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Name SMC ID No Manufacturer Status Sub. Type
 
Movicol Paediatric Plain 103/04 Norgine Ltd Accepted Abbreviated Submission
budesonide 3mg gastro-resistant capsules (Budenofalk) 1043/15 Dr Falk Pharma UK Restricted Full submission
vedolizumab (Entyvio) 1045/15 Takeda UK Ltd Accepted Full submission
vedolizumab (Entyvio) 1064/15 Takeda UK Ltd Restricted Full submission
budesonide (Cortiment) 1093/15 Ferring Pharmaceuticals Ltd Restricted Resubmission
budesonide (Cortiment) 1093/15 Ferring Pharmaceuticals Ltd Not Recommended Abbreviated Submission
naloxegol (Moventig) 1106/15 AstraZeneca UK Ltd Accepted Full submission
teduglutide (Revestive) 1139/16 NPS Pharma UK Ltd Not Recommended Non submission
Rabeprazole (Pariet®) 118/04 Janssen-Cilag Ltd Accepted Full submission
adalimumab (Humira) 1208/16 AbbVie Ltd Not Recommended Non submission
obeticholic acid (Ocaliva) 1232/17 Intercept Pharmaceuticals Accepted Full submission
Esomeprazole (Nexium®) 124/04 AstraZeneca UK Ltd Accepted Full submission
ustekinumab (Stelara) 1250/17 Janssen-Cilag Ltd Accepted Full submission
eluxadoline (Truberzi) 1292/18 Allergan Ltd Not Recommended Full submission
bezlotoxumab (Zinplava) 1293/17 MSD Not Recommended Non submission
Creon micro (Creon®) 141/04 Solvay Healthcare Ltd Restricted Abbreviated Submission
beclometasone dipropionate 5mg (Clipper) 166/05 Trinity-Chiesi Pharmaceuticals Ltd Not Recommended Full submission
Glyceryl trinitrate (GTN), 0.4% w/w (4mg/g), rectal ointment (Rectogesic®) 200/05 ProStrakan Not Recommended Resubmission
Glyceryl trinitrate (GTN), 0.4% w/w (4mg/g), rectal ointment (Rectogesic®) 200/05 ProStrakan Not Recommended Full submission
glyceryl trinitrate 0.4% rectal ointment (Rectogesic®) 200/05 ProStrakan Not Recommended Resubmission
glyceryl trinitrate 0.4% (Rectogesic) 200/05 ProStrakan Not Recommended Resubmission
mesalazine (Asacol) 222/05 Procter and Gamble Accepted Abbreviated Submission
mesalazine (Asacol) 223/05 Procter and Gamble Accepted Abbreviated Submission
mesalazine (Asacol) 224/05 Procter and Gamble Accepted Abbreviated Submission
Lansoprazole oro-dispersible tablet (Zoton FasTab®) 229/05 Wyeth Pharmaceuticals Accepted Abbreviated Submission
Rabeprazole 10 mg and 20 mg tablet (Pariet®) 232/06 Eisai Ltd Accepted Abbreviated Submission
Esomeprazole (Nexium®) 257/06 AstraZeneca UK Ltd Not Recommended Full submission
Esomeprazole (Nexium®) 274/06 AstraZeneca UK Ltd Not Recommended Full submission
infliximab 100mg powder for intravenous infusion (Remicade) 363/07 Schering-Plough Ltd Superseded Full submission
infliximab 100mg powder for intravenous infusion (Remicade) 364/07 Schering-Plough Ltd Superseded Full submission
esomeprazole 20mg and 40mg tablets(Nexium) 368/07 AstraZeneca UK Ltd Restricted Full submission
infliximab (Remicade) 374/07 Schering-Plough Ltd Not Recommended Full submission
infliximab (Remicade) 374/07 Schering-Plough Ltd Not Recommended Non submission
infliximab (Remicade) 374/07 MSD Superseded Resubmission
budesonide 2mg Rectal Foam (Budenofalk) 409/07 Dr Falk Pharma UK Accepted Abbreviated Submission
adalimumab 40mg solution for injection (Humira) 417/07 Abbott Laboratories Superseded Full submission
esomeprazole (Nexium) 422/07 AstraZeneca UK Ltd Accepted Full submission
mesalazine 1200mg gastro-resistant prolonged release tablet (Mezavant XL) 445/08 Shire Pharmaceuticals Accepted Abbreviated Submission
infliximab (Remicade) 448/08 Schering-Plough Ltd Superseded Full submission
methylnaltrexone bromide (Relistor) 518/08 John Wyeth and Brother Limited Restricted Full submission
esomeprazole IV 40mg powder (Nexium) 578/09 AstraZeneca UK Ltd Accepted Full submission
esomeprazole oral suspension (Nexium) Abbreviated 639/10 AstraZeneca UK Ltd Restricted Abbreviated Submission
prucalopride (Resolor) 653/10 Movetis UK Not Recommended Full submission
prucalopride (Resolor) 653/10 Shire-Movetis Not Recommended Resubmission
adalimumab (Humira) 800/12 Abbott Laboratories Superseded Non submission
racecadotril (Hidrasec Infants, Hidrasec Children) 818/12 Abbott Laboratories Limited Not Recommended Full submission
racecadotril (Hidrasec) 818/12 Abbott Healthcare Products Ltd Not Recommended Resubmission
adalimumab (Humira) 824/12 Abbott Laboratories Not Recommended Non submission
budesonide 3mg gastro-resistant capsule (Budenofalk) 828/12 Dr Falk Pharma UK Accepted Full submission
budesonide 9mg gastro-resistant granules (Budenofalk) Abbreviated 831/12 Dr Falk Pharma UK Accepted Abbreviated Submission
racecadotril (Hidrasec) 832/12 Abbott Laboratories Limited Not Recommended Non submission
linaclotide (Constella) 869/13 Almirall Ltd Restricted Full submission
adalimumab (Humira) 880/13 AbbVie Ltd Restricted Abbreviated Submission
ursodeoxycholic acid 500mg film-coated tablets (Ursofalk®) 889/13 Dr Falk Pharma UK Accepted Abbreviated Submission
Macrogol 4000 (Idrolax®) 94/04 Schwarz Pharma Ltd Not Recommended Full submission
golimumab (Simponi) 946/13 MSD Superseded Full submission
budesonide gastro-resistant granules (Budenofalk®) 970/14 Dr Falk Pharma UK Accepted Abbreviated Submission
lubiprostone, 24 micrograms soft capsules (Amitiza®) 977/14 Sucampo Pharmaceuticals Not Recommended Full submission

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