Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Xenpozyme 20 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Powder for concentrate for solution for infusion (powder for concentrate). White to off-white lyophilised powder. |
Each vial contains 20 mg of olipudase alfa*.
After reconstitution, each vial contains 4 mg of olipudase alfa per mL. Each vial must be further diluted before use (see section 6.6).
* Olipudase alfa is a recombinant human acid sphingomyelinase and is produced in a Chinese Hamster Ovary (CHO) cell line by recombinant DNA technology.
Excipient with known effect: Each vial contains 3.02 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Olipudase alfa |
Olipudase alfa is a recombinant human acid sphingomyelinase that reduces sphingomyelin (SM) accumulation in organs of patients with Acid Sphingomyelinase Deficiency (ASMD). |
| List of Excipients |
|---|
|
L-methionine |
20 mg of powder for concentrate for solution for infusion in a vial (Type I glass) with a siliconized chlorobutyl-elastomer lyophilization stopper, and an aluminum seal with a plastic 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/1/22/1659/001
EU/1/22/1659/002
EU/1/22/1659/003
EU/1/22/1659/004
| Drug | Countries | |
|---|---|---|
| XENPOZYME | Austria, France, Croatia, Israel, Italy, Japan, Lithuania, Romania |
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