LEVITRA

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

Active ingredients

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.

Read about Vardenafil

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
LEVITRA Film-coated tablet European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

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
Discover more medicines within G04BE09

Authorization and marketing

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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