Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
Vimizim 1 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (Sterile concentrate). A clear to slightly opalescent and colourless to pale yellow solution. |
Each ml of solution contains 1 mg elosulfase alfa*. Each vial of 5 ml contains 5 mg elosulfase alfa.
* Elosulfase alfa is a recombinant form of human N-acetylgalactosamine-6-sulfatase (rhGALNS) and is produced in Chinese Hamster Ovary cell culture by recombinant DNA technology.
Excipients with known effect:
Each 5 ml vial contains 8 mg sodium and 100 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Elosulfase alfa |
Elosulfase alfa is a recombinant form of human N-acetylgalactosamine-6-sulfatase (rhGALNS) used for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA). Elosulfase alfa is intended to provide the exogenous enzyme N-acetylgalactosamine-6-sulfatase that will be taken up into the lysosomes and increase the catabolism of the GAGs KS and C6S. |
| List of Excipients |
|---|
|
Sodium acetate trihydrate |
Clear glass vial (Type I) with a butyl rubber stopper and a flip-off crimp seal (aluminium) with a plastic cap.
Pack sizes: 1 vial.
BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
EU/1/14/914/001
Date of first authorisation: 28 April 2014
| Drug | Countries | |
|---|---|---|
| VIMIZIM | Austria, Brazil, Canada, Ecuador, Estonia, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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