This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Hong Kong, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa
The drug LEVITRA contains one active pharmaceutical ingredient (API):
1
Vardenafil
UNII 5M8S2CU0TS - VARDENAFIL HYDROCHLORIDE
|
Vardenafil is a potent and selective inhibitor of the cGMP specific phosphodiesterase type 5 (PDE5), the most prominent PDE in the human corpus cavernosum. Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction. In the natural setting, i.e. with sexual stimulation it restores impaired erectile function by increasing blood flow to the penis. |
Below package inserts are available for further reading:
Title | Information Source | Document Type | |
---|---|---|---|
LEVITRA Film-coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC code | Group title | Classification |
---|---|---|
G04BE09 | Vardenafil | G Genito urinary system and sex hormones → G04 Urologicals → G04B Other urologicals, incl. antispasmodics → G04BE Drugs used in erectile dysfunction |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
---|---|---|
Country: AU | Pharmaceutical Benefits Scheme | Identifier(s): 4290T, 4302K |
Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 515601309111214, 515601310111214, 515601312112218, 515601313119216, 538912050014413, 538912050014513, 538912050014813, 538912050014913, 538912050015013, 538916090027203 |
Country: CA | Health Products and Food Branch | Identifier(s): 02250470, 02250489 |
Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 29583-01-11, 29584-01-11, 29645-02-11, 29900-07-11 |
Country: EE | Ravimiamet | Identifier(s): 1126325, 1126336, 1126347, 1126358, 1126369, 1126370, 1126381, 1126392, 1126404, 1126415, 1126426, 1126437, 1492545, 1492556, 1492567, 1526521, 1605776, 1605787, 1605798 |
Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 03248005, 03248009IP, 03248010, 03248010IP1, 03248010IP2, 03248010IP3, 03248010IP5, 03248011IP, 03248011IP2 |
Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 147669, 147671, 186803, 379919, 379921, 43612, 43620, 43621, 43631, 43632 |
Country: HK | Department of Health Drug Office | Identifier(s): 51744, 51745, 51746, 61207 |
Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 4681, 4682, 4683, 6916, 6950 |
Country: IT | Agenzia del Farmaco | Identifier(s): 035734122 |
Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1011759, 1011760, 1011761, 1011762, 1011763, 1029412, 1029413, 1029414, 1029415, 1032065, 1032066, 1032067, 1056529, 1056530, 1056531, 1063710, 1063715, 1063718, 1063720 |
Country: MX | Comisión Federal para la Protección contra Riesgos Sanitarios | Identifier(s): 214M2002 |
Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 69191, 69205, 69213 |
Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 10652, 10653, 10654, 14174 |
Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100113741, 100113758, 100113764, 100230671 |
Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W63869001, W63869002, W63869003, W63869004, W63870001, W63870002, W63870003, W63870004, W63871001, W63871002, W63871003, W63871004 |
Country: SG | Health Sciences Authority | Identifier(s): 12317P, 12318P, 12319P, 14084P |
Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699546092444, 8699546092451, 8699546092468, 8699546092475 |
Country: US | FDA, National Drug Code | Identifier(s): 0173-0829, 0173-0830, 0173-0831, 55289-193 |
Country: ZA | Health Products Regulatory Authority | Identifier(s): 36/7.1.5/0515, 36/7.1.5/0516, 36/7.1.5/0517, 44/7.1.5/1049 |
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