MYCAMINE Powder for solution for infusion Ref.[8447] Active ingredients: Micafungin

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, Netherlands

Product name and form

Mycamine 50 mg powder for solution for infusion.

Mycamine 100 mg powder for solution for infusion.

Pharmaceutical Form

Powder for solution for infusion.

White compact powder.

Qualitative and quantitative composition

Mycamine 50 mg: Each vial contains 50 mg micafungin (as sodium).

After reconstitution each ml contains 10 mg micafungin (as sodium).

Mycamine 100 mg: Each vial contains 100 mg micafungin (as sodium).

After reconstitution each ml contains 20 mg micafungin (as sodium).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Micafungin

Micafungin non-competitively inhibits the synthesis of 1,3-β-D-glucan, an essential component of the fungal cell wall. 1,3-β-D-glucan is not present in mammalian cells. Micafungin exhibits fungicidal activity against most Candida species and prominently inhibits actively growing hyphae of Aspergillus species.

List of Excipients

Lactose monohydrate
Citric acid anhydrous (to adjust the pH)
Sodium hydroxide (to adjust the pH)

Pack sizes and marketing

10 ml Type I glass vial with an isobutylene-isoprene (PTFE-laminated) rubber stopper and a flip-off cap. The vial is wrapped with an UV-protective film.

Pack size: packs of 1 vial.

Marketing authorization holder

Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, Netherlands

Marketing authorization dates and numbers

EU/1/08/448/001
EU/1/08/448/002

Date of first authorisation: 25 April 2008
Date of latest renewal: 19 February 2018

Drugs

Drug Countries
MYCAMINE Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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