European Medicines Agency (EMA) News Channel
The European Medicines Agency's (EMEA) Committee for Medicinal Products (CHMP) has recommended that infants, children and adolescents be given priority access to Myozyme (alglucosidase alfa), from Genzyme, during the expected supply shortage of the medicine over the next few months. This is intended to ensure that these patients continue to receive Myozyme while the company solves its supply problems.
As part of its continuing efforts to ensure transparency of its operations, the European Medicines Agency (EMEA) has published a draft policy on practical measures to uphold EU citizens' rights to the widest possible access to documents held by the EMEA.
The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation of Ionsys (fentanyl hydrochloride), from Janssen-Cilag International NV, because of a defect with the delivery system of the medicine that could lead to patients being overdosed.
The European Medicines Agency (EMEA) has been formally notified by Pfizer Limited of its decision to withdraw its application for a change to the marketing authorisation for the medicine Viagra (sildenafil) 50 mg film-coated tablets.
The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Acomplia (rimonabant) from Sanofi-Aventis. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union (EU).
At its 60th meeting, held in London on 2 October 2008, the Management Board of the European Medicines Agency (EMEA) welcomed the half-year report for 2008 presented to them by EMEA Executive Director Thomas Lönngren.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Tysabri (natalizumab) be updated to further increase awareness about the risk of progressive multifocal leukoencephalopathy (PML) in patients with relapsing-remitting multiple sclerosis (MS) who have been treated with the medicine.