REZZAYO Powder for solution for infusion Ref.[107889] Active ingredients: Rezafungin

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Mundipharma GmbH, De-Saint-Exupery-Strasse 10, Frankfurt Am Main, 60549, Germany

Product name and form

REZZAYO 200 mg powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion.

White to pale yellow cake or powder.

Qualitative and quantitative composition

Each vial contains 200 mg rezafungin (as acetate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Rezafungin

Rezafungin selectively inhibits fungal 1,3-β-D-glucan synthase. This results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall which is not present in mammalian cells. Inhibition of 1,3-β-D-glucan synthesis results in rapid and concentration-dependent fungicidal activity in Candida species (spp.).

List of Excipients

Mannitol
Histidine
Polysorbate 80
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

Glass vial with chlorobutyl rubber stopper and aluminium seal with plastic flip-off cap.

Pack size: 1 vial.

Marketing authorization holder

Mundipharma GmbH, De-Saint-Exupery-Strasse 10, Frankfurt Am Main, 60549, Germany

Marketing authorization dates and numbers

EU/1/23/1775/001

Drugs

Drug Countries
REZZAYO Austria, Estonia, France, Croatia, Ireland, Lithuania, United Kingdom, United States

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