REVATIO Solution for injection Ref.[7442] Active ingredients: Sildenafil

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Product name and form

Revatio 0.8mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless solution.

Qualitative and quantitative composition

Each ml of solution contains 0.8mg of sildenafil (as citrate). Each 20ml vial contains 12.5ml of solution (10mg of sildenafil, as citrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sildenafil

Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5), the enzyme that is responsible for degradation of cGMP. Apart from the presence of this enzyme in the corpus cavernosum of the penis, PDE5 is also present in the pulmonary vasculature. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation.

List of Excipients

Glucose
Water for injections

Pack sizes and marketing

Each pack contains one 20ml clear, type I glass vial with a chlorobutyl rubber stopper and an aluminium overseal.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Marketing authorization dates and numbers

EU/1/05/318/002

Date of first authorisation: 28 October 2005
Date of latest renewal: 23 September 2010

Drugs

Drug Countries
REVATIO Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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