European Medicines Agency (EMA) News Channel
The PROTECT project (Pharmacoepidemiological Research on Outcomes of Therapeutics by a
European ConsorTium) has been accepted for funding by the Innovative Medicines Initiative Joint Undertaking (IMI JU). PROTECT is a collaborative European project aiming to develop innovative methods in pharmacoepidemiology and pharmacovigilance.
The European Medicines Agency, the European Commission and Health Canada, the Canadian regulatory authority for medicines, have agreed on an implementation plan for their confidentiality arrangement. The implementation plan details the process for both regular and ad-hoc exchanges of information, and describes the process for monitoring the progress of the implementation plan. It also foresees an exchange programme for staff to promote mutual learning and sharing of regulatory experience.
The European Medicines Agency (EMEA) has been formally notified by SP Europe of its decision to withdraw its application for a centralised marketing authorisation for the medicine Cylatron (peginterferon alfa-2b), 200 micrograms /0.5 ml, 300 micrograms /0.5 ml and 600 micrograms/0.5 ml. Cylatron was expected to be used for the adjuvant treatment of patients with stage III melanoma as evidenced by microscopic, non-palpable nodal involvement. The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Raptiva (efalizumab), from Serono. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Raptiva no longer outweigh its risks, because of safety concerns, including the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking the medicine. The European Medicines Agency (EMEA) has recommended adding a contra-indication to the Product Information for aliskiren, stating that it must not be used in patients who have experienced angioedema (swelling of the tissues beneath the skin) when taking aliskiren in the past. The Agency also recommended the inclusion of a warning, stating that patients who develop signs of angioedema should stop treatment and seek medical attention. The European Medicines Agency (EMEA) has reviewed the available information on the two cases of status epilepticus with myoclonus (repeated and prolonged seizures and loss of consciousness) reported in two girls vaccinated with the cervical cancer vaccine Gardasil in Spain. Based on the current data, the Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the cases are unlikely to be related to vaccination with Gardasil and that the benefits of Gardasil continue to outweigh its risks. Orphan medicinal products designated in accordance with Regulation (EC) No 141/2000 of 22 January 2000, are eligible for fee reductions for all fees payable under Community rules pursuant to Regulation (EEC) 2309/93, as amended. This includes fees for pre-authorisation activities such as protocol assistance (scientific advice), and for products using the centralised procedure: the application for marketing authorisation, inspections and post-authorisation activities such as variations, annual fees, etc.
