The Spanish Agency for Medicines and Wellness Goods (Competent Authority) under the Ministry of Well being, Social Services and Equal, has authorized the importation of the antitumor ‘LipoDox’ Lab Sun Pharma Global FZE, despite not getting allowed their use in Europe and give data for use in mixture with other drugs.
selection has been taken to address the difficulties of providing ‘Caelyx’ (Janssen Cilag), antitumor indicated for the therapy of metastatic breast cancer, advanced ovarian cancer, Kaposi’s sarcoma linked with AIDS and multiple myeloma, which keeps for months interrupted by international supply difficulties with its manufacture.
was interrupted in December generating ‘Caelyx’ and two months later, in February, the Competent Authority established a distribution strategy and controlled access highway on the marketplace to make certain that patients get the therapy they had been those who can advantage most of it, for its efficiency and the absence of alternatives.
Even so, provided the uncertainty about the restoration of normal supply ‘Caelyx’ in the instant future, the department head Ana Mato has decided to temporarily authorize the use of ‘LipoDox’, a medicine that consists of the identical active substance (liposomal doxorubicin hydrochloride), dose, concentration and the same administration route ‘Caelyx’. Your dealer is Pharma Mar
manufacturer has certified compliance with GMP of the European Union and the U.S. Food and Drug Administration (FDA, its acronym in English) was authorized in January 2012 to address the exact same issue. Nonetheless, Europe has not been authorized by the European Medicines Agency (EMA) or any well being authority in the Member States.
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