EMA approves two generics for fungal infections Posted 19/07/2019

On 29 May 2019, the European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for two new generics for the treatment and prevention of fungal infections, Posaconazole Accord and Posaconazole AHCL.

Posaconazole Accord will be available as 100 mg gastro-resistant tablets and Posaconazole AHCL will be available as a 40 mg/mL oral suspension. The active substance of both products is posaconazole, a triazole antimycotic (ATC code: J02AC04) that inhibits the enzyme lanosterol 14α-demethylase (CYP51), which catalyses an essential step in ergosterol biosynthesis.

Posaconazole Accord and Posaconazole AHCL are made by Accord Healthcare SLU. They are both generics of Noxafil, which has been authorized in the European Union since 25 October 2005. Studies have demonstrated the satisfactory quality of the products and their bioequivalence to the reference product. They are indicated for treatment of a number of fungal infections in adults.

Related article
Generics applications under review by EMA – January 2019

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Source: EMA

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