Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited
We would like to inform you that the “Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014” has been launched on the EMA website for public consultation. Please find the link below for your convenience:
Please submit your comments using the template form, which is available through a link in the cover page of this document.
PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines Medicines can still be given for their approved uses, with new restrictions
PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines Medicines can still be given for their approved uses,
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing the antihistamine hydroxyzine. This follows concerns over the risk of possible effects on heart rhythm with these medicines, which are available in most EU countries. Their approved uses (indications) vary considerably between countries and may include use to treat anxiety disorders, for relief of pruritus (itching), as premedication before surgery, and for treatment of sleep disorders.
More information on this, is included in the hyperlink below.
PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)
PRAC recommendations to be considered by CHMP for final opinion
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of Corlentor/Procoralan (ivabradine) and has made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia (excessively low heart rate), in patients taking the medicine. Corlentor/Procoralan is used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.
The PRAC made recommendations about the resting heart rate of patients before starting treatment or when the dose is adjusted, recommendations on when treatment should be stopped and recommendations regarding use with other medicines. Because patients treated with Corlentor/Procoralan are at an increased risk of developing atrial fibrillation (a heart condition that causes an irregular and often abnormally fast heart rate), the PRAC recommended monitoring for this condition in patients treated with Corlentor/Procoralan. In addition, the PRAC recommended that, when used for angina, Corlentor/Procoralan should only be used to alleviate symptoms as the available data do not indicate that the medicine provides benefits on outcomes such as reducing heart attack or cardiovascular death (death due to heart problems).
- PRAC recommends strengthening the restrictions on the use of valproate in women and girls Women to be better informed of the risks of valproate use during pregnancy
- PRAC review does not confirm increase in heart problems with testosterone medicines Committee recommends medicines can continue to be given for their authorised uses
- PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig PRAC recommendations to be considered by CHMP for final opinion