Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122 Parma, Italy
Elfabrio 2 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Clear, colourless, solution. |
Each vial contains 20 mg of pegunigalsidase alfa in a volume of 10 mL at a concentration of 2 mg/mL.
The strength indicates the quantity of the pegunigalsidase alfa with consideration of the pegylation.
Pegunigalsidase alfa is produced in tobacco cells (Nicotiana tabacum BY2 cells) using recombinant DNA technology.
The active substance, pegunigalsidase alfa, is a covalent conjugate of prh-alpha-GAL-A with polyethylene glycol (PEG).
The potency of this medicinal product should not be compared to the one of another pegylated or nonpegylated protein of the same therapeutic class. For more information, see section 5.1.
Excipient with known effect: Each vial contains 48 mg sodium.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pegunigalsidase alfa |
The active substance of pegunigalsidase alfa is pegunigalsidase alfa. Pegunigalsidase alfa is a pegylated recombinant form of human α-galactosidase-A. The amino acid sequence of the recombinant form is similar to the naturally occurring human enzyme. Pegunigalsidase alfa supplements or replaces α-galactosidase-A, reducing the amount of accumulation of globotriaosylceramide (Gb3) and globotriaosylsphingosine (Lyso-Gb3). |
| List of Excipients |
|---|
|
Sodium citrate tribasic dihydrate |
10 mL vial (15R clear glass) closed with coated rubber stopper and sealed with aluminium flip off cap.
Pack sizes of 1, 5 or 10 vials.
Not all pack sizes may be marketed.
Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122 Parma, Italy
EU/1/23/1724/001
EU/1/23/1724/002
EU/1/23/1724/003
| Drug | Countries | |
|---|---|---|
| ELFABRIO | Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom, United States |
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