The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the generic medicine Carmustine Obvius (carmustine), for the treatment of brain tumours, non-Hodgkin’s lymphoma and Hodgkin’s disease.
Carmustine Obvius will be available as a 100-mg powder and solvent for solution for infusion. The active substance of Carmustine Obvius is carmustine, an alkylating antineoplastic agent of the nitrosourea type, which prevents DNA replication and transcription by alkylating reactive sites on nucleoproteins.
Carmustine Obvius is a generic of Carmubris which has been authorised in the EU since 31 July 1996. Since Carmustine Obvius is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Carmubris was not required.
The full indication is: “in the treatment of new or recurrent brain tumors – glioblastoma, medulloblastoma, astrocytoma and metastatic brain tumors; Second line treatment of non-Hodgkin’s lymphomas and Hodgkin’s disease”. It is proposed that Carmustine Obvius be prescribed by physicians experienced in the treatment of cancer.
The applicant for this medicinal product is Obvius Investment B.V.
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