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 considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small
Update of product information is recommended
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing ambroxol or bromhexine. This follows concerns over the risk of allergic reactions with these medicines, which are widely used as expectorants (to help clear mucus from the airways).
The PRAC considers that the risk of allergic reactions is small, but has recommended that the product information for these medicines should be updated with further information on severe allergic reactions, and that severe skin reactions (SCARs) should be introduced as a side effect. SCARs include conditions such as erythema multiforme and Stevens-Johnson syndrome.
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