| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzymes | 4999 | 9025-60-9 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
BMN-100 and BMN 110 are recombinant GALNS; RefSeq NM_000512
|
| Dose | Unit | Route |
|---|---|---|
| 20 | mg | P |
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 28, 2014 | EMA | ||
| Feb. 14, 2014 | FDA | BIOMARIN PHARM |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Knee deformity | 55.85 | 47.25 | 10 | 648 | 1335 | 63487029 |
| Spinal cord compression | 50.13 | 47.25 | 11 | 647 | 4137 | 63484227 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Spinal cord compression | 61.70 | 49.61 | 13 | 360 | 3962 | 34952596 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Spinal cord compression | 86.94 | 41.08 | 19 | 894 | 6358 | 79737117 |
| Urticaria | 63.03 | 41.08 | 34 | 879 | 185167 | 79558308 |
| Knee deformity | 61.87 | 41.08 | 11 | 902 | 1274 | 79742201 |
| Pyrexia | 51.86 | 41.08 | 50 | 863 | 678659 | 79064816 |
| Oxygen saturation decreased | 47.50 | 41.08 | 25 | 888 | 129022 | 79614453 |
None
| Source | Code | Description |
|---|---|---|
| ATC | A16AB12 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Enzymes |
| FDA CS | M0000794 | alpha-Glucosidases |
| FDA EPC | N0000175823 | Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Mucopolysaccharidosis, MPS-IV-A | indication | 7259005 | DOID:0111391 |
None
None
None
None
None
None
| ID | Source |
|---|---|
| D10333 | KEGG_DRUG |
| 4033117 | VUID |
| N0000190127 | NUI |
| 4033117 | VANDF |
| CHEMBL2108676 | ChEMBL_ID |
| C102295 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7392 | IUPHAR_LIGAND_ID |
| DB09051 | DRUGBANK_ID |
| 1489914 | RXNORM |
| 213108 | MMSL |
| 30194 | MMSL |
| d08244 | MMSL |
| 015387 | NDDF |
| 702395005 | SNOMEDCT_US |
| 716640004 | SNOMEDCT_US |
| C3817397 | UMLSCUI |
| 9686 | INN_ID |
| ODJ69JZG85 | UNII |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| VIMIZIM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68135-100 | INJECTION, SOLUTION, CONCENTRATE | 5 mg | INTRAVENOUS | BLA | 23 sections |
| VIMIZIM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68135-100 | INJECTION, SOLUTION, CONCENTRATE | 5 mg | INTRAVENOUS | BLA | 23 sections |