Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Revatio 0.8mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless solution. |
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 |
Each pack contains one 20ml clear, type I glass vial with a chlorobutyl rubber stopper and an aluminium overseal.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/05/318/002
Date of first authorisation: 28 October 2005
Date of latest renewal: 23 September 2010
| 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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