Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands
VIAGRA 25 mg film-coated tablets.
VIAGRA 50 mg film-coated tablets.
VIAGRA 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. VIAGRA 25 mg tablets: Blue, rounded diamond-shaped tablets, marked “PFIZER” on one side and “VGR 25” on the other. VIAGRA 50 mg tablets: Blue, rounded, diamond-shaped tablets, marked “PFIZER” on one side and “VGR 50” on the other. VIAGRA 100 mg tablets: Blue, rounded diamond-shaped tablets, marked “PFIZER” on one side and “VGR 100” on the other. |
Each tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg of sildenafil.
Excipient with known effect:
VIAGRA 25 mg tablets: Each tablet contains 0.9 mg lactose (as monohydrate).
VIAGRA 50 mg tablets: Each tablet contains 1.7 mg lactose (as monohydrate).
VIAGRA 100 mg tablets: Each tablet contains 3.5 mg lactose (as monohydrate).
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 |
VIAGRA 25 mg film-coated tablets: PVC/Aluminium blisters in cartons of 2, 4, 8 or 12 tablets.
VIAGRA 50 mg film-coated tablets: PVC/Aluminium blisters in cartons or secondary heat sealed card packaging of 2, 4, 8, 12 or 24 tablets.
VIAGRA 100 mg film-coated tablets: PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets.
Not all pack sizes may be marketed.
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands
VIAGRA 25 mg film-coated tablets:
EU/1/98/077/002-004
EU/1/98/077/013
VIAGRA 50 mg film-coated tablets:
EU/1/98/077/006-008
EU/1/98/077/014
EU/1/98/077/016-019
EU/1/98/077/024
VIAGRA 100 mg film-coated tablets:
EU/1/98/077/010-012
EU/1/98/077/015
EU/1/98/077/025
Date of first authorisation: 14 September 1998
Date of latest renewal: 14 September 2008
| Drug | Countries | |
|---|---|---|
| VIAGRA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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