Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Comharsa Life Sciences Limited, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
NULIBRY 9.5 mg powder for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection (powder for injection). White to pale yellow powder. The reconstituted solution has a pH in the range of 5-7, a viscosity of 1.0 cSt, and an osmolarity within the range of 260-320 mOsmol/kg. |
Each vial contains 12.5 mg fosdenopterin hydrobromide dihydrate equivalent to 9.5 mg fosdenopterin.
After reconstitution with 5 mL of sterile water for injections, each mL of solution contains 1.9 mg of fosdenopterin (1.9 mg/mL).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fosdenopterin |
Patients with MoCD Type A have mutations in the Molybdenum Cofactor Synthesis 1 (MOCS1) gene leading to deficient MOCS1A/B dependent synthesis of the intermediate substrate, cPMP. Substrate replacement therapy with fosdenopterin provides an exogenous source of cPMP, which is converted to molybdopterin. Molybdopterin is then converted to molybdenum cofactor, which is needed for the activation of molybdenum-dependent enzymes, including sulphite oxidase (SOX), an enzyme that reduces levels of neurotoxic sulphites. |
| List of Excipients |
|---|
|
Ascorbic acid (E300) |
10 mL type I clear glass vial with an aluminium seal and butyl rubber stopper.
Pack size of 1 vial.
Comharsa Life Sciences Limited, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
EU/1/22/1684/001
| Drug | Countries | |
|---|---|---|
| NULIBRY | Austria, Croatia, Israel, Lithuania, United States |
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