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Home Industry News Three medicines step closer to EU approval

Three medicines step closer to EU approval

30th April 2018

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) have recommended 3 medicines for approval for treating HIV, pain and cancer.
Medicines include:
They recommended Gilead’s Biktarvy for approval as a treatment for HIV-1 infection. This one a day single tablet therapy had shown high rates of virologic suppression through a 48 week clinical trial phase.
FGK Representative Service GmbH’s Dzuveo (sufentanil) was endorsed for the treatment of pain. Hybrid applications rely on the results of preclinical tests and clinical trials for a reference product and in part on new data. The most common side effects are nausea, vomiting and pyrexia.
Also, Obvius Investment BV’s generic medicine Carmustine Obvius (carmustine) was recommended for approval, for the treatment brain tumours, non-Hodgkin’s lymphoma and Hodgkin’s disease.

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