The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a regulatory body representing EU Member States, has endorsed new recommendations on testosterone-containing medicines, valproate – containing medicines and related active substances, continued with the implementation of the outcome of the referral for Tazocin and medicinal product with associated names. and endorsed the new version of the Core SmPC/PL.
More information is accessible under the link bel...
Five years ago, we issued Danish Pharmacovigilance Update for the first time. We are delighted to celebrate the newsletter's fifth anniversary with more than 3,000 subscribers to the Danish and the English version, and we hope the interest in Danish Pharmacovigilance Update will continue to grow.
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Among the articles in this issue, you can read about how we have develo...
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended strengthening the restrictions on the use of valproate in women and girls, concluded that there is no evidence that testosterone-containing medicines increase the cardiovascular risk in patients with hypogonadism and recommended further measures to minimise risk of blood vessel blockage with ponatinib at its October 2014 meeting.
More information is accessible under the link below.
The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 6-9 October 2014. Topics discussed at the meeting:
PRAC recommends strengthening the restrictions on the use of valproate in women and girls
PRAC review does not confirm increase in heart problems with testosterone medicines
PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig
Five days left to respond to the consultation on public hearings
Read PRAC's monthly report from the meeti...
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a regulatory body representing EU Member States, has agreed by consensus that there is no consistent evidence of an increased risk of heart problems with testosterone medicines in men who lack the hormone (a condition known as hypogonadism)
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