Urorec Recordati Ireland Ltd · Authorised · authorised 29 Jan 2010 · ATC G04CA04
Therapeutic indication (EMA)
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Active substance
Silodosin
- SFDA 1
- US FDA 14
- EMA 3
- Health Canada 8
- US price lines 2
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Flopadex | 8 mg | Capsule, hard · Oral use | 30 Blister | SAR 64.05 | Generic · Prescription | Eva pharma for Industry | Valid |
Indications — CHI Daman Drug Formulary
BENIGN PROSTATIC HYPERTROPHY; RENAL AND URETERIC STONES
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SILODOSIN | 4MG; 8MG | capsule · oral | CHARTWELL RX | Prescription | 31 Mar 2017 |
| SILODOSIN | 4MG; 8MG | capsule · oral | LUPIN | Prescription | 3 Dec 2018 |
| SILODOSIN | 4MG; 8MG | capsule · oral | AMNEAL PHARMS CO | Prescription | 3 Dec 2018 |
| SILODOSIN | 4MG; 8MG | capsule · oral | MSN | Prescription | 3 Dec 2018 |
| SILODOSIN | 4MG; 8MG | capsule · oral | AJANTA PHARMA LTD | Prescription | 3 Dec 2018 |
| SILODOSIN | 4MG; 8MG | capsule · oral | MACLEODS PHARMS | Prescription | 3 Dec 2018 |
| SILODOSIN | 4MG; 8MG | capsule · oral | AUROBINDO PHARMA LTD | Prescription | 10 Dec 2018 |
| SILODOSIN | 4MG; 8MG | capsule · oral | HETERO LABS LTD V | Prescription | 14 Feb 2020 |
| SILODOSIN | 4MG; 8MG | capsule · oral | PHARMAZONE | Prescription | 3 Jan 2022 |
| SILODOSIN | 4MG; 8MG | capsule · oral | PRINSTON INC | Prescription | 4 Jan 2022 |
| RAPAFLO | 4MG; 8MG | capsule · oral | ABBVIE | Discontinued | 8 Oct 2008 |
| SILODOSIN | 4MG; 8MG | capsule · oral | ALEMBIC | Discontinued | 22 Nov 2019 |
| SILODOSIN | 4MG; 8MG | capsule · oral | ZYDUS PHARMS | Discontinued | 8 Dec 2022 |
| SILODOSIN | 4MG; 8MG | capsule · oral | TORRENT | Discontinued | 10 Feb 2025 |
EMA European Union — centrally authorised medicines
Silodyx Recordati Ireland Ltd · Authorised · authorised 29 Jan 2010 · ATC G04CA04
Therapeutic indication (EMA)
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
Silodosin Recordati Recordati Ireland Ltd · Authorised · authorised 7 Jan 2019 · ATC G04CA04
Therapeutic indication (EMA)
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AURO-SILODOSIN | 02478501 | 4 MG | CAPSULE · ORAL | AURO PHARMA INC |
| AURO-SILODOSIN | 02478528 | 8 MG | CAPSULE · ORAL | AURO PHARMA INC |
| JAMP SILODOSIN | 02539519 | 4 MG | CAPSULE · ORAL | JAMP PHARMA CORPORATION |
| JAMP SILODOSIN | 02539527 | 8 MG | CAPSULE · ORAL | JAMP PHARMA CORPORATION |
| PMS-SILODOSIN | 02517779 | 4 MG | CAPSULE · ORAL | PHARMASCIENCE INC |
| PMS-SILODOSIN | 02517787 | 8 MG | CAPSULE · ORAL | PHARMASCIENCE INC |
| SANDOZ SILODOSIN | 02475421 | 4 MG | CAPSULE · ORAL | SANDOZ CANADA INCORPORATED |
| SANDOZ SILODOSIN | 02475448 | 8 MG | CAPSULE · ORAL | SANDOZ CANADA INCORPORATED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | SILODOSIN 4 MG CAPSULE | $0.26502 | per EA | 23 Sep 2026 |
| US NADAC | SILODOSIN 8 MG CAPSULE | $0.31867 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 15 Dec 2020 RAPAFLO — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.