Viagra (sildenafil)
- Region
- 🇪🇺 EU
- Active substance
- sildenafil
- Company
- Viatris EESV
- Status
- Authorised
- Therapeutic area
- Erectile Dysfunction
- CHMP opinion
- Wed 27 May 1998
- EU approval
- Sun 13 Sep 1998
- Application
- EMEA/H/C/000202
- ATC
- G04BE03
- Official record
- www.ema.europa.eu
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 Viagra to be effective, sexual stimulation is required.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Revatio Authorised · Viatris EESV
- 🇪🇺 Mysildecard Authorised · Viatris Limited
- 🇪🇺 Sildenafil Actavis Authorised · Actavis Group PTC ehf
- 🇪🇺 Granpidam Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Vizarsin Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Sildenafil Teva Authorised · Teva B.V.
- 🇪🇺 Sildenafil ratiopharm Authorised · Ratiopharm GmbH
- 🇪🇺 Sildenafil FGK Application withdrawn · FGK Representative Service GmbH
- 🇪🇺 Patrex Withdrawn · Pfizer Limited
- 🇺🇸 Vybrique Approved · Ibsa
Follow Viagra
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.