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IVEMEND Powder for solution for infusion (2019)

Active ingredients: Fosaprepitant

Product Name and Form

IVEMEND 150 mg powder for solution for infusion.

Pharmaceutical form

Powder for solution for infusion.

White to off-white amorphous powder.

Qualitative and Quantitative Composition

Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant, which corresponds to 130.5 mg of aprepitant. After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant (1 mg/ml) (see section 6.6).

For the full list of excipients, see section 6.1.

Chemical substance
Description
Fosaprepitant

Fosaprepitant is the prodrug of aprepitant and when administered intravenously is converted rapidly to aprepitant. The contribution of fosaprepitant to the overall antiemetic effect has not fully been characterised, but a transient contribution during the initial phase cannot be ruled out.

List of excipients

Disodium edetate (E386)
Polysorbate 80 (E433)
Lactose anhydrous
Sodium hydroxide (E524) (for pH adjustment) and/or
Hydrochloric acid diluted (E507) (for pH adjustment)

Pack sizes and Marketing

10 ml Type I clear glass vial with a chlorobutyl or bromobutyl rubber stopper and an aluminum seal with a grey plastic flip off cap.

Pack sizes: 1 or 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Date of first authorisation: 11 January 2008

Date of latest renewal: 11 January 2013

Marketing authorization number:

EU/1/07/437/003

EU/1/07/437/004