CHMP Issues Positive Opinion for Intravenous Formulation of Merck's Noxafil
Merck (known as MSD outside the US and Canada) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion
recommending approval of a new, investigational intravenous (IV) formulation of Noxafil (posaconazole).
The CHMP positive opinion will be reviewed by the European Commission which, should they affirm the CHMP opinion, will grant a centralised marketing authorisation with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway.
The European Commission previously granted centralised marketing authorisation for Noxafil gastro-resistant tablets and Noxafil oral suspension.
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