MEVLYQ Solution for injection Ref.[109365] Active ingredients: Eribulin mesylate

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: YES Pharmaceutical Development Services GmbH, Basler Strasse 7, 61352 Bad Homburg, Germany

Product name and form

Mevlyq 0.44 mg/mL solution for injection.

Pharmaceutical Form

Solution for injection (injection).

Clear, colourless aqueous solution with a pH of 6.0-9.0.

Qualitative and quantitative composition

Each mL contains 0.5 mg eribulin mesilate equivalent to 0.44 mg eribulin.

Each 2 mL vial contains eribulin mesilate equivalent to 0.88 mg eribulin.

Excipient with known effect: Each mL solution for injection contains 40 mg ethanol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Eribulin mesylate

Eribulin is a microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents. It is a structurally simplified synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.

List of Excipients

Ethanol anhydrous
Water for injections
Hydrochloric acid (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)

Pack sizes and marketing

4 mL type I colourless glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 2 mL of solution.

The pack size is 1 vial.

Marketing authorization holder

YES Pharmaceutical Development Services GmbH, Basler Strasse 7, 61352 Bad Homburg, Germany

Marketing authorization dates and numbers

EU/1/23/1789/001

Drugs

Drug Countries
MEVLYQ Estonia, Croatia, Lithuania

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