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| 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
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 14, 2014 | FDA | BIOMARIN PHARM | |
| April 28, 2014 | EMA |
| 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 |
|---|---|---|---|---|---|---|
| Pyrexia | 70.31 | 40.75 | 57 | 914 | 660428 | 89967048 |
| Knee deformity | 66.99 | 40.75 | 12 | 959 | 1550 | 90625926 |
| Vascular access complication | 43.74 | 40.75 | 9 | 962 | 2404 | 90625072 |
| Developmental hip dysplasia | 41.29 | 40.75 | 8 | 963 | 1577 | 90625899 |
| 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 | 58.37 | 55.29 | 10 | 583 | 769 | 42619973 |
| Spinal cord compression | 57.39 | 55.29 | 13 | 580 | 4211 | 42616531 |
| 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 |
|---|---|---|---|---|---|---|
| Pyrexia | 89.62 | 43.36 | 77 | 1198 | 898188 | 109689836 |
| Knee deformity | 79.27 | 43.36 | 14 | 1261 | 1549 | 110586475 |
| Spinal cord compression | 78.18 | 43.36 | 18 | 1257 | 7534 | 110580490 |
| Developmental hip dysplasia | 46.72 | 43.36 | 7 | 1268 | 276 | 110587748 |
| Urticaria | 45.67 | 43.36 | 34 | 1241 | 318823 | 110269201 |
| Oxygen saturation decreased | 45.33 | 43.36 | 26 | 1249 | 156956 | 110431068 |
| Cough | 44.45 | 43.36 | 39 | 1236 | 461602 | 110126422 |
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 |
| CHEBI:753624 | CHEBI |
| 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 | 28 sections |