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Category: 9.8 Metabolic disorders

Name SMC ID No Manufacturer Status Sub. Type
 
alglucosidase alfa (Myozyme®) 352/07 Genzyme Therapeutics Ltd 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
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
idursulfase 2mg/ml concentrate for solution for infusion (Elaprase) 391/07 Shire Pharmaceuticals Not Recommended Full submission
Laronidase (Aldurazyme) 100/04 Genzyme Therapeutics Ltd Not Recommended Full submission
Laronidase (Aldurazyme®) 100/04 Genzyme Therapeutics Ltd Not Recommended Resubmission
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
sodium phenylbutyrate (Pheburane) 914/13 Lucane Pharma Accepted Abbreviated Submission
velaglucerase (Vpriv) 681/11 Shire Pharmaceuticals Not Recommended Non submission
velaglucerase (Vpriv) 681/11 Shire Pharmaceuticals Accepted Full submission

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