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European Medicines Agency (EMA): Recommends Approval Of Riarify for the treatment of Chronic Obstructive Pulmonary Disease

On 22 February 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Riarify, intended for the maintenance treatment of adult patients with moderate to severe chronic obstructive pulmonary disease (COPD).…

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Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (efavirenz / emtricitabine / tenofovir disoproxil) generic of Atripla now available for the Treatment of HIV infection

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is only used in patients whose levels of HIV in the blood (viral…

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Xgeva (denosumab) – EMA approves extension to existing indication: Prevention of bone complications of advanced cancers

On 22 February 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xgeva. The marketing authorisation holder for this medicinal product is Amgen Europe B.V. The full indications for Xgeva will be as…

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Bosulif (bosutinib) – an extension to the existing indication has been approved by EMA , Treatment of chronic myelogenous leukaemia (blood cancer)

On 22 February 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bosulif. The marketing authorisation holder for this medicinal product is Pfizer Limited. The CHMP adopted an extension to the existing indication for Bosulif…

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