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ECALTA Powder for concentrate for solution for infusion (2020)

Active ingredients: Anidulafungin

Product Name and Form

ECALTA 100 mg powder for concentrate for solution for infusion.

Pharmaceutical form

Powder for concentrate for solution for infusion.

White to off-white solid.

The reconstituted solution has a pH of 3.5 to 5.5.

Qualitative and Quantitative Composition

Each vial contains 100 mg anidulafungin.

The reconstituted solution contains 3.33 mg/mL anidulafungin and the diluted solution contains 0.77 mg/mL anidulafungin.

Excipient with known effect: Fructose 102.5 mg per vial.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Anidulafungin

Anidulafungin is a semi-synthetic echinocandin, a lipopeptide synthesised from a fermentation product of Aspergillus nidulans. Anidulafungin selectively inhibits 1,3-β-D glucan synthase, an enzyme present in fungal, but not mammalian cells.

List of excipients

Fructose
Mannitol
Polysorbate 80
Tartaric acid
Sodium hydroxide (for pH-adjustment)
Hydrochloric acid (for pH-adjustment)

Pack sizes and Marketing

30 mL Type 1 glass vial with an elastomeric stopper (butyl rubber with an inert polymer coating on the product contact surface and lubricant on the top surface for easier machinability, or alternatively bromobutyl rubber with a lubricant) and aluminium seal with flip-off cap.

Pack size of 1 vial.

Marketing authorization holder
Authorization dates

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium

Date of first authorisation: 20 September 2007
Date of latest renewal: 28 August 2017

Marketing authorization number:

EU/1/07/416/002