Vizarsin
Authorised
This medicine is authorised for use in the European Union
sildenafil
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Vizarsin. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vizarsin.
Vizarsin is a medicine that contains the active substance sildenafil. It is available as film-coated tablets (25, 50 and 100 mg) and as orodispersible tablets (25, 50 and 100 mg). Orodispersible means that the tablet dissolves in the mouth.
Vizarsin is a ‘generic medicine’. This means that Vizarsin is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Viagra.
Vizarsin is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Vizarsin to be effective, sexual stimulation is required.
The medicine can only be obtained with a prescription.
The recommended dose of Vizarsin is 50 mg taken as needed about one hour before sexual activity. If Vizarsin is taken with food, the onset of activity may be delayed compared with taking Vizarsin without food. The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects. Patients with reduced liver or severely reduced kidney function should start treatment with the 25-mg dose. The maximum recommended dosing frequency is one tablet per day.
The active ingredient in Vizarsin, sildenafil, belongs to a group of medicines called phosphodiesterase-type-5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cGMP, Vizarsin restores erectile function. Sexual stimulation is still needed to produce an erection.
Because Vizarsin is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Because Vizarsin is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
The CHMP concluded that, in accordance with EU requirements, Vizarsin has been shown to have comparable quality and to be bioequivalent to Viagra. Therefore, the CHMP’s view was that, as for Viagra, the benefit outweighs the identified risk. The Committee recommended that Vizarsin be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union for Vizarsin on 21 September 2009.
For more information about treatment with Vizarsin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
N/0036
22/02/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Vizarsin
- Active substance
- sildenafil
- International non-proprietary name (INN) or common name
- sildenafil
- Therapeutic area (MeSH)
- Erectile Dysfunction
- Anatomical therapeutic chemical (ATC) code
- G04BE03
Pharmacotherapeutic group
UrologicalsTherapeutic indication
Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
In order for Vizarsin to be effective, sexual stimulation is required.
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