The MSSG is also appealing to healthcare professionals and members of the public to follow some key recommendations. Information for healthcare professionals The GLP-1 receptor agonists Bydureon, Byetta, Lyxumia, Ozempic, Rybelsus, Trulicity and Victoza …
At the time of designation, CTCL affected less than 2.2 in 10,000 people in the European Union (EU). This was equivalent to a total of fewer than 112,000 people*, and is below the ceiling for orphan designation, which is 5 people in 10,000. This is based …
During its meeting of 4-5 September 2012, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/08/596 for Adcetris (brentuximab vedotin1) as an orphan medicinal product for the treatment of Hodgkin lymphoma. The COMP assessed …
The Committee for Orphan Medicinal Products reviewed the orphan designation of Adcetris at the time of change to the terms of the marketing authorisation, and confirmed that the orphan designation should be maintained. More information is available in the …
Treatment of infections Invanz was compared with ceftriaxone (another antibiotic) for the treatment of adults with community-acquired pneumonia (866 patients) and urinary tract infections (592 patients), and with a combination of piperacillin and …
EMA and the United States’ Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) offer parallel scientific advice procedures to developers of veterinary medicines who intend to apply for authorisation of their products in both regions. This …
This is the twelfth in a series of regular meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of evidence generation along the medicine’s life-cycle and related to development support activities, …
Valdoxan has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression. Three of these studies included some patients treated with other antidepressants, either fluoxetine or …
The EU (Union) list of critical medicines enables EMA, the European Commission and the Heads of Medicines Agencies (EMA) to work together to ensure they can take proactive measures to avoid medicine shortages. It contains human medicines whose continued …
English (EN) (81.94 KB - PDF) First published: 15/10/2013Last updated: 25/06/2024
English (EN) (81.94 KB - PDF) First published: 28/02/2013Last updated: 25/06/2024
Committee for medicinal products for veterinary use summary of opinion: Trocoxil: International Non-proprietary Names (INN): Mavacoxib AdoptedReference Number: EMEA/CVMP/333587/2008
English (EN) (81.94 KB - PDF) First published: 10/11/2009Last updated: 25/06/2024
English (EN) (81.94 KB - PDF) First published: 20/10/2017Last updated: 25/06/2024
The ERA-DG together with additional technical experts from the EU network is hosting a stakeholder webinar for industry and contract research organisations (CROs) on the revised ERA guideline for human medicinal products. The revised guideline will come …
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Glivec, and do not need to be repeated for Imatinib Accord. As for every medicine, the company provided studies on the …
This bilateral meeting, between European Medicines Agency (EMA) and Animalhealth Europe, is being organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations. The purpose of the meeting is to exchange views and …
EMA is holding the ninth meeting of the Industry Standing Group (ISG). This forum for interaction has been established as part of the EMA's continuous improvement for engagement with industry stakeholders. It aims to: facilitate regular exchange of …
The most common side effects with Jylamvo (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing …
The Committee adopted by consensus a positive opinion for a marketing authorisation for DIVENCE IBR Marker Live from Laboratorios Hipra, S.A., a new vaccine intended for the active immunisation of cattle from 10 weeks of age to reduce virus shedding, …
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