Estimadas y estimados,
La EMEA acaba de publicar y distribuir una nota informando de la decision del Comite de Medicamentos Humanos (CHMP), sobre la autorizacion en la Union Europea de la talidomida para mieloma multiple, un tipo infrecuente de cancer de medula osea. Su consideracion de farmaco teratogenico condiciona las medidas:
The CHMP has approved a risk management plan that includes a number of actions intended to prevent pregnancies in women being treated with thalidomide and exposure of unborn children to the medicine. For example, all women of child-bearing potential who are treated with Thalidomide Pharmion must undergo pregnancy tests before, during and after treatment, in addition to using selected and effective contraception.
Subject to the granting of a marketing authorisation by the European Commission, Thalidomide Pharmion will only be available by prescription, and treatment will be initiated and monitored by a doctor who has experience in the treatment of multiple myeloma. A clear warning will be printed on the boxes containing the medicine, indicating that Thalidomide Pharmion causes birth defects and foetal death.
Prior to the launch of Thalidomide Pharmion in each Member State, Pharmion Ltd. will provide healthcare professionals and patients with educational materials about the treatment-related risks and the precautions required to ensure the safe use of the product.
La nota completa en: http://www.emea.europa.eu/pdfs/human/press/pr/Pressrelease_Thalidomide3302408en.pdf