Myozyme 50 mg, powder for concentrate for solution for infusion

Product name and form

Myozyme 50 mg powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion.

White to off-white powder.

Qualitative and quantitative composition

One vial contains 50 mg of alglucosidase alfa.

After reconstitution, the solution contains 5 mg of alglucosidase alfa* per ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml.

*Human acid α-glucosidase is produced in Chinese hamster ovary cells (CHO) by recombinant DNA technology.

For a full list of excipients, see section 6.1.

List of Excipients

Mannitol
Sodium dihydrogen phosphate monohydrate
Disodium phosphate heptahydrate
Polysorbate 80

Pack sizes and marketing

50 mg of powder in a vial (Type 1 glass) with a stopper (siliconised butyl) and a seal (aluminium) with a flip-off cap (plastic). Pack sizes of 1, 10 or 25 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Genzyme Europe B.V.
Gooimeer 10
NL-1411 DD Naarden
The Netherlands

Marketing authorization dates and numbers

EU/1/06/333/001-003

Date of first authorisation: 29 March 2006

Date of latest renewal: 29 March 2011

Drugs

Drug
Countries
Austria, Brazil, Canada, Cyprus, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, South Africa