You are here:
Name SMC ID No Manufacturer Status Sub. Type
 
alglucosidase alfa (Myozyme®) 352/07 Genzyme Therapeutics Ltd Not Recommended Full submission
Anagrelide 0.5mg capsule (Xagrid®) 163/05 Shire Pharmaceuticals Accepted Resubmission
Anagrelide 0.5mg capsule (Xagrid®) 163/05 Shire Pharmaceuticals Not Recommended Full submission
betaine anhydrous (Cystadane) 407/07 Orphan Europe (UK) Ltd Restricted Resubmission
betaine anhydrous oral powder (Cystadane) 407/07 Orphan Europe (UK) Ltd Not Recommended Full submission
betaine anhydrous oral powder (Cystadane) 407/07 Orphan Europe (UK) Ltd Not Recommended Resubmission
calcium acetate (Phoslo) 601/10 Fresenius Medical Care (UK) Ltd Accepted Abbreviated Submission
calcium acetate and magnesium carbonate (Osvaren) 693/11 Fresenius Medical Care (UK) Ltd Not Recommended Full submission
calcium carbonate + cholecalciferol (Kalcipos-D®) 718/11 Meda Pharmaceuticals Ltd Accepted Abbreviated Submission
Calcium phosphate, cholecalciferol (Calfovit D3) 72/03 Trinity-Chiesi Pharmaceuticals Ltd Accepted Abbreviated Submission
calcium polystyrene sulphonate powder for oral/rectal suspension (Sorbisterit®) 890/13 Stanningly Pharma Limited Accepted Abbreviated Submission
carglumic acid (Carbaglu) 899/13 Orphan Europe (UK) Ltd Accepted Full submission
carglumic acid 200mg dispersible tablets (Carbaglu) 299/06 Orphan Europe (UK) Ltd Restricted Full submission
cholecalciferol 25,000 international units oral solution (InVita D3) 1011/14 Consilient Health Ltd Accepted Abbreviated Submission
cinacalcet (Mimpara) 271/06 Amgen Ltd Not Recommended Non submission
cinacalcet (Mimpara) 169/05 Amgen Ltd Superseded Resubmission
cinacalcet (Mimpara) 169/05 Amgen Ltd Superseded Full submission
colecalciferol (Desunin) 840/13 Meda Pharmaceuticals Ltd Accepted Abbreviated Submission
colecalciferol (Fultium-D3) 801/12 Internis Pharmaceuticals Ltd Accepted Full submission
colestilan (BindRen) 939/14 Mitsubishi Pharma Europe Ltd Marketing Authorisation Withdrawn Full submission
colestilan (BindRen) 939/14 Mitsubishi Pharma Europe Ltd Marketing Authorisation Withdrawn IRP
colestilan (BindRen®) 939/14 Mitsubishi Pharma Europe Ltd Marketing Authorisation Withdrawn Resubmission
Darbepoetin alfa Sureclick (Aranesp) 265/06 Amgen Ltd Superseded Non submission
Darbepoetin alfa (Aranesp®) 273/06 Amgen Ltd Superseded Non submission
deferasirox (Exjade) 866/13 Novartis Pharmaceuticals UK Ltd Not Recommended Non submission
deferasirox (Exjade) 347/07 Novartis Pharmaceuticals UK Ltd Restricted Full submission
deferasirox (Exjade) 347/07 Novartis Pharmaceuticals UK Ltd Restricted Resubmission
deferasirox (Exjade) 1246/17 Novartis Pharmaceuticals UK Ltd Restricted Abbreviated Submission
eculizumab (Soliris) 767/12 Alexion Pharma UK Ltd Not Recommended Non submission
eculizumab (Soliris) 915/13 Alexion Pharma UK Ltd Not Recommended Non submission
eculizumab (Soliris) 436/07 Alexion Pharma UK Ltd Not Recommended Non submission
eculizumab (Soliris) 436/07 Alexion Pharma UK Ltd Not Recommended Full submission
eculizumab (Soliris) aHUS 767/12 Alexion Pharma UK Ltd Not Recommended Full submission
eculizumab (Soliris) for PNH 1130/16 Alexion Pharma UK Ltd Not Recommended Full submission
eliglustat (Cerdelga) 1277/17 Sanofi Genzyme Accepted Full submission
elosulfase alfa (Vimizim) 1072/15 BioMarin Not Recommended Full submission
eltrombopag (Revolade) 1206/17 Novartis Pharmaceuticals UK Ltd Restricted Abbreviated Submission
eltrombopag (Revolade) 919/13 GlaxoSmithKline UK Ltd Accepted Full submission
eltrombopag olamine (Revolade) 1164/16 Novartis Pharmaceuticals UK Ltd Not Recommended Non submission
epoetin alfa (Binocrit) 597/10 Sandoz Ltd Accepted Full submission
epoetin delta prefilled syringe (Dynepo) 418/07 Shire Pharmaceuticals Marketing Authorisation Withdrawn Full submission
epoetin theta (Eporatio) 620/10 Ratiopharm UK Accepted Full submission
epoetin zeta (Retacrit) 467/08 Hospira UK Limited Accepted Full submission
etelcalcetide (Parsabiv) 1262/17 Amgen Ltd Not Recommended Full submission
ferric carboxymaltose (Ferinject) 463/08 Syner-Med (PP) Ltd Not Recommended Full submission
ferric carboxymaltose (Ferinject) 463/08 Vifor Pharma Not Recommended Resubmission
ferric carboxymaltose (Ferinject) 463/08 Vifor Pharma Restricted Resubmission
ferric maltol (Feraccru) 1202/16 Shield Therapeutics Not Recommended Full submission
ferumoxytol (Rienso) 833/13 Takeda UK Ltd Marketing Authorisation Withdrawn Full submission
filgrastim (Nivestim) 671/11 Hospira UK Limited Accepted Full submission
filgrastim (Ratiograstim) 577/09 Ratiopharm UK Accepted Full submission
filgrastim (TevaGrastim) 629/10 Teva UK Limited Accepted Abbreviated Submission
filgrastim (Zarzio) 704/11 Sandoz Ltd Accepted Full submission
hydroxycarbamide (Siklos) 582/09 Nordic Pharma UK Not Recommended Non submission
idursulfase 2mg/ml concentrate for solution for infusion (Elaprase) 391/07 Shire Pharmaceuticals Not Recommended Full submission
iron (III) isomaltoside 1000 (Diafer) 1177/16 Pharmacosmos UK Accepted Resubmission
iron (III) isomaltoside 1000 (Diafer) 1177/16 Pharmacosmos UK Not Recommended Full submission
iron isomaltoside 100mg/ml (Monofer) 697/11 Pharmacosmos UK Restricted Full submission
lanthanum carbonate (Fosrenol) 640/10 Shire Pharmaceuticals Not Recommended Full submission
lanthanum carbonate (Fosrenol) 821/12 Shire Pharmaceuticals Restricted Abbreviated Submission
lanthanum carbonate 500, 750, 1000mg chewable tablets (Fosrenol) 286/06 Shire Pharmaceuticals Restricted Full submission
Laronidase (Aldurazyme) 100/04 Genzyme Therapeutics Ltd Not Recommended Full submission
Laronidase (Aldurazyme®) 100/04 Genzyme Therapeutics Ltd Not Recommended Resubmission
lipegfilgrastim, 6mg, solution for injection (Lonquex®) 908/13 Teva UK Limited Restricted Full submission
magnesium aspartate dehydrate (Magnaspartate) 1042/15 Kora Healthcare Accepted Abbreviated Submission
magnesium glycerophosphate (Neomag) 1267/17 Neoceuticals Ltd Accepted Abbreviated Submission
Methoxy polyethylene glycol-epoetin beta 455/08 Roche Accepted Full submission
migalastat (Galafold) 1196/16 Amicus Restricted Full submission
miglustat (Zavesca) 632/10 Actelion Pharmaceuticals UK Ltd Not Recommended Non submission
Miglustat (Zavesca®) 133/04 Actelion Pharmaceuticals UK Ltd Accepted Full submission
paricalcitol 5 micrograms/ml and 10 micrograms/ml solution for injection (Zemplar) 288/06 Abbott Laboratories Not Recommended Resubmission
paricalcitol 5mcg/ml and 10mcg/2ml solution for Injection (Zemplar) 288/06 Abbott Laboratories Not Recommended Full submission
paricalcitol capsules 1,2 and 4 micrograms (Zemplar) 478/08 Abbott Laboratories Not Recommended Full submission
Pegfilgrastim (Neulasta®) 67/03 Amgen Ltd Restricted Full submission
plerixafor (Mozobil) 594/09 Genzyme Therapeutics Ltd Accepted Full submission
romiplostim (Nplate) 553/09 Amgen Ltd Restricted Full submission
sapropterin (Kuvan) 558/09 Merck Serono Ltd Not Recommended Non submission
sevelamer (Renagel) 423/07 Genzyme Therapeutics Ltd Not Recommended Full submission
sevelamer carbonate (Renvela) 641/10 Genzyme Therapeutics Ltd Restricted Abbreviated Submission
sevelamer carbonate (Renvela) 1304/18 Sanofi Restricted Abbreviated Submission
sevelamer carbonate 800mg film coated tablets (Renvela) 641/10 Genzyme Therapeutics Ltd Not Recommended Full submission
sodium phenylbutyrate (Pheburane) 914/13 Lucane Pharma Accepted Abbreviated Submission
sucroferric oxyhydroxide (Velphoro) 1035/15 Fresenius Medical Care (UK) Ltd Accepted Full submission
tocofersolan (Vedrop) 696/11 Orphan Europe (UK) Ltd Not Recommended Full submission
tocofersolan (Vedrop) 696/11 Orphan Europe (UK) Ltd Not Recommended Resubmission
tofacitinib (Xeljanz) 1298/18 Pfizer Ltd Restricted Full submission
velaglucerase (Vpriv) 681/11 Shire Pharmaceuticals Not Recommended Non submission
velaglucerase (Vpriv) 681/11 Shire Pharmaceuticals Accepted Full submission

Back