🇪🇺 Norvasc in European Union

EMA authorised Norvasc on 15 January 2007

Marketing authorisations

Application: EMEA/H/C/000774
Marketing authorisation holder: Novartis Europharm Limited
Local brand name: Copalia
Indication: Treatment of essential hypertension. Copalia is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Status: approved

Application: EMEA/H/C/000776
Marketing authorisation holder: Novartis Europharm Limited
Local brand name: Dafiro
Indication: Treatment of essential hypertension. Dafiro is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Status: approved

Application: EMEA/H/C/000775
Marketing authorisation holder: Novartis Europharm Ltd
Local brand name: Imprida
Indication: Treatment of essential hypertension. Imprida is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Status: withdrawn

Application: EMEA/H/C/001161
Marketing authorisation holder: Novartis Europharm Ltd.
Local brand name: Imprida HCT
Indication: Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
Status: withdrawn

Application: EMEA/H/C/001159
Marketing authorisation holder: Novartis Europharm Limited
Local brand name: Copalia HCT
Indication: Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
Status: approved

Application: EMEA/H/C/004037
Marketing authorisation holder: Mylan Pharmaceuticals Limited
Local brand name: Amlodipine / Valsartan Mylan
Indication: Treatment of essential hypertension. Amlodipine/Valsartan Mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Status: approved

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

Is Norvasc approved in European Union?

Yes. EMA authorised it on 15 January 2007; EMA authorised it on 15 January 2007; EMA authorised it on 17 January 2007.

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

Novartis Europharm Limited holds the EU marketing authorisation.