ETOPOPHOS Powder for solution for injection Ref.[8157] Active ingredients: Etoposide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Neon Healthcare Limited, Mill Studio Business Centre, Crane Mead, Ware, Hertfordshire, SG12 9PY, United Kingdom

Product name and form

ETOPOPHOS 100mg Powder for Solution for Injection.

Pharmaceutical Form

Powder for solution for injection.

White to off-white dry powder.

Qualitative and quantitative composition

Each vial contains 113.6 mg etoposide phosphate equivalent to 100 mg etoposide.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Etoposide

The main effect of etoposide appears to be at the late S and early G2 portion of the cell cycle in mammalian cells. The predominant macromolecular effect of etoposide seems to be the rupture of the double strand by an interaction with DNA-topoisomerase II or by the formation of free radicals. Etoposide has been shown to cause metaphase arrest in chick fibroblasts.

List of Excipients

Dextran 40
Sodium citrate

Pack sizes and marketing

Type I glass vial with a butyl rubber stopper and flip-off aluminium seal. Packs of 1, 5, 10, 20, 25 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Neon Healthcare Limited, Mill Studio Business Centre, Crane Mead, Ware, Hertfordshire, SG12 9PY, United Kingdom

Marketing authorization dates and numbers

PL 45043/0038

Date of first authorisation: 23 May 1996
Date of latest renewal: 22 Jan 2007

Drugs

Drug Countries
ETOPOPHOS Australia, Estonia, France, New Zealand, United Kingdom, United States

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