News FAMHP

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 European Medicines Agency (EMA) is conducting a review of the possible health effects in patients who may have taken certain lots of valsartan medicines containing an impurity called NDMA. This impurity was found in the active substance manufactured by Zhejiang Huahai Pharmaceuticals.

The new edition of the electronic newsletter "VIG-NEWS" of the federal agency for medicines and health products (famhp) is now available. The VIG-NEWS is a selection of recent news concerning pharmacovigilance from different sources.

In its judgments of 4th July 2013 the Council of State cancelled the decisions of 21st December 2011 of famhp leading to the modification of the marketing authorizations (MA) of antitussives and decongestants held by Medgenix, Qualiphar and Novartis.

The Committee for Medicinal Products for Human Use of the European Medicines Agency has reassessed the benefit / risk balance of injectable iron-containing medicines for intravenous administration. This Committee believes that their benefits outweigh their risks provided that adequate measures are taken to minimize the occurrence of allergic reactions.

The EMA has published an information file on combined hormonal contraceptives (CHC). This file refers to the ongoing reassessment of 3rd and 4th generation CHC’s for which the recommendations of the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency is expected in October 2013. This file also traces the history of the hormonal contraceptives and subsequent revaluations.

The European Medicines Agency (EMA: European Medicines Agency) has initiated a procedure of reassessment of zolpidem-containing medicines, used for the symptomatic treatment of insomnia (sleeping difficulty). This review has been made in response to concerns related to the onset in some patients of drowsiness and slow reactions the day after taking the medicine, and a potential increased risk of accidents during activities requiring alertness (e.g. when diving).