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Name SMC ID No Manufacturer Status Sub. Type
 
Zoledronic acid (Zometa®) 29/02 Novartis Pharmaceuticals UK Ltd Not Recommended IRP
Biphasic insulin aspart 30 (NovoMix 30®) 06/02 Novo Nordisk Ltd Accepted Resubmission
dapagliflozin (Forxiga) 799/12 AstraZeneca UK Ltd Restricted Resubmission
dapagliflozin (Forxiga) 799/12 AstraZeneca UK Ltd Superseded Resubmission
linagliptin (Trajenta) 850/13 Boehringer Ingelheim Ltd Accepted Resubmission
insulin degludec (Tresiba) 856/13 Novo Nordisk Ltd Accepted Resubmission
insulin degludec (Tresiba) 856/13 Novo Nordisk Ltd Not Recommended Resubmission
alogliptin (Vipidia) 937/14 Takeda UK Ltd Restricted Resubmission
Metformin hydrochloride (Glucophage SR®) 148/04 Merck Serono Ltd Not Recommended Resubmission
metformin (Glucophage SR) 148/04 Merck Serono Ltd Restricted Resubmission
Pioglitazone (Actos®) 115/04 Takeda UK Ltd Restricted Resubmission
Rosiglitazone (Avandia®) 91/04 GlaxoSmithKline UK Ltd Withdrawn Resubmission
Zoledronic acid (Zometa®) 29/02 Novartis Pharmaceuticals UK Ltd Restricted Resubmission
desmopressin (Noqdirna) 1218/17 Ferring Pharmaceuticals Ltd Restricted Resubmission
Pegvisomant (Somavert) 158/05 Pfizer Ltd Not Recommended Resubmission
pegvisomant (Somavert) 158/05 Pfizer Ltd Accepted Resubmission
Estradiol 1mg and drospirenone 2mg (Angeliq®) 230/05 Schering Health Care Ltd Full submission
1 mg estradiol/2 mg drospirenone (Angeliq®) 227/05 Schering Health Care Ltd Not Recommended Full submission
alendronate colecalciferol (Fosavance) 213/05 MSD Superseded Abbreviated Submission
choriogonadotropin alfa (Ovitrelle) 263/06 Serono Ltd Not Recommended Non submission
choriogonadotropin alfa 250 mcg/0.5 ml pre filled syringe (Ovitrelle) 263/06 Serono Ltd Accepted Abbreviated Submission
choriogonadotropin alfa (Ovitrelle) 264/06 Serono Ltd Not Recommended Non submission
choriogonadotropin alfa 250 mcg/0.5 ml pre-filled syringe (Ovitrelle) 264/06 Serono Ltd Accepted Abbreviated Submission
Biphasic insulin aspart 30 (Novomix 30®) 06/02 Novo Nordisk Ltd Not Recommended Full submission
Conjugated oestrogen medroxyprogesterone (Premique Low Dose®) 130/04 Wyeth Pharmaceuticals Accepted Full submission
sitagliptin (Januvia) 505/08 MSD Accepted Full submission
cinacalcet (Mimpara) 513/08 Amgen Ltd Not Recommended Non submission
insulin lispro (Humalog Mix25, Mix50 KwikPen) 509/08 MSD Accepted Abbreviated Submission
insulin lispro (Humalog KwikPen) 508/08 MSD Accepted Abbreviated Submission
Insulin glulisine (Apidra) 512/08 Sanofi-Aventis Restricted Abbreviated Submission
zoledronic acid (Aclasta) 535/08 Novartis Pharmaceuticals UK Ltd Not Recommended Non submission
testosterone undecanoate (Nebido) 308/06 Bayer plc/Bayer Schering Pharma Accepted Full submission
micronised progesterone (Utrogestan) 542/09 Ferring Pharmaceuticals Ltd Not Recommended Full submission
terlipressin acetate (Glyperessin Solution) 555/09 Ferring Pharmaceuticals Ltd Accepted Abbreviated Submission
mecasermin (Increlex) 563/09 Ipsen Ltd Accepted Full submission
vildagliptin (Galvus) 571/09 Novartis Pharmaceuticals UK Ltd Accepted Full submission
tolvaptan (Samsa) 605/10 Otsuka Pharmaceutical Europe Not Recommended Non submission
somatropin (Omnitrope) 598/10 Sandoz Ltd Accepted Full submission
metformin hydrochloride (Glucophage) 500mg/1000mg Powder for Solution 610/10 Merck Serono Ltd Abbreviated Submission
sitagliptin/metformin (Janumet) 492/08 MSD Restricted Abbreviated Submission
sitagliptin (Januvia) monotherapy 607/10 MSD Restricted Full submission
corifollitropin alfa (Elonva) 633/10 MSD Not Recommended Non submission
sitagliptin plus metformin (Janumet 50/1000) 627/10 MSD Accepted Abbreviated Submission
denosumab (Prolia) 651/10 Amgen Ltd Restricted Full submission
denosumab (Prolia) 670/10 Amgen Ltd Not Recommended Non submission
triptorelin pamoate (Decapeptyl SR 22.5mg) 705/11 Ipsen Ltd Accepted Abbreviated Submission
exenatide (Byetta) 684/11 Eli Lilly and Company Ltd Restricted Full submission
somatropin (Saizen) 737/11 Merck Serono Ltd Accepted Abbreviated Submission
denosumab (Xgeva) 752 /11 Amgen Ltd Superseded Non submission
prednisone MR (Lodotra) 771/12 Napp Pharmaceuticals Ltd Not Recommended Non submission
saxagliptin (Onglyza) 772/12 AstraZeneca UK Ltd Not Recommended Non submission
saxagliptin (Onglyza) 772/12 AstraZeneca UK Ltd Accepted Full submission
insulin detemir (Levemir) 780/12 Novo Nordisk Ltd Restricted Abbreviated Submission
triptorelin pamoate (Salvacyl) 796/12 Ipsen Ltd Not Recommended Non submission
pasireotide (Signifor) 815/12 Novartis Pharmaceuticals UK Ltd Not Recommended Non submission
vildagliptin (Galvus) 826/12 Novartis Pharmaceuticals UK Ltd Restricted Full submission
dapagliflozin (Forxiga) 799/12 Bristol-Myers Squibb Pharmaceuticals Ltd Restricted Full submission
hydrocortisone (Plenadren) 848/12 ViroPharma Ltd Not Recommended Non submission
hydrocortisone (Plenadren) 848/12 Shire Pharmaceuticals Not Recommended Full submission
ulipristal acetate (Esmya) 834/13 Gedeon Richter UK Ltd Accepted Full submission
linagliptin (Trajenta) 850/13 Boehringer Ingelheim Ltd Restricted Full submission
insulin degludec (Tresiba) 856/13 Novo Nordisk Ltd Not Recommended Full submission
insulin glargine (Lantus) 860/13 Sanofi-Aventis Restricted Abbreviated Submission
ulipristal acetate (Esmya) 1128/16 Gedeon Richter UK Ltd Accepted Full submission
insulin detemir (Levemir) 1126/16 Novo Nordisk Ltd Restricted Abbreviated Submission
alendronic acid (Binosto) 1137/16 Internis Pharmaceuticals Ltd Restricted Abbreviated Submission
liraglutide (Victoza) 1192/16 Novo Nordisk Ltd Not Recommended Non submission
saxagliptin (Onglyza) 958/14 Bristol-Myers Squibb Pharmaceuticals Ltd / AstraZeneca Not Recommended Non submission
alogliptin (Vipidia) 937/14 Takeda UK Ltd Not Recommended Full submission
canagliflozin (Invokana®) 963/14 Janssen-Cilag Ltd Superseded Full submission
dapagliflozin + metformin (Xigduo) 983/14 AstraZeneca UK Ltd Restricted Abbreviated Submission
empagliflozin (Jardiance) 993/14 Boehringer Ingelheim Ltd Superseded Full submission
alogliptin plus metformin (Vipdomet) 998/14 Takeda UK Ltd Restricted Abbreviated Submission
denosumab (Prolia) 1013/14 Amgen Ltd Not Recommended Non submission
canagliflozin plus metformin (Vokanamet) 1019/14 Janssen-Cilag Ltd Restricted Abbreviated Submission
follitropin alfa (Bemfola) 1025/15 FINOX Biotech Accepted Full submission
liraglutide (Victoza) 1044/15 Novo Nordisk Ltd Accepted Full submission
insulin degludec (Tresiba) 1060/15 Novo Nordisk Ltd Not Recommended Non submission
linagliptin + metformin (Jentadueto) 1057/15 Boehringer Ingelheim Ltd Restricted Abbreviated Submission
sitagliptin (Januvia) 1083/15 MSD Accepted Full submission
insulin degludec/liraglutide (Xultophy) 1088/15 Novo Nordisk Ltd Restricted Full submission
empagliflozin/metformin (Synjardy) 1092/15 Boehringer Ingelheim Ltd Restricted Abbreviated Submission
midodrine hydrochloride (Bramox) 1094/15 Brancaster Pharma Limited Accepted Abbreviated Submission
ketoconazole (Ketoconazole HRA) 1100/15 HRA Pharma UK Ltd Not Recommended Non submission
insulin glargine (Toujeo) 1078/15 Sanofi-Aventis Restricted Abbreviated Submission
denosumab (Xgeva) 1119/15 Amgen Ltd Not Recommended Non submission
tolvaptan (Jinarc) 1114/15 Otsuka Pharmaceutical Europe Accepted Full submission
dulaglutide (Trulicity) 1110/15 Eli Lilly and Company Ltd Restricted Full submission
exenatide (Byetta) 785/12 Lilly UK Accepted Full submission
vildagliptin / metformin hydrochloride (Eucreas®) 874/13 Novartis Pharmaceuticals UK Ltd Not Recommended Non submission
vildagliptin (Galvus) 875/13 Novartis Pharmaceuticals UK Ltd Not Recommended Non submission
vildagliptin (Galvus) 875/13 Novartis Pharmaceuticals UK Ltd Restricted Full submission
saxagliptin + metformin (Komboglyze) 870/13 Bristol-Myers Squibb Pharmaceuticals Ltd / AstraZeneca Restricted Abbreviated Submission
lixisenatide (Lyxumia) 903/13 Sanofi-Aventis Restricted Full submission
medroxyprogesterone acetate (Sayana Press) 896/13 Pfizer Ltd Accepted Abbreviated Submission
Dutasteride (Avodart®) 37/03 GlaxoSmithKline UK Ltd Accepted Full submission
Estradiol & levonorgesteral patches (FemSeven Sequi®) 20/02 Merck Serono Ltd Accepted Full submission
Estradiol & levonorgestrel patches (FemSeven Conti®) 28/02 Merck Serono Ltd Accepted Full submission
Ibandronic acid (Bondronat®) 123/04 Roche Accepted Full submission
Ibandronic acid (Bondronat®) 122/04 Roche Accepted Full submission
Ibandronic acid (Bonviva®) 228/05 Roche Accepted Full submission
inhaled insulin, 1mg and 3mg inhalation powder (Exubera) 254/06 Pfizer Ltd Withdrawn Full submission
Insulin detemir (Levemir®) 110/04 Novo Nordisk Ltd Restricted Full submission
Insulin detemir (Levemir®) 138/04 Novo Nordisk Ltd Restricted Abbreviated Submission
Insulin glargine (Lantus®) 11/02 Aventis Restricted Full submission
Metformin hydrochloride (Glucophage SR®) 148/04 Merck Serono Ltd Not Recommended Full submission
Oestradiol (Estradot®) range of transdermal patches 117/04 Novartis Pharmaceuticals UK Ltd Accepted Abbreviated Submission
Pioglitazone (Actos®) 115/04 Takeda UK Ltd Not Recommended Full submission
Pioglitazone 15mg/metformin 850mg hydrochloride (Competact) 252/06 Takeda UK Ltd Restricted Abbreviated Submission
Risedronate sodium (Actonel®) 46/03 Procter and Gamble Superseded Abbreviated Submission
Rosiglitazone (Avandia®) 91/04 GlaxoSmithKline UK Ltd Withdrawn Full submission
Rosiglitazone maleate (Avandia Triple Therapy®) 181/05 GlaxoSmithKline UK Ltd Withdrawn Abbreviated Submission
Rosiglitazone maleate/metformin hydrochloride (Avandamet®) 140/04 GlaxoSmithKline UK Ltd Withdrawn Abbreviated Submission
Somatropin (Genotropin®) injection 240/06 Pfizer Ltd Superseded Abbreviated Submission
Somatropin (Norditropin SimpleXx) 260/06 Novo Nordisk Ltd Restricted Abbreviated Submission
Teriparatide (Forsteo®) 71/03 Eli Lilly and Company Ltd Superseded Full submission
Testosterone gel (Testogel®) 83/03 Schering Health Care Ltd Restricted Full submission
Testosterone mucoadhesive buccal tablets (Striant®) 128/04 Ardana Bioscience Restricted Full submission
Triptorelin (Gonapeptyl Depot®) 160/05 Ferring Pharmaceuticals Ltd Accepted Full submission
Triptorelin 11.25mg injection (Decapeptyl SR®) 207/05 Ipsen Ltd Accepted Abbreviated Submission
Zoledronic acid (Zometa®) 29/02 Novartis Pharmaceuticals UK Ltd Not Recommended Full submission
rosiglitazone/metformin 2mg/500mg, 2mg/1g, 4mg/1g (Avandamet) 281/06 GlaxoSmithKline UK Ltd Withdrawn Abbreviated Submission
desmopressin 120 mcg oral lyophilisate (DesoMelt) 282/06 Ferring Pharmaceuticals Ltd Accepted Abbreviated Submission
Testosterone 50mg/5g gel (Testim) 284/06 Ipsen Ltd Restricted Abbreviated Submission
insulin glulisine for subcutaneous injection 100 units/ml (Apidra) 298/06 Sanofi-Aventis Restricted Full submission
ibandronic acid, 3mg in 3ml solution for injection (Bonviva) 301/06 Roche Restricted Full submission
zoledronic acid 5mg/100ml solution for infusion (Aclasta) 317/06 Novartis Pharmaceuticals UK Ltd Accepted Full submission
triptorelin 11.25mg vial for injection (Decapeptyl SR) 331/06 Ipsen Ltd Accepted Abbreviated Submission
testosterone (Nebido) 1000mg/4ml, solution for injection 308/06 Schering Health Care Ltd Not Recommended Non submission
parathyroid hormone (Preotact) 356/07 Nycomed UK Ltd Marketing Authorisation Withdrawn Full submission
pioglitazone 15mg, 30mg and 45mg tablets (Actos® triple therapy) 354/07 Takeda UK Ltd Restricted Full submission
desmopressin 240 micrograms oral lyophilisate (Desmomelt) 357/07 Ferring Pharmaceuticals Ltd Accepted Abbreviated Submission
desmopressin 60, 120 and 240 micrograms oral lyophilisate (DDAVP Melt) 358/07 Ferring Pharmaceuticals Ltd Accepted Abbreviated Submission
testosterone 2% gel (Tostran) 372/07 ProStrakan Restricted Abbreviated Submission
exenatide 5 or 10 micrograms, solution for injection, prefilled pen (Byetta) 376/07 Eli Lilly and Company Ltd Restricted Full submission
insulin detemir, 100 U/ml solution for injection via InnoLet device (Levemir in InnoLet) 393/07 Novo Nordisk Ltd Restricted Abbreviated Submission
testosterone 300 microgram/24 hours transdermal patch (Intrinsa) 398/07 Procter and Gamble Not Recommended Full submission
pioglitazone 15mg, 30mg and 45mg tablets (Actos) 399/07 Takeda UK Ltd Accepted Full submission
sitagliptin (Januvia) 408/07 MSD Restricted Full submission
conjugated estrogen 0.3mg tablet (Premarin) 413/07 Wyeth Pharmaceuticals Accepted Abbreviated Submission
risedronate sodium (Actonel) 424/07 Procter and Gamble Not Recommended Non submission
zoledronic acid (Aclasta) 447/08 Novartis Pharmaceuticals UK Ltd Restricted Full submission
follitropin alpha/lutropin alpha (Pergoveris) 444/08 Merck Serono Ltd Accepted Abbreviated Submission
vildagliptin (Galvus) 435/07 Novartis Pharmaceuticals UK Ltd Restricted Full submission
insulin glargine (Lantus Solostar) 456/08 Sanofi-Aventis Restricted Abbreviated Submission
insulin glulisine (Apidra Solostar) 457/08 Sanofi-Aventis Restricted Abbreviated Submission
teriparatide 20 micrograms/80 microlitres, solution for injection, in prefilled pen (Forsteo) 487/08 Eli Lilly and Company Ltd Not Recommended Non submission
vildagliptin/metformin (Eucreas) 477/08 Novartis Pharmaceuticals UK Ltd Restricted Abbreviated Submission
teriparatide (Forsteo) 490/08 Eli Lilly and Company Ltd Not Recommended Full submission
desmopressin (Noqdirna) 1218/17 Ferring Pharmaceuticals Ltd Not Recommended Full submission
insulin aspart (Fiasp) 1227/17 Novo Nordisk Ltd Accepted Abbreviated Submission
liraglutide (Saxenda) 1247/17 Novo Nordisk Ltd Not Recommended Non submission
micronised progesterone (Utrogestan Vaginal) 935/13 Besins Healthcare (UK) Ltd Accepted Full submission
micronised progesterone (Utrogestan Vaginal) 935/13 Malborough Pharmaceuticals Ltd Not Recommended Non submission
Strontium ranelate 2g granules for oral suspension (Protelos®) 178/05 Servier Laboratories Ltd Withdrawn Full submission
strontium ranelate (Protelos) 816/12 Servier Laboratories Ltd Withdrawn Non submission
saxagliptin/dapagliflozin fixed dose combination (Qtern) 1255/17 AstraZeneca UK Ltd Restricted Abbreviated Submission
albiglutide (Eperzan) 1024/15 GlaxoSmithKline UK Ltd Restricted Full submission
Pegvisomant (Somavert®) 158/05 Pfizer Ltd Not Recommended Full submission
metformin hydrochloride (Glucophage) 1308/18 Merck Serono Ltd Not Recommended Non submission
liraglutide (Victoza) 585/09 Novo Nordisk Ltd Restricted Full submission
saxagliptin (Onglyza) 603/10 Bristol-Myers Squibb Pharmaceuticals Ltd Restricted Full submission
exenatide (Bydureon) 748/11 Eli Lilly and Company Ltd Restricted Full submission
linagliptin (Trajenta) 746/11 Boehringer Ingelheim Ltd Restricted Full submission
linagliptin+metformin (Jentadueto) 841/13 Boehringer Ingelheim Ltd Restricted Abbreviated Submission
saxagliptin (Onglyza) 918/13 Bristol-Myers Squibb Pharmaceuticals Ltd / AstraZeneca Restricted Full submission
saxagliptin metformin (Kombogylze) 929/13 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Abbreviated Submission
pasireotide (as pamoate) (Signifor) 1311/18 Novartis Pharmaceuticals UK Ltd Not Recommended Non submission

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