European Medicines Agency publishes list of human medicines currently under evaluation
A significant number of novel antineoplastic medicines included on the list
- Date : 20 Mar 2012
- Topic : Anticancer agents & Biologic therapy
The European Medicines Agency has published a list of all new human medicines under current evaluation by the Committee for Medicinal Products for Human Use (CHMP). The list includes the international non-proprietary names and therapeutic areas for all new innovative medicines under evaluation, along with information on the type of salt, ester or derivative of the active substance. For generic and biosimilar medicines, it includes the international non-proprietary names and therapeutic area. The list only includes medicines whose applications have been validated.
The Agency will update this information every month following the plenary meeting of the CHMP. This initiative forms part of the drive towards increased transparency on its activities by the Agency and other European regulatory authorities.
The international non-proprietary names or generic names are the globally recognised names used to identify active ingredients in pharmaceuticals. The international non-proprietary names are selected by the World Health Organization.
The document lists information on applications for centralized marketing authorization for human medicines that the European Medicines Agency has received for evaluation.
Information on designated orphan medicines that are being assessed for marketing authorization is also available in the monthly reports of the Committee for Orphan Medicinal Products.
Antineoplastic medicines from the list
Among antineoplastic medicines, next non-orphan medicinal products are included at March 2012 list: Aflibercept, crizotinib, pertuzumab, pixantrone, vandetanib, vemurafenib, and vismodegib.
Next non-orphan generic and biosimilar medicinal products from oncology filed are included in the list: Capecitabine, docetaxel, and imatinib as antineoplastic agents; ibandronic acid and zoledronic acid as medicines for bone disease; imiquimod - chemotherapeutic for dermatological use; and megestrole acetate, endocrine therapy.
Next orphan medicinal products are included in the list: Axitinib, bosutinib, brentuximab vedotin, decitabine, pralatrexate, ridaforolimus, romidepsin, and ruxolitinib.
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