Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Nexviadyme 100 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion. White to pale yellow lyophilised powder. |
Each vial contains 100 mg of avalglucosidase alfa.
After reconstitution, each vial contains a total extractable volume of 10.0 ml at a concentration of 10 mg of avalglucosidase alfa* per ml.
* Avalglucosidase alfa is a human acid α-glucosidase produced in Chinese hamster ovary cells (CHO) by recombinant DNA technology, which is subsequently conjugated with approximately 7 hexamannose structures (each containing two terminal mannose-6-phosphate (M6P) moieties) to oxidised sialic acid residues on the molecule, thereby increasing bis-M6P levels.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Avalglucosidase alfa |
Avalglucosidase alfa is a recombinant human acid α-glucosidase (rhGAA) that provides an exogenous source of GAA. Binding to M6P receptors on the cell surface has been shown to occur via carbohydrate groups on the GAA molecule, after which it is internalised and transported into lysosomes, where it undergoes proteolytic cleavage that results in increased enzymatic activity to degrade glycogen. |
| List of Excipients |
|---|
|
Histidine |
100 mg of powder for concentrate for solution for infusion in a vial (type I glass) with a stopper (elastomeric rubber), seal (aluminium) and a flip off cap.
Each pack contains 1, 5, 10, or 25 vials.
Not all pack sizes may be marketed.
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
EU/1/21/1579/001
EU/1/21/1579/002
EU/1/21/1579/003
EU/1/21/1579/004
Date of first authorisation: 24 June 2022
| Drug | Countries | |
|---|---|---|
| NEXVIADYME | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Romania, United Kingdom |
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