MEPSEVII Concentrate for solution for infusion Ref.[7644] Active ingredients: Vestronidase alfa

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Ultragenyx Germany GmbH, Friedrichstr. 191, 10117, Berlin, Germany

Product name and form

Mepsevii 2 mg/mL concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion (sterile concentrate).

Colourless to slightly yellow solution.

Qualitative and quantitative composition

Each mL of concentrate contains 2 mg vestronidase alfa*. Each vial of 5 mL concentrate contains 10 mg vestronidase alfa.

* Vestronidase alfa is a recombinant form of human beta-glucuronidase (rhGUS) and is produced in Chinese Hamster Ovary cell culture by recombinant DNA technology.

Excipient(s) with known effect: Each vial contains 17.8 mg sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Vestronidase alfa

Vestronidase alfa is a recombinant form of human betaglucuronidase (GUS) and is intended to provide exogenous GUS enzyme for uptake into cellular lysosomes and subsequent catabolism of accumulated glycosaminoglycans (GAGs) in affected tissues.
List of Excipients

Sodium dihydrogen phosphate dihydrate
Sodium chloride
Histidine
Polysorbate 20
Water for injections

Pack sizes and marketing

Colourless glass vial (Ph. Eur. Type I) with a rubber stopper with fluoro-resin coating, and an aluminium over seal with a plastic flip-off cap.

Pack size: 1 vial containing 5 mL of concentrate for solution for infusion.

Marketing authorization holder

Ultragenyx Germany GmbH, Friedrichstr. 191, 10117, Berlin, Germany

Marketing authorization dates and numbers

EU/1/18/1301/001

Date of first authorisation: 23 August 2018

Drugs

Drug Countries
MEPSEVII Austria, Brazil, Estonia, Spain, France, Croatia, Ireland, Italy, Japan, Lithuania, Poland, United States
 
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