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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04/09/2014 Sabervel - EMEA/H/C/002510 - A31/0005
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.