European Medicines Agency (EMA) News Channel
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.
The European Medicines Agency (EMEA) has welcomed the commitment of the sponsors to continue the D:A:D study at least until 2012. This ensures that the study, which was started on the initiative of the EMEA in 1999, will remain one of the most powerful pharmacovigilance tools to monitor the long-term safety of antiretroviral medicines.
The European Medicines Agency (EMEA) has concluded that methylphenidate-containing medicines remain suitable for the treatment of children aged six years or older and adolescents with attention deficit/hyperactivity disorder (ADHD). It has also recommended that the product information be made consistent across the European Union (EU) so that all patients, carers and prescribers have the same information for safer and more appropriate use of these medicines.
The European Medicines Agency (EMEA) has recommended that Fareston (toremifene), from Orion Pharma, should not be used in patients at risk of prolonged QT intervals or other heart problems. The EMEA's Committee for Medicinal Products for Human Use (CHMP) reviewed Fareston, because of concerns that its use could lead to a prolongation of the QT interval in patients taking the medicine.