MUSE Urethral Stick Ref.[8671] Active ingredients: Alprostadil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

MUSE 500 microgram urethral stick.

Pharmaceutical Form

Urethral Stick.

MUSE is a sterile, single-use transurethral system for the delivery of alprostadil to the male urethra. Alprostadil is suspended in macrogol and is formed into a urethral stick (1.4 mm in diameter by 3 mm in length) which is contained in the tip of the polypropylene applicator.

Qualitative and quantitative composition

Each urethral stick contains 500 micrograms alprostadil.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Alprostadil

Alprostadil is chemically identical to prostaglandin E1, the actions of which include vasodilatation of blood vessels in the erectile tissues of the corpora cavernosa and increase in cavernosal artery blood flow, causing penile rigidity.

List of Excipients

Macrogol 1450

Pack sizes and marketing

MUSE is supplied as cartons of 1, 2, 3, 6 or 10 foil pouches, with each pouch containing one delivery system. Not all pack sizes may be marketed.

The pouches are composed of aluminium foil/laminate. The applicators are made from radiation-resistant medical-grade polypropylene.

Marketing authorization holder

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0183

Date of first authorization: 24 November 1997

Date of latest renewal: 10 October 2007

Drugs

Drug Countries
MUSE Austria, Canada, Estonia, Spain, Finland, Ireland, Lithuania, Netherlands, United Kingdom, United States

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