Other safety alerts
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| European Union: Review of Corlentor/Procoralan started |
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The European Medicines Agency (EMA) has started a review of the medicine Corlentor/Procoralan (ivabradine). Corlentor/Procoralan is used to treat the symptoms of adults with long-term stable angina (chest pain due to obstruction in the arteries in the heart) or long-term heart failure (when the heart cannot pump enough blood to the rest of the body).
The review follows preliminary results from the SIGNIFY study, which was evaluating whether treatment with Corlentor/Procoralan in patients with coronary heart disease reduces the rate of cardiovascular events (such as heart attack) when compared with placebo (a dummy treatment). Patients in the study received up to 10 mg twice daily, which is higher than the currently authorised maximum daily dose (7.5 mg twice daily), and the results showed a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with the medicine in a subgroup of patients who had symptomatic angina (Canadian Cardiovascular Society class II - IV).
The EMA will now evaluate the impact of the data from the SIGNIFY study on the balance of benefits and risks of Corlentor/Procoralan and issue an opinion on whether the marketing authorisation should be maintained, varied, suspended or withdrawn across the EU.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002099.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are two registered pharmaceutical products containing ivabradine, namely Coralan Tab 7.5mg (HK-55438) and Coralan Tab 5mg (HK-55439), and are registered by Servier Hong Kong Ltd. Both are prescription-only medicines. So far, the Department of Health (DH) has not received any adverse drug reaction report in connection with the drug. The DH will keep vigilant against any new safety updates with respect to the drug.
Ends/ Friday, May 09, 2014
Issued at HKT 13:00
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