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World Kidney Day: 'Acute kidney injury: stop kidney attack!'

World Kidney Day is held every year in March to raise awareness of the importance of the kidneys to overall health and to reduce the frequency and impact of kidney disease and its associated health problems worldwide. The Day is a joint initiative of the International Society of Nephrology (ISN) and the International Federation of Kidney Foundations (IFKF). In 2013 World Kidney Day is focusing on acute kidney injury with the theme: 'Acute kidney injury: stop kidney attack!'

Tackling medication errors: European Medicines Agency workshop calls for coordinated EU approach

A close collaboration between national patient safety authorities, national competent authorities, the European Medicines Agency, and the European Commission is necessary to tackle the issue of medication errors causing harm in Europe. This collaboration should engage patients and healthcare professionals. This was the conclusion of the workshop on medication errors organised by the Agency from 28 February 2013 - 1 March 2013.

Outcomes of seven years of active support to small and medium-size businesses

Micro, small and medium-sized enterprises (SMEs) that are registered with the SME office of the European Medicines Agency have seen a consistent improvement in the success rate of their marketing-authorisation applications (MAAs) over the past seven years. This is shown in the annual report from the SME office 2012, which analyses the activities of the Agency's SME office since its creation. The Agency put the SME initiative in place in December 2005 to promote innovation and development of medicines by SMEs, as it recognises that SMEs are a major driver of innovation in the pharmaceutical industry.

Committee for Orphan Medicinal Products - strengthened interactions with patients and international partners

"The European Medicines Agency's Committee for Orphan Medicinal Products (COMP) is stepping into another stage of its role in the lifecycle of orphan medicines and in the field of rare diseases, after the first 12 years of the implementation of the Orphan-Medicinal-Product Regulation in the European Union," explains Bruno Sepodes, chair of the COMP. Integrating the views of patients, expanding international cooperation and collaborating with health-technology-assessment (HTA) bodies for a better understanding of orphan designation are some of the topics the COMP will focus on this year.

European Medicines Agency starts safety review of Diane 35 and its generics

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) formally started a safety review of Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35µg), associated names and its generics at its 4 - 7 February 2013 meeting. The Europe-wide review has been initiated at the request of the French medicines regulatory agency (ANSM), following the announcement of its plan to suspend the marketing authorisations for Diane 35 and its generics for acne treatment in France over the next three months.

European Medicines Agency to review third- and fourth-generation combined oral contraceptives

The European Medicines Agency has been asked by France to review third- and fourth-generation combined oral contraceptives to determine whether there is a need to restrict the use of these medicines to women who cannot take other combined oral contraceptives. France has made this request amid recent initiatives to reduce the use of third- and fourth-generation combined oral contraceptives by French women in favour of using second-generation oral contraceptives.

European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and Trevaclyn

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has confirmed the recommendation to suspend the marketing authorisations of Tredaptive, Pelzont and Trevaclyn (nicotinic acid / laropiprant) used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol). The CHMP decision follows the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend these medicines. The marketing-authorisation holder, Merck Sharp & Dohme Ltd, has, in the meantime, announced that it is taking steps to suspend availability of the medicines across the European Union (EU).

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