Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy
Lamzede 10 mg powder for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for solution for infusion. White to off-white powder. |
One vial contains 10 mg of velmanase alfa*.
After reconstitution, one mL of the solution contains 2 mg of velmanase alfa (10 mg/5 mL).
For the full list of excipients, see section 6.1.
* Velmanase alfa is produced in mammalian Chinese Hamster Ovary (CHO) cells using recombinant DNA technology.
| Active Ingredient | Description | |
|---|---|---|
| Velmanase alfa |
Velmanase alfa is a recombinant form of human alpha-mannosidase. Velmanase alfa is intended to supplement or replace natural alpha-mannosidase, an enzyme that catalyses the sequential degradation of hybrid and complex high-mannose oligosaccharides in the lysosome, reducing the amount of accumulated mannose-rich oligosaccharides. |
| List of Excipients |
|---|
|
Disodium phosphate dihydrate |
10 mL vial (Type I glass) with a bromobutyl rubber stopper, an aluminium seal and a polypropylene flip off cap.
Each vial contains 10 mg of velmanase alfa.
Pack sizes of 1, 5 or 10 vials per carton.
Not all pack sizes may be marketed.
Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy
EU/1/17/1258/001
EU/1/17/1258/002
EU/1/17/1258/003
Date of first authorisation: 23/03/2018
| Drug | Countries | |
|---|---|---|
| LAMZEDE | Austria, Brazil, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania |
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