This is a summary of the European public assessment report (EPAR) for Tolura. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tolura.
Tolura : EPAR - Summary for the public (PDF/66.29 KB)
First published: 22/06/2010
Last updated: 21/07/2011
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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.
Krka, d.d., Novo mesto
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17/09/2018 Tolura - EMEA/H/C/001196 - IB/0029
- 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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Treatment of essential hypertension in adults.
Reduction of cardiovascular morbidity in patients with:
- manifest atherothrombotic cardiovascular disease (history of coronary heart disease or peripheral arterial disease) or;
- type 2 diabetes mellitus with documented target organ damage.