This brand name is authorized in Austria, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.
The drug PRILIGY contains one active pharmaceutical ingredient (API):
1
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UNII
U4OHT63MRI - DAPOXETINE HYDROCHLORIDE
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Dapoxetine is a potent selective serotonin reuptake inhibitor (SSRI). The mechanism of action of dapoxetine in premature ejaculation is presumed to be linked to the inhibition of neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter’s action at pre- and postsynaptic receptors. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| PRILIGY Film-coated tablet | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| G04BX14 | Dapoxetine | G Genito urinary system and sex hormones → G04 Urologicals → G04B Other urologicals, incl. antispasmodics → G04BX Other urologicals |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 4355-MEE-0818, 4433-MEE-1018 |
| EE | Ravimiamet | 1488955, 1488966, 1488977, 1488988, 1489002, 1489013, 1489024, 1489035 |
| ES | Centro de información online de medicamentos de la AEMPS | 70874, 70875 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 188811, 441646 |
| FR | Base de données publique des médicaments | 67084087, 67428136 |
| GB | Medicines & Healthcare Products Regulatory Agency | 233617, 233618, 233622, 233623 |
| HK | Department of Health Drug Office | 60174, 60175 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-635589393, HR-H-674827417 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1055892, 1055893, 1066116, 1066117, 1066118, 1066119, 1066120, 1066121 |
| MT | Medicines Authority | MA1022/00101, MA1022/00102 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 132M2009 |
| NL | Z-Index G-Standaard, PRK | 106437, 106445 |
| NZ | Medicines and Medical Devices Safety Authority | 13373, 13376 |
| PL | Rejestru Produktów Leczniczych | 100282745, 100282751 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W59982001, W59982002, W59982003, W59982004, W59983001, W59983002, W59983003, W59983004 |
| SG | Health Sciences Authority | 13880P, 13881P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699832090536, 8699832090543, 8699832090550, 8699832090567, 8699832090574, 8699832090581 |
| ZA | Health Products Regulatory Authority | 43/18.10/0692, 43/18.10/0693 |
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