LEVITRA

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

The drug LEVITRA contains one active pharmaceutical ingredient (API):

1
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 more about Vardenafil

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group 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)
AU Pharmaceutical Benefits Scheme 4290T, 4302K
BR Câmara de Regulação do Mercado de Medicamentos 515601309111214, 515601310111214, 515601312112218, 515601313119216, 538912050014413, 538912050014513, 538912050014813, 538912050014913, 538912050015013, 538916090027203
CA Health Products and Food Branch 02250470, 02250489
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 29583-01-11, 29584-01-11, 29645-02-11, 29900-07-11
EE Ravimiamet 1126325, 1126336, 1126347, 1126358, 1126369, 1126370, 1126381, 1126392, 1126404, 1126415, 1126426, 1126437, 1492545, 1492556, 1492567, 1526521, 1605776, 1605787, 1605798
ES Centro de información online de medicamentos de la AEMPS 03248005, 03248009IP, 03248010, 03248010IP1, 03248010IP2, 03248010IP3, 03248010IP5, 03248011IP, 03248011IP2
GB Medicines & Healthcare Products Regulatory Agency 147669, 147671, 186803, 379919, 379921, 43612, 43620, 43621, 43631, 43632
HK Department of Health Drug Office 51744, 51745, 51746, 61207
IL מִשְׂרַד הַבְּרִיאוּת 4681, 4682, 4683, 6916, 6950
IT Agenzia del Farmaco 035734122
LT Valstybinė vaistų kontrolės tarnyba 1011759, 1011760, 1011761, 1011762, 1011763, 1029412, 1029413, 1029414, 1029415, 1032065, 1032066, 1032067, 1056529, 1056530, 1056531, 1063710, 1063715, 1063718, 1063720
MX Comisión Federal para la Protección contra Riesgos Sanitarios 214M2002
NL Z-Index G-Standaard, PRK 69191, 69205, 69213
NZ Medicines and Medical Devices Safety Authority 10652, 10653, 10654, 14174
PL Rejestru Produktów Leczniczych 100113741, 100113758, 100113764, 100230671
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W63869001, W63869002, W63869003, W63869004, W63870001, W63870002, W63870003, W63870004, W63871001, W63871002, W63871003, W63871004
SG Health Sciences Authority 12317P, 12318P, 12319P, 14084P
TR İlaç ve Tıbbi Cihaz Kurumu 8699546092444, 8699546092451, 8699546092468, 8699546092475
US FDA, National Drug Code 0173-0829, 0173-0830, 0173-0831, 55289-193
ZA Health Products Regulatory Authority 36/7.1.5/0515, 36/7.1.5/0516, 36/7.1.5/0517, 44/7.1.5/1049

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