News FAMHP

As of 1 January 2020, medicines with only one active ingredient can be sold for treating coughs and colds.

Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The results of these risk assessments can now be reported.

A nitrosamine impurity (NDMA, N-nitrosodimethylamine) has been detected in medicines based on ranitidine. The European Medicines Agency (EMA) has started a review. As a precautionary measure, the companies involved are recalling the medicine or placing the medicines in quarantine.

The Falsified Medicines Directive (FMD), sets forth a number of measures to prevent the introduction of falsified medicines on the market. Thus, all packages of medicines that fall under this regulation must have a unique code and an anti-tampering device (ATD). On packages that do not fall under this obligation, marketing authorization holders can voluntarily attach an ATD. This information is now available in the online medicines database.

The FAMHP would like to inform consumers and patients of a recall by Stöpler Medical B.V. concerning COCUNE brand mitt-type body wipes. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.

The U.S. Food and Drug Administration (U.S. FDA) has recognized all 28 EU member states. This means that starting 11 July 2019, the United States (US) and the European Union (EU) have fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories.

During its meeting of May 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral for Xeljanz (tofacitinib). PRAC has issued restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs.

EMA is advising healthcare professionals and patients not to exceed the recommended dose of Xeljanz (tofacitinib) when treating rheumatoid arthritis. The advice follows early results from an ongoing study (study A3921133) in patients with rheumatoid arthritis which showed an increased risk of blood clots in the lungs and death when the normal dose of 5 mg twice daily was doubled.

European medicines authorities have placed the Chinese company Zheijiang Huahai under increased supervision and the Indian company Aurobindo Pharma is no longer allowed to supply irbesartan to EU member states.

The FAMHP would like to remind consumers and patients about a recall by Reckitt Benckiser of Durex Natural Feeling Extra Lubricated condoms and Durex Real Feeling latex-free polyisoprene condoms. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.