEA/H/C/002420
Marketing authorisation holder: Novartis Europharm Ltd.
Local brand name: Riprazo HCT
Indication: Treatment of essential hypertension in adults. Riprazo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone. Rirpozo HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.
Status: withdrawn

Application: EMEA/H/C/002073
Marketing authorisation holder: Novartis Europharm Ltd
Local brand name: Rasilamlo
Indication: Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.
Status: withdrawn

Application: EMEA/H/C/002421
Marketing authorisation holder: Novartis Europharm Ltd.
Local brand name: Sprimeo HCT
Indication: Treatment of essential hypertension in adults. Sprimeo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone. Sprimeo HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.
Status: withdrawn

Application: EMEA/H/C/002017
Marketing authorisation holder: Novartis Europharm Ltd.
Local brand name: Rasitrio
Indication: Rasitrio is indicated for the treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently at the same dose level as in the combination.
Status: withdrawn

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Tekturna approved in European Union?

Yes. EMA authorised it on 22 August 2007; EMA authorised it on 22 August 2007; EMA authorised it on 22 August 2007.

Who is the marketing authorisation holder for Tekturna in European Union?

Noden Pharma DAC holds the EU marketing authorisation.