The marketing authorisation for Sabervel has expired following the marketing authorisation holder's decision not to apply for a renewal.
Sabervel : EPAR - Summary for the public (PDF/513.87 KB)
First published: 23/04/2012
Last updated: 23/04/2012
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
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EL-15351 Pallini Attiki
04/09/2014 Sabervel - EMEA/H/C/002510 - A31/0005
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Agents acting on the renin-angiotensin system
Sabervel is indicated in adults for the treatment of essential hypertension.
It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.