PROSTIN VR Concentrate for solution for infusion Ref.[8672] Active ingredients: Alprostadil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Product name and form

Prostin VR 500 micrograms/ml Concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion (Sterile concentrate).

Clear, colourless solution.

Qualitative and quantitative composition

500 micrograms/ml. Each 1 ml ampoule contains 500 micrograms of alprostadil.

Excipient(s) with known effect: Each ml contains 789 mg ethanol.

For the 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

Ethanol

Pack sizes and marketing

1ml Type I clear glass ampoule.

Multipacks containing 5 × 1 ml ampoules.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Marketing authorization dates and numbers

PL 00057/1031

Date of first authorisation: 23 July 1981

Date of latest renewal: 17 April 1997

Drugs

Drug Countries
PROSTIN VR Canada, Estonia, Hong Kong, Croatia, Israel, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa

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