🇪🇺 Oral Sildenafil 50 mg in European Union

EMA authorised Oral Sildenafil 50 mg on 15 September 1998

Marketing authorisations

Application: EMEA/H/C/000204
Marketing authorisation holder: Pfizer Limited
Local brand name: Patrex
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 Patrex to be effective, sexual stimulation is required. Patrex is not indicated for use by women.
Status: withdrawn

Application: EMEA/H/C/000638
Marketing authorisation holder: Upjohn EESV
Local brand name: Revatio
Indication: Treatment of adult patients with pulmonary arterial hypertension classified as World Health Organization (WHO) functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population Treatment of paediatric patients aged one year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congen
Status: approved

Application: EMEA/H/C/001076
Marketing authorisation holder: Krka, d.d., Novo mesto
Local brand name: Vizarsin
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.
Status: approved

Application: EMEA/H/C/001073
Marketing authorisation holder: Teva B.V.
Local brand name: Sildenafil Teva
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 Sildenafil Teva to be effective, sexual stimulation is required.
Status: approved

Application: EMEA/H/C/001090
Marketing authorisation holder: Actavis Group PTC ehf
Local brand name: Sildenafil Actavis
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 Sildenafil Actavis to be effective, sexual stimulation is required.
Status: approved

Application: EMEA/H/C/001080
Marketing authorisation holder: Ratiopharm GmbH
Local brand name: Sildenafil ratiopharm
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 sildenafil to be effective, sexual stimulation is required.
Status: approved

Application: EMEA/H/C/004186
Marketing authorisation holder: Viatris Limited
Local brand name: Mysildecard
Indication: AdultsTreatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric populationTreatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease (see s
Status: approved

Application: EMEA/H/C/004289
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Granpidam
Indication: Adults Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Oral Sildenafil 50 mg approved in European Union?

Yes. EMA authorised it on 15 September 1998; EMA authorised it on 28 October 2005; EMA authorised it on 21 September 2009.

Who is the marketing authorisation holder for Oral Sildenafil 50 mg in European Union?

Pfizer Limited holds the EU marketing authorisation.