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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
aviptadil/phentolamine mesilate (Invicorp) 1284/17 Evolan Pharma AB Restricted Full 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
carbetocin (Pabal) 309/06 Ferring Pharmaceuticals Ltd Not Recommended Full submission
carbetocin (Pabal) 100 mcg/1ml solution for injection 309/06 Ferring Pharmaceuticals 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
dequalinium (Fluomizin) 1194/16 Kora Healthcare Restricted Full submission
Desogestrel (Cerazette®) 36/03 Organon Laboratories Ltd Restricted Resubmission
Desogestrel (Cerazette®) 36/03 Organon Laboratories Ltd Not Recommended Full submission
dinoprostone 10mg vaginal delivery system (Propess) 283/06 Ferring Pharmaceuticals Ltd Accepted Abbreviated Submission
Drospirenone ethinylestradiol (Yasmin®) 23/03 Schering Health Care Ltd Not Recommended 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
estradiol / dienogest (Qlaira) 583/09 Bayer plc/Bayer Schering Pharma Not Recommended Non submission
ethinylestradiol 30mcg and levonorgestrel 150mcg (Rigevidon) 646/10 Consilient Health Ltd Accepted Abbreviated Submission
ethinylestradiol and desogestrel (Gedarel) 643/10 Consilient Health Ltd Accepted Abbreviated Submission
ethinylestradiol and gestodene (Millinette) 644/10 Consilient Health Ltd Accepted Abbreviated Submission
ethinylestradiol and levonorgestrel (TriRegol) 645/10 Consilient Health Ltd Accepted Abbreviated Submission
ethinylestradiol with drosperinone (Yasmin) 23/03 Bayer plc/Bayer Schering Pharma Not Recommended Resubmission
etonogestrel (Nexplanon) 655/10 MSD Accepted Abbreviated Submission
etonogestrel (Nuvaring) 502/08 Schering-Plough Ltd Accepted Resubmission
etonogestrel/ethinyl estradiol vaginal ring (NuvaRing) 502/08 Schering-Plough Ltd Not Recommended Full submission
fesoterodine fumarate (Toviaz) 480/08 Pfizer Ltd Restricted Full submission
levonorgestrel (Jaydess) 1036/15 Bayer plc/Bayer Schering Pharma Accepted Full submission
levonorgestrel (Kyleena) 1299/18 Bayer Plc Accepted Full submission
levonorgestrel (Levosert) 1058/15 Actavis Accepted Abbreviated Submission
levonorgestrel (Upostelle) 938/14 Consilient Health Ltd Accepted Abbreviated Submission
mifepristone (Medabon) 913/13 Sun Pharmaceuticals UK Ltd Accepted Abbreviated Submission
mirabegron (Betmiga) 862/13 Astellas Pharma Ltd Accepted Full submission
misoprostol (Mysodelle) 996/14 Ferring Pharmaceuticals Ltd Accepted Full submission
nomegestrol acetate / estradiol (Zoely) 898/13 MSD Not Recommended Non submission
Norelgestomic ethinyloestradiol (EVRA®) 48/03 Janssen-Cilag Ltd Restricted Full submission
Oxybutynin 3.9mg/24h transdermal patch (Kentera®) 190/05 UCB Pharma Ltd Restricted Full submission
progesterone (Lutigest) 1185/16 Ferring Pharmaceuticals Ltd Accepted 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
solifenacin and tamsulosin (Vesomni) 945/14 Astellas Pharma Ltd Accepted Abbreviated 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
ulipristal (EllaOne) 599/10 HRA Pharma UK Ltd Accepted Full 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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