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Category: 7.4 Drugs for genito-urinary disorders

Name SMC ID No Manufacturer Status Sub. Type
 
avanafil (Spedra) 980/14 A Menarini Pharmaceuticals UK Ltd Not Recommended Full submission
avanafil (Spedra®) 980/14 A Menarini Pharmaceuticals UK Ltd Not Recommended Non submission
botulinum toxin type a (Botox) 916/13 Allergan Ltd Accepted Full submission
botulinum toxin type A (Botox) 931/13 Allergan Ltd Restricted Full submission
botulinum toxin type A (Botox®) 931/13 Allergan Ltd Not Recommended Non submission
dapoxetine (Priligy) 987/14 A Menarini Pharmaceuticals UK Ltd Not Recommended Non submission
darifenacin 7.5 mg, 15 mg prolonged-release tablets(Emselex) 377/07 Ardana Bioscience Restricted Full submission
Duloxetine (Yentreve®) 119/04 Eli Lilly and Company Ltd Restricted Full submission
dutasteride plus tamsulosin (Combodart) 628/10 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
fesoterodine fumarate (Toviaz) 480/08 Pfizer Ltd Restricted Full submission
mirabegron (Betmiga) 862/13 Astellas Pharma Ltd Accepted Full submission
Oxybutynin 3.9mg/24h transdermal patch (Kentera®) 190/05 UCB Pharma Ltd Restricted Full submission
propiverine hydrochloride 30 mg modified release capsule (Detrunorm XL) 340/07 Amdipharm PLC Accepted Abbreviated Submission
Solifenacin (Vesicare®) 129/04 Yamanouchi Pharma Ltd Accepted Resubmission
Solifenacin (Vesicare®) 129/04 Yamanouchi Pharma Ltd Not Recommended Full submission
tadalafil (Cialis) 554/09 Lilly UK Accepted Abbreviated Submission
tadalafil (Cialis) 849/12 Eli Lilly and Company Ltd Not Recommended Non submission
Tadalafil (Cialis®) 40/03 Eli Lilly and Company Ltd Accepted Full submission
Tamsulosin (Flomaxtra XL®) 149/04 Yamanouchi Pharma Ltd Accepted Abbreviated Submission
trospium chloride 20 mg film-coated tablets (Flotros) 600/10 Galen Ltd Accepted Abbreviated Submission
vardenafil (Levitra) 727/11 Bayer plc/Bayer Schering Pharma Restricted Full submission
Vardenafil (Levitra®) 47/03 GlaxoSmithKline UK Ltd Accepted Full submission

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