EMA — authorised 29 January 2010
- Application: EMEA/H/C/001092
- Marketing authorisation holder: Recordati Ireland Ltd
- Local brand name: Urorec
- Indication: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
- Status: approved
🇪🇺 Preventive administration of Rapaflo in European Union
EMA authorised Preventive administration of Rapaflo on 29 January 2010
Marketing authorisations
EMA — authorised 29 January 2010
- Application: EMEA/H/C/001209
- Marketing authorisation holder: Recordati Ireland Ltd
- Local brand name: Silodyx
- Indication: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
- Status: approved
EMA — authorised 7 January 2019
- Application: EMEA/H/C/004964
- Marketing authorisation holder: Recordati Ireland Ltd
- Local brand name: Silodosin Recordati
- Indication: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.
- Status: approved
Preventive administration of Rapaflo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Urology approved in European Union
Frequently asked questions
Is Preventive administration of Rapaflo approved in European Union?
Yes. EMA authorised it on 29 January 2010; EMA authorised it on 29 January 2010; EMA authorised it on 7 January 2019.
Who is the marketing authorisation holder for Preventive administration of Rapaflo in European Union?
Recordati Ireland Ltd holds the EU marketing authorisation.