EMA

EMEA Public Statement on Fee Reductions for Designated Orphan Medicinal Products

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.

European Medicines Agency welcomes continuation of D:A:D study

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.

European Medicines Agency makes recommendations for safer use of methylphenidate-containing 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.

European Medicines Agency recommends new contraindication for Fareston (toremifene)

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.

Priority access for children during Myozyme supply shortage

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.

Draft policy on access to EMEA documents released for public consultation

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.

EMEA recommends the suspension of the marketing authorisation of Ionsys (fentanyl hydrochloride)

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.

EMA

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