Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Revatio 20mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White, round, biconvex film-coated tablets marked “PFIZER” on one side and “RVT 20” on the other. |
Each film-coated tablet contains 20mg of sildenafil (as citrate).
Excipient(s) with known effect: ach tablet also contains 0.7mg of lactose.
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 |
|---|
|
Tablet core: Microcrystalline cellulose Film coat: Hypromellose |
PVC/Aluminium blisters of 90 tablets.
Pack size of 90 tablets in a carton.
90 × 1 tablets in PVC/Aluminium perforated unit dose blisters.
PVC/Aluminium blisters of 300 tablets.
Pack size of 300 tablets in a carton.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/05/318/001
EU/1/05/318/004
EU/1/05/318/005
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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