MedPath
EMA Approval

Levitra

G04BE09

vardenafil

Urologicals

Basic Information

G04BE09

vardenafil

Urologicals

Therapeutic indication

Treatment of erectile dysfunction in adult men.

Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

In order for Levitra to be effective, sexual stimulation is required.

Levitra is not indicated for use by women.

Overview Summary

This is a summary of the European public assessment report (EPAR) for Levitra. 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 Levitra.

Authorisations (1)

EMEA/H/C/000475

Bayer AG,Bayer AG,51368 Leverkusen,Germany

Authorised

March 6, 2003

Active Substances (1)

vardenafil

Documents (12)

Levitra : EPAR - Summary for the public

August 24, 2009

OVERVIEW_DOCUMENT

Levitra : EPAR - Procedural steps taken before authorisation

October 20, 2005

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Levitra-H-C-PSUSA-00003098/201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

December 20, 2019

CHANGES_SINCE_INITIAL_AUTHORISATION

Levitra-H-C-475-X-28 : EPAR - Assessment Report - Extension

September 23, 2010

CHANGES_SINCE_INITIAL_AUTHORISATION

Levitra-H-C-PSUSA-00003098-202403 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

January 20, 2025

CHANGES_SINCE_INITIAL_AUTHORISATION

Levitra : EPAR - Scientific Discussion

October 20, 2005

CHANGES_SINCE_INITIAL_AUTHORISATION

Levitra : EPAR - Procedural steps taken before authorisation

October 20, 2005

CHANGES_SINCE_INITIAL_AUTHORISATION

Levitra : EPAR - Product Information

August 24, 2009

DRUG_PRODUCT_INFORMATION

Levitra : EPAR - Scientific Discussion

October 20, 2005

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Levitra : EPAR - Risk-management-plan summary

June 27, 2019

RISK_MANAGEMENT_PLAN_SUMMARY

Levitra : EPAR - Procedural steps taken and scientific information after authorisation

August 24, 2009

CHANGES_SINCE_INITIAL_AUTHORISATION

Levitra : EPAR - All Authorised presentations

October 20, 2005

AUTHORISED_PRESENTATIONS

Overview Q&A (10)

Question

How is Levitra used?

Answer

The recommended dose of Levitra is 10 mg, taken about 25 to 60 minutes before sexual activity. The orodispersible tablets must be taken without liquid. If Levitra film-coated tablets are taken with a high-fat meal, the onset of activity may be delayed. The dose of the film-coated tablets may be increased to a maximum of 20 mg or decreased to 5 mg, depending on the effectiveness of treatment and any side effects.

A starting dose of 5 mg should be considered for patients with mild and moderate liver problems or severe kidney problems. The dose may need to be adjusted in patients taking other medicines that block enzymes that break down Levitra. For full details, see the package leaflet.

The maximum recommended dosing frequency is one film-coated tablet or orodispersible tablet per day.

Question

How does Levitra work?

Answer

The active ingredient of Levitra, vardenafil, 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, Levitra restores erectile function. Sexual stimulation is still needed to produce an erection.

Question

What is Levitra used for?

Answer

Levitra is used to treat adult men (aged 18 years or over) with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Levitra to be effective, sexual stimulation is required.

The medicine can only be obtained with a prescription.

Question

How has Levitra been studied?

Answer

Levitra tablets were compared with placebo (a dummy treatment) in four main studies including a total of 2,431 men with erectile dysfunction aged 20 to 83 years. One of these studies was carried out in diabetic men and another in men who had had their prostate gland removed. Two additional main studies compared orodispersible tablets with placebo in 701 men aged 21 to 84 years

In all of the studies, the main measure of effectiveness was the ability to get and maintain an erection. This was recorded in two questionnaires completed at home. The studies lasted 12 weeks.

Question

What benefit has Levitra shown during the studies?

Answer

Levitra tablets and orodispersible tablets were significantly more effective than placebo for all measures in all of the studies.

Question

What measures are being taken to ensure the safe and effective use of Levitra?

Answer

A risk management plan has been developed to ensure that Levitra is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Levitra, including the appropriate precautions to be followed by healthcare professionals and patients.

Question

Other information about Levitra

Answer

The European Commission granted a marketing authorisation valid throughout the European Union for Levitra on 6 March 2003.

For more information about treatment with Levitra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Question

What is Levitra?

Answer

Levitra is a medicine that contains the active substance vardenafil. It is available as film-coated tablets (5, 10 and 20 mg) and as orodispersible tablets (10 mg). Orodispersible tablets are tablets that dissolve in the mouth.

Question

Why has Levitra been approved?

Answer

The CHMP decided that Levitra’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Question

What is the risk associated with Levitra?

Answer

The most common side effect with Levitra (seen in more than 1 patient in 10) is headache. For the full list of all side effects reported with Levitra, see the package leaflet.

Levitra must not be used in people who are hypersensitive (allergic) to vardenafil or any of the other ingredients. It must not be used when sexual activity is inadvisable, such as in men with severe heart disease. It must also not be used in patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non?arteritic anterior ischemic optic neuropathy or NAION). Levitra must not be taken with nitrates (medicines used to treat angina).

Because Levitra has not been studied in the following group patients, they must not use the medicine:

  • patients with severe liver disease or end-stage kidney disease requiring dialysis;
  • patients who have hypotension (low blood pressure);
  • patients who have had a stroke or a heart attack within the last six months;
  • patients with unstable angina and hereditary eye problems known as ‘retinal degenerative disorders’.

Levitra must not be taken with ketoconazole and itraconazole (used to treat fungal infections) in men over 75 years of age, or with medicines called ‘HIV protease inhibitors’ such as ritonavir or indinavir (used to treat HIV infection).

In addition, Levitra must not be taken with medicines known as guanylate cyclase stimulators, including riociguat (used to treat pulmonary hypertension [high blood pressure in the lungs]).

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