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Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-8390
Trade NameDose FormStrengthIdentifier
VedafilFilm coated tablet100mg
SponsorApplication dateRegistration situationClassification
Mylan New Zealand Ltd
P O Box 11183
Ellerslie
AUCKLAND 1542
10/4/2014Consent given
Approval date: 23/9/2010
Prescription
 

Composition

ComponentIngredientManufacturer
film coated tablet, Active 
 Sildenafil citrate 140.483mg (equivalent to Sildenafil 100 mg)Mylan Laboratories Limited
Unit 8, Getula Chodavaram
Poosapatirega Mandal
Vizianagaram District
Andhra Pradesh 535 204
India
 Excipient 
 Calcium hydrogen phosphate
 Croscarmellose sodium
 Magnesium stearate
 Microcrystalline cellulose
 Opadry blue 03K80846 (TT70-03-8-24)
 Purified water
  

Production

Manufacturing stepManufacturer
Finished Product TestingMylan Laboratories Limited
F4/F12 Malegaon MIDC
Sinnar
Nashik
Maharashtra State 422 113
India
Manufacture of Final Dose FormMylan Laboratories Limited
F4/F12 Malegaon MIDC
Sinnar
Nashik
Maharashtra State 422 113
India
PackingMylan Laboratories Limited
F4/F12 Malegaon MIDC
Sinnar
Nashik
Maharashtra State 422 113
India
 Mylan New Zealand Ltd
2B George Bourke Drive
Mt. Wellington
Auckland 1060
NZ Site of Product ReleaseMylan New Zealand Ltd
2B George Bourke Drive
Mt. Wellington
Auckland 1060

Packaging

PackageContentsShelf Life
Blister pack, Clear PVC/hard tempered aluminium foil film coated with heat sealed lacquer1 tablet36 months from date of manufacture stored at or below 25°C.
Blister pack, Clear PVC/hard tempered aluminium foil film coated with heat sealed lacquer4 tablets36 months from date of manufacture stored at or below 25°C.
Blister pack, Clear PVC/hard tempered aluminium foil film coated with heat sealed lacquer8 tablets36 months from date of manufacture stored at or below 25°C.
Blister pack, Clear PVC/hard tempered aluminium foil film coated with heat sealed lacquer12 tablets36 months from date of manufacture stored at or below 25°C.

Indications

VEDAFIL is indicated for the treatment of erectile dysfunction in males

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
10/4/2014Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Awaiting payment  
14/7/2009New Intermediate-risk Medicine ApplicationNew intermediate-risk prescription medicine
Additional strength - Grade 1
Granted 23/9/201028/7/2009